Forum Archive Index - May 2002

[<dkw@paradise.net.nz>]

This story was sent to you by dkw@paradise.net.nz with these comments:

An interesting artical related to psoriasis (related to PTD.ASX, ANP.ASX, GEN 
to name a few)

(Amevive is not TNF-antibody related.)

Derek



>From CBS.MarketWatch.com, online at:

http://cbs.marketwatch.com/news/story.asp?dist=dhtml&siteid=mktw&guid=%7B0362BAAB%2D2457%2D45D0%2DB342%2DC76DC690178A%7D

BIOGEN SOARS ON FDA PANEL'S APPROVAL

        

5/24/2002 2:35:27 PM

By Ted Griffith

2:35 PM ET May 24, 2002


CAMBRIDGE, Mass. (CBS.MW) -- Shares of Biogen surged more than 20 percent Friday
after a Food and Drug Administration advisory panel voted to recommend the 
biotech
firm's experimental treatment for psoriasis.


The agency is expected to rely heavily on the panel's advice in rendering a 
final
decision on whether the drug, known as Amevive, makes it to market.


Shares of Biogen  were up $9.12, or 23 percent, to $49.44 in recent trading.


Thursday's 8-2 vote in favor of Amevive is also welcome news to the overall 
biotech
industry, which has been shaken this year by a string of regulatory setbacks for
high-profile drugs. Investors have been looking for signs that regulators will 
be
receptive to future applications for biotech drugs.


Biotech stocks enjoyed a broad, late-afternoon rally Thursday following news of 
the
panel's endorsement. The Amex Biotechnology Index  had surged 7 percent but 
gave back
some of these gains in Friday's session. See full story.



To market, to market

_______________________________________________________________________


Several biotech firms are working on treatments for the skin disease psoriasis. 
But
Biogen now appears to be leading the race to be the first to market a biotech
treatment, with company executives on record as saying that Amevive could win 
FDA
approval before the end of the year.


Some analysts are skeptical, though, of Amevive's commercial potential. Analyst 
Eric
Ende at Merrill Lynch, for one, said Amevive will eventually face daunting
competition from two of the biggest companies in the biotech and pharmaceutical
industries.


Both Amgen  and Johnson & Johnson  hope to win approval to expand the use of
rheumatoid arthritis treatments to include psoriasis. The two diseases are 
similar in
that they are both caused by problems with the body's immune system.


Amgen's Enbrel and J&J's Remicade are already blockbuster drugs in 
rheumatoid
arthritis. Amgen is acquiring the rights to Enbrel through its pending buyout of
Immunex .


"Ultimately, we believe that Enbrel and Remicade are likely to be the winners 
in the
psoriasis biologic treatment space," Ende wrote in a note to clients.


Ende, who reiterated his "sell" rating on Biogen's stock, also said FDA 
officials
may harbor more concerns about Amevive's safety than the medical experts who 
served
on the advisory panel. He said Amevive's approval could be held up if the agency
requires additional testing in patients.


But analyst Eric Schmidt at SG Cowen dismissed concerns about Biogen's drug and 
said
that "Amevive could be the industry's next blockbuster."


In a research note, Schmidt projected Amevive would generate $350 million in 
annual
revenue for Biogen by 2005. The analyst upgraded his rating on Biogen's stock to
"strong buy" from "buy" and established a price target of $64.


"Having passed its greatest hurdle to commercialization with flying colors, 
Amevive
appears to be a lock for FDA approval," Schmidt wrote.



Key second drug 

_______________________________________________________________________


Indeed, Biogen has presented Amevive as the firm's next big potential product. 
The
Cambridge, Mass.-based company now has only one drug on the market, the 
blockbuster
multiple sclerosis treatment Avonex.


But Avonex is under increasing pressure because rival biotech firm Serono  in 
March
won the right to market its MS treatment in the United States.


The FDA panel's endorsement of Amevive is something of a surprise as many on 
Wall
Street had been pessimistic about the drug's prospects. Ahead of the meeting,
Biogen's stock had been falling steadily, closing Wednesday at $40.36, near a
three-year low.  Biogen's shares had been halted for much of the session 
Thursday,
which is typical when a biotech firm's key drug is under review.


Much of the concern about Amevive centered around the drug's potential side 
effects.
Amevive suppresses a type of white blood cell, which, according to analysts,
potentially increases the risk of patients developing infections.


On Thursday, panel members seemed to have some reservations about side effects,
recommending that Biogen establish a registry to monitor the long-term effects 
of the
drug on patients. Still, the panel concluded that the benefits of Amevive 
outweighed
the risks for patients with "moderate to severe" psoriasis.


The review panels are made up of medical experts in certain specialties -- in 
this
instance, dermatology and immunology.


Expert dermatologist Mark Lebwohl, who spoke on behalf of Biogen at the meeting,
told the panel that there is a dearth of safe and effective therapies for 
psoriasis.
Serious cases of the disease are now treated with highly toxic drugs, such as 
immune
suppressant cyclosporine.


Lebwohl, of New York's Mount Sinai School of Medicine, told the panel that 
Amevive
has been "rigorously" tested and that the results of those tests "support 
approval of
this drug for a greatly underserved population."





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