Merck Tops FDA Approvals This Year With Four New Drugs
September 10, 1998 5:25 PM
By Otesa Middleton
WASHINGTON (Dow Jones)--Merck & Co. (MRK)
leads the pharmaceutical pack this year with four new
drugs approved by the U.S. Food and Drug
Administration.
With its asthma pill, Singulair; heart drug, Aggrastat;
hypertension medication, Atacand; and Maxalt, for
migraines, Merck is responsible for 20% of the new
drugs approved so far this year, based on FDA
numbers.
As of Aug. 31, the FDA approved 20 new molecular
entities, compared with 18 for the same period a year
ago. These drugs, chemically different from other drugs
already on the market, don't fit into an existing class of
medications.
Following Merck's lead, two companies had a pair of
drugs cleared for marketing in the U.S. Roche Holding
AG's U.S. unit had its Parkinson's disease drug, Tasmar,
and Xeloda, for breast cancer, approved.
Hoechst AG's (HOE) Hoechst Marion Roussel won
approval for its heart drug, Refludan, and its Priftin, the
first new tuberculosis drug approved in 25 years.
But Merck's showing this year has been exceptional,
some say.
"Getting four big drugs approved is not normal for any
company in any given year," said Viren Mehta, an
analyst who follows Merck for Mehta Partners LLC.
However, Mehta isn't surprised by Merck's success.
"Merck is a preeminent company. It is one of the better
organizations. I expect it to continue to be a leader,"
Mehta said. "This was expected. This is a good year for
Merck."
Mehta said Merck will need these new products as
some of the company's other drugs lose their patent
exclusivity in the next three years. And Mehta expects
these new drugs to do a good job of replacing the sales
of the older drugs as their markets mature.
Singulair, Mehta projects, will be the biggest seller, with
peak annual worldwide sales at $1.5 billion. Atacand
will be a close second, Mehta said, with peak sales
surpassing the $1 billion mark.
Both Aggrastat and Maxalt will have peak sales in the
"several hundred million dollar" range, Mehta said.
David Saks, who follows Merck for Gruntal & Co., said
the total sales of the four new drugs will have a positive
impact on Merck's sales.
"These may not be individual blockbuster drugs like
Viagra," Saks said, referring to Pfizer Inc.'s (PFE)
top-selling impotence drug. "But having four drugs in
different areas of serious size is important."
Saks said Merck's pace so far this year is "better than
most," but he still expects more.
"They have a series of other drugs to come," he said.
Co. Says More Drugs In Pipeline
Carol Goodrich, a Merck spokeswoman, said
developing new drugs has been a high priority for the
company.
"Innovation is the key to our success," Goodrich said.
"We need new drugs to replace old ones, certainly with
important medicines going off patent."
Merck drugs going off patent soon include popular
gastrointestinal drug, Pepcid, and high-blood pressure
medicine, Vasotec. Both will lose patent exclusivity in
2000. In 2001, Mevacor, its cholesterol drug, will go off
patent, Goodrich said.
Not only can Merck count on the four drugs approved
this year, Goodrich said, but the company has more on
the way.
"The pipeline is very promising," she said.
By the end of the year, Merck plans to file for FDA
approval of its anti-inflammatory arthritis drug, Vioxx.
Also, information on Merck's anti-depression drug will
appear in the journal Science Friday, Goodrich said.
Merck's success in getting new drugs on the market
didn't just happen this year, Goodrich said.
"Since January 1995, we've had 14 new drugs
approved and launched," Goodrich said. "This is part of
our strategy for growth."
Merck has increased its research and development
spending steadily.
In 1994, the company spent $1.2 billion on research and
development. This year, Goodrich said the company
expects to spend $1.9 billion.
Merck's 1997 sales were $23.6 billion, up from 1996's
$19.8 billion.
- Otesa Middleton; 202-862-6622 |
