News

IN WAKE OF ACTAVIS/ALLERGAN DEAL, CEOS EYE GROWTH

In the year's largest acquisition in any industry, Dublin, Ireland based specialty and generic drugmaker Actavis 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 take-over bid. Speaking with Stephen Daily, Executive Editor, News, at Bryn Mawr Communications, Allergan Chairman and CEO David Pyott (pictured at left), noted, “This is the best year in terms of sales growth that we've ever had in our 64-year history. You know, in the second quarter on a local currency basis, the company grew 16 percent. In the third quarter, it was even better, 18 percent....We're the fastest growing integrated eye care company in the world, per IMS Health, growing about 14 percent in market worldwide. That's in excess of the world market growing at about nine percent or 10 percent. In fact, double the speed of some of our major fully integrated competitors.”

Additionally, Actavis President and CEO Brent Saunders (pictured at left) noted that the organizations have “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.”

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.”

Actavis still has an eye toward growth. “Our goal was to be the best at what we do, to be leaders in every therapeutic area in which we operate,” Mr. Saunders said. “We kind of coined a new phrase for what we believe our company is, which is ‘growth pharma.' We coined that because we believe there are only a few companies are growing at the pace at which the new combined organization will grow at in terms of revenue, or sales. We think it's going to be a very dynamic environment. We think it's going to be a place that will attract and develop the best talent, and the place where we will continue to drive innovation for physicians and patients.”

“This is a true win-win,” Mr. Pyott concluded. “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.”

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.

My New Favorite Thing: BUDGET-FREE CONSULTS

“I think as an injector and as a physician in the past I would tend to limit what I would do or talk about with regard to a patient…I felt as if each patient had a budget that they had to deal with or that they had in mind prior to being treated. This year, and even more recently, I've abandoned that theory or thought and I've really tried to give them a menu of options that are available to me and to them in order to get the best result possible, putting money and budgets aside at least during the consultation process. After the process is complete, then we can talk about the finances…I think it's important [patients] have the whole menu and we not limit what we offer based upon what we think a patient can or cannot afford.”

Dr. Steve Yoelin | Newport Beach, CA

To hear Dr. Yoelin speak further about this, visit modernaesthetics.com/tv/?f=my-new-favorite-thing-budget-free-consults

Valeant and Ideal Implant Receive FDA and Health Canada Approval to Market Ideal Implant for Cosmetic Breast Augmentation

Valeant Pharmaceuticals International, Inc. and Ideal Implant Incorporated received approval from the FDA and Health Canada to market the Ideal Implant Saline-filled Breast Implant for use in primary breast augmentation or replacement of existing augmentation implants. The FDA approval of the Ideal Implant was based on an extensive review of various studies and data including a US clinical trial that began in 2009 with 45 plastic surgeons and 502 women, who underwent breast augmentation or replacement of augmentation implants. The clinical trial is on-going and will continue to provide follow-up data through 2020.

Women's Rogaine 5% Minoxidil Topical Aerosol Receives FDA Approval

The FDA-approved Women's Rogaine 5% Minoxidil Topical Aerosol once-daily use treatment for Female Pattern Hair Loss was recently launched. Women's Rogaine 5% Minoxidil Topical Aerosol penetrates into the scalp, with gentle massagmassaging to reactivate hair follicles and stimulate hair regrowth. Clinical studies show that with once daily use of Women's Rogaine 5% Minoxidil Topical Aerosol for 24 weeks, 81 percent of women regrew hair, with initial results as early as 12 weeks and new hairs coming in up to 48 percent thicker than before.

Syneron Candela Expands Capabilities of UltraShape Platform, Receives FDA 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.

FDA Clears PicoWay Picosecond Laser for Tattoo Removal

The FDA granted 510(K) clearance to Syneron Candela's PicoWay picosecond device for tattoo removal. PicoWay is a dual wavelength device, with 1064nm and 532nm wavelengths, which utilizes the proprietary PicoWay Technology to generate picosecond pulses for the removal of tattoos. The FDA clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength. The US launch of PicoWay will begin immediately, following the launch of the product in the international market in October, according to the company.

PicoWay incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high energy ultra-short picosecond laser pulse creates a strong photo-mechanical impact that optimizes fracturing of tattoo ink. The innovative PicoWay Technology is integrated into a proven, reliable Syneron Candela platform which offers high reliability, superior performance and low cost of ownership.

In support of the FDA 510(K) clearance, the performance of the PicoWay system was evaluated in a prospective, US multicenter study conducted by Eric Bernstein, MD, Arielle Kauvar, MD, and Tina Alster, MD as the primary investigators. A large majority of subjects (86 percent) achieved at least 50 percent tattoo clearance after only three treatments based on blinded, independent review. Device treatment also presented a favorable safety profile with no device-related serious adverse events, and low levels of pain or discomfort throughout the study.