NovaBiotics are delight to be sponsoring the Orphan Drug & Rare Diseases Conference in London on the 14th and 15th October 2013. Full details of the conference can be found at:
http://smi-online.co.uk/pharmaceuticals/uk/conference/orphan-drugs-rare-diseases
Malvern Cosmeceutics & NovaBiotics Ltd announce a collaboration to develop proprietary treatments for rosacea, acne & other skin conditions. Combining NovaBiotics novel anti-infective peptides & Luminaderm polymers with Malvern's bespoke Lipodisq® delivery system, this exciting partnership has already generated stand-out preclinical data in which a newly developed rosacea product candidate outperformed metronidazole & was at least equivalent to erythromycin in its activity against the bacteria that are associated with this condition. Both companies look forward to further success and to taking the products this collaboration generates forward to market with the most appropriate dermatology-focused commercial partners.
Lynovex® ex vivo study for cystic fibrosis.
NovaBiotics and the cystic fibrosis (CF) teams at Aberdeen Royal Infirmary are investigating the microbiological and mucolytic potential of Lynovex®, NovaBiotics’ drug candidate which is being developed as a novel treatment for cystic fibrosis. The collaboration with the CF clinical teams at Aberdeen Royal Infirmary allows NovaBiotics to access valuable clinical expertise and patient-derived samples so that Lynovex® can be tested (in CF sputum) under clinically relevant conditions and against the whole spectrum of very difficult to treat, drug-resistant bacteria from CF patients. NovaBiotics is delighted to be working with the CF teams and looks forward to a successful collaboration that will hopefully accelerate Lynovex® further towards the clinic as a much needed new therapy for CF.
Deborah O’Neil takes over as Editor of the European Biopharmaceutical Review
Dr. Deborah A. O’Neil, CEO and CSO of NovaBiotics, joins the European Biopharmaceutical Review(EBR) team as Editor. Deborah is very pleased to be on board at EBR and looks forward to being part of a dynamic and informative, sector-focused publication as the industry continues to transit through challenging yet undoubtedly exciting times.
Dr. Deborah A. O’Neil joins the Life Sciences Advisory Board for Scotland
Deborah O’Neil, Chief Executive & Scientific Officer of NovaBiotics Ltd is very pleased to have accepted an invitation to join LiSaB and looks forward to contributing positively to, and working with, the other Board members and the wider Scottish Life Science community during her term on the Board.
http://www.lifesciencesscotland.com/about/lisab.aspx
Dr. Deborah A. O’Neil joins the Scottish Life Sciences Association
Deborah is delighted to have joined the SLA board and to be part of a fast-growing and productive ‘new’ industry-focused organisation during such a dynamic and exciting period for the Scottish Life Science community.
http://www.scottishlifesciencesassociation.org.uk/
8th September 2012
This year we are delighted to be involved in the annual British Science Festival, this year in Aberdeen, and have a stand entitled "Life with Microbes: The Good, the Bad and the Ugly of the Bug World". We will be in the Beach Ballroom in Aberdeen on Saturday 8th September and Sunday 9th September 2012.
Details of our stand can be found using this link: NovaBiotics at the British Science Festival
NovaBiotic attends the 35th European Cystic Fibrosis Conference
NovaBiotics was been selected to present at the 35th European Cystic Fibrosis Conference on the 6th - 9th June 2012, in Dublin, Ireland. The NovaBiotics poster entitled "Lynovex®, a Novel Mucolytic-Antimicrobial Agent for the Treatment of Cystic Fibrosis" was also selected for a Guided Tour which was presented by Dr Cedric Charrier.
NovaBiotics shall be attending the Council for Nail Disorders & American Academy of Dermatology Annual Congresses in San Diego, CA, March 15th - 20th 2012
NovaBiotics Chief Executive & Scientific Officer, Dr. Deborah O'Neil, will be attending these two internationally leading events for the onychomycosis field and looks forward to participating at both conferences and the opportunity to meet there with, and update key opinion leaders on Novexatin's progress and future development plans. These two excellent conferences also provide Deborah with the opportunity to connect with NovaBiotics' clinical, mycological and regulatory advisors and to update the company's potential commercial partners on recent advances within the Novexatin and Luminaderm R&D programmes.
Patents granted in US as Novexatin® moves closer to further clinical development and commercialisation
NovaBiotics, a leading clinical-stage biotechnology company, today announces that it has further strengthened the global intellectual property position of its lead product Novexatin® with a recent patent grant in the US for the company’s under-pinning antifungal peptide platform technology.
Novexatin® is an already patented (worldwide) topical treatment for fungal nail infection (onychomycosis). NovaBiotics’ recent US patent protects the use of the same core peptide technology - and importantly the molecular architecture from which Novexatin® and related peptide products are derived - for a much broader range of fungal infections including those caused by Candida spp, Aspergillus spp and Cryptococcus spp etc. As such, this grant covers NovaBiotics antifungal drug candidate, Novamycin® (see below).
This latest grant broadens the commercial applicability of NovaBiotics novel antifungal peptide technology and is a critical milestone for the Company with key grants now in place for its lead and follow-on products being secured a relatively early stage in their lifecycle.
NovaBiotics’ current antifungal product portfolio includes Novexatin® a phase 2b-ready clinical asset and Novamycin®, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida). In addition, NovaBiotics’ antibacterial peptide drug candidate, Novarifyn® and novel mucolytic Lynovex® are now at proof of efficacy stage for the treatment of respiratory infections including multi-drug resistant forms and those associated with cystic fibrosis. Lynovex® was granted Orphan Drug Designation in Europe in 2011 and will enter the clinic in 2012.
NovaBiotics’ IP portfolio covers eight patent families which consist of more than 50 patents pending and granted worldwide.
NovaBiotics shall be attending Scottish Enterprise event entitled Personal Care: Novel, Natural and Scottish in Edinburgh. Scotland has a healthy personal care sector and this event offers a networking opportunity with companies and research groups, accessing a wealth of knowledge around the sector.
Further detail of the event can be found on the following link:
Personal Care: Novel, Natural and Scottish
NovaBiotics are pleased to announce they shall be attending the 30th Annual J. P. Morgan Healthcare Conference from 9th -12th January 2012 in San Francisco, California, USA, where meetings have been scheduled with the investment community and potential strategic partners for Novexatin and Lynovex.
NovaBiotics reveals plans for cystic fibrosis drug after EU grants orphan status
Bolstered by the an EU orphan drug designation for its drug candidate for cystic fibrosis, Lynovex (cysteamine), UK-based NovaBiotics revealed to Scrip that it plans to begin a first-in-man, safety/tolerability and evidence of efficacy study of the product in 2012, followed by other trials in 2013.
The company announced that the Committee on Orphan Medicinal Products (CHMP) of the European Medicines Agency (EMA) has granted orphan status to the novel dual mucolytic-antibacterial drug for the treatment of cystic fibrosis and added that it is "currently in discussions with a number of interested parties with a view to licensing or co-developing the drug".
NovaBiotics stated it would "now progress with follow-on orphan applications for paediatric use and also applications for orphan drug designation in the US".
"This novel drug candidate is expected to be tested in patients in 2012," the biotech firm highlighted. It told Scrip that the study slated for next year would test Lynovex when used in conjunction with conventional inhaled ABX (antibiotic) therapies in the first instance. In 2013, NovaBiotics said it would initiate a second and third trial to further assess efficacy.
The company confirmed that it intends to partner the product, and "as per our core business model [this is] most likely after the second clinical study". With respect to its finances, it said: "NovaBiotics remains fully equity funded (still pre-revenue) and this is how development has been/will be funded in the short-term for Lynovex, but as the programme develops towards final clinical studies, revenue from Novexatin and Luminaderm commercialisation deals will be reinvested into the Lynovex programme."
Last year, NovaBiotics released positive un-blinded Phase IIa data for its lead product candidate Novexatin (NP-213), a treatment for fungal nail infection and at the time said it was in ongoing partnering discussions for the medication (scripintelligence.com, 5 July 2010).
In an update the company said that partnering discussions were still active or ongoing according to region (with talks going on in the US, Japan and South America among others). It noted that NovaBiotics is also open to global deals for Novexatin.
NovaBiotics noted that cysteamine is already approved for use in an unrelated orphan indication and so has an established history of safety of oral use for a metabolic disease. In cystic fibrosis, the product works by addressing the overproduction of mucous in airways, while at the same time disrupting bacterial biofilms and attacking the bacteria that cause the recurrent infections associated with the condition. NovaBiotics said it has established its unique combined mucolytic-antibacterial profile in vitro and in vivo (and secured this through three patent families), anti-biofilm properties and synergy with existing antibiotics in vitro.
The medicine is being developed to be delivered as an aerosol co-therapy, directly into the patient's airway, enhancing and widening the spectrum of activity in currently used aerosolised antibiotics to improve the duration of effectiveness and potency of inhaled treatments.
Lynovex® Orphan Drug Status
NovaBiotics is delighted to announce that it has received a positive COMP opinion on the application for orphan designation of its novel dual mucolytic-antibacterial Lynovex®, for the treatment of cystic fibrosis.
NovaBiotics shall be attending BIO 2011 (27th - 30th June 2011)
NovaBiotics are delighted to announce they shall be attending, and have been selected to present, at the BIO International Convention 2011 being held in Washington DC from the 27th June 2011 until the 30th June 2011.
NovaBiotics shall be attending BioDundee 2011
NovaBiotics shall be attending BioDundee 2011 on the 8th & 9th June 2011. For full details of the meeting click the link below.
NovaBiotics features in IMS Drug News
NovaBiotics can announce that they are featured in IMS Drug News. To read the article click on the link below.
NovaBiotics shall be attending BioTrinity 2011 from 12th-14th April 2011
NovaBiotics shall be attending BioTrinity 2011. BioTrinity 2011 will be the largest gathering of the UK's bioindustry, and is Europe's fastest growing biopartnering and investment conference, facilitating more meetings with more investors than any other UK conference. BioTrinity 2011 will feature a showcase of the best of the UK's emerging and clinical stage companies. For further details on BioTrinity 2011, follow the link below.
http://www.biotrinity.com/silverstripe/
NovaBiotics are attending the UK-Netherlands Joint Symposium on Antimicrobial Peptides, Durham UK.
NovaBiotics are looking forward to attending this two day antimicrobial peptide symposium. This symposium brings together researchers from both the UK and the Netherlands working in different areas of antimicrobial peptide research.
Patents granted in key territories as Novexatin® moves closer to further clinical development and commercialisation
NovaBiotics, a leading clinical-stage biotechnology company, today announces that it has further secured the global intellectual property (‘IP’) position of its lead product, Novexatin® through recent patent grants in the US, EU and other territories worldwide. Novexatin® is a topical treatment for fungal nail infection and NovaBiotics’ recent patent grants protect the use of its core peptide technology in this and other related target indications.
The Company’s granted and pending IP not only protects the use of the core structure of Novexatin®, but of a related family of anti-infective peptides derived from the same technology platform. This is a critical milestone for the Company with key grants for its lead and follow-on products being secured a relatively early stage in their lifecycle.
NovaBiotics’ current antifungal product portfolio includes Novexatin® a phase 2b-ready clinical asset and Novamycin®, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida). In addition, NovaBiotics’ antibacterial peptide drug candidate, Novarifyn® and novel mucolytic agent NM001 are now at the early proof of efficacy stage for the treatment of respiratory infections including multi-drug resistant forms and those associated with cystic fibrosis.
Dr Deborah O’Neil, Founder, commented: “Recent patent grants in key territories for our expanding product portfolio is an important step in NovaBiotics’ development, particularly as we bring our lead product Novexatin® closer to market. This undoubtedly adds significant further value for the interested parties with whom we are in ongoing discussions for Novexatin®.”
NovaBiotics’ IP portfolio covers eight patent families which consist of more than 50 patents pending and granted worldwide.
Peptide Formulation & Product Development Forum
NovaBiotics will take part in a prestigious Marcus Evans forum in Vienna focused on some of the key challenges in peptide drug development around formulation and product development. Dr. O’Neil is an invited speaker and joins industry leaders in sharing NovaBiotics’ experiences in taking their Novexatin® peptide from concept to clinic and in parallel, developing Novamycin® as a related antifungal peptide intended for very different clinical use than the company’s lead product.
NovaBiotics selected to present at Bio-Europe 2010
NovaBiotics is looking forward to taking ongoing commercial discussions around Novexatin® and its pipeline products further forward with meetings scheduled at this year’s BioEurope event. The Company has also been selected to present an update on recent progress and its commercial aims alongside other leading biotechnology businesses in the parallel speaker sessions that will run throughout the 3 day event. NovaBiotics is delighted to attend the event in Munich as part of the Scottish trade mission led by Scottish Development International.
4th October 2010
Datamonitor
Life Sciences Scotland
BioPortfolio
London Stock Exchange
The Scotsman
The Telegraph
Isogenica, a biotechnology company, has entered into a collaboration agreement with NovaBiotics, a clinical-stage biotechnology company, to fast-track the development of NovaBiotic's platform peptide anti-infective technology.As part of the agreement, NovaBiotics will work with Isogenica on two research projects, one concerning peptide selection and the other concerning peptide maturation with the aim of expanding Novabiotic's product portfolio.
Deborah O'Neil, founder of NovaBiotics, said: "I am delighted to be working with Isogenica on this research project. They are experts in the field of peptide engineering and their CIS-Display technology is ideal for screening NovaBiotic's vast library of anti-infective peptides as efficiently as possible and enabling NovaBiotics to fast-track the development of its product pipeline."
Financing targets achieved
NovaBiotics is pleased to announce that it has successfully concluded the second part of this year’s planned funding rounds to bring the total of cash raised in 2010 to beyond the £2.5 m target set for the year. This additional working capital will allow continued progression of the Company’s lead and pipeline programmes. The board and management gratefully acknowledge the continued support of shareholder base who have provided the cornerstone for the Company’s £3m financing in the current year.
NovaBiotics selected to present at ICAAC 2010
NovaBiotics shall be attending ICAAC 2010 in Boston, MA, from 12th - 15th September where they are delighted to announce they have been selected to present.
8th July 2010
The Excellent Results From the Unblinding of the Novexatin® Phase IIa Clinical Trial have led to Further Press Coverage of NovaBiotics' Lead Product Candidate for the Treatment of Fungal Nail Infection.
30th June 2010
Biospace
London Stock Exchange
Unblinded Phase IIa Clinical Trial Data Delivers Excellent Results for Novexatin®, NovaBiotics' Lead Product Candidate for the Treatment of Fungal Nail Infection.
NovaBiotics, the clinical-stage biotechnology company, today announces the initial unblinded results from its Phase IIa clinical study for Novexatin®. All study end-points were met in the trial which had been designed to assess the safety and tolerability of the novel antifungal drug candidate.
Novexatin® was confirmed as being safe and well tolerated in all study subjects by the leading global clinical research organisation who conducted the study. These are very positive results in the context of the well described and significant safety/toxicological shortcomings of some currently available treatments.
48 patients with fungal nail infection were dosed daily with Novexatin® for just 28 days, on a single toe nail. Although not an efficacy study, analysis of the clinical improvement of the treated nails, as a measure of Novexatin®’s pharmacodynamic properties (i.e. its ability to penetrate the nail), revealed much better than expected initial evidence of efficacy during both the short 28-day treatment period and the 6-month follow-up assessment window. In this respect Novexatin® has thus far outperformed any other drug candidate developed to treat fungal nail infection and the Company now looks forward to confirming these exciting indicative findings in larger clinical studies specifically designed to assess efficacy in patients. NovaBiotics is currently in the process of filing an investigational new drug (“IND”) application for approvals to undertake these trials in the United States.
The results of the clinical trial strongly suggest that Novexatin® has the potential to revolutionise the market for the treatment of fungal nail infections which affects in excess of 12% of the world’s population. The safety data and pharmacodynamic assessment outcomes achieved for Novexatin® are more compelling than data derived from other products (marketed and in development) tested in larger studies, during which each drug was administered for between three and ten times longer than the Novexatin® 28-day study.
Novexatin® is part of a broad portfolio of products which are being developed by the Company using its unique patented peptide anti-infective technology. The next product in the pipeline is Novamycin®, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida) which is expected to enter clinical development in 2011.
Dr Deborah O’Neil, Founder, commented: “Now the study has completed in patients and we can interpret the significant data set acquired over the past 6 months, the positive results take the next key steps to confirming what we have always known from the laboratory; Novexatin®’s ability to safely remedy a very common and hard to treat condition. This safe and novel treatment is designed to be closely related to the body’s natural antifungals and addresses the various and well described shortfalls of the limited number of existing therapies that currently serve a global fungal nail infection market potentially worth $5 bn.”
“The data collected now points a very clear path to a phase IIb study which will take us closer to bringing this product to market.”
Successful Completion of Phase IIa clinical trial for Novexatin®, IND filing planned for Phase IIb study and successful £1.6m rights issue
NovaBiotics is delighted to confirm that following the successful completion of its Phase IIa clinical trial for its lead product Novexatin®, a brush on treatment for fungal nail infection, it is now preparing for further clinical evaluation and plans to file an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for a US-based Phase IIb study.
The Company also announces today that it has secured an indicative £1.6m from existing shareholders and is on track to reach its H1 financing target of £2.5 m to fund further development of Novexatin® and its product pipeline.
18th May 2010
Successful Completion of Phase IIa clinical trial for Novexatin®, IND filing planned for Phase IIb study and successful £1.6m rights issue
Biotechnology company NovaBiotics, confirms that following the successful completion of its Phase IIa clinical trial for its lead product Novexatin®, a brush on treatment for fungal nail infection, it is now preparing for further clinical evaluation and plans to file an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for a US-based Phase IIb study.
This announcement follows analysis of the final microbiological data set from NovaBiotics' 48 patient Phase IIa clinical study in which subjects were dosed daily with Novexatin® for 28 days. The study met its end-points of demonstrating safety and tolerability of the test item and pharmacodynamic analysis indicates that the majority of patients remain infection free 6 months after a 28 day treatment course.
The Company also announces today that it has secured an indicative £1.6m from existing shareholders and is on track to reach its H1 financing target of £2.5 m to fund further development of Novexatin® and its product pipeline.
Dr Deborah O'Neil, Founder, commented: "The phase IIa data we have generated for Novexatin® provides a clear route forward for further development and an IND filing to facilitate a phase IIb study will be a major milestone for what we believe is world beating technology. Completion of the fundraising is key to enabling us to do that and I would like to take this opportunity to thank our supportive shareholders. I am also delighted that NovaBiotics has been selected to present at this year's BIO and we already have an extensive schedule of partnering meetings and a full programme."
The fungal nail infection market is estimated to be worth $5bn globally. Novexatin® is part of a wider portfolio of products which are being developed from NovaBiotics' platform technology. The Company's second drug candidate is Novamycin®, a fast-acting antifungal peptide to treat potentially life-threatening systemic yeast and mould infections. At BIO, Dr. O'Neil will be discussing exciting new developments on Novamycin's safety and efficacy in vivo. NovaBiotics' pipeline also comprises antimicrobial peptides and compounds for respiratory, system and dermal infections.
March 2010
NovaBiotics selected to present at BIO 2010
NovaBiotics is delighted to have been selected as one of this year's presenting companies at BIO (Chicago IL, May 3rd - 6th). Combined with a busy partnering schedule and full agenda with the Scottish delegation, Dr. Deborah O'Neil and Professor Andy Porter are looking forward to the event and to updating the industry on recent NovaBiotics developments and plans for the future.
20th January 2010
Life Sciences Scotland News - Issue 48
Clinical Development Success for NovaBiotics
Aberdeen based NovaBiotics has successfully completed the dosing phase and initial analyses of its Phase IIa clinical trial for its lead product Novexatin® - a brush on treatment for fungal nail infection.
In the Phase IIa study, 48 patients have been dosed daily on one infected toe nail with Novexatin® over a 28 day period. The results thus far have been very encouraging.
The study remains blinded until all follow-ups are complete, but one third of the patient group is on placebo control while the remaining subjects are active drug candidates. This rate of indicative mycological cure after only one month of treatment is higher than has been reported for existing remedies. Importantly, there is no evidence of any of the potentially serious side effects reported for those treatments, most notably liver damage.To read the article in full click here
11th January 2010
NovaBiotics to attend PepTalk 2010 in San Diego
Dr Deborah O'Neil is scheduled to present Novexatin® as a unique, nail-penetrating compound at the engineering peptides session.
4th January 2010
NovaBiotics Prepares to Out-Licence Nail Product
Novabiotics, the Scottish biotechnology company focused on the design and development of antifungal and antibacterial therapies, successfully completed the dosing initial analysis of its phase IIa clinical trials for Novexatin®, a brush-on treatment for fungal nail infection.
Novexatin® has been proven so far to rapidly clear fungal nail infection. Nail fungus is estimated to affect around 12% of the world’s population and equates to a total global market worth of around $5 billion.
Dr Deborah O’Neil, the company’s founder, said: “This study confirmed what we anticipated. Novexatin® is a unique product that can address the global market of fungal nail infection, which is poorly served at the moment. As such, Novexatin has the potential to access a significant proportion of [the] global market.”
She added: “We are now actively in discussions with potential partners to further the clinical development of this product and the availability of this very encouraging data should now enable us to achieve our aim of taking this product to market.” To read the article in full click here