August 10, 2006: Company and People Notes

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ePT--the Electronic Newsletter of Pharmaceutical Technology

AstraZeneca, Cambrex, Celsis, Cipher, Dimensione Ricerca

Company Notes

AstraZeneca (London, England, www.astrazeneca.com) announced an exclusive global agreement with Pozen Inc. (Chapel Hill, NC, www.pozen.com) to codevelop fixed-dose combinations of naproxen and esomeprazole for chronic pain, using Pozen's proprietary formulation technology. Under this agreement, AstraZeneca will pay Pozen an upfront fee totaling $40 million. They also will make additional payments if certain development, regulatory, and sales milestones are reached. The development program will be cofunded, with Pozen responsible for the program and regulatory filings in the United States and AstraZeneca taking responsibility for all development activities and regulatory filings outside of the United States as well as worldwide manufacturing, marketing, sales, and distribution.

Celsis International plc (Newmarket, Suffolk, England, www.celsis.com) has acquired In Vitro Technologies, Inc. (IVT, Baltimore, MD, www.invitrotech.com) for $30 million in cash and an earn-out consideration capped at $5 million. The integration of IVT into Celsis will provide customers of both companies with complementary products and services and the expertise of a collective employee base of experienced scientists and client support specialists. In addition, Celsis CEO Jay LeCoque believes that the move has "created clear cross-selling opportunities which we expect to deliver material growth in the coming years."

Dimensione Ricerca S.r.l. (Rome, Italy, www.dr-group.org) and Farma ResaS.r.l. (Cantù, Italy, www.farmaresa.com) have signed a merger agreement that will form the largest CRO in Italy. Both companies have experience in the cardiovascular, oncology, infectiology, neurology, psychiatry, allergology, dermatology, endocrinology, metabolic diseases, haematology, and transplant surgery therapeutic areas. The new corporation will continue full-service drug development to regional and global pharmaceutical companies. It will also offer CGMP-compliant clinical supply management, study drug blinding, packaging, storage, destruction, stability testing, method development, over-encapsulation, and QP release. The merger is expected to be completed by Jan. 1, 2007.

Nektar Therapeutics (San Carlos, CA, www.nektar.com) annouced that it will be closing the Nektar UK site at Bradford, England as part of its ongoing strategy to realign business operations with a focus on product development using its leading drug delivery technologies. Nektar previously deemed the Bradford site to be significantly impaired, resulting in a write-off that was reported as part of the company's 2005 net loss. According to Robert B. Chess, chairman and acting president and CEO of Nektar, the company now hopes to concentrate on developing proprietary products such as "Exubera" insulin inhalation powder that are based on the company's drug delivery technology.

NovaDel Pharma (Flemington, NJ, www.novadel.com) announced the initiation of a clinical trial for its proprietary formulation of zolpidem oral spray, the active ingredient found in the hypnotic "Ambien" product. The trial is designed to evaluate the pharmacokinetic profile of NovaDel's oral spray versus the 10-mg "Ambien" tablet. In a previous pilot pharmacokinetic study conducted by NovaDel for the alpidem oral spray, higher plasma drug concentration levels were observed for the oral spray at the early time points after administration. Thus, the oral spray could shorten "Ambien"'s average time to onset of therapeutic action.

Novartis (Basel, Swizerland, www.novartis.com) sucessfully completed a two-year nationwide mass vaccination campaign in New Zealand based on its MeNZB vaccine. Novartis scientists worked closely with the New Zealand Ministry of Health and drew on earlier work at the Norwegian Institute of Public Health to develop the vaccine to combat an epidemic caused by a specific strain of meningococcal B disease. The campaign, which ran from July 2004 to June 2006, first targeted highest-risk populations such as the indiginous Maori and Pacific communities in the country's northern region. Overall, data from the campaign showed that NeNZB has an 80% efficacy rate in preventing cases of meningococcal B disease.

ONCO Life Sciences (Pune, India) signed a collaboration agreement with SPI USA, Inc. (Baltimore, MD, www.usaspi.com) to collaborate and jointly develop projects and training courses for the biotech and pharmaceutical industries. ONCO, a consultancy company focusing on life sciences, works with a philosophy of collaborations and long-term associations. SPI USA specializes in providing consulting and training services to the pharma and biotech industries.

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People Notes

Gary L. Mossman, executive vice-president, chief operating officer, and president of Cambrex Pharma (East Rutherford, NJ, www.cambrex.com), will retire, effective August 31. Executive Vice-President and Chief Operating Officer of Biopharma Steven M. Klosk then will assume Mossman’s responsibilities. He will report directly to James A. Mack, Cambrex’s chairman, president, and chief executive officer.

Cipher Pharmaceuticals (Mississauga, ON, Canada, www.cipherpharma.com) named Larry Andrews chief executive officer of the company. Andrews will retain his position as Cipher’s president, which he has held since 2004. Before joining Cipher, Andrews founded the Health Alliance Group. Former Chief Executive Officer John Mull will remain chairman of Cipher’s board of directors.

The Instrument Society of America (ISA, Research Triangle Park, NC, www.isa.org) appointed Shari L. S. Worthington as director-elect of its Management Division. Worthington will hold this position through the end of 2007 before becoming director of the Management Division in 2008. Worthington formerly was chair of ISA’s marketing and sales in the management division.

International Specialty Products (ISP, Wayne, NJ, www.ispcorp.com) appointed Dean Ross senior business-development manager of ISP Pharma Technologies. Ross will manage new business-development activities activities for ISP’s new drug solubilization enhancement business in North America. He will report to Tim Bee, senior director of pharmaceuticals and oral care in ISP’s global business unit.

MGI Pharma (Bloomington, MN, www.mgipharma.com),a biopharmaceutical company focused in oncology and acute care, promoted Mary Lynne Hedley, PhD, Eric P. Loukas, Esq., and William F. Spengler as executive vice-presidents. In addition, Hedley was promoted to the position of chief scientific officer. She will oversee MGI’s research, development, pharmacovigilence, and program-management activities. Loukas was appointed chief operating officer, and his responsibilities now include the commercial, manufacturing, and medical-affairs functions. Spengler was promoted to chief financial officer. He retains responsibility for finance, accounting, investor relations, business and corporate development, and administration.