VALEANT SELLS FILLERS TO NESTLE, UPS ALLERGAN OFFER
Valeant Pharmaceuticals International Inc. has entered into an agreement with Nestle S.A. to sell all rights to Restylane, Perlane, Emervel, Sculptra, and Dysport owned or held by Valeant for $1.4 billion in cash, according to a company news release. Nestle expects to complete its acquisition of Galderma S.A. in July and would expect to operate the acquired assets through Galderma.
The transaction is subject to customary closing conditions, including clearance or early expiration of the waiting period under the Hart-Scott-Rodino (HSR) Act. While the deal is not contingent upon a merger between Allergan and Valeant, Valeant says the move “dovetails well” with its merger plans.
“We are pleased to enter into this transaction,” J. Michael Pearson, chairman and chief executive officer, said in the news release. “Galderma, under the leadership of Humberto Antunes, CEO of Galderma, not only has a history of building strong businesses, but is firmly committed to the aesthetic dermatology. It is a clear testament to the performance of Valeant's aesthetic commercial team that Galderma recognizes their efforts and the value of the franchise they have developed. Galderma has already built a strong franchise with Restylane, Perlane, Dysport and Emervel outside North America and, with the addition of Sculptra, will now have the ability bring their expertise to the US and Canada.”
In its continued pursuit of Allergan, Inc., as of press time Valeant revised and upped its offer for the company under which each Allergan share would be exchanged for $72.00 in cash and 0.83 shares of Valeant common stock, based on the fully diluted number of Allergan shares outstanding. This offer is subject to prompt good faith negotiation of a merger agreement between Valeant and Allergan. Shareholders will continue to be able to elect cash and/or Valeant stock, subject to proration. Pershing Square, Allergan's largest shareholder with a 9.7% stake, has agreed to elect only stock consideration in the transaction and exchange their Allergan shares for Valeant shares at a 1.22659 exchange ratio, based on the closing stock prices of Allergan and Valeant at the time of the offer, and receive no cash consideration.
Allergan issued a statement regarding the filing by Pershing Square Capital Management of preliminary proxy materials with the SEC in order to solicit proxies to call a special meeting of Allergan's Stockholders. At the special meeting, Allergan stockholders would be asked to remove a majority of the company's existing directors in connection with Valeant's and Pershing Square's previously announced unsolicited proposal to acquire all of the outstanding shares of the company.
“Allergan urges all of its stockholders to refrain from taking any action, including returning any proxy card sent by co-bidders Pershing Square and Valeant, until they have reviewed the recommendation of Allergan's Board of Directors. Under federal securities laws, Pershing Square and Valeant cannot solicit proxies from Allergan stockholders until Pershing Square and Valeant provide stockholders with definitive proxy solicitation materials,” the statement read.
Allergan said, the Board will carefully review and consider the Re-Revised Proposal in due course and pursue the course of action that the Board believes is in the best interests of the Company and all of its stockholders.
FDA to Require Black-box Warnings on Sunlamp Products
The FDA issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices. The order also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years. In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications. Sunlamp products, which include tanning beds and tanning booths, emit UV radiation that may cause skin cancer.
Manufacturers will now have to submit a premarket notification (“510(k)) to the FDA–and obtain FDA clearance–prior to marketing these devices, which until now were exempt from premarket review. Manufacturers also will now have to show that their products meet certain performance testing requirements and address certain product design characteristics, and will have to include certain warnings and contraindications on sunlamp products and in certain marketing materials for sunlamp products and UV lamps that present consumers with clear information on the risks of use. Certain marketing materials promoting sunlamp products and UV lamps must carry additional warnings and contraindications, including “Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
Syneron Receives FDA Clearance to Market the Ultrashape System
Syneron Medical Ltd. received FDA 510(k) clearance to market the UltraShape System for non-invasive reduction of abdominal circumference via fat cell destruction.
The UltraShape System uses pulsed focused ultrasound energy that precisely targets subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves, and muscles intact. UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage. According to the company, this unique feature of the UltraShape technology results in a safe and comfortable treatment experience.
In the randomized, controlled clinical study of UltraShape, which was performed at three clinical sites in the US and one site outside of the US, a total of 150 subjects were treated and followed for up to four months. In this multi-site study, patients demonstrated an average reduction of 2.5cm in the treatment phase and 0.5cm reduction in the control phase.
The UltraShape System received CE mark in 2005 and is marketed in European countries, Canada, and Asia Pacific countries. The device has been used in over 220,000 procedures worldwide, with a positive safety and effectiveness profile. Syneron acquired UltraShape in March 2012.
New Data: Neodyne Biosciences embrace Advanced Scar Therapy
Neodyne Biosciences reported a highly significant improvement in scarring for patients treated with embrace® Advanced Scar Therapy versus control at one-year follow-up in a randomized, controlled trial of the device. embrace Advanced Scar Therapy actively relieves the tension surrounding a healing scar to minimize scar formation and uses technology initially developed at Stanford University and subsequently licensed to Neodyne Biosciences.
The REFINE trial enrolled patients who underwent abdominoplasty procedures, a challenging indication for scarring since the incision is closed under maximum tension. Half of each newly closed incision was selected randomly to be treated with the embrace device. The remaining portion of the incision served as the “control” side and was treated according to the plastic surgeon's standard of care.
At 12 months, the mean VAS score for embrace-treated scars was significantly improved compared to control-treated scars, (difference = 0.39, 95 percent confidence interval [0.14, 0.66], p = 0.027). Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale (POSAS), (p = 0.02 and p < 0.001, respectively).
ALPHAEON Appoints Board Of Directors
ALPHAEON Corporation, a subsidiary of Strathspey Crown Holdings LLC, recently appointed its board of directors. The new board is comprised of experts from the health-care industry, politics, science, and education.
The ALPHAEON directors include William J. Link, PhD, Robert E. Grant, Robert Hayman, Hans Keirstead, PhD, Richard L. Lindstrom, MD, Vikram Malik, Patrick Maxwell, MD, Valerie Taupin, Joseph Whitters, CPA, and Senior Advisor and Board Observer Christopher Cox. Read more about the board members on AestheticsWire. Visit www.modernaesthetics.com/wire/view.asp?20140514-alphaeon_appoints_board_of_directors.
Iluminage Skin Smoothing Laser Available for Home Use
Iluminage Beauty Inc. introduced the iluminage Skin Smoothing Laser, the first at-home laser device FDA-cleared to reduce fine lines and wrinkles around the eyes and mouth.
The iluminage Skin Smoothing Laser delivers pulses of laser light below the surface of the skin where wrinkles form. This technology triggers the body's natural response to generate new collagen fibers. When an entire area is treated, the new collagen helps tighten the skin. The skin's support structure is reinforced from within to reduce the appearance of fine lines and wrinkles.
This product was created in partnership with Unilever, utilizing Cynosure's advanced laser technology. The at-home laser was clinically tested in more than 3,640 treatment sessions, performed on 58 subjects. In the trials, 78 percent demonstrated a significant improvement in the appearance of fine lines and wrinkles by two weeks; 87 percent demonstrated a significant improvement in the appearance of fine lines and wrinkles by four weeks; and 95 percent demonstrated a significant improvement in the appearance of fine lines and wrinkles by 12 weeks.
The iluminage Skin Smoothing Laser allows users to fol- low their results by capturing treatment data from each use. Individuals can upload their data to a unique digital ecosys- tem, the iluminage Skin Clinic. During the first few days, users may notice mild, temporary redness after treatment.