Cephalon, Inc. Announces Agreement to Acquire AMRIX, A Once-Daily Extended-Release Muscle Relaxant

FDA Approved Product Will Accelerate Growth of Pain Franchise

    FRAZER, Pa., Aug. 23 /PRNewswire-FirstCall/ -- Cephalon, Inc. (
 CEPH) announced today it has signed an agreement to acquire the North
 American rights to AMRIX(R) (cyclobenzaprine hydrochloride extended-release
 capsules) from ECR Pharmaceuticals, a privately held company. Two dosage
 strengths of AMRIX (15 mg and 30 mg) were approved in February 2007 by the
 U.S. Food and Drug Administration (FDA) for short-term use as an adjunct to
 rest and physical therapy for relief of muscle spasm associated with acute,
 painful musculoskeletal conditions. The product is not yet available
 commercially in the United States; however, Cephalon expects to launch the
 product early in the fourth quarter.
     Under the agreement, which is expected to close on or about August 28,
 2007, Cephalon will acquire the rights to AMRIX for $100 million cash. The
 company also could make future cash payments to ECR upon the achievement of
 certain cumulative net sales milestones. The company anticipates that the
 transaction will be modestly dilutive in the fourth quarter due to product
 launch costs; despite this, the company is reaffirming its existing 2007
 sales and adjusted income per common share guidance. The transaction is
 expected to be accretive in 2008 and thereafter.
     "AMRIX is an excellent strategic fit with our current sales
 organization, providing us with a second product that is complementary to
 many pain relievers used today," said Robert Roche, Executive Vice
 President, Worldwide Pharmaceutical Operations. "Cyclobenzaprine HCl is the
 most widely prescribed muscle relaxant in the United States, representing
 37 percent of the 45 million prescriptions for muscle relaxants written in
 2006, according to IMS. AMRIX has convenient once-daily dosing and a side
 effect profile that includes very low rates of sedation which will provide
 physicians and patients an attractive alternative to current therapies."
     About AMRIX
     AMRIX is a once-a-day, extended-release version of cyclobenzaprine
 hydrochloride, the active ingredient in the brand Flexeril(R)*. AMRIX is
 indicated for relief of muscle spasm associated with acute, painful
 musculoskeletal conditions. AMRIX is intended for short-term use (up to two
 or three weeks) because adequate data for more prolonged use are not
 available and because muscle spasm associated with acute, painful
 musculoskeletal conditions is generally of short duration and specific
 therapy for longer periods is seldom warranted.
     With convenient, once-daily dosing, AMRIX provides relief from muscle
 spasm comparable to that with cyclobenzaprine hydrochloride taken three
 times daily. In Phase 3 clinical trials, once daily dosing of AMRIX at 15
 mg and 30 mg resulted in somnolence rates of one and two percent
 respectively. The most common side effects of AMRIX in Phase 3 clinical
 trials (greater than or equal to three percent) were dry mouth, dizziness,
 fatigue, constipation, nausea and dyspepsia.
     AMRIX is contraindicated in patients concomitantly using monoamine
 oxidase (MAO) inhibitors or within 14 days after their discontinuation; in
 patients during acute recovery phase of myocardial infarction, and in
 patients with arrhythmias, heart block conduction disturbances or
 congestive heart failure; and in patients with hyperthyroidism. AMRIX is
 not recommended for use in the elderly or in those with hepatic impairment.
     AMRIX currently has market exclusivity until the first quarter of 2010.
 There also is a pending U.S. patent application that contains claims
 directed to the formulation of the product.
     Full prescribing information is available on the FDA website at
 http://www.fda.gov/cder/foi/label/2007/021777lbl.pdf .
     About Cephalon, Inc.
     Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
 company dedicated to the discovery, development and marketing of innovative
 products in four core therapeutic areas: central nervous system, pain,
 oncology and addiction. Cephalon has delivered a seven-year compound annual
 growth rate (CAGR) greater than 75 percent and 2006 revenue of $1.760
 billion. A member of the Fortune 1000, Cephalon currently employs
 approximately 3,000 people in the United States and Europe. U.S. sites
 include the company's headquarters in Frazer, Pennsylvania, and offices,
 laboratories or manufacturing facilities in West Chester, Pennsylvania,
 Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's
 European headquarters are located in Maisons-Alfort, France.
     The company's proprietary products in the United States include:
 PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet)
 [C-II], TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone
 for extended-release injectable suspension), GABITRIL(R) (tiagabine
 hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and
 NUVIGIL(TM) (armodafinil) Tablets [C-IV]. The Company also markets numerous
 products internationally. Full prescribing information on its U.S. products
 is available at http://www.cephalon.com or by calling 1-800-896-5855.
     In addition to historical facts or statements of current condition,
 this press release may contain forward-looking statements. Forward-looking
 statements provide Cephalon's current expectations or forecasts of future
 events. These may include statements regarding the acquisition of AMRIX,
 including the strategic fit of the product with Cephalon's organization,
 the attractiveness of AMRIX to physicians and patients compared with
 current therapies, the timing of the expected closing of the transaction
 and the potential impact the acquisition, if consummated, may have on sales
 and earnings in 2007 and beyond; anticipated scientific progress on its
 research programs; development of potential pharmaceutical products;
 interpretation of clinical results; prospects for regulatory approval;
 manufacturing development and capabilities; market prospects for its
 products; sales and earnings guidance; and other statements regarding
 matters that are not historical facts. You may identify some of these
 forward-looking statements by the use of words in the statements such as
 "anticipate," "estimate," "expect," "project," "intend," "plan," "believe"
 or other words and terms of similar meaning. Cephalon's performance and
 financial results could differ materially from those reflected in these
 forward-looking statements due to general financial, economic, regulatory
 and political conditions affecting the biotechnology and pharmaceutical
 industries as well as more specific risks and uncertainties facing Cephalon
 such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed
 with the U.S. Securities and Exchange Commission. Given these risks and
 uncertainties, any or all of these forward-looking statements may prove to
 be incorrect. Therefore, you should not rely on any such factors or
 forward-looking statements. Furthermore, Cephalon does not intend to update
 publicly any forward-looking statement, except as required by law. The
 Private Securities Litigation Reform Act of 1995 permits this discussion.
     -- Flexeril is the registered trademark of Johnson & Johnson
 
 

SOURCE Cephalon, Inc.