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Valeant
Pharmaceuticals to Acquire Consensus Interferon (Infergen)
from Intermune
Valeant Pharmaceuticals International announced on November
29 that it has agreed to acquire US and Canadian rights to
the hepatitis C drug consensus interferon (aka
interferon alfacon-1) [Infergen] from InterMune,
Inc. Valeant will pay InterMune
$113.5 million in cash upon closing, and subsequent milestone
payments of up to approximately $22.5 million. Valeant also
will acquire an estimated $6.5 million in inventory from InterMune. Following are excerpts from the Valeant announcement.
“The
acquisition of Infergen will have an immediate sales impact
on Valeant and provide us with a valuable addition to one
of our core therapeutic areas,” said Timothy C. Tyson, Valeant’s
president and chief executive officer. “In addition, we intend
to hire up to 50 of InterMune’s sales and marketing force, which will help to
provide Valeant with an immediate presence in the hepatitis
C market and position us for the anticipated launch of Viramidine.”
Viramidine, currently in Phase 3 clinical trials, is expected
to be launched in 2007.
Infergen or consensus interferon,
is a bio-optimized, selective and highly potent type 1 interferon
alpha originally developed by Amgen and launched in the United States in 1997. It is currently
indicated as monotherapy for the treatment of adult patients
suffering from chronic hepatitis C viral infections with compensated
liver disease and is dosed three times per week.
Infergen is the only interferon with data in the label
regarding use in patients following relapse or non-response
to certain previous treatments. Infergen is being studied
in ongoing clinical trials to establish additional labeling
for daily use with ribavirin. Enrollment in the Phase 3 IHRC-001
(DIRECT) trial was completed in mid-2005 with 514 patients
at 40 sites in the United
States.
The DIRECT trial, which should be completed in 2007,
is evaluating the safety and efficacy of both 9mcg and 15mcg
doses of daily Infergen in combination with ribavirin in non-responders.
Management of the DIRECT trial will be transitioned from InterMune
to Valeant following the closing of the transaction.
Sales of Infergen were $22 million in 2004. For the first
nine months of 2005, sales of Infergen increased by 79 percent to $25.3 million compared
to $14.2 million for the first nine months of 2004. The acquisition
of Infergen is expected to be neutral in 2005, excluding the
impact of acquired in-process research and development, which
is estimated to be approximately $45 million, and modestly
dilutive in 2006.
According to the Centers for Disease Control and Prevention,
an estimated 3.9 million Americans (1.8 percent) have been infected with the hepatitis
C virus (HCV). HCV causes an estimated 10,000 to 12,000 deaths
annually in the United
States and is the leading
cause of the need for liver transplants. The prevalence of
HCV is increasing and approximately half of all patients with
compensated liver disease do not respond to first-line treatment.
There are approximately 250,000 of these non-responder patients
currently in the U.S.
and the number is growing by an estimated 50,000 each year.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a
global, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets
products primarily in the areas of neurology, infectious disease
and dermatology. More information about Valeant can be found
at www.valeant.com
11/30/05
Source
Valeant
Pharmaceticals. VALEANT PHARMACEUTICALS
AGREES TO ACQUIRE RIGHTS TO HEP-C DRUG INFERGEN® FROM INTERMUNE.
Press Release. November 28, 2005.
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