Ipsen Announces Health Canada Approval of DYSPORT THERAPEUTIC™ (abobotulinumtoxinA) for the Treatment of Patients with Cervical Dystonia and Adult Upper Limb Spasticity

Ipsen Biopharmaceuticals Canada (CNW Group/Ipsen Biopharmaceuticals Canada Inc.)

MISSISSAUGA, ON, March 14, 2017 /CNW/ - Ipsen Biopharmaceuticals Canada Inc., the Canadian affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Health Canada has approved DYSPORT THERAPEUTIC™ (abobotulinumtoxinA) for the treatment of patients with cervical dystonia (CD) and adult upper limb spasticity (ULS).

"ULS and CD have a profound impact on the ability of thousands of Canadians to perform daily life tasks," said Dr. Alfonso Fasano, a neurologist at Toronto Western Hospital, Clinician Investigator at Krembil Research Institute and Associate Professor at the Faculty of Medicine of University of Toronto.

"I am encouraged by the results of the clinical trials. Having another option with evidence demonstrating an impact on treatment timing and outcomes is truly welcome."

CD is a chronic neurological condition characterized by involuntary contractions of certain muscles of the neck resulting in abnormal, sustained and painful postures of the head, neck, and shoulders.ⁱ Dystonia, in all its many forms, affects about 50,000 Canadians.ⁱⁱ 

Spasticity is involuntary over-activity of muscles, most commonly occurring in adults after a stroke. In fact, about 10 per cent of stroke patients develop some form of spasticity within six months.ⁱⁱⁱ It can also result from other injuries to the central nervous system, including spinal cord injury, traumatic brain injury, as well as from diseases such as multiple sclerosis or cerebral palsy. Adult ULS can cause deformity, pain and reduced function.^iv

Promising news for the patient community
"Canadians with adult ULS can suffer real detriment to their quality of life because of pain and loss of movement," said Donna MacKay, National Associate Director of the March of Dimes. "In an international study, 72 per cent of patients with spasticity reported that it had a significant impact on their quality of life. Health Canada's approval of DYSPORT THERAPEUTIC™ will give hope to those who have been seeking new treatment options."

"We are very gratified with the news, as Health Canada's approval means Canadians will have access to a new treatment option for dystonia," said Stefanie Ince, Executive Director of the Dystonia Medical Research Foundation (DMRF) Canada.

"Our team is very proud to bring this important new treatment option to patients in need throughout Canada. The approval and launch of DYSPORT THERAPEUTIC™ expands Ipsen's commercial footprint in Canada and is Level I scientific evidence-based medicine at its best, meeting the Canadian healthcare system reference standards," said Lyndal Walker, Country Manager for Ipsen Biopharmaceuticals Canada, Inc.

ABOUT THE CLINICAL TRIALS

DYSPORT THERAPEUTIC™ and CD
Regulatory approval of DYSPORT THERAPEUTIC™ for the treatment of cervical dystonia is based on the results from two Phase III studies.^v,vi The principal analyses provide the primary demonstration of efficacy involving 252 cervical dystonia patients aged 18 years and older.  In those trials, DYSPORT THERAPEUTIC™ was statistically significantly more effective than placebo in reduction of the Toronto Western Spasmodic Torticollis Rating Score (TWSTRS) total score in subjects with cervical dystonia four weeks after treatment.  The TWSTRS evaluates the severity of dystonia, patient perceived disability from dystonia and pain.  Both of these clinical studies were followed by open label repeated treatment studies where retreatment was determined by clinical need after a minimum of 12 weeks. The median time to retreatment was 14 weeks. The safety profile observed in these studies was consistent with the known safety profile of DYSPORT THERAPEUTIC™.^vii 

DYSPORT THERAPEUTIC™ and Spasticity
Regulatory approval of DYSPORT THERAPEUTIC™ for the treatment of adult ULS is based on the results from an international Phase III study.^viii The Phase III study was the first registration study to evaluate ULS treatment in adult patients with both stroke and traumatic brain injury, with 238 adult patients participating for up to one year. The trial showed that those treated with DYSPORT THERAPEUTIC™ demonstrated statistically significant improvement in muscle tone measured by the Modified Ashworth Scale (MAS) as compared to placebo at week 4.  DYSPORT THERAPEUTIC™ significantly reduced muscle tone as measured by MAS in all primary target muscle groups, which included elbow, wrist, and finger muscles, with approximately 3 out of 4 patients responding to DYSPORT THERAPEUTIC™.  A majority of the patients in the clinical study were retreated between 12 and 16 weeks as determined by clinical need after a minimum of 12 weeks.   The safety profile observed in this study was again consistent with the known safety profile of DYSPORT THERAPEUTIC™.^viii

About DYSPORT THERAPEUTIC™ (abobotulinumtoxinA) 
DYSPORT THERAPEUTIC™ is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A. It is supplied as a lyophilized powder.

About Ipsen
Ipsen (Euronext: IPN; ADR: IPSEY) is a global specialty-driven pharmaceutical group. Its ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its fields of expertise in specialty care cover oncology, neurosciences and endocrinology. Ipsen's R&D centers are located in the heart of the leading biotechnological and life sciences hubs.

About Ipsen in North America
Ipsen Biopharmaceuticals, Inc. is the US affiliate of Ipsen, a global specialty driven pharmaceutical group. The US head office is located in Basking Ridge, New Jersey. Ipsen Biopharmaceuticals Canada, Inc. is an integrated affiliate within North America and has its head office located in Mississauga, Ontario. Ipsen Bioscience, Inc., the Ipsen US research and development center focused on peptide research in oncology and endocrinology, is located in Cambridge, Massachusetts. At Ipsen Bioscience, we focus on creating a highly cooperative and passionate R&D organization through partnerships, innovation, and continuous learning to effectively deliver new treatments for patients. At Ipsen Biopharmaceuticals, we focus our resources, investments, and energy on discovering, developing, and commercializing new therapeutic options for oncologic, neurologic, and endocrine diseases. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

DYSPORT THERAPEUTIC is a trademark of IPSEN BIOPHARM LTD

References:

ⁱDefazio G, Abbruzzese G, Livrea P, et al. Epidemiology of primary dystonia. Lancet Neurol 2004;3:673–678.
ⁱⁱ http://www.dystoniacanada.org/sites/dystoniacanada.org/files/2016-10/DMRF_WhatIsDystonia.pdf
ⁱⁱⁱ Rush R and Kumbhare D.  Spasticity. CMAJ  2015 187(6):436
^iv Shaw L and Rodgers H.  Botulinum toxin type A for upper limb spasticity after stroke.  Expert Rev. Neurother. 2009  9(12):1713-25
^v Truong D, Brodsky M, Lew M, et al.  Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia.  Parkinsonism and Related Disorders. 2010;16:316-323.
^vi Truong D, Duane DD, Jankovic J, et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005 Jul;20(7):783-91.
^vii DYSPORT THERAPEUTIC™ Product Monograph January 3, 2017
^viii Gracies J-M, Brashear A, Jech R et al.  Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury:a double-blind randomized controlled trial.  Lancet Neurol. 2015:14;992-1001.

SOURCE Ipsen Biopharmaceuticals Canada Inc.

For further information: Alanna Fox, Cohn & Wolfe, [e-mail], 647-259-3293