IHS Chemical Week


Pharma/Fine Chemicals Roundup – August 28

8:22 AM MDT | August 28, 2012 | By DEEPTI RAMESH


The U.S. FDA is establishing a new system for the electronic self-identification of generic industry facilities, sites, and organizations for the Generic Drug User Fee Act (GDUFA). GDUFA was signed into law by the U.S. president on July 9, 2012. The generic drug industry will pay about $1.5 billion over five years in return for faster and more predictable review of generic drug applications, according to the terms of GDUFA. This will help reduce drug shortages and bring drugs to the market faster. GDUFA will also significantly improve global supply chain transparency by requiring owners of facilities producing generic drug products and active pharmaceutical ingredients (APIs), as well as certain other sites and organizations that support the manufacture or approval of these products, to electronically self-identify with FDA and update that information annually, FDA says. Self-identification is necessary to determine the universe of facilities required to pay user fees, and the information provided through self-identification will enable quick, accurate, and reliable surveillance of generic drugs, and facilitate inspections and compliance, FDA says. Most facilities that self-identify will be required to pay an annual facility user fee. Those required to pay include facilities manufacturing, or intending to manufacture, APIs of human generic drugs and/or finished dosage form (FDF) human generic drugs.  Other sites and organizations must self-identify, but will not be required to pay the annual facility user fee. These others include sites and organizations that manufacture solely positron emission tomography (PET) drugs, clinical bioequivalence or bioavailability study sites, in vitro bioequivalence testing or bioanalytical testing sites, API/FDF analytical testing sites, and repackagers, FDA says. Once the self-identification process has been completed, FDA will determine facility fees and publish the amounts in the federal register.


Active pharmaceutical ingredients (API) manufacturer Hovione (Loures, Portugal) has appointed Conrad Winters as director/drug product development. Winters had previously been with Merck in the U.S. and Canada, and most recently with Xenon Pharmaceuticals (Burnaby, BC), where he was senior director/compound properties group. Winters’ experience in “particle engineering, solubilisation, drug product development, scale-up and commercialization will enable [Hovione] to solve [its] customers' most challenging problems,” says Thomas Eisele, v.p./corporate research & development.


Umicore (Brussels) says that it is launching its offering of advanced Platinum N-heterocyclic carbene catalysts, expanding the range of hydrosilylation applications for both silicone and fine chemical industries. This is in conjunction with the worldwide license agreement with silicones manufacturer Bluestar Silicones France (Lyon), Umicore says. Technological progress in the hydrosilylation catalyst market has been stagnate for many years, Umicore says. With the introduction of the new catalysts, Umicore brings innovation to the market by making the catalysts available to all users, and the new catalysts are expected to have a great potential to push novel, specialty silicone and many other applications, Umicore says.


BASF says it is increasing its European sales prices for ethanolamines with immediate effect or as existing contracts permit. The prices for monoethanolamine will increase by €90/m.t. ($113/m.t.), for diethanolamine by €100/m.t., and for triethanolamine by €120/m.t. Ethanolamines are intermediates used in the manufacture of APIs, agchems and wood protectants, surfactants for detergents and cleaning products, process chemicals for gas treatment, lubricants, and cement additives. BASF produces ethanolamines at Ludwigshafen Antwerp; and Nanjing, China. The price increase will also apply to current supply agreements as soon as possible, and to the extent permitted by their terms and conditions, BASF says.


Mylan (Canonsburg, PA) says it has signed a definitive agreement with Pfizer to establish an exclusive, long-term strategic collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The collaboration is designed to build upon each company's complementary strengths and quality assets, Mylan says. Financial details of the deal were not disclosed. Pfizer's responsibilities, under the terms of the deal, primarily consist of the commercialization of the combined generics portfolio, and managing a combined marketing and sales effort. Mylan's responsibilities primarily consist of managing operations, including research and development and manufacturing. The collaboration between Pfizer and Mylan will include a portfolio of more than 350 marketed products across a broad range of therapeutic categories, as well as more than 125 additional products in development. Products included in the collaboration are expected to be sold under the Pfizer brand, with joint labeling. Japan is the second-largest pharmaceutical market in the world, behind the U.S., and the sixth largest generic retail prescription market worldwide, with sales of about $5.2 billion in 2011, Mylan says. The Japanese government intends to grow the current volume of generic utilization from about 24% to 30% by the end of 2012, Mylan says. Pfizer and Mylan will each continue to operate independent entities in Japan, but will collaborate on current and future generic products, sharing the costs and profits resulting from the collaboration.


Iran will export pharmaceutical products worth R5 trillion ($407 million) in the current fiscal year, ending March 20, 2013, compared with products worth about $114 million in the last fiscal year, according to the Islamic Republic News Agency and as quoted in recent press reports. The country plans to substantially increase its export of pharmaceuticals. Pharmaceutical companies in Iran have the capacity to raise their production output by at least three fold, the report says. The health ministry in Iran has made a proposal to the government, where each of the 140 pharmaceutical manufacturers in the country exports $500-million worth of products. This would increase the total exports to $70 billion annually, the report says, albeit without providing a timeline.


Merck KGaA (Darmstadt, Germany) says it has entered into definitive agreements to acquire Biochrom (Berlin), a company that specializes in the production and marketing of cell-culture media and buffer solutions. The purchase price was not disclosed. Biochrom had sales of about €13 million ($16.33 million) in 2011 and the company employs 60 people. The acquisition is expected to close in the fourth quarter of 2012. The acquisition will strengthen Merck KGaA's division Merck Millipore’s process solutions business unit, which provides products, services, and solutions that simplify production complexity for pharmaceutical and biopharmaceutical manufacturers, Merck says.

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