Company and People Notes: Ratiopharm Up for Sale; Sutro Biopharma Appoints CEO, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Bristol-Myers Squibb forms collaboration with ZymoGenetics, Hana Biosciences appoints VP of regulatory affairs, more...

Company Notes

Abbott Park, Illinois (Jan. 12)-Abbott will acquire the ophthalmic-care company Advanced Medical Optics (AMO, Santa Ana, CA) for $22 per share in cash, for a total transaction value of approximately $2.8 billion, inclusive of estimated net debt at the time of closing. AMO comprises three segments: cataract surgery, laser-vision correction (LASIK), and eye-care products.

Rouses Point, NY (Jan. 6)-Akrimax Pharmaceuticals, a specialty pharmaceutical company focused on diseases related to metabolic syndrome, announced a manufacturing agreement for the production of pharmaceutical products for a global company beginning in 2009. Akrimax was selected from several potential partners. Akrimax was formed in 2007 and purchased the Rouses Point, New York, plant from Wyeth in January 2008.

Craigavon, UK (Jan. 7)-Almac Clinical Technologies, a division of the Almac Group, added 6,000 ft2 of space at its Yardley, Pennsylvania, headquarters. The company expects this expansion will accommodate growth until the move to its new headquarters in Lansdale, Pennsylvania, in 2010.

Princeton, NJ (Jan. 12)-Bristol-Myers Squibb (BMS) and ZymoGenetics, (Seattle, WA) formed a collaboration for PEG-Interferon lambda, a type 3 interferon currently in Phase Ib development for the treatment of Hepatitis C, and its related development program. Under the terms of the collaboration, BMS will pay ZymoGenetics an upfront cash payment of $85 million for the development and commercialization rights to PEG-Interferon lambda, and will pay an additional license fee of $20 million in 2009. ZymoGenetics could receive additional milestone-based payments of up to more than $1 billion: possibly receiving payments of up to $430 million in development and regulatory milestones for PEG-Interferon lambda in Hepatitis C, up to $287 million in development and regulatory milestones for other potential indications, and up to $285 million in sales-based milestones.

Leiden, The Netherlands (Jan. 7)-The biopharmaceutical company Crucell confirmed that it is in “friendly discussions” with Wyeth (Madison, NJ) that may lead to a combination of the two companies, according to a company press release. 

Tokyo (Jan. 15)-Daiichi Sankyo will take a 358-billion-yen (about $3.9-billion) write-down following its acquisition of Ranbaxy Laboratories. The write-down reflects more than a 50% decline in the market value of Ranbaxy stock versus the purchase price.

Indianapolis (Jan. 14)-Eli Lilly is reported to be close to a $1.4-billion settlement on charges that it illegally marketed its antipsychotic drug Zyprexa (olanzapine), according to an article by the New York Times. Lilly's alleged marketing practices urged doctors to use the drug in two populations, children and the elderly, for which the drug was not approved.

Chadds Ford, PA (Jan. 5)-Endo Pharmaceuticals and Indevus Pharmaceuticals (Lexington, MA) entered into a merger agreement, under which Endo will commence a tender offer to acquire 100% of the outstanding shares of Indevus in cash for approximately $370 million, or $4.50 per Indevus share, and up to an additional approximately $267 million, or $3 per Indevus share, payable in the future upon achievement of certain regulatory and sales milestones. The transaction was approved by the boards of directors of both companies.

Whippany, NJ (Jan. 6)-Halo Pharmaceutical, a specialty pharmaceutical company, acquired a manufacturing and research facility from Abbott (Abbott Park, IL). The facility contains more than 200,000 ft2 of space for manufacturing and warehousing capabilities including formulation services, operations for the aseptic filling of topical ointments, solid dosage forms, liquids, suppositories, associated packaging, and laboratory space for formulation development, preclinical and clinical supplies, and support of commercial operations.

Toronto, Canada (Jan. 9)-Patheon, a provider of contract development and manufacturing services, announced that its special committee of independent directors, which was created by its board of directors to review a proposed unsolicited offer from JLL Patheon Holdings, has engaged independent advisors to assist it in evaluating the JLL offer. The special committee will make recommendations to the board of directors and shareholders about what actions, if any, they should take in response to the JLL offer. The special committee is working with BMO Capital Markets as an independent financial advisor, Goldman, Sachs & Co. as a financial advisor, and the committee retained Davies Ward Phillips & Vineberg as legal counsel.

New York (Jan. 14)-According to a report by the Wall Street Journal, Pfizer is planning to lay off up to 800 researchers by the end of 2009. This represents 8% of its worldwide research staff.

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Ulm, Germany (Jan. 8)-The European generics company Ratiopharm was put up for sale. On Jan. 8, 2009, owner Adolf Merckle committed suicide because of financial problems with Ratiopharm and the Merckle family’s other companies, according to a Ratiopharm press release.

Haninge, Sweden (Jan. 9)-Recipharm, a contract development and manufacturing organization, and Laboratoires Fournier (Chenove, France), a subsidiary of Solvay Pharmaceuticals (Weesp, The Netherlands), entered into an agreement with regard to the Fontaine-Lès-Dijon, France, site. Under the agreement, Recipharm will acquire the site from Laboratoires Fournier for an undisclosed sum. The site, comprising a tablet and capsule manufacturing facility and logistics center, formally changed ownership on Dec. 31, 2008. The entire workforce was retained by Recipharm.

Atlanta, GA (Jan. 6)-UPS was selected by Merck & Co., Inc. (Whitehouse Station, NJ) to manage a significant portion of its US distribution of pharmaceuticals and vaccines as well as to provide package-transportation services through its subsidiary, UPS Supply Chain Solutions. UPS will manage two key Merck distribution centers, located in suburban Atlanta, Georgia, and Reno, Nevada, which provide Merck with temperature-sensitive storage, packaging, and transportation services for its pharmaceutical and vaccine products. The majority of Merck's US vaccines and pharmaceutical volume flow through these two CGMP-compliant centers. 

Rockville, MD (Jan. 15)-The US Food and Drug Administration has extended the comment period for its draft guidance, Process Validation: General Principles and Practices until Feb. 20, 2009.


People notes

Albany, NY (Jan. 12)-AMRI appointed Dr. Guo head of quality and analytical services. Guo will oversee all domestic analytical chemistry, preformulation and formulation, quality assurance and regulatory affairs efforts, including support related to early stage discovery and preclinical development, as well as the manufacturing of clinical trial materials, intermediates, and commercial active pharmaceutical ingredients. Guo fills the role vacated by Steven Hagen, who was promoted to vice-president of pharmaceutical development and manufacturing in September 2008.

Dublin, CA (Jan. 13)-Eksigent, a developer of analytical systems with microfluids for high throughput chromatography, appointed Remco van Soest to the vice-president level within the company. Van Soest continues to be responsible for product management.

South San Francisco, CA (Jan. 12)-Hana Biosciences, a biopharmaceutical company focused on cancer care, appointed Thomas J. Tarlow vice-president of regulatory affairs and quality. Tarlow will be responsible for the development and implementation of regulatory strategies and quality systems as well as managing all US and foreign regulatory filings for the company's product candidates.

Ittigen, Switzerland (Jan. 12)-Pevion Biotech appointed Thomas P. Stauffer CEO of the company, effective January 1, 2009. Before his appointment, Stauffer served as COO of Pevion. Stauffer succeeds Peter Klein as CEO.

South San Francisco, CA (Jan. 12)-Sutro Biopharma, formerly known as Fundamental Applied Biology, appointed William J. Newell CEO of the company. Daniel S. Gold, the company’s previous CEO, becomes president and COO. Sutro Biopharma is a biopharmaceutical company focused on the controlled synthesis of protein biotherapeutics.