Last year, $50 billion in research went toward new drug applications (NDAs) submitted to the Food and Drug Administration, and only 21 drugs, or new molecular entities, were approved. After carefully planning his company’s growth the last seven years, Robert Alonso of Yaupon Therapeutics, a Radnor-based specialty pharmaceuticals company, believes his company has a strong chance of seeing its soon-to-be-filed NDA for a topical treatment for lymphoma of the skin.
Alonso has good reason for optimism. He started the company with a pair of University of Kentucky scientists in 2002 with a focus on developing science from smaller universities. The focus soon shifted toward navigating the National Institute of Health grant system to validate its ideas and systems. In the last four years, Yaupon has raised $25 million in venture funds by showing strong potential to fulfill needs unmet by big pharma, like cancer and addictions.
“The entire focus of the company is to get this NDA across the goal line,” says Alonso of Clearazide, a topically delivered cytoxic agent in clinical studies for treating cutaneous T-cell lymphoma. “There’s only a handful of companies our size that can do it.”
That would be quite a score for Yaupon, which has grown from a three-person outfit to a company with 25 employees and its own labs to perform formulation work and chemistry.
Yaupon, which was named the 2005 Life Sciences Start-Up of the Year by the Eastern Technology Council and received early funding from BioAdvance and Ben Franklin Technology Partners, is also waiting to hear on an NIH grant application focusing on the emerging problem of methamphetamine addiction through Lobeline, its agent in phase 2 clinical studies that modulates dopamine production in the brain due to disease or drug abuse.
Alonso estimates there are up to 40,000 people with cutaneous T-cell lymphoma. If Clearazine is approved, Yaupon will likely commercialize the drug itself before deciding the company’s next move–pursuing more funding or going public.
“If all goes well we should have approval in the next 18 months,” says Alonso.
Source: Robert Alonso, Yaupon Therapeutics
Writer: Joe Petrucci