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News Article | May 9, 2017
Site: globenewswire.com

DURHAM, N.C., May 09, 2017 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the first quarter ended March 31, 2017. “We have made meaningful progress advancing both the short-course oral brincidofovir program and the first of several confirmatory studies of IV brincidofovir. The single ascending dose study of IV brincidofovir (BCV) demonstrated with the first dose of 10 mg that we can achieve the plasma exposures that previously showed antiviral activity in the SUPPRESS and AdVise studies, but without the previously noted gastrointestinal (GI) limitations,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. “These results together with the multiple-dose studies in healthy subjects and in infected populations will inform the planned pivotal pediatric trial for IV BCV, the MVP-Peds Study (Multi-Viral Prevention in Pediatric Allogeneic Transplant Recipients), which we hope to initiate in 2018.  We look forward to advancing this important program to bring brincidofovir to immunocompromised patients suffering with these life-threatening viral infections."                                          Recent Highlights and Program Updates: Full Data from Phase 1 Dose Escalation Study of Intravenous Brincidofovir in Healthy Subjects Reported Data from all four cohorts of the Phase 1 study of IV BCV were presented at the recent Investor Event held on April 27, 2017. In this study a total of 40 healthy subjects were randomized to receive a single dose of either IV BCV or IV placebo in one of four cohorts. IV BCV 10 mg achieved comparable plasma exposure to that achieved with the oral BCV 100 mg dose.  There were no drug-related adverse events (AEs) reported in either the 10 mg or 25 mg cohorts; this dose range is likely to be selected for future studies for treatment of adenovirus and prevention of cytomegalovirus and other DNA viruses based on the antiviral activity demonstrated with oral BCV 100 mg. Doses higher than those currently being explored for the above indications (“supratherapeutic”) of IV BCV (50 mg given over two hours in Cohort 3, 50 mg given over four hours in Cohort 4) were also administered to evaluate the potential effects of BCV on QT interval and other safety parameters.  A majority of the AEs reported were mild and self-limited. Four subjects in Cohort 3 reported drug-related AEs: one drug-related GI AE, two subjects with a mild headache, and one subject reported pain and irritation at the IV infusion site.  In Cohort 4, five subjects reported nine drug-related AEs: three subjects with GI AEs, two subjects with headache, and one subject with reversible elevations of liver transaminases reported as an AE. Therapeutic doses of IV BCV were thus very well tolerated, and no new adverse events were identified with the IV formulation of BCV compared with the large safety database for oral BCV. Following discussions with European regulators, Chimerix plans to initiate the AdAPT trial (Adenovirus after Allogeneic Pediatric Transplantation, previously referred to as “Study 999”) with short-course oral BCV later this year in Europe, and possibly in the US.  AdAPT will recruit approximately 140 patients.  Children who have received a T-cell depleted allogeneic HCT with confirmed AdV viral DNA loads greater than 1000 c/ml in plasma within 100 days from transplant will be randomized to receive oral BCV or local standard of care which is predominantly off-label cidofovir.  The study builds on the scientific understanding from multiple previous trials of BCV in patients with life-threatening AdV infection, and will provide comparative data on short-course oral BCV compared with currently available treatment. If positive, data from AdAPT could enable regulatory approval in Europe for oral BCV. Following on the encouraging data from the single ascending dose study of IV BCV, Chimerix plans to initiate a multiple ascending dose study of IV BCV in healthy subjects, and a second study to generate multiple-dose PK and safety data in virally infected patients. These data are intended to inform the planned pivotal study of Multi-Viral Prevention of DNA viral infections in pediatric HCT recipients (MVP-Peds).  Subject to the successful completion of the multiple ascending dose study, Chimerix intends to initiate the MVP-Peds study during 2018. Development of BCV for smallpox continues in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Following completion of a planned second animal efficacy study, Chimerix plans to meet with the FDA to discuss any additional required data for a regulatory decision. On April 27, 2017, Chimerix hosted an Investor Event that featured keynote presentations from Thomas Lion, MD, PhD, Professor and Medical Director of the Children's Cancer Research Institute (Vienna, Austria), who discussed the rapidly changing field of adenovirus infections in immunocompromised patients, and highlighted the need for new therapeutic options that can facilitate viral control during periods of severe immunosuppression.  Dr. Lion presented research showing that adenovirus often reactivates in the gut and that early treatment can lead to significantly improved outcomes.  Joshua Hill, MD, Associate in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center (Seattle, Washington) shared his research on the frequency of multiple viral infections in both adult and pediatric transplant recipients.  Dr. Hill showed that 90% of the predominately adult allogeneic HCT recipients whose samples were tested at their center had evidence of at least one DNA virus, and two-thirds had two or more DNA viruses.  Of the HCT recipients who reactivated CMV, more than three-quarters had at least one other DNA virus identified and were at an increased risk of death.  These data demonstrate a need for novel strategies to prevent multiple DNA viral infections and their negative impact on patient outcomes. Genovefa Papanicolaou, MD, Infectious Disease Specialist at Memorial Sloan Kettering Cancer Center (New York, NY) also spoke of her experiences with multiple DNA viruses in her allogeneic transplant recipients, which corroborated Dr. Hill’s data. Chimerix reported a net loss of $17.8 million, or $0.38 per basic and diluted share, for the first quarter of 2017. During the same period in 2016, Chimerix recorded a net loss of $26.3 million, or $0.57 per basic and diluted share. Revenues for the first quarter of 2017 decreased to $1.1 million, compared to $1.2 million for the same period in 2016. Research and development expenses decreased to $12.7 million for the first quarter of 2017, compared to $20.9 million for the same period in 2016. General and administrative expenses decreased to $6.6 million for the first quarter of 2017, compared to $6.9 million for the same period in 2016. Loss from operations was $18.3 million for the first quarter of 2017, compared to a loss from operations of $26.6 million for the same period in 2016. Chimerix's balance sheet at March 31, 2017 included $264.7 million of capital available to fund operations, no debt, and approximately 46.7 million outstanding shares of common stock. Today's Conference Call and Webcast Chimerix will host a conference call and live audio webcast to discuss first quarter 2017 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 3258363. A live audio webcast of the call will also be available on the Investors section of Chimerix's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event. About Chimerix Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients.  Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and earlier-stage compounds. Chimerix recently announced a new clinical candidate, CMX521, for the treatment and/or prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com. About Brincidofovir Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has a high barrier to resistance, no myelosuppression and low risk of nephrotoxicity. Brincidofovir has received Fast Track designation from the FDA for adenovirus, CMV and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for the treatment of adenovirus and for the prevention of CMV disease, and the Committee for Orphan Medicinal Products has issued a positive opinion for an Orphan Designation for the treatment of smallpox. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


News Article | May 9, 2017
Site: globenewswire.com

DURHAM, N.C., May 09, 2017 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the first quarter ended March 31, 2017. “We have made meaningful progress advancing both the short-course oral brincidofovir program and the first of several confirmatory studies of IV brincidofovir. The single ascending dose study of IV brincidofovir (BCV) demonstrated with the first dose of 10 mg that we can achieve the plasma exposures that previously showed antiviral activity in the SUPPRESS and AdVise studies, but without the previously noted gastrointestinal (GI) limitations,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. “These results together with the multiple-dose studies in healthy subjects and in infected populations will inform the planned pivotal pediatric trial for IV BCV, the MVP-Peds Study (Multi-Viral Prevention in Pediatric Allogeneic Transplant Recipients), which we hope to initiate in 2018.  We look forward to advancing this important program to bring brincidofovir to immunocompromised patients suffering with these life-threatening viral infections."                                          Recent Highlights and Program Updates: Full Data from Phase 1 Dose Escalation Study of Intravenous Brincidofovir in Healthy Subjects Reported Data from all four cohorts of the Phase 1 study of IV BCV were presented at the recent Investor Event held on April 27, 2017. In this study a total of 40 healthy subjects were randomized to receive a single dose of either IV BCV or IV placebo in one of four cohorts. IV BCV 10 mg achieved comparable plasma exposure to that achieved with the oral BCV 100 mg dose.  There were no drug-related adverse events (AEs) reported in either the 10 mg or 25 mg cohorts; this dose range is likely to be selected for future studies for treatment of adenovirus and prevention of cytomegalovirus and other DNA viruses based on the antiviral activity demonstrated with oral BCV 100 mg. Doses higher than those currently being explored for the above indications (“supratherapeutic”) of IV BCV (50 mg given over two hours in Cohort 3, 50 mg given over four hours in Cohort 4) were also administered to evaluate the potential effects of BCV on QT interval and other safety parameters.  A majority of the AEs reported were mild and self-limited. Four subjects in Cohort 3 reported drug-related AEs: one drug-related GI AE, two subjects with a mild headache, and one subject reported pain and irritation at the IV infusion site.  In Cohort 4, five subjects reported nine drug-related AEs: three subjects with GI AEs, two subjects with headache, and one subject with reversible elevations of liver transaminases reported as an AE. Therapeutic doses of IV BCV were thus very well tolerated, and no new adverse events were identified with the IV formulation of BCV compared with the large safety database for oral BCV. Following discussions with European regulators, Chimerix plans to initiate the AdAPT trial (Adenovirus after Allogeneic Pediatric Transplantation, previously referred to as “Study 999”) with short-course oral BCV later this year in Europe, and possibly in the US.  AdAPT will recruit approximately 140 patients.  Children who have received a T-cell depleted allogeneic HCT with confirmed AdV viral DNA loads greater than 1000 c/ml in plasma within 100 days from transplant will be randomized to receive oral BCV or local standard of care which is predominantly off-label cidofovir.  The study builds on the scientific understanding from multiple previous trials of BCV in patients with life-threatening AdV infection, and will provide comparative data on short-course oral BCV compared with currently available treatment. If positive, data from AdAPT could enable regulatory approval in Europe for oral BCV. Following on the encouraging data from the single ascending dose study of IV BCV, Chimerix plans to initiate a multiple ascending dose study of IV BCV in healthy subjects, and a second study to generate multiple-dose PK and safety data in virally infected patients. These data are intended to inform the planned pivotal study of Multi-Viral Prevention of DNA viral infections in pediatric HCT recipients (MVP-Peds).  Subject to the successful completion of the multiple ascending dose study, Chimerix intends to initiate the MVP-Peds study during 2018. Development of BCV for smallpox continues in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Following completion of a planned second animal efficacy study, Chimerix plans to meet with the FDA to discuss any additional required data for a regulatory decision. On April 27, 2017, Chimerix hosted an Investor Event that featured keynote presentations from Thomas Lion, MD, PhD, Professor and Medical Director of the Children's Cancer Research Institute (Vienna, Austria), who discussed the rapidly changing field of adenovirus infections in immunocompromised patients, and highlighted the need for new therapeutic options that can facilitate viral control during periods of severe immunosuppression.  Dr. Lion presented research showing that adenovirus often reactivates in the gut and that early treatment can lead to significantly improved outcomes.  Joshua Hill, MD, Associate in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center (Seattle, Washington) shared his research on the frequency of multiple viral infections in both adult and pediatric transplant recipients.  Dr. Hill showed that 90% of the predominately adult allogeneic HCT recipients whose samples were tested at their center had evidence of at least one DNA virus, and two-thirds had two or more DNA viruses.  Of the HCT recipients who reactivated CMV, more than three-quarters had at least one other DNA virus identified and were at an increased risk of death.  These data demonstrate a need for novel strategies to prevent multiple DNA viral infections and their negative impact on patient outcomes. Genovefa Papanicolaou, MD, Infectious Disease Specialist at Memorial Sloan Kettering Cancer Center (New York, NY) also spoke of her experiences with multiple DNA viruses in her allogeneic transplant recipients, which corroborated Dr. Hill’s data. Chimerix reported a net loss of $17.8 million, or $0.38 per basic and diluted share, for the first quarter of 2017. During the same period in 2016, Chimerix recorded a net loss of $26.3 million, or $0.57 per basic and diluted share. Revenues for the first quarter of 2017 decreased to $1.1 million, compared to $1.2 million for the same period in 2016. Research and development expenses decreased to $12.7 million for the first quarter of 2017, compared to $20.9 million for the same period in 2016. General and administrative expenses decreased to $6.6 million for the first quarter of 2017, compared to $6.9 million for the same period in 2016. Loss from operations was $18.3 million for the first quarter of 2017, compared to a loss from operations of $26.6 million for the same period in 2016. Chimerix's balance sheet at March 31, 2017 included $264.7 million of capital available to fund operations, no debt, and approximately 46.7 million outstanding shares of common stock. Today's Conference Call and Webcast Chimerix will host a conference call and live audio webcast to discuss first quarter 2017 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 3258363. A live audio webcast of the call will also be available on the Investors section of Chimerix's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event. About Chimerix Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients.  Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and earlier-stage compounds. Chimerix recently announced a new clinical candidate, CMX521, for the treatment and/or prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com. About Brincidofovir Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has a high barrier to resistance, no myelosuppression and low risk of nephrotoxicity. Brincidofovir has received Fast Track designation from the FDA for adenovirus, CMV and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for the treatment of adenovirus and for the prevention of CMV disease, and the Committee for Orphan Medicinal Products has issued a positive opinion for an Orphan Designation for the treatment of smallpox. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


News Article | May 9, 2017
Site: globenewswire.com

DURHAM, N.C., May 09, 2017 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the first quarter ended March 31, 2017. “We have made meaningful progress advancing both the short-course oral brincidofovir program and the first of several confirmatory studies of IV brincidofovir. The single ascending dose study of IV brincidofovir (BCV) demonstrated with the first dose of 10 mg that we can achieve the plasma exposures that previously showed antiviral activity in the SUPPRESS and AdVise studies, but without the previously noted gastrointestinal (GI) limitations,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. “These results together with the multiple-dose studies in healthy subjects and in infected populations will inform the planned pivotal pediatric trial for IV BCV, the MVP-Peds Study (Multi-Viral Prevention in Pediatric Allogeneic Transplant Recipients), which we hope to initiate in 2018.  We look forward to advancing this important program to bring brincidofovir to immunocompromised patients suffering with these life-threatening viral infections."                                          Recent Highlights and Program Updates: Full Data from Phase 1 Dose Escalation Study of Intravenous Brincidofovir in Healthy Subjects Reported Data from all four cohorts of the Phase 1 study of IV BCV were presented at the recent Investor Event held on April 27, 2017. In this study a total of 40 healthy subjects were randomized to receive a single dose of either IV BCV or IV placebo in one of four cohorts. IV BCV 10 mg achieved comparable plasma exposure to that achieved with the oral BCV 100 mg dose.  There were no drug-related adverse events (AEs) reported in either the 10 mg or 25 mg cohorts; this dose range is likely to be selected for future studies for treatment of adenovirus and prevention of cytomegalovirus and other DNA viruses based on the antiviral activity demonstrated with oral BCV 100 mg. Doses higher than those currently being explored for the above indications (“supratherapeutic”) of IV BCV (50 mg given over two hours in Cohort 3, 50 mg given over four hours in Cohort 4) were also administered to evaluate the potential effects of BCV on QT interval and other safety parameters.  A majority of the AEs reported were mild and self-limited. Four subjects in Cohort 3 reported drug-related AEs: one drug-related GI AE, two subjects with a mild headache, and one subject reported pain and irritation at the IV infusion site.  In Cohort 4, five subjects reported nine drug-related AEs: three subjects with GI AEs, two subjects with headache, and one subject with reversible elevations of liver transaminases reported as an AE. Therapeutic doses of IV BCV were thus very well tolerated, and no new adverse events were identified with the IV formulation of BCV compared with the large safety database for oral BCV. Following discussions with European regulators, Chimerix plans to initiate the AdAPT trial (Adenovirus after Allogeneic Pediatric Transplantation, previously referred to as “Study 999”) with short-course oral BCV later this year in Europe, and possibly in the US.  AdAPT will recruit approximately 140 patients.  Children who have received a T-cell depleted allogeneic HCT with confirmed AdV viral DNA loads greater than 1000 c/ml in plasma within 100 days from transplant will be randomized to receive oral BCV or local standard of care which is predominantly off-label cidofovir.  The study builds on the scientific understanding from multiple previous trials of BCV in patients with life-threatening AdV infection, and will provide comparative data on short-course oral BCV compared with currently available treatment. If positive, data from AdAPT could enable regulatory approval in Europe for oral BCV. Following on the encouraging data from the single ascending dose study of IV BCV, Chimerix plans to initiate a multiple ascending dose study of IV BCV in healthy subjects, and a second study to generate multiple-dose PK and safety data in virally infected patients. These data are intended to inform the planned pivotal study of Multi-Viral Prevention of DNA viral infections in pediatric HCT recipients (MVP-Peds).  Subject to the successful completion of the multiple ascending dose study, Chimerix intends to initiate the MVP-Peds study during 2018. Development of BCV for smallpox continues in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Following completion of a planned second animal efficacy study, Chimerix plans to meet with the FDA to discuss any additional required data for a regulatory decision. On April 27, 2017, Chimerix hosted an Investor Event that featured keynote presentations from Thomas Lion, MD, PhD, Professor and Medical Director of the Children's Cancer Research Institute (Vienna, Austria), who discussed the rapidly changing field of adenovirus infections in immunocompromised patients, and highlighted the need for new therapeutic options that can facilitate viral control during periods of severe immunosuppression.  Dr. Lion presented research showing that adenovirus often reactivates in the gut and that early treatment can lead to significantly improved outcomes.  Joshua Hill, MD, Associate in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center (Seattle, Washington) shared his research on the frequency of multiple viral infections in both adult and pediatric transplant recipients.  Dr. Hill showed that 90% of the predominately adult allogeneic HCT recipients whose samples were tested at their center had evidence of at least one DNA virus, and two-thirds had two or more DNA viruses.  Of the HCT recipients who reactivated CMV, more than three-quarters had at least one other DNA virus identified and were at an increased risk of death.  These data demonstrate a need for novel strategies to prevent multiple DNA viral infections and their negative impact on patient outcomes. Genovefa Papanicolaou, MD, Infectious Disease Specialist at Memorial Sloan Kettering Cancer Center (New York, NY) also spoke of her experiences with multiple DNA viruses in her allogeneic transplant recipients, which corroborated Dr. Hill’s data. Chimerix reported a net loss of $17.8 million, or $0.38 per basic and diluted share, for the first quarter of 2017. During the same period in 2016, Chimerix recorded a net loss of $26.3 million, or $0.57 per basic and diluted share. Revenues for the first quarter of 2017 decreased to $1.1 million, compared to $1.2 million for the same period in 2016. Research and development expenses decreased to $12.7 million for the first quarter of 2017, compared to $20.9 million for the same period in 2016. General and administrative expenses decreased to $6.6 million for the first quarter of 2017, compared to $6.9 million for the same period in 2016. Loss from operations was $18.3 million for the first quarter of 2017, compared to a loss from operations of $26.6 million for the same period in 2016. Chimerix's balance sheet at March 31, 2017 included $264.7 million of capital available to fund operations, no debt, and approximately 46.7 million outstanding shares of common stock. Today's Conference Call and Webcast Chimerix will host a conference call and live audio webcast to discuss first quarter 2017 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 3258363. A live audio webcast of the call will also be available on the Investors section of Chimerix's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event. About Chimerix Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients.  Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and earlier-stage compounds. Chimerix recently announced a new clinical candidate, CMX521, for the treatment and/or prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com. About Brincidofovir Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has a high barrier to resistance, no myelosuppression and low risk of nephrotoxicity. Brincidofovir has received Fast Track designation from the FDA for adenovirus, CMV and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for the treatment of adenovirus and for the prevention of CMV disease, and the Committee for Orphan Medicinal Products has issued a positive opinion for an Orphan Designation for the treatment of smallpox. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


News Article | May 9, 2017
Site: globenewswire.com

DURHAM, N.C., May 09, 2017 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the first quarter ended March 31, 2017. “We have made meaningful progress advancing both the short-course oral brincidofovir program and the first of several confirmatory studies of IV brincidofovir. The single ascending dose study of IV brincidofovir (BCV) demonstrated with the first dose of 10 mg that we can achieve the plasma exposures that previously showed antiviral activity in the SUPPRESS and AdVise studies, but without the previously noted gastrointestinal (GI) limitations,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. “These results together with the multiple-dose studies in healthy subjects and in infected populations will inform the planned pivotal pediatric trial for IV BCV, the MVP-Peds Study (Multi-Viral Prevention in Pediatric Allogeneic Transplant Recipients), which we hope to initiate in 2018.  We look forward to advancing this important program to bring brincidofovir to immunocompromised patients suffering with these life-threatening viral infections."                                          Recent Highlights and Program Updates: Full Data from Phase 1 Dose Escalation Study of Intravenous Brincidofovir in Healthy Subjects Reported Data from all four cohorts of the Phase 1 study of IV BCV were presented at the recent Investor Event held on April 27, 2017. In this study a total of 40 healthy subjects were randomized to receive a single dose of either IV BCV or IV placebo in one of four cohorts. IV BCV 10 mg achieved comparable plasma exposure to that achieved with the oral BCV 100 mg dose.  There were no drug-related adverse events (AEs) reported in either the 10 mg or 25 mg cohorts; this dose range is likely to be selected for future studies for treatment of adenovirus and prevention of cytomegalovirus and other DNA viruses based on the antiviral activity demonstrated with oral BCV 100 mg. Doses higher than those currently being explored for the above indications (“supratherapeutic”) of IV BCV (50 mg given over two hours in Cohort 3, 50 mg given over four hours in Cohort 4) were also administered to evaluate the potential effects of BCV on QT interval and other safety parameters.  A majority of the AEs reported were mild and self-limited. Four subjects in Cohort 3 reported drug-related AEs: one drug-related GI AE, two subjects with a mild headache, and one subject reported pain and irritation at the IV infusion site.  In Cohort 4, five subjects reported nine drug-related AEs: three subjects with GI AEs, two subjects with headache, and one subject with reversible elevations of liver transaminases reported as an AE. Therapeutic doses of IV BCV were thus very well tolerated, and no new adverse events were identified with the IV formulation of BCV compared with the large safety database for oral BCV. Following discussions with European regulators, Chimerix plans to initiate the AdAPT trial (Adenovirus after Allogeneic Pediatric Transplantation, previously referred to as “Study 999”) with short-course oral BCV later this year in Europe, and possibly in the US.  AdAPT will recruit approximately 140 patients.  Children who have received a T-cell depleted allogeneic HCT with confirmed AdV viral DNA loads greater than 1000 c/ml in plasma within 100 days from transplant will be randomized to receive oral BCV or local standard of care which is predominantly off-label cidofovir.  The study builds on the scientific understanding from multiple previous trials of BCV in patients with life-threatening AdV infection, and will provide comparative data on short-course oral BCV compared with currently available treatment. If positive, data from AdAPT could enable regulatory approval in Europe for oral BCV. Following on the encouraging data from the single ascending dose study of IV BCV, Chimerix plans to initiate a multiple ascending dose study of IV BCV in healthy subjects, and a second study to generate multiple-dose PK and safety data in virally infected patients. These data are intended to inform the planned pivotal study of Multi-Viral Prevention of DNA viral infections in pediatric HCT recipients (MVP-Peds).  Subject to the successful completion of the multiple ascending dose study, Chimerix intends to initiate the MVP-Peds study during 2018. Development of BCV for smallpox continues in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Following completion of a planned second animal efficacy study, Chimerix plans to meet with the FDA to discuss any additional required data for a regulatory decision. On April 27, 2017, Chimerix hosted an Investor Event that featured keynote presentations from Thomas Lion, MD, PhD, Professor and Medical Director of the Children's Cancer Research Institute (Vienna, Austria), who discussed the rapidly changing field of adenovirus infections in immunocompromised patients, and highlighted the need for new therapeutic options that can facilitate viral control during periods of severe immunosuppression.  Dr. Lion presented research showing that adenovirus often reactivates in the gut and that early treatment can lead to significantly improved outcomes.  Joshua Hill, MD, Associate in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center (Seattle, Washington) shared his research on the frequency of multiple viral infections in both adult and pediatric transplant recipients.  Dr. Hill showed that 90% of the predominately adult allogeneic HCT recipients whose samples were tested at their center had evidence of at least one DNA virus, and two-thirds had two or more DNA viruses.  Of the HCT recipients who reactivated CMV, more than three-quarters had at least one other DNA virus identified and were at an increased risk of death.  These data demonstrate a need for novel strategies to prevent multiple DNA viral infections and their negative impact on patient outcomes. Genovefa Papanicolaou, MD, Infectious Disease Specialist at Memorial Sloan Kettering Cancer Center (New York, NY) also spoke of her experiences with multiple DNA viruses in her allogeneic transplant recipients, which corroborated Dr. Hill’s data. Chimerix reported a net loss of $17.8 million, or $0.38 per basic and diluted share, for the first quarter of 2017. During the same period in 2016, Chimerix recorded a net loss of $26.3 million, or $0.57 per basic and diluted share. Revenues for the first quarter of 2017 decreased to $1.1 million, compared to $1.2 million for the same period in 2016. Research and development expenses decreased to $12.7 million for the first quarter of 2017, compared to $20.9 million for the same period in 2016. General and administrative expenses decreased to $6.6 million for the first quarter of 2017, compared to $6.9 million for the same period in 2016. Loss from operations was $18.3 million for the first quarter of 2017, compared to a loss from operations of $26.6 million for the same period in 2016. Chimerix's balance sheet at March 31, 2017 included $264.7 million of capital available to fund operations, no debt, and approximately 46.7 million outstanding shares of common stock. Today's Conference Call and Webcast Chimerix will host a conference call and live audio webcast to discuss first quarter 2017 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 3258363. A live audio webcast of the call will also be available on the Investors section of Chimerix's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event. About Chimerix Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients.  Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and earlier-stage compounds. Chimerix recently announced a new clinical candidate, CMX521, for the treatment and/or prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com. About Brincidofovir Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has a high barrier to resistance, no myelosuppression and low risk of nephrotoxicity. Brincidofovir has received Fast Track designation from the FDA for adenovirus, CMV and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for the treatment of adenovirus and for the prevention of CMV disease, and the Committee for Orphan Medicinal Products has issued a positive opinion for an Orphan Designation for the treatment of smallpox. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


News Article | April 24, 2017
Site: globenewswire.com

Hakekuljetusten ajoreitti kulkee Porin kaupunkikeskustan läpi, minkä vuoksi HCT-rekan turvallisuuteen on kiinnitetty erityishuomiota. Autoon on asennettu kameroita, jotka aktivoituvat kuljettajan näytölle, kun hän laittaa suuntavilkun tai peruutusvaihteen päälle. Lisäksi kaikkien HCT-autojen perässä on pitkästä kuljetuksesta kertova kyltti. UPM uudistaa bio- ja metsäteollisuutta. Rakennamme kestävää tulevaisuutta kuudella liiketoiminta-alueella: UPM Biorefining, UPM Energy, UPM Raflatac, UPM Specialty Papers, UPM Paper ENA ja UPM Plywood. Tuotteemme valmistetaan uusiutuvista raaka-aineista ja ne ovat kierrätettäviä. Palvelemme asiakkaitamme maailmanlaajuisesti. Yhtiössämme työskentelee noin 19 300 henkilöä ja vuosittainen liikevaihtomme on noin 10 miljardia euroa. UPM:n osakkeet on listattu Helsingin pörssissä. UPM - The Biofore Company - www.upm.fi


— Market Scenario: Interventional cardiology is a branch of cardiology that deals particularly with the catheter based treatment of auxiliary heart illnesses. Interventional cardiology involves treating patients with cardiovascular diseases such as coronary and angina heart disease .The market for Interventional cardiology is expected to grow at a high CAGR. Segments: On the basis of Treatment Type  Percutaneous Coronary Interventions  Atherectomy  Excimer Laser Procedures  Stent Placement  Coronary Thrombectomy  Others On the basis of End Users  Cardiac Catheterization Laboratories  Hospitals and Clinics  Others Study Objectives of Interventional Cardiology Market: • To provide detailed analysis of the market structure along with forecast for the next 10 years of the various segments and sub-segments of the Asia-Pacific Interventional Cardiology Market • To provide insights about factors affecting the market growth • To Analyze the Asia-Pacific Interventional Cardiology Market based on various factors- price analysis, supply chain analysis, porters five force analysis etc. • To provide historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- Americas, Europe, Asia, and Middle East & Africa • To provide country level analysis of the market with respect to the current market size and future prospective • To provide country level analysis of the market for segments by type, by end users and sub-segments. • To provide strategic profiling of key players in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market • To track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the Asia-Pacific Interventional Cardiology Market Regional Analysis of Interventional Cardiology Market: Asia Pacific is a growing market for Interventional Cardiology. The Asia Pacific market for Interventional Cardiology is expected to grow at high CAGR over the forecasted period. Brief Table Of Content 1. Report Prologue 2. Introduction 2.1 Definition 2.2 Scope of the Study 2.2.1 Research Objective 2.2.2 Assumptions 2.2.3 Limitations 2.3 Market Structure 2.4. Market Segmentation 3. Research Methodology 3.1 Research Process 3.2 Primary Research 3.3 Secondary Research 3.4 Market Size Estimation 3.5 Forecast Model 4. Market Dynamics 4.1 Drivers 4.2 Restraints 4.3 Opportunities 4.4 Mega Trends 4.5 Macroeconomic Indicators 5. Market Factor Analysis 5.1 Value Chain Analysis 5.2 Porters Five Forces 5.3 Demand & supply: gap analysis 5.4 Pricing Analysis 5.5 Investment Opportunity Analysis 5.6 Merger and Acquisition Landscape 5.7 UP-Coming trends in IOT market 5.7.1 Market trends 5.7.2 Technological trends 5.7.3 Insurance & Regulations 5.7.4 Others Continue……. This research report has provides the insights, on various levels of analyses such industry analysis, market share analysis leading market players and their profiles. This report also helps in studying the target segments by providing views on emerging & high-growth segments and market conclusion. Together the market data comprise and discuss with the basic assessments on the competitive scenarios & strategies, of the Asia-Pacific Interventional Cardiology Market, including the high-growth regions, countries and their political, economic and technological environments. Furthermore the project report also provides the views over the historical market values as well as, pricing and cost analysis of the same. Related Report Global Clinical Laboratory Test Market Information, by test type (Complete Blood Count, HGB/HCT Tests, Basic Metabolic Panel, BUN Creatinine Tests, Electrolyte Testing, HbA1c Tests, Comprehensive Metabolic Panel, Liver Panel, Renal Panel, Lipid Panel), by laboratory type (Primary Care clinics, Central laboratories) - Forecast to 2022 https://www.marketresearchfuture.com/reports/clinical-laboratory-test-market-1649 About Market Research Future: At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. For more information, please visit https://www.marketresearchfuture.com/reports/asia-pacific-interventional-cardiology-market


News Article | February 16, 2017
Site: globenewswire.com

VANCOUVER, British Columbia, Feb. 16, 2017 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX-V:KALY) (“Kalytera”) announced today that it has successfully completed the previously announced acquisition (the “Acquisition”) of Talent Biotechs Ltd. (“Talent”), strengthening Kalytera’s position as an emerging market leader in cannabidiol (“CBD”) pharmaceuticals. Talent is a privately held, Israeli-based company evaluating the use of CBD to prevent and treat Graft versus Host Disease (“GvHD”). “We feel incredibly fortunate to be continuing Talent’s groundbreaking work in GvHD,” said Andrew Salzman, M.D., Kalytera’s Chief Executive Officer. “There are currently few options to prevent or treat persons with GvHD, a large and critically underserved market. The results of Talent’s Phase 2 clinical studies are unprecedented, and mark a major milestone in the potential prevention and treatment of this severe and life-threatening disease. We are encouraged by the data and seek to rapidly advance the GvHD program into FDA Phase 2b clinical studies.” “This is a transformational transaction for Kalytera,” said Robert Farrell, President, COO, and CFO of Kalytera. “Multiple studies have demonstrated that CBD, a non-psychoactive cannabis constituent, possesses remarkable therapeutic potential across a broad range of diseases and disorders. The acquisition of Talent and its late-stage GvHD program significantly advances Kalytera’s position as an emerging leader in CBD pharmaceuticals. We expect our work in GvHD to be the first of many programs that seek to investigate and commercialize this important compound.” As consideration for the Acquisition, Kalytera will provide a combination of cash, securities, and future contingent payments to Talent. To date, Kalytera has made cash payments to Talent totaling USD$10,000,000. In addition, Kalytera has issued 17,301,208 common shares to Talent, which securities will be subject to a contractual hold period expiring December 30, 2017. Subject to the completion of certain milestones in relation to the development and commercialization of the GvHD program, Kalytera will pay up to USD$20,000,000 in aggregate future contingent payments. Kalytera shall also issue to Talent an additional 2,883,535 common shares upon the completion of the first Phase 2b clinical study, and a further additional 2,883,535 common shares upon the issuance of the first patent by the USPTO or EU with respect to certain assets of Talent acquired in connection with the Acquisition. The shareholders of Talent shall also receive additional earn-out payments equal to 5% of the aggregate annual net sales of all products covered by patent rights included in the business of Talent.  The Acquisition has been conditionally approved by the TSX Venture Exchange, but remains subject to final approval. GvHD is an orphan disease that can arise following hematopoietic stem cell transplantation (“HCT”), a procedure where the stem cells of the bone marrow or peripheral blood of a healthy donor are transplanted into a new host after chemotherapy or radiation. HCT is a lifesaving procedure for many diseases of the blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma, multiple myeloma, sickle cell anemia, and thalassemia. There were over 8,000 HCT procedures in the U.S. in 20141 and the use of HCT procedures is expected to continue to increase. While HCT procedures can be lifesaving, they pose many dangerous side effects, including infection and GvHD. GvHD is a multisystem disorder that occurs when the transplanted cells from a donor (“the graft”) recognize the transplant recipient (“the host”) as foreign. This interaction initiates an immune reaction that causes disease in the transplant recipient. This reaction can occur within days after the transplant (acute GvHD) or months to years after HCT (chronic GvHD). GvHD can be mild, moderate, severe, and even life threatening. Patients with acute GvHD may suffer from rashes and blistering of the skin, nausea, vomiting, abdominal cramps accompanied by diarrhea, and jaundice. Generally, acute reactions are more severe and life threatening. GvHD is a major cause of morbidity and mortality following HCT. Researchers estimate that even with intensive prophylaxis with immunosuppressive treatments, 30-50% of patients transplanted from fully matched sibling donors and 50-70% of patients transplanted from unrelated donors will develop some level of GvHD2. The GvHD market was valued at $295M across the six major markets in 2013, and is expected to grow to $544M by 2023, according to the research and consulting firm GlobalData3. Standard of Care: Prevention and Treatment of GvHD The first step in prevention of GvHD is the selection of donor cells that closely match the genetics of the immune system of the transplant recipient, ideally a sibling donor. From there, the patient relies on drugs that have been developed to prevent or treat GvHD. Medicinal prevention of acute GvHD is dependent on immunosuppression of the donor cells, either pharmacologically or through T cell depletion. Common drugs include methotrexate, cyclosporine tacrolimus, sirolimus, mycophenolate mofetil, and ATG. Preventive measures and clinical practices vary by institution4. Treatment of GvHD involves pharmacologic suppression of the graft’s immune cell activation and reestablishment of donor-host immune-tolerance. Most patients are prescribed corticosteroids, which directly suppress the donor’s immune cell attack on host tissue, but also raise the risk of infection and cancer relapse. As with prevention, the optimal drug strategy for GvHD is not well defined. Only 30-50% of patients with moderate to severe GvHD respond to corticosteroids, putting many at risk for fatal outcomes5. Better treatment options are needed to improve the mortality and morbidity outcomes for transplant recipients. CBD is a major component of Cannabis sativa, commonly known as marijuana. CBD possesses potent anti-inflammatory and immunosuppressive properties. Unlike the other major component of cannabis, tetrahydrocannabinol (“THC”), CBD is non-psychoactive and is well tolerated by humans when taken over extended periods of time6. CBD has shown benefit in a number of models of inflammatory diseases including diabetes7, rheumatoid arthritis8, multiple sclerosis9, and inflammatory bowel disease10. In May 2015, Moshe Yeshurun, M.D., Chief Medical Officer of Talent and of the Head of the Bone Marrow Transplantation Department at the Rabin Medical Center in Israel, published the results of a Phase 2a study that followed adult recipients of HCT receiving standard GvHD prophylaxis11. Study participants were provided with daily doses of CBD for the seven days prior to transplantation and for 30 days after HCT. Participants were monitored for an average of 16 months following treatment. Talent researchers compared the trial results to historical data and reported that: Based on these promising results, Talent commenced a second phase 2a trial to evaluate the efficacy of a longer administration of CBD following HCT. As disclosed by Kalytera in its January 18, 2017 press release, in this study, which enrolled 12 patients, participants were provided daily doses of CBD 7 days prior to transplantation and for 100 days following the procedure. With a median follow up of 8.5 months following transplantation, preliminary results show that 85% of the patients did not develop significant (Grades 2-4) acute GvHD, although most of them received bone marrow from unrelated donors, and only 2 patients developed acute GVHD (being 15% of patients), versus the predicted incidence of 50-70% in the scientific literature. Talent has completed additional pilot studies exploring the use of CBD in the treatment of GvHD. Kalytera plans to initiate placebo-controlled, double blind, randomized studies of CBD for both the prevention and treatment of GvHD. These clinical studies may support U.S. Food and Drug Administration (“FDA”) Breakthrough Therapy and Fast Track Designations, which could accelerate the regulatory approval process. About Kalytera Therapeutics Kalytera (TSX-V:KALY) is pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on Graft versus Host Disease (“GvHD”). Kalytera is focused first on developing a new class of proprietary cannabidiol (“CBD”) therapeutics. CBD is a remarkable compound that has shown activity against a number of pharmacological targets. However, there are limitations associated with natural CBD, including its poor oral bioavailability and short half-life. Kalytera is developing innovative CBD formulations and prodrugs in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera intends to file composition of matter and method of use patents covering its novel inventions, with the goal of limiting future competition. Cautionary Note Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) has in any way passed upon the merits of the proposed Transaction and associated transactions and neither of the foregoing entities has in any way approved or disapproved of the contents of this press release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release. Forward-Looking Statement Disclosure This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the proposed Transaction including statements regarding the terms and conditions of the proposed Transaction, as well as information relating to Talent. The information about Talent contained in the press release has not been independently verified by Kalytera. Although Kalytera believes in light of the experience of its officers and directors, current conditions and expected future developments and other factors that have been considered appropriate, that the expectations reflected in this forward-looking information are reasonable, undue reliance should not be placed on them because Kalytera can give no assurance that they will prove to be correct. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements, depending on, among other things, the risks of failure to obtain final approval of the TSX Venture Exchange, failure of the results of the Phase 2a clinical trial to be consistent with the preliminary results of such trial, that the Phase 2a clinical trial results are not determinative of or consistent with the results of the results of future Phase 2 or other clinical studies, that the small number of patients in the Phase 2a clinical trial may contribute to the risk that future studies may be inconsistent with the results of the Phase 2a clinical trial, and that clinical trials are subject to a number of other health, safety, efficacy and regulatory risks. The statements in this press release are made as of the date of this release. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of Kalytera, Talent, their securities, or their respective financial or operating results (as applicable). Kalytera disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws. 1 Center for International Blood and Marrow Transplant Research (CIBMTR) HCT Trends and Survival Data 2 Weisdorf D. GVHD the nuts and bolts. Hematology Am Soc Hematol Educ Program. 2007;:62-7. 4 Ruutu T, Van biezen A, Hertenstein B, et al. Prophylaxis and treatment of GVHD after allogeneic haematopoietic SCT: a survey of centre strategies by the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 2012;47(11):1459-64. 5 Weisdorf D. GVHD the nuts and bolts. Hematology Am Soc Hematol Educ Program. 2007;:62-7. 7 Weiss L, Zeira M, Reich S, et al. Cannabidiol lowers incidence of diabetes in non-obese diabetic mice. Autoimmunity. 2006;39(2):143-51. 8 Malfait AM, Gallily R, Sumariwalla PF, et al. The nonpsychoactive cannabis constituent cannabidiol is an oral anti-arthritic therapeutic in murine collagen-induced arthritis. Proc Natl Acad Sci USA. 2000;97(17):9561-6. 9 Trojano M. Advances in the management of MS symptoms: real-life evidence. Neurodegener Dis Manag. 2015;5(6 Suppl):19-21. 11 Yeshurun M, Shpilberg O, Herscovici C, et al. Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study. Biol Blood Marrow Transplant. 2015;21(10):1770-5.


“I am pleased to report another excellent set of results in 2016 from Eurofins, with organic growth nearly double our annual objective. In 2016, we made significant progress towards both our financial and operational objectives. With 89% of Group revenues now generating 21.3% EBITDA margin, Eurofins is able to continue investing for future growth such as the roll-out of multiple start-up laboratories in high-growth markets, as well as deliver profit improvements (+50bp expansion in reported EBITDA margin), and earnings expansion (+91% uplift in reported EPS). Operationally, we continue to make steady progress on key initiatives including the addition of 46,000m2 of state-of-the-art laboratory surface in 2016 alone, development and commercialization of many innovative tests to better serve our clients, internal development of tailor-made IT solutions that should further elevate the Eurofins laboratory network ahead of its peers, and the roll-out of over 20 new start-up laboratories in 2016. I would like to thank and compliment our teams in the 39 countries where we operate laboratories around the world for their outstanding dedication and performance in what was once again the best year ever for Eurofins as well as thank our clients and shareholders for their continued support.” In view of the positive developments in our start-up investment program as detailed on page 7 of this press release, the Group has significantly accelerated the current program which commenced in 2014, to open 76 start-up laboratories by the end of 2017. Start-ups complement the Group’s acquisition strategy, and provide a compelling alternative in markets or segments where acquisition prices are too high. Start-up investments therefore allow the Group to enter or reinforce its leadership in high-growth markets without putting value creation at risk by overpaying for acquisitions. In addition, despite investments to strengthen barriers to entry and secure future growth drivers, the Group continues to optimize its capital structure, successfully de-levering the balance sheet to 1.16x net debt to adjusted EBITDA, and deliver strong cash generation, with a 40% increase in free cash flow to the firm8 in 2016. Therefore, whilst the strong growth outlook of the existing businesses allows the Group to be selective to ensure that we maintain financial discipline with regards to acquisitions, our strong balance sheet means that Eurofins is better-positioned than ever to respond to large, compelling opportunities as and when they arise. Overall, the Group’s performance in the first of its 5-year plan bodes well for the achievement of our mid-term objectives. In light of these results and the continued positive outlook for the Group, the management will be proposing a 38% increase in dividends to EUR 2 per share. N.B. H2 2016 results can be found in Table 3 on page 8 of this press release Revenues grew 16.0% to EUR 699.3m in the fourth quarter, bringing revenues for the full year 2016 to EUR 2,536.6m, representing year-on-year increase of 30.1%, of which over 9% was organic. Acceleration in market share gains in most geographies, increased customer penetration, as well as continued growth in the testing market underpin the robust growth across the Group. Currency translation had a limited impact of -0.3% during the year. Taking the annualized revenues of all the acquisitions completed during the year, 2016 pro-forma revenues were EUR 2,658.6m. In Q3 and Q4 2016, Eurofins once again exceeded its 5% organic growth objective despite very strong comparable level of almost 9% in H2 2015, and clinical testing bearing most of the annual impact of cost containment measures by payors in Q4. The stronger organic growth generated by the Group compared to its 5% annual growth objective continues to be driven by a ramp-up in volumes, and supported by continued strength in the underlying trends across many of its businesses. During the year, Eurofins’ food testing business once again outperformed the Group’s organic growth objective, driven by rising awareness among consumers and across the food industry of the need for more systematic testingi, and the Group’s capability to often respond to the industry’s needs better than any other laboratory testing service provider. Strong performance from some of the Group’s environment testing businesses, notably air and water testing in France and Germany, partially offset some of the impact of slower economic activity in the rest of Europe, as well as the continued weakness in the US environment testing market. Although organic growth in environment testing for 2016 was lower than the Group average, the business is well-positioned for growth due to the scale of its network. Organic growth generated by the Group’s pharmaceutical testing business remained well above the Group’s 5% objective in 2016, on the back of further growth acceleration in pharmaceutical products testing, and as the Group unwinds and starts to see the benefits of the reorganization of its discovery services business, as well as the steady build-up of the order book in the central laboratory business. In the broader industry, the steady number of applications for FDA approvalsii, and strong growth in drug salesiii, are supportive of the underlying fundamentals for the pharma testing business in the medium term. The Group’s clinical testing business continues to gain traction, following several acquisitions in the US and in Europe. Innovation continues to be a solid growth driver in US clinical testing, while in Europe, the Group continues to roll-out its strategic footprint. In both markets, Eurofins continues to leverage its expertise in genomics, and more broadly in pharmaceutical testing. Positive trends continue to drive the growth in Eurofins’ businesses in North America, where revenues increased 24.9% to EUR 803.6m, comprising nearly 32% of total Group revenues. Regulatory catch-up remains a key growth driver for the food testing market, and Eurofins continues to gain market share, as reflected in the high single-digit organic growth generated by the Group’s US food testing business. Eurofins’ pharma testing businesses in the US delivered another solid performance in 2016, with strong organic growth in biopharma products testing driven by continued growth in drug sales and new drug applications, as well as strengthening central lab order book. The completion of the site reorganization programme in its discovery services business has also started to bear fruit, as reflected in the organic growth generated by the business in 2016 which was above Group objective. In addition, Eurofins has further expanded its footprint with the launch of medical device testing to add to its comprehensive pharma testing competencies, reinforce its market leadership, and secure additional growth driver. Organic growth in environment testing was somewhat below Group objective as market consolidation continues to be the main driver, which should purge oversupply in the market in due course. The Group’s specialty clinical diagnostics businesses contributed good organic growth in spite of strengthening reimbursement headwinds in H2 as the laboratories expand their sales forces to accelerate the commercialization of their tests and invest in further development of new innovative tests and services. Overall, trends are expected to continue to be supportive of Eurofins’ businesses in North America and the Group continues to invest in expanding its footprint in the region. In France, Eurofins’ second largest market with nearly 25% of total Group sales, revenues increased 69.3% to EUR 625.9m. Organic growth was in-line with Group objective as the clinical testing businesses, which account for over half of revenues in France, generated better than expected growth despite the annual adjustments in reimbursements being fully applied in Q4, according to the French health authority budget. The food testing business performed strongly during the year on continued market share gains supported by capacity expansion driven by innovation, such as the launch of the Maldi-TOFiv technology which significantly reduces turn-around time and increases capacity for microbiology testing. In addition, Eurofins continues to leverage its international network to become the preferred laboratory partner for clients with equally wide footprint. For example, the Group’s flagship food laboratory in Nantes gained the German QS accreditation to test for pesticides in fruits and vegetables, allowing Eurofins to partner with customers whose products are shipped in markets requiring such certification. Likewise, the selection of Eurofins by the ANEEFELv as one of a handful of reference laboratories in France to serve the fruit and vegetable industry gives access to an important market, and is another demonstration of the Group’s capabilities. The Group’s environment testing business in France also generated organic growth above Group objective driven by market share gains and positive trends especially in indoor air testing. The water testing business also delivered solid performance on the back of recently-won public tenders (“Agence de l’Eau Seine Normandie” and “Agence de l’Eau Loire Bretagne”) as well as increased volumes from existing customers. The clinical diagnostics testing business also generated better than expected growth, validating the Group’s strategy of building a differentiated platform focused on building regional leadership and leading the market for specialized, highly-innovative diagnostic tests. Revenue contribution from Germany, which makes up 11% of Group revenues, was EUR 279.4m in 2016, representing growth of 11.6%, most of which was organic. The food testing business continues to strengthen, generating the highest revenue growth in five years, with growing scale effect reflected in higher activities from cross-selling initiatives, as well as higher share of incremental market volumes driven by new regulations such as those addressing potential contaminants from packaging materialsvi. Increasingly harmonised service offering from different Eurofins laboratories was reflected in greater penetration and higher volumes from key global food customers. The Group’s environment testing business in Germany also delivered strong performance reflecting continued growth even in a mature market. The Group’s businesses in the Benelux achieved revenues of EUR 191.2m, representing 7.5% of total Group revenues, and an increase of 20.9% compared to 2015, driven by new businesses won such as the new contract for groundwater analysis in Belgium. Eurofins’ Nordic businesses generated EUR 172.4m of revenues in 2016, making up nearly 7% of total sales. The Group continues to generate robust growth despite high market share across the region as it benefits from past investments which strengthened its ability to continually expand the services it can provide to clients, resulting in increased share of clients’ testing spend. Revenues from the UK & Ireland grew 26.8% to EUR 122.0m, as the strong performance from the pharmaceutical testing business offset the exit from some water testing segments. Eurofins continues to expand its footprint in emerging markets and Asia Pacific, which contributed revenues of EUR 342.1m, an increase of 27.1% versus 2015, as the Group continued to expand its Asian footprint both organically and through acquisitions. Overall, the Group delivered strong performance across its businesses in 2016, supported both by positive underlying trends, and the benefits of past investments to build the best laboratory network infrastructure in its markets to serve the needs of its clients. The strong results achieved by Eurofins in most of its markets reflect the progress that the Group is making in securing leadership and strengthening its footprint in each of its areas of competence. Group adjusted EBITDA increased 32.9% to EUR 479.6m in 2016 as margin expanded by 40bp to 18.9% driven by the strong revenue growth and profitability improvements in both the mature businesses and those that had been recently transferred out of the start-up/businesses in reorganization perimeter. The mature businesses of the Group, i.e. excluding start-ups and acquisitions in significant restructuring, generated EUR 2,254.3m of revenues during the period, implying that the margin for these businesses further expanded to 21.3%. Start-ups and businesses in restructuring or reorganization generated the remaining EUR 282.3m of revenues, which means that these businesses now account for 11.1% of total Group revenues, compared to 12.5% in 2015. Start-up losses and restructuring costs as disclosed in the separately disclosed items2 (SDI) were EUR 18.5m in 2016, representing 3.9% of the total EBITDA generated by the mature businesses of the Group, a further reduction compared to the 4.4% level in 2015 despite the acceleration in the Group’s start-up investments and the finalization of some of the reorganization of its discovery services business in the US, the site consolidation programs in the UK and Benelux, and the relocation of its US genomics business to Louisville, KY. Even with multiple investments for future growth that are temporarily dilutive, reported EBITDA margin still expanded by 50bp to 18.2% as reported EBITDA increased by 33.6% to EUR 461.1m due to strong top line growth and economies of scale, allowing continued profit expansion in the Group’s mature businesses. Adjusted EBITAS increased 35.3% to EUR 357.6m despite the 27.6% year-on-year increase in depreciation and amortization, due largely to the elevated capital expenditures in recent years. The strong growth in profitability resulted in a 36.5% growth in reported EBITAS to EUR 319.4m as EBITAS margin expanded by 60bp to 12.6% during the year. Non-cash stock option charge and net acquisition-related expenses grew only modestly by 4.3% resulting in a growth of 42.3% in reported EBIT for the Group to EUR 281.9m. Finance costs in 2016 were EUR 70.8m, remaining stable at 2.8% of total revenuesvii, despite the cost of carrying more than EUR 820m of unused cash on the balance sheet at year-end and a similar amount throughout 2016. Adjusted Financial Result remained stable at -1.9% of Revenues. The income tax expense has decreased by more than 500bps to 26.8% of the profit before income taxesviii. This is the result of some exceptional finance income and the measures put in place by management to achieve an optimum tax structure, including the recognition of deferred tax assets where applicable. Adjusted net profit stood at EUR 221.6m for 2016. Due to the strong revenue growth and profit improvement, and with finance costs stable relative to revenues, reported net profit nearly doubled to EUR 174.0m during the year, translating to a 90.6% uplift in the Group’s basic earnings per share (EPS), which exceeded EUR 10 for the first time, at EUR 10.88. The 83.3% increase in pre-tax profit to EUR 242.6m, in addition to the successful management of net working capital to 3.7% of sales at the end of December 2016 (versus 5.1% in June, and against 5% NWC/Sales annual objective), resulted in a 27.7% increase in operating cash flow for the Group, to EUR 371.8m in 2016. Capital expenditures for 2016 were EUR 194.1m. Although the absolute amount represents an 18.5% increase from the previous year, capex/sales declined by 70bp to 7.7%, compared to 8.4% in 2015, demonstrating progress towards management’s commitment to its objective of managing capital expenditures program progressively closer to 6% of sales by 2020. Capital expenditures during the year were, among others, related to 46,000m2 of additional state-of-the-art lab surface, the launch of 22 new start-up laboratories during the year, as well as continued development and deployment of the Group’s new generation of IT solutions. The Group’s capital spending is consistent with its commitment to strengthening its long-term competitive advantage by building a state-of-the-art laboratory network and bespoke IT solutions. Eurofins generated robust cash flows in 2016, with free cash flow to the firm growing 39.5% to EUR 177.7m as strong revenue and profit growth offset the increase in capex. Likewise, free cash flow to equity increased 26.1% to EUR 125.9m despite the increase in interest payments due to higher gross debt, and penalties for early repayment of the EUR 170m Schuldschein loan (of which the amount due in July 2018 was paid two years early in July 2016) and the remaining EUR 116m OBSAAR bonds (of which the amount due in June 2017 was paid 6 months early in December 2016). At the end of December 2016, the Group’s leverage ratio stood at 1.16x net debt/adjusted EBITDA, well below the 3.5x limit, as net debt was reduced to EUR 557.8m, compared to EUR 916.3m in December 2015. The significant reduction was due to the higher cash generation, as well as the successful issuance of new shares in June and in September 2016, which raised total proceeds of EUR 496m. In 2016, Eurofins completed 27 acquisitions that either strengthen Eurofins’ leadership in existing markets, or further develop the Group’s expanding footprint in its newer markets, such as in clinical diagnostics testing, or in Asia Pacific. Some of Eurofins’ acquisitions during the year are discussed below. In January, Eurofins acquired Sinensis Life Sciences, a leading provider of pharmaceutical product testing and cGMP Quality Control (QC) services in the Netherlands, further reinforcing the Group’s global leadership in this area of pharmaceutical products testing. In the same month, Eurofins also acquired Biotech-Germande SAS, one of the leading players in the environmental clinical testing and hospital hygiene market, as well as in medical device evaluation in France. Biotech-Germande complements Eurofins' growing footprint in the testing market for the healthcare sector in France. In March, Eurofins further strengthened its pharmaceutical products testing footprint with the acquisition of ams Laboratories and Advantar, two leading independent analytical and cGMP Quality Control (QC) service providers in Australia, and the US West Coast respectively. In April, Eurofins acquired PerkinElmer, Inc.’s U.S. prenatal screening laboratory services business PerkinElmer Labs/NTD, a reference laboratory in the US for first and second trimester prenatal screening. The acquisition strengthens Eurofins’ growing footprint in the genetics segment of the specialty clinical diagnostic testing market. Eurofins completed the acquisition of EAC Corporation from Asahi Industries in Japan in May. EAC should reinforce the Group’s local footprint as well as its platform to further deploy the Group’s analytical expertise especially in water and dioxin testing. As part of the acquisition, Asahi and Eurofins entered into an exclusive service contract for a period of 3 years. At the end of May, Eurofins strengthened its leadership in the French food testing market with the acquisition of Agro-Analyses SAS, one of the leading analytical service providers supporting the food retail and catering sectors in France. In June, Eurofins acquired Bureau de Wit BV, one of the main laboratory service providers focused on food and water safety testing for the food production, hotel and catering sectors in The Netherlands. In July, the Group successfully closed the acquisition of Exova’s food, water and pharmaceutical testing business in the UK & Ireland, reinforcing Eurofins’ existing footprint as well as expanding client reach in the UK and Ireland. In September, Eurofins strengthened its footprint in the specialty clinical diagnostics market with the acquisition of VRL Laboratories, one of the leading laboratories in pre-transplant testing for the eligibility determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in the US. In the same month, Eurofins further reinforced its clinical diagnostics footprint in Europe with the acquisition of Megalab, one of the top five clinical diagnostic laboratory groups in Spain. Towards the end of the year, the Group further expanded its presence in North America with the acquisition of Exova’s environment testing business in Eastern Canada, and in Latin America with the acquisition of ASL Análises Ambientais, one of the leading environment testing service providers in Brazil. Total acquisition spend in 2016 was EUR 201mix for total annualized revenues in excess of EUR 220m. Including earn-outs for these newly acquired companies, this translates into an EV/sales multiple of ca 1x for the year 2016, which remains very reasonable and in line with our historical metrics. Eurofins delivered 46,000m2 of the 106,000m2 of laboratory surface planned to come on stream by the end of 2017 as part of its ongoing investment program to build the largest and most efficient state-of-the-art laboratory network in its industry. Between 2005 and 2016, Eurofins has added or brought to the most modern standards over 380,000m2 of laboratory space. In-line with the positive outlook in the US domestic testing market, the Group is further expanding its laboratory campus in Lancaster, already the largest independent single-site laboratory in the world, with a planned 17,200m2 extension to be completed by the end of 2018, of which 1,600m2 is expected to come on stream by the end of this year. Boston Heart Diagnostics (BHD) has also completed the extension of its testing facilities in Framingham, MA, which has increased its laboratory surface by over 40% to 9,300m2. In Asia Pacific, the Group is on track to complete the expansion of its main Chinese food testing laboratory in Suzhou, as well as the construction of new food testing laboratories in Australia and Singapore by the end of 2017. These projects follow the completion of the Group’s new laboratories in Hong Kong and India, as well as the multiple site upgrade and expansion projects in Australia and New Zealand in 2015. In addition to infrastructure expansion, the Group is also undertaking several site rationalization projects with part or full site upgrades, consolidating several small sites into fewer but larger industrialized sites, or simply moving some businesses into our large campuses to maximize synergies and optimize efficiencies across our businesses. The move to consolidate several small sites to a large campus in Hamburg is expected to be completed by 2019, as are the site consolidation programs in Benelux and Sweden. Encouraged by the strong performance from its start-up laboratories, with the newly-opened laboratories from the latest start-up program (launched in 2014) generating 101% revenue growth in 2016, and the 18 laboratories from the previous program (launched in 2010) generating 22% revenue growth and 19% EBITDA margin in 2016, the Group has accelerated its current start-ups program. Between 2014 and the end of 2017, Eurofins plans to open 76 green-field laboratories (from the original 35 announced in 2015), which would mean an average of 20 start-ups launched per year during that period. This would take total start-ups launched by the Group to 110 laboratories between 2007 and 2017. 1 Adjusted – reflects the ongoing performance of the mature and recurring activities excluding “separately disclosed items”. 2 Separately disclosed items - includes one-off costs from integration, reorganisation, discontinued operations and other non-recurring income and costs, temporary losses and other costs related to network expansion, start-ups and new acquisitions undergoing significant restructuring, non-cash accounting charges for stock options and free shares, impairment of goodwill, amortisation of acquired intangible assets, negative goodwill, discontinued activities and transaction costs related to acquisitions as well as income from reversal of such costs and from unused amounts due for business acquisitions, net finance costs related to borrowing and investing excess cash and one-off financial effects and the related tax effects. (Details in Note 2.3 of the 2016 Consolidated Financial Statements). 3 EBITDA – Earnings before interest, taxes, depreciation and amortisation, non-cash accounting charges for stock options and free shares, impairment of goodwill, amortisation of acquired intangible assets, negative goodwill, discontinued activities and transaction costs related to acquisitions as well as income from unused amounts due for business acquisitions. 4 EBITAS – Earnings before interest, taxes, non-cash accounting charges for stock options and free shares, impairment of goodwill, amortisation of acquired intangible assets, negative goodwill, discontinued activities and transaction costs related to acquisitions as well as income from unused amounts due for business acquisitions. 5 Net Profit – Net profit for equity holders after non-controlling interests but before payment to Hybrid capital holders 6 Basic EPS – earnings per share (basic) total (to equity holders before payment of dividends to Hybrid capital holders) 7 Operating Cash Flow – Net cash provided by operating activities (after tax) 8 Free Cash Flow to the Firm –Operating Cash Flow, less Net capex 9 Organic growth for a given period (Q1, Q2, Q3, Half Year, Nine Months or Full Year) - non-IFRS measure calculating the growth in revenues during that period between 2 successive years for the same scope of businesses using the same exchange rates but excluding discontinued activities. For the purpose of organic growth calculation for year Y, the relevant scope used is the scope of businesses that have been consolidated in the Group's income statement of the previous financial year (Y-1). Revenue contribution from companies acquired in the course of Y-1 but not consolidated for the full year are adjusted as if they had been consolidated as from 1st January Y-1. All revenues from businesses acquired since 1st January Y are excluded from the calculation. For details of the FY 2016 results, including consolidated financial statements and related notes, please visit: http://www.eurofins.com/investor-relations/reports-presentations/ Eurofins Scientific through its subsidiaries (hereinafter sometimes “Eurofins” or “the Group”) believes it is the world leader in food, environment and pharmaceutical products testing and that it is also one of the global independent market leaders in certain testing and laboratory services for agroscience, genomics, discovery pharmacology and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA. With over 27,000 staff in 310 laboratories across 39 countries, Eurofins offers a portfolio of over 130,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products, as well as for innovative clinical diagnostic. The Group objective is to provide its customers with high-quality services, accurate results on time and expert advice by its highly qualified staff. Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and the most comprehensive range of testing methods. As one of the most innovative and quality oriented international players in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the expanding demands of regulatory authorities around the world. The shares of Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP). This press release contains forward-looking statements and estimates that involve risks and uncertainties. The forward-looking statements and estimates contained herein represent the judgement of Eurofins Scientific’ management as of the date of this release. These forward-looking statements are not guarantees for future performance, and the forward-looking events discussed in this release may not occur. Eurofins Scientific disclaims any intent or obligation to update any of these forward-looking statements and estimates. All statements and estimates are made based on the information available to the Company’s management as of the date of publication, but no guarantee can be made as to their validity. Eurofins provides in the Income Statement certain alternative performance measures (non-IFRS information such as “Adjusted Results and Separately Disclosed Items”) that exclude certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. (Refer to description of Separately Disclosed Items). In addition, Eurofins shows the following two earnings measures in the Income Statement with the objective to be close and consistent with the information used in internal Group reporting to measure the performance of Group companies and information published by other companies in the sector: EBITDA: Earnings before interest, taxes, depreciation and amortisation, non-cash accounting charges for stock options and free shares, impairment of goodwill, amortisation of acquired intangible assets, negative goodwill, discontinued activities and transaction costs related to acquisitions as well as income from unused amounts due for business acquisitions” EBITAS: Earnings before interest, taxes, non-cash accounting charges for stock options and free shares, impairment of goodwill, amortisation of acquired intangible assets, negative goodwill, discontinued activities and transaction costs related to acquisitions as well as income from unused amounts due for business acquisitions” Organic growth for a given period (Q1, Q2, Q3, Half Year, Nine Months or Full Year) - non-IFRS measure calculating the growth in revenues during that period between 2 successive years for the same scope of businesses using the same exchange rates but excluding discontinued operations. For the purpose of organic growth calculation for year Y, the relevant scope used is the scope of businesses that have been consolidated in the Group's income statement of the previous financial year (Y-1). Revenue contribution from companies acquired in the course of Y-1 but not consolidated for the full year are adjusted as if they had been consolidated as from 1st January Y-1. All revenues from businesses acquired since 1st January Y are excluded from the calculation. Management believes that providing these alternative performance measures enhances investors' understanding of the company’s core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts and to the performance of our competitors. This information should be considered in addition to, but not in lieu of, information prepared in accordance with IFRS. i https://ec.europa.eu/food/sites/food/files/safety/docs/rasff_annual_report_2015.pdf ii http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM536693.pdf iii http://www.fiercepharma.com/sales-and-marketing/drug-sales-expected-to-top-1-3t-2018?utm_medium=nl&utm_source=internal iv Matrix Assisted Laser Desorption Ionization Time-of-Flight v Association Nationale des Expéditeurs et Exportateurs de Fruits et Légumes vi Regulation of mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH) http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+MOTION+B8-2016-0411+0+DOC+XML+V0//EN ; Legislation on Polycyclic Aromatic Hydrocarbons (PAHs) https://ec.europa.eu/jrc/en/eurl/pahs/legislation vii Compared to 2015 level adjusted for the impact of derivative financial instruments ix including earn-out payments on acquisitions completed in previous years


News Article | March 2, 2017
Site: globenewswire.com

- Conference Call at 8:30 a.m. ET Today - DURHAM, N.C., March 02, 2017 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the fourth quarter and full year ended December 31, 2016. “Today we are pleased to report the positive outcome from the third cohort of our Single Ascending Dose study of intravenous brincidofovir, which demonstrated continued safety and tolerability at higher doses and further supports brincidofovir’s potential as a potent broad spectrum antiviral,” said Garrett Nichols, MD, MS, Chief Medical Officer of Chimerix. “During 2016 we made considerable progress developing the optimal paths forward for oral brincidofovir for short course treatment and advancing intravenous brincidofovir into the clinic.  These developments have positioned the Company well to achieve a number of milestones throughout 2017 that we believe will be instrumental in advancing brincidofovir in order to benefit patients fighting these serious viral infections,” concluded Michelle Berrey, MD, MPH, President and Chief Executive Officer. The ability to provide brincidofovir (BCV) in oral and intravenous (IV) formulations enables development across multiple indications and populations with the potential for best-in-class efficacy and safety.  In 28-day animal studies and in single dose administration in healthy subjects, IV BCV has shown the potential for less gastrointestinal (GI) injury compared to oral BCV, even with higher plasma drug concentrations and longer-term dosing.  Additionally, data from animal efficacy studies and AdVise support the continued development of oral BCV for short course treatment of smallpox and adenovirus (AdV). Reported Preliminary Data from Ongoing Phase 1 Dose Escalation Study of IV BCV in Healthy Subjects In this Phase 1 study, a total of 40 healthy subjects have been randomized to receive either a single dose of IV BCV or IV placebo in one of four cohorts: In January 2017, Chimerix announced preliminary data from the first two cohorts of this ongoing Phase 1 study. Today, Chimerix announces preliminary results from the third cohort (IV BCV 50 mg given over 2 hours) of this study. In this ongoing blinded study, a favorable safety and tolerability profile has been observed in all three cohorts completed to date.  Grade 1-2 (on a scale of Grade 1-5) safety laboratory changes were observed in some subjects in the first three dosing cohorts; none were considered clinically significant. No Grade 3 or higher safety laboratory abnormalities were observed for any subjects receiving IV study drug in Cohorts 1, 2 and 3.  In Cohort 3, IV BCV 50 mg or placebo, mild Adverse Events (AEs) were reported that possibly were related to study drug included: a single lower gastrointestinal event of loose stools was reported in one subject, and two other subjects each reported a mild headache that spontaneously resolved. In addition, three subjects had bruising at the site of the IV catheter. IV BCV 50 mg provided plasma drug exposures higher than achieved with oral BCV dosing, and in the range of exposures targeted for treatment indications such as for BK nephropathy. Cohort 4 will explore IV BCV 50 mg or placebo over a longer period of infusion.  Complete clinical and pharmacokinetic data from all four cohorts are expected to be reported during the first half of 2017. On February 23, final data from the AdVise trial of BCV for the treatment of AdV infection in allogeneic hematopoietic cell transplant (HCT) recipients was presented at the combined annual meetings of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT) held February 22-26, 2017 in Orlando, FL. The AdVise trial was an open-label, multicenter study designed to evaluate the efficacy, safety and overall tolerability of oral BCV for the treatment of AdV infection. Pediatric and adult subjects were assigned to one of three cohorts: All subjects were to receive 12 weeks of oral BCV and were followed for at least 36 weeks.  This final analysis includes 158 allogeneic HCT recipients assigned to Cohorts A (23 adult and 42 pediatric patients) and B (35 adult and 58 pediatric patients). In the AdVise trial, declines in AdV viral load of ≥2 log c/mL or below the limit of detection at week four were observed in 76 percent of pediatric patients and 45 percent of adult patients.  Notably, this antiviral effect was observed even in HCT recipients who did not yet have immune recovery. In Cohort A, 55 percent of patients with baseline low immunity (CD4 counts <50 cells/μL) achieved ≥2 log c/mL decline or undetectable AdV at week four. In Cohort B, 52 percent of patients with baseline low immunity achieved ≥2 log c/mL decline or undetectable AdV over the same period of time. In patients with disseminated disease, rapid virologic response, defined as undetectable AdV viremia at week six, was associated with nearly double the survival rate and lower AdV-associated mortality compared with subjects who did not have an antiviral response, as summarized in the table below. * Responders defined as subjects with baseline AdV viremia still on study at week six who had undetectable plasma AdV at week six; non-responders defined as subjects who did not achieve the specified cut-off. A Cox model was used to compare mortality at 36 weeks in responders and non-responders. Diarrhea was the most commonly reported treatment-emergent adverse event in AdVise Cohorts A and B, reported at 38 percent of adult and 43 percent of pediatric HCT recipients. Treatment discontinuations related to diarrhea in Cohorts A and B occurred in 5 percent of adult and 6 percent of pediatric patients. Chimerix reported a net loss of $15.0 million, or $0.32 per basic and diluted share, for the fourth quarter of 2016. During the same period in 2015, Chimerix recorded a net loss of $37.8 million, or $0.82 per basic and diluted share. Revenues for the fourth quarter of 2016 decreased to $2.0 million, compared to $3.1 million for the same period in 2015. Research and development expenses were $11.7 million for the fourth quarter of 2016, and $31.8 million for the same period in 2015. General and administrative expenses decreased to $5.6 million for the fourth quarter of 2016, compared to $9.5 million for the same period in 2015. Loss from operations was $15.4 million for the fourth quarter of 2016, compared to a loss from operations of $38.2 million for the same period in 2015. Interest income was $416,000 in the fourth quarter of 2016, compared to interest income of $381,000 in the same period in 2015. Chimerix's balance sheet as of December 31, 2016, included $278.1 million of capital available to fund operations, no debt and approximately 46.5 million outstanding shares of common stock. Chimerix reported a net loss of $76.4 million, or $1.65 per basic and diluted share, for the year ended December 31, 2016. For the year ended December 31, 2015, Chimerix recorded net loss of $117.4 million, or $2.67 per basic and diluted share. Research and development expenses were $58.6 million for the year ended December 31, 2016, compared to $97.7 million for the year ended December 31, 2015. General and administrative expenses decreased to $25.0 million for the year ended December 31, 2016, compared to $31.3 million for the year ended December 31, 2015. Loss from operations was $78.0 million for the year ended December 31, 2016, compared to a loss from operations of $118.3 million for the year ended December 31, 2015. Net interest income was $1.6 million for the year ended December 31, 2016, compared to net interest income of $0.9 million for the year ended December 31, 2015. Today's Conference Call and Webcast Chimerix will host a conference call and live webcast to discuss its fourth quarter and full year 2016 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 97022450. A live audio webcast of the call and accompanying slides will also be available on the Investors section of Chimerix's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event. About Chimerix Chimerix is a biopharmaceutical company dedicated to discovering and developing medicines that improve outcomes for immunocompromised patients. Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and earlier-stage compounds. Chimerix recently announced a new clinical candidate, CMX521, for the treatment and/or prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that brincidofovir may not continue to show positive safety and tolerability at higher doses, that Chimerix may not be able to achieve milestones in 2017 to advance the development of brincidofovir, that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


News Article | February 23, 2017
Site: globenewswire.com

HCT-hakeyhdistelmätutkimushanke on osa Metsätehon puutavaran HCT-yhdistelmien tutkimusta. Sen tavoitteena on kehittää normaaliin päätieliikenteeseen sopivia, ympäristöystävällisiä, turvallisia ja tehokkaita yhdistelmiä. Yksi hakeyhdistelmähankkeen tutkimuskohteista on kuljetustekniikan kehittäminen. Esimerkiksi Lappeenrannan teknillinen yliopisto ja yhdistelmien valmistajat tekevät Tekes-rahotteista tutkimusta, jossa tutkitaan HCT-yhdistelmien runkorakenteita ja valmistusteknistä optimointia. UPM uudistaa bio- ja metsäteollisuutta. Rakennamme kestävää tulevaisuutta kuudella liiketoiminta-alueella: UPM Biorefining, UPM Energy, UPM Raflatac, UPM Specialty Papers, UPM Paper ENA ja UPM Plywood. Tuotteemme valmistetaan uusiutuvista raaka-aineista ja ne ovat kierrätettäviä. Palvelemme asiakkaitamme maailmanlaajuisesti. Yhtiössämme työskentelee noin 19 300 henkilöä ja vuosittainen liikevaihtomme on noin 10 miljardia euroa. UPM:n osakkeet on listattu Helsingin pörssissä. UPM - The Biofore Company - www.upm.fi

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