Delhi based pharma analysts have found fault with the repeated news coverage on US FDA approval for Nefazodone HCL tablets to Dr Reddy's Laboratories by a business news channel last week. They feel that the report was aimed at boosting the company's share value amidst the Bull Run. According to them the company's share price shot up from Rs 1195 to Rs 1360 within 24 hours after the news telecast.
"The inspired coverage was intended to give a feel that the drug for which the approval was given is going to be a money-spinner for the company. On the contrary, the global prospects of the drug are on the decline with more and more countries banning its use, they point out.
When enquired, medical experts also agreed to the harmful side effects of the drug and the recent decisions of several countries to prohibit its use. The analysts feel that the approval for such a dying drug should not have been given such importance.
Dr. Reddy's had announced on September 17 that the US Food and Drug Administration has issued final approval for the company's abbreviated New Drug Application for Nefazodone Hydrochloride tablets 50, 100, 150, 200 and 250 mg. The company had also informed that the product would be marketed through the company's alliance partner, Par Pharmaceuticals. The entire section of the media including the same channel had covered the same news on September 18. Analysts find the repeated coverage given to the same news after about two months intriguing.
According to medical experts, Nefazodone, an anti-depression drug is a research molecule of Bristol-Myers Squibb, and was introduced in 1994 in the world market.
"The drug has been banned in United Kingdom early this year and is due to be withdrawn from Canadian market by November 27, 2003. Nefazodone is known to cause severe and serious adverse effects on liver. A number of patients on Nefazodone have either died or needed liver transplant. The problem with the drug is that cases of liver injury do not occur immediately but take from few weeks to few years before manifesting." They explained.
Bristol-Myers Squibb is also known to have announced: "It has come to the attention of Health Canada that nefazodone (Serzone) has been associated with adverse hepatic events including liver failure requiring transplantation in Canada. Following discussions with Health Canada, Bristol-Myers Squibb Canada has decided to discontinue sales of nefazodone, effective November 27, 2003."
Medical experts feel that the safety of the drug is under cloud in several Western countries and its use could be subjected to a review even in United States in near future. According to Dr Reddy's press release "Nefazodone hydrochloride is the AB-rated generic equivalent of Bristol Myers Squibb's Serzone. Serzone is indicated for the treatment of depression. As per IMS 2002, the product had annual US brand sales of approximately $261 million."
The analysts point out that the figures given by the company is of 2002, when the safety of the drug was not under cloud. "Most investors in the Indian equity market depend upon the media for guidance on future earnings of companies. It is easy to take them for a ride by planting misleading stories" they say.