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10-Jul-2019

Newron's commercialization partner Zambon and Valeo Pharma announce the launch of Onstryv(R) (safinamide) for Parkinson's disease in Canada

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Market launch

10.07.2019 / 17:35
The issuer is solely responsible for the content of this announcement.


Newron's commercialization partner Zambon and Valeo Pharma announce the launch of Onstryv(R) (safinamide) for Parkinson's disease in Canada

Milan, Italy and Montreal, Quebec - July 10, 2019 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5.XE), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, is pleased to report that its partner Zambon S.p.A. and Valeo Pharma Inc. announced today the launch of Onstryv(R) (safinamide) for the treatment of Parkinson's disease in Canada.

"This marks another key milestone for Newron and its commercial partners in providing availability of safinamide in Canada for the treatment of patients suffering from Parkinson's disease," commented Newron CEO Stefan Weber. "Now, with the Canadian launch, safinamide is available across the North American region."

The full text of the announcement from Zambon S.p.A and Valeo Pharma Inc. is as follows:


Valeo Pharma Announces the Canadian Launch of Onstryv(R) (Safinamide Tablets) for the Treatment of Parkinson's Disease

  • First new oral treatment for Parkinson's Disease approved in over a decade
  • Parkinson's Disease affects a growing number of Canadians with over 100,000 currently afflicted
  • Total Canadian market for Parkinson's Disease drugs exceeds $100 million per year

 

MONTREAL, QUEBEC, July 10, 2019 - Valeo Pharma Inc. (CSE:VPH) ("Valeo"), a Canadian specialty pharmaceutical company with a primary focus on Neurodegenerative Diseases and Oncology, today announced the launch of Onstryv(R) (safinamide tablets) for the treatment of patients suffering from Parkinson's Disease in Canada. Valeo has the exclusive rights to commercialize Onstryv(R) in Canada under a license agreement signed with Zambon S.p.A.

Valeo announced the approval of Onstryv(R) by Health Canada, on January 15, 2019, as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson's Disease in patients experiencing "off" episodes.

Onstryv(R) is a prescription medication now available at pharmacies across Canada and comes in 50mg and 100mg tablets. Valeo's national sales team has launched a physician awareness and information campaign which is being supported by marketing and social media activities.

"The number of Canadians afflicted with Parkinson's Disease is expected to grow by more than 50% over the next decade as the Canadian population ages" said Steve Saviuk, Chief Executive Officer of Valeo. "Onstryv(R) is the first new oral treatment for Parkinson's Disease to be approved in Canada in well over a decade. Many patients experience progressive symptom difficulties with currently available treatments, and we are proud to bring a new option to address this growing need for Canadian patients. Valeo is committed to building and supporting relationships with healthcare professionals, patients and other stakeholders to build awareness and ensure access to this new treatment for Parkinson's Disease."

Roberto Tascione, CEO of Zambon said: "Since 1906, Zambon is committed to provide innovative medicines for patients and doctors and this launch is another significant step forward to fulfill our vision: Innovating Cure & Care to make patients' lives better. Right now, with this important milestone, Safinamide has been launched in 14 European Union countries, Switzerland, U.S.A, Australia and Canada and has recently been approved in Brazil and Colombia."

Parkinson's Disease is a progressive neurological disease involving the loss of dopamine-producing neurons in the brain. While tremors are the best-known symptom, Parkinson's Disease also causes other symptoms including slowed movement, rigid muscles, impaired posture and balance, speech and writing difficulties. On a per capita basis, Canada has amongst the highest incidences of Parkinson's Disease in the world and the number of patients is expected to grow significantly over the next thirty years as the median population age increases.

About Onstryv(R) (safinamide)

Safinamide, known as Onstryv(R) in Canada and Xadago(R) in the rest of the world, is a new chemical entity with a unique mode of action including selective and reversible MAO-B-inhibition. Clinical trials have established its efficacy in controlling motor symptoms and motor complications in the short term, maintaining this effect over 2 years. Results from 24-month double-blind controlled studies suggest that safinamide shows statistically significant effects on motor

fluctuations (ON/OFF time) without increasing the risk of developing troublesome dyskinesia. Onstryv(R) is a once-daily dose and has no diet restrictions due to its high MAO-B/MAO-A selectivity. Zambon acquired rights from Newron Pharmaceuticals (www.newron.com) to develop and commercialize Xadago(R) globally, excluding Japan and other key Asian territories where Meiji Seika Pharma has the rights to develop and commercialize safinamide. The rights to commercialize Xadago(R) in the USA have been granted to US WorldMeds, by Zambon.

About Valeo Pharma
Valeo Pharma is a specialty pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada. With a focus on Neurodegenerative Diseases, Oncology, Women's Health and Hospital Specialty Products, Valeo Pharma has a growing portfolio of innovative products and the full infrastructure to properly manage these products through all stages of commercialization. Headquartered in Kirkland, Quebec, Valeo Pharma has all capabilities internally to register and market health care solutions for Canadian patients. For more information, please visit www.valeopharma.com.

About Zambon
Zambon is a multinational pharmaceutical and fine-chemical company that focuses on innovation and development with the aim to improve the quality of people's health and patients' lives. Based on a valuable heritage but strongly focused on the future, its goal is to improve people's health through the development of innovative and quality medicines. Zambon products are commercialized in 86 countries. The company has 20 subsidiaries in three different Continents - Europe, America and Asia - and owns manufacturing units in Italy, Switzerland, France, China and Brazil. The company today has a strong focus on the treatment of rare diseases such as Cystic Fibrosis and specialties, such as Parkinson's disease, and it's well-established in 3 therapeutic areas: respiratory, pain and women's care. Zambon was established in 1906 in Italy and today counts around 2,700 employees all over the world. For details on Zambon please visit www.zambon.com


Forward Looking Statements

This press release contains forward-looking statements about Valeo's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or uinknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

 

For more information:

Media
Valeo Pharma
Steve Saviuk - President and CEO
Phone : +1 514 693-8830
Email : saviuk@valeopharma.com

Or

Luc Mainvile - Sr. Vice-President and CFO
Phone : +1 514 693-8854
Email : mainville@valeopharma.com

Or

Frederic Dumais - Director Communications and Investor Relations
Phone: 514-782-8803
Email: dumais@valeopharma.com


Zambon
Valentina Saffioti
Phone: +39 02 66524508
Mobile: +39 348 3486413
Email: valentina.saffioti@zambongroup.com

Italy
Cabiria Reina
Phone: +39 02 66524010
Mobile: +39 3480404321
Email: cabiria.reina@zambongroup.com
 

 

### End of Original Announcement ###

About Newron Pharmaceuticals

Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The company is headquartered in Bresso near Milan, Italy. Xadago(R) (safinamide) has received marketing authorization for the treatment of Parkinson's disease in the European Union, Switzerland, the US, Australia, Canada, Brazil, and Colombia and is commercialized by Newron's partner, Zambon. US WorldMeds holds the commercialization rights to Xadago(R) in the USA and Valeo to Onstryv(R) in Canada. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago(R) for Parkinson's disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For more information, please visit: www.newron.com

For more information about Newron, please contact:

Newron Pharmaceuticals
Stefan Weber - CEO
+39 02 6103 46 26
pr@newron.com

UK/Europe
Julia Phillips / Natalie Garland-Collins, FTI Consulting
+44 20 3727 1000
SCnewron@fticonsulting.com

Switzerland
Martin Meier-Pfister, IRF
+41 43 244 81 40
meier-pfister@irf-reputation.ch

Germany/Europe
Anne Hennecke, MC Services
+49 211 52925222
anne.hennecke@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience
+1 617 374 8800, Ext. 112
psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron's ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron's anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as "will," "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "target," and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not 5/5 actually achieve the plans, intentions or expectations disclosed in forward-looking statements, and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange, where the shares of Newron are listed. This announcement is not an offer for sale of

securities in the United States, Canada, Australia or Japan or any other jurisdiction where such an offer or solicitation would otherwise be unlawful. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Newron does not intend to register any of its securities in the United States or to conduct a public offering of its securities in the United States. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of this document shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.



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Last Updated: 10-Jul-2019