Ipsen announces positive results from phase IIa clinical study of Dysport® in the treatment of patients with Neurogenic Detrusor Overactivity (NDO)

Regulatory News:

Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today announced positive results from its phase IIa clinical trial assessing Dysport® in the treatment of Neurogenic Detrusor Overactivity (NDO) in patients with urinary incontinence not adequately managed by anticholinergics.

Results show that treatment with Dysport® was associated with a mean reduction from baseline of urinary incontinence episodes greater than 75%, 12 weeks after the injection, regardless of how the drug is administered. These results were achieved with a single dose of Dysport® 750 Units injected in either 15 or 30 sites in the detrusor muscle. Efficacy was confirmed by improvement in urodynamic parameters and quality of life. The safety profile observed in the study is consistent with the safety profile expected in this indication.

Claude Bertrand, Executive Vice-President R&D, Chief Scientific Officer of Ipsen said: “These results are very encouraging for the Dysport® franchise, which has the opportunity of potentially expanding into urology, a core therapeutic area for Ipsen”. Claude Bertrand added: “We are excited about the potential benefits Dysport® could bring to patients suffering from NDO”.

About Dysport®

Dysport® is an injectable form of botulinum toxin type A (BTX-A), which is isolated and purified from Clostridium BTX-A bacteria. It is formulated as a complex of BTX-A with haemagglutinin, a large therapeutically inert protein used to stabilise the toxin. Dysport® is formulated with lactose (Ph Eur/NF) and human serum albumin (Ph Eur/USP) and is supplied as a lyophilised powder.

Dysport® was first registered for the treatment of blepharospasm and hemifacial spasm in the United Kingdom (UK) 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), paediatric spasticity due to cerebral palsy (CP), axillary hyperhidrosis, and glabellar lines. Dysport® is not currently approved in any country for the treatment of NDO.

About Neurogenic Detrusor Overactivity (NDO)

NDO is a chronic condition defined by abnormal bladder contractions related to an underlying neurological condition such as multiple sclerosis (MS) or spinal cord injury (SCI). Current standard of care includes self-catheterisation or oral anticholinergic medications that present frequent side-effects and insufficient efficacy on the long term. In case of inadequate treatment response to anticholinergics, a botulinum toxin-A is indicated, before considering rescue treatments such as neuromodulation or bladder augmentation surgery in refractory cases.

About the phase IIa clinical trial

This phase IIa, multinational, randomised, placebo-controlled study aimed to investigate the efficacy and safety of one cycle of a single dose of 750 U Dysport® in 47 patients with NDO secondary to Multiple Sclerosis (MS) or Spinal Cord Injury (SCI). Follow-up duration was of 96 days. The primary endpoint was the mean change from baseline in daily urinary incontinence episodes frequency 12 weeks after the injection for each administration mode, i. e. 15 or 30 injections points at a constant volume by injection site. Secondary endpoints included other clinical endpoints, urodynamic measurements, and safety.

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.

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