05 March 2015
Mississauga, Ontario, Canada – March 5, 2015 – Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today provided a business update.
On January 30, 2015, the Company announced topline results of its Phase 2 clinical trial to investigate the safety and efficacy of WF10™ in patients with refractory allergic rhinitis (the 2014 Trial). As anticipated, the WF10 arm reduced allergy symptoms as evidenced by recorded patient Total Nasal Symptom Scores (TNSS) and Total Ocular Symptom Scores (TOSS). The placebo arm demonstrated an unexpectedly large reduction in patient TNSS and TOSS scores that was greater than those observed in the placebo arm in the Company’s 2010 Phase 2 Proof-of-Concept clinical trial (the 2010 Trial). Moreover, in contrast to the 2010 Trial, TNSS and TOSS scores in the placebo arm declined at each successive time point in the 2014 Trial with no tendency to revert towards baseline over time. While the WF10 arm and the two separate arms that included constituent elements of WF10 all performed better than the placebo arm, the differences were not statistically significant.
The 2010 Trial demonstrated statistical significance as measured by the change in TNSS and TOSS comparing a WF10 group with a placebo group at each of three, six, nine and twelve weeks after treatment.
After reviewing the data from both trials and consulting external experts, the Company believes that the 2010 Trial more accurately illustrates the efficacy of WF10 in the treatment of allergic rhinitis. It believes that the placebo group in the 2014 Trial did not record as high TNSS and TOSS scores compared to the 2010 Trial due to a longer enrollment period that started later in the allergy season, varying environmental conditions and other factors that resulted in some patients in the 2014 Trial not being exposed to a high enough concentration of the allergens that they were allergic to throughout the trial period.
The 2014 Trial protocol provides for unblinded, follow-up patient assessment that includes TNSS and TOSS assessments at six, twelve, eighteen and twenty-four months after initial treatment. The Company will be monitoring these data as they become available at each measurement point.
The Company is also studying alternative next steps including the option of conducting an additional confirmatory clinical study which could be a field study in patients with seasonal allergies and/or perennial allergies or an environmental exposure unit study in which allergen exposure can be more readily controlled. The Company will provide a further update once its strategy is finalized.
The Company has taken steps to curtail spending on a number of WF10 projects and studies planned for 2015 that were premised on the 2014 Trial clearly confirming the positive results of the 2010 Trial.
The Company has posted a presentation on its website that includes charts that detail TNSS and TOSS scores for the 2010 Trial and the 2014 Trial.
Topical Products and Technology (TPT) Group
The Company is focusing on maximizing the value of its topical products group which includes the approved revenue generating products Pennsaid®, Pennsaid 2%, Pliaglis and the heated lidocaine/tetracaine patch (HLT Patch). Key recent developments in the TPT Group include:
1) Increasing Volumes of Pennsaid 2%. The Company supplies Pennsaid 2% to Horizon Pharma plc (Horizon) for sale in the U.S. under an exclusive manufacturing agreement. The most recent prescription data provided by IMS Health indicates that Pennsaid 2% prescriptions in the U.S. have increased to approximately 2,500 per week compared to an average of approximately 1,200 per week in December of 2014 – the last month that Pennsaid 2% was sold in the U.S. by Nuvo’s former Pennsaid 2% licensee. Horizon assumed U.S. sales and marketing of Pennsaid 2% January 1, 2015.
2) Pennsaid 2% Phase 3 Trial in Acute Pain. The Company continues to plan for the commencement of a Phase 3 clinical trial in Germany of Pennsaid 2% for the treatment of acute pain. The trial will support regulatory approval applications for Pennsaid 2% in international jurisdictions. Commencement of the trial, which is subject to German regulatory approval, is expected in Q2 2015 with topline results anticipated in Q4 2015.
3) NovaMedica Pennsaid 2% Clinical Study in Russia. NovaMedica LLC (NovaMedica), the Company’s licensee for Pennsaid 2% in Russia, has advised the Company that it has commenced enrolling patients in a clinical study that is required to obtain Russian regulatory approval. NovaMedica has advised that it expects to receive regulatory approval and launch sales of Pennsaid 2% in 2016.
4) Pennsaid 2% Out Licensing Discussions. The Company has commenced preliminary discussions with potential Pennsaid 2% licensing partners for available international markets.
5) Delivery of Topical Formulation to Ferndale. The Company has completed and delivered its first topical formulation to Ferndale Laboratories Inc. (Ferndale) utilizing the Company’s patented multiplexed molecular penetration enhancers (MMPE™) technology. Under the terms of its collaboration with Ferndale and a leading Contract Research Organization (CRO), Ferndale and the CRO will oversee and fund the formulation’s advancement through Phase 2 clinical trials. It is anticipated that the product will then be made available for out licensing. Licensing revenues including upfront payments, milestone payments and royalties will be shared with Nuvo based on a calculation that includes compensation to Nuvo for contributing the patented formulation.
The Company has engaged Bloom Burton & Co., a Toronto-based investment bank, to assist in examining strategic transactions, including a potential restructuring of the Company, with a view to increasing shareholder value by obtaining better recognition of the value of the Company’s revenue generating assets and its cash position, which as of December 31, 2014 was approximately $58 million.
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 syndromes and adjunctive therapy of diabetic foot ulcers
About the 2014 WF10 Phase 2 Clinical Trial
184 patients were enrolled in and 179 patients completed the WF10 Phase 2 allergic rhinitis clinical trial that commenced in March 2014 at 15 sites in Germany. The 16-week trial was a randomized, double-blind, placebo-controlled trial 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 patients who suffer from refractory allergic rhinitis with positive skin test to at least one allergen. 46 patients were enrolled in each of 4 arms to receive WF10, WF10 with chlorate removed, WF10 with chlorite removed or placebo (saline). The trial measured total nasal symptom score (TNSS), total ocular symptom score (TOSS) and other secondary endpoints. The trial was designed to confirm the results of the Company’s 2010 Phase 2 WF10 proof-of-concept clinical trial for the treatment of allergic rhinitis with WF10 which achieved statistical significance (P<0.001) for its primary endpoint (change in TNSS at week 3). It was also designed to provide information on which WF10 constituent elements are contributing to its therapeutic benefit.
About the 2010 WF10 Phase 2 Proof-of-Concept Clinical Trial
In 2010, the Company conducted a Phase 2 proof-of-concept clinical trial to evaluate WF10 as a treatment for persistent allergic rhinitis. The trial was a 60-subject, randomized, double-blind, placebo-controlled, single-center trial to assess the efficacy and safety of a regimen of five WF10 infusions. The trial met its primary endpoint as measured by the change in Total Nasal Symptom Score (TNSS) from baseline to assessment after three weeks comparing the WF10 group with the placebo group. The trial also met its secondary endpoints as measured by the change in TNSS at six, nine and twelve weeks and in the Total Ocular Symptom Score (TOSS) from baseline to assessment after three, six, nine and twelve weeks. The TNSS and TOSS are validated scales to measure nasal and ocular symptoms associated with allergic rhinitis. The results were statistically significant for all primary and secondary endpoints with p-values less than 0.001 except for the change in TOSS after three weeks for which the p-value was less than 0.003. WF10 was very well tolerated and there were few reported adverse events.
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 in the U.S. for twice daily dosing compared to four times a day for Pennsaid. Pennsaid 2% 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 2% has not yet received regulatory approval outside of the U.S. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories.
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 was no longer 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.
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 currently has four commercial products, a pipeline of topical and transdermal products focusing on pain and dermatology and multiple 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.
Certain statements in this press release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to statements concerning the Company’s future objectives, strategies to achieve those objectives, as well as statements with respect to management’s beliefs, plans, estimates, and intentions, 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 19, 2015 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 press 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 press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press 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.Print
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