GLG News by Physicians who Treat Onychomycosis (US)

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Starpharma gets US patent for use of VivaGel for protection against STIs

September 29, 2009

Analysis of:Starpharma gets US patent for use of VivaGel for protection against STIs | www.pharmabiz.com

Starpharma's lead product, is a vaginal microbicide gel under development for the prevention of sexually transmitted infections (STIs), including genital herpes and HIV infection. The VivaGel® product concept is designed to offer a safe, convenient and affordable means for women to protect themselves from infection with genital herpes and HIV during sex. Surveys show that there is substantial demand in North America and Europe for such a product with an estimated billion dollar market for STI prevention products in the developed world.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Stelara new Option for Psoriasis

September 26, 2009

Analysis of:Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults | www.webmd.com

The FDA approved Stelara based on three studies of 2,266 patients who either got shots of Stelara or a placebo. Patients who got Stelara were more likely to achieve the studies' benchmark for reduction in psoriasis.In a news release, the FDA notes that because Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. "Serious infections have been reported in patients receiving the product and some of them have led to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer," the FDA states.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Good and Bad From Astellas Joint Venture With Maxygen

July 5, 2009

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%).  

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Efalizumab Withdrawn Due to Serious Side Effect

April 16, 2009

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.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Various Generic Topiramate Tablets Approved by FDA

March 31, 2009

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.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

No Bidding War For CV Therapeutics From Astellas

March 17, 2009

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

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Multivitamin Supplements can not prevent Cancer or Heart Disease.

March 12, 2009

Analysis of:Multivitamins: Fact or Fiction | www.usatoday.com

As a pharmaceutical consultant, I read this article with great interest. Overall this article support my thinking that multivitamin supplements can not prevent Cancer or Heart Disease due to these reasons: Our Daily requirements of Multivitamins supplements are very low and food is the best source of vitamins and minerals is from our body Multivitamins should be used as part of an overall healthy lifestyle Despite many health warnings, the quest for the right multivitamin still uncontrollable.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Indian pharmaceutical Companies Are Attractive For Multinational Companies

February 24, 2009

Analysis of:Pharma cos on lookout for Indian drug firms | economictimes.indiatimes.com

As a pharmaceutical consultant, working with various clients in India and here, I think Indian pharmaceutical companies are attractive for acquisitions by Multinational Companies due to these reasons: * Their relatively low valuation compared to firms elsewhere * India's massive internal market * Multinational Companies has few patented drugs in the market and       generic market is growing in USA.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

How Should NIH Spend $10B ?

February 12, 2009

Analysis of:Senate Passes Recovery Bill with $10B for NIH | www.genomeweb.com

I read this news with great interest. I think NIH should spend this money in these direction:   Take the opportunity to revamp the system including labs, buildings, equipments and researchers. I think either altering or completely retooling the peer review process to allow for a greater dispersal of NIH funds among American scientists. We might want to update our aging and decaying instruments, so save a little money for that and improve our lab productivity and will attract more researchers

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Great News For NIH

February 5, 2009

Analysis of:Economic Recovery Act Now Holds $10B for NIH | www.genomeweb.com

I read this article with great interest and hope that this additional funding will be god send for NIH specifically  in the area of biomedical research Congress, passed an amendment yesterday (Feb. 3) to add $6.5 billion in National Institutes of Health funding on top of the $3.5 billion already allotted to the agency in the bill. I think that the US still has the best opportunities for scientists, Providing money will certainly provide the stimulus!

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