Moving forward: NovaBay's present and future plans for its compounds




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Video title: Moving forward: NovaBay's present and future plans for its compounds
Released on: October 22, 2009. © PharmaVentures Ltd
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  • Summary
  • Transcript
  • Participants
  • Company
In this interview, filmed at BioPharm in San Francisco, Dr Fintan Walton speaks with Ron Najafi, Chief Executive Officer at NovaBay Pharmaceuticals, a product development firm targeting infections in hopstials and the community

They discuss:

• NovaBay's background as a company
• the fields in which NovaBay operates and its common compounds
• the application of NovaBay's new technologies
• reducing infections in hospitals
• how 2009 has been a positive year for the company
• innovation and Genentech’s involvement in adopting new breakthrough therapeutic approaches
• alliances and getting new products to market
NovaBay's background as a company.
Fintan Walton:
Hello and welcome to PharmaTelevision news review here in San Francisco at BioPharm America. On this show I have Dr Ron Najafi, who is Chairman and CEO of NovaBay Pharmaceuticals based in Emeryville here in the Bay Area. Welcome to the show.
Ron Najafi:
Thank you.
Fintan Walton:
Ron Najafi, NovaBay is a novel company in the sense that it's focused on anti-infectives but with a different twist to the normal antibiotic approach that pharmaceuticals companies have taken in the past, your company has done deals and are continuing to do deals. So tell me a little bit more about NovaBay, and how was founded and how you are focused on the anti-infective area?
Ron Najafi:
Sure. So we you are aware of the drug resistant problem that we have pretty much with all of our 150 antibiotics that are available to our doctors in the hospitals. We believe the future is going to have a mix of different technologies and we're going to have a product that does not give rise to resistance, which is based on the variation on compounds generated within white blood cells, these are novel chemical entities that are invented at NovaBay's several years ago.
Fintan Walton:
Okay.
Ron Najafi:
And we have partnerships with Alcon and Galderma moving forward on developing these technologies.
he fields in which NovaBay operates and its common compounds
Fintan Walton:
Okay. So you're focused on anti-infective you, clearly through your alliance and partnership with Alcon, [PharmaDeals ID = 25300] you've got an interest in the, in the ophthalmic field but you've also got an interest in the hospital field. So how do you differentiate that and how do you set that as a business model for yourselves going forward?
Ron Najafi:
So we see our compounds which we call Aganocide, Aganocide -- the name Aganocide comes from Greek Agonos which means gentle warrior, these compounds are extremely gentle to human tissue and they have the potential of being useful in eye surface, in the nose, in sinuses and potentially bladder, we have potential in eradicating or preventing Catheter-associated urinary tract infection. So the way we are seeing this is as you know we see ENT, ear, nose, throat, ophthalmology as one opportunity, we see dermatology as another opportunity, we see hospital field as the third and also a potential respiratory. We break them up and we are looking to form alliances around those technologies and we have discovered over 150 different molecules and the lead compound is really NVC-422 which is moving forward and we have several other compounds that are right behind it.
The application of NovaBay's new technologies
Fintan Walton:
Okay. So what is the basis of your technology then, what is it? How does it work and what's the proprietary...
Ron Najafi:
Right.
Fintan Walton:
position that you have?
Ron Najafi:
Sure. So the basis of the technology is a compound generated naturally in your body right now, it's called N-chlorotaurine and N,N-dichlorotaurine .These compounds are produced on demand by your white blood cell. The compounds are extremely unstable they fall apart, so the only way to make them available to a patient is by a pharmacist mixing them. We've eliminated that by creating a novel compound that doesn't have the characteristics of falling apart on you know at the pharmacy level, so the compound has two-year shelf life and it can go on the pharmacy shelf. Alcon is doing clinical trials right now Phase II trials in Ophthalmology.
Fintan Walton:
So it's stable and it still remains bio active?
Ron Najafi:
Absolutely.
Alliances and getting new products to market
Fintan Walton:
So, obviously then the strategy was to set out an alliance partnership with Alcon for one specific area which clearly has a huge market and requires specialized certain sales force, you've chosen to go down the hospital ?
Ron Najafi:
Right.
Fintan Walton:
infection route so what molecules are you actually developing there and why you developing them?
Ron Najafi:
We have other molecules in mind for potentially taking you know taking forward in hospital associated infections. There are number of hospital associated infection companies who have a great deal of interest, as you know hospitals are under tremendous pressure to do something about their infections as of last October, October of 2008 CMS announced that hospitals will not be reimbursed for preventable hospital infection, they are now even giving a bonus for reducing their infection rates. I think there is tremendous interest on the hospital side to do something about their infection rates in wound care, in catheter care, in central venous line infection and those are all opportunities as that we are interested in.
Fintan Walton:
And that all is around the same type of molecule that you've, you've talked about earlier?
Ron Najafi:
Similar technology, what we have in mind our strategy is to develop these compounds pass the Phase II and then look for a partner for Phase III and then hopefully a commercial partner that would do the Phase III and commercialize the product.
How 2009 has been a positive year for the company and Innovation and Genentech's involvement in adopting new breakthrough therapeutic approaches.
Fintan Walton:
You're listed on the AMEX exchange, 2009 is being a tough time for a lot of biotech companies, what is it like been for NovaBay?
Ron Najafi:
2009, obviously it's been a very good year for us, we despite the market we've managed to get a very important partnership with Galderma in March of 2009 [PharmaDeals ID = 32855]. We've attracted a very good board member to NovaBay, Harry Hixson former President of Amgen has joined the board of NovaBay and we've also started the Phase I and a Phase II in viral conjunctiva virus with our partner Alcon. So, so far so good, we are moving ahead.
Fintan Walton:
So that's good, but in terms of trying to finance a biotech company like NovaBay?
Ron Najafi:
We are, our cash balance obviously is public, we have roughly with our recent financing about 13 billion in the bank. Our first six-month of 2009 we only burned 1.6 billion.
Fintan Walton:
Okay.
Ron Najafi:
So if that continues forward-looking statement you know you can see what our cash burn could be.
Fintan Walton:
The alliance with Alcon obviously is an important one and that particular area tends to get products to market relatively quickly...
Ron Najafi:
Right.
Fintan Walton:
In relation to other prescription type drugs. So when you look forward into the forecast of your organization, when do you expect to see cash flows coming through as a result of sales of these products?
Ron Najafi:
I am glad you asked that question, because anti-infectives in general have a much higher chance of success both historically, both topical, and systemic, because the end points are very clear cut, you either kill the bug or you don't. So you'll eliminate a lot of the bad compounds in the lab and you don't take them forward into the clinic. So we are moving into the clinic and Phase I with obviously conjunctiva virus, eye infection is accomplished, we are going into Phase II and we believe the compound with Alcon you know Alcon's logo on it could be on the market as earlier as 2013, which is very good for the time frame for you know pharma and drug. We also have potential opportunity with Alcon in contact lens solution, which is a different molecule and that could be on the market as early as 2011, 2012 with a, and that has a much lower regulatory barrier than drug. We also have a number of device opportunities with Catheter associated UTI or central venous catheters, and those are primarily going through the device division of the FDA, and they could be PMA type drug regulatory and much quicker to the market strategy.
Reducing infections in hospitals
Fintan Walton:
And what about hospital infections, do you expect those type of drugs to get through quicker?
Ron Najafi:
Absolutely. I think again depending on whether the drugs or device, it really depends on what kind of claim your are asking, you know FDA for and you have to have the safety. I think by and large we've passed a safety phase, we have an, you know huge safety data behind us, backing us so it's really going in and showing efficacy on device and getting approval. And we hope that 2012 could be our commercialization year on the device side. And of course the drug side on with Alcon could be 2013.
Fintan Walton:
Dr Ron Najafi, thank you very much indeed for coming on the show.
Ron Najafi:
My pleasure indeed. Thank you.
Ron Najafi
Chairman and Chief Executive Officer
Ron Najafi is the founder and Chairman of NovaBay. He has served as President since July 2002, and as Chief Executive Officer since November 2004. Previously, Dr. Ron Najafi served in various management positions within NovaBay including as Chief Scientific Officer. Prior to founding NovaBay, Dr. Ron Najafi was the President and CEO of California Pacific Labs, Inc., a chemical laboratory safety devices company. He has also held scientific roles at Rhone Poulenc Rorer (now Sanofi-Aventis), Applied Biosystems, a division of PerkinElmer, Inc., and Aldrich Chemical. Dr. Ron Najafi received a B.S. and M.S. degree in Chemistry from the University of San Francisco and a Ph.D. in Organic Chemistry from the University of California at Davis.
NovaBay
NovaBay is focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and community environments. Many of these infections have become increasingly difficult to treat because of the rapid increase in infectious microbes that have become resistant to current drugs. NovaBay 's in vitro and in vivo tests have demonstrated that our compounds kill a wide range of bacteria, viruses and other infection causing microbes, including those that are resistant to multiple antibiotics. The firm is developing hospital indications and has partnered certain other indications with Alcon, the world's leading eye care company, and with Galderma S.A., a global leading pharmaceutical company dedicated exclusively to the field of dermatology.