Amgen Receives CHMP Positive Opinion For IMLYGIC™; Spectrum Receives CRL from FDA for EVOMELA Print E-mail
By Mary Davila   
Friday, 23 October 2015 19:28
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 23, 2015.
Amgen (NASDAQ: AMGN) announced the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies.
IMLYGIC, administered via intralesional injection, is designed to cause the death of tumor cells and to initiate an anti-tumor immune response.
"We are pleased that IMLYGIC has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Metastatic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease."
The positive CHMP opinion was based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of IMLYGIC in patients with Stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). In the 436-patient study, IMLYGIC significantly improved durable response rate (DRR), the primary endpoint of the trial, in the intent-to-treat population. DRR is defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of six months. A key secondary endpoint was overall survival (OS). The positive CHMP opinion reflects subgroup analyses where the effect on OS was largest in patients with unresectable melanoma that has not spread beyond the skin or lymph nodes.
The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain. Overall, 98 percent of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis.
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer, and remains a significant public health concern in the European Union (EU).2,3 In 2012, it was estimated that there were 56,000 new cases of melanoma in France, Italy, Spain, Germany and the U.K. causing nearly 9,500 deaths.4,5
Following this CHMP opinion, Amgen expects a decision on the Marketing Authorization from the European Commission in the coming months. IMLYGIC is also under review by the U.S. Food and Drug Administration.
Spectrum Pharmaceuticals (NASDAQ: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA). A Complete Response Letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA did not identify any clinical deficiency in Spectrum's NDA package.
"We will work swiftly with the FDA to address the Complete Response Letter," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We remain committed to bringing EVOMELA to the market for patients and plan to work closely with the FDA."
Spectrum Pharmaceuticals gained global development and commercialization rights to EVOMELA from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013. Spectrum assumed responsibility for completing the pivotal Phase 2 clinical trial, and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.
Also Friday:
Acadia Healthcare Company, Inc. (NASDAQ:ACHC) today announced that it will release its third quarter 2015 earnings on Tuesday, November 3, 2015, after the market closes. Acadia will conduct a conference call with institutional investors and analysts at 9:00 a.m. ET on Wednesday, November 4, 2015. Additionally, a live broadcast of the earnings conference call will be available at in the "Investors" section of the website. The webcast of the conference call will be available through November 19, 2015.
Balchem Corporation (NASDAQ:BCPC) today announced that a conference call will be held on Tuesday, November 3, 2015, at 11:00 AM Eastern Time (ET) to review third quarter 2015 results. Ted Harris, President & Chief Executive Officer, and Bill Backus, Chief Financial Officer, will host the call.              Quarterly results will be released to the market on Tuesday, November 3, 2015 at 9:30 AM (ET). The press release, and its accompanying financial exhibits, will also be available on the Company website,, prior to the conference call.               We invite you to listen to the conference by calling toll-free 1-877-407-8289 (local dial-in 1-201-689-8341), five minutes prior to the scheduled start time of the conference call. The conference call will be available for replay two hours after the conclusion of the call through end of day Tuesday, November 17, 2015. To access the replay of the conference call, dial 1-877-660-6853 (local dial-in 1-201-612-7415), and use conference ID #13623616.
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it will be making an oral presentation for solithromycin at CHEST 2015, the annual meeting of the American College of Chest Physicians, being held in Montreal from October 24-28, 2015.              The slide presentation will take place during the Chest Infections Session on October 25, 2015 from 1:30 p.m. to 3:00 p.m. EDT in the Convention Center; Room 512cg.               "Results from a Phase 3 Trial in Moderate to Moderately Severe Community Acquired Bacterial Pneumonia (CABP) Treated as Outpatients with a New Oral Macrolide, Solithromycin" – abstract number 8002, presented by Carlos Barrera, M.D., FCCP.
Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that it will be presenting at the annual American Association of Blood Banks conference in Anaheim, California October 24-27. The poster, entitled "Volume Reduction and RBC Depletion of Apheresis Products for Cryopreservation," will report progress of research using Cesca's AutoXpress® technology platform in nucleated cell purification of apheresis product, the nucleated cells being the primary component of blood used for treating blood-based cancers such as leukemia. Apheresis is a process that removes one component of blood (for example white blood cells) while returning the remaining components (red blood cells and plasma) to the donor. The process is currently the main methodology for concentrating hematopoietic stem cells for transplantation.              "This project is one of several in Cesca's current CellWerks™ pipeline advancing the application of our AutoXpress technology for rapidly evolving needs in hematology/oncology," stated Mitchel Sivilotti, Senior VP and Chief Biologist for Cesca Therapeutics. "As ex vivo cell expansion technology matures, our technology is being positioned to address advanced therapeutic and bioprocessing protocols across multiple sources of potent, viable hematopoietic cells. We are very encouraged by these results and recent collaborations, they create lasting value in our next generation products."
Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today it has been selected to present at the Cavendish Global Health Impact Forum co-hosted by The Cleveland Clinic and taking place October 25th to October 28th at The Cleveland Clinic in Cleveland, Ohio. The purpose of the Forum is to help family offices and foundations develop and implement their individual pro-social impact investing, grant-giving, and philanthropy programs within health and the life sciences. To accomplish this mission, the Forum showcases presentations and panel discussions by leading family offices, accomplished foundations, research institutions, and private-sector companies engaged in developing innovations with the potential for transformational impact on disease prevention, diagnosis and treatment. A unique gathering of family offices, Cavendish Impact Forums are hosted by leading institutions around the world and take place three times each year. The next Forum is being co-hosted by The Cleveland Clinic and Cleveland Clinic Innovations.             Michael Moffat, Cavendish co-founder and chief executive officer explains, "The theme of our Cleveland Clinic hosted Forum is a 'Celebration of Philanthropy, Impact Investing and Innovation that is Changing the World.' With the help of our expert advisors, we conduct a global search of research institutions and private-sector companies in order to identify organizations that meet the required standard of excellence. The quality and originality of Galectin Therapeutics' research and scientific insights in fibrotic disease, including fatty liver disease and NASH (non-alcoholic steatohepatitis) and cancer, positions them to make a major contribution in the field of biotechnology."              "We are honored to be selected to present at this unique event, and it is further recognition of our innovative approach to fibrotic disease and cancer afflicting populations around the world today," said Jim Czirr, executive chairman of the board. "We welcome the chance to interact with many of world's most accomplished scientists, thought-leaders and generous philanthropic individuals and families who are all dedicated to the common cause of improving the health and lives of people around the world."
MannKind Corporation (NASDAQ:MNKD) today announced that the Tel Aviv Stock Exchange (TASE) has approved the new listing of MannKind's common shares beginning on October 28, 2015 under the ticker symbol MNKD. Based on the current market capitalization, MannKind's shares are anticipated to be included in five TASE equity indexes: TASE's TA-75, TA-100, TA-BlueTech, TA-Tech-Elite and TA-Biomed.               "The new listing also offers an opportunity to expand and diversify our shareholder base by increasing our exposure and improving our accessibility to Israeli investors," said Hakan Edstrom, President and CEO of MannKind. "This listing is also an extension of the long-standing relationship between our Executive Chairman, Alfred Mann, and the Israeli biotechnology industry, including the Alfred Mann Institute at the Technion (Israel Institute of Technology)."              TASE CEO, Yossi Beinart said, "We welcome MannKind to the TASE Dual Listing, and believe that this is a recognition of the Biomed sector's special position at the Tel Aviv Stock Exchange. MannKind has long and strong relations with the Israeli Biomed Sector, via the founder and executive chairman Mr. Alfred E. Mann, one of pioneers of the Biomed sector in the U.S., who has supported developing and commercializing Israeli technologies for many years. We are proud that a company with a market value of more than a billion US dollars chose to join 50 dually-listed companies, as well as the TASE leading indices. Joining TASE entitles MannKind to significant benefits, including added exposure among Israeli investors, extension of the trading duration, investment by Exchange Traded Product vendors and easy access to institutional and retail investors."
National Research Corporation (NASDAQ:NRCIA) (NASDAQ:NRCIB) today announced that it will provide an online Web simulcast of its 2015 third quarter conference call on Wednesday, November 4, 2015. The Company's results for the third quarter will be released after the close of the market on Tuesday, November 3, 2015.             The live broadcast of National Research Corporation's conference call will begin at 11:00 a.m. Eastern Time on November 4, 2015. A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast.             A live audio webcast can be accessed at                 The webcast will also be available for replay.              National Research Corporation, headquartered in Lincoln, Nebraska, is a leading provider of performance measurement, improvement services, and governance education to the healthcare industry in the United States and Canada.
NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing novel immuno-oncology and infectious-disease products to improve the lives of patients, reported that it will release its third quarter 2015 financial results on Tuesday, November 3, 2015.  The company has scheduled a conference call for 8:30 AM ET the same day to discuss the results and to give an update on clinical and business development activities.             NewLink’s senior management team will host the conference call, which will be open to all listeners.  There will also be a question and answer session following the prepared remarks.              Access to the live call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 66888213.  The replay will be available for two weeks from the date of the call.
Orexigen Therapeutics (NASDAQ: OREX) will announce corporate and financial results for the third quarter 2015 on Thursday, November 5 after the market closes.               Following the announcement, Orexigen will provide a business update and discuss the financial results in a live webcast and conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).              The live call may be accessed by phone by calling (800) 708-4540 (domestic) or (847) 619-6397 (international), participant code 41044938. The webcast can be accessed live on the Investors section of the Orexigen web site at, and will be archived for 14 days following the call.
Sientra, Inc. (NASDAQ:SIEN), a medical aesthetics company, today issued the following statement regarding a recent development at Silimed's manufacturing facilities:              We are aware of a fire in one of the two manufacturing buildings at Silimed, and are in contact with Silimed in order to assess the situation. Our thoughts are with the entire Silimed team. Our management team is working diligently to get answers and we will share additional information when it is available.

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