Starpharma Holdings Limited’s VivaGel on the Fast Track to the Market

Starpharma Holdings Limited (ASX: SPL) makes and develops its products using nanotechnology. Its main drug is called VivaGel, a gel-based microbicide designed to protect women from sexually transmitted diseases, including HIV.

The gel has made it through Phase 1 clinical trials, and the United States Food & Drug Administration (FDA) has even granted the drug fast-track status — and fast-track designation is nothing to scoff at. The term was coined in the FDA Modernization Act of 1997 in an effort to speed up the approval process for some worthy causes. The designation is reserved for new drugs that could address unmet medical needs and treat serious or life-threatening conditions.

While a fast-track designation is not a guarantee that the drug will ever be approved, it is an indication that the product has a better chance at one day being actively marketed than the average new drug applicant.

A study at the Tufts Center for the Study of Drug Development says that the FDA’s fast track program results in a 62% approval rate after the first three years. Considering that the length of the total drug testing and approval process is conservatively estimated at 12 years, this is an immense difference.

On top of its fast track designation, this company has been awarded $20.3 million by the United States National Institute of Health to accelerate its development. While this all speaks very favorably for the future of this drug, it could still very well be many years before the product actually materializes.

Of a more immediate concern to shareholders is a recent acquisition. In October, Starpharma bought Dendritic Nanotechnologies, Inc. Dendritic’s specialty chemicals are much more closer to commercialization than Starpharma’s technology. The firm’s near-term success will most likely be based on its ability to get some of this acquired technology on the market.

This is a company worth checking out.

Greg Guenthner
for Markets and Money

Greg Guenthner

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