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August 5th 03, 09:07 AM
http://investmentsmagazine.com/managearticle.asp?C=20&A=4892

Aventis Hit By New Challenge To Lovenox

Aventis, the French pharmaceuticals group, faced a second patent
challenge to Lovenox in as many days after Teva, the Israeli drug
company, said on Friday that it planned to start selling a cheap
generic copy of the blockbuster blood-thinning drug.


Teva's challenge comes after the announcement on Thursday that
Amphastar Pharmaceuticals of the US had filed an application with the
US Food and Drug Administration to develop and market a generic
version of Lovenox, a drug which had sales of ?1.56bn ($1.8bn) last
year and is Aventis' second-biggest selling product.


Aventis shares fell for the second day running, trading down 1.7 per
cent at ?47.27 at midday, deepening a 6.7 per cent fall on Thursday.


Aventis played down the threat of the patent challenges. It said that
although the first five-year non-patent data exclusivity over the
drug's enoxaparin sodium compound expired in 1998, a second patent for
the drug did not expire until December 2004, preventing generic
competition before then. It has also applied for a modification of the
challenged patent, which it said could be completed by the end of
2004.


Analysts at Wood Mackenzie forecast steady growth for Lovenox,
reaching $2.2bn-a-year by 2007, driven by new uses including angina
and heart attack treatments. But the patent challenges are a blow to
sentiment towards Aventis which is already facing a slowdown in sales
of allergy-pill Allegra, its top-selling product.


"This latest news adds one more overhang to a stock besieged with
multiple product controversies: impact of Allegra OTC and generics,
Lovenox sales growth deceleration, Lantus penetration in the type II
diabetes market, and Ketek approval in the US," said Catherine Arnold
of independent analysts Bernstein.


For investors, the growing uncertainty over patent disputes has become
almost as big a concern as the large number of drugs approaching the
end of their patent life. Sales of branded products can fall steeply
in a matter of weeks when generics are launched. The issue is
especially problematic for drug companies that have no new product to
relace the old ones that are losing patent protection. Despite three
potential product launches for Aventis in 2004 none of them have
blockbuster potential.