Oct. 26 Notes: Lilly Completes Phase 1 of Expansion, Luciano Packaging and SSI Collaborate on New Track-and-Trace Technology, Merck Enters into Agreement with Glenmark, and more

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Applied Biosystems, Aptuit, Barr, Bioenvision, Bioject, Bionomics, Charles Ross, Connetics, Curalogic, Cytogen, Doxa, Eli Lilly, FDA, Imclone, Laureate, Luciano Packaging, Microtest, Orexo, PLIVA, SAFC, Sanofi-Aventis, SSCI, SSI, Stiefel, Teva

Company Notes


Greenwich, CT (Oct. 26)-Aptuit, Inc. (www.aptuit.com) signed an agreement to acquire SSCI, Inc. (www.ssci-inc.com), a leading solid-state chemistry company focused on the crystallization, characterization, and chemistry of solid materials. The acquisition will enable Aptuit to leverage SSCI's expertise in solid-state pharmaceutical product development to broaden its service offering for customers. The acquisition is expected to close within 30 days. Financial terms were not disclosed.

Hauppauge, NY (Oct. 26)-Charles Ross & Son Company (www.mixers.com) completed its manufacturing plant expansion in Wuxi, China. The expansion adds nearly 20,000 ft2 to the existing building. The plant manufactures several Ross products including high-speed dispersers, dual- and triple-shaft mixers, planetary mixers, discharge systems, pressure vessels, tanks, and other fabricated equipment. Ross equipment built at these locations is primarily intended for sales in China and in other the East Asian markets.

Palo Alto, CA (Oct. 23)-Connetics Corporation (www.connetics.com), a specialty pharmaceutical company that develops and commercializes dermatology products, signed a definitive merger agreement with Stiefel Laboratories, Inc. (Coral Gables, FL, www.stiefel.com) a company specializing in dermatology. Holders of Connetics's common stock will receive $17.50 per share in cash, with an aggregate value of approximately $640 million. The transaction is expected to close in late 2006 or early 2007.

Indianapolis, IN (Oct. 23)-Eli Lilly and Company (www.lilly.com) completed the first phase of a $560-million expansion to its biotech facility in Indianapolis. The investment is part of a $1-billion effort to strengthen and build the company's biotechnology drug research and development capabilities. Company officials dedicated a bioproducts pilot manufacturing plant that will help the company bring biotech medicines to market through more efficient, productive, and dependable manufacturing processes. The company also announced the opening of a research support facility, into which 700 scientists, engineers, and support staff will relocate.

Princeton, NJ (Oct. 25)-Laureate Pharma, Inc. (www.laureatepharma.com) renewed its agreement with Cytogen Corporation (www.cytogen.com) for the CGMP manufacture of Cytogen's "ProstaScint" monoclonal antibody immunoconjugate which is used for imaging in patients diagnosed with prostate cancer. Under the agreement, Laureate will provide CGMP protein production, purification, conjugation of Cytogen's proprietary linker chelator, and aseptic filling services to support Cytogen's commercial ProstaScint requirements. Terms of the agreement were not disclosed.

Somerville, NJ (Oct. 24)-Luciano Packaging Technologies, Inc. (www.lucianopackaging.com) and Secure Symbology, Inc. (SSI, Wayne, NJ, www.securesymbology.com) collaborated on a new barcode-based, track-and-trace technology that can be read by existing retail scanners to verify product authenticity through the Internet. SSI's data-management technology and secure server is used to track and trace pharmaceutical packages from the manufacturing to the retail level. Luciano Packaging developed a primary carton-printing system integrated with the SSI software and network communications to enable on-line printing and data gathering at speeds of 250 cartons/min. A system was tested and validated at a Cardinal Health facility. Luciano Packaging will display the system at the upcoming Pack Expo meeting in Chicago.

Agawam, MA (Oct. 19)-MicroTest (www.microtestlabs.com) expanded its contract parenteral-manufacturing services with a $7.5-million capital improvement program at its Agawam, Massachusetts headquarters facilities and laboratories. MicroTest’s expanded contract manufacturing facilities include a dedicated aseptic processing suites, in-process and release testing of final drug products, automated labeling, and aqueous- and oil-based product handling.

Uppsala, Sweden (Oct. 24)-Orexo (www.orexo.com) and medical technology company Doxa (www.doxa.se) will collaborate to develop new pharmaceuticals based on a drug delivery technology for the slow and controlled release of active ingredients. The initial objective is to develop an improved pain treatment. The companies believe Doxa’s expertise in bioactive ceramics will enable new, innovative administration forms.


Woodcliff Lake, NJ (Oct. 24)-Barr Pharmaceuticals, Inc.'s (www.barrlabs.com) European subsidiary finalized the legal and regulatory requirements to acquire PLIVA (Zagreb, Croatia, www.pliva.com). Under the terms of Barr’s formal $2.5-billion cash tender offer, Barr made a payment of HRK 820 per share for all shares tendered during the offer period. The transaction closed with 17,056,977 shares being tendered as part of the process, representing 92% of PLIVA’s total share capital being tendered to Barr. With the addition of the treasury shares held by PLIVA, Barr now owns or controls in excess of 95% of PLIVA’s voting share capital. The combination of Barr Pharmaceuticals and PLIVA creates the third largest global generic pharmaceutical company, based on revenue.

St. Louis, MO (Oct. 24)-SAFC, a member of the Sigma-Aldrich Group (www.sigma-aldrich.com), announced that its SAFC Pharma business segment was appointed by biotech company Curalogic A/S (Copenhagen, Denmark www.curalogic.com) to provide protein isolation, extraction, and purification services in connection with the development of allergy products. SAFC chemists working at the existing St. Louis protein purification and extraction facility will begin the initial phases of the project in which they will determine a suitable process for producing sufficient quantities of CGMP material for future clinical trials and commercial launch of these products. Subsequent phases of the Curalogic project will be transferred into SAFC’s new CGMP protein extraction and purification facility after its scheduled completion in April 2007. In other news, Bionomics Limited (Thebarton, Australia www.bionomics.com.au) and SAFC Pharma signed a manufacturing contract to produce 1.5 kg of BNC105, Bionomics’s lead cancer compound. This material will be used to complete preclinical trials and for Phase I/IIa clinical trials of BNC105.

Paris (Oct. 25)-The commercial subsidiary of Sanofi-Aventis (http://en.sanofi-aventis.com) in France presented a reorganization plan to its joint consultative committee that would cut 399 positions in its sales force and 105 jobs from the headquarters structure of its French affiliate. Sanofi-Aventis says the plan remains within the scope of Sanofi-Aventis France and concerns neither the industrial sites or the research and development activities of Sanofi-Aventis in France.

People Notes

Foster City, CA (Oct. 20)-Applied Biosystems (www.appliedbiosystems.com), an Applera Corporation business, announced that its president, Catherine M. Burzik, resigned from her position. Tony L. White, chairman, president, and chief executive of Applera, will become interim president, partnering with the Applied Biosystems leadership team. The changes are effective immediately.

New York, NY (Oct 24)-Bioenvision, Inc. (www.bioenvision.com), a developer of anticancer therapeutics, announced that MaryJane Rafii, PhD, joined the company as vice-president of regulatory affairs. Rafii brings to Bioenvision more than 12 years of pharmaceutical and biotechnology industry experience and has held positions at the Ludwig Institute for Cancer Research, Sankyo USA, and Escalon Ophthalmics.

Portland, OR (Oct. 20)-Needle-free drug delivery specialist Bioject Medical Technologies (www.bioject.com) announced that Jim O'Shea will retire as president, chief executive office, and director on Dec. 31, 2006. Effective Oct. 20, O'Shea resigned as chairman and Jerald S. Cobbs, Bioject's lead director and chair of the Nominating Committee, was elected Chairman.

New York, NY (Oct. 25)-ImClone Systems Inc. (www.imclone.com) announced that its Board of Directors has appointed Carl C. Icahn chairman of the Board. The company also announced that Joseph L. Fischer resigned as interim chief executive officer and as a member of the Board of Directors. He has been replaced by a newly formed Executive Committee of the Board, which will be chaired by Alex Denner, PhD, and will include Directors Richard Mulligan, PhD, and Charles Woler, MD, PhD. The committee will serve as the principal executive body for the company until a chief executive officer is named.

Rockville, MD (Oct. 23)-The US Food and Drug Administration (www.fda.gov) promoted three senior agency scientists and physicians to members of the Commissioned Corps of the US Public Health Service. Rear Admiral Linda Tollefson, DVM, was promoted to rear admiral, upper half (0-8, two-star), and Captains Paul J. Seligman, MD, and Sandra L. Kweder, MD, were each promoted to rear admiral, lower half (0-7, one-star). Tollefson is the assistant FDA commissioner for science. She directs FDA's Offices of Women's Health and Orphan Products Development, and chairs the Research in Human Subjects Committee, FDA's Institutional Review Board. Seligman is the associate director for safety policy and communication in the Center for Drug Evaluation and Research (CDER). He directs the program responsible for FDA's Drug Safety Board and the MedWatch Program, and plays a central role in safety and communications initiatives affecting regulated drugs. Kweder is the deputy director of CDER's Office of New Drugs (OND). She is involved in all OND drug oversight activities and oversees the Pediatric and Maternal Health staff and the Study Endpoints and Labeling Development staff. FDA also selected Julie Beitz for the position of director of the Office of Drug Evaluation III. Beitz has had a 12-year career at FDA involving both pre- and postapproval regulatory activities.  

Jerusalem, Israel (Oct. 18)-Teva Pharmaceutical Industries Ltd.'s (www.tevapharm.com) president and CEO, Israel Makov, announced his plans to retire from the company in 2007. Shlomo Yanai will join the company as president and CEO-designate during the first part of 2007. Makov will continue to work with Teva as a senior strategic advisor to the company for the next two years and, during the transition period.