Jersey Shore Edition

There were good vibrations at the Pharma ChemOutsourcing conference in Long Branch, NJ, this week. Contract producers of active pharmaceutical ingredients (APIs), milling about the bonfire with cocktails on Wednesday night, agreed that business is picking up. “Our pots and pans are full, especially at the pilot stage,” said Don LeFerle, senior vice president of sales and marketing at PCAS. LeFerle, who is taking over for Joe Tessier at the French company’s U.S. office in Hoboken, N.J., said there is a distinct uptick in requests for proposals. Roger LaForce, managing director of ZaCh System, a division of Zambon in Italy, said that although new chemical entities are moving very slowly into the system, there is a wave of business coming back to the west from China and India. That wave, which has been rolling for about two years now, is stoked in part by a trend in India away from API production and toward finished dosage formulation, he said.   Manufacturing has been strong for two years now at Albany Molecular Research Inc (AMRI), according to David J. Fairfax, business development manager. Development research is following along, and AMRI’s discovery services business is picking up. “Why? Good question,” he said, speculating that venture funding is coming back to the emerging pharma and biotech sectors. Recent announcements from contract API manufacturers have also been brimming with optimism. Wisconsin-based Cambridge Major Laboratories announced an expansion of API production at its recently-expanded plant in Germantown. Meanwhile, LaForce’s former employer, Italy’s Fabbirca Italiana Sintetici (FIS), is investing in biotechnology by taking a stake in Areta International, a contract developer and manufacturer of biotech therapeutics. FIS is coming off a major acquisition last year of Delmar Chemicals, an API manufacturer near Montreal, Canada. Consultant Howard Foote of Meadowbrook Associates attests to the uptick. “Capacity is getting full. Most of the companies I talk to say they are full all the time,” said Foote. “A number of them were running half empty only two years ago.” He said pharma pipelines are moving along, and drug companies are getting out of manufacturing, thus outsourcing more API production. He noted, for example, that Abbott no longer does any manufacturing in the U.S. Meanwhile, funding has increased in the biotech sector, he said. With little hope for IPOs, biotech firms are looking for deals with big pharma, which tends to accelerate compounds through the system. One of the more interesting expressions of optimism was the participation of Apertus Pharmaceuticals, a brand new controlled substance API manufacturer just getting started in St. Louis. The firm, started by former Millipore and Mallinckrodt employees, hopes to have its first FDA inspection in the early second quarter of 2013. The up mood in Long Branch may have been fostered by the beach bonfire, casino night, and karaoke. But soirees come fast and furious in this business. Indeed, a new fine chemicals event focusing on the U.S. agricultural market, Specialty & Agro Chemicals America, was launched this week in Wilmington, N.C. Fine Line, alas, can only be on one beach at a time. So any feedback from the Wilmington event would be appreciated in the comments below. We convene next at CPhI in Madrid, just in time for Columbus Day. Forward!

Author: Rick Mullin

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