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NovaCal Pharmaceuticals HQ n California

By Editorial Staff

Of the 55 companies that presented to more than 100 of the most active Silicon Valley and Sacramento venture capital investors at the Golden Capital Network Sacramento Venture Capital Conference, the judging panelists deemed NovaCal Pharmaceuticals, an East Bay bioscience company that manufactures a revolutionary solution for the care of chronic wounds, the Best of Show. “NovaCal was the clear winner based on the size of the market, the strength of its management team, the revolutionary nature of its technology and the defensibility of its market position,” said John H.N. Fisher, Managing Director of Draper Fisher Jurvetson, one of the judging panelists.

NovaCal Pharmaceuticals was founded by Dr. Ramin (Ron) Najafi. This is his third entrepreneurial venture. Dr. Najafi, who has a PhD in chemistry from UC Davis, had previously worked in the pharmaceutical and biotech industry at Rhone Poulenc Rorer and at Applied Biosystems, where he was recognized as “Scientist of the Year”.

Working with Dr. Mansour Bassiri, who is NovaCal’s Director of Cell and Microbiology, Dr. Najafi focused on making the same chemicals that white blood cells use to kill bacteria and other microbes. “Manufacturing and formulating these chemicals so that they can be used as anti-infective products has been a major breakthrough that required several scientific discoveries to ensure that they could be put in a bottle with adequate shelf-life”, said Dr. Najafi. “NovaCal has succeeded in finding out how to make these chemicals usable and how to preserve them for long periods”.

“Not only has NVC-101 proved to be highly anti-microbial” says Dr Bassiri, “but it is safe for use in the eye and at the proposed dosage does no harm to human cells.” In addition to laboratory and animal studies, a safety study on patients with 91 wounds was conducted at Seton Wound Care Center, which showed that even in the very sensitive conditions of chronic ulcers wounds, NVC-101 appeared to be safe and to be reducing or eliminating infections that delayed healing. What makes these results important is that the U.S. Public Health Service condemns the use of all other anti-infective solutions on ulcer wounds, because they are all cytotoxic at the doses required. There are 3 million people suffering from chronic ulcer wounds in the United States and these are constantly being infected.


Left to right: Jack O'Reilly, NovaCal's CEO - Jane Yang, Chemist & Microbiologist - Ramin Najafi Ph.D., Founder - Dr. Lu Wang, Director of Chemistry - Mansour Bassiri, Director of Micro & Cell Biology

NVC-101’s strong anti-microbial impact has been confirmed by tests at Lawrence Berkeley National Laboratories, where it rapidly killed anthrax spores. Based on these positive results, the Defense Department is about to test NVC-101 against anthrax in the lungs of animals. “There is a long way to go before we can say whether NVC-101 is effective against inhaled anthrax”, says Dr. Najafi, “but if it does work that would be a real bonus”.

One of NovaCal’s Board Members, Paul Freiman, the former Chairman and CEO of Syntex Corporation and the current CEO of Neurobiological Technologies, introduced Dr Najafi to Jack O’Reilly early last year. Jack headed Corporate Development at Syntex and has headed other early-stage biotech companies. “When Ron asked me to join the company as CEO,” said Jack, “I spent a day at Seton Wound Care Center and I was convinced by looking at the data and by talking with the staff there that NVC-101 had helped their patients. Our task now is to do everything that is necessary to obtain approval from the FDA to enable all patients to benefit from this unique product”.

NovaCal raised $1.1 million in a Series A financing and has just started raising a Series B financing and $0.5 has been subscribed to date. NovaCal is continuing discussions with potential investors. The Series B financing is designed to fund NovaCal’s initial clinical trials. The company is currently valued at about $8 million. “With a successful clinical trial, the valuation for the next round should be about $40 million,” estimates Jack O’Reilly.

Dr Najafi believes that NVC-101 could be used on 700,000 patients that arrive in the emergency room with serious burns, in the prevention of infection in surgery and in ophthalmic infections. “Every time we talk with Directors of Infection Control at major hospitals, they come up with new needs for products like ours”, says Dr. Najafi.

“The market potential for our products is so broad, that it would be a great mistake for a small company to attempt to market them. With such a wide range of applications, the total market potential could be in the billions”, says Jack O’Reilly, “We expect to be able to sell the company to a major pharmaceutical multinational when we have completed the package required for approval by the FDA. This should be in 2005/6. Based on comparable valuations for companies with products at that stage we would expect a sale price in excess of $500 million, obviously provided that our trials are successful.”

NovaCal is not just depending on NVC-101. It has recently filed patents on a new compound, NVC-320, that Dr Najafi, Dr Lu Wang, NovaCal’s Director of Chemistry, and Dr. Bassiri have been working on. This compound is also produced as a result of the activities of white blood cells. Dr Najafi says “NVC-320, our new compound, adds significantly to the strength of our company, because it is long acting and amazingly safe in early tests.”
Based on the strength of its R & D, NovaCal looks as if it could be one of the leading biotech companies in the anti-infective arena.

For more information, please contact Dr. Ramin (Ron) Najafi at 415-747-2087 or najafi@novacal.com.

 

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