In April 2017, Novartis declared that it has exercised an option deal that was struck quietly last year with a Boston-based biopharma, Lubris LLC., without disclosing the financial terms. Lubris’s compound, ECF843, which is in development for the treatment of dry eye syndrome (DES), is at the heart of this deal, in which Novartis obtains rights to ophthalmic indications worldwide except in Europe, where Lubris has already licensed the technology to Italian drug company Dompe Group. Lubris will retain the commercial rights for non-ophthalmological indications, such as osteoarthritis.
Given the promising performance of ECF843 during the early-stage clinical studies together with its potential to address the unmet need in DES, the in-licensing of this possible first-in-class therapeutic will bolster Novartis’s pipeline. It will also build upon the company’s leadership in ophthalmology and DES treatment, supplementing its global portfolio of artificial tear products, which include Systane, Tears Naturale, and Genteal. And if this drug makes it through late-stage trials, it would position Novartis to be a strong rival to Allergan , whose blockbuster dry eye drug Restasis (cyclosporine) has firmly established itself as the main player in the US market. Novartis’ dry eye drug will also face competition with Shire’s Xiidra (lifitegrast), which came to market last year.
Novartis focuses on ophthalmology
This is the second ophthalmology-related agreement for Novartis in the last few months. In late December 2016, the Swiss drug giant reached a definitive agreement to acquire Encore Vision, which is focused on developing a novel topical therapeutic for presbyopia, a common age-related vision disorder. The Encore deal was announced after Novartis’ eye drug franchise was hit by the failure of two Phase III eye combo studies (OPH 1002 and OPH 1003), which tested Novartis’ Lucentis (ranibizumab) combined with its in-licensed ophthalmology candidate, Fovista (pegpleranib), for treating patients with neovascular age-related macular degeneration (nAMD), an area where Novartis already has a strong business built around Lucentis.
In fact, according to press reports, Novartis is also considering selling its under-performing Alcon eyecare unit. The Encore and Lubris deals represent a bid by Novartis to boost its investment in the eye division and confirm its leadership in ophthalmology, employing the strategies of entering new eye therapies and strengthening its leadership in DES.
Lubris’s compound, ECF843, is a recombinant form of the human lubricant lubricin (rh-Lubricin), which is an endogenous glycoprotein found in high shear stress and friction areas throughout the body. In the eye, lubricin is present in the tear film, where it binds to and protects the ocular surface, the assumed mechanism that the drug addresses. Lubricin deficiency has been observed in patients with DES, and the presence of lubricin has been shown to significantly reduce friction between the cornea and conjunctiva.
DES affects over 334 million patients globally and is characterized by inadequate moisture in the eye, resulting in inflammation, discomfort, and sensitivity to light. It is hypothesized that the drug is able to restore the tear film function, reduce friction, and relieve the associated syndromes by addressing a similar mechanism as lubricin.
Promising trial results for ECF483
Last year Lubris reported promising results from its small Phase II clinical trial assessing the efficacy and safety of ECF843 compared with 0.18% sodium hyaluronate eye drop (Vismed) in 40 patients with moderate to severe dry eye disease. Significant instant improvement of symptoms was observed with patients receiving ECF843, likely via enhancing lubrication across various eye and tear surfaces. Additionally, a significant improvement in signs of dry eye was demonstrated within 28 days with the drug, in the absence of treatment-related adverse events.
Such a consistent and sizable therapeutic effect, especially when compared against another active compound, has not been reported for any other treatment. Currently, there are no approved treatments that can instantly relieve dry eye symptoms in a timely manner, which remains a substantial unmet medical need and a relevant factor for patient compliance and treatment success. Therefore, ECF843 could potentially become the first-in-class therapy for DES, which could potentially fulfil this pressing unmet need.
GlobalData (2015). PharmaPoint: Dry Eye Syndrome – Global Drug Forecast and Market Assessment to 2024, November 2015