PARIS, France I November 28, 2014 I Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) in the treatment of upper limb spasticity in adult patients.

The regulatory filing was based on a clinical Phase III study involving nearly 250 adult patients with upper limb spasticity. The international, multi-center, double-blind, randomized, placebo-controlled trial compared the efficacy of Dysport® versus placebo in hemiparetic patients following a stroke or brain trauma. The data showed that those treated with Dysport® demonstrated a statistically significant (p<0.0001) improvement in muscle tone and a higher clinical benefit, versus placebo. The safety profile observed in the study was consistent with the known safety profile of Dysport®.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated “The filing of Dysport® in adult upper limb spasticity is an important step in the reinforcement of the US neurology franchise.” Marc de Garidel added: “Upon FDA approval, Dysport® will become a new treatment option for adults who suffer from upper limb spasticity in the United States.”

Dysport® is approved for the treatment of upper limb spasticity in many international markets, but not in the United States (U.S.). Dysport®’s only approved therapeutic indication in the U.S. is for the treatment of adults with cervical dystonia (referred to as spasmodic torticollis in other markets). As such, data from the Phase III study in adults with upper limb spasticity are with respect to an investigational use of Dysport® in the U.S.

About the study

This phase III research study included 243 patients and was multicenter, prospective, double blind, randomised, and placebo-controlled. It was conducted in the USA, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary.

The purpose of this phase III study was to assess the efficacy of Dysport® compared to placebo in improving upper limb spasticity in hemiparetic patients following a stroke or a brain trauma. The study co-primary endpoints were the improvement of muscle tone in the treated upper limb measured by the Modified Ashworth Scale (MAS) and the clinical benefit for the patients assessed by the Physician Global Assessment (PGA). In addition, Dysport®’s efficacy was assessed on passive function as measured by the Disability Assessment Scale (DAS).

Patients were offered the option to continue in an open label long-term study where they would receive additional treatment with Dysport® for a total of 15 months.

About Dysport®

Dysport® is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium BoNT-A bacteria. It is supplied as a lyophilized powder.

Dysport® was first registered for the treatment of blepharospasm and hemifacial spasm in the United Kingdom in 1990, and is licensed in more than 75 countries for various indications including: blepharospasm, adult upper and lower limb spasticity, hemifacial spasm, spasmodic torticollis (ST) (previously referred to as cervical dystonia), pediatric lower limb spasticity due to cerebral palsy (CP), axillary hyperhidrosis, and glabellar lines.

Dysport® is approved for the treatment of upper limb spasticity in many international markets, but not in the United States (US). Dysport®’s only approved therapeutic indication in the United States (US) is for the treatment of adults with cervical dystonia (referred to spasmodic torticollis in other markets). As such, data from this study in adults with upper limb spasticity are with respect to an investigational use of Dysport® in the USA.

About Ipsen

Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2013. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen’s R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2013, R&D expenditure totaled close to €260 million, representing more than 21% of Group sales. Moreover, Ipsen also has a significant presence in primary care. The Group has close to 4,600 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.

SOURCE: Ipsen