Company and People Notes: EMD Serono to Open Cambridge, MA, site; Akorn Appoints Interim CEO; More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, SOCMA changes name; two FDA approvals; Biogen Idec names chief operating officer; more...

Company notes

Almac (Craigavon, Northern Ireland) is proceeding with the contruction of its new North American headquarters located on a 40-acre site in Lower Salford, Pennsylvania. The $78-million project will include a 166,600-ft2 facility housing clinical supply warehouse and storage, packaging, shipping and receiving, label control areas, as well as a second 75,000-ft2 facility housing administration, communication, and the network operations center. Both buildings are expected to be fully operational in 2010 and more than 760 people will be employed at the site.

Avigen (Alameda, CA), a biopharmaceutical company, announced on Mar. 31, 2009 that, based on a final tabulation of votes by its stockholders, Biotechnology Value Fund (BVF, San Francisco, CA) does not have the necessary support to remove and replace the company's current board of directors. Avigen announced last week that its board of directors had discontinued its strategic merger discussions with BVF and intended to develop a plan of liquidation if BVF nominees were not elected to the board. Avigen said Monday that the board is "developing a plan of liquidation in an expeditious manner," according to a company press release.

Cortex Pharmaceuticals (Irvine, CA) announced a significant restructuring of its organization that involves a reduction of personnel by approximately 50% and the reduction of salaries for the company’s executive officers. Cortex is taking steps to reduce its monthly spending requirements to align its current resources with its strongest near-term opportunities. Cortex will focus its efforts on the development of its clinical programs that it believes will have the greatest shareholder value, including CX717, one of the company’s Low Impact Ampakine drugs that achieved proof-of-concept in opioid-induced respiratory depression, and CX1739, an Ampakine compound that is currently in a Phase II sleep apnea study. Cortex also significantly reduced basic research efforts in early, nonclinical stage programs.

EMD Serono, an affiliate of Merck KGaA (Darmstadt, Germany), will open a site in Cambridge, Massachusetts, to support its growing research function. The Cambridge laboratory space will accommodate EMD Serono’s US drug discovery activities in neurodegenerative diseases, which will augment the company’s existing US research in oncology and fertility. EMD Serono expects to employ nearly 50 scientists across disciplines, including neurobiology, pharmacology and chemistry.

Merck KGaA (Darmstadt, Germany) formed Merck Serono Ventures, a strategic, corporate venture capital fund to invest in emerging biotechnology companies. The fund will support biotech start-up companies that have the potential to provide innovative products in the Merck Serono division’s core therapeutic areas, particularly, neurodegenerative diseases, oncology and autoimmune and inflammatory diseases.

Generic drug manufacturer Mylan (Pittsburg, PA) announced plans to purchase the remaining interest in Matrix Laboratories (Secunderabad, Andhra Pradesh, India) from minority shareholders pursuant to a voluntary delisting offer. Mylan, through a wholly owned subsidiary, currently owns approximately 71.2% of Matrix and controls more than 76% of its voting rights. The impact of the transaction is anticipated to be accretive to Mylan's 2009 earnings.

Patheon (Toronto), a provider of drug development and manufacturing services, announced that after consideration of the December 2008 unsolicited offer by JLL Patheon Holdings and affiliates, the company believes that the offer breaches Ontario’s securities laws. Patheon called JLL’s actions “coercive, abusive of the public shareholders of Patheon, and contrary to the public interest,” in a company press release. Patheon requested that the Ontario Securities Commission investigate its complaint against JLL.

In other news, Patheon formed an alliance with Swiftwater Group to provide regulatory advisory services to support clients’ drug-development programs.

Poniard Pharmaceuticals (South San Francisco, CA), a biopharmaceutical company, announced it will concentrate its cash resources on the clinical and commercial development of its late-stage oncology candidate, picoplatin. As a result, the company has discontinued its in-house preclinical research operations and reduced its workforce by approximately 12%, or eight employees, effective Mar. 31, 2009. The company continues to evaluate strategic alternatives for its preclinical research programs.

SAFC (St. Louis, MO), a member of the Sigma-Aldrich Group, announced details of its new Vendor Audit Services, designed to identify supply chain process improvements and control for purchased raw materials. The program also aims to reduce the cost and personnel impact that customers often experience when conducting international vendor audits.

SAFC Biosciences (St. Louis, MO), a member of the Sigma-Aldrich Group that provides cell culture materials and services for the biopharmaceutical industry, completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, Kansas, to animal-component-free (ACF) status. Part of a global facility conversion strategy, this is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.

Syngene International, a subsidiary of Biocon (Bangalore), and Bristol-Myers Squibb (BMS, New York) announced the opening of a research and development facility for BMS in Biocon Park in Bangalore, Karnataka, India. The 200,000-ft2 facility is dedicated to helping advance BMS’s work in discovery and early drug development, and is currently occupied by 270 researchers.

Members of the Synthetic Organic Chemical Manufacturers Association (Washington, DC) voted on Mar. 19, 2009, to change the group’s name to the Society of Chemical Manufacturers and Affiliates. The reason for the change is to better serve the batch, custom, and specialty chemical industry. Since its founding, SOCMA’s overall charter had been to serve the synthetic organic chemical industry, despite recent decades of achievements in service to the batch, custom, and specialty chemical industry. The adopted bylaw changes, in addition to updating SOCMA’s name, formally broaden the scope of SOCMA’s activity to reflect service to the batch, custom, and specialty chemical industry.


Zydus Cadila (Ahmedabad, Gujarat, India), a global healthcare group, signed a drug discovery and development agreement with Eli Lilly (Indianapolis, IN) focused in the area of cardiovascular research. Zydus will initiate the drug discovery, lead identification and optimization, and conduct preclinical studies and clinical trials up to Phase II human proof-of-concept. Lilly will provide chemical starting points as well as expertise and feedback regarding toxicology, ADME, chemistry, biology, clinical and regulatory aspects as needed to potentially increase the probability of success of the program, which may continue for up to six years.

Regulatory Roundup

The US Food and Drug Administration on Mar. 30, 2009, approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies. Afinitor is manufactured by Novartis (Basel, Switzerland). Afinitor is a kinase inhibitor, meaning it interferes with cell communication and prevents tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib), manufactured by Pfizer (New York) or Nexavar (sorafenib), manufactured by Bayer HealthCare AG (Leverkusen, Germany). While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin, or mTOR. The protein-blocking action disrupts the growth, division and metabolism of cancer cells.

On Mar. 30, 2009, the US Food and Drug Administration approved IXIARO, a vaccine to prevent Japanese encephalitis (JE), which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO, manufactured by Intercell Biomedical (Livingston, UK), will be the only vaccine for JE available in the United States. The vaccine is manufactured using cell-culture technology, which has been shown to improve manufacturing efficiency and provide a more reliable control of the vaccine manufacturing process.

People Notes

Acura Pharmaceuticals (Palatine, IL), a specialty pharmaceutical company, named Garth Boehm vice-president of modified-release dosage form development. Boehm is currently employed as vice-president of product development at Actavis Pharmaceuticals and is expected to commence employment with Acura in May 2009.

Akorn (Lake Forest, IL), a manufacturer and marketer of sterile specialty pharmaceuticals, appointed Jeffrey A. Whitnell interim chief executive officer. Whitnell joined Akorn in June 2004 as vice-president of finance and chief financial officer. He was appointed secretary and treasurer in August 2004 and was promoted to senior vice-president in November 2004. A search is underway for a new CEO.

Biogen Idec (Cambridge, MA) named Robert A. Hamm chief operating officer of the company. Hamm has been executive vice-president of pharmaceutical operations and technology at the company since 2007 and replaces Hans Peter Hasler, who is leaving the company.

Christina Shasserre was appointed to global head of bioscience for Merck KGaA (Darmstadt, Germany), effective immediately. Shasserre will be located in San Diego at the bioscience site of EMD Chemicals (Gibbstown, NJ), the North American chemical sector of Merck KGaA. The company plans to consolidate its core US capabilities in bioscience at the San Diego site by the end of 2009.

Nabriva Therapeutics (Vienna, Austria), a biotechnology company, appointed David Chiswell its CEO. Chiswell has been involved with Nabriva since its founding and served as chairman of the supervisory board for the past three years.

C. Richard Piazza joined the board of directors of Nano Risk Assessment, the parent company of nanoTox (Austin, TX), a provider of risk analysis and profiling exclusively for nanoparticles. Piazza is founder and CEO of the private equity firm La Jolla Capital Partners and has experience in the biotechnology and pharmaceutical industries.

NovaDel Pharma (Flemington, NJ), a specialty pharmaceutical company developing oral spray formulations for a range of drugs, announced Michael E. Spicer’s resignation as chief financial officer and corporate secretary, effective April 1, 2009. Deni M. Zodda, NovaDel’s chief business officer, was appointed interim chief financial officer and corporate secretary.