XADAGO® (Safinamide) Now Available in the U.S. for Parkinson’s Disease Patients

  • XADAGO (safinamide) is a once-daily tablet for Parkinson’s disease patients as an add-on to levodopa/carbidopa who are experiencing “off” episodes, providing “on” time without troublesome dyskinesia [involuntary movements].
  • XADAGO is the first New Chemical Entity (NCE) approved in the U.S. for motor fluctuations in Parkinson’s disease in more than a decade.
  • US WorldMeds has licensed XADAGO for U.S. distribution from Zambon, a pharmaceutical company based in Milan. XADAGO has been available since 2015 in the EU and is now sold in 12 countries.

XADAGO® (safinamide) tablets (Photo: Business Wire)

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MILAN & LOUISVILLE, Ky.--()--Alliance partners Newron Pharmaceuticals S.p.A. and Zambon S.p.A. based in Milan, and Louisville-based US WorldMeds announced today that XADAGO (safinamide) is now available as an add-on therapy for U.S. patients with Parkinson’s disease (PD) currently taking levodopa/carbidopa and experiencing “off” episodes. It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). XADAGO, a once-daily tablet, is the first New Chemical Entity approved in the U.S. for PD-related motor fluctuations in more than a decade for the estimated 1 million patients currently affected by PD.

According to the U.S. Food and Drug Administration (FDA), an “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. XADAGO is an inhibitor of monoamine oxidase B (MAO-B). Inhibition of MAO-B activity, by blocking the breakdown of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain.

Dr. Stuart Isaacson, MD, Director Boca Raton Institute for Neurodegenerative Disorders commented: “The approval of XADAGO offers an important new treatment option for the Parkinson’s community. XADAGO is the first New Chemical Entity approved for the treatment of PD-related motor fluctuations in the U.S. in over a decade. In clinical trials, patients on once-daily XADAGO demonstrated significant improvement in ‘on’ time without troublesome dyskinesia.”

The efficacy of XADAGO was shown in clinical trials with over 1100 PD patients who were taking levodopa/carbidopa and experiencing “off” time. Those receiving XADAGO experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome dyskinesia, compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a physician-assessed measure of motor function performed during “on” time than before treatment.

“We are very excited to be launching XADAGO,” said P. Breckinridge (“Breck”) Jones, CEO of US WorldMeds. “Part of US WorldMeds’ mission is to develop and market meaningful and accessible healthcare products that improve lives and result in a thriving community of patients. We are confident that XADAGO will progress that mission by providing a new treatment option to Parkinson’s patients."

The U.S. Food and Drug Administration (FDA) approved XADAGO, which is under license from Zambon S.p.A., a multinational specialty pharmaceutical company based in Milan. XADAGO has been available since 2015 in the EU and is now sold in 12 countries.

Zambon is proud to announce the U.S. market launch of XADAGO by our partner US WorldMeds, whose experience and commitment to Parkinson’s disease will bring value to patients in need of new treatment options,” said Roberto Tascione, CEO of Zambon.

US WorldMeds has licensed XADAGO from partner Zambon for distribution in the U.S. and partnered with Newron Pharmaceuticals S.p.A. (“Newron”, SIX: NWRN), a biopharmaceutical company focused on development of novel therapies for patients with diseases of the central nervous system and pain.

Stefan Weber, CEO of Newron Pharmaceuticals said: “We are proud to see XADAGO become the first FDA approved new chemical entity for Parkinson’s disease in more than 10 years. We believe XADAGO has the potential to significantly improve the quality of life of PD patients in the U.S., as it already has in many other countries around the world.

For more information about XADAGO (safinamide) in the U.S., visit www.XADAGO.com, or call 888-4-XADAGO (888-492-3246).

About XADAGO (safinamide)

Safinamide is a New Chemical Entity with a mechanism of action characterized by selective MAO-B-inhibition. Results from two double-blind, placebo-controlled, multinational, 6-month studies with over 1,100 patients revealed that safinamide provides a statistically significant increase in on time without troublesome dyskinesia, as well as a decrease in off time. Safinamide is a once-daily dose and has high MAO-B versus MAO-A selectivity. Safinamide is an add-on therapy to levodopa/carbidopa, and has not been shown to be effective when used alone. Zambon has the rights to develop and commercialize XADAGO globally, excluding Japan and other key territories where Meiji Seika has the rights to develop and commercialize the compound. The rights to develop and commercialize XADAGO in the U.S. have been granted to US WorldMeds, by Zambon. For more information about XADAGO in the U.S., visit www.XADAGO.com, or call 888-4-XADAGO or 888-492-3246.

References:
Borgohain R, et al. (2014) Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations. Mov Disord, 29: 229–237.

Schapira A, Fox S, Hauser R, et al. (2016) Assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with Parkinson disease and motor fluctuations. A randomized clinical trial. JAMA Neurology 2017 Feb 1;74(2):216-224. doi: 10.1001/jamaneurol.2016.4467

About Parkinson’s disease (PD)

PD is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals aged ≥ 65 years worldwide. The prevalence of the PD market is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. The diagnosis of PD is mainly based on observational criteria of muscular rigidity, resting tremor, or postural instability in combination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on L-dopa. L-dopa remains as the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitating motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, many patients experience involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the disease progresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symptoms while managing LID and the “off-time” effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopaminergic transmission that leads to amelioration of motor symptoms.

References:
BMC Oertel. European Handbook of Neurological Management, Vol1, Chapter 14 & 15, 2011. NICE PD guideline, 2006.

About US WorldMeds, LLC

US WorldMeds is a specialty pharmaceutical company that is inspired by the patients and communities where their treatment options are making a difference. US WorldMeds takes an entrepreneurial, agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US, WorldMeds has more than 15 years of experience in the development, licensure and commercialization of unique products designed to improve the lives of patients with challenging conditions and unmet medical needs, including Parkinson’s disease, cervical dystonia, malignant hyperthermia and more. For more information about US WorldMeds, visit www.usworldmeds.com.

About Zambon S.p.A.

Zambon is a leading Italian pharmaceutical and fine-chemical multinational group that has earned a strong reputation over the years for high quality products and services. Zambon S.p.A., the pharma company with €600 million sales in 2016, is well-established in 3 therapeutic areas: respiratory, pain and women’s health, and is very strongly committed to its entry into the CNS space with Xadago® (safinamide) for the treatment of Parkinson’s disease, and rare diseases with Promixin® in cystic fibrosis. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 19 countries with subsidiaries and almost 2,800 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 84 countries. For details on Zambon please see: www.zambongroup.com.

About Newron Pharmaceuticals S.p.A.

Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy, with a subsidiary in Morristown, NJ, USA. Xadago® (safinamide) has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland and the USA, and is commercialized by Newron’s partner Zambon. US WorldMeds holds the commercialization rights in the USA. In addition to Xadago® 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. www.newron.com.

Important Safety Information

XADAGO (safinamide) is a type of prescription medicine known as a monoamine oxidase type B (MAO-B) inhibitor used with levodopa/carbidopa to treat adults with Parkinson’s disease (PD) who are having off episodes.

It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). It is not known if XADAGO is safe and effective in children.

Tell your physician if you are taking, or planning to take, any prescription or over-the-counter drugs.

  • Do not take XADAGO if you are taking other monoamine oxidase inhibitors (MAOIs), as it could cause a sudden severe increase in your blood pressure.
  • The combination of MAO-B inhibitors such as XADAGO and antidepressants has resulted in a serious and sometimes fatal condition called serotonin syndrome.
  • Do not take XADAGO with opioid medications including meperidine, tramadol, methadone, or propoxyphene, as this could result in serious, sometimes fatal, reactions.
  • Also, do not take XADAGO with amphetamine, cyclobenzaprine, methylphenidate, or St. John’s wort. Taking these drugs together can also result in serotonin syndrome, which could be fatal.
  • Do not use XADAGO with dextromethorphan, as this has been reported to cause episodes of psychosis or abnormal behavior.

Do not use XADAGO if you have hypersensitivity to safinamide, as this can cause swelling of the tongue and mouth and trouble breathing.

You should not take XADAGO if you have severe liver disease. Do not exceed a dose of 50 mg per day of XADAGO if you have moderate liver disease.

During treatment with XADAGO you may experience increases in blood pressure. Inform your physician if you have a history of high blood pressure. Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, confusion, seizures, shortness of breath, severe anxiety, and nausea and vomiting. Contact your doctor or seek immediate medical attention if you experience any of these symptoms.

Some patients treated with XADAGO experienced drowsiness or sudden onset of sleep. Do not drive, operate heavy machinery, work in high places or do other dangerous activities until you know how XADAGO affects you.

Restriction of foods and beverages containing tyramine is usually not required when treated with the recommended doses of XADAGO. However, it is recommended that you avoid foods containing high amounts of tyramine, such as aged cheeses, as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure.

The most common side effects seen with XADAGO are uncontrolled movements (dyskinesia), falls, nausea, and insomnia.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-492-3246 (1-888-4XADAGO). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Patient Information on www.XADAGO.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 commercialization 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 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 programs, development activities, commercialization 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 up-date 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 document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Contacts

Media
US WorldMeds – XADAGO inquiries for the U.S.
Edelman | Health
Lara Blosser, +1 404-443-7393
lara.blosser@edelman.com
or
Zambon - Italy
Milva Naguib, +39 02 66524095
Mobile: +39 3459215675
milva.naguib@zambongroup.com
or
Newron
Stefan Weber, +39 02 6103 46 26
CEO
pr@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
or
Switzerland
IRF Communications
Martin Meier-Pfister, +41 43 244 81 40
or
Germany
MC Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
Newron/Zambon
Public Relations - U.S.
LaVoieHealthScience
Andrew Mastrangelo, +1 617-374-8800, Ext. 108
amastrangelo@lavoiehealthscience.com
or
Investors and Analysts
Newron
Stefan Weber, +39 02 6103 46 30
CEO
ir@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
or
Germany/Europe
MC Services AG
Anne Hennecke, + 49 211 52925222
anne.hennecke@mc-services.eu
or
Newron/Zambon
Public Relations - U.S.
LaVoieHealthScience
Beth Kurth, +1 617-374-8800, Ext. 106
bkurth@lavoiehealthscience.com

Release Summary

Newron Pharmaceuticals, Zambon and US WorldMeds announced today that XADAGO® (safinamide) is now available for U.S. Parkinson's disease patients.

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Contacts

Media
US WorldMeds – XADAGO inquiries for the U.S.
Edelman | Health
Lara Blosser, +1 404-443-7393
lara.blosser@edelman.com
or
Zambon - Italy
Milva Naguib, +39 02 66524095
Mobile: +39 3459215675
milva.naguib@zambongroup.com
or
Newron
Stefan Weber, +39 02 6103 46 26
CEO
pr@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
or
Switzerland
IRF Communications
Martin Meier-Pfister, +41 43 244 81 40
or
Germany
MC Services AG
Anne Hennecke, +49 211 52925222
anne.hennecke@mc-services.eu
or
Newron/Zambon
Public Relations - U.S.
LaVoieHealthScience
Andrew Mastrangelo, +1 617-374-8800, Ext. 108
amastrangelo@lavoiehealthscience.com
or
Investors and Analysts
Newron
Stefan Weber, +39 02 6103 46 30
CEO
ir@newron.com
or
UK/Europe
FTI Consulting
Julia Phillips, +44 (0)20 3727 1000
or
Germany/Europe
MC Services AG
Anne Hennecke, + 49 211 52925222
anne.hennecke@mc-services.eu
or
Newron/Zambon
Public Relations - U.S.
LaVoieHealthScience
Beth Kurth, +1 617-374-8800, Ext. 106
bkurth@lavoiehealthscience.com