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VALEANT PHARMACEUTICALS AGREES TO ACQUIRE RIGHTS TO HEP-C DRUG INFERGEN FROM INTERMUNE
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Press announcement today from Valeant Pharma
COSTA MESA, Calif., November 28, 2005 - Valeant Pharmaceuticals International (NYSE:VRX) today announced that it has signed a definitive agreement to acquire the United States and Canadian rights to the hepatitis C drug Infergen (interferon alfacon-1) from InterMune, Inc. (NASDAQ:ITMN).
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. The transaction was approved by Valeant's board of directors and is expected to close following the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, as amended. Closing is expected in late 2005.
"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, which is 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.
Important Safety Information
Alpha interferons, including Infergen, cause or aggravate fatal or life-threatening
neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping Infergen therapy. The most common side effects are
flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile and the box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders, by visiting www.infergen.com.
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.
Viramidine is a registered trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant, including our ability to successfully close the transaction with InterMune and integrate Infergen into Valeant's existing product line, obtain approval of other pipeline candidates within the company's estimated timeline or at all, to realize expected results of operations relating to Infergen, and successfully expand the
company's infectious disease business. These statements are based upon the current expectations and beliefs of Valeant's management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
These risks and uncertainties include market conditions and other factors beyond Valeant's control, adverse events that would require clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Infergen is not advisable, and the risk factors
and other cautionary statements discussed in Valeant's filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any of the forward-looking statements in this press release, which speak only as of the date of this press release. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or
circumstances after the date of this press release or to reflect actual outcomes.
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