Ipsen Biopharmaceuticals has entered an exclusive three-year agreement with Saol Therapeutics to promote Dysport (abobotulinumtoxinA), a therapy indicated for injection in adults with spasticity and in children with lower limb spasticity – common in amyotrophic lateral sclerosis (ALS) patients.
Under the agreement, Saol will set up a sales team to promote Dysport in U.S. hospitals starting in August 2017. Ipsen will also maintain its sales representatives, but additional details have not yet been disclosed.
Dysport is the only botulinum toxin approved by the U.S. Food and Drug Administration (FDA) for the treatment of lower limb spasticity in children ages 2 and older. The FDA approved Dysport in July 2015 as a treatment for upper-limb spasticity in adults and in July 2016 for lower-limb spasticity in children 2 and older.
In June this year, the FDA expanded the approval of Dysport to include the treatment of adults with lower-limb spasticity, as well.
The drug was developed as an injectable form of botulinum toxin type A (BoNT-A), which stems from BoNT-A-producing Clostridium bacteria. The FDA has also approved Dysport for the treatment of other indications in the U.S., including spasticity and cervical dystonia (CD).
“As the only botulinum toxin approved by the FDA for the treatment of spasticity in adults 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,” Cynthia Schwalm, president of Ipsen’s North American commercial operations, said in a press release.
“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,” she said.
Like all botulinum toxin products, Dysport has a boxed warning stating that the effects of the drug may spread from the area of injection to other areas of the body, which could cause symptoms similar to those of botulism. For this reason, Dysport is not indicated for patients with known hypersensitivity to any botulinum toxin preparation or to any of its components.
Dysport should also be avoided in case of an existing infection at the proposed injection site or in patients known to be allergic to cow’s milk protein. Read full prescribing information here.
“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 David Penake, Saol’s CEO.
“Our agreement with Ipsen helps us in that mission,” he added. “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.”
Saol currently markets Lioresal Intrathecal (baclofen injection) for the treatment of severe spasticity. Intrathecal administration requires an injection in the spinal canal. Lioresal was the first intrathecal baclofen approved by the FDA for the treatment of severe spasticity.