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Pharma/Fine Chemicals Roundup – October 4

4:47 AM MDT | October 4, 2011 | By DEEPTI RAMESH

TAKEDA ACQUIRES NYCOMED FOR €9.6 BILLION

Takeda Pharmaceutical (Osaka, Japan) says it has completed the acquisition of pharmaceuticals company Nycomed (Zurich, Switzerland) for €9.6 billion ($12.8 billion). Frank Morich has been named CEO of Nycomed, in addition to his current role as executive v.p./international operations at Takeda Pharmaceuticals International.

Takeda has a strong presence in the Japanese and U.S. markets, while Nycomed has a significant business infrastructure in Europe and high-growth emerging markets that will enhance Takeda’s regulatory development expertise and commercialization capability, Takeda says. The acquisition will also bring Takeda an increase in cash flow generated from annual revenue of more than €2.8 billion from the acquired business. The combined company will have commercial presence in the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, central nervous system diseases, inflammatory and immune disorders, respiratory diseases and pain management, as well as having a well-balanced presence in pharmaceutical markets of Japan, North America, Europe and Asia/emerging markets, Takeda says.


SILVERFLEET CAPITAL REPLACES LDC AS MAJORITY SHAREHOLDER IN AESICA

Aesica Pharmaceuticals (Newcastle upon Tyne, U.K.), a supplier of active pharmaceutical ingredients (API), formulations, and custom synthesis, says that private equity firm Silverfleet Capital (London) has replaced Lloyds TSB Development Capital (LDC) as its majority shareholder, and members of the Aesica executive have reinvested for a large minority stake in the company. The investment by Silverfleet Capital is subject to regulatory clearance from German authorities, and is expected to be completed in the next four weeks. Aesica says it plans for further growth and expansion following the investment from Silverfleet Capital, and that the investment will enable Aesica to continue its rapid expansion into new markets.

Silverfleet Capital was chosen “as our financial partner because of their deep knowledge of our market and their experience and successful track record of building global businesses of scale through buy and build strategies,” says Robert Hardy, CEO of Aesica. “Our long term strategic plan was to establish a manufacturing presence in the U.S. and Asia in 2012 and with the support from Silverfleet Capital we can continue to expand into new markets, evolve and grow more swiftly.”

“Global outsourcing of pharmaceutical manufacturing was worth $44 billion in 2010 and is forecasted to grow at 7% /yearfor the foreseeable future. Aesica is in a strong position to benefit from that growth through further expanding its international footprint in Europe, the U.S. and Asia and by increasing the number of strategic partners it works with,” says
Adrian Yurkwich, partner at Silverfleet Capital/healthcare.


GENERICS SAVED THE U.S. $931 BILLION IN TEN YEARS

The Generic Pharmaceutical Association (GPhA; Washington) says that an independently conducted analysis show that the use of generic prescription drugs in the U.S. has saved consumers and the health care system $931 billion during 2001-2010. The analysis, conducted for GPhA by the IMS Institute for Healthcare Informatics and IMS Health (Danbury, CT), shows that in 2010 alone, generic drug use generated nearly $158 billion in savings, an average of $3 billion every week.

“The analysis shows beyond doubt that savings achieved through the use of safe and effective generics deliver a huge win to consumers looking to hold down their health care costs,” says Ralph G. Neas, president and CEO of GPhA. “Moreover, the savings provide a winning solution to those in Washington trying to address the sustainability of the nation’s health care system, as well as the national economy.”
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 78% of the prescriptions dispensed in the U.S. but consume just 25% of the total drug spending, GPhA says.


FDA ISSUES WARNING LETTER TO API PLANT IN CHINA

The U.S. Food and Drug Administration (FDA) issued a warning letter last month to the active pharmaceutical ingredient (API) manufacturing facility of Sichuan Pharmaceutical, located in Pengzhou, Sichuan province, China, for deviating from current good manufacturing practice (cGMP). An FDA inspection from June 23, 2010 to June 29, 2010 at the API facility of Sichuan Pharmaceutical identified significant deviations from cGMP for the manufacture of APIs, FDA says. Sichuan Pharmaceutical responded on August 5, 2010 and December 13, 2010, and the FDA says it has reviewed the response, and that the corrective actions taken by Sichuan Pharmaceutical are not sufficient.

The cGMP violations for the manufacture of APIs at the site include failure to have appropriate procedures in place to prevent cross-contamination. Additionally, the firm is neither registered nor has it listed every API in commercial distribution in the U.S. with FDA, as required. Until all corrections have been completed, the FDA may withhold approval of any new applications or supplements listing Sichuan Pharmaceutical firm as an API manufacturer. In addition, failure to correct these deviations may result in FDA refusing admission of articles manufactured at the Pengzhou facility, into the U.S., FDA says.













 
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