May 24, 2007 Notes: AAI Acquires Brazilian CRO, Biovail Investigated by SEC, Pall Opens Center of Excellence, more

May 24, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

AAI, AstraZeneca, Biovail, West, more

Company Notes

Wilmington, NC (May 17)-AAI Pharma (www.aaipharma.com) completed its acquisition of the Brazilian contract research organization Instituto de Pesquisa Clinica de São Paulo, Ltd. The terms of the transaction were not disclosed.

Albany, NY (May 21)-Albany Molecular Research, Inc. (AMRI, www.albmolecular.com) will acquire two pharmaceutical manufacturing sites and additional land for future expansion in Aurangabad and Navi Mumbai, India. AMRI will acquire facilities, employees, products, and equipment from Ariane Orgachem Pvt. Ltd. (Aurangabad, India, www.arianeorgachem.com) and Ferico Laboratories Ltd. (Navi Mumbai, India). The facilities currently manufacture pharmaceutical intermediates and bulk active ingredients. AMRI plans to invest approximately $15 million to expand its capabilities in India over the next three years. The land and facilities were acquired for approximately $11 million. The deal is expected to close in the second or third quarter of 2007.

London (May 18)-AstraZeneca (www.astrazeneca.com) received approval from the US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) for "Seroquel XR" extended-release tablets. Seroquel is a once-daily medicine for the treatment of schizophrenia.

Toronto (May 14)-Biovail Corp. (www.biovail.com) and two of its executives received "Wells Notices" from the US Securities and Exchange Commission (SEC, Washington, DC, www.sec.gov). The notices relate to SEC's investigation of Biovail's accounting and disclosure practices for the fiscal year 2003 and certain transactions associated with a coprorate entity Biovail acquired in 2002. The company's chairman, Eugene Melnyk, and its senior vice-president and chief financial officer, Kenneth Howling, also received Wells Notices. Biovail's former financial officer and one other current company executive also are expected to receive notices.

Los Angeles, CA (May 21)-CytRx Corp. (www.cytrx.com) announced plans to expand its research and development of therapeutic products and open a new research and development facility. The company hopes to explore products based on its orally administered molecular chaperone amplification technology and broaden its focus beyond the treatment of diseases related to the central nervous system CytRx also will open a new facility in San Diego to provide it with a dedicated laboratory to accelerate its molecular-chaperone drug-development programs. In addition, CytRx will transfer its research facilities in Worcester, Massachusetts to RXi (Worcester).

Rockville, MD (May 21)-The US Food and Drug Administration (FDA, www.fda.gov) issued a safety alert for "Avandia," a drug approved for the treatment of Type 2 diabetes. A recent study indicates that Avandia may increase the risk of heart attacks and heart-related deaths in patients. The evidence, however, is contradictory, so FDA is not asking GlaxoSmithKline (London, www.gsk.com), the drug's manufacturer, to take any specific action. In response to the study's findings, Rep. Henry A. Waxman (D-CA), chairman of the committee on oversight and government reform, called a hearing for June 6, 2007 to explore FDA's role in evaluating Avandia's safety. Witnesses who have been invited to testify include FDA Commissioner Andrew C. von Eschenbach and Dr. Jean-Pierre Garnier, chief executive officer of GlaxoSmithKline.

Pasadena, CA (May 22)-Jacobs Engineering Group Inc. (www.jacobs.com) will provide engineering and construction services for Genentech Inc.'s (South San Francisco, CA, www.gene.com) new manufacturing facility in Tuas, Singapore. The facility will manufacture bulk "Lucentis" for the treatment of wet age-related macular degeneration.

Basel, Switzerland (May 16)-Lonza (www.lonza.com) announced its strategy for strengthening its postiion as a custom manufacturer. The company will consolidate all microbial activities in the US in Hopkinton, Massachusetts and invest more than $30 million in the Hopkinton site to support microbial process development and manufacturing growth plans. The current commercial operations and biopharma service activities in Baltimore, Maryland will continue to operate until early 2008 to ensure a sufficient supply of commerical products currently manufactured in Baltimore and to ensure a fully compliant technology transfer to Hopkinton. The development of the Hopkinton site is expected to create up to 250 additional positions, some of which will be offered to employees affected by the closure of the Baltimore site.

Cambridge, MA (May 17)-Molecular Insight Pharmaceuticals, Inc. (www.molecularinsight.com) will acquire a commercial-scale radiopharmaceutical manufacturing facility in Denton, Texas for $3 million. The facility is currently owned by NeoRx Manufacturing Group, Inc. and contains more than 80,000 square feet of pharmaceutical manufacturing, warehouse, cleanroom, and administrative office space.

Exton, PA (May 21)-Morphotek, Inc. (www.morphotek.com) will provide CMC Biopharmaceuticals (Copenhagen, Denmark, www.cmcbiopharmaceuticals.com) with development, GMP manufacturing, and regulatory support for MORAb-028, a cancer-targeting therapeutic antibody. Morphotek already has developed this antibody and established a process for large-scale production. MORAb-028 is expected to begin clinical trials in 2008.

East Hills, NY (May 16)-Pall Corp. (www.pall.com) opened its newest Life Sciences Center of Excellence in Bangalore, India. The center will drive process optimization innovations for the life sciences market. It includes a proteomics laboratory to help customers speed the drug-discovery process, a validation laboratory, and a training facility.

Shanghai (May 22)-Contract research organizations Sundia MediTech Co., Ltd. (www.sundia.com), United PharmaTech Ltd., and HD Biosciences Co., Ltd. (www.hdbiosciences.com) joined to form a contract research organization service alliance (CROSA). The CROSA will use the companies' specialized expertise to provide CRO services for drug discovery and development. It will be located in Shanghai's Zhangjiang HiTech Park.

Singapore (May 22)-West Pharmaceutical Services, Inc. (www.westpharma.com) is investing approximately $29.4 million to expand its facility in Singapore. The expansion, which is expected to be completed in 2010, will add manufacturing capacity for West's premium product technologies for pharmaceutical and medical device components. West expects the expansion to increase its production in Singapore by 30% and create over 100 new jobs.

Geneva, Switzerland (May 23)-The World Health Organization (WHO, www.who.int) will provide Thailand with a $2-million grant to help the country establish a pilot facility for the production of pandemic flu vaccine. Under the terms of the agreement, 10% of the doses Thailand manufactures will be reserved for purchase by UN agencies for use in developing countries in case of a pandemic.

People Notes

Thousand Oaks, CA (May 22)-Amgen (www.amgen.com) confirmed David Lacey as senior vice-president, head of research. Lacey has acted as interim head of research for the past year. He joined the company in 1994 as associate medical director in the department of experimental pathology.

South San Francisco, CA (May 23)-Anesiva, Inc. (www.anesiva.com) named Yvonne Richardson vice-president of manufacturing and Shaun Comfort director of clinical research. Richardson joins the company from Bayer Healthcare, where she was responsible for the project-management office and strategic projects for the company's hematology business. She previously served in manufacturing capacities at Hospira, Inc. and Abbott Laboratories. Comfort was associate director central nervous system and analgesics research and development at Johnson & Johnson Pharmaceutical Research and Development. He also was a medical officer with the US Food and Drug Administration's division of therapeutic-biologic internal-medicine products and the division of anesthetics, critical care, and addiction drug products.

Princeton, NJ (May 16)-Braham Shroot, PhD, was named chief scientific officer of Barrier Therapeutics, Inc. (www.barriertherapeutics.com). Shroot previously was chief scientific officer andvice-president of research and development with DFB Pharmaceuticals. He also has held positions with Galderma Reserach and Pfizer.

Irving, TX (May 21)-Carlton E. Turner, PhD, president and chief executive officer of Carrington Laboratories, Inc. (www.carringtonlabs.com) will retire on December 31, 2008.

Los Angeles, CA (May 22)-CytRx Corp. (www.cytrx.com) named Shi Chung Ng, PhD, senior vice-president of research and development. He will be based in the company's planned facility in San Diego, California, which is scheduled to open in the third quarter of 2007. Ng joins the company from Ligand Pharmaceuticals, where he was vice-president of molecular oncology. He also has held positions at Arqule Inc., Abbott Laboratories, Pfizer, and Bristol-Myers Squibb Corp. CytRx also announced that Mark Tepper, senior vice-president of drug discovery, will be leaving the company. Tepper will continue working with CytRx as a consultant for the next few months.

Cambridge, MA (May 15)-Mark Benjamin was named president and chief executive officer of Galenea Corp. (www.galenea.com). Benjamin previously was chief business officer of Jura Inc. Earlier in his career, Benjamin was vice-president of global business development for Manteia SA and senior business development executive of Rosetta Inpharmatics.

Los Altos, CA (May 21)-InteKrin Therapeutics, Inc. (www.intekrin.com) appointed Linda Slanec Higgins, PhD, vice-president of preclinical research and development. Higgins will be responsible for the biology and early-stage development of the company's pipeline products. She joins InteKrin after serving as head of research at Scios, Inc.

Whitehouse Station, NJ (May 20)-Peter Loescher, president of global human health at Merck & Co., Inc. (www.merck.com) announced his resignation, effective July 1, 2007. Loescher will take the position of president and chief executive officer of Siemens AG.

San Diego, CA (May 22)-Mpex Pharmaceuticals, Inc. (www.mpexpharma.com) named Daniel D. Burgess chief executive officer. Burgess joins the company from Hollis-Eden, where he was chief operating officer and chief financial officer. He also has held positions at Nanogen and Gensia Sicor, Inc.

New York (May 20)-John LaMattina, president of Pfizer Global Reserach and Development (www.pfizer.com) will retire at the end of the year. The company has initiated a search for a replacement, and LaMattina has agreed to remain with the company until a replacement is found. In addition, the company's chief financial officer, Alan Levin, resigned to pursue other opportunities.

Union City, CA (May 21)-Questcor Pharmaceuticals, Inc.'s (www.questcor.com) president and chief executive officer, James Fares, is leaving the company. Don M. Bailey, a member of Questcor's board of directors, was appointed interim president. The board is conducting a search for a permanent chief executive officer.

Blythewood, SC (Apr. 26)-Pat Tillisch was promoted to US president and general manager of Spirax Sarco Inc. (www.spiraxsarco.com/us). He will assume his new responsibilities on June 1, 2007. Tillisch joined Spriax in 1986 and most recently served as vice-president of sales.

San Diego, CA (May 22)-Victory Pharma, Inc. (www.victorypharma.com) named Shawn A. Scranton vice-president of scientific operations. Scranton joins the company from Kalypsys, Inc., where he was senior director of translational medicine. He also held the position of director of clinical development and program director of the SDX101 program with Salmedix, Inc.