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Biotech firm Azaya working to bring generic cancer drug to market
November 9, 2012

Mike Dwyer, CEO of Azaya Therapeutics, is leading the local biotech firm toward the launch of a generic version of a popular anti-cancer drug.

By Mike W. Thomas, San Antonio Business Journal

Since 2003, Azaya Therapeutics has been working to commercialize a patented drug delivery technology that could make cancer treatments more effective and less harmful to patients.

The San Antonio-based startup has developed a method of encasing toxic drug therapies inside fatty cells, known as liposomes, that can then be injected into a patient. These liposomes are supposed to keep the toxic drug from harming healthy cells in the body while the medicine is being delivered to the tumor cells.

Recently, the U.S. Food and Drug Administration approved a study where Azaya will test the efficacy of its delivery system with a generic version of the popular cancer drug Doxil.

Doxil has been used widely to treat patients suffering from ovarian cancer. Azaya's generic version of Doxil is called ATI-0918.

"We have been working on this development program of ATI-0918 since 2009 and it is gratifying to finally get the product into the clinic for final testing," says Mike Dwyer, president and CEO of Azaya. "We expect to have the results of this study by mid-year 2013 and file all of the required information and the clinical data for regulatory approval shortly thereafter."

Sales of Doxil, which is owned by Johnson & Johnson, have topped $500 million annually in recent years. But last year, the company that was manufacturing Doxil had to shut down its operations and that led to a worldwide shortage of the drug.

In response, Azaya has accelerated efforts to produce its generic version of the drug in hopes of having the product on the market by 2014. Now with FDA approval for the new study, Azaya expects to file for full approval to market the drug later next year

"Since the shortage of Doxil arose in 2011, we have redoubled our efforts to complete the development program for ATI-0918," Dwyer says. "Azaya's goal with ATI-0918 is to have it approved as a generic equivalent to Doxil and offer physicians and patients another reliable source for this important product." Doxil is currently sold in 80 countries and analysts have estimated it has a $600 million market. However, the patent for Doxil ran out two years ago and once a generic hits the market, it tends to capture up to 80 percent of the business because it is less expensive, Dwyer says.

Next step
Azaya will be looking to raise additional capital in the future as it gets closer to the point of taking ATI-0918 to market. Dwyer says he expects Azaya will need about $15 million to finish the next cycle of development.

"We expect it will take about a year to get approval (for the drug)," Dwyer says. "We are currently in discussion with potential partners to market and distribute the drug once it is approved."

Dwyer says Azaya would like to control the manufacturing of the drug while contracting out the distribution

Over the years, Dwyer has taken a number of startup companies, like Azaya, through the development stage and then sold them to larger companies. York Duncan, president of the Texas Research Park Foundation, says Dwyer is one of the most experienced technology CEOs in San Antonio who has taken a number of companies from startups to exit strategy.

"We invested in one of his first companies that was bought out, so I've had first-hand experience watching him work," Duncan says. "Over the years, he has probably raised well over half a billion dollars in venture capital for the companies he has worked with."

Duncan says he recommended Dwyer for the CEO position at Azaya back when the company was being set up by John Kerr, a local investor and former board chair of the Texas Biomedical Research Institute.

"John called to tell me he was starting a new cancer drug company and was looking for someone to run it," Duncan recalls. "I said Mike Dwyer is your guy. I would trust him with any technology company, especially in the medical field. And sure enough, he has been there ever since."



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