Lilly Announces Reorganization
Eli Lilly and Company is undergoing a companywide reorganization that is intended to accelerate the progress of the company’s pipeline.

Single Dose H1N1 Vaccines Get FDA OK
The US Food and Drug Administration has approved four vaccines for the H1N1 influenza virus, while other companies, including GlaxoSmithKline, have reported promising results from clinical studies with a single-dose vaccine.

FDA's Sharfstein Outlines Principles of Public Health Agency
Speaking to the audience of the 2009 PDA–FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner Joshua Sharfstein outlined four principles that define FDA’s role as a public health agency.

Senate Finance Committee Introduces Latest Legislative Proposal for Healthcare Reform
The Senate Finance Committee through its chairman, Max Baucus (D-MT), introduced on Sept. 16, 2009, a bill, “America’s Healthy Future Act of 2009,” representing the latest Congressional proposal for healthcare reform.

Scientists Discover RNA Interference in Budding Yeast
Vaccine makers and other pharmaceutical manufacturers using yeast protein-expression systems are taking note of a discovery this week by a team of researchers who have found RNA interference in Saccharomyces castellii.

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.”

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.

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.

The US Food and Drug Administration issued a public alert regarding recently stolen vials of long-acting insulin (Levemir, Novo Nordisk) that may still be on the market. FDA first alerted the public to the theft in June 2009. “Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use,” according to the alert. In related news, Dey, a subsidiary of Mylan, issued an advisory regarding the theft of two types of its respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials. The lots were on a tractor-trailer that was stolen in Florida. Although some lots were successfully transferred to the marketplace, Dey is recalling all related lots of these medications to be sure the public is safe.

FDA’s new enforcement plan went into effect this week on Sept. 15, 2009. The agency announced the program, aimed at improving public health by taking timely action, in August. Companies that fail to respond to a Form 483 within 15 business days are subject to receiving an FDA Warning Letter. (see back story, Warning Letter Enforcement Begins in September)

On Oct. 24–29, in St. Louis, Missouri, the Steering Committee and Expert Working Groups of the International Conference on Harmonization (ICH) will meet. In preparation for the event, FDA is holding a public meeting on Oct. 14 in Rockville, Maryland, to provide information and receive comments on the ICH efforts, according to an FDA notice. The ICH Global Cooperation Group will also meet in Missouri. Individuals interested in the public meeting must register with Mary Morrison at Mary.Morrison@fda.hhs.gov or by fax at 301.827.0003.

On Sept. 14, 2009, the Innovative Medicines Initiative (IMI), a public–private partnership between the European Commission and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), announced the topics of research of its second call for proposals. IMI was launched in 2007 to “support more efficient discovery and development of better medicines for patients by removing research bottlenecks in the current drug development process,” according to an IMI release. The IMI budget for 2008–2017 is €2 billion ($2.9 billion), with half coming from the European Community and half from industry. In April 2008, IMI received 134 proposals, 15 of which were selected to receive €246 million (approximately $359 million). The funding available for the second proposal call is €156.3 million ($227.9 million), with €76.8 million ($112 million) to be provided by the European Commission and €79.5 million ($116 million) to be provided by EFPIA member companies.

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).