Pharma/Fine Chemicals Roundup – February 21

INFORMEX USA: ACQUISITIONS, EXPANSIONS IN THE CARDS

Alex Scott in New Orleans
Companies at Informex USA, a fine-and specialty-chemicals expo held last week in New Orleans, appear to be in growth mode with many unveiling plans for acquisitions or capacity expansions. Exhibitors totaled 469, down from 489 last year, with visitor numbers of more than four thousand estimated by event organizer UBM (London), about the same as a year ago.

ABBOTT TO EXPAND API MANUFACTURING SITE IN IRELAND

Abbott Laboratories (Chicago, IL) says it will invest €85 million ($111 million) to expand its pharmaceutical manufacturing operations at Sligo, Ireland. The manufacturing facility at Sligo manufactures active pharmaceutical ingredients (APIs) as well as finished drug products. The expansion of the facility will be completed in 2014.

FDA ISSUES WARNING LETTER TO MERCK KGAA’S API PLANT IN SWITZERLAND

The U.S. Food and Drug Administration (FDA) issued a warning letter in December 2011, to the active pharmaceutical ingredient (API) facility at Corsier-sur-Vevey, Switzerland, of Merck KGaA’s Merck Serono (Geneva) division, for deviating from current good manufacturing practice (cGMP). The FDA published the warning letter on its website, earlier this month. An FDA inspection of the Corsier-sur-Vevey API facility from June 1-June 9, 2011, identified significant deviations from cGMP for the manufacture of APIs and significant violations to requirements regarding reporting changes to an approved application, FDA says. The company responded to the FDA in June and July 2011. The FDA says it has reviewed the response, and that the corrective actions taken by the company are not sufficient.

SIGMA-ALDRICH PROFITS RISE 15% DRIVEN BY CUSTOM FINE CHEMICALS

Alex Scott
Sigma-Aldrich has reported net income of $108 million for the fourth quarter of 2011, a 15% hike compared with the same period a year earlier. Corresponding sales increased 5% to $610 million. Organic sales for the group’s Research unit grew 1% during the quarter, with Sigma-Aldrich Fine Chemicals (SAFC), the group’s custom fine chemicals business, recording organic sales of $185 million, a 7% rise when compared with the same quarter one year earlier.

PFIZER AND CHINESE COMPANY TO FORM $545-MILLION GENERICS JV

Pfizer says it has signed a framework agreement with Zhejiang Hisun Pharmaceutical (Taizhou, China), a leading pharmaceutical company in China, to establish a joint venture to develop, manufacture and commercialize off-patent pharmaceutical products in China and global markets. The framework agreement builds on a memorandum of understanding signed between the companies in June 2011. According to the framework agreement, the potential jv will be called Hisun Pfizer Pharmaceutical. Hisun will own 51% and Pfizer will own the remaining 49% in the jv, and the total investment and registered capital will be $295 million and $250 million respectively. Both companies could contribute selected existing products, manufacturing sites, cash and other relevant assets after the jv is formed, Pfizer says. The jv is subject to the satisfaction of certain closing conditions, including approval of relevant government authorities in China, Pfizer says.

ROBINSON BROTHERS REPORTS RISE IN SALES

Robinson Brothers (West Bromwich, U.K.) has reported an 18% rise in sales in 2011, compared with 2010, to over $50 million. Robinson Brothers provides specialty organic chemical intermediates for various sectors including pharmaceuticals, agchems, specialty rubber additives, flavors and fragrances, food and beverage and materials sciences. From the increased sales, Robinson Brothers plans to invest over £1.2 million across its business in 2012. “Sales were up across all of our business units,” says Adrian Hanrahan, managing director of Robinson Brothers. “The strong sales performance means that we can accelerate investment plans for the business.”

AMPAC FINE CHEMICALS JOINS RX-360

Ampac Fine Chemicals (AFC; Rancho Cordova, CA), a subsidiary of American Pacific Corp. (Las Vegas, NV), says it has joined Rx-360 as an active member. Rx-360 is a pharmaceutical and biotech industry consortium that was formed in 2009 by industry leaders to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. AFC says it is contributing to the Rx-360's joint audit pilot program as the first U.S.-based active pharmaceutical ingredient (API) manufacturer to be audited.