Premark Pharma licenses ophthalmic drug candidate from Novartis

Premark Pharma announced today the completion of a licensing deal with Novartis Pharma AG, granting Premark exclusive worldwide rights to develop and commercialise PMP2207, an ophthalmic ointment formulation, as a potential treatment for blepharitis. Premark Pharma, based in Reinach (BL), was founded by Ian Vessey, former Head of Early Phase Marketing for the Novartis Ophthalmics Business Unit. In March 2019, Premark has successfully completed a first round of financing, supported by investments from a consortium of US-based ophthalmologists and senior pharma industry executives. Sufficient funds have been generated to support business activities up to the commencement of the planned PMP2207 Phase 3 programme in blepharitis.

Blepharitis is a chronic inflammatory condition of the eyelids, eyelid margins and ocular surface, affecting more than 30% of the people consulting an ophthalmologist. The condition often results in an unsightly redness and crusting of the eyelid margins, which troubles patients. Blepharitis is uncomfortable, with a broad spectrum of ocular symptoms ranging from mild transient irritation to persistent burning, itching, pain, contact lens intolerance, photophobia, ocular fatigue and visual disturbance.

There are currently no approved treatments for blepharitis, which is one of the most common reasons for a patient to consult an ophthalmologist. The condition affects more than 10 million people visiting an ophthalmology clinic in the United States and a similar number is estimated for Europe.

Encouraging phase 2 results

The results of a Phase 2, 12-week, randomized, double-blind study, generated clear evidence of a clinically meaningful treatment effect of PMP2207 in blepharitis. Compared to patients receiving the ointment vehicle, those treated with PMP2207 experienced a greater improvement in both the signs and symptoms of blepharitis, which was evident after only two weeks and was sustained throughout the 12 weeks of treatment.

“Today, there are no approved pharmacological treatments for blepharitis and the off-label options have significant issues, especially with longer-term use,” said Professor Thomas Reinhard, Medical Director of the Eye Centre, University Hospital Freiburg, Germany, and lead investigator for the Phase 2 study. “PMP2207 has the potential to become the standard of care in managing this condition. The efficacy shown in the Phase 2 trials is compelling and the active compound has a clean and well-documented safety profile. We are looking forward to commencement of the Phase 3 programme.”

In the absence of a recognised standard of care for blepharitis, ‘off-label’ topical corticosteroids and topical antibiotics are the most widely prescribed treatments. The evidence base supporting this practice is weak and neither are good options for longer-term use. Topical corticosteroids have well-documented and sight-threatening side-effects, while topical antibiotics run the risk of promoting antimicrobial resistance.

“This asset represents a significant opportunity for Premark Pharma, our investors and, ultimately, the millions of blepharitis patients without a tried and tested treatment option,” said Ian Vessey, Founder of Premark Pharma. “Our plans for the Phase 3 programme are progressing well. We have already initiated consultation with the EMA and FDA and are actively seeking partners for the next stage of development.”

(Press release / SK)