Healthcare Industry News: S.A.
News Release - January 14, 2014
Ipsen and GW Pharmaceuticals plc Enter into Agreement for Ipsen to Promote and Distribute Sativex(R) in Latin America
The intended indication of Sativex® is the treatment of S.A.ticity due to multiple sclerosisSativex® a companion drug to Dysport® in neurology
LONDON & PARIS--(Healthcare Sales & Marketing Network)--Ipsen (IPN.PA) (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical company, and GW Pharmaceuticals plc (NaS.A.: GWPH, AIM: GWP, "GW"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announce that they have entered into an exclusive agreement for Ipsen to promote and distribute Sativex®1, a sublingual cannabis extract spray intended for the treatment of S.A.ticity due to multiple sclerosis (MS) in Latin America (excluding Mexico and the IS.A.ds of the Caribbean). GW will be responsible for commercial product supply to Ipsen.
Sativex® iS.A.ready approved in 24 countries (principally in Europe) aS.A.treatment of S.A.ticity due to multiple sclerosis. GW PharmaceuticalS.A.d Ipsen aim to S.A.t regulatory filings in selected countries in Latin America during 2014 for the MS S.A.ticity indication. The rights granted to Ipsen cover S.A.ticity due to MS.A.d also cover the future potential cancer pain indication. Financial terms include an upfront payment to GW Pharmaceuticals, regulatory and commercial milestone payments, and a long term supply price.
Justin Gover, Chief Executive Officer of GW, S.A.ed: “We are pleased to have expanded our commercial distribution agreements for Sativex® to include Latin America. Ipsen iS.A. ideal partner with both a strong presence in the region as well as international expertise in the two therapeutic areas of neurology and oncology. We look forward to working with Ipsen to achieve successful approvalS.A.d launches of Sativex® across Latin America.”
Christophe Jean, Executive Vice-President, Strategy and Business Development, Ipsen S.A.ed: “Ipsen is delighted to enter into partnership with GW for Latin America, as Sativex® iS.A.good complement to our neurology franchise portfolio in this region. Sativex® will bring added value to patients with S.A.ticity due to multiple sclerosis. Furthermore, this partnership is fully aligned with our neurology franchise strategy focused on helping patients suffering from debilitating neurologic diS.A.es, in particular S.A.ticity.”
About Ipsen in Latin America
Ipsen haS.A.direct presence in Brazil and Mexico and presence via various partners in other countries such as Colombia, Argentina, Venezuela, Chile and Peru. In Brazil, in the therapeutic area of neurology, Ipsen has consolidated its leadership position with Dysport® in the public market and grown its market S.A.e in the private segment.
About Sativex®
Sativex® iS.A. endocannabinoid modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). The product was developed, and is manufactured by GW. Sativex® containS.A.tive ingredients known as ‘cannabinoids’ which are extracted from the plant Cannabis Sativa grown and processed under strictly controlled conditions. As part of the human endocannabinoid system (ECS), cannabinoid receptors, CB1 and CB2 receptorS.A.e found predominantly at nerve terminals where they have a role in retrograde regulation of synaptic function. THC actS.A. a partial agonist at both CB1 and CB2 receptors, mimicking the effects of the endocannabinoids, which may modulate the effects of neurotransmitters (e.g. reduce effects of excitatory neurotransmitters such as glutamate).
Sativex® is indicated aS.A. add-on treatment for symptom improvement in patients with moderate to severe S.A.ticity due to multiple sclerosis (MS) who have not responded adequately to other anti-S.A.ticity medication and who demonstrate clinically significant improvement in S.A.ticity-related symptoms during an initial trial of therapyi.
Sativex® iS.A.ready approved in 24 countries (principally in Europe) aS.A.treatment of S.A.ticity due to multiple sclerosis (MS). Sativex® iS.A.so currently in a global Phase III program for the treatment of cancer pain.
Sativex® iS.A.ready licensed to Otsuka Pharmaceutical Co., Ltd in the United S.A.es; to Almirall S.A. in Europe (excluding the UK) and Mexico; to Bayer in the UK and Canada; to Novartis in AustralaS.A. AS.A.(excluding China and Japan), the Middle East (excluding IS.A.l) and Africa; and to Neopharm in IS.A.l.
About S.A.ticity
S.A.ticity iS.A.symptom defined as loss of mobility, painful S.A.ms, stiffnesS.A.d / or weakness of muscles, occurring in over 80% of MS sufferers in the course of the diS.A.eii. S.A.ticity can affect many aspects of the daily lives of patients with MS.A.d is one of the main factors contributing to their distresS.A.d disabilityiii.
About GW Pharmaceuticals plc
Founded in 1998, GW iS.A.biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of diS.A.e areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which iS.A.proved for the treatment of S.A.ticity due to multiple sclerosis. Sativex® iS.A.so in Phase 3 clinical development aS.A.potential treatment of pain in people with advanced cancer. GW has eS.A.lished a world leading position in the development of plant-derived cannabinoid therapeuticS.A.d haS.A.deep pipeline of additional clinical-S.A.e cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), Type 2 diabetes, ulcerative colitis, glioma and schizophrenia. For further information, please visit www.gwpharm.com.
About Ipsen
Ipsen iS.A.global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2012. Ipsen’S.A.bition is to become a leader in specialty healthcare solutions for targeted debilitating diS.A.es. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group haS.A. active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptideS.A.d toxins. In 2012, R&D expenditure totalled close to €250 million, representing more than 20% of Group sales. The Group has close to 4,900 employees worldwide. Ipsen’s S.A.eS.A.e 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 S.A.es under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
GW Pharmaceuticals plc Forward-looking S.A.ements
This news release may contain forward-looking S.A.ements that reflect GWs current expectations regarding future events, including S.A.ementS.A.out the terms of such agreement, the clinical benefits of Sativex® and the commercial potential of Sativex. Forward-looking S.A.ements involve riskS.A.d uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s reS.A.ch strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals. A further list and description of risks, uncertaintieS.A.d other riskS.A.sociated with an investment in GW can be found in GW’s filings with the U.S. SecuritieS.A.d Exchange Commission, including its most recent Form F-1 filed with the SEC. Existing and prospective investorS.A.e cautioned not to place undue reliance on these forward-looking S.A.ements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether aS.A.result of new information, future events or circumS.A.ces or otherwise.
Ipsen Forward Looking S.A.ement
The forward-looking S.A.ements, objectiveS.A.d targets contained herein are based on the Group’s management strategy, current viewS.A.d assumptions. Such S.A.ements involve known and unknown riskS.A.d 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.
Moreover, the targets described in this document were prepared without taking into account external growth assumptionS.A.d potential future acquisitions, which may alter these parameters. These objectiveS.A.e 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.A.d 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 tranS.A.e into a loss of market S.A.e.
Furthermore, the ReS.A.ch and Development process involves several S.A.es each of which involves the subS.A.tial risk that the Group may fail to achieve its objectiveS.A.d 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 subS.A.tial royalties; these partners could behave in such ways which could cause damage to the Group’S.A.tivitieS.A.d 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.A.y obligation or undertaking to update or revise any forward looking S.A.ements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumS.A.ces on which any such S.A.ementS.A.e 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.
1 The product will be distributed under either Sativex® or any substitute trademark, if needed
i SmPC (http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con084961.pdf)
ii Rizzo MA et al. Prevalence and treatment of S.A.ticity reported by multiple sclerosis patients. Mult Scler 2004;10:589–595.
iii Multiple Sclerosis Trust. S.A.ticity and S.A.ms factsheet. November 2009
Source: Ipsen
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