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 Replacement diaphragms offer durability and traceability
NewFlo replacement diaphragms from Newman Sanitary Gasket (Lebanon, OH) are intended to provide tight seals and long service. The facing of the two-piece diaphragms is made from a modified fluoropolymer that has high steam resistance and flex life. In third-party testing, the diaphragms withstood 500 steam cycles and more than 100,000 valve cycles, according to Rick Schroder, the company’s chemist and engineering manager. The units’ durability and flex life help increase the time between maintenance cycles, thus reducing maintenance costs and downtime.
Newman’s proprietary marking system molded into the diaphragms lists manufacturer name and part number, diaphragm material types, lot number, and month and year of manufacture. In addition, Newman provides the standard traceability paperwork for each diaphragm. The company also controls all materials and processes it uses to make the diaphragms. The controls include a final 100% in-house inspection of all parts. The diaphragms are appropriate for steam service, water-for-injection, and processing areas.
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Aptuit (Greenwich, CT) will acquire GlaxoSmithKline’s (GSK, London) Medicines Research Center in Verona, Italy. The facility’s staff will continue their employment, and Aptuit will supply GSK with research and development services from the facilities. Financial terms were not disclosed.
Arena Pharmaceuticals (San Diego, CA) and Eisai (Woodcliff Lake, NJ) formed a marketing and supply pact that will allow Eisai to market lorcaserin for obesity and weight management in the United States following approval from the US Food and Drug Administration. Arena will receive an upfront payment of $50 million, up to $90 million in milestone payments, and more than 30% of product sales.
Judge Joseph Farnan, Jr., US District Court, District of Delaware, has found that the substance patent protecting AstraZeneca’s (London) Crestor (rosuvastatin calcium) is valid and enforceable. AstraZeneca and patent owner Shionogi (Osaka, Japan) filed patent-infringement suits against eight manufacturers who had challenged the substance patent. The Crestor patent expires in 2016.
BASF (Ludwigshafen, Germany) reorganized its fine-chemicals operations, merging its Swiss group companies BASF Orgamol Pharma Solutions and BASF Fine Chemicals Switzerland to a single organization. The merged company is called BASF Pharma (Evionnaz) and is based in Evionnaz, Switzerland. Martin Widmann, president of the new organization, said in a company press release that the move reduces complexity and simplifies processes.
Biopharmaceutical company Celgene (Summit, NJ) agreed to acquire Abraxis BioScience (Los Angeles, CA), a biotechnology company focused on oncology treatments. Under the agreement, each share of Abraxis BioScience common stock will be converted into the right to receive an upfront payment of $58.00 in cash and 0.2617 shares of Celgene common stock, as well as eligibility to receive future milestone and royalty payments. The upfront payment values Abraxis BioScience at approximately $2.9 billion, net of cash.
Eli Lilly (Indianapolis) agreed to acquire Alnara Pharmaceuticals (Cambridge, MA), a privately held biotechnology company developing protein therapeutics for the treatment of metabolic diseases. Alnara's lead product in development is liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT) currently under review by FDA for the treatment of exocrine pancreatic insufficiency. Financial terms of the agreement were not disclosed.
GlaxoSmithKline (GSK, London) and the Singapore Economic Development Board (EDB), the government agency responsible for economic growth and development, committed $35 million in funding for eight research projects based in Singapore focused on green and sustainable manufacturing. The first round of projects will receive close to $3.5 million in funding under the $24-million GSK–Singapore Partnership for Green and Sustainable Manufacturing. The partnership will be funded by the GSK–EDB $35-million joint fund.
In a separate announcement, GlaxoSmithKline (London) said it created a new operating unit, called the Developing Countries and Market Access, dedicated to developing countries that will focus on diseases that disproportionately affect the world’s poorest people. The group will develop approaches to expand access to medicines for patients living in these countries.
Contract manufacturer JHP Pharmaceuticals (Parsippany, NJ) entered into a multiyear contract supply agreement with an undisclosed ophthalmic company. JHP will be responsible for the manufacturing and supply of a proprietary ophthalmic product, which is targeted for launch next year.
Merck & Co. (Whitehouse Station, NJ) won the Vioxx lawsuit brought by the State of Louisiana. The case was tried before federal district court Judge Eldon E. Fallon without a jury. According to a Merck press release, Judge Fallon stated in his ruling that "the weight of the evidence indicates that Vioxx has gastrointestinal benefits as compared to traditional NSAIDs [nonsteroidal anti-inflammatory drugs]" and further stated that Merck's marketing of the gastrointestinal benefit was "consistent with the conclusions of their clinical trials."
Novartis (Basel) expects the closing of the transaction for 77% majority ownership of Alcon (Hünenberg,Switzerland) in late third quarter or fourth quarter of 2010, according to a company press release. Novartis nominated five directors to replace the five Nestlé-nominated directors on the Alcon board.
Roche (Basel) and IBM (Armonk, NY) agreed to develop a nanopore-based sequencer that will read and decode human DNA. The technology, developed by IBM Research, offers single-molecule sequencing by decoding molecules of DNA as they are threaded through a nanometer-sized pore in a silicon chip. The collaboration aims to accelerate human genome analysis and enable advancements in personalized healthcare, according to a company press release.
In a separate announcement, Roche (Basel) said that it renamed its industrial biotechnology business. Roche Applied Science Industrial Business is now called Roche Custom Biotech. The company launched a new webpage for the business unit on the Roche Applied Science website.
sanofi-aventis (Paris) agreed to acquire TargeGen (San Diego, CA), a biopharmaceutical company developing small-molecule kinase inhibitors for the treatment of certain forms of leukemia, lymphoma, and other hematological malignancies and blood disorders. sanofi-aventis will pay TargeGen an upfront payment of $75 million upon closing of the transaction and up to $560 million in milestone payments for the development of TargeGen’s lead product, TG 101348. The companies expect the deal to close in the third quarter of 2010.
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In a separate company release, sanofi-aventis (Paris) announced that it partnered with the Juvenile Diabetes Research Foundation (JDRF) to develop treatments such as immune therapies and beta cell regeneration for people with Type 1 diabetes as well as preventing diabetes in those at risk. sanofi-aventis and JDRF will jointly fund research by academic investigators and nonprofit medical research organizations. The partnership will provide sanofi-aventis with options to the intellectual property developed by the program.
Shire (Dublin), a specialty biopharmaceutical company, purchased the Lexington Technology Park campus in Lexington, Massachusetts, for $165 million cash. The purchase will be used for the company’s Human Genetic Therapies business, which focuses on the discovery, development, and manufacturing of treatments for rare genetic diseases. Shire had previously leased three buildings on the campus, and owns the parcel of land where its new 200,000-ft2 manufacturing plant is located. Shire purchased the remaining land, including three existing buildings comprising 280,000 ft2.
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Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Avrio Biopharmaceuticals (Irvine, CA) named David A. Gelber its director of manufacturing. Gelber previously served as the director of operations for AAI Development Services (Wilmington, NC).
Biogen Idec (Weston, MA) appointed George A. Scangos CEO and a member of the board of directors, effective July 15, 2010. Scangos joins Biogen Idec from Exelixis (South San Francisco, CA), where he served as president and CEO since 1996.
Elan (Dublin) appointed Eliseo Oreste Salinas executive vice-president and chief medical officer. Salinas will be based at Elan's South San Francisco, California, campus, will be a member of the company's executive leadership team, and will report to Carlos Paya, Elan’s president.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) unanimously reelected Eric Abadie as its chair and Tomas Salmonson as its vice-chair for a second three-year mandate.
Exelixis (South San Francisco, CA) named Michael Morrissey president, CEO, and a member of the board of directors, effective July 15, 2010. Morrissey is currently president of research and development for Exelixis. He will replace George Scangos, who has resigned to become president and CEO of Biogen Idec (Weston, MA), effective July 15, 2010. Scangos will serve as a member of the Exelixis board for the remainder of his current term.
Jiangbo Pharmaceuticals (Laiyang, China) appointed Linxian Jin CEO. Wubo Cao, who resigned as CEO on June 29, 2010, will retain his position as chairman of the company's board.
Lux Biosciences (Jersey City, NJ), a biotechnology company focused on ophthalmic diseases, appointed Dean Mitchell president and CEO. Mitchell was formerly president and CEO of Alpharma (Bridgewater, NJ).
Jiri Michal stepped down as CEO of Zentiva (Prague), which is part of sanofi-aventis (Paris) and serves the pharmaceutical markets in Central and Eastern Europe. Michal was with Zentiva for 36 years. Rob Koremans, formerly senior vice-president of generics Europe at sanofi-aventis and president of Zentiva, replaced Michal as CEO.
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The Citizens for Responsibility and Ethics in Washington, a nonprofit organization dedicated to promoting ethics and accountability, sent a letter to the Federal Trade Commission (FTC) on July 6, 2010, asking for the commission to investigate drug companies “that offer significant discounts to doctors for providing patients with only that company’s vaccines.” The organization claims that Sanofi Pasteur and Merck “offer significant price discounts” if healthcare groups agree to buy their vaccines solely from one manufacturer. The organization states that this practice prevents doctors from using alternative vaccines, even when they may better meet patient needs.
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