Week of Nov. 16, 2009: GSK and Nabi Form Nicotine Vaccine Agreement; Eli Lilly Research Exec to Retire; More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...

Company Notes

Abbott (Abbott Park, IL) acquired the global rights to PanGenetics’s (Royston, UK) PG110 fully humanized antibody to nerve growth factor (NGF). The agreement includes an upfront payment of $170 million plus additional milestone payments, for a total of up to $190 million. PG110 is a biologic currently being studied in a Phase I clinical trial in patients with osteoarthritis. If the Phase I trial is successful, Abbott anticipates evaluating the compound in a number of other pain states, including chronic lower back pain, cancer pain and diabetic neuropathic pain, according to a company press release.

Almac (Craigavon, UK) recently launched site-specific PEGylation technology services. The technology focuses on the engineering of both recombinant proteins and synthetic peptides.

Bristol-Myers Squibb (BMS, New York) will split off its holdings in Mead Johnson Nutrition Company. The company expects the split-off to be a tax-advantaged way to deliver value to Bristol-Myers Squibb shareholders, according to a company press release.

In a separate announcement, BMS said it formed an agreement with Alder Biopharmaceuticals (Bothell, WA) to develop and commercialize ALD518, a biologic that has completed Phase IIa development for the treatment of rheumatoid arthritis. BMS gains worldwide exclusive rights to develop and commercialize ALD518 for all potential indications except cancer, for which Alder will retain rights and grant Bristol-Myers Squibb an option to co-develop and commercialize outside the United States. Alder will receive an upfront cash payment of $85 million, potential development and regulatory milestone payments of up to $764 million, potential sales-based milestones of more than $200 million, and royalties on net sales.

GlaxoSmithKline Biologicals (GSK, London) and Nabi Biopharmaceuticals (Rockville, MD) formed an option and licensing agreement for a nicotine conjugate candidate vaccine, NicVAX, an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second-generation nicotine vaccine. Under the agreement, GSK will pay Nabi $40 million upfront and more than $500 million in option fees and milestone payments. Nabi will also receive double-digit royalties on global sales of NicVAX, should GSK exercise its option, as well as royalties on global sales of next generation nicotine vaccines.

Genzyme (Cambridge, MA) issued letters to healthcare providers regarding its enzyme replacement products Cerezyme (imiglucerase for injection), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alfa), Aldurazyme (laronidase), as well as Thyrogen (thyrotropin alfa for injection), filled at its Allston Landing manufacturing facility. The letters remind providers of the product labeling recommendations advising both visual inspection of vials and in-line filtration of the products to look for foreign particles. Genzyme’s quality control processes have detected foreign particles in these products at a rate of approximately 1%, according to a press release, which also stated that the company’s rate has not increased over time.

In a separate announcement, Genzyme said it received a complete response letter from FDA regarding its application to market Lumizyme (alglucosidase alfa) for the treatment of Pompe disease. The agency stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the risk evaluation and mitigation strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed. Genzyme said it would transition production of alglucosidase alfa 2000-L scale (Lumizyme) to its facility in Geel, Belgium, and is working with FDA to complete the necessary approvals.

Onyx Pharmaceuticals (Emeryville, CA) acquired Proteolix (South San Francisco, CA), a biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors. N. Anthony Coles, president and chief executive officer of Onyx, said in a company press release, “The lead asset, carfilzomib, with its potential for an accelerated approval in 2011, may provide the next generation of therapy for patients with multiple myeloma who often relapse or become resistant to current treatment options.”

The contract research organization Particle Sciences (Bethlehem, PA) acquired additional space, bringing its total to approximately 21,000 ft2. The company plans to use the space for a purpose‐built sampling and weighing area for highly potent materials and for clinical trial material manufacturing, according to a press release. Particle Sciences expects the new space to be operational in early 2010.


sanofi aventis (Paris) and Regeneron Pharmaceuticals (Tarrytown, NY) extended their existing global collaboration to discover, develop, and commercialize fully-human therapeutic monoclonal antibodies. sanofi aventis will increase its annual funding commitment from $100M to $160 million beginning in 2010, and the research funding will now extend through 2017. The companies aim to advance an average of four to five antibodies into clinical development each year, and sanofi aventis has an option to extend the discovery program for up to an additional three years for further antibody development and preclinical activities, according to a company press release.

Sciele Pharma (Atlanta, GA), a Shionogi & Co. (Osaka, Japan) company, will acquire Addrenex Pharmaceuticals (Durham, NC), a pharmaceutical company specializing in drugs that regulate the adrenergic system, for $29 million in cash. Sciele previously licensed three products from Addrenex: Clonicel (clonidine HCl sustained release) for attention deficit hyperactivity disorder, Jenloga XR (once-daily clonidine) for hypertension, and rights to ADX-415 for the treatment of vasomotor systems and hypertension. The new drug application for Clonicel was filed with the US Food and Drug Administration  in October 2009.

People Notes

Cannasat Therapeutics (Toronto) appointed Anthony J. Giovinazzo president and CEO. Giovinazzo succeeds David Hill as CEO, and Hill will continue with the company as vice-chairman and will become an advisor to Giovinazzo.

CellCyte Genetics (Eastgate, WA), an emerging biotechnology company, appointed Douglas Cerretti chief science officer and director of business development. Ceretti will guide the development of CellCyte’s bioreactor product toward commercialization, according to a company press release. The product is a cell expansion device that allows the culture of cells at high density and under precisely controlled oxygenation, providing an alternative to standard cell culture methods.

Cornerstone Therapeutics (Cary, NC), a specialty pharmaceutical company, appointed Andrew K. W. Powell executive vice-president, general counsel, and secretary. Powell will join the company's executive management team and manage its legal function and corporate governance processes. He will report to Craig Collard, the company’s president and CEO.

Eli Lilly (Indianapolis, IN) announced that Steven M. Paul, executive vice-president of science and technology, and president of Lilly Research Laboratories, will retire, effective Feb. 28, 2010. Jan M. Lundberg, executive vice-president and head of global discovery research at AstraZeneca (London), is to become his successor. Lundberg plans to join Lilly in Indianapolis as early as January 2010, subject to completion of the US immigration process, according to a company press release.

Mirna Therapeutics (Austin, TX) appointed Paul Lammers president, CEO, and a member of the board of directors. Lammers is responsible for driving fundamental biological discoveries in the field of microRNA by the Mirna team.

Watson Pharmaceuticals (Morristown, NJ) appointed Robert A. Stewart to newly created position of senior vice-president of global operations. Stewart will have responsibility for global manufacturing, supply chain, quality and technical operations. The company also announced that Thomas R. Russillo, executive vice-president and president of the generics division, was named executive vice-president of global generics and will head the company's newly formed Global Generics business. Both Stewart and Russillo report to Paul Bisaro, president and CEO of Watson.