Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More

Company notes

Cambridge, MA and Carlsbad, CA (Sept. 7)-Alnylam Pharmaceuticals and Isis Pharmaceuticals launched Regulus Therapeutics LLC, a joint venture focused on the discovery, development, and commercialization of microRNA (miRNA) therapeutics. Regulus will combine the strengths and assets of Isis’ and Alnylam’s technologies, intellectual property and leadership.

Hayward, CA and Lenexa, KS (Sept. 6)-Aradigm and CyDex entered into a two-year collaboration agreement for the development and commercialization of combination products containing inhaled corticosteroids, anticholinergics, and beta-2 agonists for the treatment of asthma and chronic obstructive pulmonary diseases.

Deerfield, IL (Sept. 10)-Baxter International and Halozyme Therapeutics (San Diego, CA) agreed to apply Halozyme’s proprietary “Enhanze” technology to the development of a subcutaneous route of administration for Baxter’s “GAMMAGARD LIQUID 10%” [Immune Globulin Intravenous (Human)] (IGIV) (known as “KIOVIG” in Europe). Under the terms of the agreement, Baxter will provide Halozyme an initial upfront payment of $10 million. Pending successful completion of a series of regulatory and sales milestones, Baxter may make further milestone payments totaling $37 million to Halozyme. Baxter also will assume development, manufacturing, clinical, regulatory, sales and marketing costs. Halozyme will be responsible for the supply of the recombinant human hyaluronidase (rHuPH20) enzyme that provides the basis for Enhanze Technology. Upon regulatory approval, Halozyme will also receive royalties on GAMMAGARD LIQUID 10% administered subcutaneously using Enhanze Technology both in kits and in coformulations.

Mississauga, ON, Canada (Sept. 5)-DRAXIS Pharma, the contract manufacturing division of DRAXIS Health, expanded its existing contract manufacturing relationship with Johnson & Johnson Consumer Companies (New Brunswick, NJ). DRAXIS Pharma has entered into a definitive supply agreement to provide commercial manufacturing services for a broad portfolio of multiple nonsterile specialty semi-solid products. The new multi-year contract runs to the end of 2013. It includes approximately two years of manufacturing site transfer and process validation activities followed by five years of commercial production, which is scheduled to begin in 2009.

St. Paul, MN (Sept. 10)-GelStat Corporation, a company that develops and markets over-the-counter products, signed a five-year deal with Icarus Medical Industries (Surra, Kuwait) to distribute GelStat’s products throughout the Middle East.

Whippany, NJ (Sept 6)-Image Solutions, a provider of submissions solutions, process services, and consulting agreed to terms to acquire Zurich Biostatistics (Morristown, NJ). With the Life Sciences industry moving to standards-based regulatory submissions, the acquisition strengthens ISI’s Clinical Data Interchange Standards Consortium (CDISC) capabilities, the FDA-supported standard for clinical trials data and metadata.

West Haven, CT (Sept. 10)-NanoViricides signed a letter of agreement with the Pharmaceutical and Life Science Group (PLSG) at Grubb & Ellis/BRE Commercial (G&E/BRE), a commercial real estate organization headquartered in Chicago, Illinois. The PLSG will help NanoViricides develop manufacturing operations and address the needs of NanoViricides’ nanomedicine pharmaceutical facility requirements.

Princeton, NJ (Sept. 6)-Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), received approval from the US Food and Drug Administration to manufacture and market carvedilol tablets, 3.125 mg, 6.25 mg, 12.5, and 25 mg, a beta blocker used to treat heart failure. The Office of Generic Drugs, FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug “Coreg” tablets of GlaxoSmithKline (London).

Cranbury, NJ (Sept 10)-Systech International, a company focused on packaging execution systems, announced that its Serialized Product Tracking (SPT) application was successfully implemented by Purdue Pharma (Stamford, CT) to provide the key commercial infrastructure needed to expand GEN 2 RFID tagging of “OxyContin” tablets. Systech’s software enables Purdue to verify product authenticity throughout the pharmaceutical supply chain.

Blue Bell, PA (Sept. 10)-VGX Pharmaceuticals was awarded a contract from the Defense Threat Reduction Agency (Alexandria, VA) to develop VGX’s constant current electroporation technology for intradermal delivery of DNA vaccines and therapeutics. The contract is for $1.9 million over 12 months. Under the contract, VGX will work to demonstrate in vivo efficacy of novel vaccines derived from DNA plasmid-based pox virus antigens delivered using a skin micro-electroporation system.

People Notes

Baltimore (Sept. 7)-Alba Therapeutics Corporation appointed Betsy Van Parijs, PhD, to senior vice-president of clinical development and medical affairs. Van Parijs will also serve as a member of Alba’s executive management leadership team.

Berkeley Heights, NJ and Raleigh, NC (Sept. 10)-Clinsys Clinical Research, a clinical research organization, appointed Rajagopalan Srinivasan, PhD, as vice-president of global biostatistics.

Leiden, The Netherlands (Sept. 10)-Dutch biotechnology company Crucell named Cees de Jong as chief operating officer. De Jong will also serve as a member of Crucell’s management committee.

Los Angeles (Sept. 12)-CytRx Corporation, a biopharmaceutical company, appointed Mitchell K. Fogelman as chief financial officer, effective immediately, replacing Matthew Natalizio, who plans to pursue other opportunities.

Bethesda, MD (Sept. 12)-Micromet, a biopharmaceutical company named Mark Reisenauer as senior vice-president and chief commercial officer.

Vancouver (Sept. 12)-Response Biomedical named S. Wayne Kay as chief executive officer. Kay was also appointed to the company’s board of directors.