November 9, 2006 Company and People Notes: Akorn Adds Two Drugs to Sharing Agreement with Natco, Biovitrum Enters Manufacturing Agreement with Resistentia, More

November 9, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Akorn, Natco, Illumigen, Avecia

Company Notes

Buffalo Grove, IL (No.v 2)-Two injectable drug products have been added to the API supply and margin sharing agreement between Akorn, Inc. (www.akorn.com) and Natco Pharma Limited (Hyderabad, India, www.natcopharma.co.in). The two products are designed to relieve chemotherapy-related nausea and vomiting. Under the agreement, Natco will supply the active pharmaceutical ingredients for the drug products and Akorn will be responsible for manufacturing, regulatory submissions, marketing, and distribution in the United States and Canada.

Tees Valley, UK (Oct. 31)-Avecia (www.avecia.com) has entered into an agreement with Illumigen Biosciences Inc. (Seattle, WA, www.illumigen.com) for the process development and manufacture of Ilumigen's product IB657 to treat Hepatitis C and other RNA viruses. Under the terms of the agreement, Avecia will develop the drug manufacturing process and conduct initial manufacture of IB657 to provide Illumigen with sufficient quantities to complete Phase 1a clinical trials.

Stockholm, Sweden (Nov. 8)-Biovitrum (www.biovitrum.com) has entered into an agreement with Resistentia (Uppsala, Sweden, www.resistentia.se) to develop and manufacture Resistentia's RES 08 allergy treatment. Biovitrum will develop the existing process for manufacturing RES 08 so that it meets the standards for a clinical phase III trial. In addition, Biovitrum will manufacture the substance for the trial. The project will commence in November 2006 and is expected to run more than two years.

San Antonio, TX (Nov. 3)-DPT Laboratories, Ltd. (www.dptlabs.com) officially opened its new research, development, manufacturing, and distribution facilities during an opening ceremony that coincided with the American Association of Pharmaceutical Scientists (AAPS) convention in San Antonio. The $24 million, 258,000 ft2 facility will allow DPT to expand its formulation development and analytical chemistry capabilities and includes manufacturing processes,. quality control labs, areas to store raw materials and finished goods, and worldwide product distribution.

Leiden, The Netherlands (Nov. 8)-Crucell, N.V. (www.crucell.com) and its technology partner DSM Biologics (Parsippany, NJ, www.dsmbiologics.com) have jointly opened the Percivia Per.C6 Development Center in Cambridge, Massachusetts. The center was conceived and designed to further develop the Per.C6 cell line and to provide solutions to for the production of pharmaceutical proteins to those licensees utilizing Per.C6. DSM has already signed a biopharmaceutical manufacturing agreement based on the Per.C6 manufacturing platform with UMN Pharma (Akita, Japan, www.umnpharma.com). Under the agreement, DSM will provide full process and analytical development services and cGMP manufacturing batches for UMN's UMN-03 fusion protein for the treatment of muscular dystrophy and metabolic diseases.

Cambridge, MA (Nov. 7)-Genzyme Corporation (www.genzyme.com) has completed its tender offer to acquire all outstanding shares of AnorMED for $13.50 per share, totaling approximately $584 million. Genzyme has acquired about 41.5 million shares, 96% of shares outstanding. Genzyme has now acquired and plans to commercialize AnorMED's "Mozobil," a late-stage product candidate in development for hematopoietic stem cell transplantation.

San Diego, CA (Nov. 8)-Inovio Biomedical Corporation (www.inovio.com) has formed a $64.5-million nonexclusive licensing deal with Wyeth Pharmaceuticals (Madison, NJ, www.wyeth.com) that gives Wyeth the rights to use Inovio's "MedPulser" electroporation delivery technology in DNA vaccines. Under the terms of the arrangement, Wyeth will pay $4.5 million up front plus annual license maintenance fees, research support, and up to $60 million in possible milestone payments.

Basel, Switzerland (Nov. 6)-Novartis (www.novartis.com) plans to create a new biomedical R&D center in Shanghai. The work at the center will be primarily focused on infectious causes of cancer endemic to China and Asia. A 5000-m2 start-up facility is expected to open in May 2007, and construction of a permanent 38000-m2 facility for approximately 400 scientists will begin in July 2007. The design and construction of both facilities is expected to cost USD $100 million.

Jerusalem, Israel (Nov. 2)-Oramed Pharmaceuticals, Inc. (www.oramedpharma.com) signed a manufacturing agreement with Swiss Caps AG (Kirchburg, Switzerland, www.swisscaps.com). Swiss Caps will provide Oramed with gel capsules for upcoming Phase I clinical trials. Swiss Caps has agreed to a straight equity exchange rather than a cash payment for its services.

Toronto, ON, Canada (Nov. 6)-Orbus Pharma Inc. (www.orbus.ca) and its partner in drug development, Alfred E. Tiefenbacher GmbH & Co., KG (AET, Hamburg, Germany, www.tiefenbacher.com) have entered into an agreement with Desitin Arzneimittel GmbH (Hamburg, Germany, www.desitinpharma.com) to allow Desitin to utilize Orbus's immediate-release tablets containing oxcarbazepine. Desitin will be permitted to use oxcarbazepine to obtain marketing authorizations throughout the European Unioin and in Switzerland, Romania, Norway, Turkey, and Iceland. Orbus will manufacture the product for sales within those countries.

New York, NY (Nov. 7)-Pfizer Inc. (www.pfizer.com) has ceased operations at its Augusta, Georgia facility. The factory’s equipment is being liquidated and will be sold at a public auction in late January 2007. Coastal Xethanol are the new owners of the factory and will produce ethanol biofuels at the site (See “Pfizer to Sell Georgia Manufacturing Plant to Xethanol,” Pharmaceutical Technology ePT, May 25, 2006). The liquidation will continue until the end of the year. Rabin Worldwide, will conduct the auction in Georgia and online at www.rabin.com.

Berlin, Germany (Nov. 8)-Shering AG (www.schering.de) has been given the green light to be integrated into the Bayer Group (Leverkusen, Germany, www.bayer.com). The new Bayer Schering GmbH is offering Shering's outside stockholders EUR 89.36 (approximately USD $114.10) per share, which is the weighted average price of Schering stock over the three-month period preceding the September 13, 2006 Extraordinary Stockholders' Meeting.

San Diego, CA (Nov. 7)-Vical Incorporated (www.vical.com) has entered into an agreement with Bioject Medical Technologies Inc. (Portland, OR, www.bioject.com) for an option to license Bioject's needle-free technology for use with some of Vical's DNA-based vaccines. Vical will pay an up-front fee to Bioject and will make additional payments to extend the option term and license additional targets. Additional payments will also be made upon the achievement of specific milestones.

Corona, CA (Nov. 6)-Watson Pharmaceuticals, Inc. (www.watsonpharm.com) has completed its acquisition of Andrx Corporation (Fort Lauderdale, FL). The purchase price was approximately $1.9 billion, and Andrx stockholders will receive $25.00 in cash.

Berkeley, CA (Nov. 7)-Xoma Ltd. (www.xoma.com) has been designated as a subcontractor under a prime contract between SRI International (SRI, Menlo Park, CA, www.sri.com) and the National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www.niaid.nih.gov). The subcontract will run 5 years and could reach $28.1 million. Under the subcontract, XOMA would manufacture monoclonal antibody therapeutic agents for NIAID.

New York, NY (Nov. 6)-Ziopharm Oncology, Inc. (www.ziopharm.com) has signed a difinitive agreement to acquire synthetic anti-cancer agent "Indibulin" from Baxter Healthcare Corporation (Deerfield, IL, www.baxter.com). The oral form of the drug is currently in phase I trial. As part of the agreement, Ziopharm has acquired the existing supply of Indibulin manufactured by Baxter and has assumed responsibility for the drug's phase I trial.

People Notes

Denver, CO (Nov. 6)-ARCA Discovery, Inc. has appointed Richard B. Brewer president and CEO. Brewer, a 30-year veteran of the biotechnology industry, joins the company from Cres Asset Management, where he provided guidance and invested in promising biotechnology opportunities. He also spent more than 10 years at Genentech in various mangement positions.

Gribbstown, NJ (Nov. 2)-Meiken Krebs has been promoted to president and CEO of EMD Chemicals Inc. (www.emdchemicals.com), the North American specialty-chemical extension of Merck KGaA (Darmstadt, Germany, www.merck.de). Krebs joined Merck in 2003 as vice-president of corporate auditing and risk management.

Rockville, MD (Nov. 2)-The US Food and Drug Administration (www.fda.gov) announced that Stephen Mason, the former director of government relations for the Generic Pharmaceutical Association, will be joining FDA as a senior advisor in the office of legislation. In this capacity, he will work on various issues pending before Congress, including generic drug legislation.

Lake Forest, IL (Oct. 31)-Hospira, Inc. (www.hospira.com) announced that Roger W. Hale has been elected to the company's board of directors. Hale is the retired chairman and chief executive officer of LG&E Engergy Corporation.

Tucson, AZ (Nov. 6)-The board of directors of ImaRx Therapeutics, Inc. (www.imarx.com) has promoted Bradford A. Zakes to the position of president and chief executive officer. Zakes previously served as the company's chief operating officer.

Princeton, NJ (Nov. 6)-Irwin Lerner has been named Medarex, Inc.'s (www.medarex.com) interim president and chief executive officer. Lerner, who has served as the company's chairman of the board since 1997, replaces Donald L. Drakeman, who resigned from the board and from his position as president and chief executive officer. Drakeman will remain with the company as a consultant until March 2007 to assist with the transition to new leadership.