MISSISSAUGA, ON, Dec. 21, 2018 /PRNewswire/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI; OTCQX:NRIFF), a globally focused, healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today announced that its wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC (Nuvo Ireland) has entered into a license and supply agreement (License Agreement) with Heumann Pharma GmbH & Co. Generica KG (Heumann) for the exclusive right to distribute, market and sell Resultz® in Germany (the Territory). Heumann is headquartered in Nuremberg, Germany, and is part of the Torrent Pharma Group which has an international presence across 40 countries. Heumann is a large, well-established pharmaceutical company with a long history and a wide range of prescription and over-the-counter medicines.
"The agreement with Heumann, further demonstrates the Company's focus to maximize the value of Resultz through out-licensing to commercial partners in international markets," said Jesse Ledger, Nuvo's President & CEO. "Heumann's strong presence and expertise in providing OTC products to patients in Germany, makes them an ideal partner for Resultz."
License Agreement Details The License Agreement grants Heumann the exclusive rights to market, sell and distribute Resultz in the Territory. Resultz is approved in Germany as a class one medical device for the human treatment of head lice infestation. Nuvo Ireland will receive upfront consideration, milestone payments, royalties on net sales of Resultz in the Territory and will earn revenue from Heumann pursuant to an exclusive supply agreement. Resultz is currently manufactured by the Company's contract manufacturing partner in Belgium.
About Resultz Resultz is a pesticide-free pediculicide rinse that addresses the challenge of increasing pesticide resistance in lice and concerns about patient safety through exposure to pesticides. In as little as a 5-minute application (the shortest treatment time for head lice products), Resultz acts to disrupt the wax covering of the head louse resulting in their dehydration and death. Resultz lice and egg removal kit facilitates removal of lice, nymphs and nits with efficacy of up to 100% when used as directed. If necessary, a second application approximately 7-10 days later will eliminate any remaining lice. The Resultz lice and egg removal kit and its unique physical mechanism of action allows Resultz to work even with pesticide resistant super lice. Resultz is indicated for treating both children and adults. It has an excellent safety profile and contains active ingredients commonly found in many cosmetic products. Resultz was first launched as a medical device in the United Kingdom and Ireland in 2005 and more than ten million patients have been treated globally to-date. Current global licensees include Reckitt Benckiser Group PLC, Aralez Pharmaceuticals Inc. and Fagron Belgium NV. Resultz is also pending registration in Japan, where the local license is held by Sato Pharmaceutical Co. Ltd. Resultz is protected by a robust portfolio of 40 issued patents globally.
About Nuvo Pharmaceuticals Inc. Nuvo (TSX: NRI; OTCQX: NRIFF) is a globally focused, healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo has four commercial products that are available in a number of countries: Pennsaid® 2%, Pennsaid, Resultz and the heated lidocaine/tetracaine patch. Nuvo manufactures Pennsaid 2% for the U.S market, Pennsaid for the global market and the bulk drug product for the HLT Patch at its U.S. Food and Drug Administration (FDA), Health Canada and E.U. approved manufacturing facility in Varennes, Québec. The Company's focus is to maximize the value of Pennsaid 2% and Resultz through out-licensing to commercial partners in international markets and identifying new opportunities to acquire additional, revenue generating or late-stage products or businesses to further diversify the Company's existing product portfolio. For additional information, please visit www.nuvopharmaceuticals.com.
About Heumann Pharma GmbH & Co. Generica KG Founded in 1913, Heumann is a large, well-established pharmaceutical company with a long history and a wide range of prescription and over-the-counter medicines. Heumann has a large portfolio of prescription medicines with more than 160 active ingredients. This allows Heumann to cover a wide range of indications. In 2016, over 14 million packs of Heumann prescription medicines made it into the homes of patients. Heumann also offers affordable over-the-counter medicines, currently 27, to treat many common ailments such as headaches or colds. For additional information, please visit www.heumann.de.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Forward looking information in this press release includes, but is not limited to, statements with respect to the ability of the parties to complete the Aralez Transaction (the Transaction) and the financing arrangements with Deerfield (including the satisfaction of the conditions to completion of the Transaction and the financing arrangements with Deerfield) and the timeline for the closing of the Transaction. The forward-looking information contained in this press release is based on certain expectations and assumptions made by Nuvo, including the receipt of required approvals and the satisfaction of other conditions to the Transaction and the financing arrangements with Deerfield; and that the definitive agreements in respect of the Transaction and the commitment letter in respect of the financing arrangements with Deerfield will not be amended or terminated.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on the Company's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Nuvo's actual results and financial condition may differ materially from those indicated in the forward-looking statements due to a number of factors and risks. Material factors and assumptions used to develop the forward-looking information contained in this news release, and material risk factors that could cause actual results to differ materially from the forward-looking information, include but are not limited to, the failure to satisfy the conditions relating to the Transaction and the financing arrangements with Deerfield (including failure to obtain any required approvals, including the approval of the U.S. Court and the Ontario Court); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreements in respect of the Transaction or the commitment letter in respect of the financing arrangements with Deerfield; material adverse changes in the business or affairs of the acquired businesses or Nuvo; either party's failure to consummate the Transaction or the financing arrangements with Deerfield when required; competitive factors in the industries in which the acquired businesses and Nuvo operate; interest rates, prevailing economic conditions; and other factors, many of which are beyond the control of Nuvo. Additional factors that could cause Nuvo's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Nuvo's most recent Annual Information Form dated March 22, 2018 under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by Nuvo with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo'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 none of Nuvo or any other person assumes responsibility for the accuracy and completeness of these forward-looking statements.
Any forward-looking statement made by the Company in this press release is based only on information currently available to it and speaks only as of the date on which it is made. Except as required by applicable securities laws, Nuvo undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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"The agreement with Heumann, further demonstrates the Company's focus to maximize the value of Resultz through out-licensing to commercial partners in international markets," said Jesse Ledger, Nuvo's President & CEO. "Heumann's strong presence and expertise in providing OTC products to patients in Germany, makes them an ideal partner for Resultz."
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License Agreement Details The License Agreement grants Heumann the exclusive rights to market, sell and distribute Resultz in the Territory. Resultz is approved in Germany as a class one medical device for the human treatment of head lice infestation. Nuvo Ireland will receive upfront consideration, milestone payments, royalties on net sales of Resultz in the Territory and will earn revenue from Heumann pursuant to an exclusive supply agreement. Resultz is currently manufactured by the Company's contract manufacturing partner in Belgium.
About Resultz Resultz is a pesticide-free pediculicide rinse that addresses the challenge of increasing pesticide resistance in lice and concerns about patient safety through exposure to pesticides. In as little as a 5-minute application (the shortest treatment time for head lice products), Resultz acts to disrupt the wax covering of the head louse resulting in their dehydration and death. Resultz lice and egg removal kit facilitates removal of lice, nymphs and nits with efficacy of up to 100% when used as directed. If necessary, a second application approximately 7-10 days later will eliminate any remaining lice. The Resultz lice and egg removal kit and its unique physical mechanism of action allows Resultz to work even with pesticide resistant super lice. Resultz is indicated for treating both children and adults. It has an excellent safety profile and contains active ingredients commonly found in many cosmetic products. Resultz was first launched as a medical device in the United Kingdom and Ireland in 2005 and more than ten million patients have been treated globally to-date. Current global licensees include Reckitt Benckiser Group PLC, Aralez Pharmaceuticals Inc. and Fagron Belgium NV. Resultz is also pending registration in Japan, where the local license is held by Sato Pharmaceutical Co. Ltd. Resultz is protected by a robust portfolio of 40 issued patents globally.
About Nuvo Pharmaceuticals Inc. Nuvo (TSX: NRI; OTCQX: NRIFF) is a globally focused, healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo has four commercial products that are available in a number of countries: Pennsaid® 2%, Pennsaid, Resultz and the heated lidocaine/tetracaine patch. Nuvo manufactures Pennsaid 2% for the U.S market, Pennsaid for the global market and the bulk drug product for the HLT Patch at its U.S. Food and Drug Administration (FDA), Health Canada and E.U. approved manufacturing facility in Varennes, Québec. The Company's focus is to maximize the value of Pennsaid 2% and Resultz through out-licensing to commercial partners in international markets and identifying new opportunities to acquire additional, revenue generating or late-stage products or businesses to further diversify the Company's existing product portfolio. For additional information, please visit www.nuvopharmaceuticals.com.
About Heumann Pharma GmbH & Co. Generica KG Founded in 1913, Heumann is a large, well-established pharmaceutical company with a long history and a wide range of prescription and over-the-counter medicines. Heumann has a large portfolio of prescription medicines with more than 160 active ingredients. This allows Heumann to cover a wide range of indications. In 2016, over 14 million packs of Heumann prescription medicines made it into the homes of patients. Heumann also offers affordable over-the-counter medicines, currently 27, to treat many common ailments such as headaches or colds. For additional information, please visit www.heumann.de.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Forward looking information in this press release includes, but is not limited to, statements with respect to the ability of the parties to complete the Aralez Transaction (the Transaction) and the financing arrangements with Deerfield (including the satisfaction of the conditions to completion of the Transaction and the financing arrangements with Deerfield) and the timeline for the closing of the Transaction. The forward-looking information contained in this press release is based on certain expectations and assumptions made by Nuvo, including the receipt of required approvals and the satisfaction of other conditions to the Transaction and the financing arrangements with Deerfield; and that the definitive agreements in respect of the Transaction and the commitment letter in respect of the financing arrangements with Deerfield will not be amended or terminated.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on the Company's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Nuvo's actual results and financial condition may differ materially from those indicated in the forward-looking statements due to a number of factors and risks. Material factors and assumptions used to develop the forward-looking information contained in this news release, and material risk factors that could cause actual results to differ materially from the forward-looking information, include but are not limited to, the failure to satisfy the conditions relating to the Transaction and the financing arrangements with Deerfield (including failure to obtain any required approvals, including the approval of the U.S. Court and the Ontario Court); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreements in respect of the Transaction or the commitment letter in respect of the financing arrangements with Deerfield; material adverse changes in the business or affairs of the acquired businesses or Nuvo; either party's failure to consummate the Transaction or the financing arrangements with Deerfield when required; competitive factors in the industries in which the acquired businesses and Nuvo operate; interest rates, prevailing economic conditions; and other factors, many of which are beyond the control of Nuvo. Additional factors that could cause Nuvo's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Nuvo's most recent Annual Information Form dated March 22, 2018 under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by Nuvo with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo'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 none of Nuvo or any other person assumes responsibility for the accuracy and completeness of these forward-looking statements.
Any forward-looking statement made by the Company in this press release is based only on information currently available to it and speaks only as of the date on which it is made. Except as required by applicable securities laws, Nuvo undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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