in this issue
Pharma/Fine Chemicals Roundup – January 17
6:13 AM MST | January 17, 2012 | By DEEPTI RAMESH
GENERIC DRUG USER FEE PROGRAM GOES TO CONGRESS
The U.S. Food and Drug Administration (FDA) says it has completed its recommendations for the proposed generic drug user fee program (GDUFA). The recommendations were transmitted by the Department of Health and Human Services to Congress on January 13.
GDUFA will require FDA to improve significantly its regulatory activities for the benefit of generic drug providers and U.S. generic drug consumers. The global generics industry, in exchange, will provide FDA with $299 million/year in user fees over the next five years. The key benefits for drug providers will be faster and more predictable regulatory review times, including speeding up the backlog of applications and parity of inspections between domestic and foreign sites for active pharmaceutical ingredients (API) and finished-dosage form manufacturers.
The FDA receives 800 to 900 new generic-drug-related applications annually, and these applications are increasingly complex and frequently involve products manufactured outside of the U.S., FDA says. In exchange for fees on facilities and product applications, the proposal includes performance metrics such as review timeframes and a commitment to achieve parity between surveillance inspections of foreign and domestic establishments by the 2017 fiscal year, FDA says. As a result, FDA expects that the proposal would effectively eliminate the review backlog and significantly reduce review times.
CARBOGEN AMCIS ACQUIRES FRENCH FIRM
Pharma process-development firm and active pharmaceutical ingredient (API) producer Carbogen Amcis (Bubendorf, Switzerland), says it has acquired Creapharm Parenterals, a subsidiary of Creapharm Group (Le Haillan, France). Creapharm Parenterals, formerly MP5, is a contract manufacturer of clinical trial materials focused on formulation, aseptic filling, and lyophilization of APIs, cytotoxics and other high potency drugs, as well as biologics. Financial details of the deal were not disclosed. Following the acquisition, Creapharm Parenterals has changed its name to Carbogen Amcis SAS. Carbogen Amcis is a subsidiary of Dishman Pharmaceuticals & Chemicals (Ahmedabad, India).
“We believe that the combined capabilities and services of our two companies present a one-stop solution to pharmaceutical, biotech and virtual pharmaceutical companies looking for a single reliable partner that can provide API and drug product development for preclinical and clinical studies,” says Maxime Laugier, development and projects director at Creapharm Parenterals.
SASOL TO SELL ONE OF ITS PRODUCTION SITES IN GERMANY
Sasol Germany (Hamburg) has agreed to sell its production site at Witten, Germany, and the associated oleochemicals business to Cremer Oleo (Hamburg). Details about the price of the transaction have not been disclosed. The Witten production site is one of three plants that Sasol has in Germany and it produces more than 250 different oleochemicals that are used in the cosmetics, pharmaceutical, and food industries as well as technical applications.
NOVARTIS TO CUT 1,960 JOBS IN U.S.
Novartis (Basel, Switzerland) says it plans to restructure the company’s business in the U.S. The restructuring is mainly to respond to the loss of patent exclusivity for Diovan, the market-leading hypertension medication, expected in the U.S. in September 2012, and also because of the expected impact on worldwide sales of Rasilez/Tekturna after Altitude clinical study termination, the company says. The company will restructure its general medicines business in the U.S. market, and as a result, the field force will be reduced by about 1,630 positions and headquarters functions will realign to support the new organization, resulting in an additional reduction of about 330 positions. The changes are planned to take effect in second-quarter 2012.
NOVALIX AND TEIJIN PHARMA FORM DRUG DISCOVERY COLLABORATION
NovAliX (Illkirch, France) says it has entered into a integrated drug discovery collaboration with Teijin Pharma (Tokyo). The companies will collaborate to develop novel drug candidates against multiple targets across different therapeutic areas. NovAliX will receive technology access fees as well as further research funding payments, under the terms of the deal. Financial details were not disclosed. NovAliX will initially use its protein biochemistry expertise in combination with its biophysical technology platform, and will also apply its proprietary Graffinity SPR-based screening technology for the identification of novel chemotypes, and then engage its native nano-MS technology for further characterization of selected small molecule hit structures.
“In this collaboration Teijin will have the opportunity to leverage the entire spectrum of our capabilities in biochemistry, biophysics and medicinal chemistry,” says Stephan Jenn, president of NovAliX.
PHARMA PAYS UP FOR SCARCE ASSETS
When it comes to healthcare deals, the new motto may be "too expensive to fail."
Drug companies have been forced to pay massive premiums on acquisitions as the selection of target companies with viable prospects narrows and the need to fill out their portfolio of medicines intensifies.