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3M Drug Delivery Systems (St. Paul, MN) signed an agreement with VaxInnate (Cranbury, NJ) a biotechnology company, under which VaxInnate acquires the use of 3M’s toll-like receptor (TLR) agonists for use as vaccine adjuvants. Under the terms of the agreement, 3M provides its TLR agonists to VaxInnate for an undisclosed licensing fee, in addition to milestone and royalty payments.
Althea Technologies (San Diego, CA), a provider of development and manufacturing services for biopharmaceutical products, announced the addition of customized formulation development services. The company recently appointed James Matsuura director of formulation development to oversee the new services.
Biovitrum (Stockholm, Sweden) and Swedish Orphan International (Stockholm, Sweden) will be combined to form Swedish Orphan Biovitrum. The new company will focus on making orphan drugs and niche specialty pharmaceuticals available for patients with rare diseases and unmet medical needs. Biovitrum will acquire 100% of the shares and warrants in Swedish Orphan, and will pay an upfront payment of approximately SEK 3.5 billion ($515 million). The transaction is expected to occur by March 2010.
The contract manufacturing organization Carbogen Amcis (Bubendorf, Switzerland) will restructure its Swiss operations, resulting in a loss of up to 40 positions out of 400 employees at its Swiss facilities. The early-phase services will be consolidated at the Aarau site. The Hunzenschwil site will focus on new technologies such as microreactors and crystallization. The company’s late-phase and high-potency service groups, located at the Bubendorf facility, will be expanded.
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Catalent Pharma Solutions (Somerset, NJ), a drug-delivery technology provider, announced that the US Food and Drug Administration granted marketing approval for Metozolv ODT (orally disintegrating tablets, (metoclopramide HCL)) using Catalent’s Zydis fast-dissolve technology. Metozolv ODT is the first orally disintegrating tablet formulation for both acute and recurrent diabetic gastroparesis and for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease who fail to respond to conventional therapy, according to a company press release.
In a separate announcement, the company said it launched a melamine-testing service for food and medicine.
Finally, the company also announced it entered into a strategic alliance with Endotis Pharma (Romainville, France) for the development of oral formulations of synthetic oligosaccharides. The companies will focus on the preclinical development of Endotis’ EP37151 compound. EP37151 is an oral synthetic oligosaccharide anticoagulant that, as an indirect factor Xa inhibitor, acts via antithrombin activation. The companies expect to initiate a Phase I clinical trial program during the second quarter of 2010, according to a Catalent press release.
DSM Pharmaceutical Products (Parsippany, NJ) formed a manufacturing alliance with Galenix (Saint Jean D'Illac, France), under which DSM will be the preferred commercial-scale manufacturing partner for Galenix commercial products.
Financial terms were not disclosed.
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Enzon Pharmaceuticals (Bridgewater, NJ), agreed to sell its specialty pharmaceutical business to the Sigma-Tau Group (Rome, Italy) for $300 million plus up to $27 million based on success milestones. Enzon will also receive royalties of 5–10% on incremental net sales above a 2009 baseline amount from Enzon’s four marketed specialty pharmaceutical products through 2014. Enzon’s specialty pharmaceutical business includes four marketed products: Oncaspar (pegaspargase), Adagen (pegademase bovine), DepoCyt (cytarabine liposome injection), and Abelcet (amphotericin B), as well as the manufacturing facility in Indianapolis, Indiana, which will be purchased by a US subsidiary of Sigma-Tau Pharmaceuticals, Inc. (Gaithersburg, MD).
Merck & Co. (Whitehouse Station, NJ) completed its merger with Schering-Plough (Kenilworth, NJ) and began combined operations on Nov. 4, 2009. The company released a statement outlining the details and strategy of the new Merck.
ProChon Biotech (Woburn, MA), a company focused on tissue regenerative technologies, selected Lonza’s (Basel) Hopkinton, Massachusetts, facility to manufacture its proprietary fibroblast growth factor (FGF2v) variant in the United States. FGF2v is a key regulator of cellular processes involved in blood vessel formation, wound healing and the remodeling of bone and cartilage.
Particulate Systems, a brand of Micromeritics Instrument Corp. (Atlanta, GA), and Surface Measurement Systems (Alperton, UK) announced a global strategic collaboration. Particulate Systems will have the exclusive distribution rights for certain Surface Measurement Systems products in selected regions of the United States as well as in South America, Central America, and the Middle East. In addition, Surface Measurement Systems will extend its service and support for customers in the USA via the Particulate Systems’ extensive aftercare network. Particulate Systems will also have codistribution rights to sell Surface Measurement Systems products in China. In addition, the companies will begin organizing joint academic meetings, symposia, and other academic training programs to advance the development of particle and sorption technology.
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Quintiles (Research Triangle Park, NC), a biopharmaceutical services company, opened its expanded regional headquarters facility in Singapore’s Science Park I. The new 79,000-ft2 of space doubles the size of its previous space in Singapore and can accommodate approximately 550 employees when fully occupied.
In a separate announcement, Quintiles said it formed an alliance with AstraZeneca (London) under which Quintiles will assume the operational responsibilities for the majority of AstraZeneca’s clinical pharmacology delivery.
ViiV Healthcare (London), a new specialty HIV company established by GlaxoSmithKline (London) and Pfizer (New York), was officially launched. Dominique Limet, ViiV Healthcare’s chief executive officer, outlined the company’s mission to meet the increasingly diverse and complex needs of people living with HIV/AIDS worldwide.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com
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The US Food and Drug Administration introduced the Safe Use Initiative, a program designed to reduce the likelihood of preventable harm from medication use. The agency said in a press release that millions of people are harmed every year from inappropriate medication use, and that many injuries occur as a result of incomplete access to information about a drug, patient, or patient’s condition. FDA intends to collaborate with healthcare professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm.
The agency also made public new draft guidance titled Dosage Delivery Devices for OTC Liquid Drug Products for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage-delivery devices such as calibrated cups, droppers, syringes, and spoons.
FDA Comissioner Margaret Hamburg sent a letter on Nov. 10, 2009, to America’s healthcare professionals that acknowledged their efforts during the 2009 influenza A (H1N1) outbreak and provided information on the safety of the H1N1 vaccines. The letter offered information designed to aid physicians in their discussions with patients about the manufacture, monitoring, and safety of the vaccine.
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John F. Thero was appointed chief financial officer of Amarin (Dublin, Ireland), a biopharmaceutical company focused on cardiovascular disease. Thero will report directly to CEO Declan Doogan.
Bruker (Billerica, MA), a provider of high-performance scientific instruments for molecular and materials research, appointed Bill Knight chief operating officer and Brian Monahan chief financial officer, effective Feb. 1, 2010. Presently, Knight serves as CFO, and Brian Monahan serves as chief accounting officer.
The biopharmaceutical company Gentium (Como, Italy) appointed Khalid Islam interim CEO on a temporary and part-time basis. Islam, who replaces former CEO Laura Ferro, brings extensive industry and regulatory experience to the company.
RXi Pharmaceuticals (Worcester, MA), a biopharmaceutical company focused on RNA interference, named Noah D. Beerman as its new president and CEO. Beerman succeeds RXi’s cofounder, Tod Woolf, who will remain a member of the company’s scientific advisory board.
TRIN Pharma (Appenzell, Switzerland), which focuses on the development of small-molecule drugs for tumor treatment, appointed Stefan Wohlfeil CEO of the company. Wohlfeil previously served as chief medical officer at the company.
UCB (Brussels, Belguim) appointed Ismail Kola executive vice-president of UCB and president of UCB New Medicines, the company’s organization dedicated to discovery research through proof of concept. Kola will join UCB's executive committee on Nov. 23, 2009.
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Process and Technical Solutions to Gain Operational Efficiencies and Avoid Time-to-Market Delay. Join your esteemed industry colleagues and hear presentations from: Genzyme, Hoffmann-La Roche, J&J, sanofi-aventis, Watson Pharmaceuticals and more! Program chairperson: Theresa Brunone, Assistant Director, Global Regulatory Operations, GlaxoSmithKline. To register, call 800-817-8601 or visit
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Special Report: Sharing Supply-Chain Security |
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| Angie Drakulich |
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A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.
Coming Soon: A special report looks at the results of PharmTech’s annual employment survey in the December 2009 issue of Pharmaceutical Technology. |
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The Next Generation of Innovators
At this month's AAPS Annual Meeting & Exposition, several graduate students are being awarded as young innovators. What are your thoughts on innovation and the next generation?
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Redesigned bulk-bag filler offers convenience