MONTREAL, February 28, 2017 – BELLUS Health (TSX:BLU), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical needs, and NEOMED Institute (NEOMED), a not-for-profit organization bridging the gap between basic research and the commercialization of new drugs, today announced that BELLUS Health has obtained an exclusive worldwide license to develop and commercialize BLU-5937 (formerly NEO5937) for the treatment of chronic cough. BLU-5937 is a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor.
Under the terms of the agreement, BELLUS Health will pay NEOMED an upfront fee of CAD $3.2 million, consisting of CAD $1.7 million in cash and CAD $1.5 million with 5,802,177 BELLUS Health common shares. NEOMED will be entitled to receive a royalty on net sales-based revenues. In lieu of milestone payments, a certain portion of all other revenues received by BELLUS Health from BLU-5937 will be shared with NEOMED according to a pre-established schedule whereby the shared revenue portion decreases as the program progresses in development.
“This transaction adds a potentially best-in-class drug candidate to our pipeline that will be a core focus of our drug development efforts going forward,” said Roberto Bellini, President and CEO of BELLUS Health. “BLU-5937 targets a clinically validated target, the P2X3 receptor, in the chronic cough pathway, and based on its high potency and selectivity for the P2X3 receptor, we believe it has the potential to become a superior treatment option for the millions of patients who suffer from chronic cough.”
The P2X3 antagonist program was initiated by AstraZeneca scientists in Montreal, and assigned to NEOMED in October 2012. BLU-5937 was selected as a drug candidate to advance towards the clinic based on development efforts and extensive pre-clinical work in chronic cough done at NEOMED.
“I am extremely pleased to announce this collaboration with BELLUS Health to further the development of our P2X3 program which was discovered and developed at our Ville St. Laurent R&D facility. NEOMED’s mission is to advance innovative Canadian science programs to the point where they can be successfully progressed by a partner. We have strong confidence in the ability of the scientific and clinical team at BELLUS Health to rapidly and efficiently develop this program for the benefit of providing a new and much needed therapeutic option for these underserved patients.” declared Donald Olds, President & CEO of NEOMED Institute.
Chronic cough is a cough that lasts more than eight weeks and is associated with significant adverse social, psychosocial and physical effects on quality of life. It is estimated that, in the United States alone, more than 2.7 million patients suffer from chronic cough that is not controlled by currently available medications.
Jacky Smith, MB, ChB, MRCP, PhD, Professor and Honorary Consultant in Respiratory Medicine, University of Manchester and University Hospital Manchester NHS Foundation Trust, and a leading investigator in the field of chronic cough, said, “Millions of adults suffer from poorly-controlled chronic cough and often experience significant physical, social and psychosocial complications. These complications include sleep deprivation, exhaustion, incontinence, work disruption, social exclusion, anxiety and depression, illustrating this significant unmet medical need. BLU-5937’s potency and selectivity for the P2X3 receptor support its promise as an efficacious and safe treatment option for chronic cough patients, with the potential to significantly improve their quality of life.”
A more detailed presentation on BLU-5937, chronic cough, the role of P2X3 in chronic cough and this transaction can be found on the BELLUS Health website, www.bellushealth.com. A redacted version of the exclusive license agreement between BELLUS Health and NEOMED will be available on SEDAR (www.sedar.com) under BELLUS Health’s profile.
BLU-5937 is a small molecule administered orally that is being developed for the treatment of chronic cough. It is a potent and selective antagonist of P2X3 receptor. These receptors are located on the sensory neurons of the airways and are involved in their hypersensitization, leading to an increased urge to cough and a decreased threshold for cough reflex activation. The potent antitussive effect of BLU-5937 has been demonstrated in preclinical cough models.
About Chronic Cough
The prevalence of chronic cough, defined as a cough that lasts more than eight weeks, is estimated to be more than 10% of adults in the U.S. While an underlying etiology may contribute to cough in some of these patients, including gastro-oesophageal reflux, asthma, or allergic rhinitis, an underlying condition cannot be identified in 10%-40% of chronic cough patients (unexplained chronic cough). A portion of patients with an underlying condition as well as the large majority of unexplained chronic cough patients are not well controlled by current therapies.
About BELLUS Health
BELLUS Health is a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need. Its pipeline of projects includes BLU-5937 for chronic cough, KIACTA™ for sarcoidosis and Shigamab™ for sHUS. BELLUS Health also has economic interests in several other partnered drug development projects.
About The NEOMED Institute
The NEOMED Institute is a not‐for‐profit organization whose mission is to bridge the gap between basic research and the commercialization of new drugs by providing industrial expertise in drug discovery and development, combined with funding and a favorable ecosystem, to transform innovations into solid therapeutic solutions. NEOMED drives drug discovery activities up to the stage of human proof of concept. NEOMED has two fully integrated research and development campuses: one in Ville Saint‐Laurent, specializing in small molecule therapeutics, and the other in Laval, specializing in the development of biologics and vaccines. Both facilities function as open‐access drug discovery hubs housing independent commercial businesses (29 independent companies employing almost 300 people) and providing a dynamic environment that stimulates collaboration, innovation, and creativity. NEOMED’s wholly-owned for-profit subsidiary, NEOMED-LABS, a Contract Research Organization (CRO) providing customized and high-throughput immune-monitoring for clinical vaccine development, is one of these tenants.
NEOMED is jointly funded by the pharmaceutical industry, the Ministère de l’Économie, de la Science et de l’Innovation du Québec, and the Networks of Centres of Excellence (NCE) of Canada.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute “forward-looking statements” within the meaning of Canadian securities legislation and regulations. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health Inc.’s control. Such risks factors include but are not limited to: the ability to obtain financing, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate. In addition, the length of the BLU-5937 development process, the market size for chronic cough, the commercial value of BLU-5937 and the sharing of proceeds between NEOMED and BELLUS Health Inc. from potential future revenue of BLU-5937 are dependent upon a number of factors. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. The Company believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health Inc. is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health Inc.’s public filings with the Canadian securities regulatory authorities, including the Annual Information Form, for further risk factors that might affect BELLUS Health Inc. and its business.
|For BELLUS Health
|For The NEOMED Institute
President & CEO