Week of Apr. 28, 2011: Company and People Notes: sanofi-aventis signs research pact with Stanford; Paul Maffuid joins AAIPharma Services; and More.

Apr 28, 2011
By PharmTech Editors
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Company Notes

The biopharmaceutical company Alnylam Pharmaceuticals and the nanotechnology firm Precision NanoSystems have agreed to jointly develop small lipid nanoparticles (sLNPs) using microfluidics technology.

The solid-state research company Avantium has spun out its solid-state research and drug preformulation business into a new company named Crystallics, following a management buyout. The spin-out is part of Avantium’s plan to focus on its catalyst and chemicals activities.

Baxter International has agreed to acquire the specialty pharmaceutical company Prism Pharmaceuticals. The acquisition includes a total consideration of up to $338 million, consisting of an upfront cash payment of $170 million at closing, and up to $168 million in future sales-based milestone payments. The transaction is expected to close in the second quarter of 2011, subject to customary closing conditions.

The biopharmaceutical company Caliber Biotherapeutics has opened a plant-based manufacturing facility capable of producing 10–100 million doses of vaccines per month, and hundreds of thousands of doses of protein biotherapeutics, such as monoclonal antibodies, according to the company. In addition, Caliber also will develop a proprietary product pipeline for cancer and infectious diseases, using cell- and microbial-based production systems.

Eli Lilly has announced a partnership with the medical-technology firm Medtronics for delivering a potential new medicine to the brain, using an implantable drug-delivery system. The goal of this pact is to develop a therapeutic approach for Parkinson's disease that combines Lilly's biologic, a modified form of glial cell-derived neurotrophic factor (GDNF), with Medtronic's implantable drug-infusion system technology.

The biopharmaceutical companies Genmab and Seattle Genetics have expanded their antibody drug conjugate (ADC) pact. Under the new agreement, Genmab has rights to use Seattle Genetics' ADC technology for its development of HuMax-CD74, an antibody in preclinical development to target CD74, which is expressed on a wide range of hematological malignancies and solid tumors. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a codevelopment and cocommercialization option for any resulting ADC products at the end of Phase I clinical development.

The biopharmaceutical company Gilead Sciences has formed a drug-development agreement with MicroDose Therapeutx for the development and commercialization of MDT-637, MicroDose’s inhalable small-molecule antiviral fusion inhibitor used for the treatment of respiratory syncytial virus (RSV). Under the terms of the agreement, Gilead will pay MicroDose an upfront payment and provide research funding to support MicroDose’s continued development of MDT-637 through Phase IIa clinical trials. Gilead will assume full responsibility for clinical development following Phase IIa. MicroDose could also receive additional payments based on the achievement of certain development, regulatory, and commercial milestones, as well as development fees and royalties on future potential net sales.

GlaxoSmithKline (GSK) said it "welcomes" an agreement with the World Health Organization (WHO) on a framework to support global preparedness for a future influenza pandemic. The agreement states that companies supplying vaccines, antivirals, and diagnostics for influenza, will become key stakeholders in the WHO Global Influenza Surveillance Network (GISN), which tracks the development and movement of influenza viruses globally. Industry will increase its financial contribution to the GISN to enable the network’s geographical expansion, and support technical improvements that will accelerate the start of vaccine production, enabling industry to deliver seasonal and pandemic influenza vaccines more quickly.

OncoMed Pharmaceuticals, a company developing stem-cell therapies, has expanded its collaboration with Bayer HealthCare. Bayer’s US affiliate will manufacture clinical supplies of a second Wnt inhibitor in the alliance. Bayer will manufacture the bulk drug substance at its Berkeley, California, clinical manufacturing center to support Phase I clinical testing planned to begin in 2012.

The contract development and manufacturing organization Pharmatek has added spray drying to its drug-formulation and manufacturing capabilities. The company has purchased a Buchi B-290 Mini Spray Dryer for formulation feasibility studies and small-scale clinical manufacturing. This technology can be used for both oral and parenteral dosage forms. In other news, Pharmatek has received approval from the US Drug Enforcement Agency (DEA) for the analysis of Schedules I through V controlled substances, complementing its existing license to develop and manufacture drug products containing Schedules IV and V controlled substances.

sanofi-aventis has signed a multi year research collaboration agreement with the Stanford University Bio-X program that supports, organizes, and facilitates interdisciplinary, collaborative, and innovative research projects in the early phases of development. Under the terms of the agreement, a Stanford Bio-X and sanofi-aventis Joint Steering Committee will fund up to five programs a year. sanofi-aventis may also host postdoctoral fellows at the company, and sanofi-aventis scientists may also be invited by Stanford faculty to be visiting scholars and to pursue research collaborations at Stanford.

The specialty pharmaceutical company Valeant Pharmaceuticals has issued a letter to the shareholders of the biopharmaceutical company Cephalon regarding its bid for Cephalon to state that Valeant is willing to increase its bid of $73 per share modestly. Valeant has issued the letter in connection to the consent solicitation statement process.

People Notes

AAIPharma Services, a provider of pharmaceutical product development and manufacturing services, appointed Paul Maffuid as executive vice-president of operations. Maffuid will have responsibility of the company's drug product development services functions.

The biopharmaceutical company Novavax has appointed Louis Fries III, MD as vice-president of clinical and medical affairs, and Jane Halpern, PhD, as vice-president of regulatory affairs. Before joining Novavax, Fries was director of global clinical development at GSK Biologicals, North America. Halpern was previously staff scientist and regulatory affairs specialist at the Vaccine Research Center of the National Institute of Allergy and Infectious Disease (NIAID), in the National Institutes of Health.