In Wake of Actavis/Allergan Deal, CEOs Eye Growth as Industry Landscape Compresses

In the year's largest acquisition in any industry, the Ireland based specialty and generic drugmaker Actavis last month announced plans to acquire Allergan for $66 billion in cash and stock. The transaction, still subject to the approval of shareholders of both companies and regulatory clearances, will create one of the top 10 global pharmaceutical companies by sales revenue, with combined annual pro forma revenues of more than $23 billion anticipated in 2015. Actavis will acquire Allergan for $219 per share, made up of about 60 percent in cash and the balance in stock.

The purchase price represents a significant increase over Allergan's trading price in the lead up to Valeant and Pershing Square's hostile takeover bid. Speaking with Stephen Daily, Executive Editor, News, at Bryn Mawr Communications, Actavis President and CEO Brent Saunders noted that the organizations have a “complementary culture.” “I think we both view innovation as incredibly important. We view supporting the medical communities in which we operate in as critical, and we view supporting our brands and people as compelling.” Allergan CEO David Pyott echoed these sentiments. “This is a true win-win,” Mr. Pyott observed. “We were very happy to take 41 percent of the consideration in Actavis stock, because we believe there's a great upside for Allergan stockholders who choose to remain stockholders when they receive the exchange into Actavis shares. Not just a good deal on day one, but a great deal as we generate this upside in the coming years.”

Although the long campaign for Allergan's future has been decided, less certain is the company's future direction under Actavis, according to Joel Schlessinger, MD, Chief Cosmetic Surgery Editor of Practical Dermatology^®. “With Actavis taking the company over at such an exorbitant price, the cost savings they now need to realize will be painful for existing employees and will likely result in significant unwanted changes in management and involvement in the company,” said Dr. Schlessinger.

The companies acknowledged that the new joint venture will reduce the combined R&D budget. “We feel that about a little more than half of that can come from back office and administrative and management side of R&D, so not programs,” Mr. Saunders said. “Things like pharmacovigilance, clinical trial management, informatics, medical writing, stuff like that. And the reason you can do that is, you have scale.”

“The other half will be from programs, but we will put all the programs, all the Actavis programs and all the Allergan programs, on the table. Those won't come out of just ophthalmology or aesthetics. They could come out of CNS. They could come out of GI. They could come out of women's health. We're going to put our best programs that we believe have the most innovation and the best chance of success forward, and we'll probably take the ones with less chance of success and less innovation off the table. But it won't be significant, it'll be a few programs here or there.”

Given how the Valeant-Allergan struggle has dominated healthcare industry headlines for much of the year, the eventual move by Actavis represents an almost surreal ending to the saga, according to Dr. Schlessinger. “I keep waiting for the other shoe to drop,” he noted. “Sadly, with whoever took over Allergan, there was almost zero chance of the company doing business as it had done and wanted to do business,” he noted. “The numbers are the numbers, and they are going to determine how this company ends up operating into the future.”

While the Valeant deal would not necessarily have been more favorable to those in dermatology and aesthetics, Dr. Schlessinger observed that Actavis is essentially an unknown entity in dermatology. “Whereas dermatologists would have been unforgiving if Valeant had messed with the culture of Allergan too much, Actavis has no such restriction,” said Dr. Schlessinger. “Either scenario was going to be painful, but this scenario combines pain with uncertainty, and that's concerning,” he observed.

ArteFill Changes Name to Bellafill

Suneva Medical, Inc.'s ArteFill dermal filler has been rebranded as Bellafill in the US.

“We feel that the brand Bellafill better embodies the transformational outcomes this unique product can provide to our customers and their patients,” said Suneva Medical's Chairman and Chief Executive Officer, Nicholas L. Teti, Jr. “In addition, Suneva will build and invest in Bellafill to increase awareness for the new brand.”

Bellafill is FDA-approved for the correction of nasolabial folds. Proven safe and effective, the dermal filler is comprised of 80 percent purified bovine collagen with 20 percent polymethylmethacrylate (PMMA) microspheres, and lidocaine. In addition to adding volume to smooth away smile lines, Bellafill helps skin re-create its own firmer structure.

Sienna Labs Obtains Fifth Patent Relating to Use of Plasmonic Nanoparticles in Treatment of Sebaceous Glands and Hair

Sienna Labs was issued US Patent No. 8,895,071 covering, among other aspects, methods of using the company's plasmonic nanoparticle platform for localizing thermal damage to sebaceous glands and hair, a key mechanism for their investigational acne treatment and hair removal indications.

Sienna Labs' invention, “Thermal Treatment of a Philosebaceous Unit with Coated Metal Nanoparticles,” specifically relates to using gold, silver, nickel, platinum, or titanium plasmonic nanoparticles to localize thermal damage to sebaceous glands, hair, and other components of the pilosebaceous unit. Several claims of the patent protect key methods for applying these plasmonic nanoparticles to the skin, delivering them specifically into the pilosebaceous unit, and activating the particles with light to localize thermal damage to the gland and hair follicle. Included in certain claims are methods for delivering particles specifically into the pilosebaceous unit using mechanical vibration devices including massage or ultrasound. Other key claims relate to the use of coatings that have the ability to, for example, reduce non-specific adsorption of particles on non-target epidermal surfaces and/or ensure stable mono disperse particle formulations.

Galderma Partners with AARS in Support of CDC's “Get Smart About Antibiotics Week”

Galderma Laboratories, L.P. joined the American Acne and Rosacea Society (AARS) and the Centers for Disease Control and Prevention's (CDC) Get Smart About Antibiotics Week 2014 (November 17 – 23). AARS and Galderma Laboratories, the first dermatology partner to join with AARS on the initiative, are raising awareness of the threat of antibiotic resistance and the importance of appropriate antibiotic use.

“Antibiotic use, appropriate or otherwise, in any specialty contributes to the development of antibiotic resistance,” said CDC's Lauri Hicks, DO, Medical Director, Get Smart: Know When Antibiotics Work. “In dermatology, this is true for acne medications that contain antibiotics. This year, Get Smart About Antibiotics Week continues to provide healthcare providers with resources to determine whether antibiotics are truly necessary, and empower patients to learn more about their treatment options.”

FDA ACTIONS

AD Drug Dupilumab Awarded Breakthrough Status
The FDA has awarded breakthrough therapy designation to the investigational drug dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who had an insufficient response to and/ or who are not suitable for topical prescription therapy. Dupilumab blocks IL-4 and IL-13, which are required for Th2 responses. Co-developers Sanofi and Regeneron noted that the FDA's designation was supported by positive data from Phase I and Phase II studies. Results reported earlier this year showed that dupilumab was associated with significantly greater improvements in Eczema Area and Severity Index scores from baseline compared to placebo in patients with moderate-tosevere AD for whom topical treatment was not advisable or failed to adequately control disease activity.

Syneron Candela Expands Capabilities of UltraShape Platform, Receives Clearance for the New U-Sculpt Transducer and Enhanced Ultrasound Power
The FDA cleared Syneron Medical Ltd.'s U-Sculpt transducer for the UltraShape non-invasive fat destruction platform. The FDA also cleared the V3.1 platform for a 25 percent increase in Ultrasound power in the new U-sculpt transducer and the previously cleared larger VDF transducer. This 25 percent power enhancement is designed to increase the efficacy of treatment and improve both the user experience and patient comfort, according to the company.

The UltraShape System is a non-invasive body shaping treatment that uses pulsed focused ultrasound energy to precisely target 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.

With this new clearance, the UltraShape system is now available with two transducers, the currently cleared VDF transducer as well as the new U-Sculpt transducer. The new U-Sculpt transducer is smaller and 50 percent lighter than the existing full-size VDF transducer, it is ergonomically designed to treat any shape and size of fat pockets and is easily interchangeable with the full-size VDF transducer during treatment sessions. With the new FDA clearance the VDF transducer can be operated in two energy density levels and utilizes four available treatment modes.

Heliocare Brand Partners with Walgreens to Support Vitamin Angels Project

Ferndale Healthcare^®, Inc. has committed to support Vitamin Angels and Walgreens in their effort to help at-risk populations in need—specifically pregnant women, new mothers, and children under five—gain access to highquality lifesaving and life-changing vitamins and minerals. In 2013, Vitamin Angels connected nearly 30,459,000 children and mothers in over 40 countries, including the US, with the vital nutrients they need as a foundation for good health. In 2014, the non-profit organization hopes to increase this number to reach 40 million children and mothers in approximately 45 countries.

Through 2017, a percentage of each Heliocare purchase at any Walgreens location will be donated to help Vitamin Angels provide 100 million children and mothers with the vitamins and minerals they need to live healthy lives. Heliocare® has a Suggested Retail Price of $29.99 and can be purchased in-store or online at www.walgreens.com. To learn more about the program or see a full list of products and participating vendors, please visit: www.walgreens.com/ vitaminangels.

PV-10 Data Published; Phase III Protocol Published

Phase II data for PV-10, presented at scientific meetings this fall, were published in Annals of Surgical Oncology in October. In the 80-subject study, the best overall response rate for target lesions was 51 percent, and the complete response rate was 26 percent. Eight percent of patients had no evidence of disease after 52 weeks. Response was dependent on untreated disease burden, with complete response achieved in 50 percent of patients receiving PV-10 to all of their disease. Adverse events were predominantly mild to moderate and locoregional to the treatment site, with no treatment-associated grade 4 or 5 adverse events. The study was an international, multicenter, open-label, single-agent study.

Also this fall, Provectus published online the protocol for Phase III Study Of PV-10 as treatment for melanoma. The study is “an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600E wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/ or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms. The Primary Outcome Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months. Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every 12 weeks up to 18 months); the change in total symptom score from baseline using the patient reported Skindex-16 instrument (to be assessed 12 weeks after Day 1); Overall survival (OS) to be assessed every 12 weeks up to 18 months; and number of participants with adverse events assessed every 4 weeks until 28 days after last treatment.