Click here to read the full press release. Source: PR Newswire – October 17, 2014
Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced that it has completed the sale of its PENNSAID 2% U.S. sales and marketing rights to Horizon Pharma plc (NASDAQ: HZNP) for a cash payment of US$45 million (CDN$50 million) which was payable on closing. Effective January 1, 2015, Horizon will assume U.S. commercialization of PENNSAID 2% from Nuvo’s former U.S. marketing licensee. Nuvo retains all rights to PENNSAID and PENNSAID 2% outside of the U.S. and will be seeking a marketing partner or partners for international territories. Nuvo will supply PENNSAID 2% to Horizon for the U.S. market from its Varennes, Québec manufacturing facility pursuant to an exclusive long-term manufacturing agreement.
“This sale was made possible by our recent litigation settlement with our former U.S. marketing licensee that returned the U.S. PENNSAID and PENNSAID 2% rights to Nuvo,” said John London, Nuvo’s President and Co-CEO. “This transaction, together with the US$10 million litigation settlement payment, have generated gross proceeds of over CDN$60 million of non-dilutive cash. We will continue to explore opportunities to maximize the value of our robust product pipeline including our lead development asset, WF10, which is currently being studied in a 183 patient Phase 2 refractory allergic rhinitis clinical study with results expected in Q1 2015.”
About PENNSAID 2%
PENNSAID 2% is a topical product containing 2% diclofenac sodium compared to 1.5% for original PENNSAID. It is approved in the U.S. for pain of osteoarthritis (OA) of the knee(s). It is more viscous than PENNSAID, is supplied in a metered dose pump bottle and has been approved for twice daily dosing compared to four times a day for PENNSAID. The new drug application (NDA) for PENNSAID 2% was approved by the FDA on January 16, 2014 and the drug is protected by 6 U.S. patents that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations database or “Orange Book”.
PENNSAID is used to treat the signs and symptoms of OA of the knee(s). The drug combines a transdermal carrier (containing dimethyl sulfoxide, popularly known as DMSO) with 1.5% diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) and delivers the active drug through the skin directly to the site of inflammation and pain. Effective January 1, 2015, PENNSAID will no longer be marketed in the U.S. It is currently marketed in Canada by Paladin Labs Inc. and marketed under license and/or distribution agreements in Greece, Italy and the U.K.
WF10 is a solution containing stabilized chlorite ions that focuses on supporting the immune system by targeting the macrophage, a type of white blood cell that coordinates much of the immune system, to regulate normal immune function. WF10 is an infusion therapy currently approved only in Thailand under the name IMMUNOKINE for the treatment of post-radiation-therapy syndrome.
About The Company’s Ongoing WF10 Phase 2 Clinical Trial
This 16-week clinical trial is a randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy, safety and tolerability of a regimen of five infusions of either WF10 or its main constituents (sodium chlorite and sodium chlorate) relative to saline control in allergic rhinitis patients experiencing persistence or recurrence of symptomatic episodes in spite of conventional treatment over the previous year. The trial will measure total nasal symptom score (TNSS) and other secondary endpoints. The trial is being conducted at 15 sites in Germany. It is fully enrolled with 183 patients participating. Top-line results are expected in Q1 2015. The trial is designed to confirm the results of the Company’s 2010 60 patient, randomized, double-blind, placebo-controlled, single-center Phase 2 clinical study of WF10 for the treatment of allergic rhinitis which achieved statistical significance (P<0.001) for its primary endpoint (change in TNSS at week 3).
About Refractory Allergic Rhinitis
Allergic rhinitis, a highly prevalent condition characterized by nasal symptoms (runny, blocked, or itchy nose; chronic sneezing) is triggered by an inappropriate immune response to one or more allergens such as pollens, house dust mites and pet dander. Refractory allergic rhinitis patients often suffer from severe symptoms and do not respond adequately to common forms of treatment such as antihistamines and nasal corticosteroids. Most refractory allergic rhinitis patients suffer from multiple allergies.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company with a diverse portfolio of products and technologies. The Company operates two distinct business units: the Topical Products and Technology (TPT) Group and the Immunology Group. The TPT Group has four U.S. Food and Drug Administration (FDA) approved commercial products, a pipeline of topical and transdermal products focusing on pain and dermatology and four drug delivery platforms that support the development of patented formulations that can deliver actives into or through the skin. The Immunology Group has two commercial products, a development program for the treatment of allergic rhinitis and an immune system modulation platform that has the potential to support treatments for a broad range of immune system related disorders. For additional company information visit www.nuvoresearch.com.
Management to Host Conference Call/Webcast
Management will host a conference call to discuss the sale of the PENNSAID 2% U.S. rights to Horizon today (October 17, 2014) at 8:30 a.m. ET. To participate in the conference call, please dial 1 (888) 231-8191 or (647) 427-7450, reference number 22766789. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.
A taped replay of the conference call will be available two hours after the live conference call and will be accessible until Friday, October 24, 2014 by calling 1 (855) 859-2056 or (416) 849-0833, reference number 22766789.
A live audio webcast of the conference call will be available through www.nuvoresearch.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.
Certain statements in this news release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to the Company’s anticipated use of proceeds from the Private Placement, the Company’s future share price and the Company’s possible election to accelerate the expiry date of any of the warrants or the brokers warrants and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “outlook”, “objective”, “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “should”, “plans” or “continue”, or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management’s current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include general business and economic uncertainties and adverse market conditions as well as other risk factors included in the Company’s Annual Information Form dated February 20, 2014 under the heading “Risks Factors” and as described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. This list is not exhaustive of the factors that may impact the Company’s forward-looking statements. These and other factors should be considered carefully and readers should not place undue reliance on the Company’s forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The factors underlying current expectations are dynamic and subject to change. Although the forward-looking information contained in this news release is based upon what management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. All forward-looking statements in this news release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this news release and except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Nuvo Research Inc.