Custom Producers End Difficult Year

CUSTOM CHEMICALS

The pace of activity was frenetic at the 15th annual CPhI Worldwide trade show in Brussels last week.

Producers of fine and custom chemicals were cautiously optimistic that changes within the industry might start yielding positive results next year, after a difficult 2004. Many industry players, including those working in niche areas, said they are pleased with the level of customer interest they are seeing. Some, especially the larger companies, are hoping that their recent restructurings will better position their businesses.

Success also seems to depend on where companies target their activities. Sigma-Aldrich, which officially launched its new fine chemicals business SAFC at the meeting, said its spring acquisition of Ultrafine has given it a full range of capabilities to support customers from the preclinical stage through clinical development to commercialization. The move has contributed in part to a doubling of inquiries over the past six months, said Ed Roullard, director of SAFC Europe.

Cambrex, meanwhile, hopes to emerge as a specialty pharmaceutical player, explained new CEO John R. Leone, even marketing its own product--a cell therapy for wound healing called Orcel--with partner Ortec International in 2005.

DSM Anti-Infectives broadened its line of biotech products with the introduction of Puridrox (cefadroxil) and Purilex (cephalexin), both produced through enzymatic reactions that eliminate about seven chemical steps--post-fermentation--from standard production routes. The new brand name for the anti-infectives is DSM PureActives. DSM also announced a restructuring of its anti-infectives business last week (see page 12).

On the more traditional chemistry front, Clariant is expanding its hydrogenation capacity in Origgio, Italy, by 20%. Drug industry demand for such reactions is strong, said Ralf Pfirmann, global business director for pharmaceutical fine chemicals, with the new capacity "already booked to the end of 2005."

Helsinn, meanwhile, is expanding its high-potency products facility in Biasca, Switzerland. And SEAC, a division of NuPharm, has added a small-volume lab in France capable of producing 500-g to 1-kg quantities. The new plant complements the firm's existing lab- and commercial-scale capabilities.

While their pharmaceutical customers chafe under increased regulatory scrutiny, fine chemicals companies are asking for more scrutiny in their own sector. In Brussels, the new European Fine Chemicals Group (EFCG) called for mandatory Good Manufacturing Practice (GMP) standards within the EU. While firms that supply active pharmaceutical ingredients (APIs) to the U.S. must meet costly GMP standards, explained Hovione CEO Guy Villax, the lack of comparable controls in Europe places European manufacturers that have invested to meet those standards at a disadvantage.

"EFCG wants to help the members who are API manufacturers to lobby for a level playing field in the enforcement of GMP compliance," said Peter Nagler, EFCG chairman and head of Degussa's exclusive synthesis and catalysts unit.