Pharmaceutical News: New Hepatitis C Drug Wins FDA Approval

New Hepatitis C Drug Wins FDA Approval

Vertex Pharmaceutical’s hepatitis C drug, telprevir, received Food and Drug Administration (FDA) approval Monday not long after the agency cleared a competing medicine by Merck.

Telprevir, which will be marketed under the brand name Incivek, is approved for use with interferon therapy, the FDA said.

The drug was approved on clinical data that showed about 79 percent of patients receiving Incivek with older drugs had no signs of the virus 24 weeks after stopping treatment.
Merck recently enlisted the aid of rival Roche to promote its drug, Victrelis.

Clinical data has suggested that Incivek has superior efficacy to Victrelis and may capture more of what is expected to be a multi-billion-dollar market.

The FDA approved Victrelis May 13, based on clinical data showing that about two-thirds of patients receiving Victrelis in combination with the older drugs had no signs of the virus 24 weeks after stopping treatment.

Transcept Pharmaceuticals Inc. Stock Upgraded (TSPT)

Transcept Pharmaceuticals (Nasdaq:TSPT) has been upgraded by TheStreet Ratings from sell to hold. The company’s strengths can be seen in multiple areas, such as its increase in stock price during the past year and notable return on equity. However, as a counter to these strengths, we find that the growth in the company’s net income has been quite unimpressive.

Highlights from the ratings report include:
The change in net income from the same quarter one year ago has exceeded that of the Biotechnology industry average, but is less than that of the S&P 500. The net income has decreased by 5.3% when compared to the same quarter one year ago, dropping from -$1.84 million to -$1.94 million.
Current return on equity exceeded its ROE from the same quarter one year prior. This is a clear sign of strength within the company. Compared to other companies in the Biotechnology industry and the overall market, TRANSCEPT PHARMACEUTICALS’s return on equity significantly trails that of both the industry average and the S&P 500.
Compared to where it was 12 months ago, the stock is up, but it has so far lagged the appreciation in the S&P 500. Despite the fact that it has already risen in the past year, there is currently no conclusive evidence that warrants the purchase or sale of this stock.
Despite the stagnant revenue growth, the company outperformed against the industry average of 6.9%. Since the same quarter one year prior, revenues have remained constant. Both the company’s revenue growth and earnings per share have remained constant.
TRANSCEPT PHARMACEUTICALS reported flat earnings per share in the most recent quarter. This company has reported somewhat volatile earnings recently. But, we feel it is poised for EPS growth in the coming year. During the past fiscal year, TRANSCEPT PHARMACEUTICALS continued to lose money by earning -$0.70 versus -$1.66 in the prior year. This year, the market expects an improvement in earnings ($0.89 versus -$0.70).

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of proprietary products that address therapeutic needs in neuroscience. Transcept has a market cap of $134.7 million and is part of the health care sector and drugs industry. Shares are up 38.9% year to date as of the close of trading on Friday.

Par Pharma to Buy India-Based Generic Drug Maker

Par Pharmaceutical Cos. will acquire India-based generic drug maker Edict Pharmaceuticals for up to $37.6 million.

The company expects the deal to close by the end of the year and add to earnings in 2013.

Par, itself a maker of generic drugs, has also been moving into the branded pharmaceutical market by developing updated versions of off-patent drugs.

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Privately held Edict develops and manufactures solid oral dosage generic drugs with a focus on niche first-to-file, first-to-market formulations. The company has eight abbreviated new drug applications awaiting approval from the U.S. Food and Drug Administration, one application filed in the name of a development partner and 14 products in development.

Par President Paul V. Campanelli said the drug maker has a long-standing relationship with Edict Chief Executive Muthusamy Shanmugan after the two companies collaborated on numerous current Par products.

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