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Nuvo's Topical Anesthetic Nearing FDA Decision

Nuvo's Topical Anesthetic Nearing FDA Decision
4/9/2012 3:45 PM ET

The regulatory decision on Nuvo Research Inc.'s (NRI.TO: Quote) topical local anesthetic cream Pliaglis is just a week away. Originally developed by Zars Pharma Inc., Pliaglis came into Nuvo's fold when Zars was acquired by Nuvo in May 2011.

Pliaglis was approved by the FDA in June 2006 to provide topical local analgesia for superficial dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal.

In February 2007, Zars Pharma granted Swiss firm Galderma Pharma S.A., the promotion and distribution rights of Pliaglis in the U.S and Canada. The following year - in March 2008, Galderma was granted worldwide marketing rights to Pliaglis.

Pliaglis was voluntarily removed from the U.S. market by Galderma in 2008, due to manufacturing issues at Galderma's third-party contract manufacturer. Galderma has since transferred Pliaglis manufacturing to its own facilities.

Having resolved the manufacturing issues, Galderma filed the sNDA for Pliaglis, which was accepted for review by the FDA earlier this year with a decision date set for April 16, 2012.

Pliaglis is also under review in several European Union countries, and a response from the E.U. regulatory authorities is expected this quarter.(2Q, 2012). In February of this year, Health Canada accepted the New Drug Submission for Pliaglis for review.

If all goes well as planned, Pliaglis is expected to be launched in the U.S., E.U., and rest of the world by Galderma in the fourth quarter of this year. Pursuant to Nuvo's license agreement with Galderma, Nuvo is entitled to receive milestone payments totaling US$8.0 million from Galderma once Pliaglis is launched in the E.U. and South America. Nuvo will also pocket royalties that average in the mid-teens from worldwide Pliaglis sales.

Nuvo's first commercialized pain product is Pennsaid, a non-steroidal anti-inflammatory drug, used to treat signs and symptoms of osteoarthritis of the knee. Nuvo licensed the U.S. marketing rights for Pennsaid to Covidien under an agreement signed in 2009.

Pennsaid sales in the U.S. have been growing since its launch in April 2010. The number of Pennsaid prescriptions dispensed were 167,000 in 2011, an increase of 149% over 2010. The growing Pennsaid sales implies higher royalty revenue for Nuvo. Pennsaid is also marketed in Canada and certain European countries.

A new, improved version of Pennsaid with more convenient dosing regimen - Pennsaid 2%, has also been developed. The dosing regimen of Pennsaid 2% is twice per day compared to current Pennsaid and its main competitive product, Endo Pharmaceuticals Inc.'s (ENDP) Voltaren Gel, which are four times per day dosing. In addition, Pennsaid 2% is easier to apply as it is more viscous than Pennsaid and dispensed via a simple to use metered dose pump.

Covidien intends to submit a Supplemental New Drug Application for Pennsaid 2% with the FDA this quarter (2Q, 2012).

Yet another approved product of Nuvo is Synera, a topical patch to provide local dermal analgesia for superficial venous access and superficial dermatological procedures, such as excision, electrodessication, and shave biopsy of skin lesions. In Europe, Synera is marketed under the brand name Rapydan, and is approved for surface anaesthesia of normal intact skin in connection with needle puncture in adults and children from 3 years of age.

Synera/ Rapydan comes to Nuvo's roster from the stables of Zars Pharma. Prior to coming under the aegis of Nuvo, the Synera patch was marketed in the U.S. by Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (ENDP).

Now, Nuvo holds the sales and marketing rights for Synera in the United States, Canada, South America and some regions of Asia. In all other regions worldwide, EuroCept BV, a Dutch-based pharmaceutical company, holds the global sales and marketing rights to the topical patch.

Nuvo, which launched Synera in the U.S. in February of this year, directly markets the product to interventional pain doctors with a dedicated 21 person contract sales force. In several European countries too, Nuvo's licensing partner EuroCept has initiated a pan-European launch of the product under the name Rapydan.

The company is also developing WF10, a compound for the treatment of immune related diseases, through its subsidiary, Nuvo Research GmbH, based in Leipzig, Germany. A phase II allergic rhinitis clinical trial utilizing WF10 was completed in 2010 and the study met its primary endpoint. Last December, Nuvo filed a patent application for improved reformulated WF10.

A quick look at Nuvo's balance sheet...

The net loss in 2011 narrowed to C$7.71 million or C$0.016 per share from C$13.27 million or C$0.032 per share in 2010. Revenue, consisting of product sales, royalties, license fee revenue and research and other contract revenue, in 2011 was C$16.7 million compared to C$17.0 million a year before.

Given the renewed momentum to Pennsaid franchise, re-launch of Synera in the U.S. and expansion in the E.U., and the pending decision on Pliaglis' U.S. and European approvals, it is worth keeping an eye on Nuvo.

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by RTT Staff Writer

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