Premark Pharma Licenses Worldwide Rights to PMP2207 for Ophthalmic Indications and Targets a First Regulatory Approval for Blepharitis
BASEL, Switzerland, June 25, 2019 (Newswire.com) - 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.
PMP2207 is a novel ocular formulation of an established and well-characterised anti-inflammatory medicine. Initially, development activities will be focused on blepharitis, a chronic inflammatory condition of the eyelids, eyelid margins and ocular surface. There are currently no approved treatments for blepharitis, which is one of the most common reasons for a patient to consult an ophthalmologist1,2. The condition affects more than 10 million people visiting an ophthalmology clinic in the United States and a similar number is estimated for Europe.
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.”
For further details about collaborating on this venture, please contact Ian Vessey (email@example.com).
Blepharitis is a chronic inflammatory condition of the eyelids, eyelid margins and ocular surface, affecting more than 30% of the people consulting an ophthalmologist1,2. 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. In the most severe cases, ulceration and perforation of the cornea may occur.
PMP2207 is a novel ocular formulation of an established anti-inflammatory medicine. Results of a randomized, double-blind Phase 2 study demonstrated a statistically significant and clinically meaningful treatment effect compared to vehicle/placebo, in blepharitis patients. The active agent has a well-characterized safety profile and is free from corticosteroid side effects.
About Premark Pharma
Premark Pharma, based in Switzerland, is a privately owned, development-stage pharmaceutical company focused on the development and commercialisation of topical treatments for inflammatory diseases of the skin, eye, mucosae and mucocutaneous surfaces. The management team includes experts in ophthalmic clinical practice, drug development and strategic marketing and the lead investor is a consortium of US-based ophthalmologists. The company’s current priority is the development and commercialization of the first drug treatment for blepharitis and PMP2207 is the lead asset.
1. Lemp MA, Nichols KK; Blepharitis in the United States 2009: a survey-based perspective on prevalence and treatment. Ocular Surface. 2009; 7(Suppl 2): S1–14.
2. William WC, Stewart JA, Nelson LA; Blepharitis: New Treatment Survey. Data on File, 2019
Ian Vessey, Founder & Managing Director
Telephone: +41 796 19 37 44
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