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WASHINGTON (Reuters Health) – Shares of Schering-Plough Corp. and Sepracor Inc. rose Monday morning on news that the US Food and Drug Administration (FDA) had approved Clarinex (desloratadine), a new version of Schering-Plough's blockbuster allergy pill Claritin.
Shares of Kenilworth, New Jersey-based Schering-Plough were up 0.91 to 37.26 on the New York Stock Exchange, while shares of Sepracor rose 3.15 to 56.70 on the NASDAQ.
Sepracor Inc. said late Friday that Schering-Plough received an "approvable letter" from the US Food and Drug Administration (FDA), following the market close.
Marlborough, Massachusetts-based Sepracor helped develop the new formulation in exchange for royalties on US sales.
Shares of Schering-Plough rose despite the accompanying disclosure of the company's financial woes. On Friday, Schering-Plough said that full year 2001 earnings would be below Wall Street expectations, or $1.57 a share compared with $1.64 last year. The company said that 2002 earnings are also expected to grow in the low double digits.
Analysts had expected Schering-Plough to report 2001 earnings of $1.63 a share and 2002 earnings of $1.86 a share.
Investor interest on Monday, however, appeared to focus on the resolution of the company's manufacturing problems. In making the announcement regarding the approval of Clarinex, Schering-Plough also reported that it was in negotiations with the FDA to resolve issues stemming from previously noted manufacturing problems at its Puerto Rico and New Jersey plants.
The FDA temporarily halted the approval of all new Schering-Plough products until those issues could be resolved. Schering-Plough said in the statement that it would now sign a consent decree, amounting to as much as a $500 million fine.
The FDA confirmed on its Web site that Clarinex had been approved but made no mention about the talks with Schering-Plough.
Claritin is Schering-Plough's $3 billion a year flagship product. It is due to go off patent in December 2002.
Sepracor said that Schering-Plough expects to launch Clarinex in January 2002. The company estimated the potential market for the drug at $4.5 billion a year.
Industry analyst Hemant Shah called the Clarinex approval "good news for Schering." He told Reuters, "Now the tough battle starts. The difficult task is to convert Claritin users to Clarinex."
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