Ondine Biopharama Takes On Philosophy

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It's no secret, it's a tough market out there for start-up companies in the biotech industry that are looking for financing, but contrary to what some may believe there are reasons to be optimistic thanks to the many success stories that do exist out there.

Vancouver-based Ondine Biopharma Corporation is one of those success stories due to years of hardwork, determination and the creativity of its founder, president and CEO, Carolyn Cross. Cross has been with the company since 1999, fighting to make it what it is today. Involved with several other start-ups directly and indirectly in the past, Cross knew quite a bit about starting a company.

As a former vice president with Royal Bank Investment Management Inc., the fund management arm of the Royal Bank of Canada, Cross didn’t have a background in biotech but did bring with her an institutional investor approach to the management of Ondine. Holding a CFA designation, an MBA from York University and an HB from the University of Western Ontario, Cross went into the position educated and ready for a challenge.

Now comes the part Cross is really passionate about, what is it that Ondine Biopharma produces? Ondine is currently developing an innovative laser-activated approach to broad-spectrum disinfection. Antibiotic resistant microorganisms are flourishing world wide, prompting an intensive search for new antimicrobials that do not induce bacterial resistance.
Ondine’s patented PhotoDynamic Disinfection (PDD) technique targets bacteria for rapid destruction without damage to human host cells in vitro and without encouraging the formation and spread of bacterial resistance. Ondine is first introducing this innovative technology into the multi-billion dollar periodontal disease market.

"I loved the simplicity of the idea and I've really enjoyed the process. I feel like it's become my calling," explained Cross.

Ondine's mission is "to become a global leader in the development of innovative non-antibiotic therapies."

Its platform PDD technology uses light activated therapy to selectively target and kill bacteria, viruses and fungi. Topical agents applied to infected tissue and photo-activated by a low-power (cold) laser rapidly destroy pathogens. The applications for this technology are numerous and in turn Ondine is targeting three initial clinical applications for development and commercialization, which are periodontal disease, wound infections and fungal infections.

Ondine's non-antibiotic technology positions it squarely to penetrate the growing and underserved market to treat MRSA superbugs, the primary pathogen responsible for hospital derived infections. A common environmental and skin-surface pathogen is Staphylococcus aureus, a spherical Gram-positive aerobe. MRSA accounts for up to 40 percent of nosocomial S. aureus infections, which represents a multi-billion dollar problem in critical care units, intensive care units, long term care facilities and general hospitals worldwide. More than 90 percent of patients with MRSA do not respond to first-line antibiotics, due to the natural ability of bacteria to adapt against relatively slow, relative low-sterilization depth antimicrobials.

Certain S. aureus strains are now resistant to glycoprotein antibiotics like vancomycin, removing the last remaining effective treatment for the disease.
Ondine’s technology can also be applied to the treatment of nailbed fungus or Onychomychosis (OM), an affliction that impacts 90 percent of elderly people. Infection may occur in any component of the nail unit, including the nail matrix, nail bed or nail plate. OM is not life threatening, but it can cause inconvenience, pain, discomfort and often serious physical and occupational limitations. Psychological and emotional effects resulting from OM are widespread and have a significant impact on quality of life.

Traditionally the medical management of OM has been limited to topical therapy and two unreliable systematic drugs. Topical therapy is usually only beneficial for mild cases involving the very surface of the nail plate. The use of these drugs is plagued by high relapse rates (70-85 percent), prolonged treatment regimes (10–18 months for toe nails), constant laboratory monitoring and numerous side effects. Systematic drugs such as itraconazole and terbinafine can cause hepatic (liver) damage, are expensive and are of only limited efficacy.

Ondine has already started to enjoy success with the launch of its oral care product, PeriowaveTM in March 2006. The company received a Class II Medical Device License from Health Canada to market PeriowaveTM for the treatment of chronic periodontitis. The product also received the European CE Mark Approval in March 2005.

Periodontitis (gum disease) is a common human affliction, affecting one third of all adults and over half of the population over the age of 50. Periodontitis results in gum tissue detachment, bleeding gums, oral malodour, bone and tooth loss as well as other complications. Currently, the standard of care for treating periodontal disease is scaling and root planning ('SRP'), or gum surgery or both. SRP is the sub-gingival removal of plaque biofilm adhering to the root surfaces. Periodontitis is associated with a host of other serious conditions including heart disease, stroke, premature births and diabetes.

"PeriowaveTM is a novel non-antibiotic approach for eliminating the bacteria associated with periodontal disease," said Cross. "Our disinfection technology destroys a broad spectrum of pathogens without encouraging the formation and spread of bacterial antibiotic resistance. PeriowaveTM is a significant advancement in the treatment of periodontal disease and has the potential to become a standard adjunctive therapy in the treatment of periodontal diseases."

PeriowaveTM is being marketed to Canadian dentists and periodontists by Ondine's own direct sales force and its distribution partner, Henry Schein. With a 75 percent market share, Henry Schein is the largest distributor of healthcare products to office-based practitioners in the combined North American/European Union market.
Current therapies for oral-cavity disinfection include antibiotics and antiseptics. Antibiotics are less effective in the oral cavity as they must stay uncomfortably in place for long periods of time, frequently resulting in patient non-compliance. Ondine's PeriowaveTM treatment can be applied, activated and then removed from the affected site, maximizing patient comfort.

The benefits of this technology include: rapid action, broad-spectrum efficacy, high specificity to disease-causing bacteria and low levels of toxicity to host cells in vitro.

"The dental market is not renowned for rapid uptake, having said that we're pleasantly surprised at the reaction," said Cross.

"The first pilot study that was done on humans managed to get statistical significance, which meant we didn't have a huge breadth of clinical studies behind us. We are still doing it though, because it (the studies) helps to give us credibility in the marketplace," continued Cross. "Our first priority is to make sure we have great success in our product launch, so we are taking our time and making sure we really understand the marketplace and how to sell our product."

Second generation Perio products are currently in the research and development phases. The second generation products will include a Photosonic Scaler (combining PDD with traditional ultrasonic scaling) and Photoweld (PDD with gum reattachment.

Looking back on the lengthy seven year process, Cross has a number of words of wisdom for other start-up companies.
"You better be prepared to work like hell," stressed Cross. "I think it's a very difficult industry to get into. People need to go in with their eyes wide open. There isn't adequate funding out there and people need to know that."

When speaking of the burden of financing, Cross goes on to explain that it's not just the initial start-up costs, but the whole process. "Be well aware of the financing needs not just at the beginning but all the way through. There is very limited money in venture capital in Canada."

Time management is another of Cross' key points. "It takes at least 90 percent of the CEO's time to organize the financing alone".

Ondine Biopharma's approach was to take things slow and steady, with small milestones along the way instead of one big goal from the start. Its starting point was to create a solid business plan that laid out the milestones and just how much each one would cost to reach. Cross suggests enlisting the help of one, if not many financial planners right from the start to figure out how the business plan will realistically play out and work.

The company has its future mapped out as well with a solid plan. It plans to meet its mission statement by leveraging core strengths, domain expertise and strategic relationship realized in the development of the first product line. Ondine's ultimate goal is to develop a broad product pipeline portfolio of proprietary anti-infective products.