Botox Biosimilar in the Works

Mylan N.V. and Revance Therapeutics, Inc. are partnering to develop a biosimilar to Botox (onabotulinumtoxinA).

The companies plan to work together to gain regulatory approval in the development of this biosimilar product, and commercialize this product in the US, Europe, and applicable markets throughout the rest of the world.

The collaboration includes an upfront payment of $25 million to Revance, with contingent milestone payments upon achievement of additional clinical, regulatory, and sales targets, plus sales royalties in all relevant markets.

Revance’s Botox rival, daxibotulinumtoxinA for injection (RT002), is not yet FDA approved. They reported positive Phase 3 data for the treatment in December and said then that it planned to launch the drug in 2020, pending FDA approval.

Sensus Healthcare Launches New Line of Laser Systems

Sensus Healthcare, Inc. launched Sensus Laser Systems, a unique multi-platform line of high-quality, cost-effective dermatological lasers to compliment the company’s existing superficial radiation therapy (SRT) system. Sensus Laser Systems includes applications for hair and tattoo removal, acne lesion correction, skin rejuvenation and pigmentation/large pore treatment.

“With the launch of Sensus Laser Systems, we are uniquely positioned to offer such a wide range of aesthetic and clinical solutions to patients not only to treat skin cancer but also to help people look and feel their best from head to toe,” said Kal Fishman, Sensus Healthcare CTO. “Sensus Laser Systems marks the Company’s entrance into the aesthetic laser market and offers outstanding value for providers, ultimately enabling them to offer more solutions—from cutaneous oncology to keloids to aesthetics—to patients.”

Sensus’ three new laser systems include:

• Fractional CO2—for surgical applications that require ablation vaporization, excision, incision and coagulation of soft tissue
• IPL—for hair removal, skin rejuvenation, vascular and pigmented lesions
• Q-Switched ND:YAG—for tattoo removal, pigmented lesion treatment, age spots, freckles, and sun spots

Joe Sardano, Sensus Healthcare CEO, says the lasers are sustainable, serviceable, and effective, explaining that the company offers cost-effective technology to physicians.

“As we have other indications that are on the horizon, our mission is not only to bring state-of-the-art lasers to patients all over the world but also to focus on developing the next generation of aesthetic dermatology products overall. 2018 will be the year to watch the company as we expand into aesthetics and beyond,” Mr. Sardano says.

Dermira Presents Positive Data on Treating Pediatric Patients with Axillary Hyperhidrosis

Dermira, Inc. presented new findings from its glycopyrronium tosylate Phase 3 clinical program showing that when applied topically, the investigational therapy improved disease severity, reduced sweat production, and was associated with improved quality of life outcomes for pediatric patients (ages 9 to 16) with primary axillary hyperhidrosis, compared to vehicle-treated patients.

These findings, consistent with results previously reported in adult patients (ages 17 and older), were featured in an oral presentation during the Late-Breaking Research Forums at the 76th Annual Meeting of the American Academy of Dermatology (AAD) in San Diego.

Glycopyrronium tosylate is an investigational agent formulated as a topical, once-daily anticholinergic wipe, designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.

Thermi and Sinclair Terminate Collaboration on Silhouette Instalift

Thermi, an Almirall S.A. company, and Sinclair Pharma have mutually agreed to terminate their collaboration for the marketing of Silhouette Instalift.

Both companies have been working through a joint marketing agreement for two years. Thermi and Sinclair have decided, given the growth opportunities in this market, to focus on their own core business in order to fully leverage its potential.

Under terms of the agreement entered into in May 2016, Thermi was granted exclusive four-year distribution rights for the US market until mid-2020. The agreement involved a material investment in the launch and marketing of Silhouette Instalift by Sinclair. Almirall will receive an undisclosed consideration from Sinclair.

Thermi will continue offering the ThermiRF platform.

BTL Aesthetics Unveils Body by BTL Campaign

BTL Aesthetics is celebrating the brand’s innovation with a first-of-its-kind campaign for the professional aesthetics industry emphasizing full body results. The Body by BTL campaign showcases the brand’s breadth of treatment solutions that are appropriate for everybody, and every body. Aligning the diversified treatment portfolio with a variety of personalities, the campaign chronicles first-hand experiences and life-changing results to inspire consumers to be their most confident self, BTL says.

Body by BTL comes to life through a short video highlighting the treatment journey of eight individuals who say treatment not only transformed their shape, but also their self-confidence.

Comprised of men and women of all ages, Body by BTL highlights BTL Aesthetics’ full treatment portfolio: BTL Vanquish ME, BTL Exilis Ultra, BTL Cellutone, BTL ULTRA FEMME 360, and BTL EMSELLA.

The Body by BTL campaign was unveiled at the AAD Annual Meeting aboard the U.S.S. Midway at an exclusive, invitation-only event.