BASKING RIDGE, N.J.--(BUSINESS WIRE)--Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), today announced that Donald Pearl has joined the company as Vice President of Neurology. Mr. Pearl will work closely with senior leadership to build out the neurology commercial structure in the U.S. as Ipsen builds upon its 20 years of clinical experience with Dysport® (abobotulinumtoxinA) and pursues a comprehensive and ambitious neurotoxin clinical study program.
Mr. Pearl joins Ipsen from SkinMedica, an Allergan Company, where he was recently Vice President, International Sales and Marketing. His 25-year career also includes positions of increasing responsibility in neurology sales and marketing. His experience spans selling pharmaceuticals, surgical devices and topical skincare, leading U.S. and international sales and marketing teams, corporate account management, leading reimbursement policy and access teams and sales operations.
"With neurology as one of our three strategic focus areas, and our continuing commitment to cutting edge clinical trials investigating the efficacy and safety of Dysport® in potential new patient populations, Donald's experience and expertise in the field of neurotoxins will bolster our plans for growth in that category," said Cynthia Schwalm, President and CEO, Ipsen Biopharmaceuticals, Inc. "Using highly innovative R&D platforms focused on peptides and toxins, Ipsen remains committed to developing new formulations and new toxins that will considerably expand the spectrum of clinical applications and better address patients' needs."
Mr. Pearl's sales and marketing experience includes launch support for BOTOX® (onobotulinumtoxinA), such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in cervical dystonia, upper limb and lower limb spasticity, hyperhidrosis, juvenile cerebral palsy, chronic migraines and incontinence due to neurogenic detrusor overactivity. He also played a significant role partnering with Managed Markets, Government Affairs and Healthcare Policy regarding toxin utilization policies, and has extensive experience in training neurology and physical medicine and rehabilitation field forces. Mr. Pearl holds a Bachelors degree from Rutgers College and a Certificate in Healthcare Management from New York University. Donald Pearl is a retired U.S. Army Infantry Officer with experience at the Battalion, Brigade and Division levels.
About Dysport® (abobotulinumtoxinA)
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®'s is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.
Important Safety Information about Dysport®
Warning: Distant spread of toxin effect
Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
Dysport is contraindicated in patients with hypersensitivity to any botulinum toxin product or its excipients, including human albumin, lactose, and cow's milk protein, or who have an infection at the proposed injection site.
Lack of interchangeability between botulinum toxin products
The potency Units of Dysport are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of Dysport cannot be compared to or converted into Units of any other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded.
Dysphagia and breathing difficulties
Immediate medical attention may be required in cases of respiratory, speech, or swallowing difficulties. Dysphagia may persist for several weeks, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.
Pre-existing neuromuscular disorders
Patients with neuromuscular disorders should be monitored particularly closely when given botulinum toxin as they may be at increased risk of clinically significant effects, including severe dysphagia and respiratory compromise from typical doses.
Dysport contains human albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases or Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD have ever been identified for albumin.
The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established.
Patients receiving concomitant treatment of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated. Use of anticholinergic drugs may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxins during the course of treatment with Dysport is unknown.
Based on animal data, may cause fetal harm. Dysport should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Care should be exercised when administering Dysport to elderly patients, reflecting the greater frequency of concomitant disease and other drug therapy.
The most commonly observed adverse reactions (>5% of patients) with Dysport for the treatment of cervical dystonia are muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-877-397-7671.
You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information for Dysport available at http://www.dysport.com/hcp/PDFs/Dysport_Patients_PI_Sept2013.pdf
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding EUR1.2 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 EUR260 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, visit www.ipsen.com.
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