Wednesday, July 31, 2013

Cubist will boost antibiotics lineup with Optimer and Trius buys

FDA will expedite review of Vanda's sleep-disorder drug tasimelteon | FDA OKs molecular Dx test to detect HAI-causing bacteria | Samsung BioLogics, Bristol enter manufacturing deal for melanoma drug
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July 31, 2013
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Cubist will boost antibiotics lineup with Optimer and Trius buys
Cubist Pharmaceuticals has deals to acquire antibiotics-makers Optimer Pharmaceuticals for about $801 million and Trius Therapeutics for $818 million contingent on certain milestones in a bid to increase its product pipeline. The deal grants Cubist access to Optimer's recently approved drug Dificid for Clostridium difficile-associated diarrhea and Trius' late-stage antibiotic tedizolid phosphate. Reuters (7/31), Bloomberg Businessweek/The Associated Press (7/30)
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Health Care & PolicySponsored By
FDA will expedite review of Vanda's sleep-disorder drug tasimelteon
The FDA granted priority-review status to Vanda Pharmaceuticals' regulatory application for tasimelteon, an experimental treatment for blind people with the non-24-hour disorder. If approved, tasimelteon will be the first drug cleared for the condition. A decision is expected by Jan. 31. Bloomberg (7/30)
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FDA OKs molecular Dx test to detect HAI-causing bacteria
The FDA has cleared IntelligentMDx to market an assay used to detect certain genes linked to vancomycin-resistant enterococci, which can trigger hospital-acquired infections in the bloodstream, surgical wounds and the urinary tract. The assay, which runs on Abbott's m2000 diagnostic platform, takes less than three hours to generate results for as many as 46 samples. GenomeWeb Daily News (free registration) (7/29)
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Samsung BioLogics, Bristol enter manufacturing deal for melanoma drug
Samsung BioLogics signed a 10-year deal to manufacture Bristol-Myers Squibb's melanoma drug Yervoy, or ipilimumab, at its facility in Songdo Incheon, South Korea. Samsung is beginning trial production, and commercial production will follow the securing of regulatory OKs. PharmaTimes (U.K.) (7/30)
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Audentes signs deal with ReGenX for rare-disease drug collaboration
Audentes Therapeutics and ReGenX Biosciences agreed to collaborate in the development and marketing of treatments for X-linked myotubular myopathy and Pompe disease using ReGenX's NAV rAAV8 and rAAV9 vector technology. The deal entitles ReGenX to an undisclosed upfront payment, milestone fees and potential sales royalties. Genetic Engineering & Biotechnology News (7/30)
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Study links more oversight to better orphan drug access
A study sponsored by the Drug Information Association found that countries with more regulatory structures for advancing treatments for rare diseases have greater access by patients to orphan drugs compared with countries with less extensive regulatory frameworks. The U.S. did not do as well as France, Spain, the U.K. and Germany in providing access to 13 orphan treatments, according to the study. PharmExec.com/PharmExecBlog (7/29)
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Company & Financial News
Pfizer divides businesses for patent-protected, generic drugs
Pfizer announced plans to split its generic and patent-protected drug operations into different business units -- "value" and "innovative" -- with an eye toward possibly spinning off its generic-drug business. The "value" business unit will comprise biosimilars and products set to lose patent protection through 2015. The "innovative" unit will be subdivided into one section including vaccines, oncology drugs and consumer products and another covering drugs for inflammation, immunology, cardiovascular and metabolic diseases, rare diseases, neuroscience, pain and other areas. Reuters (7/29)
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Mass. biotech raises $18M to advance rare-disease drug
A Series B funding round from new and existing investors has brought in $18 million for Edimer Pharmaceuticals, a Cambridge, Mass.-based biotech firm specializing in treatments for rare genetic conditions. Edimer will use the money to advance clinical development of ED1200, its experimental drug for X-linked hypohidrotic ectodermal dysplasia. American City Business Journals/Boston/bioflash blog/Mass High Tech (7/30)
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The Latest From BIO ...
Save on energy costs through BIO's newest cost-savings program
Reduce your company's energy expenses through the BIO Business Solutions program's newest initiative. BIO has aligned with APPI Energy, an energy consulting firm, to assist its member companies save on electrical and natural gas costs.
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Food & Agriculture
Syngenta to invest $94M in N.C. expansion
Syngenta Biotechnology plans to invest $94 million to construct a 200,000-square-foot office and laboratory building as part of an expansion in North Carolina's Research Triangle Park, which is home to the firm's plant biotechnology research and development headquarters. The expansion is expected to create 150 jobs. The Herald-Sun (Durham, N.C.) (free registration) (7/30)
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Industrial & Environmental
Work begins on Quad County Corn Processors' cellulosic ethanol project in Iowa
Quad County Corn Processors has begun building its cellulosic ethanol plant in Galva, Iowa. The $8.5 million facility, which will produce ethanol from corn kernel fibers, will rise next to the cooperative's corn ethanol plant. "If implemented industrywide, [Adding Cellulosic Ethanol] will be able to create an additional 2 billion gallons of cellulosic ethanol on an annual basis," said Delayne Johnson, general manager of the co-op. The project's progress is an indication that the industry is continuing to evolve and the Renewable Fuel Standard is working, said Bob Dinneen, president and CEO of the Renewable Fuels Association. KTIV-TV (Sioux City, Iowa) (7/29), KWQC-TV (Davenport, Iowa)/The Associated Press (7/30)
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The BIO Convention in China brings together executives from biotechnology, pharmaceutical companies and investment firms from North America, Europe and Asia to meet and explore business opportunities with China's emerging biotech sector. BIO is renowned for its successful business development, partnering and investor meetings in North America, Europe and Asia. Partnering at this conference will be powered by BIO One-on-One Partnering, an interactive environment to intelligently search, contact and schedule private meetings with potential partners and investors. Learn more and register today.
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SmartQuote
Success is to be measured not so much by the position that one has reached in life as by the obstacles which he has overcome."
-- Booker T. Washington,
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