JAN-FEB 2013 ISSUE

News & Trends

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INDUSTRY CONSOLIDATION CONTINUES, Valeant/ Medicis Deal Complete

Valeant Pharmaceuticals acquired Medicis Pharmaceutical for $44 per share in cash in December, in a deal worth approximately $2.6 billion. The combined operations will be located in Scottsdale, AZ, and will operate under the name Medicis.

Medicis' portfolio of aesthetic and dermatologic drugs includes Solodyn (Minocycline HCl Extended Release Tablets), the Restylane family of injectable fillers, the Perlane family of injectable fillers, Dysport (abobotulinumtoxinA), and Zyclara (imiquimod). Valeant reports that the company plans to have roughly 350 sales representatives in the US, targeting prescription dermatology, aesthetics, and podiatry.

Immediately upon the closing, Valeant implemented plans to cut $225 million in costs, slashing more than 300 jobs in redundant departments. According to Reuters, Valeant CEO J. Michael Pearson predicated in an analyst call that revenue would hit up to $4.8 billion in 2013 (up from an expected $3.4 to $3.6 billion in 2012).

At the 2012 Cosmetic Surgery Forum (CSF) in Las Vegas in December, former CEO of Medicis Jonah Shacknai spoke about the pending acquisition and expressed gratitude for his many years in the dermatology industry. He stressed his confidence in the new leadership at Medicis and Valeant. On receiving the Lifetime Achievement Award in Dermatology at CSF, Mr. Shacknai observed that he expects new leadership at Valeant to bring greater customer-centricity to the company as it continues to grow and serve the specialties it targets. “Valeant is now the largest dermatology company in the world, and with that kind of stature comes a whole lot of responsibility,” said Mr. Shacknai.

The company's dermatology R&D operations will be located in Laval, Quebec, Scottsdale, AZ, and Petaluma, CA, and corporate support functions will be based in New Jersey.

In other acquisition news, Allergan, Inc. completed the acquisition of SkinMedica, Inc. Under terms of the agreement, which was first announced on November 16, 2012, Allergan paid approximately $350 million (subject to certain adjustments) for the business, best known for marketing a variety of physician dispensed non-prescription aesthetic skin care products and prescription products. Allergan plans to operate SkinMedica as a separate global business based out of SkinMedica's current headquarters in Carlsbad, CA.

Belotero Now Available Nationwide

Belotero Balance is now available nationwide from Merz Aesthetics for the correction of moderate-to-severe facial wrinkles and folds. This dermal filler joins the Merz Aesthetics portfolio of injectable products, which includes Radiesse Volumizing Filler and Asclera (polidocanol) Injection. The FDA approved Belotero Balance based on the results from a randomized, double-blind, activecontrolled, multicenter study of 118 patients. In a splitface design, patients received bilateral treatment with the product and an approved bovine collagen filler for the correction of moderateto- severe nasolabial folds. Treatment with Belotero Balance resulted in a decrease in the severity of the folds from baseline, according to the company.

New research shows that while buying beauty products has become mainstream for men, those age 18-34 agree that buying online is more convenient than shopping in-store. This compares to 52% of women of the same age and 41% of older men, research firm Mintel reports.

In-office dispensers, take note: 43% of men who shop online said it gives them early access to new products, while 73% think it saves them time. Consumers are hungry for product guidance. About half of men and women said they would use apps to guide product selection. Roughly half of men and a third of women wanted interactive features like live chat to aid online shopping.

New Fractionated Skin Resurfacing Module Enhances RF Laser Treatments

The PixelRF fractionated skin resurfacing module from Alma Lasers, Inc. uses proprietary InMotion Refractive Radiofrequency Micro Plasma Technology, which both ablates and heats the skin through controlled, focused delivery of energy without using disposables. The PixelRF was recently added to Alma's Accent family of products, and it can achieve in as little as one session what would require multiple sessions with other RF technologies, according to the company. It works by causing evaporation, mechanical damage, and thermal damage deep beneath the epidermis surface, providing significant dermal impact with minimal epidermal disruption. Patients are recommended to undergo one to four PixelRF treatments, administered every four weeks. Optimal results are typically seen in two to three months.

FDA Approves Pliaglis Novel Topical Anesthetic

Nuvo Research's Pliaglis (lidocaine & tertacaine) Cream 7%/7% topical anesthetic cream, designed to minimize pain during aesthetic dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal, now has FDA approval. Galderma has partnered with Nuvo to market the product. The approval comes on the heels of a Complete Response Letter issued by the FDA earlier this year, which raised issues that Nuvo and Galderma (its partner on Pliaglis) have successfully addressed. Pliaglis uses Nuvo's proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. Earlier this year, Galderma stated that several European countries have approved Pliaglis, suggesting a global launch of the product is imminent.

Valeant, Galderma Revise Agreement Terms

Valeant Pharmaceuticals International, Inc. reached agreement on terms of a revised North American aesthetics arrangement with Galderma S.A. Under the terms, Galderma will continue to supply Restylane and Perlane to Valeant, under the terms and conditions that Galderma currently supplies those products to Medicis Pharmaceutical Corporation. In addition, Valeant will make an upfront payment and a royalty to Galderma on sales of Sculptra. Valeant will obtain North American rights to Emervel, a family of hyaluronic acid fillers.

Residency Trends in Cosmetic Dermatology

Sixty seven percent of dermatology resident responding to a recent survey say they have formal lectures focusing on cosmetic dermatology, according to new survey data from the American Academy of Dermatology (AAD; J Am Acad Dermatol. e-pub). Lecture topics reported by more than 50 percent of respondents included botulinum toxin injection, lasers, soft tissue augmentation, chemical peels, and sclerotherapy. Topics such as dermabrasion, liposuction, and scar revision were less commonly taught. The most commonly encountered and performed procedures were botulinum toxin injection and lasers (100 percent), followed by soft tissue augmentation (98.8 percent), and encounter both chemical peels and sclerotherapy (95.4 percent). Varying widely, however, was resident experience performing procedures as the first assistant or as the first surgeon.

Study: Face Product Dyes Pose Health Risks

European researchers are urging formulators to remove two dyes—both possibly used in US products—from skin care products and after-shave, based on a recent study suggesting risk to product users. Brilliant Blue (E133) and Patent Blue (E131), both authorized as cosmetic coloring substances in the EU, have been found to permeate shaved or damaged skin in a recently published study (Food and Chemical Toxicology; 52:19-27). The Brilliant Blue dye is FDA approved as an additive for usage in food, drug, and cosmetic products.

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