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FDA Confirms September 16th Advisory Committee Meeting To Review Lorcaserin For Obesity And Weight Management

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

“Our primary objective at this time is to obtain FDA approval of lorcaserin,” said Jack Lief, Arena’s President and Chief Executive Officer. “We have been preparing for this anticipated Advisory Committee meeting, and look forward to reviewing lorcaserin’s profile with the panel members.”

Arena submitted the lorcaserin NDA on December 22, 2009, and the FDA assigned a PDUFA date, the target date for the agency to complete its review of the application, of October 22, 2010. Read more

               

Allergan’s Botox Migraine FDA Review Extended 3 Months

IAPAM News: Aug. 2 (Bloomberg) — Allergan Inc. said U.S. regulators extended by three months a review of its top product, the wrinkle-smoother Botox, for a new use as a migraine treatment. The U.S. Food and Drug Administration asked for information on safety monitoring of Botox as a migraine treatment and requested doctor training, the Irvine, California-based company said in a statement. Allergan said it gave that information to the FDA, without specifying a decision date. Read more

               

Merz Aesthetics™ Asclera™ (polidocanol) Injection Now Available in Doctors’ Offices Nationwide

Merz Aesthetics today announced it is now shipping Asclera™ (polidocanol) Injection sclerotherapy treatment to doctors’ offices throughout the U.S.  Previously only available in Europe, Asclera™ was recently approved by the U.S. Food and Drug Administration (FDA).

In a study published in the June issue of Phlebology, leading experts conclude that polidocanol is a highly effective sclerotherapy treatment.

Asclera™ was approved by the FDA on March 30 to treat uncomplicated spider veins (varicose veins less than or equal to 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremities. It has not been studied in larger varicose veins greater than 3 mm in diameter. Once injected, it acts by damaging the cell lining of blood vessels, causing them to close and eventually disappear.

Clinical support for Asclera™ continues to grow.  In the recent Phlebology study, the authors found that polidocanol demonstrated significant efficacy over other treatment options, like sodium tetradecyl sulfate (STS) 1%. In addition, patients reported better satisfaction with polidocanol than with other treatment options. Highlights from the study include:

•The treatment success rate for polidocanol was 95% at week 12 and 95% at week 26 vs. 92% and 91% for STS, respectively; both were significantly higher than placebo (P< 0.0001).
•The majority of patients treated with polidocanol were satisfied with the treatment.
- 87% at week 12 and 84% at week 26 for patients treated with polidocanol
- 64% at week 12 and 63% at week 26 for patients treated with STS
- 14% at week 12 and 16% at week 26 for patients treated with placebo
•Treatment with polidocanol was safe and, apart from local “mild”-to-”moderate” symptoms at the injection site, well tolerated.

“The arrival of Asclera™ has been highly anticipated among physicians, with very positive initial reactions and the number of pre-orders exceeding our expectations,” said Dennis Condon, President of BioForm Medical, Inc., a Merz Aesthetics company. “We are proud to finally deliver the next level of cosmetic procedure performance that physicians and patients demand.” Read more

               

FDA Agrees to UltraShape 510(k) Pathway - Expected to Shorten FDA Clearance Process

UltraShape Ltd. announced today that the US Food and Drug Administration advised the company that it may submit a request for clearance of its Contour I system under the 510(k) regulation rather than as a Pre-Market Approval (PMA) as was previously advised.

Proceeding under the 510(k) pathway is expected to simplify and shorten the submission process to the FDA for clearance to sell the Company’s Contour I system in the United States.

UltraShape CEO, Assaf Eyal, said “The United States is the largest and most important market in the world, and represents a huge opportunity for our products. Submission for FDA market clearance under the 510(k) regulation is a major milestone for UltraShape. The recent launch of our new third generation product, together with our efforts to gain regulatory approval in the United States and China, provide us with a major growth opportunity.” Read more

               

FDA approves adapalene lotion for acne

The Food and Drug Administration (FDA) has approved the lotion formulation of adapalene (Differin 0.1 percent, Galderma) for the topical treatment of acne in patients age 12 and older, Medscape Today reports.FDA approval was based on data from two 12-week, multicenter clinical trials of 2,141 patients with 20 to 50 inflammatory and 30 to 100 noninflammatory acne lesions at baseline. Results showed that use of adapalene 0.1 percent lotion yielded significant reductions in the total number of lesions, inflammatory lesions and noninflammatory lesions compared with the vehicle alone.

Dry skin of mild to moderate severity was the most frequently reported adverse event, occurring primarily during the first two weeks of treatment and decreasing with continued use. Other treatment-related effects included erythema, scaling, dryness and stinging or burning. Read more

               

FDA Issues Warning Letters for Drugs Promoted in Fat Elimination Procedure

The U.S. Food and Drug Administration issued warning letters to six U.S. based medical spas and a company in Brazil for making false or misleading statements on their Web sites about drugs they claim will eliminate fat in a procedure called “lipodissolve,” or for otherwise misbranding lipodissolve products.

The U.S. companies involved have made claims that the drugs they use for their lipodissolve procedures are safe and effective; however, these products have not been evaluated or approved by the FDA for this use.

Lipodissolve is a procedure involving a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. It also is known as mesotherapy, lipozap, lipotherapy, or injection lipolysis. The most commonly injected drugs are phosphatidylcholine and deoxycholate, usually in various combinations with one another.

In some cases, other ingredients, including drugs or components of other products such as vitamins, minerals, and herbal extracts are added to the mixture. The FDA is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination, and their safety when used alone or in combination is unknown. Read more

               

Mesa firm gets FDA approval on ultrasound device

A Mesa startup company has developed a medical device that uses ultrasound technology to treat everything from sagging eyebrows to liver cancer.

Guided Therapy Systems of Mesa said the device allows doctors to see and treat tissue without using traditional surgery.

The device will be used initially for cosmetic purposes, but backers say the technology has the potential to treat tumors without invasive surgery.

Ulthera Inc., a Mesa-based spinoff of Guided Therapy, gained Food and Drug Administration approval in September to market the device for cosmetic facial treatment. The company now is building its sales staff to market the device to cosmetic dermatologists and plastic surgeons.

Yet Guided Therapy, which describes itself as a technology incubator, sees more possibilities for the ultrasound and imaging technology. Read more

               

Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store Dual Laser System

Solta Medical, Inc., recently announced it has received FDA 510(k) clearance for the new Fraxel re:store Dual laser system. The Fraxel re:store Dual system adds a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market, to the company’s existing technology. The new Fraxel re:store Dual system is optimized for both on face and large body areas to address clearance of pigmentation and other superficial skin conditions all in a single treatment, according to Solta Medical. Read more

               

Pharma bracing for tougher FDA guidance on trials

Transparency welcomed, but threat of added costs creates concerns.

Pharmaceutical companies in New Jersey and elsewhere face more stringent requirements from the Food and Drug Administration on disclosures of mishaps in clinical trials.

And while industry groups and advisers have broadly welcomed the increased transparency and the move toward safer drugs, they want these actions to strike a balance with the costs of complying with them.

As of Sept. 27, the FDA requires drug manufacturers to include the general public in disclosures on “adverse” and “serious adverse” events beyond the regulator and patients participating in trials, said Satish Tadikonda, president of Virtify Inc., in Cambridge, Mass., which provides compliance services to life sciences companies.

Adverse events are side effects like rashes or headaches, while serious adverse events are those that result in death, disability or life-threatening situations, among others, Tadikonda said. Read more

               

Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson

BURLINGTON, Mass., Oct. 16 /PRNewswire-FirstCall/ — Palomar Medical Technologies Inc. (Nasdaq: PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, today announced the termination of its agreement with Johnson & Johnson Consumer Companies Inc (”JJCC”), a Johnson & Johnson company, to develop, clinically test and commercialize home-use, light-based devices for (i) reducing or reshaping body fat including cellulite; (ii) reducing appearance of skin aging; and (iii) reducing or preventing acne. Despite Palomar having met all of its deliverables under the agreement, JJCC terminated the agreement referencing the current unfavorable economic conditions as the reason for its decision. With this decision, JJCC avoids having to make a large commercialization payment to Palomar and avoids having to commit to the significant level of funding required to successfully launch a new product into the mass market. Upon termination of the agreement, JJCC’s license to Palomar technology was terminated and all technology and intellectual property rights related to light-based devices developed under the agreement were assigned to Palomar. JJCC is also precluded from further development or commercialization of the light-based devices developed under the agreement.

Palomar will continue with the commercialization of the light-based devices developed under the agreement. In June 2009, Palomar was the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home-use, laser device for the treatment of periorbital wrinkles. OTC clearance allows this wrinkle treatment device to be marketed and sold directly to consumers without a prescription. This consumer wrinkle treatment device was developed by Palomar and completed together with JJCC. Designed specifically for use in the home and based on years of research and clinical testing, this consumer device represents a major breakthrough in the aesthetic device industry.

In order to achieve FDA clearance, numerous clinical studies with hundreds of subjects and thousands of treatments were conducted. These studies demonstrated that the laser-based device delivers comfortable, effective, skin and eye safe wrinkle treatment around the eyes.

Commenting on this development, Palomar Chief Executive Officer Joseph P. Caruso said, “We have developed game changing technology in the consumer area. Over the past few years we have developed advanced patented technology that allows us to penetrate the home market. Wrinkle treatments using OTC products are a multi-billion dollar market opportunity and we plan on entering that market with our products during the second half of next year. The current economic climate does not warrant a large scale investment in a mass market launch at this time. Therefore, we have adjusted our launch plans to be more in line with current economic conditions. In the short-term, our goal is to establish our consumer products in the market using certain specialty channels and gather the valuable information needed to fully execute our long-term strategy of a full mass market launch. Our long-term goal remains the same; to tap into the mass market using our patented technology in a number of key areas with multiple product offerings and multiple channels worldwide”.

Mr. Caruso continued, “We believe that light-based anti-aging applications will one day be an ordinary and necessary part of maintaining a healthy appearance done in the privacy and convenience of the home. We were fortunate to have advanced this technology with the help of a partner who invested significant resources along the way in research, development, clinical testing, consumer testing, and patent protection that will make this a reality and ensure that Palomar maintains a leadership position in this innovative technology. We envision a strong market for this OTC device and an increase in consumer awareness that will help drive growth in our professional business.”

About Palomar Medical Technologies Inc:

Palomar is a leading researcher and developer of light-based systems for cosmetic treatments. Palomar pioneered the optical hair removal field, when, in 1997, it introduced the first high-powered laser hair removal system. Since then, many of the major advances in light-based hair removal have been based on Palomar technology. In December 2006, Palomar became the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, light-based hair removal device. In June 2009, Palomar became the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, laser device for the treatment of periorbital wrinkles. OTC clearance allows the product to be marketed and sold directly to consumers without a prescription. There are now millions of light-based cosmetic procedures performed around the world every year in physician offices, clinics, spas and salons. Palomar is testing many new and exciting applications to further advance the hair removal market and other cosmetic applications. Palomar is focused on developing proprietary light-based technology for introduction to the mass markets.

For more information on Palomar and its products, visit Palomar’s website at www.palomarmedical.com. To continue receiving the most up-to-date information and latest news on Palomar as it happens, sign up to receive automatic e-mail alerts by going to the Investor Relations’ section of the website.

    Contacts:  Kerry McAnistan
               Investor Relations Assistant
               Palomar Medical Technologies Inc.
               781-993-2411
               ir@palomarmedical.com

SOURCE: Palomar Medical Technologies Inc.
Kerry McAnistan, Investor Relations Assistant of Palomar Medical Technologies Inc., +1-781-993-2411, ir@palomarmedical.com

               

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