Biomedical Advanced Research and Development Authority

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Washington, DC, United States
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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.


Recent developments in the RiVax® program have also described immune correlates of protection for the ricin toxin vaccine, which are important to facilitating potential approval of thermostabilized RiVax® via the US Food and Drug Administration (FDA) "Animal Rule". As a biodefense vaccine, RiVax® also has the potential to qualify for a priority review voucher (PRV) upon FDA approval. Recent PRVs have sold for as much $350 million. "ThermoVax® has successfully demonstrated that it can thermostabilize a number of different alum-adjuvanted protein antigens, including antigens for ricin, anthrax, human papillomavirus and Ebola," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The RiVax® program continues to progress towards potential approval under the Animal Rule, and as our most advanced product candidate using the ThermoVax® technology, it also provides positive proof-of-concept for use of this proprietary heat stabilization platform with other development and commercial vaccines. While we advance RiVax® with the support of NIAID contract funding, we also look forward to potentially applying the ThermoVax® technology to other vaccine candidates in the future." The ThermoVax® technology is designed to eliminate the cold chain production, distribution and storage logistics required for most vaccines. The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax® has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations. The underlying ThermoVax® technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. By employing ThermoVax® during the final formulation of RiVax®, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. Similar stabilization at temperatures as high as 50 degrees Celsius for up to 3 months (maximum timepoint tested) have also been demonstrated with other antigens (e.g., human papillomavirus, Ebola and anthrax). RiVax® is Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax®, Soligenix is a world leader in the area of ricin toxin vaccine research. RiVax® contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax® that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax® induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals. To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax® was subsequently formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax® was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax®. In preclinical animal studies, the Alum formulation of RiVax® also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine. Vaccination with the thermostabilized Alum-adjuvanted RiVax® formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin. The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure. These results are described in a publication available here. The development of RiVax® has been sponsored through a series of grants from both NIAID, part of the National Institutes of Health, and the FDA, which were granted to Soligenix and to the University of Texas Southwestern (UTSW) where the vaccine protein originated. To date, Soligenix, Dr. Ellen Vitetta and her colleagues at UTSW have collectively received approximately $25 million in funding from NIAID for development of RiVax® and related vaccine technologies. Currently, Soligenix is developing RiVax® under NIAID contract #HHSN272201400039C, worth up to $26 million, assuming all options are exercised.   RiVax® has received orphan drug designation from the FDA. RiVax® potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack. As a new chemical entity, an FDA approved RiVax® vaccine also has the potential to qualify for a biodefense PRV, which allows the holder accelerated review of a drug application. Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs are transferable and can be sold, with sales in recent years varying from between $125 million to $350 million. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com. This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will be approved for the PRV program or the amount for which a PRV for  RiVax® can be sold.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/soligenix-receives-japanese-patent-for-thermovax-vaccine-heat-stabilization-platform-technology-300453773.html


-- Presented additional Phase 3 EPIC and CARE trial data highlighting the safety and efficacy of plazomicin during late-breaker session at ECCMID -- -- Plazomicin registration activities on track; NDA submission planned for the second half of 2017 -- SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the first quarter 2017, and provided an update on its corporate and clinical development activities. "Advancing plazomicin registration activities is our top priority; we are encouraged by our progress with manufacturing and had a productive pre-NDA meeting with FDA in April. We remain on track with our plans to file the plazomicin NDA in the second half of 2017,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “We have made excellent progress with our C-Scape program and plan to initiate a Phase 1 clinical trial in the second quarter of 2017.” Plazomicin has successfully completed two Phase 3 clinical trials and the Company plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2017 and to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. The EPIC (Evaluating Plazomicin In cUTI) trial is expected to serve as a single registration trial supporting an NDA for plazomicin in the United States and an MAA in the European Union. The second study, the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial was a resistant pathogen trial designed to evaluate the efficacy and safety of plazomicin in patients with serious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE) and provides additional data supporting the NDA and plazomicin therapy in these patients. C-Scape – Achaogen is developing an orally-available antibacterial candidate, C-Scape, that is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, with the potential to treat patients with cUTI due to MDR pathogens such as extended spectrum beta-lactamase (ESBL) producing Escherichia coli and Klebsiella pneumoniae. Unrestricted cash, cash equivalents and short-term investments totaled $132.0 million at March 31, 2017 compared to $145.9 million at December 31, 2016. Contract revenue totaled $7.5 million for the first quarter of 2017 compared to $5.8 million for the same period of 2016. The increase in contract revenue during the quarter was primarily due to the increased research and development activities under the contract Option 3 with BARDA. As of March 31, 2017, $0.1 million and $0.6 million remains on the BARDA and NIAID contracts, respectively. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the research and development of product candidates. Research and development (R&D) expenses were $18.6 million for the first quarter of 2017 compared to $13.9 million reported for the same period in 2016. The increase in R&D expenses during the first quarter were attributable to: a) concluding the plazomicin clinical trials and initiation of engineering and validation manufacturing campaigns, b) initiation of the C-Scape program, and c) continued advancement of the Company’s earlier stage pipeline. General and Administrative (G&A) expenses were $6.8 million for the first quarter of 2017 compared to $3.8 million for the same period in 2016. The increase in G&A expenses was primarily attributable to higher personnel related expenses and increased activity to prepare for registration and potential commercialization of plazomicin. Change in warrant and derivative liabilities were $15.0 million for the first quarter of 2017 compared to nil for the same period in 2016. The increase was primarily related to non-cash charges for the revaluation of warrants issued in the private placement of common stock and warrants to purchase common stock in June 2016. Net loss for the first quarter of 2017 was $33.3 million, or $0.93 per share, compared to a net loss of $12.2 million, or $0.66 per share, for the first quarter of 2016. As of March 31, 2017, there were approximately 35.8 million shares of common stock outstanding. Conference Call The Company will host a conference call today, May 8, 2017 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 877-719-9786 (Domestic) or 719-325-4773 (International). The conference ID number is 3868586. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.achaogen.com. The archived audio webcast will remain available on the Company's website for 30 days following the conference call. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen's expectations regarding potential regulatory approval of plazomicin, Achaogen's commercial objectives and Achaogen's pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


GAITHERSBURG, Md., May 10, 2017 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today held a ribbon-cutting ceremony led by Dr. Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), and Daniel J. Abdun-Nabi, Emergent’s president and chief executive officer, to mark the formal opening of the company’s newly expanded Center for Innovation in Advanced Development and Manufacturing (CIADM) at its Bayview Campus in Baltimore. The facility is one of three centers designated by the U.S. Department of Health and Human Services to provide advanced development and manufacturing of medical countermeasures to support the U.S. government’s national security and public health emergency needs. “With the expansion of our Bayview campus, Emergent is pleased to directly support BARDA’s vision of enhancing the nation’s capability to respond quickly to both known and emerging public health threats,” said Abdun-Nabi. “This milestone strengthens our manufacturing infrastructure, which is one of our core competencies, and symbolizes Emergent’s commitment to the City of Baltimore and the State of Maryland, where we are proud to meaningfully contribute to economic activity and job growth.” “The Centers for Innovation in Advanced Development and Manufacturing were designed as public-private partnerships to provide greater speed, flexibility, and domestic capacity to produce medical countermeasures to address public health emergencies,” said Bright. “The work that we do in BARDA – and that we do together with industry partners at our CIADMs – is critical to protecting Americans’ health in emergencies and is fundamental to our nation’s security.” Emergent has doubled the Bayview facility’s footprint to 112,000 square feet with investments to the original 56,000-square-foot facility purchased by the company in 2009. The facility, comprised of laboratory, manufacturing and office space, offers flexible manufacturing of drug substance from microbial, cell culture or viral production platforms and is equipped with disposable manufacturing technology to enable Emergent to meet the government’s domestic preparedness priorities on a cost-effective, reliable and sustainable basis. The new suite within the expanded facility is expected to come online with cGMP production capabilities in late 2018. Since its inception, the Emergent CIADM has been awarded four task orders by BARDA to develop Ebola and Marburg therapeutics and a Zika vaccine. Emergent also successfully manufactured some of its product candidates at the CIADM and an Ebola vaccine candidate as part of a third-party collaboration. Emergent employs approximately 1,200 employees worldwide. More than 500 employees are located across four sites in Maryland, including its Bayview Campus, Camden manufacturing facility, and corporate headquarters and product development site in Gaithersburg. BARDA contract HHSO100201200004I, awarded to Emergent in June 2012 to establish a CIADM, consists of an eight-year base period of performance valued at approximately $220 million (cost-shared between the government and Emergent) and up to 17 additional one-year option periods. BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. Sen. Chris Van Hollen (D-Md.) “Maryland’s biopharmaceutical industry continues to grow and create good-paying jobs. Emergent's new Bayview facility is an exciting addition to their statewide footprint, and people across the nation could benefit from their vaccines and therapeutic treatments like those for anthrax and Zika. A successful biopharmaceutical industry requires a coordinated strategy to both expand job opportunities and ensure our next generation of workers has the skills needed to fill these jobs. I will continue to work on the federal level to help the industry grow in Maryland so the lifesaving innovations made in this sector also provide an economic boost to our state.” Rep. John Sarbanes (D-3rd District) “Maryland is home to a vibrant biotechnology industry that supports thousands of good-paying jobs. The expansion of Emergent BioSolutions’ Bayview facility in Baltimore will help ensure that Maryland remains a leader in biotechnology innovation and will help boost our state’s economy for many years to come.” Rep. Andy Harris (R-1st District) “I congratulate Emergent BioSolutions today on the expansion of their Center for Innovation in Advanced Development and Manufacturing that fulfils such a critically important component of America’s countermeasure development and biosecurity enterprise.” Rep. C.A. Dutch Ruppersberger (D-2nd District) “Emergent BioSolutions’ expansion was a public-private investment in the welfare of all Americans through the development of vaccines and treatments for diseases from the flu to Ebola. For us Baltimoreans, it’s also exciting because it means more high-quality manufacturing jobs in the cutting-edge biosciences sector. I congratulate Emergent and thank them for their commitment to Maryland and our great city.” Maryland Governor Larry Hogan “Emergent BioSolutions plays a critical role in addressing many of our nation’s emerging public health threats and we are proud they are continuing to do that important work right here in Maryland. Doubling the size of its Bayview facility and adding new jobs to meet its increased capabilities is further confirmation that Maryland offers an outstanding environment for life sciences companies to thrive.” Baltimore Mayor Catherine E. Pugh  “It’s exciting to witness the continued growth of Emergent BioSolutions in Maryland and Baltimore City. I am encouraged by so many businesses investing and expanding in Baltimore. Not only does Emergent make meaningful products, which improve public health, the company is bringing and keeping manufacturing jobs in the city – jobs that provide family-sustaining wages.” Baltimore City Council President Bernard C. “Jack” Young “I am extremely pleased to see Emergent expanding its manufacturing capabilities in Maryland. They are at the forefront of innovation, and represent everything we want in a Baltimore area company. Emergent also continues to emphasize local hiring, which I have fought hard to promote so we can increase job opportunities and put our city to work. I commend Emergent for its commitment to our city schools where they teach students about manufacturing and expose them to potential career paths in science. I am confident Emergent will continue to be an asset to Baltimore.” About Emergent BioSolutions Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at emergentbiosolutions.com. Follow us @emergentbiosolu.


Dr. Schaber continued, "We also continue to actively enroll patients in our pivotal Phase 3 study in cutaneous T-cell lymphoma with SGX301 (synthetic hypericin), in which we expect data by the end of the year.  In our Vaccines/BioDefense business segment, we are pleased with the efficacy results from our heat stable ricin vaccine, RiVax®, which has demonstrated significantly enhanced thermostability and 100% protection in preclinical ricin aerosol challenge models." Soligenix's revenues for the quarter ended March 31, 2017 were $1.3 million as compared to $2.6 million for the prior year. Revenues included contracts with NIAID and Biomedical Advanced Research and Development Authority (BARDA) in support of the advanced development of the Company's thermostabilization technology, ThermoVax®, combined with its ricin toxin vaccine RiVax®, as a medical countermeasure to prevent the effects of ricin exposure and OrbeShield® (oral beclomethasone 17,21 dipropionate) in the treatment of gastrointestinal acute radiation syndrome. Soligenix's basic net loss was $1.7 million, or $(0.32) per share, for the quarter ended March 31, 2017 as compared to $1.1 million, or $(0.37) per share for the same quarter of the prior year. Included in the net loss for the quarter ended March 31, 2016 is non-cash other income of $0.8 million. This non-cash other income reflects the change in fair value of the liability related to warrants issued in the Company's June 25, 2013 registered public offering and is not included in other income for the quarter ended March 31, 2017, as the warrant liability was reclassified to equity during the year ended December 31, 2016. Research and development expenses were $1.2 million as compared to $1.4 million for the quarters ended March 31, 2017 and 2016, respectively. The decrease is primarily a result of the completion of the Phase 2 trial of SGX942 for the treatment of oral mucositis in head and neck cancer patients during the first quarter of 2017 and the trial initiation costs incurred for the Phase 3 trial of SGX301 during the first quarter of 2016. General and administrative expenses were $0.8 million as compared to $0.9 million for the quarters ended March 31, 2017 and 2016, respectively. This decrease is the result of a decrease in professional fees. As of March 31, 2017, the Company's cash position was $7.1 million. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com. This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy and the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/soligenix-announces-recent-accomplishments-and-first-quarter-2017-financial-results-300455811.html


GAITHERSBURG, Md., May 10, 2017 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today held a ribbon-cutting ceremony led by Dr. Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), and Daniel J. Abdun-Nabi, Emergent’s president and chief executive officer, to mark the formal opening of the company’s newly expanded Center for Innovation in Advanced Development and Manufacturing (CIADM) at its Bayview Campus in Baltimore. The facility is one of three centers designated by the U.S. Department of Health and Human Services to provide advanced development and manufacturing of medical countermeasures to support the U.S. government’s national security and public health emergency needs. “With the expansion of our Bayview campus, Emergent is pleased to directly support BARDA’s vision of enhancing the nation’s capability to respond quickly to both known and emerging public health threats,” said Abdun-Nabi. “This milestone strengthens our manufacturing infrastructure, which is one of our core competencies, and symbolizes Emergent’s commitment to the City of Baltimore and the State of Maryland, where we are proud to meaningfully contribute to economic activity and job growth.” “The Centers for Innovation in Advanced Development and Manufacturing were designed as public-private partnerships to provide greater speed, flexibility, and domestic capacity to produce medical countermeasures to address public health emergencies,” said Bright. “The work that we do in BARDA – and that we do together with industry partners at our CIADMs – is critical to protecting Americans’ health in emergencies and is fundamental to our nation’s security.” Emergent has doubled the Bayview facility’s footprint to 112,000 square feet with investments to the original 56,000-square-foot facility purchased by the company in 2009. The facility, comprised of laboratory, manufacturing and office space, offers flexible manufacturing of drug substance from microbial, cell culture or viral production platforms and is equipped with disposable manufacturing technology to enable Emergent to meet the government’s domestic preparedness priorities on a cost-effective, reliable and sustainable basis. The new suite within the expanded facility is expected to come online with cGMP production capabilities in late 2018. Since its inception, the Emergent CIADM has been awarded four task orders by BARDA to develop Ebola and Marburg therapeutics and a Zika vaccine. Emergent also successfully manufactured some of its product candidates at the CIADM and an Ebola vaccine candidate as part of a third-party collaboration. Emergent employs approximately 1,200 employees worldwide. More than 500 employees are located across four sites in Maryland, including its Bayview Campus, Camden manufacturing facility, and corporate headquarters and product development site in Gaithersburg. BARDA contract HHSO100201200004I, awarded to Emergent in June 2012 to establish a CIADM, consists of an eight-year base period of performance valued at approximately $220 million (cost-shared between the government and Emergent) and up to 17 additional one-year option periods. BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. Sen. Chris Van Hollen (D-Md.) “Maryland’s biopharmaceutical industry continues to grow and create good-paying jobs. Emergent's new Bayview facility is an exciting addition to their statewide footprint, and people across the nation could benefit from their vaccines and therapeutic treatments like those for anthrax and Zika. A successful biopharmaceutical industry requires a coordinated strategy to both expand job opportunities and ensure our next generation of workers has the skills needed to fill these jobs. I will continue to work on the federal level to help the industry grow in Maryland so the lifesaving innovations made in this sector also provide an economic boost to our state.” Rep. John Sarbanes (D-3rd District) “Maryland is home to a vibrant biotechnology industry that supports thousands of good-paying jobs. The expansion of Emergent BioSolutions’ Bayview facility in Baltimore will help ensure that Maryland remains a leader in biotechnology innovation and will help boost our state’s economy for many years to come.” Rep. Andy Harris (R-1st District) “I congratulate Emergent BioSolutions today on the expansion of their Center for Innovation in Advanced Development and Manufacturing that fulfils such a critically important component of America’s countermeasure development and biosecurity enterprise.” Rep. C.A. Dutch Ruppersberger (D-2nd District) “Emergent BioSolutions’ expansion was a public-private investment in the welfare of all Americans through the development of vaccines and treatments for diseases from the flu to Ebola. For us Baltimoreans, it’s also exciting because it means more high-quality manufacturing jobs in the cutting-edge biosciences sector. I congratulate Emergent and thank them for their commitment to Maryland and our great city.” Maryland Governor Larry Hogan “Emergent BioSolutions plays a critical role in addressing many of our nation’s emerging public health threats and we are proud they are continuing to do that important work right here in Maryland. Doubling the size of its Bayview facility and adding new jobs to meet its increased capabilities is further confirmation that Maryland offers an outstanding environment for life sciences companies to thrive.” Baltimore Mayor Catherine E. Pugh  “It’s exciting to witness the continued growth of Emergent BioSolutions in Maryland and Baltimore City. I am encouraged by so many businesses investing and expanding in Baltimore. Not only does Emergent make meaningful products, which improve public health, the company is bringing and keeping manufacturing jobs in the city – jobs that provide family-sustaining wages.” Baltimore City Council President Bernard C. “Jack” Young “I am extremely pleased to see Emergent expanding its manufacturing capabilities in Maryland. They are at the forefront of innovation, and represent everything we want in a Baltimore area company. Emergent also continues to emphasize local hiring, which I have fought hard to promote so we can increase job opportunities and put our city to work. I commend Emergent for its commitment to our city schools where they teach students about manufacturing and expose them to potential career paths in science. I am confident Emergent will continue to be an asset to Baltimore.” About Emergent BioSolutions Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at emergentbiosolutions.com. Follow us @emergentbiosolu.


-- Presented additional Phase 3 EPIC and CARE trial data highlighting the safety and efficacy of plazomicin during late-breaker session at ECCMID -- -- Plazomicin registration activities on track; NDA submission planned for the second half of 2017 -- SOUTH SAN FRANCISCO, Calif., May 08, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the first quarter 2017, and provided an update on its corporate and clinical development activities. "Advancing plazomicin registration activities is our top priority; we are encouraged by our progress with manufacturing and had a productive pre-NDA meeting with FDA in April. We remain on track with our plans to file the plazomicin NDA in the second half of 2017,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “We have made excellent progress with our C-Scape program and plan to initiate a Phase 1 clinical trial in the second quarter of 2017.” Plazomicin has successfully completed two Phase 3 clinical trials and the Company plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2017 and to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. The EPIC (Evaluating Plazomicin In cUTI) trial is expected to serve as a single registration trial supporting an NDA for plazomicin in the United States and an MAA in the European Union. The second study, the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial was a resistant pathogen trial designed to evaluate the efficacy and safety of plazomicin in patients with serious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE) and provides additional data supporting the NDA and plazomicin therapy in these patients. C-Scape – Achaogen is developing an orally-available antibacterial candidate, C-Scape, that is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, with the potential to treat patients with cUTI due to MDR pathogens such as extended spectrum beta-lactamase (ESBL) producing Escherichia coli and Klebsiella pneumoniae. Unrestricted cash, cash equivalents and short-term investments totaled $132.0 million at March 31, 2017 compared to $145.9 million at December 31, 2016. Contract revenue totaled $7.5 million for the first quarter of 2017 compared to $5.8 million for the same period of 2016. The increase in contract revenue during the quarter was primarily due to the increased research and development activities under the contract Option 3 with BARDA. As of March 31, 2017, $0.1 million and $0.6 million remains on the BARDA and NIAID contracts, respectively. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the research and development of product candidates. Research and development (R&D) expenses were $18.6 million for the first quarter of 2017 compared to $13.9 million reported for the same period in 2016. The increase in R&D expenses during the first quarter were attributable to: a) concluding the plazomicin clinical trials and initiation of engineering and validation manufacturing campaigns, b) initiation of the C-Scape program, and c) continued advancement of the Company’s earlier stage pipeline. General and Administrative (G&A) expenses were $6.8 million for the first quarter of 2017 compared to $3.8 million for the same period in 2016. The increase in G&A expenses was primarily attributable to higher personnel related expenses and increased activity to prepare for registration and potential commercialization of plazomicin. Change in warrant and derivative liabilities were $15.0 million for the first quarter of 2017 compared to nil for the same period in 2016. The increase was primarily related to non-cash charges for the revaluation of warrants issued in the private placement of common stock and warrants to purchase common stock in June 2016. Net loss for the first quarter of 2017 was $33.3 million, or $0.93 per share, compared to a net loss of $12.2 million, or $0.66 per share, for the first quarter of 2016. As of March 31, 2017, there were approximately 35.8 million shares of common stock outstanding. Conference Call The Company will host a conference call today, May 8, 2017 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 877-719-9786 (Domestic) or 719-325-4773 (International). The conference ID number is 3868586. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.achaogen.com. The archived audio webcast will remain available on the Company's website for 30 days following the conference call. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen's expectations regarding potential regulatory approval of plazomicin, Achaogen's commercial objectives and Achaogen's pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


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.

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