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Commercial Collaboration Deal for (Oral) Lynovex®

5th August 2016

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 Lynovex® dramatically 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 Lynovex® continuing to deliver positive clinical data and thereafter receiving the required marketing approvals. We look forward to a successful commercial collaboration going forwards.”

 

Older News

NovaBiotics secures an additional £3.0 million investment from Woodford Investment Management | 3rd March 2017
Commercial Collaboration Deal for (Oral) Lynovex® | 5th August 2016
NovaBiotics Announces New Data on Cysteamine (Nylexa™) as an Antimicrobial Resistance Breaker in Multi Drug Resistant Bacteria | 18 June 2016
NovaBiotics Highlights Importance of Co-ordinated Approach to Antimicrobial Resistance | 7th June 2016
NovaBiotics Wins Investment of the Year Award | 5 Feb 2016
Lynovex® Activity in CF sputum & Against the Emerging CF Pathogen, Mycobacterium abscessus | 12 Aug 2015
Phase IIa clinical study results for NovaBiotics' Lynovex® presented at the 38th Annual European Cystic Fibrosis Symposium | 12 Jun 2015
Launch of the BEAM Alliance | 9 Jun 2015
NovaBiotics Quoted in "What Investment" on 11 February | 11 Feb 2015
NovaBiotics Raises £5.0 million in a Private Placement from Woodford Investment Management | 19 Jan 2015
NovaBiotics' Dr Deborah O'Neil Named EY UK Health Products & Services Entrepreneur of 2014 | 7 Oct 2014
Showcases increasing investor interest in the global stem cell sector | 22 Sep 2014
NovaBiotics Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for Lynovex® | 16 Sep 2014
Scotland's Pharmacells Group creates 12 new jobs at BioCity Scotland following acquisition by Precious Cells Group, London | 18 August 2014
Precious Cells Biobank Acquires Stem Cell Technology Leader Pharmacells Group | 25 July 2014
NovaBiotics' Dr Deborah O'Neil Wins Entrepreneur of the Year | 27 June 2014
NovaBiotics Initiates Phase IIa Clinical Study for Lynovex in Cystic Fibrosis | 25 June 2014
NovaBiotics' Dr Deborah O'Neil Named EY Scotland Entrepreneur of 2014 | 20 June 2014
NovaBiotics Initiates Development of Orphan Drug in Cystic Fibrosis | 17 December 2013
Pharmacells to expand following funding boost | 24 September 2013
NovaBiotics Enters into Agreement with Taro | 28 August 2013
First patient dosed at Aberdeen Royal Infirmary in major international study | 29 August 2012
Pharmacells in talks to extend reach overseas | 24 January 2012
New hope in cystic fibrosis fight as Scots patients first to test drug | 2 January 2012
NovaBiotics reveals plans for cystic fibrosis drug after EU grants orphan status | 19 December 2011
Pharmacells stores stem cells for teenager paralysed in car crash | 20 October 2011
NovaBiotics Ltd - Presentation at BIO International 2011, Washington DC | 24 June 2011
Launch of Oristem® | 04 June 2011
GBP in Nexxus newsletter, Spring 2011 | 22 March 2011
Patents granted in key territories as Novexatin® moves closer to further clinical development and commercialisation | 21 February 2011
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Latest News

NovaBiotics secures an additional £3.0 million investment from Woodford Investment Management
3rd March 2017

Commercial Collaboration Deal for (Oral) Lynovex®
5th August 2016

NovaBiotics Announces New Data on Cysteamine (Nylexa™)
18th June 2016

NovaBiotics Highlights Importance of Co-ordinated Approach to Antimicrobial Resistance
7th June 2016

NovaBiotics Wins Investment of the Year Award
5th February 2016

Lynovex® Activity in CF sputum & Against the Emerging CF Pathogen, Mycobacterium abscessus
12th August 2015

Phase IIa clinical study results for NovaBiotics' Lynovex® presented at the 38th Annual European Cystic Fibrosis Symposium
12th June 2015

Launch of the BEAM Alliance
9th June 2015

NovaBiotics Quoted in "What Investment" on 11 February
11th February 2015

NovaBiotics Raises £5.0 million in a Private Placement from Woodford Investment Management
19th January 2015

NovaBiotics' Dr Deborah O'Neil Named EY UK Health Products & Services Entrepreneur of 2014
7th October 2014

Showcases increasing investor interest in the global stem cell sector
22nd September 2014

NovaBiotics Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for Lynovex®
16th September 2014

Scotland's Pharmacells Group creates 12 new jobs at BioCity Scotland following acquisition by Precious Cells Group, London
18th August 2014

Precious Cells Biobank Acquires Stem Cell Technology Leader Pharmacells Group
25th July 2014