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JHS Secures Four Sterile Parenteral Products Manufacturing Contracts; Samsung Biologics, Biogen Idec Establish Biosimilars Joint Venture; and More.
Enanta Pharmaceuticals, an R&D company, has entered into an exclusive collaboration and license agreement with Novartis for the worldwide development, manufacture, and commercialization of its lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program. Enanta has received investigational new drug approval for EDP-239 from FDA. Under the terms of the agreement, Enanta will receive an upfront payment of $34 million and is eligible to receive up to $406 million if certain clinical, regulatory, and commercial milestones are met. Enanta is also eligible to receive tiered double-digit royalties on worldwide sales of products, and retains codetail rights in the United States. Novartis will be responsible for all costs associated with the development, manufacture, and commercialization of EDP-239 and will fund Enanta’s drug-discovery efforts on certain additional compounds targeting NS5A. Read More
Glenmark Generics USA has issued a voluntary, nationwide, consumer-level recall of seven lots of the oral contraceptive norgestimate and ethinyl estradiol tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch. Any blister for which the lot number and expiration date is not visible is subject to recall. The tablets subject to recall were manufactured and packaged by Glenmark Generics India and are distributed by Glenmark Generics USA. The products were distributed to wholesalers and retail pharmacies nationwide between Sept. 21, 2011 and Dec. 30, 2011. Read More
Jubilant HollisterStier (JHS), a subsidiary of Jubilant Life Sciences, has recently secured contracts with four life-science companies for the commercial manufacturing of sterile parenteral products for sale in the United States and Europe. These agreements will be executed at its Spokane, Washington, facility for the contract manufacturing of products ranging from liquid to lyophilization presentations across a variety of patient indications. The total value of these contracts is more than $90 million to be delivered during a five-year period. The commercial transfer to the JHS manufacturing facility has commenced for all contracts. Read More
Samsung Biologics and Biogen Idec have established a previously announced joint venture (JV), Samsung Bioepis, to develop, manufacture, and market biosimilars in keeping with their agreement announced in December 2011. Christopher Hansung Ko, previously senior vice-president of Samsung’s strategic business development division, has been named as CEO of Samsung Bioepis. The JV’s board of directors will consist of five directors and one auditor. The construction of Samsung Bioepis’s R&D center, located at Samsung Biologics’s site in Song-do Incheon, Korea, has started and will be completed by the end of the year. Read More
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More