|Momenta Announces Launch of Generic Lovenox(R) Triggers Change in Terms; Lilly Withdrawals Xigris®|
|By Staff and Wire Reports|
|Tuesday, 25 October 2011 19:02|
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, announced Sandoz has confirmed the launch of an authorized generic version of Lovenox in the fourth quarter of 2011.
Under the terms of Momenta's 2003 Collaboration and License Agreement with Sandoz, upon the launch of an authorized generic Lovenox, for the remainder of the product year ending June 30, 2012, Sandoz is obligated to pay Momenta a 10-12% royalty on its net sales of enoxaparin sodium until the contractual profits from those net sales reaches a prorated contractual amount of approximately $99.1 million. Thereafter, provided that no other third party is marketing a generic Lovenox, Sandoz is obligated to pay Momenta 45% of contractual profits on net sales through the remainder of the product year ending June 30, 2012.
Going forward, if the authorized generic is the only marketed generic Lovenox, at the start of each subsequent product year, Sandoz is obligated to pay to Momenta a 10-12% royalty on net sales of enoxaparin sodium until the contractual profit reaches $135.0 million. Thereafter, for the balance of the product year, Sandoz is obligated to pay Momenta a 45% profit share.
Eli Lilly and Company (NYSD: LLY) announces withdrawal of its Xigris® [drotrecogin alfa (activated)] product in all markets following results of the PROWESS-SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. The company is working with regulatory agencies on this withdrawal, and is in the process of notifying health care professionals and clinical trial investigators.
Xigris was approved in the United States by the Food and Drug Administration (FDA) in November 2001, and was licensed in the European Union in 2002. The PROWESS-SHOCK study was initiated in March of 2008 as a condition for continued market authorization in Europe. Lilly committed to conduct a new placebo-controlled clinical trial to help refine appropriate patient identification for treatment with Xigris and to confirm the benefit-risk profile of the product.
BioCritica, Inc. has sales and marketing rights for Xigris in the United States and Puerto Rico, and Lilly sells and markets Xigris in other countries.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Alberto J. Montero, M.D., Assistant Professor, Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, an Investigational New Drug (IND) approval for the initiation of a randomized Phase 2 trial in chemotherapy refractory triple-negative (ER/PR/HER2-negative) luteinizing hormone-releasing hormone receptor (LHRH-R)-positive metastatic breast cancer with the Company's targeted cytotoxic LHRH analog, AEZS-108.
Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it plans to issue its third-quarter 2011 financial results after the close of the market on Wednesday, November 2, 2011.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Samuel P. Sears, Jr. has been appointed as an independent director of the Company effective October 21, 2011.
BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, Ph.D. will present a keynote address at the Translational Strategies for Tissue Engineering Conference in Boston, MA at 9:30 a.m. EDT on Tuesday, November 1, 2011.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that Ronald A. Pepin, Ph.D., Senior Vice President and Chief Business Officer of Celldex Therapeutics, Inc., will participate with other deal experts in a panel discussion moderated by Karen Bernstein, Co-Founder, Chairman and Editor-in-Chief of BioCentury, at the 17th Annual BIO-Europe® 2011 Biotechnology Partnering Conference on Monday, October 31, 2011, in Duesseldorf, Germany.
Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) today announced that it has resubmitted the pixantrone New Drug Application ("NDA") to the U.S. Food and Drug Administration's ("FDA") Division of Oncology Drug Products ("DODP") for accelerated approval to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") in patients who failed two or more lines of prior therapy.
China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM") in China, today announced that the Company has recently hosted a technical exchange between 13 senior research specialists in the field of Traditional Chinese Medicine (TCM) and herbal medicine.
China Medical Technologies, Inc. (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that it has recently received approximately 2,200,000 of its American Depositary Shares ("ADSs") from two investment banks which borrowed the ADSs in connection with the issuance of the Company's convertible notes in August 2008.
Compugen Ltd. (NASDAQ: CGEN), announced today that CGEN-15001 was the subject of a presentation by Joseph Podojil, Ph.D. of the Feinberg School of Medicine Northwestern University, at the 2nd International Conference on Immune Tolerance, now being held in Amsterdam.
Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced the filing of a patent for an automated instrument to measure total body albumin.
DHS Holding Co. (PINKSHEETS: DHSM) is pleased to announce the appointment of Mr. Charles Barrett as President and Chief Operating Officer.
Geron Corporation (Nasdaq: GERN) today announced data on the use of GRNOPC1, oligodendrocyte progenitors derived from human embryonic stem cells, for myelin repair in a non-human primate model.
Illumina, Inc. (NASDAQ:ILMN) today announced its financial results for the third quarter of 2011.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, will host a conference call on Tuesday, November 8th, 2011, at 8:30 AM ET, to discuss its financial results for the third quarter of 2011.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced CEO Frank Reynolds will showcase InVivo’s most recent breakthroughs and provide a business update to potential investors during the 113th FSX (Financial Services Exchange) Conference set for October 26-29 at the Ritz Carlton in Coconut Grove, Fla.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that it will release its third quarter 2011 financial results before the open of the market on Tuesday, November 8, 2011.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to recommend that boys 11 to 12 years old be vaccinated routinely with GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] to help prevent anal cancer caused by human papillomavirus (HPV) types 16 and 18, anal dysplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and genital warts caused by HPV types 6 and 11.
Micro Imaging Technology, Inc. (OTCBB: MMTC) (OTCQB: MMTC) announced that it has received a substantial exclusive licensing proposal from EPIC Corporation that offers initial payments of $2 million and royalty payments in perpetuity for sales of MIT hardware and software technologies.
Northcore Technologies Inc. (TSX:NTI) (OTCBB:NTLNF), a global provider of asset management and social commerce solutions, announced that it entered into an agreement to provide the e- tendering technology for the Irish Government Health Services Executive's (HSE) initial online acquisition pilot.
Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that its work entitled "Evaluation of the Safety and Efficacy of Two Oral Insulin Formulations in Healthy Volunteers" will be presented at the Eleventh Annual Meeting of the Diabetes Technology Society, to be held in San Francisco, California.
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that the Company has expanded its capabilities to provide biopharmaceutical companies with dedicated support for their commercialization goals.
PURE Bioscience, Inc. (NASDAQ: PURE) today announced that it will report results for the fourth quarter and fiscal year 2011 after market close on Monday October 31, 2011.
Quest Diagnostics Incorporated (NYSE: DGX) today announced that its Board of Directors has begun the process of identifying a successor to Surya N. Mohapatra, Ph.D., President, Chairman and Chief Executive Officer.
Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that the Company will report third quarter 2011 financial results following the close of the U.S. financial markets on Tuesday, November 8, 2011.
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that it has initiated a phase II clinical trial of ADCETRIS™ (brentuximab vedotin) for patients with CD30-positive non-lymphoma malignancies, including multiple myeloma, leukemia and solid tumors.
Shares of micro-cap biotech TapImmune, Inc. (OTCBB: TPIV) have seen a steady increase in volume and trading activity in recent weeks.
Techne Corporation's (NASDAQ: TECH) financial results for the quarter ended September 30, 2011 include the following highlights: First quarter earnings were $27.5 million or $.74 per diluted share.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Dr. Reddy’s Laboratories (NYSE: RDY) announced today the commercial launch of Olanzapine Tablets, the generic version of Eli Lilly’s Zyprexa®.
ZYTO Corp (OTCBB: ZYTC) ZYTO Corp, a Utah-based company specializing in biocommunication applications, today announced the appointment of leading experts to its newly formed Scientific Advisory Board.