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The Wall Street Journal
JANUARY 12, 2008

Merck Sets Authorized-Generic Fosamax Pact
==========================================
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By PETER LOFTUS
Merck & Co. has signed an authorized-generic deal with an unidentified
company to market a copycat version of its blockbuster osteoporosis
drug Fosamax, which could go on sale next month.

Merck spokesman Ron Rogers declined to identify the generics company
on Friday, saying details of the deal were proprietary at this time.
Fosamax's key U.S. patent is set to expire on Feb. 6, which will clear
the way for generic competition.

Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals Inc. are
planning to launch generic copies of Fosamax. Under federal law, Teva
and Barr have been scheduled to be the only third-party marketers of
generic Fosamax for about six months, because they were the first to
file for Food and Drug Administration approval of generic Fosamax.
But the six-month exclusivity period doesn't stop Merck from selling
its own generic, either by itself or with a generic-company partner.
In recent years, Merck and other branded pharmaceutical companies have
begun to strike these authorized-generic deals.

Critics say authorized-generic deals undercut the competitive
advantage held by the generic companies that are supposed to have
six-month exclusivity periods. Branded manufacturers, however, say the
deals give consumers another generic option.
The Federal Trade Commission is now conducting a study of the
competitive impact of authorized-generic deals. It recently requested
information from numerous pharmaceutical companies about the deals.

Fosamax is one of Merck's best-selling drugs and was forecast to
generate sales of $2.9 billion to $3.1 billion in 2007. However, sales
are expected to plunge to $1.1 billion to $1.4 billion this year as a
result of generic competition. Earlier this week, the FDA also advised
doctors and patients about the possibility of severe and sometimes
incapacitating bone, joint or muscle pain linked to Fosamax and other
osteoporosis drugs.
Barr said Friday that it plans to launch a generic version of Fosamax
70 milligram tablets on Feb. 6 and that it is entitled to the 180-day
exclusivity period.

"We had anticipated sharing the exclusivity with Teva for this
product," the company said. "We are not surprised that Merck is
launching an authorized generic, as this has become a common
antigeneric strategy for brand companies."
A Teva spokeswoman couldn't immediately be reached for comment.

Write to Peter Loftus at peter.loftus@dowjones.com
Printed in The Wall Street Journal, page A3

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