Allergan, Inc. (NYSE:AGN) confirms that U.S. District Judge Andrew J. Guilford, after conducting a full trial, ruled that Merz Pharmaceuticals and Merz Aesthetics violated California’s Uniform Trade Secrets Act and issued a permanent injunction against them. In a written decision, Judge Guilford concluded that Merz misappropriated important trade secrets belonging to Allergan, including “the specific identities and financial details (including sales targets, actual sales amounts, and product volumes over time) of Allergan’s relationships with virtually all of its physician customers in the United States for BOTOX ® Cosmetic (onabotulinumtoxinA) and JUVÉDERM ® and a large segment of Allergan’s physician customers in the United States for BOTOX ® (for therapeutic indications).” The court also found that Merz misappropriated “Allergan's strategic marketing plans, including its plans to address competition from Merz Aesthetics and Merz Therapeutics. The value of this information is incalculable.” The court concluded that the injunction, which prohibits Merz from, among other things, selling or soliciting purchases of their product, Xeomin ®, in the facial aesthetics market for 10 months, was necessary to serve the public interest. As the court noted, "the right of free competition does not include the right to use the confidential work product of others." In addition to the U.S. ruling, Allergan prevailed last week in two separate cases that were filed against Merz in Europe. In Germany, the Hamburg Regional Court ruled that Merz is prohibited from claiming a 1:1 dose equivalent ratio between units of Allergan’s BOTOX ® (onabotulinumtoxinA) and Merz’s Xeomin ®, which is in line with a prior decision of that Court in December 2011. In Spain, Merz was found to be in breach of the Spanish Pharmaceutical Code for referring to a conversion ratio without, at the same time, making an express warning about the fact that the unit doses are not interchangeable. The full text of the Spanish ruling can be found at http://www.autocontrol.es/pdfs/pdfs_recursos/rect1069.pdf. The findings in Germany and Spain are consistent with the U.S. Food and Drug Administration’s (FDA) substantial efforts to emphasize the non-interchangeability of BOTOX ® and other botulinum toxin type A products. In order to protect the public health, the FDA established a class-wide requirement that the labeling for all botulinum toxin type A products state that potency units of the different products are not interchangeable and that they cannot be compared or converted in dosing. “We believe that full and fair competition is healthy,” said David E.I. Pyott, Allergan’s Chairman of the Board, President and Chief Executive Officer. “It is important to ensure that physicians and consumers receive accurate and truthful information and are able to make informed decisions about the products they choose to use. As the leader and innovator in the medical aesthetics category, we remain committed to supporting and growing this market on behalf of physicians and the customers they serve.”
About BOTOX ® (onabotulinumtoxinA)BOTOX ® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX ® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX ® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX ® neurotoxin is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three to ten months, depending on the indication and on the individual patient. BOTOX ® Cosmetic results have been shown to last up to four months; individual results may vary. BOTOX ® was first approved by the FDA more than 22 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval in 1989, BOTOX ® has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide. In the United States, BOTOX ® neurotoxin is also approved to treat seven medical conditions, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; and most recently, for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. In addition to its therapeutic uses, the same formulation of BOTOX ® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX ® Cosmetic (onabotulinumtoxinA). BOTOX ® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age. In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX ® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX ® and BOTOX ® Cosmetic in Allergan’s clinical trials. 1 Worldwide, approximately 30 million vials of BOTOX ® and BOTOX ® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010). 2 With approximately 2,500 articles on BOTOX ® and BOTOX ® Cosmetic in scientific and medical journals, 3 BOTOX ® neurotoxin is one of the most widely researched medicines in the world. BOTOX ® (onabotulinumtoxinA) & BOTOX ® Cosmetic Important Information Indications BOTOX ® is a prescription medicine that is injected into muscles and used:
- to treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease who still have leakage or experience too many side effects after trying an anticholinergic medication.
- to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
- to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.For BOTOX ® and BOTOX ® Cosmetic full Product Information including Boxed Warning and Medication Guide click here . Important JUVÉDERM ® Safety Information JUVÉDERM ® injectable gel (including JUVÉDERM ® Ultra, JUVÉDERM ® Ultra Plus, JUVÉDERM ® Ultra XC, and JUVÉDERM ® Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Treatment side effects are usually mild to moderate, lasting 7 days or less, and include temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM ® is not for people with severe allergies. For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM ® injectable gel is available by prescription only. About Allergan, Inc. Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
Forward-Looking StatementsThis press release contains "forward-looking statements," including the statements by Mr. Pyott, statements regarding the outcome of litigation and other statements regarding the safety, effectiveness and adverse events associated with BOTOX ® or BOTOX ® Cosmetic. 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 Allergan's expectations and projections. Risks and uncertainties include, among other things, the uncertainties associated with the litigation and appeal process; general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning the above-referenced risk factors and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2011 Annual Report on Form 10-K. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 714-246-4636. © 2012 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc. All rights reserved. Myobloc ® is a registered trademark of Solstice Neurosciences, Inc. Dysport ® is a registered trademark of Ipsen Biopharm, Ltd. Xeomin ® is a registered trademark of Merz Pharma Gmbh & Co. 1 Allergan data on file; Medical Affairs 2 Allergan data on file; Global Regulatory Affairs 3 Allergan data on file; Global Literature & Information Services