Study Group: Medical Tourism Experts

GLG News^SM Analyses by this Study Group's Leading Experts(?)

Good and Bad From Astellas Joint Venture With Maxygen

July 5, 2009

Analysis by:Kuldeepak Sharma, President/Pharmaceutical Consultant,

Analysis of:Astellas Announces Joint Venture with Maxygen to Develop Protein Pharmaceuticals | www.pipelinereview.com

I read this news with great interest. This joint venture called (MPC) will advance Maxy 4 development program for rheumatoid arthritis and transplant rejection. Maxygen & Astellas  are committing $ 10 million each for this joint venture. Since I have worked with Astellas (Yamanouchi) and based on my experience, I think this joint venture (JV) is good for shareholders of Maxygen and Astellas but bad for Maxygen employees. I think Maxygen will shift programs and assets to other companies and it's R&D operations and personnel will go to this new JV with Astellas. This will leads to layoff form financial, administrative, corporate and support departments. This press release did not said when and how many pink slips will be handed out. .I think This strategy is already working based on Maxygen stock closed on July 1 at $7.17 up $0.45 (6.7%).  

Efalizumab Withdrawn Due to Serious Side Effect

April 16, 2009

Analysis by:Kuldeepak Sharma, President/Pharmaceutical Consultant,

Analysis of:Efalizumab withdrawn from US Market | www.medscape.com

I read with great interest that Genentech, the maker of Raptiva (Efalizumab) to treat psoriasis, has begun a voluntary, phased withdrawal of the drug from the U.S. market. The drug is not being withdrawn immediately to give physicians and patients taking Raptiva time to safely and appropriately discontinue treatment. Because it's possible that abruptly discontinuing Raptiva may cause a severe flare of psoriasis, As a pharmaceutical consultant and pharmacist, I think phase withdrawal is a good approach. Overall I do not think this withdrawal will have long term impact on other biologic products in US and world.Genentech estimates that approximately 2,000 patients in the United States may currently be receiving Raptiva for chronic plaque psoriasis. Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva.

Thriving in a time of adversity - Sun Pharma pounces on shortage by getting approval on Oxycodone

April 13, 2009

Analysis by:Aemad Aslam, President,

Analysis of:Sun Pharma gets USFDA's nod to market painkillers | www.hindu.com

Sun Pharma can greatly benefit from the nationwide shortage of Oxycodone Immediate Release Tablet, by getting approval from the FDA on their own generic. With recent recalls from different manufacturers, and the shortage of a comparable product Morphine Sulphate, the FDA currently estimates that return to normal supply levels of Oxycodone may occur in approximately 2 months, during which time Sun Pharma can capitalize on the shortage by securing longer term contracts with wholesalers.

Various Generic Topiramate Tablets Approved by FDA

March 31, 2009

Analysis by:Kuldeepak Sharma, President/Pharmaceutical Consultant,

Analysis of:Ranbaxy, Aurobindo get US FDA nod for epilepsy drug | economictimes.indiatimes.com

As a Pharmaceutical consultant and pharmacist I read this article with great interest since prices Topiramate will further reduced due to additional generic company. Topamax® is very useful drug for the treatment of adult and pediatric Epilepsy. On September 2006, Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets, 25mg, 100mg and 200mg On March 28, 2009, Various companies (Teva, Sun, Ranbaxy) will market its version of the Topiramate tablets, the medicine in Topamax, in dosages of 25, 50, 100, and 200 mg. Annual sales of Topamax(R) were approximately $2.4 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data.

No Bidding War For CV Therapeutics From Astellas

March 17, 2009

Analysis by:Kuldeepak Sharma, President/Pharmaceutical Consultant,

Analysis of:Astellas to Terminate Offer for CV Therapeutics | www.pipelinereview.com

I read this news with great interest since I have worked with Astellas (Yamanouchi). Based on my experience with Astellas I am not surprise that Astellas did not increase prices (although Astellas had so much to gain from a merger with CV) due the these reasons: * Astellas (as a Japanese company) is a disciplined acquirer * $20 per share offer from Gilead, which values the company at around $1.4 billion is too expensive for Astellas * Astellas now needs to look elsewhere in order to find a company or products * Astellas will follow other Japanese drug companies like Takeda and Eisai

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