Novartis Says FDA Asks Data Before Clearing Exelon (Update1)
Bloomberg News
July 9, 1998, 1:18 p.m. ET
Novartis Says FDA Asks Data Before Clearing Exelon (Update1)
(Adds U.S. share price in paragraph seven, other drugmakers
in paragraph six and background in paragraph eight.)
Basel, Switzerland, July 9 (Bloomberg) -- Novartis AG, the
world's largest health-care company, said the U.S. Food and Drug
Administration requested more analyses of its Exelon drug before
approving it as a treatment for Alzheimer's Disease.
Novartis said the FDA wants further examination on whether
the drug is safe for patients to take in high doses, although the
U.S. authorities didn't ask for further clinical trials.
The Basel, Switzerland-based drugmaker won approval to sell
Exelon in the European Union in May, and the drug has been
approved in more than 30 countries. Exelon is one of three key
drugs Novartis plans to introduce this year.
Novartis said in a statement it is ''confident about the
safety and efficacy of Exelon.'' Jerry Karabelas, head of
Novartis's health-care unit, said in a statement that Novartis
''anticipates that Exelon will be approved in the U.S. as
expeditiously as possible.''
Exelon could generate sales of 700 million Swiss francs
($455 million) a year within five years, according to analyst
Claudio Werder at Bank J. Vontobel & Co. AG. Other key new
Novartis products include heart treatment Diovan and Apligraf, a
treatment for venous leg ulcers.
The market for Alzheimer's drugs is currently dominated by
Warner-Lambert Co.'s Cognex and Pfizer Inc.'s and Eisai Co.'s
Aricept. Hoechst AG is also developing a drug for the disease.
Novartis registered shares fell 23 francs to 2,550 francs on
the Swiss exchange. The announcement was made after the market
closed. American depositary receipts in the company were
unchanged at 84 1/4 in midday trading.
About 4 million Americans have Alzheimer's, which is the
fourth leading cause of adult death in the U.S. behind heart
disease, cancer, and stroke. With the aging of the baby boomers,
researchers estimate that the number could increase to 14 million
by 2050.
--Theresa Waldrop in the Zurich newsroom (411) 224 4111 with |
