in this issue
Pharma/Fine Chemicals Roundup – February 28
7:09 AM MST | February 28, 2012 | By DEEPTI RAMESH
PHARMA FINE CHEMICAL SUPPLY CHAIN UNDER THREAT
Industry experts, including Tom Beil, v.p./quality and regulatory affairs at Sigma-Aldrich Fine Chemicals (SAFC), say the fine chemical supply chain remains under threat from a range of sources and that contract fine chemicals manufacturers and pharma companies must remain vigilant. Beil was among a group of expert panelists providing insights into the state of the fine chemicals supply chain during the Informex USA fine and specialty chemicals expo in New Orleans, LA this month.
MYLAN NORTH AMERICA PRESIDENT ELECTED CHAIRMAN OF GPHA
Mylan (Canonsburg, PA) says that Tony Mauro, president of Mylan North America and the company's Mylan Pharmaceuticals subsidiary, has been elected to serve as chairman of the Generic Pharmaceutical Association (GPhA; Washington, DC) board of directors. The GPhA represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Mauro's term as chairman of GPhA will last for one year.
“With growing populations, economic recessions and increasing health care costs, the need for widespread access to more affordable medicine has never been so great,” Mauro says. “The generic pharmaceutical industry, which accounts for 78% of all prescriptions dispensed in the U.S., has played an important role in saving the U.S. health care system and consumers an estimated $931 billion over the past decade.”
“Generic drug makers also have stepped forward to assist the FDA in addressing the industry-wide challenges, experienced by both brand and generics companies, caused by the globalization of the drug supply chain and the corresponding increase in the FDA's workload,” he says. “This effort positions GPhA at the forefront of our industry's important issues, and advises policy makers that they should look to us as a key partner when tackling current and future challenges.”
RANBAXY’S API BUSINESS REPORTS RISE IN SALES
The active pharmaceutical ingredients (API) business of Ranbaxy Laboratories (Gurgaon, India) has recorded an 8% increase in sales in the fourth quarter of 2011, compared with the year-ago period, to Rs2.18 billion ($44 million). API sales for the full year 2011 increased 26%, to Rs.6.77 billion. Earnings figures for the API business were not disclosed. During the full year, Ranbaxy made 160 drug master files (DMF) submissions for APIs.
GRINDEKS REPORTS RISE IN API SALES
Pharmaceutical company Grindeks (Riga, Latvia) says that the company’s active pharmaceutical ingredients (API) business reported a 24.3% rise in sales for the full year 2011, compared with 2010, to lats9.2 million ($18 million). Grindeks produces 22 APIs, and in 2011, the company introduced 7 new APIs. The main API export markets for Grindeks are Germany, Japan, the Netherlands, and the U.S.
“In 2011, Grindeks continued to strengthen its position in existing markets and increased the [total] turnover to lats69.9 million. In order to achieve better results in the future, the strategic priority of Grindeks will be product range expansion. In addition to existing therapeutic groups, Grindeks will develop new therapeutic directions – gastrointestinal and antimicrobial medications. In 2012, Grindeks will also pay special attention to strengthening the position of the foreign representative offices in all markets,” says Juris Bundulis, chairman of the board of Grindeks
ELI LILLY TO INVEST $444 MILLION TO BUILD NEW PLANT IN IRELAND
Eli Lilly says it will invest €330 million ($444 million) in a new facility at the company’s Kinsale campus at Cork, Ireland. The investment will expand the Kinsale site's existing biopharmaceutical capacity. The new facility, when fully operational, will require up to 200 highly skilled employees, Lilly says. “This investment is part of Lilly’s planned growth strategy and proof of our confidence in Lilly’s pipeline of new products, many of which are derived from biotechnology,” says Paul Ahern, senior v.p./global API and dry product manufacturing.
The planned biopharmaceutical commercialization and manufacturing facility will further enhance the company’s ability to bring treatments for illnesses such as cancer and diabetes to patients worldwide, Lilly says. This is the second large investment Lilly has made at its Kinsale site in recent years. In 2006, the company announced a €300 million investment in its first biopharmaceutical manufacturing and new-product commercialization facility at the Kinsale campus, which came onstream in 2010.
MERCK KGAA PREPARES FOR COST REDUCTIONS, JOB CUTS
Merck KGaA (Darmstadt, Germany), a producer of pharmaceuticals and specialty chemicals, says it is poised to restructure all of its businesses across all regions in order to cut costs and improve the group’s efficiency. “Implementation of the efficiency program may include workforce reductions across all businesses and all regions,” the company says. The company plans to cut an undisclosed number of jobs. It has 40,000 employees in 67 countries.
OPKO HEALTH ACQUIRES TECHNOLOGY TO ENHANCE SOLUBILITY OF DRUGS
OPKO Health (Miami, FL) says it has made an investment in BioZone Pharmaceuticals (Pittsburg, CA), and acquired rights to BioZone's novel drug delivery platforms, including its QuSome technology. With BioZone's proprietary chemical and formulation technology, the solubility of many drugs can be enhanced to provide superior final dosage forms, OPKO Health says. BioZone's technology is simpler and results in less costly drug manufacturing than other systems, OPKO Health says. OPKO has acquired, under the deal, a worldwide license for the development and commercialization of products utilizing BioZone's proprietary drug delivery technology, including QuSomes, exclusively for OPKO in the field of ophthalmology and non-exclusive for all other therapeutic fields, subject in each case to certain excluded products.
FOSTER WHEELER AWARDED CONTRACT FOR PHARMACEUTICAL FACILITY IN SAUDI ARABIA
Foster Wheeler says that a subsidiary of its global engineering and construction group has been awarded a conceptual and basic design contract by Saja Pharmaceuticals for the expansion of a manufacturing facility at Jeddah, Saudi Arabia. Saja Pharmaceuticals is a joint venture between Tamer Industries (Jeddah), Daiichi Sankyo (Tokyo), and Astellas Pharma (Tokyo), and it produces branded formulations as well as generics for the Saudi Arabian and other Mideast markets. Foster Wheeler’s scope of work is expected to be completed in May 2012. The value of the contract was not disclosed.
Foster Wheeler will provide conceptual and basic design services for a new research and development building, which will also be designed to manufacture small production lots for launching new products on the market, a new oral solid dosage manufacturing and packaging facility, a warehouse, quality control laboratories and an administrative building.