Allergan's BOTOX Receives U.S. FDA Approval for Cervical Dystonia and Associated Pain; Cervical Dystonia Indication Expands U.S Approved Uses of BOTOX Therapy

Business Wire, Dec 27, 2000

Business Editors and Health/Medical Writers

IRVINE, Calif.--(BW HealthWire)--Dec. 27, 2000

Allergan, Inc. (NYSE: AGN) today announced it has received United States Food and Drug Administration (FDA) approval of BOTOX(R) (Botulinum Toxin Type A) Purified Neurotoxin Complex for the treatment of adults with cervical dystonia, a neurological movement disorder characterized by involuntary muscle contractions that force the head and neck into abnormal and sometimes painful positions. When injected into the affected muscles, BOTOX(R) decreases the severity of abnormal head position and neck pain associated with this condition by blocking the release of the neurotransmitter acetylcholine from the peripheral nerve terminal to the muscle.

"The physical and emotional pain suffered by cervical dystonia patients is truly striking," said Valerie F. Levitan, PhD, executive director of the Dystonia Medical Research Foundation. "We're pleased that the FDA has approved BOTOX(R) for cervical dystonia so that more people living with this debilitating condition become aware of the treatment and have access to it."

BOTOX(R) has also been approved by regulatory agencies in 40 other countries as a treatment for cervical dystonia and has been marketed for over 10 years in the U.S. by Allergan, Inc. The FDA approval for cervical dystonia allows Allergan to actively support clinicians in the U.S. using BOTOX(R) to treat the condition. The use of BOTOX(R) (Botulinum Toxin Type A) therapy for cervical dystonia has been endorsed by the American Academy of Neurology and the National Institutes of Health (NIH) since 1990(a).

The FDA approval was based on a Phase III randomized, multi-center, double blind, placebo-controlled study of original BOTOX(R) conducted from 1995 to 1997. The study was designed to evaluate safety and efficacy in the treatment of cervical dystonia for up to 10 weeks post injection. The study evaluated 170 subjects with a mean duration of disease of 11 years. The BOTOX(R) group showed significantly greater improvements than placebo subjects in decreasing the severity of abnormal head position and neck pain.

The most frequently reported adverse events in clinical trials were dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%). The incidence of these adverse events in the placebo group was dysphagia (4%), upper respiratory infection (7%), neck pain (7%), and headache (7%). Caution should be exercised when administering BOTOX(R) to individuals with peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis, motor neuropathy) or neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome). Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of BOTOX(R). Rare consequences of severe dysphagia include aspiration, dyspnea, pneumonia and the need to reestablish an airway.

In 1997, Allergan introduced the current BOTOX(R) and patients were able to receive therapy while being exposed to less neurotoxin complex protein (approximately 5ng/100 unit vial) than with original BOTOX(R) (approximately 25ng/100 unit vial). The potential for antibody formation with the use of BOTOX(R) may be minimized by injecting with the lowest effective dose given at the longest feasible intervals between injections. It is important to note that units of BOTOX(R) cannot be compared to, nor converted into, units of any other botulinum toxin.

"Allergan has been studying BOTOX(R) in a variety of movement disorders for more than 10 years. Our research team has established a leadership position in the therapeutic use of botulinum toxins," said Lester J. Kaplan, PhD, President, Research and Development and Global BOTOX(R) for Allergan, Inc. "We will continue our aggressive investment in research and development to broaden our understanding of neurotoxin science and to register new clinical indications for BOTOX(R)."

Allergan is currently studying BOTOX(R) for use in certain cosmetic and neurological conditions.

BOTOX(R) net product sales for the year ended December 31, 1999 were $176 million, an increase of 40 percent over the prior year. For the first nine months of 2000, BOTOX(R) net product sales grew to $173 million, a 42 percent increase over the same period last year.

Forward-Looking Statements

This press release contains "forward-looking statements", such as statements regarding the effectiveness of BOTOX(R), potential growth rates and availability of this product. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Companies' expectations and projections. Risks and uncertainties include general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for a new pharmaceutical product; potential difficulties in manufacturing a new product formulation; domestic and foreign health care reforms; and trends toward managed care and health care cost containment, and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Certain Factors and Trends Affecting Allergan and Its Businesses" in Allergan's 1999 Annual Report on Form 10-K and Form 10-Q for the quarter ended September 30, 2000. Allergan's filings are available publicly and upon request from Allergan's Investor Relations Department: 714.246.4636 or http://www.allergan.com. For more product information refer to http://www.botox.com.