Spotlight on Bio Advances

Spotlight on Bio Advances

NuPathe waits for migraine patch approval

by E. Teresa Touey on 03/31/12

Profile: Emerging Biotechnology Company in Pennsylvania

NuPathe of Conshocken, Pennsylvania, offers a strong model of an emerging biotechnology company. Its growth path illustrates the positive impact of communication and feedback between developer and regulator during the new drug application process.

Its CEO, Jane Hollingsworth, commented after a presentation to investors at the winter conference held by BIO,“We welcome the evolution in the FDA’s approach to increasing the two-way communication regarding drug applications. Increased dialogue and interaction are always helpful and should certainly improve the regulatory process.”

In 2010, NuPathe’s initial public offering raised the company an additional $50 million, accessing more diverse capital. The IPO was motivated by NuPathe to take advantage of favorable migraine market dynamics to commercialize its migraine patch. The patient pool for the patch turns to the internet to find solutions to one of the major symptoms of migraine, considerable migraine-related nausea. Marketing the migraine patch became self-evident.

NuPathe’s website elaborates, “If approved, NP101 will be the first transdermal patch for the treatment of migraine. NP101 actively delivers sumatriptan, the most widely prescribed migraine medication. In clinical trials involving more than 10,000 applications, NP101 offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). It utilizes SmartRelief, our proprietary transdermal delivery technology, that rapidly transports medication through the skin using a process called iontophoresis.”

Early-stage capital helped NuPathe get to the innovative product candidate attracting more venture capital from Safeguard Scientifics, Quaker Partners and SR One, GlaxoSmithKline’s venture group. Early-stage financing came from friends of management, management, greenhouse money from BioAdvance, and Ben Franklin Partners Technology Partners of Southeastern Pennsylvania.

Now, the market is primed to be developed. The core patient population is both working age, 25 to 55 year old, and social media sophisticated, thus a lower percentage of NuPathe’s capital will be used to market the product than has historically been the case with many other products. Staying nimble, efficient and fast as a management team has led to NuPathe achieving the hard technical challenge of developing the transdermal technology.

The management team brings complementary skills. Jane Hollingsworth is a lawyer with deep experience in the pharmaceutical industry. Terri Sebree is a neuroscientist with a long track record of getting product candidates approved by the FDA. Their prior joint, co-founding venture at Auxilium gave them the experience to develop a model for a biotechnology company that has emphasized an industry trend: Big Pharma is partnering with biotechnology companies to fill its pipeline. NuPathe has grown slowly and surely, developing a pipeline of therapeutic candidates as well as the financial structure to support its growth. In common, Hollingsworth and Sebree have strong leadership skills and consider problem solving an important element in drug development. Also, they have been patient with the process. At this point, they have invested six years.

Where does its product stand in the regulatory process? NuPathe completed a new drug application in the fall of 2010. It received an August 2011 complete response letter from the FDA, which included additional questions about the application. As a result of a meeting with the FDA to reach an agreement about resubmission details, NuPathe will resubmit the new drug application in the next several months, starting a new clock for a six-month review.

In the closing conference session, Dr. Stephen P. Spielberg, deputy FDA commissioner, talked about the modernizing the regulatory process. “Since my career began 35 years ago in the 1960s, science has changed. We have a huge change of our understanding of biology. The innovation and the technology have created a sea change. Science is complex and at times overwhelmingly so and it has outpaced our sociology.” The challenge to do so while meeting the standards of efficacy, safety and quality impacts all stakeholders.

As the FDA application is processed, NuPathe continues to develop contacts with migraine experts, potential business development partners, and investors interested in its migraine patch, SmartRelief transdermal technology and two other product candidates using the company’s long-term biodegradable implant technology: one for Parkinson’s disease and one for schizophrenia and bipolar disorder.

And forward, the clock moves while the national BIO organization continues to work on legislative efforts in two areas – renegotiation of the fifth series of PDUFA allowing the FDA to collect fees from companies that produce human drugs and biologics to support limited FDA activities around the drug review process and the TREAT act which would create an accelerated approval pathway at the FDA for treatments for diseases or conditions that are serious or life-threatening.

Jane Hollingsworth, CEO of NuPathe, with the migraine patch.
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