Week of Sept. 14, 2009: Evotec and Biogen Idec Form Pact; Marijn Dekkers Leaves Thermo Fisher Scientific for Bayer; More...

Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more...

Company notes

AM Technology (Runcorn, UK) joined an European Union-funded project that seeks to develop flow processes for the industrial synthesis of pharmaceutical compounds.The Pharmagen project, which is being coordinated by Serichim (Torviscosa, Italy) and has five other partners, will use a multidisciplinary approach to tackle the obstacles that face the development of flow chemistry techniques for industrial pharmaceutical processes.

Amylin Pharmaceuticals (San Diego, CA) and Biocon (Bangalore) will develop, commercialize, and manufacture a novel peptide therapeutic for the potential treatment of diabetes. Research will center on Amylin's "phybrid" technology, which is a peptide hybrid molecule that combines the pharmacological effects of two peptide hormones into a single molecular entity. Under the agreement, Amylin will focus on peptide hormone development, particularly in the area of phybrid technology, and Biocon will use its resources in recombinant microbial expression to manufacture the compound.

The US Food and Drug Administration put the generic-drug manufacturer Apotex (Toronto, Canada) under import alert for violations in the manufacture of non-sterile oral solid dosage drug products. As noted in a recently posted Warning Letter, FDA found current good manufacturing practice deviations during an inspection and subsequent Apotex responses to the deviations were unsatisfactory to the agency. Apotex issued a statement saying, “We are actively working with the FDA to resolve the identified concerns as quickly as possible, and are optimistic that there will be a prompt resolution.”

Bristol-Myers Squibb (New York) announced that FDA has accepted, for filing and review, the company’s submission of a biologic license application for belatacept, which is in ongoing Phase III development for use in kidney transplantation. Belatacept is designed to help prevent graft rejection and maintain kidney function following renal transplantation.

Discovery Laboratories (Warrington, PA) will meet with FDA on Sept. 29, 2009 to discuss options for the company to resolve issues stemming from an Apr. 17, 2009, Complete Response letter for Surfaxin (lucinactant). Discovery will work with FDA to gain marketing approval for Surfaxin for the prevention of respiratory distress syndrome in premature infants.

Elan (Dublin, Ireland) issued a statement that it has resolved an unintended breach of its Tysabri collaboration agreement with Biogen (Cambridge, MA) that had been identified by the United States District Court for the Southern District of New York. Elan's previously announced transaction with Johnson & Johnson (New Brunswick, NJ) has been amended to eliminate in its entirety the strategic financing and collaboration agreement that was the subject of the court's September 3, 2009, hearing and of Biogen's previously disclosed notice of breach.

Evotec (Hamburg, Germany), a provider in the discovery and development of small-molecule drugs, and Biogen Idec (Cambridge, MA), a biopharmaceutical company, entered into a research agreement. Evotec will use technologies in protein production, assay development, and high-throughput screening to identify hit molecules for Biogen Idec. Financial details were not disclosed.

The biologics contract manufacturing organization Goodwin Biotechnology (Plantation, FL) completed the manufacturing and vialing under current good manufacturing practice regulations of AREVA Med’s (Bethesda, MD) monoclonal antibody-chelator conjugate, which wil be used in Phase I clinical trials to treat several types of deadly forms of cancers.

Lonza Group (Basel) broke ground for its new facility for its Cell Therapy business, located at Tuas Biomedical Park in Singapore and adjacent to Lonza’s large-scale mammalian manufacturing facility. Construction of the manufacturing facility will begin early in 2010, and the facility is expected to begin manufacturing therapies by mid-2011.

Merck & Co. (Whitehouse Station, NJ) updated the status of the clinical-development programs for telcagepant (MK-0974) and MK-3207, the company's investigational oral calcitonin gene-related peptide receptor antagonists for the intermittent treatment of acute migraine. The company is reviewing clinical data for telcagepant, currently in Phase III of clinical development, in preparation for discussions with regulatory agencies later this year. Separately, Merck announced it will discontinue the development program for MK-3207. While efficacy was demonstrated in a Phase II study, some subjects in extended Phase I clinical pharmacology studies were found to have experienced delayed, asymptomatic liver test abnormalities, generally following discontinuation of drug administration. The company said in a press release that this information led to the discontinuation of MK-3207 development.

Micromeritics (Norcross, GA) announced that a Novartis (East Hanover, NJ) research team used a Micromeritics ASAP 2020 Accelerated Surface Area and Porosity analyzer to characterize different batches of active pharmaceutical ingredient that exhibited different flow properties. The scientists found that the amorphous content of the batches varied, and concluded that the varying amorphous content of the batches was the source of the variability in flow behavior.

OctoPlus (Leiden, the Netherlands), a drug delivery company, signed a pharmaceutical development and manufacturing contract with Axentis Pharma (Zurich, Switzerland). OctoPlus will perform process development and clinical manufacturing of Axentis’s lead product, which is an inhalable liposomal formulation of tobramycin for the treatment of cystic fibrosis. Financial terms of the deal were not disclosed.

Sanofi Pasteur (Lyon, France), the vaccines division of sanofi aventis group (Paris), signed an agreement with Brazil’s biomedical research center the Butantan Institute for the production and supply of a vaccine against the H1N1 influenza virus for the Brazilian government. The agreement includes an initial supply of 18 million doses of the H1N1 influenza virus vaccine: 1 million doses in final presentation and 17 million doses in bulk form.

Targeted Genetics (Seattle, WA) sold certain assets, including manufacturing technologies, and other adeno-associated viral (AAV) vector technology, to Genzyme (Cambridge, MA) for up to $7 million in cash. Genzyme also received a license to use certain technology and materials necessary for manufacturing AAV vectors.

XOMA (Berkeley, CA) and Arana Therapeutics (Sydney, Australia), a subsidiary of Cephalon, entered into a collaboration involving multiple proprietary XOMA antibody research and development technologies, including a new antibody phage display library, and a suite of integrated information and data management systems. Arana will pay XOMA a fee of $6 million plus milestone payments and royalties on product sales.

People notes

Alkermes (Cambridge, MA) announced that Richard Pops assumed the duties of president and CEO. Pops, who will retain his duties as chairman of the board, replaces David Broecker, who is leaving the company.

Bayer (Leverkusen, Germany) appointed Marijn E. Dekkers to succeed Werner Wenning as CEO from October 1, 2010, and will join the Bayer Management Board on January 1, 2010. Dekkers is currently president and CEO of Thermo Fisher Scientific (Waltham, MA). In a transition phase, he will also serve as CEO of Bayer HealthCare, succeeding Arthur J. Higgins, will to leave the company during the first half of 2010 for personal reasons.

Cellexus (Huntingdon, UK), a supplier of disposable bioreactors, appointed Sandy Primrose as its new chairman. Primrose, who has been a nonexecutive director of the company since July 2009, succeeds Kevin Borrett, who is also standing down as a director from Cellexus Limited and Cellexus Inc.

The Helsinn Group (Lugano, Switzerland) promoted William Mann from chief operating officer to CEO of its American subsidiary, Helsinn Therapeutics (Bridgewater, NJ). The company also named William Brown vice-president of commercial operations USA. Brown will focus on building a Helsinn Therapeutics direct sales structure in the United States, according to a company press release.

The international specialty chemicals company Innospec (Newark, DE) appointed David Williams vice-president, general counsel, and chief compliance officer, effective Sept. 17, 2009. Williams will be based at the company’s Littleton, Colorado, office.

Ironwood Pharmaceuticals (Cambridge, MA) named Thomas McCourt chief commercial officer and senior vice-president of marketing and sales. McCourt will be responsible for overall commercial strategy.

POZEN (Chapel Hill, NC), a pharmaceutical company focused on treating pain-related conditions, appointed Elizabeth A. Cermak executive vice-president, chief commercial officer. Cermak will be responsible for the development and implementation of the company’s commercialization strategy for its future product candidates.

Joseph Acker, president and CEO of the Society of Chemical Manufactures and Affiliates (SOCMA), will retire in December 2009 after 16 years of service to the organization. Acker plans to spend more time with his family and to begin consulting. SOCMA is a trade association serving the batch, custom, and specialty chemical industries.

The generics manufacturer SOHM, Inc. (Buena Park, CA) appointed Nitin Shah vice-president of marketing for SOHM, India. Shah has 28 years of experience in pharmaceutical marketing and sales.

Laboratory equipment manufacturer Thermo Fisher Scientific (Waltham, MA) appointed Marc N. Casper president, CEO, and a director of the company, effective October 15, 2009. Casper currently serves as executive vice-president and chief operating officer. The announcement follows the decision of Marijn E. Dekkers to resign as president, CEO, and a member of the board, to join Bayer (Leverkusen, Germany).