NuPathe Tumbles After CRL Delays Migraine Patch Zelrix
BioWorld Today Managing Editor
NuPathe Inc.'s Zelrix, a version of sumatriptan delivered via a patch for migraine sufferers unable to take the oral therapy, won't hit the market next year as planned after the FDA issued a complete response letter (CRL) requesting additional information, news that sent shares of the Conshohocken, Pa.-based firm plunging 34.6 percent.
The stock (NASDAQ:PATH) lost $1.40 to close Tuesday at $2.65, a far cry from the firm's 2010 initial public offering (IPO) price of $10. After dropping slightly on its debut a year ago, NuPathe's stock has continued to slide; all told, shares have lost about 72 percent of their value since the IPO. (See BioWorld Today, Aug. 9, 2010.)
Reaction to the latest news stemmed in part from the lack of detail provided by the company, which stated in a press release only that the CRL "primarily contained chemistry, manufacturing and safety questions," which NuPathe said it has or should have shortly. The company said it may have to conduct additional Phase I or preclinical studies, but spelled out no specific requirements, and the firm could not be reached for further comment.
NuPathe, which intends to request an end-of-review meeting with the FDA, said the agency acknowledged that Zelrix's efficacy had been established.
With few details available, analysts were left to speculate, and the estimated delays to product launch ran the gamut, from six months to more than two years. Leerink Swann analyst Joseph Schwartz wrote in a research note that a one-year delay is possible. "In a best-case scenario, Zelrix could be approved within one year if no further clinical trials are needed and it can resubmit before the end of 2011," followed by a six-month review period, he said.
Schwartz added that he spoke with NuPathe's management, who described safety questions as relating to skin reactions and the coating material of the patch. The firm also reportedly said that chemistry, manufacturing and control issues were "close to being resolved."
But, for many, the reference to manufacturing and safety issues brought to mind the troubled history of Ionsys (fentanyl iontophoretic transdermal system), a pain patch developed by Johnson & Johnson subsidiary ALZA Corp. that gained approval in 2006 but failed to reach market in the U.S. and was recalled in Europe two years later.
Like Ionsys, Zelrix is designed to deliver drug through the skin via an electronic pulse. One of the manufacturing issues that plagued Ionsys was the corrosion of component parts, which caused the active drug to be released without patient activation. Ionsys now is in the hands of newly founded Incline Therapeutics Inc. and is part of an option deal with San Diego-based Cadence Pharmaceuticals Inc. (See BioWorld Today, June 23, 2010.)
NuPathe's Zelrix successfully completed a pivotal Phase III trial in 2009, as well as two pharmacokinetic trials in healthy subjects. Had the FDA granted approval this week, the firm would have launched the drug with its own specialty sales force in the first half of 2012.
Zelrix is only expected to garner a small percentage of the migraine market now that GlaxoSmithKline plc's oral sumatriptan is available in generic form. NuPathe, however, has cited the need for a non-oral product in migraine, since many patients suffer nausea and vomiting, which makes it difficult to take an oral medication.
Yet, even at a 5 percent market share, Zelrix could still bring NuPathe sales of about $300 million in peak sales.
It's not clear how the regulatory delay will affect the firm's financials. As of June 30, NuPathe had about $36 million on its balance sheet. Earlier this year, the company inked a common stock purchase agreement with Aspire Capital Fund LLC, which committed to purchasing up to $30 million over the next 24 months at NuPathe's discretion.
Beyond Zelrix, the company's pipeline includes preclinical candidates NP201, a ropinirole implant for Parkinson's disease, and NP202, an atypical antipsychotic implant for schizophrenia and bipolar disorder.
Published: August 31, 2011
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