Company and People Notes: Merck to Expand North Carolina Vaccine Facility, PDI's Michael J. Marquard Retires, More...

June 26, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Stiefel Laboratories will acquire Barrier Therapeutics, Danube Pharmaceuticals appoints Brian Levy COO, more...

Company Notes

Edinburgh, UK (June 12)-Angel Biotechnology, a biopharmaceutical contract manufacturer, formed a good manufacturing practices (GMP) manufacturing deal with Novolytics for the manufacture and supply of GMP materials for use in a bacteriophage-based MRSA prophylactic treatment as part of a Phase I–II clinical trial scheduled to begin in 2009. Terms of the contract have not been disclosed.

Austin, TX (June 17)-Appian Labs, a biopharmaceutical company, launched as a new company focused on providing drug deliv­ery and design services for pharmaceutical companies. Appian Labs addresses a number of drug delivery problems, including poor bioavailability or solubility, dose timing, toxicity and many others. The company is funded and managed by venture firm Emergent Technologies, Inc. (ETI) and research is led by Chief Scientist Nicholas Peppas, a pioneer in the field of drug delivery and controlled release chemistry.

Ingelheim, Germany (June 17)-Boehringer Ingelheim formed an agreement to acquire Actimis Pharmaceuticals (San Diego, CA), a privately owned biotechnology company. The acquisition will occur through a structured buyout, in a deal worth up to $515 million, in which Boehringer Ingelheim will acquire shares of Actimis depending on the achievement of several milestones with Actimis’ leading asthma compound “AP768.” If AP768, currently in Phase I clinical development, is advanced into a Phase III, Boehringer Ingelheim will own 100% of Actimis’ shares.

London, UK (June 17)-The European Medicines Agency (EMEA) recommends information on lung cancer cases to be included in “Exubera” (insulin human [rDNA origin]) product information, advising that the information be updated with new information on a total of seven cases of lung cancer seen in patients taking the medicine. The relatively small number of cases and the limited information provided, as well as the fact that they only occurred in patients who had been smokers, did not allow EMEA’s Committee for Medicinal Products for Human Use (CHMP) to establish a causal relationship between the cases of lung cancer and treatment with Exubera. However, as a precautionary measure, the CHMP recommended to update the product information.

Ahmedabad, India (June 20)-The biopharmaceutical company Intas Biopharmaceuticals acquired Biologics Process Development (BPD), a contract research organization based in Poway, California. The agreement is in the final stages of completion, and financial details have not been disclosed. Scott M. Brown will continue as President and chief scientific officer, and Rajeev Datar will be the new chief executive officer of BPD.

Durham, NC (June 20)-Merck will invest $300 million to expand its Durham, North Carolina, vaccine-manufacturing facility and add up to 180 new jobs. The company will use the plant to produce childhood vaccines and an adult vaccine for shingles, and expects the expansion to be completed by 2011.

San Diego, CA (June 18)-PacificGMP and Pacific Biopharma Group (PBG) signed a definitive merger agreement and will develop a current good manufacturing practices (CGMP) biologics contract manufacturing organization in Taizhou, China, called China Quantitative Biomedicine (CQB). Under conditions of the merger agreement, PacificGMP will receive funds to expand its operation in San Diego and assist in the development of the CQB and preparations for FDA and EMEA audits. At approximately 200,000 ft2, CQB will be one of the largest single-use biomanufacturing facilities in the US or China. The new facility will be part of a new biopharmaceutical park called China Medical City, a 12-km2 life sciences park located 2.5 hrs outside of Shanghai. Construction of the facility in Taizhou should be completed in August 2008 with internal work expected to be completed by the end of 2008.

Toronto, Canada (June 18)-Patheon, a provider of contract development and manufacturing services, selected locations in Research Triangle Park and Durham, North Carolina, for its global headquarters and new analytical development laboratory facilities. The company has already selected the location of the new site in Research Triangle Park and will be ready for operation in the next three months. There will be no impact to Patheon’s presence in Ontario, Canada, where it operates four facilities with more than 1500 employees.

Toronto, Canada (June 17)-PharmEng International announced that its wholly owned subsidiary, Keata Pharma, relocated its contract manufacturing operations from its Perth, Canada, facility to its pharmaceutical manufacturing facility in Sydney, Canada. This included existing pharmaceutical supply contracts, manufacturing equipment and personnel. The 46,400 ft2 Sydney facility, designed to meet all CGMP requirements, features offices for PharmEng’s pharmaceutical consulting division, pilot laboratories for formulation development, production rooms with various capabilities such as high shear mixing, container blending and equipment for modified release technologies. The facility provides formulation development and testing services to manufacture and package products in solid and liquid dosage forms. Keata’s long-term goal is to develop capabilities in other dosage forms, such as suppositories, topicals and injectables. The transition to the Sydney facility was completed on May 30, 2008.

Gurgaon, India (June 18)-Ranbaxy Laboratories and Pfizer (Princeton, NJ) announced an agreement that will settle most of the patent litigation worldwide involving the cholesterol-lowering medicine atorvastatin (“Lipitor”). Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of atorvastatin and the fixed-dose combination of atorvastatin-amlodipine besylate in the United States effective Nov. 30, 2011. Ranbaxy was the first generic challenger to the listed Lipitor patents, and it retains the right to the marketing exclusivity of 180 days in the United States. Ranbaxy will also have a license to sell atorvastatin on varying dates in an additional 7 countries, including:  Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia.  Ranbaxy and Pfizer have also resolved their disputes regarding atorvastatin in Malaysia, Brunei, Peru and Vietnam. Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania. Read the full press release for more detail.

Laupheim, Germany (June 20)-Rentschler Biotechnologie, a biopharmaceutical contract manufacturing organization, expanded its capacity by starting operation of a 2500-L multiprocess production suite. The 2,500 L bioreactor can run batch, fed-batch, or perfusion cell culture processes. Protein purification is performed in two suites for pre- and post-virus inactivation, respectively. Rentschler now has nine good manufacturing practices suites with volumes of 30, 250, 500 and 2500 liters, allowing the production of material for clinical trials and for market supply.

Basel, Switzerland (June 24)-Roche successfully completed a tender offer, begun on May 23, that will increase its ownership stake in the biotechnology company Chugai Pharmaceutical (Tokyo, Japan) from 50.1% to 59.9%. Chugai shareholders had the opportunity to tender their shares at a price of Yen 1,730 ($16) per share. The transaction is based on Roche’s right to increase its stake to 59.9% at any time after the 5th anniversary of its alliance with Chugai, which was formed in October 2002.

Paris, France (June 18)-Sanofi-aventis will make a competing bid for all issued and outstanding ordinary shares in the share capital of generics company Zentiva (Prague, Czech Republic) at an offer price of CZK 1,050 ($68) in cash per share. The bid values Zentiva at 40,043 million CZK ($2.6 million) based on 38,136,230 shares issued at the end of 2007. Sanofi-aventis is already established in the various markets where Zentiva operates.

St. Louis (June 19)-Sigma-Aldrich entered into a five-year collaboration to develop optimal cell lines for the production of monoclonal antibodies with scientists at the University of California, San Francisco, who will lead the research into antibodies for a variety of cancer targets, autoimmune diseases, stem cell characteristics and commonly neglected disease targets. Under the terms of the agreement, research targets will be determined by a steering committee, and the university will have free access to the antibodies resulting from the partnership for its ongoing immunology and disease research.

Coral Gables, FL (June 23)-Stiefel Laboratories, a pharmaceutical company focused on dermatology, signed a definitive merger agreement to acquire Barrier Therapeutics (Princeton, NJ), also a pharmaceutical company specializing in dermatology. The agreement outlines a tender offer followed by a merger of Barrier Therapeutics into a wholly owned subsidiary of Stiefel Laboratories, at a price of $4.15 in cash per share of Barrier’s common stock. The transaction, valued at approximately $148 million, is subject to the valid tender of a majority of Barrier’s fully diluted common stock and regulatory approvals, but is not subject to any financing conditions. The companies expect the transaction to close by the end of the third quarter of 2008.

People Notes

New York (June 23)-Danube Pharmaceuticals, a biopharmaceutical company focused on ophthalmology, appointed Brian Levy chief operating officer. Prior to joining Danube, Levy served as corporate vice-president and chief medical officer of Bausch & Lomb worldwide.

Elkton, MD (June 24)-Greg Tronto, business leader for single-use bioprocess components at W.L. Gore & Associates, was named to the Delaware BioScience Association board of directors. The Delaware BioScience Association is a nonprofit trade association formed to advance the growth of the bioscience industry in Delaware and the Mid-Atlantic region.  

King of Prussia, PA (June 23)-MDS Pharma Services, a contract research organization, named Patrice Hugo vice-president of scientific affairs for its global central laboratory network. Hugo will lead the development of biomarkers and assays to enhance clinical development productivity from Phases I–IV.

Saddle River, NJ (June 20)-PDI, a provider of commercialization services to the biopharmaceutical industry, announced the retirement of Michael J. Marquard as chief executive officer and as a member of the board of directors, effective today. While PDI searches for a new CEO, John P. Dugan, chairman of the board, former CEO, and founder of the company, will oversee operations. Jeffrey E. Smith, PDI’s executive vice-president of finance and chief financial officer, has been named interim CEO. James Farrell, vice-president and controller, assumed Smith’s CFO duties on an interim basis.

South San Francisco, CA (June 24)-Portola Pharmaceuticals, a clinical-stage biopharmaceutical company, named Bill Lis vice-president of business and commercial development. Lis will be responsible for the company's corporate partnering activities as well as commercial strategy for its clinical and preclinical programs.