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Pharma/Fine Chemicals Roundup – May 29
3:14 AM MDT | May 29, 2012 | By DEEPTI RAMESH
SENATE APPROVES FDA SAFETY AND INNOVATION ACT
The U.S. Senate, on May 24, 2012, approved the Food and Drug Administration Safety and Innovation Act (S. 2516), which would enable the U.S. to have a safer drug supply chain. The bulk pharmaceutical task force (BPTF; Washington), an affiliate of Socma, has commended the Senate for approving the Safety and Innovation Act. BPTF is an industry organization for U.S. manufacturers of active pharmaceutical ingredients (APIs), pharma intermediates, and excipients. The legislation reauthorizes FDA user fee programs. The previously announced generic drug user fee program (GDUFA), which is included in S. 2516, levels the playing field for domestic pharmaceutical producers by requiring that all foreign and domestic drug production facilities be inspected, a key step in improving the drug supply chain, BPTF says.
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 market faster. The legislation also allows the FDA to perform inspections on a risk basis, focusing on the facilities posing the greatest risk to drug safety. There will be parity of inspections between domestic and foreign sites for API and finished-dosage form manufacturers.
GRINDEKS REPORTS FALL IN API SALES
Pharmaceutical company Grindeks (Riga, Latvia) says that the company’s active pharmaceutical ingredients (API) business reported a 6.5% fall in sales for the first quarter, compared with the year-ago period, to lats1.45 million ($2.6 million). Grindeks produces 22 APIs, and there are currently four new APIs under development, the company says. The main API export markets for Grindeks are Germany, Japan, the Netherlands, and the U.S.
ALBEMARLE TO INCREASE IBUPROFEN API PRICES
Albemarle says it will increase global prices for all grades of ibuprofen active pharmaceutical ingredient (API) by 15% effective immediately, or as contracts allow.
Albemarle's ibuprofen and other generic APIs are part of the company's fine chemistry services division in the Fine Chemistry global business unit.
MERCK EXTENDS ENZYMES COLLABORATION WITH CODEXIS
Codexis (Redwood City), an enzymes technology firm, says Merck has signed a three-year extension to an ongoing catalyst and process development collaboration for pharmaceutical manufacturing. Under the terms of the deal, Merck will continue to use Codexis’ enzyme products to develop cost- and resource-efficient manufacturing processes for therapeutic candidates. The initial agreement was signed in April 2007, and has been extended to 2015. To date, Merck has used Codexis’ enzymes “extensively across programs in various stages of development,” notably for the production of Januvia active pharmaceutical ingredient sitagliptin, Codexis says.
U.K. GOVERNMENT PLANS INVESTMENT IN SYNTHETIC BIOLOGY APPLICATIONS
The U.K. government, via its Technology Strategy Board (TSB), Biotechnology and Biological Sciences Research Council (BBSRC), Engineering and Physical Sciences Research Council (EPSRC), and Economic and Social Research Council (ESRC) is planning to invest £6.5 million to encourage U.K.-based companies and research organizations to explore innovative industrial applications for synthetic biology. The projects would aim to demonstrate the feasibility of using technological advancements in synthetic biology in the creation of novel or improved products and processes.
Applications for synthetic biology may provide the tools for medical intervention at the molecular level, with engineered biological devices able to act within the body as "smart drugs." Micro-devices like these may also be capable of producing pharmaceutical compounds, for which production using the existing methods of chemical or biological synthesis is extremely challenging, TSB says.
DSM APPOINTS NEW HEAD OF PHARMACEUTICAL FINISHED DOSAGE BUSINESS
DSM says it has appointed Laura L. Parks as president and business unit director of DSM Pharmaceuticals (Greenville, NC), the finished dosage business of DSM Pharmaceutical Products (Parsippany, NJ), effective June 1, 2012. Parks is currently senior v.p./marketing & sales at DSM Pharmaceutical Products. Parks will continue to report to Alexander R. Wessels, president and CEO of DSM Pharmaceutical Products. The finished dosage business, DSM Pharmaceuticals, employs over 880 people at the Greenville site, which specializes in the manufacture of solid dosage medicines and biopharmaceuticals.
LUBRIZOL LAUNCHES LIFESCIENCE POLYMERS
Lubrizol says it has formed LifeScience Polymers, a new product line created to better enable the delivery of polymer technologies and solutions to the pharmaceutical and healthcare markets. Lubrizol LifeScience Polymers is primarily focused on developing technologies for pharmaceutical ingredients, wound care, short- and long-term implants, medical devices, and oral care.
AESICA APPOINTS NEW SITE DIRECTOR AT NOTTINGHAM
Aesica Pharmaceuticals (Newcastle upon Tyne, U.K.), a provider of active pharma ingredients (API), formulations, and custom synthesis, says it has appointed Ian Lafferty as site director of the company’s formulation development facility at Nottingham, U.K. The Nottingham site’s high potency suite has also been extended, Aesica says. Lafferty was previously chief technical officer at Aesica. Lafferty will “oversee the growth of the Nottingham site and the increased interest in high potency and biological formulations following the recent expansion of its high containment and sterile manufacturing suite,” Aesica says.
“Our high potency facility is currently undergoing significant expansion which will strengthen our offering on the international stage. One of my key goals initially is to attract new strategic partners in the coming months based on our high containment capabilities,” Lafferty says.
TAKEDA TO ACQUIRE BRAZILIAN FIRM FOR $272 MILLION
Takeda Pharmaceutical (Osaka, Japan) says that its Takeda Farmacêutica Brasil (São Paulo, Brazil) subsidiary will acquire Multilab Indústria e Comércio de Produtos Farmacêuticos (São Jerônimo, Brazil) for up to R$540 million ($272 million). This will include an upfront payment of R$500 million and up to R$40 million in additional future milestone payments. Multilab is a mid-sized pharmaceutical company with revenues of R$140 million in 2011, and the company employs about 650 people. Its business consists of branded generics and over-the-counter pharmaceutical products. Takeda expects that the transaction to be completed later this year. The acquisition of Multilab will position Takeda as one of the top ten pharmaceutical companies in Brazil, Takeda says.
“Takeda has ambitious plans for growth in emerging markets. Brazil is our second largest emerging market after Russia/CIS in terms of revenues and the acquisition of Multilab is a clear signal of our intention to become a significant player both in Brazil and other high-growth markets,” says Jostein Davidsen corporate officer, head of emerging markets commercial operations at Takeda.