August 17, 2006: Company and People Notes

August 17, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Auriga, Balchem, Generex, ImClone, Intranasal Therapeutics, MedImmune, Schering

Company Notes

Auriga Laboratories, Inc. (Norcross, GA, www.aurigalabs.com) and Balchem Corporation (New Hampton, NY, www.balchem.com) will codevelop a set of combination medicines in the rapid-dissolve format. Balchem will provide its “Pharmashure” taste-making technology for Auriga to use in its prescription pain products. Auriga’s CEO, Philip Pesin, says that the taste-making technology will also be used for the company’s respiratory franchise in the future.

Generex Biotechnology (Toronto, ON, Canada, www.generex.com) launched its new “Glucose RapidSpray” product in the United States at the American Association of Diabetes Educators 33rd Annual Meeting & Exhibition, held in Los Angeles August 9-12. The spray, which will be sold over the counter, delivers glucose directly into the mouth, where it is quickly absorbed. It was developed using the company’s buccal drug-delivery technologies.

The board of directors of ImClone Systems Incorporated (New York, NY, www.imclone.com) has decided that the company will remain independent. The decision comes after the board’s review of the company’s strategic alternatives. According to interim chief executive officer Joseph L. Fischer, the board concluded that the alternatives, which included bids received for the acquisition of the company, “did not match the value potential of ImClone Systems as an independent company.”

Intranasal Therapeutics (ITI, Lexington, KY and Montvale, NJ, www.intranasal.com) closed a $39.1-million financing commitment from a sydicate of venture investors. The money will be used to launch the company’s proprietary hydromorphone nasal spray for acute pain and to expand ITI’s manufacturing facility in Lexington, Kentucky.

Lannett Company, Inc. (Philadelphia, PA, www.lannett.com) announced that it plans to lease, with an option to purchase, a new 65,000 square-foot facility located on seven acres in the city of Philadelphia. The facility will be used as the company’s main warehouse for products and as its future headquarters. It will allow Lannett to more than double its manufacturing capacity and expand its pharamceutical development capability. The five-year lease begins September 1.

MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com) submitted its response to the Complete Response Letter (CRL) received from US Food and Drug Administration for the cold-adapted influenza vaccine, trivalent (CAIV-T). FDA had requested clarification and additional information about the data MedImmune had submitted in its supplemental biologics license application. MedImmune is seeking approval to switch formulations from frozen “FluMist,” which is currently approved for use in healthy individuals aged five to 49 years, to the refrigerator-stable CAIV-T formulation.

RPG Life Sciences (Maharashtra, India, www.rpglifesciences.com) announced plans to open a biotech unit in Thane, India. The facility would be one of the few US Food and Drug Administration-compliant biopharmaceutical plants in India, says the company. The initial investment is set at Rs15 crore to Rs 20 crore (approximately 3.2–4.3 million USD). The investment will be scaled up in the next two or three phases. In addition, the company reported that its manufacturing plant in Ankleshwar, Gujarat, India will soon be made FDA compliant.

Sigma-Aldrich Corporation (SAFC, St. Louis, MO, www.sigma-aldrich.com) has acquired Pharmorphix Limited (Cambridge, England, www.pharmorphix.com), a provider of solid-form research services. The addition of Pharmorphix is expected to broaden SAFC’s manufacturing services customer base and enhance the technology services it offers to existing customers. It also will enhance SAFC’s capacity to manufacture active pharamceutical ingredients and complement SAFC’s existing API development and production sites.

People Notes

Altus Pharmaceuticals, Inc. (Cambridge, MA, www.altus.com) has appointed John M. Sorvillo, PhD to the position of vice-president of business development. He will be responsible for establishing partnerships for the company’s late-stage products and seeking development collaborations for its early-stage and preclinical programs. Sorvillo’s past experience includes positions at ArQule and OSI Pharmaceuticals.

Larry Hsu, PhD, president of IMPAX Laboratories (Hayward, CA, www.impaxlabs.com), will assume the additional position of chief executive officer on Oct. 1, 2006. He will replace Barry R. Edwards, who plans to serve as a special consultant to the company through October 2008.

MedImmune (Gaithersburg, MD, www.medimmune.com) has promoted Ed Mathers to the position of executive vice-president of corporate development and venture. In this position, he will be responsible for the company’s licensing and business development activities. Mathers joined the company in 2002. Previously, he held positions at Glaxo Wellcome, Inc. and Ortho Pharmaceuticals.

Pfizer (New York, NY, www.pfizer.com) CEO Jeffery Kindler announced that Vice-Chairman David Shedlarz will be assuming expanded responsibilities, which include Pfizer global manufacturing and worldwide strategic planning, licensing, and business development and technology. He will be applying technology across the company in an effort to improve productivity and help develop new products and services. In addition, Kindler announced that Vice-Chairman Karen Katen will be leaving the company, although she plans to provide advice and leadership over the next several months in areas such as Pfizer Health Solutions and Pfizer Healthy Directions.

Schering-Plough (Kenilworth, NJ, www.schering-plough.com) announced the appointment of Trevor Juniper as general manager, Schering-Plough China for its Shanghai-based pharmaceutical business. Juniper joined the company in 2003 and served as senior director, regional marketing, primary care, Asia-Pacific region. He also provided leadership to the Schering-Plough Merck joint venture in the Asia region and other business-development initatives.

Dennis Goldberg, PhD, has been appointed chief executive officer of Transport Pharmaceuticals (Framingham, MA, www.transportpharma.com). Goldberg has served as president and chief operating officer of Transport since 2004.

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