NovaBiotics Ltd, the UK-based clinical-stage anti-infectives biotechnology company, today announced that it has entered into an agreement with an undisclosed global partner to commercialise Lynovex, the Company’s first-in-class oral intervention for acute infectious exacerbations associated with cystic fibrosis (“CF”).
Under the terms of the agreement, NovaBiotics’ collaboration partner has exclusive global rights to market and sell oral Lynovex for CF exacerbations and will have responsibility for manufacturing oral Lynovex. NovaBiotics will continue to be responsible for pre-registration development of Lynovex which is scheduled to enter a two-part global registration study in Q4 2016. The commercial terms of the agreement are such that NovaBiotics will receive development milestone payments, and tiered sales and commercial royalties thereafter. Both parties will jointly manage post-approval development activities for oral Lynovex.
Lynovex is designated as an orphan drug in Europe and the U.S and is the first multi-active therapy of its kind (anti-infective, mucolytic, anti-biofilm, antibiotic potentiating) to be developed specifically for alleviating the infectious trigger and symptoms of CF exacerbations. Data from the successful Phase IIa clinical study, which was supported by a grant from the UK’s Cystic Fibrosis Trust, confirmed that the product was well tolerated and absorbed into the lungs of CF patients. There were also positive results on a number of clinical parameters measured, including sputum bacterial load, sputum viscosity etc. In addition, the Company has demonstrated that Lynovexdramatically enhances the effect of existing anti-infective drugs used in CF therapy.
Dr Deborah A O’Neil, NovaBiotics CEO commented: “This is the next important step in the process of getting oral Lynovex to the patients in the CF community whom it can benefit. We strongly believe that the partnership deal we have signed provides the optimal strategy for market access, through a world leader in orphan drug marketing – subject of course to Lynovexcontinuing to deliver positive clinical data and thereafter receiving the required marketing approvals. We look forward to a successful commercial collaboration going forwards.”