NuPathe Inc. has raised $30 million in a Series B equity financing, money that will fund Phase III testing and regulatory filings for the company's lead product for acute migraine.
The Conshohocken, Pa.-based company has initiated large Phase III trials to evaluate the safety and efficacy of the company's transdermal patch for acute migraine, NP101.
Jane Hollingsworth, NuPathe's CEO, said the company is prepared to commercialize the migraine patch on its own. However, she said the company also is in discussions with potential partners.
The migraine patch delivers sumatriptan, a leading antimigraine medication sold by GlaxoSmithKline plc under the trade name Imitrex. GSK's venture capital arm, SR One Ltd., led the financing along with Quaker BioVentures.
Annual sales of triptans, the leading class of agents for acute migraine, exceed $2 billion in the U.S., according to NuPathe's figures.
While Hollingsworth said sumatriptan is well accepted by physicians and patients, a key advantage for the NuPathe antimigraine patch could be that it bypasses the gastrointestinal tract, she noted. Oral migraine medications have been associated with GI absorption problems, she said.
An estimated 36 million Americans suffer from migraine, and more than 50 percent of migraine sufferers experience nausea in a majority of their attacks, according to NuPathe.
Although the bulk of the funding will go toward its drug-device migraine patch, part of the money also will fund NuPathe's other skin patch, NP201, a dopamine agonist for Parkinson's disease.
long-acting patch is expected to provide stable dosing over a period of one to three months, offering an alternative to existing treatments.
According to NuPathe, the primary treatments for Parkinson's disease, including dopamine agonists and/or carbidopa-levodopa, are effective, but movement disorders, dyskinesias and other dose complications are common.
Many experts attribute those complications to variable drug levels resulting from frequent dosing or poor compliance with the prescribed dosing, the company said.
NP201 currently is undergoing preclinical testing in primates.
The migraine patch technology is based on NuPathe's SmartRelief electronically assisted drug delivery system called iontophoresis.
SmartRelief iontophoresis uses low-level electrical energy to transport drugs through the skin in a safe and effective manner.
The rate and amount of drug delivered is controlled electronically, so that the patient receives consistent therapy each and every time, according to NuPathe.
The disposable patch is "pre-programmed" and cost effective.
Its patch for Parkinson's disease is based on Long-Acting Delivery Technology, which consists of a small biodegradable polymer matrix, formed into a small rod, no bigger than a grain of rice.
A dose is administered through an injection and resides just below the skin where it slowly degrades over a defined period of time, according to the NuPathe website.
In other financing news,
• Cara Therapeutics Inc., of Shelton, Conn., said that it had closed on $12.3 million of additional funding to its original $24 million Series C financing, which was completed in 2007. The additional funds will be used primarily for further clinical development of both intravenous and oral formulations of Cara's second-generation peripherally selective kappa opioid agonist, CR845, currently in Phase Ia studies. Animal studies indicated that CR845 is effective in reducing pain of inflammatory, neuropathic and visceral origin. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus), impair breathing or elicit signs of addiction in animal models. The round was led by new investor Devon Park Bioventures and included participation by Connecticut Innovations.
• Cardiome Pharma Corp., of Vancouver, British Columbia, said that it has entered into an agreement with CR Intrinsic Investments LLC, an investment fund managed by CR Intrinsic Investors LLC, an affiliate of S.A.C. Capital Advisors LLC, to purchase Series A convertible preferred shares for gross proceeds of $25 million. Proceeds will be used for general corporate purposes, costs associated with the ongoing strategic process and continued development of Cardiome's clinical programs.
• Cell Therapeutics Inc., of Seattle, said that a single institutional investor has agreed to purchase $44.5 million units consisting of senior convertible notes and warrants. The newly issued 18.33 percent convertible senior notes come due in 2011, with a conversion price of 79 cents per share. Of the total purchase, $22.25 million will be funded this week and the remaining $22.25 million must be funded prior to Aug. 25.
• Genomic Vision, a Paris-based diagnostic and drug discovery company, said it has raised €4 million (US$6.3 million) in a series B financing round. The funds will be used to expand Genomic Vision's in-house research and development programs and automation, as well as to strengthen the firm's collaborative programs.