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News Article | February 15, 2017
Site: www.prweb.com

Bioclinica®, a provider of specialized science and technology-enabled services supporting clinical trials, today announced three executive additions to its global Medical Imaging & Biomarkers leadership team. With global headquarters in Princeton, New Jersey, Bioclinica’s Medical Imaging & Biomarkers business segment is the world clinical trial leader in medical imaging, providing cardiac safety monitoring services, specialized biochemical marker analysis, and clinical lab services in the Bioclinica molecular marker laboratory. Joining Bioclinica are Andrew Kraus, Chief Operating Officer; Souhil Zaim, MD, Head of Global Medical and Science Affairs; and Sara Levy, Vice President, Client Services. All three will report to David Herron, President, Medical Imaging & Biomarkers. “As the global leader in medical imaging and biomarkers, our teams are proud to have supported more than 3,000 clinical trials and 149 FDA approvals. An incomparable clinical trial track record spanning three decades attracts the world’s best in our domain,” commented David Herron, President Medical Imaging & Biomarkers. “I am very happy to have these three, multi-talented individuals join our incredible team, adding their expertise, experience and passion for creating value for patients, customers and the industry.” Kraus is a recognized clinical research industry senior executive with more than 24 years of technical and regulatory knowledge, and a track record of financial growth and operational delivery. Among his primary responsibilities Kraus will be pivotal in driving strategic planning, spearheading technology-enabled global operations, supporting Bioclinica’s tremendous growth, and driving superior outcomes for clients. Most recently, Kraus was chief operating officer and treasurer of the Cardiovascular Research Foundation in New York City where he led a period of historical growth. Prior to this he was with ICON, plc. for ten years serving as executive vice president, Global Data Technologies after a tenure as executive vice president and chief technology officer of the Medical Imaging Division. Kraus has co-founded two successful businesses in the clinical trials services industry after beginning his long career at Bio-Imaging Technologies, which would later become Bioclinica. Kraus has both a bachelor’s and a master’s degree in Bioengineering from the University of Pennsylvania. Dr. Zaim is a recognized medical imaging industry senior executive with more than 25 years of medical, scientific and industry experience and was most recently chief medical officer at Median Technologies. He will be responsible for ensuring the strategic and long-term medical, scientific and technical development of Bioclinica’s Medical and Science Affairs organization in concert with the Medical Imaging & Biomarkers’ Chief Medical Officer, Dr. Michael O’Neal, and Chief Science Officer, Dr. Thomas Fuerst. Dr. Zaim was previously with SYNARC (merged with Bioclinica in March 2014) for more than a decade in various leadership roles, including medical director, chief medical officer, vice president of radiology, and director of radiology services, Europe. In these roles, Dr. Zaim established and developed global medical and science affairs teams supporting an array of clinical trial indications. Dr. Zaim is regularly published in peer-reviewed journals, and has extensive central reading and adjudication experience encompassing thousands of patients in hundreds of clinical trials in Oncology, Arthritis, Osteoporosis and other areas. Prior to this he was assistant professor of Radiology at the University of California at San Francisco. He earned a medical degree from the University of Algiers and is board certified in Radiology with a certificate in Magnetic Resonance, both from the University of Paris. Dr. Zaim is a member of the Radiological Society of North America, the European Society of Radiology, Osteoarthritis Research Society International, and the American Society of Clinical Oncology. Levy is a proven clinical research operating executive with more than 18 years of client and clinical data management experience. She was most recently clinical practice director at Penobscot Community Health Center leading a health service delivery venture with athenahealth. She will provide executive leadership for Bioclinica’s clinical project management teams across the Medical Imaging & Biomarker business, supporting operations and delivery focused on consistency of service and customer satisfaction, and will play a pivotal role in the ongoing development of new client-service offerings. Levy is a graduate of Trinity College with a Bachelor of Science degree in Psychology and Cognitive Science with a focus on the neurosciences. About Bioclinica Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment is the global clinical trial leader in medical imaging, providing cardiac safety monitoring services, specialized biochemical marker analysis and clinical lab services in the Bioclinica molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. The Company serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia. Learn more about Bioclinica at http://www.bioclinica.com.


News Article | February 20, 2017
Site: globenewswire.com

Basel, Switzerland, February 20, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced its financial results for 2016 today with product sales from Cresemba® (isavuconazole) and Zevtera®/Mabelio® (ceftobiprole) of CHF 7.1 million in Europe, royalties on US Cresemba sales of CHF 7.3 million, total revenue of CHF 66.0 million, a year-end cash and financial investment position of CHF 289.0 million and a reduced operating loss of CHF 43.9 million. Basilea's CEO Ronald Scott said: "We've launched Cresemba addressing severe fungal infections in the first European markets and made substantial progress in the commercialization of both Cresemba and our antibiotic Zevtera/Mabelio. We are pleased to announce that we achieved sales for the full year of CHF 7.1 million in Europe. The Cresemba launch is also going well in the USA, where our license partner Astellas Pharma US reported 2016 sales of USD 46 million, on which we received CHF 7.3 million in royalties." He continued: "We plan to initiate a ceftobiprole clinical phase 3 development program under our agreement with BARDA in mid-2017 to support a potential future US regulatory filing and we continue to make good progress on our oncology development programs addressing tumor resistance. We were able to expand our BAL101553 oral phase 1/2a study to include brain cancer patients according to plan." Anti-infectives: Cresemba and Zevtera/Mabelio marketed by Basilea in first European countries with partnerships in place for important additional markets Basilea is marketing Cresemba and Zevtera/Mabelio in Germany, Italy, the UK, France and Austria; Zevtera is also marketed in Switzerland. Basilea's licensing partner Astellas Pharma US markets Cresemba in the United States. In 2016, Basilea entered into distribution agreements for isavuconazole and ceftobiprole with Grupo Biotoscana S.L. in nineteen Latin American countries and with Unimedic Pharma AB for the Nordics. The distribution agreement with Hikma Pharmaceuticals LLC for the Middle East and North Africa (MENA) region was extended to include isavuconazole in addition to ceftobiprole. In addition, Basilea concluded a license agreement with Asahi Kasei Pharma Corporation for the development and commercialization of isavuconazole in Japan. Basilea's existing partnerships cover more than forty countries around the world in addition to the countries that Basilea is directly serving. The latest guideline issued by the European Conference on Infections in Leukaemia (ECIL) recommends Cresemba for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients. The guideline states that isavuconazole is as effective as voriconazole with a better safety profile.1 This recommendation in one of the most relevant treatment guidelines in Europe underscores the potentially important clinical role of Cresemba in the treatment of patients with these life-threatening infections. Contract with BARDA to support ceftobiprole phase 3 development for US market Basilea entered into a contract in 2016 with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US, the largest market value-wise for branded hospital antibiotics. BARDA provides initial funding of approximately USD 20 million for the preparation of the phase 3 program. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Basilea submitted clinical study protocols to the US Food and Drug Administration (FDA) for two phase 3 studies, one in Staphylococcus aureus bacteremia (SAB) and one in acute bacterial skin and skin structure infections (ABSSSI). Basilea will initiate the phase 3 clinical development program once it completes the FDA Special Protocol Assessment (SPA) process. Two oncology drug candidates in clinical development: tumor checkpoint controller BAL101553 and panRAF/SRC kinase inhibitor BAL3833 In 2016 Basilea further strengthened its oncology pipeline, the second pillar of its hospital-focused strategy, by broadening BAL101553's clinical development program. A separate study arm for patients with glioblastoma was added to the ongoing phase 1/2a clinical study with oral BAL101553, based data in preclinical glioblastoma tumor models demonstrating activity of the drug candidate in this often lethal brain cancer. Potential patient-selection biomarkers have also been identified and will be assessed in BAL101553-treated glioblastoma patients. In addition, a further phase 1/2a clinical study was initiated to explore continuous intravenous infusion. Dose-escalation in the phase 1 study with orally administered BAL3833 in patients with solid tumor cancers, including metastatic melanoma, is continuing with the aim to determine the maximum tolerated dose. Preclinical data on BAL3833 presented at the American Association for Cancer Research (AACR) annual meeting showed that the drug candidate has anti-cancer activity in KRAS-driven in vitro and in vivo tumor models via inhibition of the RAF and SRC family kinases. This indicates that BAL3833 may also be effective in non-melanoma KRAS-mutant cancers such as pancreatic, colorectal and non-small-cell lung cancer, potentially providing a new therapeutic option in these indications. Focus 2017 on growing product sales and progress in pipeline Basilea's CEO Ronald Scott stated: "In 2017, we expect to further grow our product sales as we continue to execute on our commercialization and partnering strategy. We anticipate seeing initial contributions from our current distributors as their first marketing authorizations are granted. We are also working towards further agreements with potential partners to cover remaining commercially relevant markets including Asia Pacific, Russia/CIS, and certain European countries. In addition, we anticipate that Swissmedic will complete its review of our isavuconazole marketing authorization application in 2017." He added: "An important goal for us this year is to finalize the Special Protocol Assessment process with the US FDA in order to start the clinical phase 3 program for ceftobiprole under our BARDA contract. Our initial focus will be on skin and bloodstream infections, two areas of high medical need." Ceftobiprole will have a total of ten years of market exclusivity in the US from potential approval based on its Qualified Infectious Disease Product designation granted by the FDA. Upon successful completion of the studies, the phase 3 data could be used to support supplemental marketing authorization applications for ceftobiprole in Europe and other territories, potentially resulting in label extensions for ceftobiprole. In 2017, Basilea will further advance the clinical development of its oncology drug candidates and expects to complete dose-escalation in BAL101553's phase 1/2a studies and BAL 3833's phase 1 study. Notes: Consolidated figures in conformity with US GAAP; rounding was consistently applied. The consolidated financial statements of Basilea Pharmaceutica Ltd. for the financial year 2016 can be found on the company's website at http://annualreport.basilea.com. Full-year product revenue 2016 amounted to CHF 7.1 million (2015: none). Contract revenue 2016 amounted to CHF 57.7 million (2015: CHF 51.2 million), including CHF 37.7 million (2015: CHF 37.6 million) related to the global agreement for Toctino® and CHF 19.3 million (2015: CHF 13.6 million) related to the license agreement with Astellas for isavuconazole. Total operating income in 2016 including sales amounted to CHF 66.0 million (2015: CHF 52.8 million). Research and development net expenses in 2016 amounted to CHF 48.4 million (2015: CHF 60.1 million) and were mainly related to activities for the phase 1/2a development of oncology drug candidate BAL101533, phase 1 clinical development of oncology drug candidate BAL3833, costs for the pediatric program for ceftobiprole and activities related to isavuconazole. The decrease of CHF 11.7 million as compared to 2015 is mainly due to 2015 isavuconazole pre-launch activities. Selling, general and administration expenses in 2016 amounted to CHF 56.1 million (2015: CHF 54.2 million), and included costs related to the commercialization of Cresemba and Zevtera/Mabelio and stock-based compensation of CHF 4.2 million (2015: CHF 4.6 million). In 2016, the operating loss was reduced by 29% to CHF 43.9 million from CHF 61.5 million in 2015 and net loss 2016 was reduced to CHF 51.3 million (2015: CHF 61.6 million), resulting in a lower basic and diluted loss per share of CHF 5.07 (2015: CHF 6.09). The net cash used for operating activities in 2016 amounted to CHF 75.0 million as compared to CHF 67.8 million in 2015. The increase in comparison to 2015 is mainly due to the milestone payment from Astellas in 2015 upon approval of isavuconazole in the US, which reduced the net cash used in the previous period. Combined cash and financial investments amounted to CHF 289.0 million as of December 31, 2016, compared to CHF 364.7 million as of December 31, 2015. Basilea continues to focus on growing sales of its two marketed products while at the same time advancing its clinical development pipeline. Basilea anticipates total annual product sales of approximately CHF 15 million in 2017, a more than 100% increase over 2016, and a participation in US sales through royalties of approximately CHF 14 million. Total operating expenses after anticipated BARDA reimbursements for 2017 are estimated at approximately CHF 10 million on average per month with an operating loss of approximately CHF 3 million on average per month. Cresemba (isavuconazole) - an i.v. and oral azole antifungal for the treatment of invasive mold infections Isavuconazole is an i.v. and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.3 The European marketing authorization is valid in all 28 European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea is marketing isavuconazole as Cresemba in Germany, Italy, the UK, France and Austria. In the United States Cresemba is marketed by Basilea's licensee Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. The European Conference on Infections in Leukaemia (ECIL) recommends isavuconazole in its current guideline for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients.1 Zevtera/Mabelio (ceftobiprole) - a broad-spectrum antibiotic from the cephalosporin class for i.v. administration with bactericidal activity against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp. Ceftobiprole (European trade name Zevtera or Mabelio, depending on the country) is approved for sale in 13 European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).4 Basilea is currently marketing the drug in Germany, Italy, the UK, France, Austria and Switzerland. Ceftobiprole received Qualified Infectious Disease Product (QIDP) designation from the US FDA for the potential treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The drug is not approved in the United States. In 2016, Basilea entered into a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Initial studies are planned in acute bacterial skin structure infections (ABSSSI) and Staphylococcus aureus bacteremia (SAB). BAL101553 - a tumor checkpoint controller in phase 1/2a clinical testing in patients with advanced solid tumors including recurrent or progressive glioblastoma The small molecule oncology drug candidate BAL101553 (prodrug of BAL27862) is being developed as a potential therapy for diverse cancers, including tumor types unresponsive to standard therapeutics. The drug is currently undergoing clinical phase 1/2a evaluation (oral and continuous infusion) in patients with advanced solid tumors. In December 2016, the oral study was extended by adding a separate arm for patients with recurrent or progressive glioblastoma after prior radiotherapy. The drug candidate has shown evidence of clinical anti-tumor activity in a phase 1/2a study with weekly 2-hour i.v. infusion, during which the maximum tolerated dose and the recommended phase 2 dose for this administration regimen was established.5 BAL3833 (also known as CCT3833) is an orally administered small-molecule panRAF/SRC kinase inhibitor targeting cell proliferation signaling pathways that are associated with tumor growth and resistance development to current therapies. It is the lead compound of a series of kinase inhibitors in-licensed by Basilea in April 2015 under an agreement with The Institute of Cancer Research, Cancer Research Technology, the Wellcome Trust, and The University of Manchester. BAL3833 is currently being investigated in a phase 1 study in adult patients with advanced solid tumors including metastatic melanoma. The compound originates from the renowned UK cancer research institution, The Institute of Cancer Research, where it was developed by scientists funded by Cancer Research UK and the Wellcome Trust. Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Monday, February 20, 2017, 4 p.m. (CET), during which the company will discuss today's press release. A playback will be available 1 hour after the conference call until Wednesday, February 22, 2017, 6 p.m. (CET). Participants requesting a digital playback may dial: and will be asked to enter the ID 19991 followed by the # sign. The shareholders of Basilea Pharmaceutica Ltd. are informed that the Ordinary General Meeting of Shareholders of Basilea Pharmaceutica Ltd. for the business year 2016 will take place on Thursday, April 27, 2017 at 2 p.m. at the Radisson Blu Hotel in Basel, Switzerland. The invitation will be published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt, SHAB). Shareholders who are recorded in the share register with voting rights on April 13, 2017 will be entitled to participate and exercise their voting rights. Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address the medical problem of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from www.basilea.com. 1  F. Tissot et al. ECIL-6 guidelines for the treatment of invasive candidiasis, aspergillosis and mucormycosis in leukemia and hematopoietic stem cell transplant patients. Haematologica 2016 (101), published online ahead of print; www.haematologica.org/content/early/2016/12/20/haematol.2016.152900 [Accessed February 17, 2017] 2  Cresemba US prescribing information [Accessed: February 17, 2017] 3  European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: February 17, 2017] 4  UK Summary of Product Characteristics (SPC) Zevtera®: http://www.mhra.gov.uk/ [Accessed: February 17, 2017] 5  J. Lopez et al. Phase 1/2a trial of intravenous BAL101553, a novel tumor checkpoint controller (TCC), in advanced solid tumors. American Society of Clinical Oncology (ASCO) annual meeting 2016, abstract 2525, poster board #225


News Article | February 20, 2017
Site: globenewswire.com

Basel, Switzerland, February 20, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced its financial results for 2016 today with product sales from Cresemba® (isavuconazole) and Zevtera®/Mabelio® (ceftobiprole) of CHF 7.1 million in Europe, royalties on US Cresemba sales of CHF 7.3 million, total revenue of CHF 66.0 million, a year-end cash and financial investment position of CHF 289.0 million and a reduced operating loss of CHF 43.9 million. Basilea's CEO Ronald Scott said: "We've launched Cresemba addressing severe fungal infections in the first European markets and made substantial progress in the commercialization of both Cresemba and our antibiotic Zevtera/Mabelio. We are pleased to announce that we achieved sales for the full year of CHF 7.1 million in Europe. The Cresemba launch is also going well in the USA, where our license partner Astellas Pharma US reported 2016 sales of USD 46 million, on which we received CHF 7.3 million in royalties." He continued: "We plan to initiate a ceftobiprole clinical phase 3 development program under our agreement with BARDA in mid-2017 to support a potential future US regulatory filing and we continue to make good progress on our oncology development programs addressing tumor resistance. We were able to expand our BAL101553 oral phase 1/2a study to include brain cancer patients according to plan." Anti-infectives: Cresemba and Zevtera/Mabelio marketed by Basilea in first European countries with partnerships in place for important additional markets Basilea is marketing Cresemba and Zevtera/Mabelio in Germany, Italy, the UK, France and Austria; Zevtera is also marketed in Switzerland. Basilea's licensing partner Astellas Pharma US markets Cresemba in the United States. In 2016, Basilea entered into distribution agreements for isavuconazole and ceftobiprole with Grupo Biotoscana S.L. in nineteen Latin American countries and with Unimedic Pharma AB for the Nordics. The distribution agreement with Hikma Pharmaceuticals LLC for the Middle East and North Africa (MENA) region was extended to include isavuconazole in addition to ceftobiprole. In addition, Basilea concluded a license agreement with Asahi Kasei Pharma Corporation for the development and commercialization of isavuconazole in Japan. Basilea's existing partnerships cover more than forty countries around the world in addition to the countries that Basilea is directly serving. The latest guideline issued by the European Conference on Infections in Leukaemia (ECIL) recommends Cresemba for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients. The guideline states that isavuconazole is as effective as voriconazole with a better safety profile.1 This recommendation in one of the most relevant treatment guidelines in Europe underscores the potentially important clinical role of Cresemba in the treatment of patients with these life-threatening infections. Contract with BARDA to support ceftobiprole phase 3 development for US market Basilea entered into a contract in 2016 with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US, the largest market value-wise for branded hospital antibiotics. BARDA provides initial funding of approximately USD 20 million for the preparation of the phase 3 program. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Basilea submitted clinical study protocols to the US Food and Drug Administration (FDA) for two phase 3 studies, one in Staphylococcus aureus bacteremia (SAB) and one in acute bacterial skin and skin structure infections (ABSSSI). Basilea will initiate the phase 3 clinical development program once it completes the FDA Special Protocol Assessment (SPA) process. Two oncology drug candidates in clinical development: tumor checkpoint controller BAL101553 and panRAF/SRC kinase inhibitor BAL3833 In 2016 Basilea further strengthened its oncology pipeline, the second pillar of its hospital-focused strategy, by broadening BAL101553's clinical development program. A separate study arm for patients with glioblastoma was added to the ongoing phase 1/2a clinical study with oral BAL101553, based data in preclinical glioblastoma tumor models demonstrating activity of the drug candidate in this often lethal brain cancer. Potential patient-selection biomarkers have also been identified and will be assessed in BAL101553-treated glioblastoma patients. In addition, a further phase 1/2a clinical study was initiated to explore continuous intravenous infusion. Dose-escalation in the phase 1 study with orally administered BAL3833 in patients with solid tumor cancers, including metastatic melanoma, is continuing with the aim to determine the maximum tolerated dose. Preclinical data on BAL3833 presented at the American Association for Cancer Research (AACR) annual meeting showed that the drug candidate has anti-cancer activity in KRAS-driven in vitro and in vivo tumor models via inhibition of the RAF and SRC family kinases. This indicates that BAL3833 may also be effective in non-melanoma KRAS-mutant cancers such as pancreatic, colorectal and non-small-cell lung cancer, potentially providing a new therapeutic option in these indications. Focus 2017 on growing product sales and progress in pipeline Basilea's CEO Ronald Scott stated: "In 2017, we expect to further grow our product sales as we continue to execute on our commercialization and partnering strategy. We anticipate seeing initial contributions from our current distributors as their first marketing authorizations are granted. We are also working towards further agreements with potential partners to cover remaining commercially relevant markets including Asia Pacific, Russia/CIS, and certain European countries. In addition, we anticipate that Swissmedic will complete its review of our isavuconazole marketing authorization application in 2017." He added: "An important goal for us this year is to finalize the Special Protocol Assessment process with the US FDA in order to start the clinical phase 3 program for ceftobiprole under our BARDA contract. Our initial focus will be on skin and bloodstream infections, two areas of high medical need." Ceftobiprole will have a total of ten years of market exclusivity in the US from potential approval based on its Qualified Infectious Disease Product designation granted by the FDA. Upon successful completion of the studies, the phase 3 data could be used to support supplemental marketing authorization applications for ceftobiprole in Europe and other territories, potentially resulting in label extensions for ceftobiprole. In 2017, Basilea will further advance the clinical development of its oncology drug candidates and expects to complete dose-escalation in BAL101553's phase 1/2a studies and BAL 3833's phase 1 study. Notes: Consolidated figures in conformity with US GAAP; rounding was consistently applied. The consolidated financial statements of Basilea Pharmaceutica Ltd. for the financial year 2016 can be found on the company's website at http://annualreport.basilea.com. Full-year product revenue 2016 amounted to CHF 7.1 million (2015: none). Contract revenue 2016 amounted to CHF 57.7 million (2015: CHF 51.2 million), including CHF 37.7 million (2015: CHF 37.6 million) related to the global agreement for Toctino® and CHF 19.3 million (2015: CHF 13.6 million) related to the license agreement with Astellas for isavuconazole. Total operating income in 2016 including sales amounted to CHF 66.0 million (2015: CHF 52.8 million). Research and development net expenses in 2016 amounted to CHF 48.4 million (2015: CHF 60.1 million) and were mainly related to activities for the phase 1/2a development of oncology drug candidate BAL101533, phase 1 clinical development of oncology drug candidate BAL3833, costs for the pediatric program for ceftobiprole and activities related to isavuconazole. The decrease of CHF 11.7 million as compared to 2015 is mainly due to 2015 isavuconazole pre-launch activities. Selling, general and administration expenses in 2016 amounted to CHF 56.1 million (2015: CHF 54.2 million), and included costs related to the commercialization of Cresemba and Zevtera/Mabelio and stock-based compensation of CHF 4.2 million (2015: CHF 4.6 million). In 2016, the operating loss was reduced by 29% to CHF 43.9 million from CHF 61.5 million in 2015 and net loss 2016 was reduced to CHF 51.3 million (2015: CHF 61.6 million), resulting in a lower basic and diluted loss per share of CHF 5.07 (2015: CHF 6.09). The net cash used for operating activities in 2016 amounted to CHF 75.0 million as compared to CHF 67.8 million in 2015. The increase in comparison to 2015 is mainly due to the milestone payment from Astellas in 2015 upon approval of isavuconazole in the US, which reduced the net cash used in the previous period. Combined cash and financial investments amounted to CHF 289.0 million as of December 31, 2016, compared to CHF 364.7 million as of December 31, 2015. Basilea continues to focus on growing sales of its two marketed products while at the same time advancing its clinical development pipeline. Basilea anticipates total annual product sales of approximately CHF 15 million in 2017, a more than 100% increase over 2016, and a participation in US sales through royalties of approximately CHF 14 million. Total operating expenses after anticipated BARDA reimbursements for 2017 are estimated at approximately CHF 10 million on average per month with an operating loss of approximately CHF 3 million on average per month. Cresemba (isavuconazole) - an i.v. and oral azole antifungal for the treatment of invasive mold infections Isavuconazole is an i.v. and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.3 The European marketing authorization is valid in all 28 European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea is marketing isavuconazole as Cresemba in Germany, Italy, the UK, France and Austria. In the United States Cresemba is marketed by Basilea's licensee Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. The European Conference on Infections in Leukaemia (ECIL) recommends isavuconazole in its current guideline for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients.1 Zevtera/Mabelio (ceftobiprole) - a broad-spectrum antibiotic from the cephalosporin class for i.v. administration with bactericidal activity against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp. Ceftobiprole (European trade name Zevtera or Mabelio, depending on the country) is approved for sale in 13 European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).4 Basilea is currently marketing the drug in Germany, Italy, the UK, France, Austria and Switzerland. Ceftobiprole received Qualified Infectious Disease Product (QIDP) designation from the US FDA for the potential treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The drug is not approved in the United States. In 2016, Basilea entered into a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Initial studies are planned in acute bacterial skin structure infections (ABSSSI) and Staphylococcus aureus bacteremia (SAB). BAL101553 - a tumor checkpoint controller in phase 1/2a clinical testing in patients with advanced solid tumors including recurrent or progressive glioblastoma The small molecule oncology drug candidate BAL101553 (prodrug of BAL27862) is being developed as a potential therapy for diverse cancers, including tumor types unresponsive to standard therapeutics. The drug is currently undergoing clinical phase 1/2a evaluation (oral and continuous infusion) in patients with advanced solid tumors. In December 2016, the oral study was extended by adding a separate arm for patients with recurrent or progressive glioblastoma after prior radiotherapy. The drug candidate has shown evidence of clinical anti-tumor activity in a phase 1/2a study with weekly 2-hour i.v. infusion, during which the maximum tolerated dose and the recommended phase 2 dose for this administration regimen was established.5 BAL3833 (also known as CCT3833) is an orally administered small-molecule panRAF/SRC kinase inhibitor targeting cell proliferation signaling pathways that are associated with tumor growth and resistance development to current therapies. It is the lead compound of a series of kinase inhibitors in-licensed by Basilea in April 2015 under an agreement with The Institute of Cancer Research, Cancer Research Technology, the Wellcome Trust, and The University of Manchester. BAL3833 is currently being investigated in a phase 1 study in adult patients with advanced solid tumors including metastatic melanoma. The compound originates from the renowned UK cancer research institution, The Institute of Cancer Research, where it was developed by scientists funded by Cancer Research UK and the Wellcome Trust. Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Monday, February 20, 2017, 4 p.m. (CET), during which the company will discuss today's press release. A playback will be available 1 hour after the conference call until Wednesday, February 22, 2017, 6 p.m. (CET). Participants requesting a digital playback may dial: and will be asked to enter the ID 19991 followed by the # sign. The shareholders of Basilea Pharmaceutica Ltd. are informed that the Ordinary General Meeting of Shareholders of Basilea Pharmaceutica Ltd. for the business year 2016 will take place on Thursday, April 27, 2017 at 2 p.m. at the Radisson Blu Hotel in Basel, Switzerland. The invitation will be published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt, SHAB). Shareholders who are recorded in the share register with voting rights on April 13, 2017 will be entitled to participate and exercise their voting rights. Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address the medical problem of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from www.basilea.com. 1  F. Tissot et al. ECIL-6 guidelines for the treatment of invasive candidiasis, aspergillosis and mucormycosis in leukemia and hematopoietic stem cell transplant patients. Haematologica 2016 (101), published online ahead of print; www.haematologica.org/content/early/2016/12/20/haematol.2016.152900 [Accessed February 17, 2017] 2  Cresemba US prescribing information [Accessed: February 17, 2017] 3  European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: February 17, 2017] 4  UK Summary of Product Characteristics (SPC) Zevtera®: http://www.mhra.gov.uk/ [Accessed: February 17, 2017] 5  J. Lopez et al. Phase 1/2a trial of intravenous BAL101553, a novel tumor checkpoint controller (TCC), in advanced solid tumors. American Society of Clinical Oncology (ASCO) annual meeting 2016, abstract 2525, poster board #225


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

NEWS RELEASE   REGULATED INFORMATION  INSIDE INFORMATION    Record revenue of $30 million, up 70% from 2015 Total test volume up 57% over 2015 Conference call for analysts and investors today at 15:00 CET / 09:00 EST, details below IRVINE, CA, and HERSTAL, BELGIUM - 7:00 AM, February 23, 2017 - MDxHealth SA (Euronext: MDXH.BR), or the "Company", today announced its financial results for the financial year ended December 31, 2016. Dr. Jan Groen, Chief Executive Officer of MDxHealth commented: "The strong progress made in 2016 with the accelerated adoption of ConfirmMDx and the successful launch of our first liquid biopsy test, SelectMDx, demonstrates the significant potential of MDxHealth's world leading urological oncology franchise." "With the ongoing roll out of SelectMDx, together with the planned launch of our second liquid biopsy test AssureMDx for Bladder Cancer this year, the Company continues to make rapid and meaningful progress in the expansion of its portfolio of products that address unmet medical needs for cancer patients, while leveraging the commercial infrastructure we have built over the last several years.  We are pleased with our progress in 2016 and believe MDxHealth is well positioned to build strong, sustainable growth in 2017 and beyond." Strong growth of ConfirmMDx driven by wide market adoption and continued expansion of reimbursement coverage NCCN Guideline inclusion and increasing adoption has enabled MDxHealth to secure 19 reimbursement contracts, while 28 payors issued positive medical coverage policies. The test is now also covered under the California Medical Assistance Program (Medi-Cal), the single largest state-run public health program in the US with nearly 12 million enrollees. This positive trend will continue in 2017 with Horizon Blue Cross Blue Shield recently issuing positive policy coverage for more than 3.8 million members. The recently obtained unique ConfirmMDx CPT code, effective January 2018, is expected to further streamline the Company's reimbursement efforts and significantly reduce collection periods. Further to the period end, MDxHealth was awarded a US Government Services Administration (GSA) contract.  This contract is critical to making ConfirmMDx widely accessible to authorized government customers. The Company's continued investments in demonstrating clinical utility and improved patient care from use of ConfirmMDx has resulted in publication in 10 clinical scientific publications and presentations, including in the journal The Prostate. Scientific data were also presented at several urology conferences across the US, including the Annual Meeting of the American Urology Association (AUA) in San Diego, and the Symposium of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco. Successful global commercial launch of first liquid biopsy test SelectMDx. Second liquid biopsy test AssureMDx for Bladder Cancer set for 2017 full commercial launch Following the European launch in late 2015, the Company's proprietary liquid biopsy test SelectMDx was commercially launched in the US in March 2016. This non-invasive urine-based test identifies men at risk for clinically significant prostate cancer who may benefit from an initial prostate biopsy or magnetic resonance imaging (MRI). The validation study published in European Urology confirms the superior performance compared to other commonly used biomarker tests and risk calculators. The enrollment of the prospective 4M clinical study on 600 subjects evaluating the synergy of MRI and SelectMDx is complete and results are expected to be published in the course of 2017. In the US, SelectMDx is marketed as a Laboratory Developed Test (LDT) through MDxHealth's sales force. Outside the US, the Company pursues a direct sales strategy in the Benelux, Germany and Italy, complemented by European and global distributors and commercial lab partners. The Company concluded several agreements for the distribution of SelectMDx, covering various countries in Europe, Central and Latin America, Israel and most recently Hong Kong and Macao China. Outside the US, the test is currently performed at the Company's ISO 13485:2016 certified lab in Nijmegen, The Netherlands. Volumes for SelectMDx since its US launch in 2016 were nearly 3.5 times higher compared to the first year for ConfirmMDx, representing 17% of the total test volume for 2016. The fast uptake of this test by urologists and their patients has already resulted in 11 payor contracts in the first year. In the last quarter of 2016, the Company beta launched its second liquid biopsy test, AssureMDx for Bladder Cancer. The launch followed the publication of two clinical validation studies underscoring the test's clinical validity. AssureMDx has a very high negative predictive value of 99% and may significantly reduce unnecessary invasive and costly cystoscopy procedures. With 700,000 cystoscopy procedures performed in the US every year, AssureMDx addresses a potential $300 million market in the US, and is scheduled for commercial launch in the US as an LDT by the end of the first half of 2017. MDxHealth has built a robust portfolio of proprietary biomarkers for molecular assays for areas such as colorectal, lung and brain cancers. In addition to its proprietary offering in uro-oncology, the Company leverages this non-core portfolio of biomarkers and technologies through various licensing agreements. In 2016, MDxHealth granted a non-exclusive worldwide license for its methylation-specific PSR (MSP) technology to QIAGEN for use in its diagnostic cervical cancer assay, QIAsure. Key unaudited consolidated figures for the financial year ended December 31, 2016 (thousands of US dollars, except number of shares and per share data): Total revenues for the year ended December 31, 2016 amounted to $30 million, an increase of 70% compared to total revenues of $17.6 million a year earlier and included $25 million of product and service income. The strong growth in the US contributed $24.4 million or 82% of total revenue. Non-US revenues included initial sales of SelectMDx, milestone payments and royalties from license deals, and came in at $5.5 million, up 133% or $2.4 million compared to 2015. Total net billings for 2016 amounted to $49.3 million. However, the Company only recognizes revenue when there is reasonable evidence that the test will effectively be reimbursed. As a result, a significant portion of the revenue is only recognized when the payment is collected, leaving a significant portion of invoiced amounts unrecognized in 2016. The deferral of part of the revenue gradually decreases as the Company concludes firm agreements for reimbursement with a growing number of payors. Cost of goods sold for 2016 came in at $10.1 million, compared to $6.9 million in 2015. Increased revenues resulted in a gross profit of $19.9 million, while a sustained focus on operational efficiencies yielded an improvement of the gross profit margin from 60.9% in 2015 to 66.3% in 2016. Operating expenses for the year ended December 31, 2016 amounted to $32.7 million, an increase of $7.6 million or 30.2%. The year-on-year increase is mainly attributable to the acquisition of NovioGendix (renamed to MDxHealth BV), which was only included for one quarter in 2015. Furthermore, MDxHealth invested in the build-out of the organisation to support the global commercial launch of SelectMDx. MDxHealth adopts a direct sales strategy for SelectMDx in Benelux, Germany and Italy, supported by European and global distributors and commercial lab partners. The Company appointed a global commercial team to cover business development and direct sales. Finally, the Company continued to validate the clinical utility of its expanded offering through clinical trials and publications. R&D spending remained level with last year despite the increased pace of newly developed product launches. EBITDA for the year improved by $2.5 million as the loss was reduced from $13.6 million in 2015 to $11.1 million. This improvement was partly offset by increased amortization charges, bringing the Company's net loss for 2016 to $13.2 million, $1.3 million better than in 2015. The increased amortization resulted from scheduled amortization of intangible assets associated with the acquisition of NovioGendix in 2015. Cash and cash equivalents stood at $30.8 million at the end of 2016 after having successfully raised $21.7 million (€20.4 million) in a private placement of 4,526,962 new shares at €4.50 ($4.99) per share. The number of outstanding shares at December 31 was 49,796,595. Increased private payor adoption and a sustained focus on reimbursement has helped to improve working capital throughout 2016. Cash used by operations amounted to $16.6 million, compared to $14.4 million in 2015, and included cash collections of $19.7 million, a 61% increase year-on-year. The award of a unique CPT code by the AMA, which will become effective January 1, 2018, is expected to significantly shorten collection periods from both Medicare and private payors. MDxHealth is committed to maintaining its focus on its strategic priorities during 2017. These include: MDxHealth will host a conference call today at 15:00 CET / 14:00 GMT / 09:00 EST / 06:00 PT to discuss its Financial Year 2016 results. To access the conference call, please dial one of the appropriate numbers below quoting the conference ID 69886101. The call will be conducted in English and a replay will be available for 30 days. The presentation will be made available on the investors section of the MDxHealth website shortly before the call and can be accessed at: http://mdxhealth.com/investors. The Company's statutory auditor, BDO Bedrijfsrevisoren Burg. Ven. CBVA, has confirmed that its audit procedures with respect to the Company's consolidated financial statements, prepared in accordance with the International Financial Reporting Standards as adopted in the European Union, have been substantially completed, that these procedures have not revealed any material adjustments that would have to be made to the accounting information derived from the Company's consolidated financial information that is included in this press release, and that it intends to issue an unqualified opinion. The condensed Consolidated Statement of Comprehensive Income may be found on the Company's website at www.mdxhealth.com. The full Annual Report is expected to be made available to the public via the Company's website in April 2017. MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The Company's tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. MDxHealth's European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth. This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.  This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the US Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable US securities laws. NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx, AssureMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.


News Article | February 13, 2017
Site: globenewswire.com

DURHAM, N.C., Feb. 13, 2017 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) (“Argos”), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced that the company will present at the 2017 Genitourinary Cancers Symposium being held February 16-18 at the Rosen Shingle Creek in Orlando, FL. Irina Tcherepanova, Ph.D., senior director of research and development for Argos, will review a poster titled, “Development of a novel immunotherapy for muscle invasive bladder cancer (MIBC),” during Poster Session C: Penile, Urethral, and Testicular Cancers; Renal Cell Cancer on Saturday, February 18 from 7:00-7:55am ET and 11:30am-1:00pm ET. The 2017 Genitourinary Cancers Symposium is a three-day scientific and educational meeting cosponsored by the American Society of Clinical Oncology (ASCO), American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology (SUO). For more information, visit http://gucasym.org/. About the Arcelis® Technology Platform Arcelis® is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis® process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy. About Argos Therapeutics Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, rocapuldencel-T is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for renal cell carcinoma (RCC) and for the treatment of non-small cell lung cancer (NSCLC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. Forward Looking Statements Any statements in this press release about Argos’ future expectations, plans and prospects, including statements about the expected use of the leased manufacturing space, Argos’ financial prospects, future operations and sufficiency of funds for future operations, clinical development of Argos’ product candidates, expectations regarding future clinical trials and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," “may,” "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.  Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the periods anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos' product candidates will advance through the clinical trial process on a timely basis; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether Argos can successfully establish commercial manufacturing operations on a timely basis or at all; and other factors discussed in the "Risk Factors" section of Argos’ Form 10-Q for the quarter ended September 30, 2016, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos’ views as of the date hereof. Argos anticipates that subsequent events and developments will cause Argos’ views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos’ views as of any date subsequent to the date hereof.


Schilsky R.L.,American Society of Clinical Oncology
Nature Reviews Clinical Oncology | Year: 2014

Implementing personalized cancer care requires a sound understanding of cancer genomics, familiarity with the analytical methods used to study cancer, knowledge of the mechanisms of action of targeted drugs, and ways to assimilate and understand complex data sets. Perhaps the greatest challenge is obtaining the drugs predicted to be beneficial based on the genomic profile of a patient's tumour. A potential solution is creation of a national facilitated access programme and registry for off-label use of targeted anti-cancer drugs. Within such a programme, patients could receive the targeted agent matched to the genomic profile of their tumour. Physicians would receive guidance in interpretation of complex genomic tests and access to drugs. Pharmaceutical companies, payers and regulators would receive data on off-label drug and test use and clinical outcomes to inform their research and development plans and coverage decisions and to track real-world safety. Although recently launched prospective clinical trials will determine the true benefit of matching drugs to genomic alterations, the approach proposed here will facilitate delivery of personalized medicine services to participating patients while at the same time making observations that allow us to learn from each patient to inform clinical care and future research initiatives. © 2014 Macmillan Publishers Limited. All rights reserved.


Schilsky R.L.,American Society of Clinical Oncology
Clinical Cancer Research | Year: 2015

Defining clinically meaningful outcomes for clinical trials provides a foundation for assessing and improving the value of cancer care by conducting multidisciplinary research in clinical trial design, comparative effectiveness, patient preferences, health outcomes, and economics captured through analysis of data generated in clinical trials and real-world clinical practice. © 2014 American Association for Cancer Research.


Trent L.,American Society of Clinical Oncology
Journal of Oncology Practice | Year: 2014

With unsustainable and rising health care costs reaching what are regularly termed crisis levels, the United States' current fragmented and inefficient health care system is in need of reforms that will allow oncology practices to adapt to changing delivery systems that put the patient at the center of care. Oncology accounts for roughly 10% of all health care costs and is a prime target for reform-minded stakeholders, particularly in the realm of reimbursement for care. ASCO believes that successful physician payment reform will be physician led and driven. This article was developed by the ASCO Clinical Practice Committee Payment Reform Workgroup and underwent subsequent review and approval by the full Clinical Practice Committee and the ASCO Board of Directors. The following represents an abridged version of the original document, edited for length. The entire document may be found at www.asco.org/paymentreform. It includes a critical survey of the current reimbursement landscape and lays out the foundation for a comprehensive, multifaceted solution that would replace the current fee for service structure. This foundation includes quality measurements and incentives, a replacement for the current "buy and bill" system for chemotherapy drugs, value-based pathways, episodic or bundled care payments, and care coordination to decrease use of expensive resources. ASCO intends to pursue further development, modeling, and testing of these concepts and invites others in the oncology community to prepare to lead efforts to a more rational and stable payment plan that will support high-quality care for our patients. Copyright © 2014 by American Society of Clinical Oncology.


Kirkwood M.K.,American Society of Clinical Oncology
Journal of Oncology Practice | Year: 2015

The US cancer care system remains in a state of transition. In 2014, the United States made significant progress in cancer care as demonstrated by improvement in the 5-year cancer survival rate for many cancer types and a record 14.5 million cancer survivors, as well as by the availability of 10 new drugs and several new tests for the diagnosis, treatment, or management of cancer.1 At the same time, a growing demand for cancer services, turbulence in the cancer care delivery system, and growing concerns about cost of care are creating uncertainties about the capacity of the system to continue to provide high-quality care for all patients with cancer. These factors have focused attention on the need for better definitions of value and meaningful ways to assess quality. In this second annual State of Cancer Care in America report, the American Society of Clinical Oncology (ASCO) chronicles the challenges currently facing the US cancer care system. The report provides background and context to help understand what is happening today in cancer care and describes trends in the cancer care workforce and diverse practice environment that may affect cancer care in the coming years. Copyright © 2015 by American Society of Clinical Oncology.


Gilmore T.R.,American Society of Clinical Oncology
Journal of oncology practice / American Society of Clinical Oncology | Year: 2013

The Quality Oncology Practice Initiative (QOPI) Certification Program (QCP) evaluates individual outpatient oncology practice performance in areas that affect patient care and safety and builds on the American Society of Clinical Oncology (ASCO) QOPI by assessing the compliance of a practice with certification standards based on the ASCO/Oncology Nursing Society standards for safe chemotherapy administration. To become certified, a practice must attain a benchmark quality score on certification measures in QOPI and attest that it complies with 17 QCP standards. Structured on-site reviews, initially performed in randomly selected practices, became mandatory beginning in September 2011. Of 111 practices that have undergone on-site review, only two were fully concordant with all of the standards (median, 11; range, seven to 17). Most practices were subsequently able to modify practice to become QOPI certified. The QCP addresses the call from the Institute of Medicine to close the quality gap by aligning evidence-based guidelines and consensus-driven standards with requirements for oncology practices to develop and maintain structural safety components, such as policies and procedures that ensure practice performance. On-site practice evaluation is a high-impact component of the program.

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