Healthy Skepticism Library item: 13345

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Todd S.
Industry Insider: Once again, a spotlight on Vytorin
The Star Ledger 2008 Mar 20
http://www.nj.com/business/ledger/index.ssf?/base/business-1/1205991306283090.xml&coll=1

Full text:

The American College of Cardiology said yesterday it would bend its own rules to place the controversial Vytorin clinical trial on center stage at the organization’s scientific conference in Chicago later this month.

In a pre-conference press briefing yesterday, ACC President James Dove said the results will be featured in a “showcase” where scientists will present the results and a panel of experts will discuss them on March 31. The conference runs through April 2.

Schering-Plough and Merck have seen their shares plunge after the study found Vytorin worked no better in preventing build-up of fatty plaque in arteries than the generic version of Zocor. The companies released the study’s findings in January under pressure from Congress.

Usually, ACC forbids the presentation of results announced in advance of the conference. Since release of the results barred it from the coveted “Late Breaking Clinical Trial” sessions, Dove said, the Vytorin study was given a prominent Monday time slot and dubbed a “showcase.”

“This data needed to be released. We’re not complaining about that,” Dove said of the drugmakers’ pre-conference announcement. “It’s a very important and interesting clinical trial and that’s why we put it in a showcase.”

The idea, he said, “is to present the information and discuss the trial and the trial design, what it shows and didn’t show. It’s giving the profession a chance to hear a balanced view of this information.”

— George E. Jordan

Nycomed’s blues

The other shoe dropped this week in Nycomed’s acquisition of Bradley Pharmaceuticals, with word nearly two-thirds of Bradley’s work force will be let go.
Nycomed, a Swiss specialty drugmaker that has local offices in Florham Park, told state officials that it plans to eliminate 196 jobs that were once based at Bradley’s headquarters in Fairfield. The layoffs take effect April 30, according to information on the New Jersey Department of Labor’s website.

When the $346 million deal was completed last month, Nycomed said it would transfer “key employees” of Bradley from Fairfield to Florham Park, which will be home to the Swiss company’s PharmaDerm division. Before the sale, Bradley had employed roughly 300 people.

An undisclosed number of layoffs were made on Nycomed’s side, too, according to Mindy Kirsch, a spokeswoman for Nycomed US. With Bradley folded in, the PharmaDerm unit will have 150 to 160 employees, some 30 to 35 of whom will work at Florham Park, she said.

The purchase of Bradley makes privately held Nycomed one of the top five companies selling prescription dermatology products.

— Jeff May

Gardasil a moneymaker

Merck’s investment in the Gardasil vaccine could soon produce an even bigger payoff.
Federal drug regulators notified the company yesterday they will accelerate their review of Merck’s request for expanded approval of the vaccine in women between the ages of 27 and 45.

The vaccine is already approved for girls and young women between the ages of 9 and 26 as a protection against four strains of the human papillomavirus, which often leads to cervical cancer, precancerous lesions or genital warts.

With the accelerated review, Merck could see its market for the vaccine broaden within the next six months.

Gardasil, which was approved in 2006, has been a boon for Merck’s business. The vaccine generated $1.5 billion in its first year of sales, and the additional approval for older women can only send revenues soaring higher. Gardasil is also credited with pushing the company’s vaccine business to $4.3 billion in 2007.

What’s next? Whitehouse Station-based Merck already is working to prove the vaccine is effective at protecting teenage boys and young men from HPV.

The drugmaker expects to submit a filing with the Food and Drug Administration later this year requesting approval to use the vaccine in males between the ages of 16 and 26.