Movapo® (apomorphine hydrochloride) for Patients with Advanced Parkinson's Disease Now Reimbursed in Most Canadian Provinces

MONTREAL, Oct. 23, 2019 /CNW/ -- Paladin Labs Inc., a subsidiary of Endo International plc (NASDAQ: ENDP), today announced that patients diagnosed with advanced Parkinson's disease (PD) living in Alberta, Manitoba, New Brunswick, Nova Scotia, Ontario, Quebec and Saskatchewan will now have access to Movapo^® if they meet certain reimbursement criteria for the treatment of sudden loss of control of body movements (a condition called hypomobility or  "off" episodes).  Movapo^® is an injection that is taken along with other oral drugs for the treatment of PD.

Please visit the links below to the respective provincial formularies to see the exact criteria:

• Alberta: https://idbl.ab.bluecross.ca/idbl/drugDetails?_cid=e42ae784-558a-4f73-a6e7-8289292c0462&id=0000084605&intchg_grp_nbr=1&detailId=594965
• Manitoba: https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin105.pdf  
• New Brunswick: https://www2.gnb.ca/content/dam/gnb/Departments/h-s/pdf/en/NBDrugPlan/NewBrunswickDrugPlansFormulary.pdf
• Nova Scotia: https://novascotia.ca/dhw/pharmacare/documents/formulary.pdf
• Ontario: http://health.gov.on.ca/en/pro/programs/drugs/docs/frequently_requested_drugs.pdf
• Quebec: http://www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/2019/liste_med_2019_08_15_fr.pdf
• Saskatchewan: http://formulary.drugplan.ehealthsask.ca/SearchFormulary/BG/555262 

"We are pleased to announce that Movapo^® is now eligible for reimbursement in the majority of Canadian provinces as an adjunct therapy for patients with advanced Parkinson's disease that are experiencing hypomobility or 'off' episodes," said Livio Di Francesco, Vice President & General Manager of Paladin Labs Inc. "Paladin Labs is committed to supporting the needs of Canadian patients and caregivers dealing with this condition which includes public access to this meaningful product."

About MOVAPO^®

Movapo^® (apomorphine hydrochloride 10 mg/mL) is currently the only adjunct therapy approved in Canada for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced PD taking oral medications for the treatment of PD.ⁱ It is an intermittent subcutaneous injection that is given as an adjunct to oral medications used for the treatment of PD.  Movapo^® is a registered trademark of Britannia Pharmaceuticals Limited.

About Parkinson's Disease

Parkinson's disease (PD) is a progressive, neurodegenerative disease that involves impaired motor functions and generally affects individuals greater than 50 years of age.  The characteristic features of PD include resting tremor, rigidity, bradykinesia, and postural instability leading to loss of control of voluntary movement. The impairment in motor functions may worsen over time, resulting in debilitating disability by 10 to 15 years after onset.  Patients in advanced-stage PD often present with dyskinesia and motor fluctuations, which may manifest as unpredictable "off" times (immobility/hypomobility), unpredictable "on/off" fluctuations, and "end-of-dose wearing off" episodes. "Off" times can involve problems in breathing and swallowing in addition to rigidity, dystonia, tremor, and freezing. Patients frequently report an increase in daily "off" time and concomitant shortening of "on" time as the disease progresses. Patient and caregiver quality of life is therefore severely affected, as maintaining a social life and performing daily activities, work, household chores, and recreational activities become difficult or impossible and require significant planning and dependence on caregivers. A PD patient group survey identified that 70% of respondents have experienced "off" periods with their existing medications.ⁱⁱ

About Paladin Labs Inc.

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin is an operating company of Endo International plc (NASDAQ: ENDP), a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Learn more at www.endo.com or www.paladin-labs.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including the statements by Mr. Di Francesco and other statements relating to reimbursement for Movapo^®, within the meaning of the Private Securities Litigation Reform Act of 1995 and the relevant Canadian securities legislation. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward- looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward- looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with securities regulators in the United States and Canada including under the caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and with securities regulators in Canada on System for Electronic Document Analysis and Retrieval ("SEDAR") and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in forward-looking statements contained in Endo's Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause Endo's actual results to differ materially from expected and historical results. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities law.

ⁱ Movapo Product Monograph Nov 21, 2016
ⁱⁱ CADTH Common Drug Review – Clinical Review Report – Apomorphine Hydrochloride (Movapo).  https://www.cadth.ca/sites/default/files/cdr/clinical/SR0527_Movapo_CL_Report.pdf .  Accessed April 18, 2019

SOURCE Endo International plc

For further information: Endo International plc: Media: Heather Zoumas-Lubeski, [phone], [email protected]; Investors: Pravesh Khandelwal, [phone], [email protected], http://www.endo.com

Related Links

http://www.endo.com