in this issue
Pharma/Fine Chemicals Roundup – July 10
9:32 AM MDT | July 10, 2012 | By DEEPTI RAMESH
OBAMA SIGNS OFF ON FDA GENERIC DRUG USER FEE ACT - Lindsay Frost
President Obama has signed into law a measure that will revise FDA’s ability to oversee certain provisions related to pharmaceutical ingredients and which includes a generic drug user fee program. The new statute represents a significant victory for Socma, which for years has been urging lawmakers to take steps to make sure U.S. makers of active pharmaceutical ingredients (APIs) do not face unfair competition from overseas producers. It also is one of the few industry-related measures to pass Congress this year.
SIEGFRIED TO BUILD PHARMA INGREDIENTS PLANT IN CHINA
Siegfried (Zofingen, Switzerland), a producer of APIs, intermediates, and finished drugs, says it will build a new production facility at Nantong, China. Siegfried told CW last year that it was planning a production facility in China. In the first phase of the Nantong project, Siegfried will build a plant to produce APIs and pharma intermediates. Production is expected to begin in 2014. The second phase of the project plans to expand the facility to produce finished dosage form products. The project is being supported by the Nantong Economic and Technological Development Area (NETDA), a Chinese development organization, Siegfried says. The facility in China will strengthen Siegfried’s competitive position and create additional sales opportunities in Asia, the company says.
MYLAN WELCOMES FDA SAFETY AND INNOVATION ACT
Mylan (Canonsburg, PA) says it applauds President Barack Obama’s signing of the Food and Drug Administration Safety and Innovation Act, legislation that will significantly enhance the safety and security of the U.S. drug supply chain, level the playing field to hold all drug manufacturers to FDA's inspection standards, and improve timely access to high-quality, affordable generic drugs. The Generic Drug User Fee Act "has stepped up to the plate to help address an industry wide issue by providing FDA with approximately $1.5 billion over five years in order to help fund these increased inspections of drug facilities and ensure faster and more predictable review of generic drug applications," Mylan says.
LONZA LAUNCHES NEW GS GENE EXPRESSION SYSTEM
Lonza says it has today launched the new GS Xceed gene expression system—the latest generation of Lonza’s GS System, which has been used to create over 100 cell lines and 13 therapeutic drugs currently on the market. GS Xceed has been shown to reduce cell line development timelines by up to 6 weeks over the existing CHOK1SV based system and has achieved titers of up to 6 g/L, Lonza says. Both emerging and established companies with protein therapeutics in their pipeline can access the new system by either a research evaluation agreement or a commercial license. Additionally, the new system is available worldwide, allowing multinational companies global access to the system in all pharmaceutical and biotechnology markets, Lonza says.
CHINA TO SPEND $81.7 BILLION ON PHARMACEUTICALS IN 2012
China will spend about $81.7 billion on pharmaceuticals in 2012, compared with $66.7 billion in 2011, says a new market research report by Business Monitor International (BMI; London). Despite the country's calls for cheaper pharmaceutical access, China will be a highly attractive market for pharmaceutical players, BMI says. Its strong pharmaceutical trade in 2011 and in the first quarter of 2012 highlight that the general weakness in its macroeconomics has not filtered down to the sector and, instead, the sector performance will largely hinge on the country's healthcare reform plans, BMI says.
BRISTOL-MYERS SQUIBB BEGINS TENDER OFFER TO ACQUIRE AMYLIN PHARMACEUTICALS
Bristol-Myers Squibb (BMS; New York) says it has today commenced the previously announced tender offer to purchase all outstanding shares of common stock of biopharmaceutical company Amylin Pharmaceuticals (San Diego, CA). BMS announced last month that it would acquire Amylin for about $5.3 billion. Amylin is focused on the discovery, development, and commercialization of medicines for patients with diabetes and other metabolic diseases. The tender offer will expire on August 7, 2012, unless extended. Upon the closing of the tender offer, shareholders of Amylin will receive $31 in cash for each share of Amylin common stock validly tendered.
AMGEN ACQUIRES KAI PHARMACEUTICALS FOR $315 MILLION
Amgen (Thousand Oaks, CA) says it has completed the acquisition of privately held KAI Pharmaceuticals (San Francisco, CA) for $315 million. The acquisition includes KAI's lead product candidate KAI-4169, which is a novel agent being initially studied for the treatment of secondary hyperparathyroidism in patients with on dialysis for chronic kidney disease.