Long Road For GSK's Cervarix Vaccine To Get To US

British based pharmaceutical company, GlaxoSmithKline Plc. announced on Monday that its human papillomavirus (HPV) vaccine, Cervarix would take even longer to get to the United States than it was expected.

In the early 2007, world’s second largest drugmaker, GlaxoSmithKline had first filed a marketing application to get cervical-cancerdefine vaccine, Cervarix to the US market but in December, the Food and Drug Administration (FDA) decided that it needed more information.

Now, Glaxo says that the company has given satisfactory answers to the FDA’s questions but still wants to submit additional data from an ongoing study that should finish by the end of this year.

Barbara Howe, GSK’s head of North American vaccine development, said: "Study 008 is a key study that will be completing later this year and we expect the final results will strengthen the U.S. label for Cervarix."

At present, Merck's Gardasil has captured the US market in the absence of any competitor but, the Cervarix is considered to be a 'probable blockbuster treatment' that is central to the company's future growth. The market for cervical cancer vaccine is estimated to be worth more than $1 billion a year in sales.

Glaxo’s Cervarix provides protection against some types of HPV that lead to cervical cancer. The vaccine is included in the national health programmes in 5 EU countries such as Britain, France, Germany, Austria and Italy and many more are considering about it. Cervarix is already on the market in Europe, Mexico, Australia and parts of Asia.

The vaccine protects against the two types of human papillomavirus or HPV (HPV 16 and HPV 18) responsible for about 75% of cervical cancers.

HPV infections are very common. Many cases of cervical cancer are caused by the sexually transmitted human papillomavirus making it the second most common type of cancer in women. According to the World Health Organization, each year 250,000 women die from cervical cancer.

Approximately 300,000 people die each year due to the disease, mostly in developing countries.

On Wednesday, GlaxoSmithKline announced that U.K.'s Department of Health has chosen their human papillomavirus (HPV) vaccine, Cervarix over Merck's Gardasil for its immunisation programme.

Last week, FDA delayed its decision on Eli Lilly's new heart drug, Prasugrel and said it will take another three months to review the drug. And after that Merck & Co., the third-largest U.S. drugmaker said that the company has to wait for a change in label to its already approved cervical cancer vaccine, Gardasil.

Since 2006, Merck’s blockbuster Gardasil has had the U.S. market to itself. The company added nearly US$300 million in sales in the last quarter alone.