Company and People Notes: Akorn Enters Supply Agreement, Vernalis Makes Changes to Senior Management Positions, More

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Genmab will acquire PDL Pharma's Minnesota manufacturing facility, DSM Pharmaceuticals appointed Hans Engels president and business unit director, more...

Company Notes

Buffalo Grove, IL (Feb. 14)-Akorn announced that it entered a five-year contract manufacturing and supply pact with a major US pharmaceutical company for an ophthamlic drug product. The company’s Somerset, New Jersey, facility will manufacture the product, which Akorn expects to launch mid-year.

Irving, TX (Feb. 25)-Carrington Laboratories, biopharmaceutical and consumer products company, signed a supply agreement with Universal Harvest of Nevada in which Carrington will provide Universal Harvest with product development, manufacturing and packaging services. Carrington’s Costa Rican subsidiary Sabila Industrial will be involved in manufacturing the finished product for international users, and product included in the agreement will contain a proprietary raw material from Sabila Industrial.

New York and Haikou, China (Feb. 25)-China Pharma Holdings, a manufacturer of generic and branded biopharmaceutical products in China, announced it received new purchase orders from one of its main distributors for its product “Pusen OK,” a generic version of “Aleve-D.” The orders total approximately $5.6 million and are expected to be fulfilled this year.

San Diego, CA (Feb. 25)-Cypress Bioscience will acquire San Diego-based Proprius Pharmaceuticals, a privately held specialty pharmaceutical company, in a transaction that includes an upfront payment of $37.5 million in cash. The agreement also includes an additional $37.5 million in potential milestone payments for the development of Proprius’ therapeutic candidates.

Foster City, CA (Feb. 21)-Entelos, a company building predictive computer models for drug discovery and development, signed an agreement with PDL Biopharma (Redwood City, CA) to use Entelos’ technology to conduct in silico research and “virtual clinical trials” for PDL. The research is expected to take two months and is focused on identifying primary endpoints, patient types, and optimal doses for one of PDL’s antibody development programs.

Copenhagen, Denmark (Feb. 21)-Genmab will acquire PDL Biopharma’s (Redwood City, CA) antibody manufacturing facility located in Brooklyn Park, Minnesota, for $240 million in cash. The facility has a production capacity of 22,000 liters, and features two 1,000-liter and two 10,000-liter bioreactors, and the transaction also includes land, equipment, and access to a leased space with a development lab. Genmab plans to retain the approximately 170 employees currently working at the manufacturing facility. Under a clinical supply agreement, Genmab will produce clinical material to supply some of PDL’s investigational studies of its pipeline products.

New York (Feb. 20)-Pfizer will acquire Encysive Pharmaceuticals (Houston, TX), a publicly held biopharmaceutical company, through a cash tender offer for all shares of Encysive for $2.35 per share, representing an approximate total of $195 million. Pfizer will gain the rights to “Thelin” (sitaxsentan sodium), a product for the treatment of pulmonary arterial hypertension (PAH). Thelin is commercially available in much of the European Union and is approved in other markets. Pfizer plans to conduct a Phase III trial to support registration in the US, where Thelin has received three approvable letters from the US Food and Drug Administration.

In other Pfizer news, the Court of Appeal of The Hague in the Netherlands upheld Pfizer’s basic patent covering atorvastatin, the active ingredient in Lipitor. The decision means Ranbaxy is unable to launch a generic version of the drug before Lipitor’s basic patent (EP 247,633) expires in November 2011. Ranbaxy can seek to appeal the decision to the Supreme Court of the Netherlands.

Nottingham, UK (Feb. 20)-Upperton, a biotechnology company specializing in spray drying and particle technologies, will collaborate with Novozymes (Bagsvaerd, Denmark) for commercializing the companies’ jointly-owned “rP-nano” technology, a targeted drug delivery system that uses the natural binding properties of recombinant protein nanoparticles to enhance drug and gene bioavailability. The rP-nano technology can produce nanoparticles from peptides and proteins, including monoclonal antibodies and enzymes, without denaturation. Under the terms of the agreement, Upperton will use rP-nano technology to generate nanoparticles from recombinant proteins expressed in Novozymes’ proprietary, yeast-based expression system. The rP-nano technology can generate nanoparticles of  10–120 nm and be optimized for permeability and retention, according to Upperton. The nanoparticles produced through this process retain the natural binding properties of the recombinant proteins from which they are made and bind to specific cell types to enable more targeted drug delivery and improved bioavailability, according to the company.

Winnersh, UK (Feb. 20)-Vernalis made an early settlement on a $56-million loan due to Endo Pharmaceuticals. The loan was originally due for repayment in August 2009. The company also announced restructuring plans, including a reduction in workforce from 210 to about 90 employees and reorganization of senior management (see People Notes below). According to a company release, the early loan settlement and the restructuring were triggered by FDA’s recent nonapproval of the company’s supplementary NDA submission for its product “Frova” for the treatment of menstrual migraine.


People Notes

Cranford, NJ (Feb. 25)-Akrimax Pharmaceuticals, a privately-held, fully-integrated emerging specialty pharmaceutical company, appointed Alan L. Rubino as its new president.

Bloomington, IN (Feb. 20)-Fred Larimore, PhD, was named vice-president of scientific affairs and chief scientific officer for Cook Pharmica, the contract biopharmaceutical manufacturing division of Cook Medical.

Parsippany, NJ (Feb. 20)-DSM Pharmaceuticals, a business unit of DSM Pharmaceutical Products, appointed Hans Engels president and business unit director of DSM Pharmaceuticals. Engels joined DSM in 2000, and most recently served as the chief operating officer of DSM Pharmaceutical Products. He will continue to be based out of the Greenville, North Carolina, facility.

Berkeley, CA (Feb. 25)-Dynavax Technologies appointed Martin E. Sanders executive vice-president and chief development officer. He will direct Dynavax’s product development programs. Sanders joins Dynavax from Palingen, a biopharmaceutical company, where he served as president and chief executive officer from 2004 to 2007.

Los Angeles (Feb. 21)-ImmunoCellular Therapeutics (IMUC) announced that Manish Singh, PhD, will be the company’s new president and chief executive officer. Prior to joining IMUC, Singh was a director of California Technology Ventures (Pasadena, CA), a venture capital firm from June 2003 to December 2007. He also acted as the interim CEO of Aliva Biopharmaceuticals, a human monoclonal antibody production company.

Cambridge, MA (Feb. 25)-Metabolix, a biosciences company, appointed Richard P. Eno president and chief executive officer, effective March 17, 2008. Eno is replacing Jay Kouba, PhD, who has served as the company’s chairman, president and CEO since May 2007 while the company searched for a new CEO. Kouba will remain as chairman of the board.

Nottingham, UK (Feb. 22)-Molecular Profiles, a contract research organization, appointed Mike Fanfarillo as operations director and Robert Sherry as associate director in pharmaceutics.

Toronto, Canada (Feb. 19)-Patheon made changes to the roles of several company executives. Nick DiPietro will relinquish his responsibilities as president and chief operating officer of Patheon and will assume a new role as executive vice-president of corporate development effective March 1, 2008. Clive Bennett, currently president of Patheon USA, will assume a new role as chief technical officer effective March 1, 2008. Both Bennett and DiPietro will report to Wes Wheeler, chief executive officer. Steve Liberty is appointed senior vice-president of cperations, Canada and USA.  Liberty will report to Terence Novak, who joined Patheon on February 18, 2008 as president of North American operations and chief marketing officer.

Winnersh, UK (Feb. 20)-Vernalis, a specialty biopharmaceutical company, announced changes in its management organization in conjunction with restructuring plans for the company. Simon Sturge will step down as chief executive officer and a director of the company at the end of this month, by mutual agreement with the board. John Slater was appointed chief operating officer, effective immediately. In addition to his existing responsibilities, the research and new product development functions will report to him for all operational matters. Tony Weir will continue as chief financial officer. All will report directly to Dr. Peter Fellner, executive chairman, who will oversee the scientific and clinical elements of research and development programs.