in this issue
Pharma/Fine Chemicals Roundup – November 8
5:27 AM MST | November 8, 2011 | By DEEPTI RAMESH
CAMBREX SWINGS TO PROFIT
Cambrex (East Rutherford, NJ) reported net profits of $2.76 million for the third quarter ended September 30, 2011, compared with a net loss of $1.45 million in the year-ago period. Net sales for the quarter increased 18%, to $57.8 million. The rise in sales is primarily due to higher sales of an active pharmaceutical ingredient (API) to a customer who experienced a disruption in its supply chain for most of 2010; higher volumes of controlled substances; and increased volumes of products utilizing Cambrex’s drug delivery technology, and for a recently approved innovator product, Cambrex says. These increases were partially offset by lower pricing across several product categories, lower sales of generic APIs, and lower custom development sales, the company adds.
The third quarter saw “increased revenues from custom manufacturing, controlled substances and drug delivery products. While generic API revenues were slightly lower during the quarter, incoming orders remain strong for this product category. We continue to focus on generating free cash flow, lowering our production costs and developing new products to support continued growth,” says Steven M. Klosk, president and CEO of Cambrex.
INDUSTRY POISED TO INTRODUCE GLOBAL PHARMA EXCIPIENTS CERTIFICATION SCHEME
By Alex Scott
Manufacturers of excipients have come together to create Excipact, a scheme for international pharmaceutical excipients certification. The scheme is designed to cut out risks along the supply chain that could compromise product safety and quality through a substantial increase of physical audits. Companies with products that pass the audit will be issued with an Excipact certificate. Overall audit costs will be reduced, however, through an organized audit sharing system.
Excipact is slated to become operational in the first quarter of 2012. Excipact is an initiative being driven by five industry groups including the European Fine Chemicals Group (Brussels), a part of Cefic. The Excipact initiative was unveiled by EFCG at the CPhI pharmaceuticals expo held recently in Frankfurt.
Excipact will be a voluntary, self-regulated and global initiative. It has been designed to ensure that current GMP and GDP requirements are applied to pharma excipients through a recognized auditing and certification process that will increase the safety and reliability as well as transparency of the pharma supply chain. A large number of third party auditing companies will be recognized and listing on the organization’s website. Companies that pass – as well as fail – the audits also will be listed on the website.
FDA APPROVED 35 NEW INNOVATIVE DRUGS IN FISCAL 2011
The U.S. Food and Drug Administration (FDA) says it approved 35 new medicines in the fiscal year ended September 30, 2011. This is among the highest number of approvals in the past decade, surpassed only by 2009, when 37 drugs were approved. The FDA provided details of the drug approvals in a report released this week. The approved drugs include two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years. Seven of the new medicines are major advances in cancer treatment, FDA says. The report shows faster approval times in the U.S. when compared to the FDA’s counterparts around the globe - 24 of the 35 approvals occurred in the U.S. before any other country in the world and also before the European Union.
EVONIK ACQUIRES SURMODICS PHARMACEUTICALS
Evonik Industries says it has reached an agreement to acquire SurModics Pharmaceuticals (Birmingham, AL), the pharmaceutical business of SurModics (Eden Prairie, MN). SurModics Pharmaceuticals is a leading provider of injectable drug delivery systems. The business includes two facilities for the development and manufacturing of polymers and drug delivery systems. The company employs about 80 pharmaceutical experts and had revenues of about $15 million in 2010. The acquisition is expected to be completed soon, and it enables Evonik to further develop its healthcare business, the company says.
AJINOMOTO ANNOUNCES NEW PRICING STRUCTURE FOR PHARMA-GRADE AMINO ACIDS
Ajinomoto (Tokyo) has announced a new pricing structure for its pharmaceutical and food-grade bulk amino acids. An increase of 10%-15% is currently in effect as a result of global increases in raw material and energy costs, the company says. This new pricing structure affects bulk amino acids sold worldwide by Ajinomoto and the company’s subsidiaries.