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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...
Sunnyvale, CA (July 30)-American Peptide Company, a manufacturer of peptides and peptide conjugates, and its parent company, Ito Life Sciences (Ibaraki, Japan), will be acquired by Otsuka Chemical Company (Osaka, Japan), part of the Otsuka Group. Otsuka Chemical will be the new owner of American Peptide Company and Ito Life Sciences Shanghai, both subsidiaries of Ito Life Sciences, beginning September 1, 2008. Ito Life Sciences is currently owned by Itoham Foods.
San Francisco, CA (July 31)-Bilcare Global Clinical Supplies, a provider of clinical trial services, opened its new global US headquarters in San Francisco, California. The headquarters will be led by CEO Vito Mangiardi. The opening marks the latest development in the company’s recent growth: in the past year the company has nearly doubled its workforce; completed a $2.3-million capital investment program in the US; expanded its facility in Rajgurunagar, near Pune, India; and is planning $21-million towards a new clinical supplies facility in South Wales.
Washington, DC (July 31)-A bill was introduced in Congress to create a federal "academic detailing" program that would provide unbiased information about prescription drugs to physicians. The bill was sponsored by US Senate Special Committee on Aging Chairman Herb Kohl (D-WI), Senate Majority Whip Dick Durbin (D-IL), Senate Committee on Health, Education, Labor, and Pensions Chairman Ted Kennedy (D-MA), Senator Bob Casey (D-PA), House Committee on Oversight and Government Reform Chairman Henry Waxman (D-CA), and House Energy and Commerce Subcommittee on Health Chairman Frank Pallone (D-NJ). In a press release posted on the website of the Committee on Aging, one reason for the bill is that “pharmaceutical sales representatives are one of the only ways doctors learn about new drugs on the market, and evidence has shown that interaction with them can impact doctors’ prescribing patterns.” The bill calls for grants to produce the unbiased, educational materials on prescription drugs for doctors, and it also allows for grants that would send trained medical staff to visit doctors’ offices to distribute the information.
Hillsboro, OR (Aug. 4)-FEI Company, a provider of high-resolution imaging and analysis systems, and Max Planck Institute of Biochemistry (Martinsried, Germany), a biochemical research institution, will collaborate on a new microscopy method that enables scientists to quickly and easily acquire high-resolution transmission electron microscope (TEM) images of molecular entities found using optical microscopy techniques. Initial shipments are expected in the fourth quarter of 2008.
Hong Kong, China (July 21)-The International Pharmaceutical Excipients Council of America (IPEC–Americas) announced in its July newsletter that IPEC Association (China) Limited received its certificate of incorporation from the Hong Kong Register of Companies on July 21, 2008. The affiliate, which will be known as IPEC China internally, becomes the fourth IPEC association worldwide, joining IPEC–Americas (1991), IPEC Europe (1992), and JPEC (1993). Among IPEC China’s initial goals will be to translate existing published IPEC guidance into Chinese and to work with China's State Food and Drug Association officials to present an excipient-control-strategy seminar at the November ChinaPharm Conference that will be attended by government and industry representatives.
Cambridge, MA (July 31)-Javelin Pharmaceuticals, a specialty pharmaceutical company, agreed to expand its commercial supply relationship with Baxter Healthcare. The new agreement relates to “Dyloject” (diclofenac sodium injection), Javelin's proprietary injectable diclofenac product currently marketed in the United Kingdom and in the second of two pivotal trials in the United States, for acute post-operative pain. The agreement provides additional manufacturing capacity for Dyloject and builds on the existing manufacturing agreement executed between Javelin and Baxter for the United States.
Solna, Sweden (Aug. 4)-Meda, a specialty pharmaceutical company, signed an agreement to acquire the specialty pharmaceutical company Valeant’s (Aliso Viejo, CA) pharmaceutical business in Western and Eastern Europe, including Russia, for $392 million. Meda will gain Valeant’s subsidiaries and the rights to all products and licenses in the divested region. Valeant’s Central European businesses, which include Poland, Hungary, Slovakia and Czech Republic, are excluded from this transaction.
Houston, TX (August 1)-Solvay Chemicals, the international chemicals group, introduced its “Soda Ash IPH,” a pharmaceutical grade of soda ash, to the North American market. Long a leading sodium carbonate-based excipient in Europe, Soda Ash IPH is a suitable material proposed for the manufacture of effervescent formulations. The white, crystalline-powdered excipient is manufactured in facilities that comply with current good manufacturing practices (CGMP) according to the ICH Q7A standard; and the sodium carbonate meets the specifications of the USP 31–NF 26 standard for pharmaceutical ingredients.
Leeds, UK (Aug. 1)-The University of Leeds launched the Institute of Process Research and Development (iPRD), an organization designed to connect university research with commercial needs for applied innovation in fine chemicals, notably pharmaceuticals. The group, made up of teams from School of Chemistry, the School of Process, Environmental and Materials Engineering, and companies from across the pharmaceutical, agrochemical, and fine chemicals sectors, will study issues of chemical manufacturing, from route design to catalysis, process development, purification and waste management, with a focus on delivering lower cost, cleaner and more sustainable products.
Hafnarfjordur, Iceland (Aug. 5)-Sigurdur Oli Olafsson was named as the new chief executive officer (CEO) of Actavis Group, a pharmaceutical company focused on generics. Olafsson is the former deputy CEO. Olafsson succeeds Robert Wessman, who stepped down as the chief executive officer to pursue other interests. Wessman will continue to serve on the Actavis board of directors.
Pittsburgh, PA (Aug. 5)-Bayer announced today that Claudio Abreu will become president and CEO of Bayer Business and Technology Services (BBTS) LLC, effective October 1, 2008. He will assume this role in addition to his current responsibilities as head of Bayer Business Services in North America and global head of IT operations. The functions that currently operate within the US legal entity Bayer Corporate and Business Services LLC will transition to the new US legal entity BBTS LLC, effective October 1.
On July 31, the board of Bayer announced that Greg Babe will become president and CEO of Bayer Corporation and the senior Bayer representative in North America. Babe succeeds Attila Molnar, who will retire from the company after 30 years of service, effective October 1, 2008. Babe will also maintain his role as president and CEO of Bayer MaterialScience LLC, a producer of polymers and high-performance plastics, and a part of the global Bayer MaterialScience business.
Somerset, NJ (Aug. 1)-Catalent Pharma Solutions appointed George L. Fotiades interim president and CEO of Catalent, effective immediately. Fotiades succeeds John W. Lowry, who is leaving Catalent to pursue other opportunities. Lowry will assist Fotiades during the leadership transition.
Branford, CT (Aug. 5)-Marinus Pharmaceuticals, a privately held specialty pharmaceutical company, appointed John Krayacich as president and CEO. Krayacich will be responsible for leading the company's drug and business development for ganaxolone, an adult and pediatric epilepsy candidate in Phase II, and chelerythrine, a preclinical schizophrenia candidate.
Gaithersburg, MD (Aug. 5)-Panacea Pharmaceuticals, a privately held biopharmaceutical company, appointed Suzanne Sensabaugh as vice-president of regulatory affairs. Sensabaugh will assume responsibility for formulating strategies and managing all US and foreign regulatory filings for the company's products.
St. Louis, MO (Aug. 5)-SAFC, a member of the Sigma-Aldrich Group, appointed Tom Beil vice-president of quality and regulatory affairs, effective July 21, 2008. Beil will report to SAFC President Frank Wicks and to Rich Keffer, general counsel and secretary for Sigma-Aldrich Corporation.