Reuters SGP story confirms SEPR's DCL involved, even mentions LLY deal
(1230, We have two 75-76 I-sellers @45K shares holding us down, do you have your seat belt buckled?)
issued 1139 am est
Schering-Plough seeks oks for Claritin-cousin drug
By Ransdell Pierson
NEW YORK., Oct 26 (Reuters) - Schering-Plough Corp. [SGP-news]
said on Tuesday it has asked U.S. and European Union regulators to
approve an allergy drug closely related to Claritin, its blockbuster
which loses U.S. patent protection in 2002.
Schering-Plough said the experimental drug, desloratadine, is an
active metabolite -- or chemically altered version -- of Claritin
(loratadine). Claritin, a nonsedating antihistamine, is the New Jersey
company's top-selling product, with global sales of $716 million in the
third quarter of 1999.
Analysts have said Schering-Plough might extend the life of its
Claritin franchise for up to a decade by launching a patent-protected
new form of the drug, such as desloratadine -- particularly if it could
demonstrate safety or efficacy advantages over Claritin.
Company spokesman William O'Donnell told Reuters he was unable
to comment, for proprietary and regulatory reasons, on whether
desloratadine indeed demonstrated any such advantages over Claritin
in four large recently completed clinical trials.
"Desloratadine is a new chemical entity, a different drug than Claritin,
that has been developed to extend the company's position in the
allergy area," he said.
The separate U.S. and European Union marketing applications for
desloratadine -- also a nonsedating, long-acting antihistamine -- are
based on the four trials, Schering-Plough said.
O'Donnell said his company had licensed certain patent rights from
Massachusetts biotech company Sepracor Inc. [SEPR-news] to sell
desloratadine.
He said Schering-Plough and Sepracor each have different patents on
desloratadine. Schering-Plough's "is a patent on the metabolite
itself," or composition of matter patent, that expires in 2004,
O'Donnell added.
Sepracor's patent on the metabolite, by contrast, covers its "method
of use" in certain therapeutic areas and does not expire until 2014, a
full decade after the expiration of Schering-Plough's patent on the
experimental compound.
Sepracor specializes in developing altered and supposedly safer
forms of existing drugs. It agreed in late 1997 to license its worldwide
patents on desloratadine to Schering-Plough in exchange for
undisclosed royalties that begin when the drug is launched
commercially.
"The royalties (from Schering-Plough) to Sepracor will escalate over
time upon achievement of sales volume of desloratadine and other
milestones," O'Donnell said, declining to specify amounts.
Schering-Plough has been lobbying Congress to pass a controversial
bill that would extend the patent life of Claritin three years beyond its
looming 2002 expiration date.
Opponents of the bill, however, have argued the legislation would
provide an undeserved windfall to Schering-Plough at the expense of
allergy sufferers, who would have to wait longer for cheaper generic
versions of Claritin.
Among other drugs Sepracor has developed is an altered form of
Prozac, the blockbuster anti-depressant sold by Eli Lilly and Co.
[LLY-news] . In Demember 1998 Lilly agreed to pay Sepracor $20
million up front plus up to $70 million in later payments for global
rights to the Sepracor experimental compound. Lilly's last U.S.
patent on Prozac expires in late 2003.
Shares of Schering-Plough were off 1-3/4 to 46-5/16 on the New York
Stock Exchange. Sepracor was up 2-1/4 to 75 on the Nasdaq. |
