January 11, 2007 Notes: Akorn Signs Development Agreement with Azad, Alkermes and Eli Lilly Form Manufacturing Agreement, more

January 11, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Akorn, Alkermes, Eli Lilly, Cambrex, more

Buffalo Grove, IL (Jan. 9)-Akorn, Inc. (www.akorn.com) signed an agreement with Azad Pharma (Toffen, Switzerland, www.azad.ch) to develop and supply latanoprost, bimatoprost, and travoprost abbreviated new drug application (ANDA)drug products for the treatment of glaucoma. The products will be manufactured by Taejoon Pharmaceutical Co. Ltd., (Seoul, South Korea). Both Taejoon and Azad will complete the regulatory dossiers and will manufacture and supply the products to Akorn upon ANDA approval. Akorn will file and own the ANDAs and will have exclusive marketing and distribution rights for the drug products in the United States and Canada.

Cambridge, MA (Jan. 8)—Alkermes, Inc. (www.alkermes.com) signed a commercial manufacturing agreement with Eli Lilly and Company (Indianapolis, IN, www.lilly.com) for “AIR” inhaled insulin. Under the agreement, Alkermes will manufacture insulin powder for the system. The agreement also provides for an additional investment by Lilly for the construction and operation of a second manufacturing line at Alkermes's commercial-scale production facility. Alkermes would be responsible for overseeing the construction of the manufacturing line, including process development, scale-up, and validation. If inhaled insulin formulations are successfully developed and commercialized, Lilly will purchase product from Alkermes.
 
East Rutherford, NJ (Jan. 4)—Cambrex Corporation (www.cambrex.com) will hold a special meeting of shareholders on Feb. 5, 2007 to vote on the proposal to sell its Bioproducts and Biopharma subsidiaries to Lonza Group AG (Basel, Switzerland, www.lonza.com/group/en.html). Those who were shareholders as of the close of business on Dec. 27, 2006 are entitled to vote on the proposal. The meeting will begin at 2 p.m. at the Sheraton Meadowlands Hotel & Conference Center in East Rutherford.

Plantation, FL (Jan. 9)-DHL (www.dhl.com) formed a multiyear agreement with Wyeth Pharmaceuticals (Madison, NJ, www.wyeth.com) for the logistics coordination of Wyeth's global clinical trial materials distribution. The two companies will jointly create a closed-loop clinical trial materials supply chain to streamline track-and-trace capabilities, financial and performace indicators, and operational process flows. This agreement includes the global distribution by DHL of clinical materials and a framework for warehousing solutions.

Parsippany, NJ (Jan. 3)-DSM Pharmaceuticals (www.dsmpharmaceuticals.com) completed an expansion to its sterile parenteral manufacturing facility in Greenville, North Carolina. The expansion adds a clinical-trial materials manufacturing suite that is capable of manufacturing large- and small-molecule liquid and lyophilized products.

Bridgewater, NJ (Jan. 4)-Enzon Pharmaceuticals, Inc. (www.enzon.com) entered into an agreement with Ovation Pharmaceuticals, Inc. (Deerfield, IL, www.ovationpharma.com) to supply the active ingredient, L-asparaginase, which is used in the production of Enzon's “Oncaspar” treatment for acute lymphoblastic leukemia. The existing supply agreement between the two companies expired Dec. 31, 2006. Under the new agreement, Ovation will supply L-asparaginase material through 2009.

Rockville, MD (Jan. 10)-“As a precaution,” the US Food and Drug Administration (www.fda.gov) is recommending that sponsors of new drug applications and abbreviated new drug applications re-evaluate pharmacokinetic (PK) studies performed for them by two Canadian laboratories owned by MDS Pharma Services (MDS, King of Prussia, PA, www.mdsps.com). At the Wednesday press conference announcing the move, FDA's Joseph Famulare, deputy direcor of the Office of Compliance at the Center for Drug Evaluation and Research, stressed that though inspections “raised questions about the validity and accuracy” of PK test results, the agency has no reason to suspect that the drugs concerned are not safe and effective. (For the FDA statement, see www.fda.gov/cder/news/pharmaco_studies/default.htm.)

South San Francisco, CA (Jan. 8)Genentech (www.gene.com) entered into an exclusive worldwide license agreement with Seattle Genetics, Inc. (Bothell, WA, www.seattlegenetics.com) for the development and commercialization of the humanized monoclonal antibody SGN-40. SGN-40 is currently in clinical trials for multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin's lymphoma. Seattle Genetics will receive an upfront payment of $60 million as well as potential milestone payments exceeding $800 million and royalties on annual net sales of SGN-40. Genentech will fund future research, development, manufacturing, and commercialization costs.

Aurora, ON, Canada (Jan. 5)-Helix BioPharma Corp (www.helixbiopharma.com) signed an agreement with BioVectra (Charlottetown, PEI, Canada, www.biovectra.com) to manufacture L-DOS47 bulk drug product for clinical testing in patients with adenocarcinoma of the lung. According to Helix's vice-president of corporate development, John Docherty, BioVectra was chosen because it is “one of the largest North American producers of the urease substance at the heart of the L-DOS47 product.”

Toronto (Jan. 5)—IntelliPharmaCeutics Corp. (www.intellipharmaceutics.com) concluded an agreement with Par Pharmaceutical Companies, Inc. (Woodcliff Lake, NJ, www.parpharm.com) to develop a generic, controlled-release drug product for the US market. Par will submit the abbreviated new drug application to the US Food and Drug Administration (www.fda.gov) and will provide regulatory and legal support for the application. Both companies will share in the net profits from sales of the resulting products, and Par will retain US marketing rights.

Brisbane, CA (Jan. 9)-InterMune, Inc. (www.intermune.com) completed large-scale synthesis and delivery to its partner Roche (Basel, Switzerland, www.roche.com) of an active pharmaceutical ingredient for drug candidate ITMN-191. As a result, InterMune received a $10-million milestone payment from Roche.

Pasadena, CA (Dec. 14)-Materia, Inc. (www.materia-inc.com) granted a nonexclusive license for its metathesis platform to Merck & Co., Inc. (Whitehouse Station, NJ, www.merck.com) to use in the discovery and development of pharmaceuticals. Metathesis catalysts enable the formation and manipulation of carbon-carbon bonds in the synthesis of new pharmaceutical products and in the development of new, more efficient, and low-cost production processes for existing products.

Pittsburgh, PA (Jan. 8)-Mylan Laboratories Inc. (www.mylan.com) has completed its acquisition of approximately 51.5% of Matrix Laboratories Limited's (Hyderabad, India, www.matrixlabsindia.com) outstanding shares. Mylan has agreed to pay Rs 306 (approximately $6.90) per share. Mylan now controls more than 75% of the voting share capital of Matrix.

Bethesda, MD (Jan. 5)-Parenteral Drug Association (PDA, www.pda.org) and United States Pharmacopeia (USP, Rockville, MD, www.usp.org) are offering a joint conference dealing with the effects the new USP General Chapter <467> about residual solvents will have on the pharmaceutical and excipient industry. The conference will take place Jan. 18 and 19 in Bethesda and is designed to help excipient producers better understand the new USP General Chapter and how implementation will affect them and their pharmaceutical customers.

Castres, France (Jan. 8)-Pierre Fabre (www.pierre-fabre.com) acquired UCB's (Brussels, Belgium, www.ucb-group.com) over-the-counter business in France, Benelux, Switzerland, and Greece. The transaction includes brand-name drugs such as “Carbolevure,” “Revitalose,” “Balsoclase,” and “Toclase.” UCB will continue to manufacture and supply some of the transferred products during a transitional period. In addition, the two companies have entered into a distribution agreement under which Pierre Fabre will market UCB's antihistamine “ZyrtecSet” in France.

Windsor, ON, Canada (Jan. 9)-The Qualicaps Group (www.qualicaps.com), a supplier of empty two-piece gelatin and non-gelatin capsules, signed an agreement to acquire empty gelatin capsule manufacturer Pharmaphil (Windsor, ON, Canada www.pharmaphil.ca). The transaction, subject to final due diligence and customary regulatory clearances, is expected to close within the next few days.

Morton Grove, IL (Jan. 6)-Regis Technologies, Inc. (www.registech.com) added supercritical fluid chromatography (SFC) to its separations services and will offer GMP separations starting April 1, 2007. Regis will offer SFC as a stand-alone service or in concert with its GMP manufacturing.

London (Jan. 9)-SkyePharma PLC (www.skyepharma.com) plans to sell its injectable business to Blue Acquisition Corp. for more than $82 million. The total includes an initial payment of $20 million and up to $62 million in milestone payments, plus a percentage of sales on certain future products.

Brisbane, CA (Jan. 5)-VaxGen (www.vaxgen.com) announced plans to cut 51% of its work force as part of its restructuring efforts following the federal government's cancellation of an $877.5-million contract to develop an anthrax vaccine. The company hopes to cut its monthly expenditures in half, and it has already substantially downsized its manufacturing and quality assurance/quality control functions.

Kalamazoo, MI (Dec. 26)-Western Michigan University Foundation (www.wmich.edu/foundation) has withdrawn a purchase agreement with Pfizer, Inc. (New York, NY, www.pfizer.com) to acquire Pfizer's downtown Kalamazoo facility known as Building 126. The facility, which was slated for purchase at the end of 2006 for $3.8 million, has annual operating costs of $1.5–$2 million, which the university deemed too expensive.

People Notes

Dallas, TX (Jan. 8)Access Pharmaceuticals, Inc. (www.accesspharma.com) appointed Stephen R. Seiler president and CEO. Seiler previously served as acting CEO of Effective Pharmaceuticals, Inc. and as CEO of Hybridon, Inc.

Alexandria, VA (Jan. 2)-The Association for Operations Management (APICS, www.apics.org) elected Joseph F. Shedlawski president of its board of directors. Shedlawski is principal of commercial operations at Wyeth Consumer Healthcare. He has been a member of the northern New Jersey chapter of APICS for more than 21 years and served as the chapter's president in 1991.
 
San Carlos, CA (Jan. 8)Howard R. Robin was appointed president and CEO of Nektar Therapeutics (www.nektar.com). Robin was previously president and CEO of Sirna Therapeutics and also held positions at Berlex Laboratories.

Tarrytown, NY (Jan. 8)-Progenics Pharmaceuticals, Inc. (www.progenics.com) named Walter M. Capone vice-president of commercial development and operations. Capone previously worked for Trimeris, Inc, where he was senior vice-president of commercial operations.