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Pharma news in brief, January 04, 2007

The latest pharma news in brief
Astellas transfers three European plants
Astellas Pharma Europe and German pharmaceutical company, Temmler, have signed an agreement providing for the transfer by Astellas of bulk assets comprising the Munich Plant and Klinge Ireland Plant of Astellas Deutschland and all stocks of Produzioni Farmaceutiche Carugate to Temmler. Astellas' mid-term five-year management plan stated that the number of production sites would be reduced from 18 to around to around 10 by 2010 to achieve an optimal production system. Through the sale of the plants, Astellas aims to attain a reduction in its assets, while maintaining a guaranteed supply of its products, which Temmler will continue to manufacture, at these sites.

New River and Shire get approvable letter for Vyvanse for ADHD
New River Pharmaceuticals and its UK-based collaborative partner, Shire, have revealed that the FDA has issued a second approvable letter for the ADHD treatment, Vyvanse (lisdexamfetamine). In early October 2006, the FDA issued an approvable letter for the drug and New River Pharmaceuticals submitted a complete response to the FDA later that month. The FDA has not requested additional studies and both companies report they will work together to provide full and timely responses to the agency's request. Vyvance is expected to launch in Q2 2007, while the US Drug Enforcement Agency's parallel review of Vyvance's scheduling assignment should complete in Q1 2007, with an expected classification as a Schedule II controlled substance available in three dosages: 30mg, 50mg and 70mg for once daily dosing.

2007 will see biggest effort to give up smoking
The new year is expected to be the biggest to date for smokers attempting to conquer their addiction, according to a survey for the charity No Smoking Day. The results showed that 2.8 million smokers shall definitely try to stop when England goes smoke-free on 1 July 2007. GfK NOP, which carried out the survey, found that one in four UK smokers said that getting rid of smoking in pubs, clubs, restaurants and bars would be the boost they needed to quit. The survey questioned 2,000 UK respondents between 18 and 28 February 2006.

EUR 2.0 million EU grant for Angiostop anti-angiogenesis programme
Belgian biopharmaceutical company, ThromboGenics, and Swedish research-based pharmaceutical company, BioInvent, have received a EUR 2.0 million (£1.4 million) EU grant for the joint development of a new class of anti-angiogenesis agents. The new agents will be based on antibodies against Placental Growth Factor (PIGF). The grant will support the research efforts initiated in 2004 by the companies as part of a strategic collaboration to develop antibody-based candidate TB-403 for the treatment of tumours, inflammation and eye disease. The Angiostop consortium comprises four academic groups from Belgium, Germany and the UK: the University of Leuven Centre for Transgene Technology and Gene Therapy, the University Medicine Berlin and Cardiff University, respectively.

Alpharma completes share repurchase
Alpharma has completed its previously announced agreement to repurchase from A L Industrier (ALI) 100% of the company's Class B shares at $25.50 per share. Including related fees, the aggregate cost of the repurchase is approximately $308 million. Through its ownership of the Class B shares, ALI had voting power that provided it with effective control of the company. Control of Alpharma will now rest in the holders of the Class A shares acting by the majority applicable under Delaware law and the company's charter documents. The 11.9 million Class B shares repurchased represented approximately 22% of the company's total shares outstanding of 54.9 million at 30 November 2006. On 13 December 2006, Alpharma announced it had reached agreement with ALI to repurchase these shares, contingent on shareholder agreement. On 28 December, ALI shareholders voted to approve the transaction. The company also announced that it was discontinuing its quarterly dividend payment and would instead allocate these cash outlays to support its growth initiatives.

Ranbaxy wins FDA approval to market and manufacture atenolol tablets
Indian generics manufacturer, Ranbaxy, has received approval from the FDA to manufacture and market 25mg, 50mg, and 100mg atenolol tablets for hypertension. The Office of Generic Drugs at the FDA has determined the Ranbaxy formulations to be bio-equivalent and have the same therapeutic effect as that of the reference listed drug Tenormin of AstraZeneca. Total market sales for atenolol were $133.6 million, according to September 2006 IMS data.

4th January 2007


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