NEWS OF THE WEEK

SHOWCASE Companies rolled out new products at this year's CPhl trade show.

C U S T O M C H E M I C A L S

CUSTOM PRODUCERS END DIFFICULT YEAR Pharmaceutical ingredient makers look for renewed interest in 2005

T HE PACE OF ACTIVITY WAS frenetic at the 15th annual CPhl 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

I M M I G R A T I O N P O L I C Y

Visa Provision Grants 20,000 New Work Visas

F oreign nationals who hold master's or Ph.D. degrees from U.S. colleges and uni­versities will have a better chance of being

granted a visa to work in the U.S., thanks to a provision included in the spending bill approved by Congress in November.

President George W. Bush is expected to sign the legislation, which would allocate 20,000 H-1B temporary work visas for foreign applicants hold­ing advanced degrees from a U.S. institution. Visas issued under this provision would not count against the annual H-1B visa cap set by U.S. Citi­zenship & Immigration Services (USCIS).

According to Bill Strassberger, a USCIS spokesman, details on the implementation of the provision will be finalized once the bill is signed into law. At this time, he says, it appears the legislation will cover any individual holding a U.S.-granted master's or above degree regard­less of when it was obtained.

Also, although the fiscal 2005 cap has already been reached, Strassberger says the new allo­

cation of visas could be made available to appli­cants as soon as 90 days after the provision be­comes law.

The number of H-1Β visas issued for fiscal 2005 was capped at 65,000, the same as fiscal 2004 but significantly lower than the fiscal 2003 cap of 195,000 visas. According to D. Ronald Webb, manager of doctoral recruiting and uni­versity relations for Procter & Gamble, the drastically reduced cap has hampered indus­try's ability to hire much-needed talent.

"It used to be easy for us to consider a for­eign national because 195,000 visas would last the whole fiscal year," he said. "The system was very user-friendly and met a business need." For fiscal 2005, the H-1 Β visa cap was met within weeks of the start of the fiscal year on Oct. 1.

Webb says he is pleased with the provision overall and that the additional 20,000 visa allot­ment "seems like a reasonable estimate" to meet recruiters' needs.—VICTORIA GILMAN

(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 hydrogénation 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 Vil-lax, 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 De-gussa's exclusive synthesis and catalysts unit.-ANN THAYER AND RICKMULLIN

6 C & E N / D E C E M B E R 1 3 , 2 0 0 4 H T T P : / / W W W . C E N - O N L I N E . O R G