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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?


To: Anthony Wong who wrote (1569)5/25/1999 8:03:00 PM
From: Anthony Wong  Respond to of 1722
 
SmithKline says FDA approved diabetes drug Avandia
Tuesday May 25, 7:31 pm Eastern Time

PHILADELPHIA, May 25 (Reuters) - SmithKline Beecham
Plc(quote from Yahoo! UK & Ireland: SB.L) (NYSE:SBH - news)
has been granted U.S. regulatory approval to sell its Avandia
drug for adult-onset type II diabetes, as a stand-alone therapy
and in combination with another drug, metformin, the company
said on Tuesday.

Avandia, which will be co-marketed by British-based SmithKline Beecham and U.S.-based Bristol-Myers Squibb Co. (NYSE:BMY - news), won a recommended rating from a Food and Drug Administration advisory panel last month. It is among the first three members of the new glitazone class of diabetes drugs, which include Rezulin, sold by New Jersey-based Warner-Lambert Co. (NYSE:WLA - news), and Actos, under development by Japan's Takeda Chemical Industries Ltd. .

biz.yahoo.com



To: Anthony Wong who wrote (1569)5/25/1999 8:08:00 PM
From: Anthony Wong  Respond to of 1722
 
SmithKline's Diabetes Pill Avandia Wins U.S. Approval (Update1)

Bloomberg News
May 25, 1999, 7:39 p.m. ET

SmithKline's Diabetes Pill Avandia Wins U.S. Approval (Update1)

(Adds company comment, background in 3rd, 4th paragraphs.)

Washington, May 25 (Bloomberg) -- SmithKline Beecham Plc
said its diabetes pill Avandia won U.S. approval, giving the U.K.
drugmaker a jump on a new rival medicine that's also vying to
grab market share from Warner-Lambert Co.'s similar Rezulin.

The U.S. Food and Drug Administration approved use of the
SmithKline drug alone or in combination with Bristol-Myers Squibb
Co.'s diabetes medicine, Glucophage, the company said. The FDA
also is reviewing Actos, a drug from Japan's Takeda Chemical that
Eli Lilly & Co. will market in the U.S.

Analysts expect doctors to begin prescribing Avandia rather
than Rezulin because Rezulin has been linked to about 35 cases of
death and serious liver damage. More than 1.5 million diabetics
have tried Rezulin since 1997. SmithKline intends to lose no time
getting Avandia to the U.S. market ahead of Actos.

''We plan on making the product commercially available in
the next few days,'' Chief Executive Jan Leschly said in a
statement.

Early research suggests Avandia and Actos are less likely to
cause liver damage than is Rezulin, a drug that Warner-Lambert
licenses from Japan's Sankyo Co.

SmithKline will work with Bristol-Myers to market Avandia.
Analysts say Avandia and Actos could both achieve sales of more
than $1 billion a year in what could become a $5-billion-a-year
market for diabetes treatments.

FDA approval of Avandia was expected today.

SmithKline Beecham's American depositary receipts rose 15/16
to 62 1/8. Morris Plains, New Jersey-based Warner-Lambert fell
3/8 to 63 1/2.



To: Anthony Wong who wrote (1569)6/1/1999 9:39:00 PM
From: muddphudd  Read Replies (2) | Respond to of 1722
 
Anthony,

I received a bulletin from InfoBeat stating that Teva Pharmaceuticals is very confident that it will get FDA approval for their Claritin generic despite the Schering-Plough lawsuit claiming that Teva infringed on their patent. What do you make of this? I would imagine that a generic Claritin would very seriously hurt Schering's bottom-line.

Thanks.