Cath Lab Digest

OWM: Please describe your education, training, and work experiences that have prepared you for your current position as CEO of NovaBay Inc.
  As a young man, I worked as a pharmaceutical sales rep for my father’s company in Tehran, Iran. I always enjoyed interacting with healthcare professionals and found providing patients with medications that would have a positive impact on their quality of life very rewarding. Over time, I grew more interested in the mechanism of action of drugs and their power to cure, such as with antibiotics, or to treat diseases like diabetes. After arriving in the United States, I spent years studying chemistry at the University of Pittsburgh and University of San Francisco, and ultimately I received my PhD in synthetic organic chemistry at UC Davis.

  Post graduation, I was eager to invest my knowledge in the field of pharmaceutical drug development. I gained valuable experience working at Sigma Aldrich (St. Louis, MO), Sanofi Aventis (Bridgewater, NJ), and Applied Biosystems (Carlsbad, CA). My early years working at my father’s pharmaceutical company and later for Sanofi Aventis prepared me for a career in healthcare and specifically the pharmaceutical industry. My experience in drug development combined with my entrepreneurial spirit led to my founding of NovaBay Pharmaceuticals in 2000.

  From the beginning, NovaBay focused on the development of new compounds for treating topical infections of the eye, skin, and chronic wounds, with a new class of non-antibiotic/anti-infective technology. In 2007, I successfully launched NovaBay’s initial public offering, and the company is now listed on the NYSE-Amex exchange under the symbol, NBY. My passion lies in developing potential cures for untreatable illnesses, meeting unmet clinical needs, working with talented scientists, and building a successful pharmaceutical company. Every morning, I come to work excited about the potential our products have to save or improve countless lives. I feel very fortunate to work in an industry that has the potential to create life-saving cures, while building value for investors.

OWM: What should our readers know about NovaBay?
  NovaBay’s technology has led to the development of compounds that are based on the mechanism of action our bodies’ white blood cells use to fight infection. These unique first-in-class anti-infectives fight bacteria, viruses, and fungi without the potential of developing resistance. As such, they are perfectly positioned to address the growing worldwide healthcare crisis of antibiotic resistance.

OWM: How were you first introduced to wound care and why do you enjoy working in this arena?
  Over a decade ago I became intrigued by how human white blood cells fight microbes without incurring resistance. One of the key components of the white blood cell defense mechanism is its production of hypochlorous acid to fight infection. The elegance and simplicity of this molecule challenged me to see why this has never been commercialized. In its natural state, pure hypochlorous acid is unstable and only produced on-demand by white blood cells. Almost 100 year ago, Dr. Henry Dakin produced a pH7 form of hypochlorous acid, but it contained a significant impurity called sodium hypochlorite, also known as bleach; even more problematic, the product was only stable for a few days at best. Today, we are proud to say, NovaBay is the only company producing a consistently pure form of shelf-stable hypochlorous acid with no toxic byproducts or preservatives. More importantly, this product, known as NeutroPhase®, has been cleared by the US Food and Drug Administration for human use. Working with Dr. John Crew of the San Francisco Center for Advanced Wound Care at the Seton Medical Center in the early days of NovaBay, we undertook a 54-patient study involving 90 wounds to compare the pure form of hypochlorous acid in our NeutroPhase product to the post debridement standard-of-care of saline treatment with wet-to-moist dressing. The results demonstrated that not only was NeutroPhase safe and efficacious, but also that only 2% of the NeutroPhase arm did not precede to active healing versus 20% of the saline arm. We are determined to share this technology with the wound healing community around the world and are dedicated to developing additional products that will save lives and limbs. We recently announced an important partnership around our NeutroPhase product in China. Pioneer of Shanghai, with more than 1,000 medical representatives, will have a strong capability to introduce NeutroPhase to more than 7,500 of China’s largest Hospitals.

OWM: What are some of the company’s biggest accomplishments thus far? What are some of your key products and/or functions that clearly distinguish your brand?
  Our distinguishing factor is that we are the only company to have developed a patented approach to manufacturing pure hypochlorous acid, our NeutroPhase product. We are preparing NeutroPhase for commercial launch in early 2012, and we also are developing mimetic molecules of the immune system, such as our NVC-422, which is currently in advanced Phase 2 clinical trials for topical nonsystemic skin, eye, and urological infections. In the skin infection category, we are fortunate to have Galderma S.A. (Lausanne, Switzerland) as our worldwide development partner while we seek additional partners in urology and ophthalmology.

OWM: Please describe the mission/vision of your company and how your personal vision fits with the company’s goals.
  Simply put, NovaBay is dedicated to developing and providing patients with novel products to prevent and treat drug-resistant and nonresistant infections. Our vision is to be recognized as the leading company developing nonantibiotic technology to treat infection.

  My personal vision and NovaBay’s goals are very straightforward and directly aligned to develop a state-of-the-art technology for treating infections, meeting unmet medical needs, curing patients, reducing amputations, and reducing cost to our healthcare system.

  Our goal is to develop products that are on the top of everyone list for delivering value. They must provide ease of use, deliver significant value in relation to their cost, and promote improved compliance.

OWM: Please explain what must take place on a daily basis at NovaBay in order to accommodate patients, clinicians, and healthcare facilities.
  One of the primary considerations in all of our drug development programs is how our products can optimally benefit patients and caregivers in a variety of healthcare settings. Dedication and focus are the watchwords. As a small biotechnology company, NovaBay must remain focused on our mission of developing first-in-class molecules that physicians can add to their armamentarium to fight the onslaught of antibiotic resistant microbes that are an ever-growing threat to worldwide human health.

OWM: Looking ahead, what are some incentives or products the company is working on?
  Due to the broad applicability of NovaBay’s compounds to treat a wide variety of bacterial, viral, and fungal infections, one of our main challenges is to focus on serving patient populations that will most readily benefit from our technology. To this end, NovaBay has established four Business Units to direct our resources where we believe we will have the best opportunities to have the optimum patient impact while achieving the most efficient and cost effective approach to drug development. Our Business Units are directed at four distinct therapeutic areas: dermatology, ophthalmology, urology and, with our NeutroPhase product, hospital infections. In dermatology, the focus is on developing our NVC-422 gel formulation for the highly contagious skin infection, impetigo. In our Ophthalmology Business Unit, the goal is to develop an eye drop for viral conjunctivitis, or “pink eye” as it’s called. There is currently no approved drug to treat this potentially sight-threatening condition. Our Urology Business Unit is focused on reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. Our approach is to use an irrigation solution containing NVC-422 to maintain catheter patency. Finally, as I discussed previously, our Hospital Infection Business Unit is targeting the six million-patient market of chronic nonhealing wounds, such as pressure, venous stasis, and diabetic ulcers with NeutroPhase. Given the demonstration in multiple clinical trials that our compounds are safe, well tolerated, and effective against bacteria and viruses, the path ahead is clear. We must effectively launch our NeutroPhase product around the world and rapidly conclude the multiple Phase 2 clinical programs that are currently underway.