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Post by nateb on Dec 21, 2015 16:45:43 GMT
JHam,
I agree. The story just became a lot clearer for any potential suitors. We still own a company with solid growing revenues and room to grow. I think we move up from here.
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Post by JHam on Dec 22, 2015 12:33:50 GMT
Nuvo Research® Reacquires Pliaglis North American Development and Marketing Rights MISSISSAUGA, ON, Dec. 22, 2015 /CNW/ - Nuvo Research Inc. (TSX:NRI) (Nuvo or the Company), a life sciences company with growing revenues and a diverse portfolio of topical products, today announced it has reacquired Pliaglis development and marketing rights for the U.S., Canada and Mexico. "We are pleased to reacquire the Pliaglis rights for the U.S., Canada and Mexico," said Dan Chicoine, Nuvo's Chairman and Co-CEO. "Our plan is to reevaluate the marketing strategy for the product and determine the optimal way to reenter the market to allow the product to reach its full potential." Pliaglis is approved for sale in all three countries and is currently being marketed and sold by Nuvo's global licensee, Galderma S.A. (Galderma), in the U.S and Canada. During a transition period, Galderma will continue to market Pliaglis in the U.S., Canada and Mexico and pay Nuvo a royalty on such sales. Under terms of the agreement, Nuvo paid Galderma 125,000 Swiss Francs (approximately $174,000 Canadian) and will pay an additional 125,000 Swiss Francs upon transfer of certain rights and documents. Beginning in 2021, Nuvo has the right to reacquire the rest of world rights on a country-by-country basis without additional compensation if Galderma does not achieve minimum sales targets. About Pliaglis Pliaglis is a topical local anesthetic cream that provides safe and effective local dermal analgesia on intact skin prior to superficial dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. This product consists of a proprietary formulation of lidocaine and tetracaine that utilizes proprietary phase-changing topical cream Peel technology. About Nuvo Research Inc. Nuvo (TSX:NRI) is a life sciences company with a diverse portfolio of products and technologies. On September 15, 2015, Nuvo announced that it plans to split Nuvo into two separate, publicly traded companies. One company, to be known as Nuvo Pharmaceuticals Inc. (Nuvo Pharma), would be a commercial healthcare company that would own the Company's Pennsaid and Pennsaid 2% franchises and related assets and have revenue and EBITDA. The other company, to be known as Crescita Therapeutics Inc. (Crescita), would be a drug development company that would own the Company's existing drug development business including its pipeline of product candidates. The companies would be distinct and separately traded public companies. Nuvo shareholders would receive shares of both companies. Complete details of the proposed transaction will be set forth in information circular that will be mailed to Nuvo's shareholders in Q1 2016 in connection with a special meeting that will be called by Nuvo to approve the proposed transaction. Completion of the proposed transaction is subject to certain conditions, including final approval by the Nuvo Board of Directors, confirmation of the potential tax-free nature of the transaction for Canadian shareholders, regulatory approval requirements and the approval of Nuvo's shareholders. If approved by shareholders, Nuvo expects the proposed transaction would be completed in Q1 2016 (subject to the satisfaction of all conditions). However, there can be no assurances regarding the ultimate timing of the proposed transaction or that the proposed transaction will be completed. For additional company information visit www.nuvoresearch.comForward-Looking Statements Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "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, plans for and timing of the potential development of the Company's product candidates, the proposed reorganization of the Company into two separate publicly-traded companies, 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 "may", "will", "proposed", "expect", "intend", "believe", "should" or "plans", 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, but are not limited to, general business and economic uncertainties and adverse market conditions; uncertainties that may delay or negatively impact the proposed reorganization or cause the proposed reorganization to not occur, including the failure to obtain any required approvals; 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. 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. SOURCE Nuvo Research Inc. For further information: Investor Relations, Email: ir@nuvoresearch.com This information is being distributed to you by / Cette information vous est transmise par : Nuvo Research Inc. Nuvo Research Inc., 7560 Airport Road, Unit 10, Mississauga, ON L4T 4H4 ww.nuvoresearch.com
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Post by nateb on Jan 23, 2016 14:55:12 GMT
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Post by nateb on Jan 23, 2016 14:57:08 GMT
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Post by nateb on Jan 24, 2016 16:06:05 GMT
Finally had chance to listen, not a lot of new information, but they plan on starting trading as two separate companies around the 1st of March.
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Post by nateb on Jan 30, 2016 15:11:55 GMT
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Post by JHam on Feb 8, 2016 12:52:55 GMT
Nuvo Research® and Horizon Pharma plc Extend Term of Manufacturing Agreement
MISSISSAUGA, ON, Feb. 8, 2016 /CNW/ - Nuvo Research Inc. (TSX:NRI), a life sciences company with growing revenues and a diverse portfolio of topical products, today announced it has agreed with Horizon Pharma plc (NASDAQ:HZNP) (Horizon) to extend the term of their manufacturing agreement for the production of PENNSAID® 2% for the U.S. market to December 31, 2029, which extends the agreement by an additional seven years. The amended agreement also provides for tiered pricing based on volumes of product supplied.
"This amendment secures the long-term future of the core business of Nuvo Pharmaceuticals, the commercial healthcare company to be 100% owned by Nuvo shareholders upon completion of our previously announced reorganization of Nuvo into two separate, publicly traded companies," said John London, Nuvo's President and Co-CEO. "We intend to build upon that core business by out-licensing PENNSAID 2% internationally and by seeking to acquire complementary, accretive businesses or products."
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Post by JHam on Mar 1, 2016 12:42:35 GMT
I sold my small position shortly after WF10 failed, but the spin off is now official. Good luck to anyone still holding. Hopefully this will bring some much needed liquidity to this one: Nuvo Research® Inc. Completes Reorganization into Two Publicly Traded Companies - Nuvo Pharmaceuticals Inc. and Crescita Therapeutics Inc. to commence independent trading on March 7, 2016 - MISSISSAUGA, ON, March 1, 2016 /CNW/ - Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo Pharma or the Company), formerly known as Nuvo Research Inc. and Crescita Therapeutics Inc. (TSX:CTX) (Crescita), today announced the completion of the reorganization of Nuvo Research Inc. into two separate publicly traded companies (the Reorganization). As a result of the Reorganization, the shareholders of what was formerly Nuvo Research Inc., now own 100% of Nuvo Pharma, a revenue and EBITDA generating commercial healthcare company, and 100% of Crescita, a drug development company. The Reorganization was approved by the shareholders of Nuvo Research Inc. at a special shareholders meeting on February 18, 2016 and by the Ontario Superior Court of Justice on February 24, 2016. "This transaction gives both businesses greater flexibility to focus on, and pursue, their respective growth strategies," said John London, President and CEO of Nuvo Pharma. "Nuvo Pharma is a profitable business with significant revenue and EBITDA growth potential." "We are very excited about the launch of Crescita," added Dan Chicoine, Chairman and CEO of Crescita. "We have exciting technologies, a proven management team that has obtained FDA approval for four topical pharmaceutical products and a strong balance sheet to support our growth." Under the Reorganization, existing Nuvo Research Inc. share certificates now represent common shares of Nuvo Pharma and the right to receive a share certificate representing an equal number of Crescita common shares. The distribution record date (the Record Date) for certificates representing Crescita common shares is Thursday March 3, 2016. However, the TSX has implemented due bill trading for the Nuvo Pharma common shares (TSX: NRI) until the close of trading on Friday March 4, 2016. Accordingly, shareholders who purchase Nuvo Pharma common shares through the facilities of the TSX prior to the close of trading on Friday March 4, 2016 will automatically receive one Crescita common share for each Nuvo Pharma common share purchased. Crescita common shares (TSX:CTX) are expected to commence trading on the TSX on Monday March 7, 2016. Nuvo Pharma and Crescita shareholders are encouraged to contact their brokers for additional information. As part of the Reorganization, Nuvo has changed its name from "Nuvo Research Inc." to "Nuvo Pharmaceuticals Inc." About Nuvo Pharmaceuticals Inc. Effective with the Reorganization, Nuvo Pharma (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo Pharma has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch. Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ:HZNP) and is available for partnering in certain other territories around the world. Nuvo Pharma manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA licensed GMP facility in Varennes, Québec. For additional information, please visit www.nuvopharmaceuticals.com. About Crescita Therapeutics Inc. Effective with the Reorganization, Crescita (TSX:CTX) is a well-capitalized biotech company that owns a pipeline of topical and transdermal product candidates for treating medical conditions in a number of therapeutic areas, including pain and dermatology. Crescita owns multiple proprietary drug delivery platforms that support the development of patented formulations that can facilitate the delivery of active drugs into or through the skin. Crescita has one commercial product, Pliaglis that is licensed globally (except for Canada, the United States and Mexico where Crescita owns the rights). Crescita's board and management team have demonstrated success in building Nuvo Research Inc., including developing multiple drugs that are now approved and commercialized and negotiating multiple transactions that have generated more than $100 million in non-dilutive funding. For additional information, please visit www.crescitatherapeutics.com.
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Post by Yelk on Mar 2, 2016 5:41:58 GMT
I'm still holding but stock isn't budging ... zzz small size WF10 was disappointing we will see what pennsaid and others can do over time.
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Post by JHam on Mar 7, 2016 15:38:40 GMT
Ouch: Nuvo Pharmaceuticals™ Inc. Announces Results from European Ankle Sprain Study with Pennsaid® 2%
- Pennsaid 2% Already Approved for Osteoarthritis of the Knee in the United States -
MISSISSAUGA, ON, March 7, 2016 /CNW/ - Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo or the Company) today announced top line results from its multi-centre, randomized, placebo-controlled, double-blind, parallel group trial in patients, with grade I or II ankle sprains conducted in Germany (the Trial).
The Study The Trial enrolled 126 patients (the full analysis set or FAS) of which 116 patients followed the protocol (the per protocol set or PP). The patients enrolled in the Trial applied either Pennsaid 2% or a placebo consisting of a topical vehicle that included all of the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium, to their injured ankle twice a day for 8 days. Randomly assigned double-blind treatment was started after baseline evaluation within 12 hours after injury (Day 1); the patients returned to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment. Results were tabulated for both the FAS and PP groups.
Primary Endpoint The primary endpoint for the Trial was reduction in pain on movement (POM) at day 5 in the FAS group. On average, patients treated with Pennsaid 2% had a larger reduction in POM scores over the course of the study. For the FAS group, the difference vs. placebo was statistically significant on the secondary time point on day 3 (p=0.0119), but not at the primary time point on day 5 (p=0.2430) or the secondary time point on day 8 (p=0.2603). In the PP group, which excluded those patients with a lower usage of medication than as set out in the Trial protocol (9 patients excluded out of 126 for this reason), the Pennsaid 2% group showed a statistically significant improvement at both the primary time point (day 5 p=0.0416), as well as the secondary time points (day3 p=0.0018 and day 8 p=0.0490).
Secondary Endpoints The Trial also included the measure of a number of secondary endpoints. These data are supportive of Pennsaid 2% being effective to treat ankle sprain injuries and specifically showed the following outcomes:
Tenderness - Pennsaid 2% demonstrated a statistically significant reduction in tenderness compared to placebo in the FAS group at days 3, 5 and 8 with p-values of 0.0055, 0.0150 and 0.0104, respectively.
Ankle Function - Pennsaid 2% demonstrated a statistically significant increase in ankle function compared to placebo in the FAS group at days 3 and 8 with p-values of 0.0115 and 0.0232, respectively, but not at day 5 with a p-value of 0.1549.
Ankle Swelling - Pennsaid 2% demonstrated a statistically significant decrease in ankle swelling compared to placebo in the FAS group at days 3, 5 and 8 with p-values of 0.0020, 0.0018 and 0.0142, respectively.
Overall Assessment of Benefit and Satisfaction - Patients treated with Pennsaid 2% reported a statistically significantly higher level of satisfaction with and benefit of their treatment compared to placebo in the FAS group with a p-value of 0.0001 for the treatment benefit and a p-value of <0.0001 for satisfaction.
Purpose of the Trial Pennsaid 2% is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of the pain of osteoarthritis (OA) of the knee(s). The Trial was conducted to support regulatory applications for marketing approval of Pennsaid 2% for the treatment of acute pain in the E.U., Canada and Australia which are potential new markets for Pennsaid 2%. The Company believes that most other jurisdictions will base their marketing approval on existing data, including the current U.S. FDA approval of Pennsaid 2% and will not require additional clinical efficacy data.
Next Steps The Company will be reviewing the Trial results in more detail and meeting with its consultants and with regulators to determine what steps, if any, are needed to obtain regulatory approval of Pennsaid 2% in Canada, Australia and the E.U.
The Trial results will not affect the marketing and sale of Pennsaid 2% in the U.S. where it is approved by the FDA for the treatment of the pain of OA of the knee(s) nor will it impact the Company's efforts to out-license Pennsaid 2% in other jurisdictions.
"We are encouraged by the results of this first study of Pennsaid 2% for the treatment of ankle sprains," commented John London, President and CEO of Nuvo. "Although the study did not achieve its primary endpoint at day 5, we saw statistically significant reductions in pain on movement scores at day 3 and also at days 3, 5 and 8 in the 116 patients who followed protocol. The positive results on pain on movement score reduction were further reinforced by positive results for the majority of secondary endpoints which also demonstrated a statistically significant benefit with Pennsaid 2% treatment. We remain committed to our goal of making Pennsaid 2% a global brand and believe these data will be beneficial in our ongoing partnering discussions in key ex-U.S. territories."
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 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 multiple 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.
About Nuvo Pharmaceuticals Inc. Nuvo (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch. Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ:HZNP) and is available for partnering in certain other territories around the world. Nuvo manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA licensed GMP facility in Varennes, Québec.
For additional information, please visit www.nuvopharmaceuticals.com.
Forward-Looking Statements
Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, the future approval, marketing and sale of Pennsaid 2% in certain jurisdictions, 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 "may", "will", "expect", "intend", "believe", "should" or "plans", 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, but are not limited to, general business and economic uncertainties and adverse market conditions; as well as other risk factors included in the Company's Management Information Circular dated December 31, 2015 and the Company's Annual Information Form dated February 17, 2016 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. 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. 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.
SOURCE Nuvo Pharmaceuticals Inc.
For further information:
Investor Relations, Email: ir@nuvopharm.com
This information is being distributed to you by / Cette information vous est transmise par : Nuvo Pharmaceuticals Inc.
7560 Airport Road, Unit 10, Mississauga, ON L4T 4H4 www.nuvoresearch.com
If you wish to stop receiving these types of messages from us, you can unsubscribe at any time. / Si vous ne souhaitez plus recevoir ce type de messages de notre part, vous pouvez vous désabonner à tout moment.
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Post by Yelk on Mar 7, 2016 21:21:03 GMT
There is something seriously shady here how technicals always suggest sell of before bad news. Tbh I don't really get how its okay to work in U.S. if it fails somewhere else. There are still positive things going on with the company but I'm mostly out. Glad I was in literally tiny. Lost a very small amount so far and entry wa like 5's anyways.
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Post by JHam on Mar 9, 2016 16:24:38 GMT
There is something seriously shady here how technicals always suggest sell of before bad news. Tbh I don't really get how its okay to work in U.S. if it fails somewhere else. There are still positive things going on with the company but I'm mostly out. Glad I was in literally tiny. Lost a very small amount so far and entry wa like 5's anyways. Because the trial in the EU had a different protocol, based on totally different end points. In the EU it was focused solely on ankle sprains. They seriously need to learn how to design a trial though. I don't think the product is bad for ankle sprains either, I just think they didn't design the trial to show it. I am totally out of this one and have no plan to add again at this time.
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Post by nateb on Mar 11, 2016 17:46:17 GMT
Yeah, this whole situation is a bummer and one I frankly wasn't expecting since the product is approved here in the US. I am still in and my shares finally split. Despite the European trial issues I am still hopeful that Nuvo Research will do well, as they should start showing profits.
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Post by Yelk on Apr 2, 2016 17:41:33 GMT
I got 100% out a bit ago fwiw flat and will not be looking back. Reasons are pretty simple for those following this. Management is a serious issue, company is failing to deliver results and though Pennsaid 2% will be selling nicely in U.S. and we have a lot of cash somehow I just don't care. I've lost interest and faith here after EU trial fail and though was WF10 icing on the cake I was hoping to have that continue as well.
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Post by nateb on May 10, 2016 16:47:07 GMT
Seems to be coming back, I am finally up now .
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Post by JHam on Jul 13, 2016 11:32:03 GMT
Good news for any of you still in this one: Nuvo Pharmaceuticals™ Inc. Announces Pennsaid 2% Phase 3 Trial to Support Regulatory Approvals in the E.U., Canada and Australia MISSISSAUGA, ON, July 13, 2016 /CNW/ - Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo or the Company) today announced it will conduct a new placebo-controlled, multi-centre Phase 3 trial (Trial) in Germany to study Pennsaid 2% for the treatment of acute ankle sprains. Topline results of the Trial are expected to be available in late Q2 or early Q3 2017. The Trial is subject to approval by German regulatory authorities and the ethical review committee. Pennsaid 2% is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of the pain of osteoarthritis of the knee(s). The Trial will be conducted to support regulatory applications for marketing approval of Pennsaid 2% for the treatment of acute pain in the E.U., Canada and Australia. The Company believes that most other jurisdictions will base their marketing approval on existing data, including the current U.S. FDA approval of Pennsaid 2% and will not require additional clinical efficacy data. The Trial will cost approximately CDN$1.5 million spread over the second half of 2016 and the first half of 2017. The Company believes that potential revenue to be generated by the Trial far exceeds its modest cost. "The Trial incorporates what we learned from a similar trial that we conducted in 2015 that produced encouraging results and we believe that Pennsaid 2% can show positive results in this setting," said John London, Nuvo's President and CEO. "In particular, we have changed the primary endpoint (pain on movement) to the third day after initial treatment which was a secondary endpoint at which Pennsaid 2% demonstrated statistical significance in the 2015 trial." About the Trial The Trial will be conducted in Germany and will enroll approximately 130 patients who have suffered a grade I or grade II ankle sprain as assessed by the investigator within 12 hours of injury. Patients will then be randomly assigned on a double-blind basis to an active arm or a placebo arm and will apply either Pennsaid 2% or a placebo consisting of a topical vehicle that includes all of the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium, to their injured ankle twice a day for 8 days. The patients will return to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment. The primary endpoint for the Trial will be reduction in pain on movement (POM) at day 3. The Trial will measure a number of secondary endpoints including tenderness, ankle function, ankle swelling, overall assessment of benefit and satisfaction and use of rescue medication. About Pennsaid 2% Pennsaid 2% is topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium. It is approved by the FDA for treating the pain of osteoarthritis of the knee(s). Pennsaid 2% is a gel formulation that is supplied in a metered dose pump bottle. It is the only topical NSAID approved by the FDA for twice daily dosing. Pennsaid 2% is protected by multiple 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. About Nuvo Pharmaceuticals Inc. Nuvo (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch. Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ:HZNP) and is available for partnering in certain other territories around the world. Nuvo manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA, Health Canada and EU approved manufacturing facility in Varennes, Québec. For additional information, please visit www.nuvopharmaceuticals.com. Forward-Looking Statements Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, the future approval, marketing and sale of Pennsaid 2% in certain jurisdictions, 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 "may", "will", "expect", "intend", "believe", "should" or "plans", 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, but are not limited to, general business and economic uncertainties and adverse market conditions; as well as other risk factors included in the Company's Management Information Circular dated December 31, 2015 and the Company's Annual Information Form dated February 17, 2016 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. 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. 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. SOURCE Nuvo Pharmaceuticals Inc. For further information: Investor Relations, Email: ir@nuvopharm.com This information is being distributed to you by / Cette information vous est transmise par : Nuvo Pharmaceuticals Inc. 3655, Chemin de la Côte-Bissonnette, Varennes, QC, J3X1P7, Canada www.nuvopharmaceuticals.com/
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Post by JHam on Oct 17, 2016 12:25:13 GMT
Took a "bit" longer than expected, but better later than never: Nuvo Pharmaceuticals™ Receives Approval from German Regulatory Authorities to Conduct Pennsaid® 2% Phase 3 Trial for Treatment of Acute Ankle Sprains - Trial Results Expected Q2 2017 - MISSISSAUGA, ON, Oct. 17, 2016 /CNW/ - Nuvo Pharmaceuticals Inc. (TSX: NRI), (Nuvo or the Company), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today announced it has received approval from the German Federal Institute for Drugs and Medical Devices and Ethical Review Committee to conduct a placebo controlled Phase 3 trial of Pennsaid 2% for the treatment of acute ankle sprains (the Trial). The 130 patient Trial will be conducted in Germany commencing this month. Topline results are expected to be available in Q2 2017. The Trial is intended to support regulatory applications for marketing approval of Pennsaid 2% in the E.U., Canada and Australia. "We are excited to get this Trial underway as it is part of our strategy to expand the Pennsaid 2% brand globally," said John London, Nuvo's President and CEO. "Although many jurisdictions will base their regulatory approval of Pennsaid 2% on its current FDA approval, the E.U., Canada and Australia require a successful Phase 3 study to support our applications for approval. We are in ongoing discussions with a number of potential international licensing partners that have the commercial capabilities to effectively market Pennsaid 2% in their respective jurisdictions." About the Trial The Trial will be conducted in Germany and will enroll approximately 130 patients who have suffered a grade I or grade II ankle sprain as assessed by the investigator within 12 hours of injury. Patients will then be randomly assigned on a double-blind basis to an active arm or a placebo arm and will apply either Pennsaid 2% or a placebo consisting of a topical vehicle that includes all of the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium, to their injured ankle twice a day for 8 days. The patients will return to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment. The primary endpoint for the Trial will be reduction in pain on movement (POM) at day 3. The Trial will measure a number of secondary endpoints including tenderness, ankle function, ankle swelling, overall assessment of benefit and satisfaction and use of rescue medication. The Trial will cost approximately CDN$1.5 million spread over the second half of 2016 and the first half of 2017. About Pennsaid 2% Pennsaid 2% is topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium. It is approved by the U.S. Food and Drug Administration (FDA) for treating the pain of osteoarthritis of the knee(s). Pennsaid 2% is a gel formulation that is supplied in a metered dose pump bottle. It is the only topical NSAID approved by the FDA for twice daily dosing. Pennsaid 2% is protected by multiple U.S. patents that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database or Orange Book. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories. Pennsaid 2% has not yet received regulatory approval outside of the U.S. About Nuvo Pharmaceuticals Inc. Nuvo (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch. Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ:HZNP) and is available for partnering in certain other territories around the world. Nuvo manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA, Health Canada and EU approved manufacturing facility in Varennes, Québec. For additional information, please visit www.nuvopharmaceuticals.com.
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