|Aeterna Zentaris Commences Promotional Activities for EMD Serono's Saizen®; Merck Receives Positive CHMP Opinion for Investigational Antibiotic ZERBAXA™|
|By Marilyn Mullen|
|Monday, 27 July 2015 19:51|
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 27, 2015.
Aeterna Zentaris (NASDAQ AEZS) (TSX: AEZ) announced it has started promoting Saizen® [somatropin (rDNA origin) for injection] in 25 territories in the United States, pursuant to its co‑promotion agreement signed this past May with EMD Serono, the U.S. biopharmaceutical businesses of Merck KGaA, Darmstadt, Germany. Saizen® is a recombinant human growth hormone (r-hGH) registered in the U.S. for the treatment of growth hormone deficiency (GHD) in children and adults.
Under the agreement, Aeterna Zentaris details Saizen® to designated medical professionals in addition to EMD Serono's current promotional activities. Payment to Aeterna Zentaris is based on new eligible patient starts on Saizen®, above an agreed-upon baseline.
Jude Dinges, Senior Vice President and Chief Commercial Officer of Aeterna Zentaris, commented, "Our sales force has initiated the promotion of Saizen®, a product with a broad portfolio of devices and comprehensive patient support services. We recognize the value of direct promotion in this category and we look forward to achieving increased market share and growth for Saizen® by significantly increasing the share-of-voice in support of Saizen®."
David A. Dodd, Chairman and Chief Executive Officer of Aeterna Zentaris also stated, "This exciting start of the field promotion of Saizen® represents another important step in the transformation of Aeterna Zentaris into a commercially operating company. With its ongoing efforts in the development of electronic recombinant human growth hormone injection devices, EMD Serono is a leader in the field of growth hormone and offers us with Saizen®, a perfect fit with the endocrinology portfolio that we are developing. We will continue to look for products that we can co-promote, in-license or acquire as we build our portfolio and our commercial capabilities."
Merck (NYSE:MRK), announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of the investigational antibiotic ZERBAXA™ (ceftolozane and tazobactam) for the treatment of the following infections in adults: complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections.
The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Amedica Corporation (Nasdaq:AMDA), a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopedic implants, today announced that it expects to report second quarter 2015 revenue in the range of $4.7 million and $4.9 million, as compared to $4.7 million during the first quarter of 2015.
Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announced that it has successfully signed definitive agreements for the conversion and restructuring of approximately $175 million of debt, to be converted to Amyris common stock, with an additional $5 million of debt converted into joint venture ownership by its joint-venture partner, Total. Simultaneously, Amyris signed definitive agreements for a $25-million private placement led by long-term investor and Board member John Doerr of Kleiner Perkins Caufield & Byers, as well as Total and Naxyris.
Bacterin International Holdings, Inc. (OTCQX:BONE), a leader in the development of revolutionary bone graft material, announced today that it intends to purchase the outstanding shares of privately held X-spine Systems, Inc., a global medical device manufacturer of leading products for spinal surgery, headquartered in Miamisburg, Ohio, in exchange for approximately 4.24 million shares of Bacterin common stock and approximately $60 million in cash, subject to customary working capital adjustments, and including the extinguishment of approximately $13 million of X-spine debt.
Bacterin International Holdings, Inc. (OTCQX:BONE), a leader in the development of revolutionary bone graft material, has announced the pricing of $65 million aggregate principal amount of convertible senior unsecured notes due 2021 (the "Notes").
Biogen (NASDAQ:BIIB) and the Parkinson’s Institute and Clinical Center today announced the formation of a strategic alliance focused on enhancing the understanding of the underlying biology of Parkinson’s disease (PD) and the creation of novel tools and programs that could accelerate research and the development of new PD treatments. The agreement will combine the unique clinical expertise and data of the Institute with Biogen’s focus on neurodegenerative disease and approach to clinical development.
BioTelemetry, Inc. (NASDAQ:BEAT), the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, is pleased to announce that the Honorable Juan R. Sanchez has denied MedTel24’s Motion for Relief From Consent Judgment, upholding a prior Judgment from January 2014 that stated MedTel24’s use or sale of certain Heart Monitoring software infringes upon BioTelemetry patents.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that it has commenced an underwritten public offering of shares of its common stock of up to $65 million.
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, diagnostic surveillance solutions for transplant recipients, today announced that it will release financial results for the second quarter 2015 after the close of trading on Monday, August 10, 2015.
Cellular Biomedicine Group Inc. (NASDAQ:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced that it has received two new certifications from the China Food and Drug Administration (the "CFDA") for its proprietary cell and tissue preservation media kits respectively, in accordance with the CFDA's new regulations announced on June 1, 2015.
ConforMIS, Inc. (NASDAQ:CFMS) announced today that it will host a conference call on Tuesday, August 11, 2015 at 8:30 a.m. Eastern Time to discuss its financial results for the second quarter ended June 30, 2015.
FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's investigational new drug (IND) application for the study of FG-3019 in patients with Duchenne muscular dystrophy (DMD), and clinical study may proceed.
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced it will release its financial and operational results for the second quarter ended June 30, 2015 on August 12, 2015 before the market opens.
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it has initiated a phase I trial to evaluate Inovio's DNA immunotherapy in men with biochemically relapsed prostate cancer.
Lombard Medical, Inc. (NASDAQ:EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today reported financial results and provided an operational update for the second quarter and six-months ended June 30, 2015.
Lumenis Ltd. (NASDAQ:LMNS), the world's largest energy-based medical device company for surgical, ophthalmology and aesthetic applications, announced today its support for the second World Head and Neck Cancer Day, recognized annually on July 27.
Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today announced that it will report second quarter 2015 financial results for the period ended June 30, 2015, on Monday, August 10, 2015, at 4:00 p.m. Eastern Time.
Praxsyn Corporation's (OTCQB:PXYN) today announced that Justin Cary, 33, has been appointed by the Board of Directors as the company's Chief Financial Officer (CFO) effective immediately.
PRA Health Sciences, Inc. (NASDAQ:PRAH) today reported financial results for the quarter ended June 30, 2015.
Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today announced that financial results for its fiscal first quarter ending June 30, 2015 will be released after market close on Monday, August 3rd, 2015.
Radius Health, Inc. (NASDAQ:RDUS), a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive metastatic breast cancer, today announced that it has hired Dr. Lorraine A. Fitzpatrick as Chief Medical Officer of the Company.
SANUWAVE Health, Inc. (OTCQB:SNWV), a leading shock wave technology company, today encouraged the Company's stockholders to vote no later than tomorrow, Tuesday, July 28, 2015, their proxy on the proposal to amend the Company's Articles of Incorporation in order to increase the number of authorized shares of capital stock, par value $0.001 per share, from 155,000,000 to 355,000,000.
SeaSpine Holdings Corporation (Nasdaq:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the addition of two experienced leaders in the spine industry to the Company's management team.
The University of Colorado Cancer Center and Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development.