8 May 2019 - - US-based biopharmaceutical company Ligand Pharmaceuticals Inc. (NASDAQ: LGND) has acquired economic rights to SB206 from biotechnology company Novan, Inc., the company said.

SB206 is a Phase 3 topical antiviral gel for the treatment of skin infections, including molluscum contagiosum.

Ligand will pay USD 12m to Novan and in return will be entitled to receive a tiered royalty of 7% to 10%, as well as up to USD 20m in regulatory and commercial milestones.

Novan is responsible for all expenses to develop or commercialize SB206, and will use 100% of the proceeds from this transaction in the development and pursuit of regulatory approval for SB206.

Novan is developing SB206 as a nitric-oxide-based topical gel for the treatment of viral skin infections, with a current focus on the treatment of molluscum contagiosum, a contagious skin infection caused by the molluscipoxvirus.

There are currently no therapies approved by the US Food and Drug Administration for the treatment of molluscum. Nitric oxide has diverse biological activity within the body, affecting the immune, cardio/pulmonary and neurological systems, and depending on dose and release kinetics, nitric oxide can have agonistic or antagonistic effects.

The role and mechanics of nitric oxide have been well researched.

Novan's technology platform is the first macromolecular platform to achieve stable, tunable and druggable delivery of nitric oxide.

SB206, if approved, could be a topical, at-home, caregiver-applied therapy with a rapid treatment benefit. Novan's issued US and foreign patents and pending US and foreign patent applications, if issued, relating to SB206 are projected to expire between 2026 and 2034.

Molluscum contagiosum is a contagious skin infection caused by the molluscipoxvirus. Molluscum affects approximately six m people in the US annually.

The greatest incidence is in children aged one to 14 years. The average time to resolution is 13 months, and 13% of children experience lesions that may not resolve in 24 months.

There is no FDA approved treatment for molluscum, and caregivers are faced with potentially painful in-office, physician-administered treatments or off-label prescriptions with no molluscum indication, no proven clinical efficacy and tolerability issues.

As a result of the inadequate treatment paradigm, over 50% of patients diagnosed with molluscum are untreated.

The majority of patients that receive treatment undergo procedures with painful effects such as scraping, freezing, burning and blistering, and the remainder are often prescribed products indicated for the treatment of external genital warts.

Novan is a clinical development-stage biotechnology company focused on leveraging nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs.

Novan believes that by deploying nitric oxide in a solid form, on demand and in localized formulations allows the company to potentially improve patient outcomes in a variety of dermatology, women's health and gastrointestinal diseases.

Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines.

PRO-ACT is an ongoing, two-year, real-world study evaluating patient-reported treatment satisfaction among RRMS patients who switched to Lemtrada from another disease-modifying therapy, as measured by the Treatment Satisfaction Questionnaire for Medication.

The TSQM includes four domains: global satisfaction, effectiveness, side effects, and convenience; these are rated on a scale of 0 to 100, with higher scores indicating greater satisfaction.

In an interim analysis of the PRO-ACT study, patients who had completed TSQM assessments at baseline and 12 months after starting Lemtrada reported improvements in global satisfaction (primary endpoint) and effectiveness; the side effects score decreased and the convenience score was stable.

The most common prior disease-modifying therapy before switching to Lemtrada was natalizumab (37%), followed by oral therapies fingolimod, dimethyl fumarate and teriflunomide (14, 13 and 12%, respectively), interferons-beta (11%) and glatiramer acetate (8%).

The most frequent reason for switching was lack of efficacy (75%). These percentages are based on 201 patients enrolled in PRO-ACT as of June 2018.

PROMiS is an ongoing, one-year, real-world study evaluating patient-reported health-related quality of life, function and degree of disability in RRMS patients treated with Lemtrada.

It utilises three patient-reported outcomes questionnaires: the Multiple Sclerosis Impact Scale -29, which evaluates health-related quality of life (the specific physical and psychological impact of MS); and the Multiple Sclerosis Performance Scale and the Patient-Determined Disease Steps, both of which evaluate functional health (MS-associated disability). Higher scores indicate greater disability in functional health (MSPS and PDDS) or worse health-related quality of life (MSIS-29).

In an interim analysis that included 171 patients at baseline, over eight months after initiation with Lemtrada, patients reported significant and clinically meaningful improvements in health-related quality of life. Patients also reported statistically significant improvements in functional health.

Mean MSIS-29 scores improved at month 8 after Lemtrada initiation (n=134) vs. baseline (physical impact score, 43.0 vs. 53.1; psychological impact score, 36.8 vs. 49.4; both p