Company and People Notes: BMS and Otsuka Extend Abilify Agreement; Takeda Reorganizes Corporate Structure; More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Genzyme and Bayer HealthCare form agreement; FDA releases draft guidances; TransMolecular appointed Robert Radie president and CEO

Company notes

Altea Therapeutics (Atlanta, GA) entered into an agreement with Eli Lilly (Indianapolis) and Amylin Pharmaceuticals (San Diego, CA) to develop and commercialize a novel daily transdermal patch delivering sustained levels of exenatide (Amylin’s Byetta) using Altea Therapeutics’ proprietary PassPort transdermal delivery system. Altea Therapeutics, supported by Lilly and Amylin, recently completed an initial Phase I clinical study of the exenatide transdermal patch in people with Type 2 diabetes.

Bristol-Myers Squibb (Princeton, NJ) and Otsuka Pharmaceutical (Tokyo) agreed to extend the US portion of the companies’ long-standing agreement for the development and commercialization of Abilify (aripiprazole) from the currently scheduled end date of November 2012 until the expected loss of the drug's exclusivity in April 2015. In addition, the companies established an oncology collaboration for two Bristol-Myers Squibb products: Sprycel (dasatinib) and Ixempra (ixabepilone).

Catalent Pharma Solutions (Somerset, NJ) and BAVARIA Industriekapital (Munich, Germany) announced the completion of the purchase of Catalent’s Osny, France, oral manufacturing business by an affiliate of BAVARIA. The Osny business provides CGMP development and manufacturing services for hormonal and other highly potent drugs in oral dose forms that are either approved for commercial marketing or in clinical development. Terms of the transaction, which is effective Mar. 30, 2009, were not disclosed.

Emisphere Technologies (Cedar Knolls, NJ), a biopharmaceutical company focused on drug delivery, and AAIPharma (Wilmington, NC), a drug-development company, formed a strategic alliance intended to expand the application of Emisphere’s Eligen technology, a delivery method for therapeutic molecules and nutritional supplements, and AAIPharma’s drug-development services. The key benefit of the Eligen technology is that it improves the ability of the body to absorb small and large molecules.

Genzyme (Cambridge, MA) entered into an agreement to acquire the worldwide rights to Campath (alemtuzumab) from Bayer HealthCare (Leverkusen, Germany). Genzyme will have the primary responsibility for the development and commercialization of this potential treatment for multiple sclerosis (MS). Bayer will continue to fund a portion of alemtuzumab’s development in MS and will retain an option to copromote the product in MS upon approval. In addition, Genzyme will assume sole responsibility for worldwide sales and marketing for Campath in B-cell chronic lymphocytic leukemia. Bayer will retain the right to develop and commercialize alemtuzumab in solid organ transplant indications. Additionally, Genzyme will acquire a new, Seattle-area Leukine (sargramostim) manufacturing facility for between $75 and $100 million and hire the plant’s operating personnel following FDA plant approval, which is expected in 2010.

Girindus (Cincinnati, OH), a manufacturer of therapeutic oligonucleotides, signed a collaboration agreement with RiboTask (Odense, Denmark), a provider of oligonucleotides for use in research and development. Under the terms of the agreement, RiboTask will gain access to the sales and marketing team of Girindus, and Girindus will have the ability to offer its customers a wide variety of oligonucleotides from small volume to commercial quantities.

A new £30-million ($44.2 million) ‘virtual’ Knowledge Centre for Materials Chemistry (KCMC) was launched in northwest England on Mar. 26, 2009. The KCMC brings together research and expertise from the Universities of Bolton, Liverpool, and Manchester with the Science and Technology Facilities Council, Daresbury Laboratory. One of the goals of the new facility will be to “provide a single point of access for industry to a wide spectrum of multidisciplinary research in applied materials chemistry, in order to achieve innovative knowledge transfer for companies of all sizes," according to a press release.

Microtest Laboratories (Agawam, MA), a provider of contract analytical solutions, announced that it added dissolution testing to its current suite of analytical testing and stability services.

Novavax (Rockville, MD) formed a joint venture (JV) with Cadila Pharmaceuticals (Ahmedabad, Gujarat, India) to develop, manufacture and market vaccines, pharmaceuticals, and diagnostic products in India. The JV will develop and commercialize Novavax’s seasonal influenza virus-like-particle (VLP)-based vaccine candidate and Cadila’s therapeutic vaccine candidates against cancer as well as its adjuvants, biogeneric, and biological diagnostic products in India. Novavax will also contribute technology to the JV for the development of several other VLP vaccine candidates against diseases such as hepatitis E and Dengue fever.

OctoPlus (Leiden, the Netherlands) signed a drug-delivery technology evaluation contract with a European biotech company. OctoPlus said in a press release that this is the seventh client for which it will work on a controlled-release formulation.

Patheon (Toronto), a provider of drug-development and manufacturing services, entered into a strategic alliance agreement with Kemwell Pvt. (Bangalore, Karnataka, India), a provider of contract manufacturing and formulation-development services. The alliance allows Patheon and Kemwell to refer and market each others' services to clients to better meet their respective clients' requirements. The alliance is effective immediately, and Patheon expects full promotion by its business development units by mid-year, according to a press release.

The contract research organization PPD (Wilmington, NC) will divest its wholly owned subsidiary, Piedmont Research Center, to Charles River Laboratories International (Wilmington, MA). Piedmont Research Center provides preclinical research and evaluation of anticancer agents and therapies. In other news, PPD acquired Magen BioSciences (Waltham, MA), a biotechnology company focused on dermatologic therapies. The acquisition expands PPD's compound partnering program into dermatology.

Solvay Group (Brussels) issued a press release on Apr. 1, 2009, confirming that it is evaluating options for its pharmaceutical business. The company said it issued the statement in response to “the rumors reported today in a press article.”


Sutro Biopharma (South San Francisco, CA), a company focused on open cell-free synthesis for the discovery and production of proteins, announced it achieved the production of a therapeutic protein at 100-L scale using a cell-free synthesis technology. This milestone for the company triggered $15 million of Series B financing.

The Dow Chemical Company (Midland, MI) completed its acquisition of the specialty materials company Rohm and Haas (Philadelphia, PA). The combined company creates a $14.0-billion diversified business portfolio, which will be called Dow’s Advanced Materials division, according to a Dow press release.

Vetter Pharma-Fertigung GmbH & Co. KG (VPF, Ravensburg, Germany) launched a new subsidiary, Vetter Pharma International GmbH (VPI), on Apr. 1, 2009. VPI is responsible for all Vetter sales, marketing and customer service activities on a worldwide level. Peter Soelkner was named managing director, and Oskar Gold serves as vice-president of the new entity.

Regulatory Roundup

The US Food and Drug Administration issued a new guidance for industry, Q10 Pharmaceutical Quality System, based on the International Conference on Harmonization’s Q10 Guideline. The ICH guideline was approved by all three ICH regions (the US, EU, and Japan) in June 2008 and focuses on how to implement an effective quality management system. The EU published the guidance last July. Read the full guidance.

In other harmonization news, the US Food and Drug Administration issued three guidances on microbial testing of nonsterile products. The guidances, Annexes 6, 7, and 8, are tied to ICH’s Q4B chapter on evaluation and recommendation of pharmacopeial texts covering uniformity of dosage units, dissolution tests, and sterility tests. Read about the guidances on the ICH website. Read FDA’s published Annex guidances (Annex 4A, 4B, and 4C). Note that these annexes to ICH Q4B are still in Step 3 of the harmonization process, regional consultation, and have not yet reached the final approval stage by the US, EU, and Japanese regulatory bodies.

People Notes

Biovail (Toronto), a specialty pharmaceutical company, appointed Rochelle Seide vice-president of intellectual property of Biovail Laboratories International. Seide has more than 23 years of experience as a patent attorney, with the majority of it focused in the life sciences industry.

Jazz Pharmaceuticals (Palo Alto, CA), a specialty pharmaceutical company, announced on Apr. 3, 2009, that Samuel R. Saks, CEO and a member of its board of directors, has resigned from both positions. Saks will serve as a consultant to the company after his departure. The board appointed Bruce C. Cozadd as the new CEO. Cozadd has been the company’s executive chairman and a member of the board of directors since its founding in 2003. Robert M. Myers, Jazz Pharmaceuticals' President, was appointed to the board to fill the vacancy created by Dr. Saks' resignation.

Quintiles Transnational (Research Triangle Park, NC), a contract research organization, appointed Richard Pilnik to serve as president of Innovex, a Quintiles company. Pilnik has 25 years of experience in the pharmaceutical commercial sector, most recently as group vice-president and chief marketing officer at Eli Lilly (Indianapolis).

Takeda Pharmaceutical (Osaka, Japan) reorganized its corporate structure. The company is streamlining executive reporting relationships to Yasuchika Hasegawa, president, by creating corporate-level, center of excellence research and development, commercial, and administrative functions. Effective April 1, 2009, Shigenori Ohkawa became chief scientific officer and Alan MacKenzie became executive vice-president of international operations. A chief administrative officer role will be established. Additionally, the global development headquarter functions will be moved to Takeda’s Deerfield, Illinois, headquarters. More details on the reorganization can be found in the company’s press release.

TransMolecular (Cambridge, MA), a biotechnology company, appointed Robert Radie president and CEO. Additionally, E. Michael Egan, former president and CEO, was promoted to the position of vice-chairman of the board.