Allergan to Acquire Kythera

Allergan has entered into a definitive agreement to acquire Kythera Biopharmaceuticals in a cash and stock transaction valued at $75 per share, or approximately $2.1 billion. Once the transaction is complete, Kythera’s recently approved Kybella (deoxycholic acid) will be part of an aesthetic portfolio that also includes Botox Cosmetic (onabotulinumtoxinA).

According to Joel Schlessinger, MD, Chief Cosmetic Surgery Editor of Practical Dermatology® magazine, the synergies of these two companies are obvious and the additive value that Kybella will offer for the cosmetic patient is significant, as well. “This will dovetail well for all the Botox, Juvederm, and other cosmetic patients in the Allergan fold,” Dr. Schlessinger notes. “Additionally, the immediate reach and pull of Allergan’s rewards program, Brilliant Distinctions, will lead to a quick uptake in adoption with these already self-identified cosmetic patients.” 

Beyond the obvious growth of a wider aesthetic portfolio, Dr. Schlessinger predicts that the transition will likely be quick and efficient from a business perspective, as well. “The integration of these two companies will be easily effected given the fact that many of them come from Allergan and understand the culture and structure of this company,” says Dr. Schlessinger.

Cynosure’s SculpSure Receives Expanded FDA Clearance for Lipolysis of the Abdomen

Cynosure, Inc. has received 510(k) clearance from the FDA to market SculpSure for non-invasive lipolysis of the abdomen. In May, the FDA cleared SculpSure for non-invasive lipolysis of the flanks. SculpSure is designed to reduce fat non-invasively by disrupting subcutaneous fat cells. The hands-free device features a flexible applicator system to treat multiple anatomical areas of the body. SculpSure, which uses a 1060nm laser, can treat an anatomical area in approximately 25 minutes. Patients are able to achieve desired results without downtime or surgery. The technology is expected to launch in the US in the second half of 2015.

Gene Linked to Melanoma Growth, Worse Outcomes

High levels of a specific protein linked to gene expression are associated with worse outcomes in melanoma, according to a study led by researchers at Icahn School of Medicine at Mount Sinai and published online in the journal Molecular Cell.

Research shows that the protein, called H2A.Z.2, promotes the abnormal growth seen in melanoma cells as they develop into difficult-to-treat tumors. H2A.Z.2 is part of the chromosome structure that packages genes, and has the ability to switch them on off. Having high levels of this protein aberrantly activates growth-promoting genes in melanoma cells.

According to a release from Mt. Sinai, an emerging theory in cancer research is that abnormal growth may result not only from unfortunate, mutations in patients’ genes, but also from epigenetic mechanisms that turn genes on and off. In the current study, authors found that blocking the functions of H2A.Z.2, either alone or in combination with cancer therapies, effectively blocked tumor growth and killed melanoma cells.  

Restylane Lyft Approved for Cheek Augmentation and Midface Contour Deficiencies

The FDA approved Galderma’s Restylane Lyft for cheek augmentation and the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane Lyft, formerly marketed as Perlane-L, is an injectable gel used to increase volume and smooth wrinkles in the face. With this new indication, Restylane Lyft is the only FDA approved filler indicated to provide fullness to the midface area and to correct and smooth the nasolabial folds. 

In a clinical trial involving 200 patients, investigators observed that 88.7 percent of patients treated with Restylane Lyft showed an improvement in fullness in the right and left midface areas (combined) at two months, and more than half maintained improvement for 12 months. Additionally, 95 percent of patients reported improvement with the appearance of their midface at two months and 73 percent of patients reported improvement at 12 months. The most common adverse events observed in the trial included: tenderness, redness, bruising, swelling and itching. These events decreased in severity over time and most were resolved within two weeks. For more coverage of the approval, watch the latest episode of DermWireTV, available at DermTube.com. n

Take 5

With Todd Zavodnick, President, Galderma in the US

Todd Zavodnick, formerly Vice President and General Manager for Galderma’s Aesthetic and Corrective Business, is now at the helm of the company’s US operations. He spoke with us about Galderma’s global footprint, commitment to physicians, and future in the US marketplace.

1. Galderma is Growing

“The foundation of Galderma was built in the US…The US is the marquee market, but the company does business in Latin America, Europe, and Asia.”

Galderma is growing its global footprint. Under the umbrella of Nestle Skin Health, the company is poised to increase business around the world and in the US. Last year’s acquisition of several fillers from Valeant marked Galderma’s foray into the aesthetic marketplace, which Mr. Zavodnick calles “extremely dynamic.”

2. Innovation is the Name of the Game

“Galderma is 100 percent committed to bringing new innovations to the market place at a rapid pace. Innovation is the name of the game.”

Mr. Zavodnick notes that the company remains focused on supporting skin health, including medical care and aesthetics. Galderma has five R&D sites, including its 270,000 square foot research center in Sophia Antipolis, France—the largest dermatology research site in the world.

3. Physician Relationships Matter

“Training physicians is not about launching new innovations. It’s about launching new innovations properly.”

Mr. Zavodnick says Galderma is committed to educating physicians to ensure best outcomes and protect patient safety. The company also seeks to support physicians in their practices. This spring, the company launched its new ASPIRE Rewards program for physicians and consumers.

4. Skin Health Requires Medical Solutions

“We are medical solutions. Not derm-aesthetic. Not aesthetic-active.”

Mr. Zavodnick says the company is dedicated to bringing medical solutions to consumer skin health. The goal is to enable physicians to recommend scientifically-based formulations that provide an outcome for a medical need, he says. Development is focused on new ingredients for optimized outcomes.

5. Instability in the Space Persists

“Galderma is dedicated to offering innovation and stability at a time when there is a lot instability.”