Licensing of Topical Cerdulatinib

Dermavant Sciences Announces Licensing of Topical Cerdulatinib from Portola Pharmaceuticals for Dermatologic Indications

– Cerdulatinib is a dual spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor – Dermavant plans to develop cerdulatinib as a topical therapy for a range of dermatologic conditions while Portola retains all systemic rights – Jim Lee, MD, PhD, named Chief Medical Officer of Dermavant

BASEL, Switzerland, Dec. 21, 2016 /PRNewswire/ — Dermavant Sciences, a biopharmaceutical company focused on developing innovative therapies for dermatologic conditions, today announced that it has entered into an exclusive worldwide licensing agreement with Portola Pharmaceuticals, Inc. for the development and commercialization of cerdulatinib in topical applications beyond oncology.

Cerdulatinib is a dual spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor that Portola is developing to treat patients with resistant or relapsed hematologic cancer. Cerdulatinib is currently being investigated in an ongoing Phase 2a trial in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies. Under the terms of the agreement with Dermavant, Portola retains full rights to all non-topical formulations of cerdulatinib, including oral formulations.

Dermavant, a subsidiary of Roivant Sciences, intends to pursue the clinical development of cerdulatinib as a topical therapy for a variety of dermatologic conditions. Dermavant believes that the profile of cerdulatinib is ideal for development in these skin diseases where a growing body of evidence suggests that both JAK and Syk are important drivers of disease manifestation.

“The addition of cerdulatinib to our pipeline renders Dermavant an emerging leader in medical dermatology,” said Jim Lee, MD, PhD, the newly-appointed Chief Medical Officer of Dermavant. “Given the anti-inflammatory properties associated with both JAK and Syk inhibition we look forward to advancing the clinical development of cerdulatinib as a potential therapy for a number of dermatologic conditions with significant unmet need.”

Appointment of Dr. Jim Lee as Chief Medical Officer

Dermavant’s Chief Medical Officer, Dr. Jim Lee, brings over 17 years of experience in successfully developing multiple therapies across various indications in the field of dermatology. Most recently he served as Vice President, Global Head of Clinical Development at Stiefel Laboratories from 2011 to 2016. Dr. Lee previously served as Chief Medical Officer at Graceway Pharmaceuticals LLC and Director of Immunology at Centocor Inc. Dr. Lee received his MD and PhD in Biochemistry and Molecular Biology from the University of Illinois College of Medicine.

About Dermavant Sciences

Dermavant Sciences is a biopharmaceutical company focused on developing innovative therapies for dermatologic conditions. Dermavant is currently enrolling patients with mild-to-moderate atopic dermatitis in a Phase 2 clinical study for RVT-501, an investigational topical phosphodiesterase-4 inhibitor. Dermavant also plans to pursue the clinical development of RVT-201, a novel caspase-1 inhibitor, as a topical therapy for multiple dermatologic conditions.

Related Links

http://roivant.com/eczema/

Licensing of RVT-501

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into an agreement to license its in-house discovered selective phosphodiesterase 4 (PDE4) inhibitor E6005 to Roivant Sciences Ltd. (Roivant).

Under the agreement, Eisai will grant Roivant an exclusive worldwide license (including Japan) concerning the research, development, manufacture and marketing of E6005. Currently, E6005 is at the Phase II clinical trial stage for atopic dermatitis in Japan, and Roivant will conduct research and development going forward. Furthermore, according to the agreement, Eisai will receive a one-time upfront payment from Roivant, and will also receive milestone payments in line with future development progress as well as specified royalty payments after market launch.

Discovered in-house by Eisai’s Tsukuba Research Institute, E6005 is a selective PDE4 inhibitor. It is known that PDE4 is an enzyme that degrades the second messenger cyclic AMP. PDE4 is involved in inflammation and the immune response. In non-clinical and clinical studies conducted to date by Eisai, E6005 exhibits anti-inflammatory effects and suggests suppression of itching relating to atopic dermatitis by selectively inhibiting PDE4. Furthermore, in clinical studies of the agent in adult and pediatric patients with atopic dermatitis, no serious safety concerns that could pose problems in a clinical setting were observed. As it is known that the interaction between itching and inflammation leads to worsening and the chronic state of atopic dermatitis, E6005 has the potential to become a new treatment option for atopic dermatitis with its demonstrated effect on reducing inflammation and suppressing itching as well as favorable safety profile.

Roivant is a pharmaceutical company with a unique business model of strategically acquiring businesses and pipeline products from other companies. Eisai positions oncology and neurology as its key therapeutic areas, and focuses investment of research and development resources accordingly. By licensing E6005, which will be known as RVT-501 going forward to Roivant, Eisai aims to maximize the value of the compound as well as accelerate its development in order to contribute to the treatment of patients with inflammatory/autoimmune diseases starting with atopic dermatitis as soon as possible.

About E6005 (Roivant development code: RVT-501)

E6005 (RVT-501) is a selective phosphodiesterase 4 inhibitor discovered in-house by Eisai. Distributed in many cells involved in inflammation and immune response, PDE4 is an enzyme that influences the transmission of inflammation signals by degrading the intracellular signaling molecule cyclic AMP. It is reported that exacerbation of PDE4 activity leads to increased production of inflammatory mediators, making the condition worse and chronic in nature, and at atopic dermatitis lesion sites, exacerbation of PDE4 activity can be observed. In non-clinical and clinical studies conducted by Eisai, E6005 exhibits anti-inflammatory effects and suggests suppression of itching relating to atopic dermatitis by selectively inhibiting PDE4. Currently, E6005 is at the Phase II stage of clinical trials as a transdermal PDE4 inhibitor for adults and pediatric patients with atopic dermatitis, and with its demonstrated effect on both reducing inflammation and suppressing itching as well as favorable safety profile, E6005 has the potential to become a new treatment option for atopic dermatitis.