Sorry!! The article you are trying to read is not available now.
Thank you very much;
you're only a step away from
downloading your reports.

Gardasil: The Merck Blockbuster That Wasn't


Seeking approval to market the HPV vaccine to older women.

Merck (MRK) is still hoping that women ages 27 to 45 will want to be "one less". But one less might not be enough.

The Big Pharma company said in a statement on its website that it's still pursuing the approval of its HPV vaccine Gardasil for older women, emphasizing that the FDA typically takes six months to review a drug for a new indication. The company got a no-go from the agency early last year when it was asked for further evidence that the vaccine was effective in women over the age of 26. That was the second time that the new indication has been passed over.

Gardasil is approved for the prevention of the human papilloma virus. There are more than 100 different strains of HPV and 15 of those are known to cause cervical cancer. Vaccines like Gardasil are made to prevent only a few of the 15 strains that cause cervical cancer, but can still significantly reduce the risk of getting the deadly cancer. Cervical cancer is the second-leading cause of cancer-related death in US women ages 20 to 39, after breast cancer. There are an estimated 3.5 million abnormal Pap smears annually in the US, and more than 1.5 million precancerous lesions diagnosed.

Despite the huge population that the vaccine caters to, Merck has seen its share of disappointments with the drug since it hit the worldwide market in 2006. It was originally approved for women ages 9 to 26 years old, but the pharma company had trouble getting the idea of a cervical cancer vaccine to catch on with that age group.

Aside from problems getting women over 20 to consider the vaccine, there was plenty of backlash from moms who weren't sure the vaccine was safe for their young girls and from religious groups that felt it was a promotion for unsafe sex. (Both of these concerns eventually died down, but could still be reasons for the drug's lackluster performance).

Merck has continued to see sales of the drug drop; worldwide sales fell 25% year-over-year to $841 million in the first nine month of 2009. Merck has tried all sorts of things to help fix the sales problem with Gardasil. It's likely you've seen the company's advertising for the vaccine that is played on most networks and has young girls chanting that they want to be "one less".

In January 2009, the company shuffled leadership on the Gardasil project in hopes of affecting change. Merck even got approval from the FDA in October 2009 to expand the vaccine to the prevention of genital warts in boys and men. Yet nothing has pushed the company to expand its sales forecasts for the drug, which Merck has consistently guided to be just above $1 billion each year that Gardasil has been on the market.

While the vaccine may be considered a blockbuster by conventional standards (it typically has annual sales over $1 billion), Gardasil isn't seeing the numbers it should considering the size of the market and the fact that there have been no competitors in the US market until just recently.

GlaxoSmithKline (GSK) got approval for its cervical cancer vaccine in October 2009 (the same day the FDA approved Gardasil for men). Glaxo's Cervarix has been available in Europe for years and has been one of the major reasons that Merck has had disappointing sales outside of the US.

While analysts don't expect Cervarix to catch on in the US, the new competition could mean one less shot in an American arm with Gardasil.

Minyanville's stock portfolio, FlexFolio by Quint Tatro, has beaten the S&P 500 by 24% since inception and is off to a great start in2010. With a FREE 14 day trial you'll get access to the portfolio, trade alerts before each trade and interactive strategy sessions. Learn more.
< Previous
  • 1
Next >
No positions in stocks mentioned.

The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.

Copyright 2011 Minyanville Media, Inc. All Rights Reserved.

Featured Videos