Ipsen Announces Co-Promotion Agreement With Saol Therapeutics To Promote Dysport® (abobotulinumtoxinA) in the United States

Saol sales team to promote Dysport® for select approved therapeutic indications in U.S. hospitals

PARIS, France I June 30, 2017 I Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its US affiliate has entered into an exclusive, three-year agreement with Saol Therapeutics Inc. to promote Dysport® (abobotulinumtoxinA) for injection for approved therapeutic indications in adult spasticity and pediatric lower limb spasticity in the United States.

“By adding the Saol team's extensive experience with physicians in the hospital setting to our existing efforts, we are able to educate more U.S. healthcare professionals on Dysport®,” said Cynthia Schwalm, Executive Vice-President and President, North American Commercial Operations, Ipsen. “As the only botulinum toxin approved by the FDA for the treatment of spasticity in adult in upper and lower limbs, and also for the treatment of lower limb spasticity in children ages two and older, it is critical to raise awareness of Dysport® as a potential option for appropriate patients.”

Dysport® and all botulinum toxin products have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. Dysport® is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow's milk protein. The potency Units of Dysport® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products. Please see below for additional Important Safety Information.

Under the terms of the agreement, Saol’s sales force will promote Dysport® to healthcare professionals largely in the hospital setting beginning August 2017. Ipsen will maintain its current number of sales representatives fully dedicated to Dysport® including all its therapeutic indications. Additional details of the agreement are not disclosed.

Based in Roswell, GA, Saol Therapeutics is a privately held specialty pharmaceutical company focused on providing therapies to patients with unmet medical needs. The company has a strategic emphasis on spasticity and neurologic areas. Saol currently markets Lioresal® Intrathecal (baclofen injection), the first FDA-approved intrathecal baclofen for the treatment of severe spasticity. By detailing both products, Saol believes it can further support healthcare professionals and the patients they serve with forms of spasticity that each product is FDA approved to treat.

“At Saol, we are committed to the treatment of patients with spasticity. As a cornerstone to that, we believe it is important that physicians are made aware of available treatment options,” said Saol Therapeutics Chief Executive Officer, David Penake. “Our agreement with Ipsen helps us in that mission. It also allows us to align with a company that matches our passion for doing everything we can to support and educate physicians. We look forward to working with Ipsen and growing our organization, with the goal of helping patients in the United States.”

Please find included Important Safety Information – including BOX WARNINGS – for Dysport® and Lioresal® Intrathecal (baclofen injection).

About Dysport® (abobotulinumtoxinA) for Injection
Dysport® 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. Dysport® has approved indications in the United States for the treatment of adults with Cervical Dystonia (CD) and for the treatment of spasticity in adult patients. Dysport® is also the first and only FDA-approved botulinum toxin for the treatment of lower limb spasticity in pediatric patients two years of age and older.

About IPSEN CARES®
IPSEN CARES® (Coverage, Access, Reimbursement, & Education Support) is dedicated to ensuring patients, providers and caregivers have the resources needed to help access the Ipsen medications that are critical to managing their conditions. IPSEN CARES® is staffed Monday to Friday by experts who can assist with a broad range of medical, educational, logistical and coverage information regarding Ipsen medicines. Involving the entire treatment team that surrounds patients on a daily basis, IPSEN CARES® can provide benefits verification (research of a patient’s medical or pharmacy benefit insurance coverage); prior authorization information; a patient assistance program (free medications for uninsured patients); co-pay assistance programs for eligible patients; billing and coding support; coordination with specialty pharmacies. Additional information is also available by visiting (http://www.ipsencares.com).

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the United States

DYSPORT® INDICATIONS
Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:

  • Spasticity in adult patients
  • Adults with cervical dystonia
  • Lower limb spasticity in pediatric patients 2 years of age and older.

The safety and effectiveness of Dysport® injected into upper limb muscles or proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established.
Safety and effectiveness in pediatric patients with lower limb spasticity below 2 years of age have not been evaluated.
Safety and effectiveness in pediatric patients with cervical dystonia or upper limb spasticity have not been established.

About Ipsen in North America
Ipsen Biopharmaceuticals, Inc. is the US affiliate of Ipsen, a global specialty-driven biopharmaceutical group. The US head office is located in Basking Ridge, New Jersey. Ipsen Biopharmaceuticals Canada, Inc. is an integrated business unit within North America and has its head office located in Mississauga, Ontario. Ipsen Bioscience, Inc., the Ipsen US research and development center focused on the discovery of highly differentiated and competitive products in oncology and rare diseases, 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, 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.

About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.

SOURCE: Ipsen

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