Medicis Announces FDA Clearance of LIPOSONIX(R) System
SCOTTSDALE, Ariz., Sept. 8, 2011 — Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the LIPOSONIX® system for non-invasive waist circumference reduction. The LIPOSONIX system uses advanced high-intensity focused ultrasound (HIFU) technology to permanently destroy targeted fat just beneath the skin in the treatment area.
“We are pleased with FDA’s decision to clear the LIPOSONIX system for sale in the United States,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis Pharmaceutical Corporation. “We believe the LIPOSONIX system is an innovative technology which delivers results. The treatment itself is designed as a noninvasive and nonsurgical approach to aesthetic waist circumference reduction. We believe many adults wishing to reduce their waistlines by several centimeters could be potential candidates for the LIPOSONIX treatment.”
The LIPOSONIX system is currently marketed in Canada, the European Union and Japan. As announced in February, Medicis is exploring strategic alternatives for its LIPOSONIX business, including, but not limited to, the sale of the stand-alone business, as the Company focuses on its core heritage of medical dermatology and facial aesthetics. The LIPOSONIX business was classified as a discontinued operation for financial statement reporting purposes beginning in the first quarter of 2011. Medicis is not planning to launch the LIPOSONIX system in the U.S., and would anticipate that plans for a U.S. launch will be announced by an acquiring company, if any, if and when such acquiring company deems appropriate. In the meantime, Medicis will continue supporting existing LIPOSONIX customers worldwide.
The LIPOSONIX system was evaluated in a multicenter, randomized, sham-controlled, single blind study. Treatment with the LIPOSONIX system was shown to be superior to a sham control in reducing waist circumference, meeting the pre-specified primary endpoint of the study. The 59 J/cm2 treatment group demonstrated an approximately 1 cm greater waist circumference reduction as compared to sham. On average, the mean change in waist circumference of approximately 2.6 cm (1 inch) compared to baseline was demonstrated in the 59 J/cm2 treatment group. This could equal one dress or pant size.
The safety of treatment with the LIPOSONIX system was assessed through 24 weeks post-treatment. Safety was assessed by monitoring adverse events, results from a pre-specified battery of blood tests and physical examinations. The adverse events resulting from treatment with the LIPOSONIX system during this study included procedural pain, post-procedural pain, bruising and swelling. These were mostly mild, short-lived in duration and resolved without incident. There were no serious adverse events or unanticipated adverse device effects related to treatment with the investigational device.1
The LIPOSONIX treatment is not intended as a replacement for liposuction surgery or a healthy lifestyle, or a way to lose weight, but as a noninvasive, nonsurgical approach to aesthetic waist circumference reduction when diet and exercise are not enough. According to the American Society for Aesthetic Plastic Surgery (ASAPS), liposuction represented the second highest number of surgical cosmetic procedures in 2010 with over 280,000 procedures. This equates to a combined U.S. market of over $1.6 billion for liposuction and abdominoplasty.2
About the LIPOSONIX System
The LIPOSONIX system technology was developed over a period of 10 years by leading scientists and ultrasound experts with more than 200 years combined experience in the development of therapeutic and diagnostic ultrasound devices.
The LIPOSONIX system uses advanced HIFU technology to permanently destroy targeted fat just beneath the skin in the treatment areas of the abdomen and flanks as a noninvasive, nonsurgical approach to aesthetic waist circumference reduction. Clinical studies conducted by Medicis Technologies Corporation showed an average waist circumference reduction of approximately 2.6 cm after a single treatment with the LIPOSONIX system. Office visit time and individual results may vary. Results are typically seen in 8 to 12 weeks.
The LIPOSONIX treatment is not a replacement for liposuction surgery or a healthy lifestyle, or a way to lose weight. No special diet or exercise program is required. The LIPOSONIX system has a well-defined safety profile. There is no need for anesthesia.
Important Safety Information for the LIPOSONIX System
The LIPOSONIX treatment may pose certain risks and may not be suitable for everyone. The LIPOSONIX system is intended for adults over 18 years of age who have at least 1.0 cm of fat thickness beyond the selected treatment focal depth of the system in the area to be treated. The most frequently reported side effects during the LIPOSONIX treatment are: discomfort, pain, cold, prickling, tingling or warmth. The most frequently reported side effects after the LIPOSONIX treatment, when used as recommended, are: pain (discomfort), bruising, redness and swelling, which are generally described (or rated) as mild. You should not have the LIPOSONIX treatment if you are pregnant or think you may be pregnant. The LIPOSONIX treatment is available only from a qualified healthcare professional.
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company’s products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
The Company’s products include the brands DYSPORT® (abobotulinumtoxinA) 300 Units for Injection, PERLANE® Injectable Gel, PERLANE-L® Injectable Gel with 0.3% Lidocaine, RESTYLANE® Injectable Gel, RESTYLANE-L® Injectable Gel with 0.3% Lidocaine, LOPROX® (ciclopirox) Gel 0.77% and Shampoo 1%, SOLODYN® (minocycline HCl, USP) Extended Release Tablets, VANOS® (fluocinonide) Cream, 0.1%, ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL® (sodium phenylbutyrate) Tablets and Powder and the over-the-counter brand ESOTERICA®.
For more information about Medicis, please visit the Company’s website at www.Medicis.com. Printed copies of the Company’s complete audited financial statements are available free of charge upon request.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements, including the occurrence, timing and financial terms or effect of the Company’s proposed disposition of LIPOSONIX, are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Several of these risks are outlined in the Company’s most recent annual report on Form 10-K for the year ended December 31, 2010, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.
NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company or by visiting http://www.Medicis.com. All trademarks are the property of their respective owners.