New Leadership Team for Ipsen Operations in North America to Drive Growth in Neurology and Endocrinology

BASKING RIDGE, N.J.--(BUSINESS WIRE)--

Ipsen IPN US operations today announced that it completed the appointment of its nine-member US Leadership Team tasked with advancing business and commercialization activities for its specialty medicines, Somatuline^® Depot (lanreotide) Injection and Dysport^® (abobotulinumtoxinA) for Injection. These medicines treat, respectively, a rare hormonal growth disorder called acromegaly and the debilitating condition of cervical dystonia – orphan conditions each affecting fewer than 250,000 patients.¹ The executive appointments follow the recent relocation of Ipsen operations from California to New Jersey – a pivotal part of the Company's overall US market growth strategy.

“North America is a key market in Ipsen's growing international footprint. The quality of our new leadership team and the depth of New Jersey-based talent joining our Company are key to bringing our products in the US market to the level of success we have achieved elsewhere,” said Christophe Jean, Executive Vice President, Chief Operating Officer, Ipsen Group.

Ipsen appointments include senior marketing talent in specialty endocrinology and neurology – the company's two lead product categories – and pharmaceutical industry expertise in medical, regulatory, legal, ethics and compliance, and business operations functions.

Leadership Team appointments for Ipsen US operations are:

		•		Sean McKercher, President and General Manager, Ipsen, North America: In his role as President of Ipsen in North America, Sean McKercher is responsible for overseeing Ipsen regional business strategy and implementation. He reports to Christophe Jean, Executive Vice President and Chief Operating Officer, Ipsen Group.
				Mr. McKercher has more than 30 years' experience in the pharmaceutical industry, most recently serving as Senior Vice President of Corporate Business Development for Ipsen. In his previous role as Vice President, Commercial Development, Mr. McKercher was instrumental in executing the Ipsen commercial entry into the United States. Prior to joining Ipsen, Mr. McKercher held various leadership positions with Abbott Laboratories, including Commercial Director, Pacific/Asia/Africa Region; General Manager, South Africa and Africa Region; and General Manager for a number of US business areas.
		•		Anthony Venditti, Head, Endocrinology Franchise: In his role as Endocrinology Franchise Head, Anthony Venditti is responsible for the overall marketing, sales and franchise strategy efforts for the company's lead endocrinology product, Somatuline® Depot – indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option – as well as for Increlex® (mecasermin [rDNA origin] injection), the only FDA-approved treatment for severe primary IGF-1 deficiency, a rare condition of severe growth failure in children.
				Mr. Venditti has more than 30 years' experience in pharmaceutical and specialty product marketing and sales, most recently serving as Vice President, Marketing and Sales for Noven Pharmaceuticals. Prior to that, Mr. Venditti served as the Vice President of Marketing and Sales for Novartis Neuroscience and Novartis Transplant businesses and the Head of Marketing and Analytics for Novartis Oncology.
		•		Lisa Pilla, Head, Neurology Franchise: In her role as Neurology Franchise Head, Lisa Pilla is responsible for the overall marketing, sales and franchise strategy efforts for the company's lead neurology product, Dysport®, 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.
				Ms. Pilla brings to Ipsen more than 25 years' experience in pharmaceuticals in the areas of sales, marketing, new product commercialization and global marketing planning in primary care and specialty. She served most recently as Vice President and Business Unit Head, Neurology-Psychology Division, at Novartis Pharmaceuticals Corporation.
		•		Bill Soucie, Vice President, Market Access: In his role as Vice President of Market Access, Bill Soucie is responsible for overseeing the company's payer access strategies, channel operations, reimbursement services, and patient services for Ipsen endocrinology and neurology products.
				With 20 years of industry experience, Mr. Soucie brings to Ipsen a diversified background in establishing managed market functions across a wide range of pharmaceutical product areas. Prior to joining Ipsen, Mr. Soucie served as Head of Managed Markets and Payer Strategies for Nycomed US and Vice President, Managed Markets for Reliant Pharmaceuticals.
		•		Habib Ramdani, Chief Financial Officer and Vice President, Strategy: In his role as Chief Financial Officer and Vice President, Strategy, Habib Ramdani will oversee Ipsen financial activities and integrity as well as provide strategic oversight relating to the over-arching business in North America.
				Mr. Ramdani joined Ipsen in 2002 at its French Headquarters, and was instrumental in creating and developing the new Group Strategic Planning function. He was then appointed Corporate Strategic Planning Director and Secretary to the Executive Committee. Most recently, he served as Ipsen Group Controller where he oversaw Corporate Finance, and the Business Controlling, Consolidation and Accounting Departments. Prior to joining Ipsen, Mr. Ramdani was a consultant with the Boston Consulting Group.
		•		Cathryn Clary, MD, Senior Vice President, Medical and Regulatory Affairs: In her role as Senior Vice President, Medical and Regulatory Affairs, Cathryn Clary oversees commercial regulatory affairs, medical affairs activities, safety and pharmacovigilance. Dr. Clary has 15 years of industry experience, primarily in medical affairs. Prior to joining Ipsen in 2009 as head of US Drug Development and Medical Affairs, Dr. Clary served as Senior Vice President, US Medical at Pfizer, and led its US External Medical Affairs group.
		•		Deborah Moorer, Vice President, Human Resources: In her role as Vice President, Human Resources, Deborah Moorer oversees the strategic direction of all aspects of Human Resources for the company's new headquarters in New Jersey, and will be instrumental in shaping the company's culture and employee development initiatives. Ms. Moorer brings more than 20 years of HR experience to the role. Prior to joining Ipsen, Ms. Moorer served as Senior Vice President and Human Resources Advisor at Citibank and Vice President, Human Resources at Alpharma.
		•		Jennifer Benenson, Esq., Vice President and North American General Counsel: Jennifer Benenson brings 20 years' experience as counsel for the pharmaceutical industry to her role as Vice President and North American General Counsel. Prior to joining Ipsen, Ms. Benenson served as Vice President and General Counsel at Daiichi Pharmaceuticals for 10 years, Vice President of Legal Affairs at Dr. Reddy's Laboratories and was Vice President, Legal at Medco Health Solutions working in research and personalized medicine.
		•		Justin Dillon, Vice President and Chief Compliance Officer: As Vice President and Chief Compliance Officer, Justin Dillon is responsible for ensuring ethics and compliance are embedded in Ipsen business practices and organizational activities. Prior to joining Ipsen, Mr. Dillon served as Deputy Compliance Officer, North America and Puerto Rico Pharmaceutical, Vaccines and Commercial Operations at GlaxoSmithKline and held similar compliance responsibilities in addition to commercial leadership roles during his 15 years with Merck & Co., Inc.

“For Ipsen, 2012 marks a year of renewed focus and determination as we chart a course to drive sales growth for our endocrinology and neurology products in the US,” said Sean McKercher, President, Ipsen North America. “Our new leadership team is poised to take Ipsen therapies to the next level of awareness, ensuring access to innovative medicines for the underserved patient populations who need them most. I'm honored to be working with top industry talent to achieve this mission.”

Enhancing US-based R&D and Technical Operations Capabilities for Ipsen

Separately in the US, Ipsen is making a $45 million capital investment in its Milford, MA research and development (R&D) and technical operations facility. The existing facility serves as a center for Ipsen US-based peptide and toxin R&D platforms, as well as a cGMP manufacturing facility focused on production of recombinant proteins for the treatment of hemophilia. Ground-breaking for the facility expansion is anticipated for second half of 2012, with construction of the new building targeted for completion in early 2014. The new facility will house R&D and Process Sciences laboratories that support Ipsen strategic objectives to deliver five New Molecular Entities (NMEs) and three Proofs of Concept (POCs) by 2015.

About Somatuline^® Depot and Acromegaly

In August 2007, the US Food and Drug Administration (FDA) approved Somatuline^® Depot for marketing in the United States. Somatuline^® Depot is indicated in the US for the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

At the end of 2011, Ipsen marketed the product under the names Somatuline^® and Somatuline^® Autogel^® in more than 54 countries for various uses.

Acromegaly is a rare hormonal disorder that results from an excess production of growth hormone (GH) usually caused by a pituitary tumor. Disease-related symptoms include abnormal growth of the hands and feet, and changes in facial features. Acromegaly, if ignored, can lead to serious health complications.

Important Safety Information about Somatuline^® Depot

Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline^® Depot may experience hypoglycemia or hyperglycemia. Glucose level monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients. Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline^® Depot 60 mg. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline^® Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother. Somatuline^® Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels. Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline^® Depot may reduce the intestinal absorption of coadministered drugs. Caution should be used. The most common adverse reactions (incidence >5%) are diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), flatulence (7%), arthralgia (7%), and loose stools (6%). Please see full prescribing information for Somatuline^® Depot at http://www.somatulinedepot.com/hcp/.

About Dysport^® and Cervical Dystonia

The active substance in Dysport^® is a botulinum neurotoxin type A complex, which acts at the level of the neuromuscular junction in the targeted muscle. Dysport^® is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm.

Dysport^® is indicated in the US 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.

Cervical dystonia is an orphan condition in the US affecting approximately 125,000 people.² It is a chronic and painful condition characterized by neck muscles contracting involuntarily, which causes abnormal movements and awkward posture of the head and neck. Symptoms usually begin in people age 40 years or older, and women are more commonly affected by the condition than men.

Important Safety Information about Dysport^®

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. 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 (877- DYSPOR1). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full prescribing information for Dysport^® at http://www.dysport.com/ps/Prescribing-Info.php.

About Increlex^® and Severe Primary IGF-1 Deficiency

Increlex^® is indicated for the long-term treatment of growth failure in children with severe Primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe Primary IGFD is defined by: height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH). Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.

Important Safety Information about Increlex^®

Increlex^® is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating Increlex^® treatment. Increlex^® is not a substitute for GH treatment. Increlex^® should not be used for growth promotion in patients with closed epiphyses. Increlex^® is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops. Intravenous administration of Increlex^® is contraindicated. Increlex^® should not be used by patients who are allergic to mecasermin (IGF-1) or any of the inactive ingredients in Increlex^®. Increlex^® contains benzyl alcohol as a preservative, which has been associated with neurologic toxicity in neonates. Increlex^® has not been studied in patients under 2 years old. Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth. Local or systemic allergic reactions may occur. In clinical studies of 71 subjects with severe Primary IGFD treated for a mean duration of 3.9 years and representing 274 subject-years, no subjects withdrew from any clinical study because of adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy, with 14 (47%) having a history of hypoglycemia prior to treatment. Most cases were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion, and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. The frequency of hypoglycemia was highest in the first month of treatment, and episodes were more frequent in younger children. Hypoglycemia was generally avoided when a meal or snack was consumed either shortly before or shortly after administration. Tonsillar hypertrophy was noted in 11 subjects (15%) in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Intracranial hypertension occurred in three subjects. In two subjects, the events resolved without interruption of Increlex^® treatment. Increlex^® treatment was discontinued in the third subject and resumed later at a lower dose without recurrence. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full prescribing information for Increlex^® at http://www.increlex.com/hcp-full-prescribing-information.asp.

About Ipsen

Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2011. Ipsen's ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by four franchises: neurology / Dysport^®, endocrinology / Somatuline^®, uro-oncology / Decapeptyl^® and hemophilia. Moreover, the Group has an active policy of partnerships. R&D is focused on innovative and differentiated technological patientdriven platforms, peptides and toxins. In 2011, R&D expenditure totaled more than €250 million, above 21% of Group sales. The Group has total worldwide staff of close to 4,500 employees. 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.

Forward Looking Statement

This press release contains forward-looking statements that reflect our current views about future events. The words "anticipate," "assume," "believe," "estimate," "expect," "intend," "may," "plan," "project," "should" and similar expressions are used to identify forward-looking statements. These statements are subject to many risks and uncertainties.

The forward-looking statements contained herein are based on current expectations and assumptions that are subject to risks and uncertainties, many of which are outside of our control, and could cause our actual results to materially differ from our expectations. Such risks and uncertainties, include, but are not limited to: a decline of consumer demand and investment activity in Western Europe or the United States, or a downturn in major economies; deterioration of the situation in the global credit and financial markets; changes in currency exchange rates or interest rates; our inability to take to market a product that is promising in the early phases of development or pre-clinical trials due to, among other reasons, such product's failure to obtain regulatory approval or failure in clinical trials; a loss of market share due to increased competition from generic products; at any stage of the development process, our abandoning a potential product that fails to produce desired objectives and our subsequent failure to recoup significant up front research and development costs for such product; and acts by third-parties beyond our control that could damage the Group, the Group's brand or the Group's financial results.

For further information regarding risks and uncertainties associated with our businesses, please refer to our registration documents filed with the French Autorité des Marchés Financiers.

Ipsen undertakes no duty to update or revise any forward-looking statement whether to conform this statement to actual results or changes in the company's expectations or otherwise, except as required by law.

¹ Holdaway IM, Rajasoorya C. Epidemiology of Acromegaly. Pituitary. 1999 Jun 1;2(1):29–41. Saunders-Pullman R et al. (2005) A new screening tool for cervical dystonia. Neurology 64: 2046–2049.

² Saunders-Pullman R et al. (2005) A new screening tool for cervical dystonia. Neurology 64: 2046–2049.