Week of Oct. 12, 2009: GSK and Prosensa Form Pact; Cardiokine Appoints CEO; More...

October 15, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Company and People Notes: Bayer Schering Pharma forms collaboration with Compugen; Takeda San Francisco appoints VP of process science; more...

Company Notes

3M Drug Delivery Systems (St. Paul, MN) opened a new laboratory site at the 3M Singapore facility in Yishun. The Singapore lab will develop products in both the inhalation and transdermal drug-delivery categories. The laboratory is Drug Delivery Systems’ first contract research and development facility in the Asia-Pacific region dedicated to pharmaceutical product development, according to a company press release.

Catalent Pharma Solutions (Somerset, NJ) announced that its integrated dose form development, manufacturing, and packaging facility in Schorndorf, Germany, completed an FDA inspection. This inspection, triggered by preapproval inspection requirements for two separate products, resulted in three minor observations on FDA Form 483. The facility currently produces products approved by other regulators including those in Germany, Brazil, and Taiwan.  

Creapharm Europe (Bordeaux, France), a clinical supply company and contract manufacturer, established a US subsidiary, Creapharm-MP5 (Chicago, IL). The company appointed Matthew Maupin vice-president of business development for North America.

Compugen (Tel Aviv, Israel), a drug and diagnostic product candidate discovery company, signed a collaboration agreement with Bayer Schering Pharma (Leverkusen, Germany) focused on the evaluation of a Compugen-discovered tumor target and its splice variants. Following an initial six month joint-research stage, the agreement provides Bayer with an option for an exclusive worldwide royalty bearing license for development of monoclonal antibodies and other therapeutic agents addressing these novel target molecules, according to a company press release.

Heptares Therapeutics (Welwyn Garden City, UK), a drug-discovery company focused on G-protein-coupled receptor (GPCR) targets, entered into an option agreement with the venture fund Novartis Option Fund under which Heptares will apply its StaR technology to generate novel drug leads against a nominated, unspecified GPCR target of interest to Novartis. The agreement includes upfront and milestone payments to Heptares of up to $200 million, plus royalties. Full financial terms were not disclosed.

Labopharm (Laval, Canada) announced that it was informed by Angelini, the manufacturer of the active pharmaceutical ingredient for its novel trazodone formulation, that it received a letter from FDA stating that Angelini has appropriately addressed all deficiencies cited by FDA following its inspection of the manufacturing facility in June and July of this year. The letter further states that Angelini's manufacturing facility has been classified as acceptable.

Merck KGaA (Darmstadt, Germany) acquired Bangalore Genei (India) Private (BGIP, Bangalore, India) from the Sanmar Group. BGIP focuses on the development, production, marketing, and sales of products for proteomic and genomic research and has more than 100 employees.

Novartis Pharma (Basel) entered into an agreement with Vanda Pharmaceuticals (Rockville, MD) for exclusive US and Canadian rights to Fanapt (iloperidone), a new oral medication approved by FDA for the treatment of adults with schizophrenia. Novartis plans to launch Fanapt in the US in early 2010. Under the agreement with Vanda, Novartis will have exclusive commercialization rights to the oral formulation in the US and Canada as well as exclusive rights to develop and commercialize a long-acting injectable formulation of this medicine for these markets. Vanda will receive an upfront payment of $200 million and will be eligible for milestone payments of up to $265 million, as well as royalties on sales.

In a related announcement, Titan Pharmaceuticals (South San Francisco, CA) stated that under the terms of its sublicense agreement with Novartis, Titan is entitled to receive royalties on global net sales of Fanapt equal to 8% on annual net sales up to $200 million, and 10% on annual net sales above $200 million. Titan incurs no ongoing expenses associated with this potential future income, according to a company press release.

Onyx Pharmaceuticals will acquire the biopharmaceutical company Proteolix (South San Francisco, CA) for up to $851 million. Proteolix's lead compound, carfilzomib, is a proteasome inhibitor currently in multiple clinical trials, including an advanced Phase IIb clinical trial for patients with relapsed and refractory multiple myeloma. Under the terms of the deal, Onyx will make a $276-million cash payment upon closing of the transaction, $40 million in milestone payments, and up to $535 million contingent upon the anticipated approvals for carfilzomib in the US and Europe. The companies expect the deal to close in the fourth quarter of 2009, subject to customary closing conditions.

Prosensa (Leiden, The Netherlands), a biopharmaceutical company focused on RNA-modulating therapeutics, and GlaxoSmithKline (GSK, London) will collaborate to develop and commercialize RNA-based therapeutics for Duchenne Muscular Dystrophy (DMD). DMD is a severely debilitating childhood neuromuscular disease that affects one in 3500 newborn boys, and currently, there is no treatment to prevent the eventual fatal outcome, according to a company press release. The financial terms include a GBP 16 million ($25 million) upfront payment by GSK, up to GBP 412 million ($655 million) in milestone payments, and double-digit royalties on product sales.

SAFC Pharma (St. Louis, MO) has completed a $12-million expansion to its contract manufacturing facility in Carlsbad California. The expansion includes two fully segregated, viral-product manufacturing suites that will expand the company’s biologics, viral-vaccine, and gene-therapy manufacturing to commercial-scale quantities. Additionally, the expansion includes dedicated cell expansion, bioreactor production, purification, and cleanroom suites.

People Notes

Cardiokine (Philadelphia, PA), a specialty pharmaceutical company, named Amber Salzman president, CEO, and a member of the board of directors. Salzman previously was a member of the research and development executive team at GlaxoSmithKline (London).

CMC Biologics (Copenhagen, Denmark), a contract development and manufacturing organization, appointed David Wolton vice-president of manufacturing. Wolton previously held positions with Elan (Dublin, Ireland), Wyeth (Madison, NJ), and Lonza (Basel).

Curemark (Rye, NY), a drug research and development company focused on the treatment of neurological diseases, promoted Elisa Zinberg to senior vice-president of operations and Matthew Heil to senior vice-president of drug development. Both were vice-presidents of the company.

OXiGENE (South San Francisco, CA), a biopharmaceutical company, announced that Chief Executive Officer John A. Kollins resigned from his position and as a member of the board of directors. Peter Langecker, executive vice-president and chief development officer, will serve as interim CEO while the company searches for Kollins’s replacement.

RetroVirox (San Diego, CA), a biotechnology company focused on antivirals, appointed Ronald C. Griffith vice-president of research and development and a member of the board of directors. Griffith will report to Juan Lama, founder and CEO of the company. In addition, Richard Martin joins the company as director of chemistry, and Richard W. Michitsch was appointed director of screening operations.

Takeda San Francisco, a subsidiary of Takeda Pharmaceutical (Osaka, Japan), appointed Michael Buckley vice-president of process sciences. Buckley will be responsible for directing the materials supply to support research and prepare for production of therapeutic antibody candidates at Takeda's center of excellence for biologics.