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Communicating with the FDA? Be proactive, startup veteran says

Stephanie Baum

Jane Hollingsworth, the CEO of NuPathe (NASDAQ:PATH), tends to stand out around Philadelphia. It’s not just because she has founded two drug development companies — Auxilium Pharmaceuticals (NASDAQ:AUXL) and NuPathe — and taken them public. It’s also because the region is not exactly teeming with drug development startups led by women.

Hollingsworth said one of her concerns is the changing fundraising landscape for small life science startups.

“One of the things I worry about is that as the big companies wait until approval or later in the drug development process to partner with or buy smaller biopharma companies, and as the regulatory process becomes longer and more uncertain, the ability to raise funds to develop products becomes harder and harder. Venture capital firms have not historically been prepared to finance companies for that long.”

Six years after NuPathe’s launch to develop drugs for central nervous system disorders from migraines to schizophrenia to Parkinson’s disease, the company is in the process of refiling its first New Drug Application for its Zelrix migraine patch after receiving a complete response letter. The letter from the U.S. Food and Drug Administration essentially delays any approval of the drug until certain questions are resolved by the producers.

The patch uses iontophoresis, a transdermal drug-delivery method using an electrical charge, and was developed as a way to speed up the delivery process while avoiding the gastrointestinal system since nausea is a common symptom in people who suffer migraines, like Hollingsworth and Conshohocken, Pennsylvania-based NuPathe co-founder Terri Sebree.

Reflecting the increased time it takes for a drug to be approved these days, Auxilium’s testosterone replacement gel, Testim, was approved by the FDA within 22 months of its initial product development in 2002.

Hollingsworth says that she has taken a proactive approach in her communications with the FDA, but even when companies think they’ve answered all of the FDA’s questions, there are often more questions or follow-ups to previous ones. “It is key to try to have these communications as early in the process as possible.”

In addition to Zelrix, the company is in the preclinical trial phase of developing drugs for the continuous symptomatic treatment of Parkinson’s disease, NP201, and for NP202, a drug for the long-term treatment of schizophrenia and bipolar disorder.

Despite the broad push for innovation in the healthcare industry, when it comes to regulatory approval in the United States, innovation can mean things take longer to get approved. Although innovation is desirable for many reasons, there can be a downside.

“There is a need for innovation, but the more innovation you have in your product, the more difficult it can be for [the regulators] to understand it, at least within the review cycle time line,” Hollingsworth said. “By definition, innovation does not fit in a box or the mold for what has come before, and that can strain the regulatory system, particularly if it is a system that favors caution and safety over innovation.”

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