Friday, December 26, 2014

Different outcomes for 2 cancer vaccines

Merck's Gardasil has been on the U.S. market for two years, but GlaxoSmithKline's Gardasil is stalled in the regulatory process.

Different outcomes for 2 cancer vaccines

There’s a reason companies rush to be the first to market with a product.

You can establish your brand and build a lead that competitors may not be able to trim.

Merck & Co. Inc. and GlaxoSmithKline PLC spent years developing vaccines to prevent cervical cancer. Merck’s Gardasil won approval from the Food and Drug Administration two years ago.

Through the end of March, Merck sold $2.1 billion worth of its vaccine.

And GlaxoSmithKline? Its Cervarix is mired in the FDA approval process. It submitted its application in March 2007, but the FDA in mid-December demanded more information about Cervarix.

GlaxoSmithKline on Monday said that it had responded to the FDA’s questions, but it now intends to submit final data from a late-stage clinical trial during the first half of 2009. That means it could be late 2009 before the FDA could render its decision.

That would give Merck a 3 1/2-year lead with a drug that targets the second-most-common cancer among women worldwide. More than 280,000 women die from cervical cancer every year, most in the developing world.

Fortunately for GlaxoSmithKline, Cervarix has been approved in 67 other countries, including the European Union, Mexico and the Philippines. So Merck and GlaxoSmithKline can duke it out overseas.

But the U.S. market is where drug companies can make the most money. From here, it looks like Merck will have the U.S. all to itself for another 18 months.

Staying in N.J.

When A.C. Moore Arts & Crafts Inc. announced on June 10 that its chief financial officer had resigned, the retailer said only that Marc Katz would be pursuing a “career opportunity in the private equity sector.”

On Monday, Katz was named executive vice president and chief accounting officer of Burlington Coat Factory Warehouse Corp., the South Jersey-based retailer of outwear and other apparel.

How is that a job in the private-equity industry?

Well, Burlington Coat was taken private in April 2006 by Bain Capital LLC in a deal valued at $2.1 billion.

Mike Armstrong Inquirer Columnist
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