Akorn (Lake Forest, IL), a niche generic pharmaceutical company, reported that its Akorn-Strides LLC joint venture agreed to sell 16 abbreviated new drug approvals (ANDAs) and six filed ANDAs to Pfizer (New York) for $35 million in cash. Akorn-Strides LLC will continue to manufacture and distribute the approved products until April 30, 2011.
AMRI (Albany, NY) formed a research and licensing agreement with Genentech (South San Francisco, CA), part of the Roche Group (Basel), for a family of antibacterial compounds discovered from AMRI's research of its natural products sample collection. Genentech will receive an exclusive license to develop and commercialize multiple potential products from AMRI's proprietary antibacterial program, and the companies will conduct research to identify antibacterial agents. AMRI will receive an upfront license fee and research funding, milestone payments, and royalties on product sales.
BASi (Bioanalytical Systems Inc., West Lafayette, IN) a contract research organization, entered into a preferred provider agreement with Pharmasset (Princeton, NJ), a clinical-stage pharmaceutical company, to provide preclinical services. The agreement includes provisions to provide exclusive toxicology services as well as pharmaceutical analysis and bioanalytical services as needed.
Gilead Sciences (Foster City, CA) agreed to acquire Arresto Biosciences (Palo Alto, CA), a biotechnology company that develops medicines to treat fibrotic diseases and cancer, for $225 million and potential future payments based on achievement of certain sales levels. Gilead anticipates that the deal would close in the first quarter of 2011.
Lpath (San Diego), a therapeutic antibody company, formed an agreement with Pfizer (New York) for an exclusive option for a worldwide license to develop and commercialize iSONEP, Lpath's lead monoclonal antibody product candidate, which is being evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other ophthalmology disorders. Pfizer will pay $14 million upfront and share the cost of the planned Phase Ib and Phase IIa trials. Following completion of the two studies, Pfizer can exercise its option for worldwide rights to iSONEP for an undisclosed option fee, which will make Lpath eligible to receive up to $497.5 million in milestone payments. Lpath will also be entitled to receive royalties based on product sales. The agreement also grants Pfizer a time-limited right of first refusal for asonep, Lpath's anticancer product candidate.
FDA informed the biopharmaceutical company MannKind (Valencia, CA) on Dec. 27, 2010, that it would not be able to complete the review of the new drug application (NDA) for Afrezza (insulin human [rDNA origin]) Inhalation Powder by the action date of Dec. 29, 2010. The agency said it will require approximately four additional weeks to complete its review of the NDA.
Santaris Pharma (Hoersholm, Denmark), a biopharmaceutical company focused microRNA-targeted therapies, and Pfizer (New York) expanded their collaboration to develop and commercialize RNA-targeted medicines using Santaris’s Locked Nucleic Acid (LNA) drug platform. Santaris will receive $14 million up front from Pfizer, up to $600 million in milestone payments, plus royalties on product sales. The newly expanded alliance builds on the original collaboration formed in January 2009 between Santaris and Wyeth, which was acquired by Pfizer.
Novo Nordisk (Bagsværd, Denmark), a global healthcare company focusing on diabetes care, appointed Anne Phillips vice-president of clinical development for medical and regulatory affairs for North America. Phillips reports directly to Jerzy Gruhn, president of Novo Nordisk Inc., the company's US affiliate, and senior vice-president for Novo Nordisk A/S North America. Phillips will serve as a member of the US executive team.
Dominique Baly is responsible for the cross-divisional management of marketing, sales, and service for the Sartorius (Goettingen, Germany) laboratory business as president of Sartorius Group Laboratory Business. Baly reports to CEO Joachim Kreuzburg and is a member of the group executive committee.
Savient Pharmaceuticals (East Brunswick, NJ), a specialty biopharmaceutical company, initiated a search for a CEO. Paul Hamelin, Savient's president since November 2008 and its most senior executive officer, will continue to lead the day-to-day operations of the company until Savient hires a CEO.
Ziopharm Oncology (New York), a biopharmaceutical company, appointed Mark O. Thornton executive vice-president and chief development officer. He will report to Jonathan Lewis, the company’s CEO and chief medical officer.