Healthcare Industry News: dysphagia
News Release - November 5, 2014
Ipsen Biopharmaceuticals, Inc. Announces Hire of Donald Pearl as Vice President of Neurology25 years of experience in pharmaceuticals and biologics, including neurotoxins
BASKING RIDGE, N.J.--(Healthcare Sales & Marketing Network)--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.
“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.
Forward Looking Statements
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today.
Use of the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from Generics that might translate into a loss of market share.
Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfill their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law.
The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.
DYSPORT® is a registered trademark of IPSEN Biopharm Limited.
All other trademarks are property of their respective owners.
Source: Ipsen Biopharmaceuticals
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