Pharma/Fine Chemicals Roundup – March 20
8:42 AM MDT | March 20, 2012 | By DEEPTI RAMESH
AMPAC FINE CHEMICALS: RELYING ON TECHNOLOGY CAPABILITY TO DRIVE GROWTH
Ampac Fine Chemicals (AFC; Rancho Cordova, CA), the wholly owned pharmaceutical fine chemicals subsidiary of American Pacific Corporation (AMPAC; Las Vegas, NV) reported a loss for the first nine months of fiscal 2011. But, things are turning around at AFC. AFC president Aslam Malik tells CW that the company has a burgeoning project pipeline and that it is once again poised for growth.
BIOMAR EXPANDS FACILITY IN SPAIN TO PRODUCE APIS
Biotech company Biomar Microbial Technologies (León, Spain) says it has invested €2 million ($2.63 million) to expand its production facility at León in order to produce kilograms of active pharmaceutical ingredients (APIs).
“We have the necessary infrastructure to become the laboratory for the development of production methods for new therapeutic entities. We have met GMP quality standards applying to international external laboratories and the large-scale production of pharmaceuticals, complying with international regulations in this area,” says Antonio Fernandez Medarde, managing director of Biomar.
BAYER HEALTHCARE TARGETS IMPROVED RESULTS THROUGH 2014
Bayer says it is targeting increased sales and profit margins for its healthcare subgroup through 2014. Sales of Bayer HealthCare are expected to reach €20 billion ($26 billion) in 2014, compared with €17.2 billion in 2011, the company says. Bayer's optimism about the future performance of its healthcare business is its "well-stocked" development pipeline in pharmaceuticals. "Our goal is to successfully commercialize the late-stage pharmaceutical pipeline and take advantage of our business opportunities in the emerging markets," says Marijn Dekkers, CEO of Bayer.
FDA TO INSPECT DR. REDDY’S API SITE IN MEXICO WHICH RECEIVED A WARNING LETTER
Pharmaceutical company Dr. Reddy’s Laboratories (Hyderabad, India) says that the U.S. Food and Drug Administration (FDA) will inspect in the last week of March 2012, the company’s wholly owned Industrias Quimicas Falcon de Mexico manufacturing facility at Cuernavaca, Mexico. The facility produces intermediates and active pharmaceutical ingredients (API). The Cuernavaca facility received a warning letter from the FDA in June 2011. An FDA inspection of the Cuernavaca facility in November 2010 identified certain deviations from current good manufacturing practice (cGMP) for the manufacture of APIs. Dr. Reddy’s responded to the observations by implementing corrective actions, but the FDA said the corrective actions taken by the company were not sufficient, and asked for additional data and corrective actions. The FDA also issued an import alert or detention without physical examination (DWPE) alert on certain products manufactured at the Cuernavaca facility. And as a result, the facility is unable to export some API to U.S. customers until the concerns raised in the warning letter is addressed to their satisfaction and the DWPE alert is lifted, the company says.
Dr. Reddy’s says it is working collaboratively with the FDA to resolve the matters contained in the warning letter, and has been informed of an inspection by the FDA of its Mexico facility during the last week of this month.
DSM SECURES DEAL TO PRODUCE ANTI-CANCER DRUG FOR PHASE III CLINICAL TRIALS
DSM Pharmaceutical Products has signed a new contract to supply Agennix (Heidelberg, Germany), a biopharma company, with sufficient quantities of talactoferrin, a prototype drug for treating small-cell lung cancer (NSCLC) that is anticipated to move in phase III clinical trials shortly. Financial terms were not disclosed. DSM has been the producer of talactoferrin for batches used in earlier phase clinical trials and has also been responsible for process development. Under the new contract, DSM is also positioned to supply talactoferrin to Agennix should the drug gain full approval for commercial use. The contract includes the opportunity to significantly expand production capacity as needed.
PIEDMONT AND HISUN SIGN DEAL TO DEVELOP ANIMAL HEALTH PHARMACEUTICALS
Piedmont Pharmaceuticals (Greensboro, NC) says it has signed an agreement with Zhejiang Hisun Pharmaceutical (Taizhou, China), a leading pharmaceutical company in China, to develop companion animal health pharmaceuticals for China and other markets worldwide. “This product development agreement is a significant component of our strategy to become a leading global supplier of animal health pharmaceuticals,” says Hua Bai, CEO and chairman of Hisun.
Piedmont and Hisun will combine their strengths in research, development, regulatory, manufacturing, and distribution for developing the animal health pharmaceuticals business. Hisun currently has more than 200,000 sq feet of new space under construction at the Fuyang site in China, including 35,000 sq feet for the new animal health business.
Hisun also supplies active pharmaceutical ingredients (APIs) to some of the world's largest pharmaceutical companies, including Pfizer, Novartis, and Eli Lilly.
Last month, Hisun signed a framework agreement with Pfizer, to establish a $545-million generics joint venture.