Leo Pharma’s appointment this week of a new head of translational medicine is the dermatology-focused drug developer’s latest step toward fulfilling its public commitment to developing treatments that help 125 million patients by 2025.

Thomas Hultsch, MD, PhD, will oversee Leo’s effort to establish a new translational medicine group in Boston, as well as other translational medicine efforts across the U.S. and Europe. Hultsch previously served as senior director for translational medicine at Sanofi US, where he built a translational medicine team, and has a background in both basic and clinical research focused on inflammatory diseases in the U.S. and Europe.

Leo says its approach to translational medicine will be to establish leadership in translational dermatology and immunology by using novel technologies to build its own precision medicine platform capable of translating scientific and patient insights, with the goal of bolstering its understanding of diseases.

Hultsch’s appointment, announced Monday, is Leo’s second executive hire in translational medicine in the past month. On January 9, Leo announced the appointment of Adam B. Raff, MD, PhD, as director and medical advisor in translational medicine.

Leo’s increased focus on translational medicine comes as the company digests several recent expansion-focused transactions—including its acquisition of Bayer’s prescription dermatology portfolio, completed in September 2018 for an undisclosed price, followed two months later by the launch of an up-to-$760 million collaboration with PellePharm to develop and commercialize its patidegib topical gel 2% for basal cell nevus syndrome (BCNS or Gorlin Syndrome).

Patidegib, a hedgehog pathway inhibitor launched a Phase III trial (NCT03703310) in January that is designed to assess its efficacy and safety in participants using the drug for 12 months.

In October, at NORD’s Rare Diseases and Orphan Products Breakthrough Summit 2018 in Washington, D.C., Leo presented positive updated data from two Phase II studies showing clinical clearance and prevention of basal cell carcinoma (BCC) tumors after 6 months of treatment with patidegib in patients with Gorlin Syndrome. The data also showed both clinical and histologic clearance after 3 months of treatment in patients with sporadic, nodular BCCs.

“We hope that we will be able to have interim data either by the end of this year or by the first quarter of 2020,” Kim D. Kjoller, MD, executive vice president for global research and development at Leo Pharma, said in a recent interview.

More than halfway there

Speaking with GEN in San Francisco, where he attended the recent J.P. Morgan 37th Healthcare Conference, Kjoller said the PellePharm collaboration was “basically the last leg of our 2025 strategy.

“We have some years ahead of us before we reach 125 million. We hope to be closer to 100 million in the coming year, but 125 million, that will be by 2025,” Kjoller said. “I think with the pipeline that we have now, we are perhaps 60% there, so we also have quite some ground to cover in terms of new partnerships.”

Leo sought to lay groundwork toward future partnerships centered on new “innovative” treatments at J.P. Morgan, where Kjoller said the company had scheduled around 80 meetings involving executives it flew to San Francisco.

Kjoller said Leo foresees advancing to its 125 patient-goal going forward through partnerships rather than larger-scale, portfolio-expanding acquisitions like the Bayer deal and its €675 million ($773 million) purchase of Astellas Pharma’s dermatology business, completed in 2016.

The Astellas deal added assets and associated responsibilities relating to Astellas’ treatments of acne and skin infections including Protopic® for atopic dermatitis in most of the world except Japan, and other products predominantly sold in the Europe-Middle East-Africa (EMEA) region, including Locoid® and Locobase® for skin care and Zineryt® for acne.

Also in 2016, Leo began partnering with AstraZeneca to develop the anti-IL-13 monoclonal antibody tralokinumab for atopic dermatitis. Tralokinumab (LP0162) is the subject of seven ongoing Phase III trials, including the ECZTEND long-term extension trial (NCT03587805), one of three trials now recruiting patients.

AstraZeneca also gave Leo exclusive rights to develop and commercialize the IL-17 receptor monoclonal antibody brodalumab in Europe; the drug was approved in 2017 by the European Commission under the name Kyntheum.

The Bayer acquisition included branded topical prescription treatments for acne (Skinoren®), fungal skin infections (Travogen® and Travocort®) and rosacea (Finacea®), and a range of topical steroids (Advantan®, Nerisona®, and Desonate®). Not included were Bayer’s over-the-counter dermatology brands, which include Bepanthen® and Canesten®.

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