Eland Oil & Gas Regulatory News (ELA)

6 Mar 2007 15:15

Amarin Corporation Plc06 March 2007 AMARIN EXPANDS NEUROLOGY PIPELINE WITH EPILEPSY PRODUCT CANDIDATE Acquires Global License to Novel Nasal Lorazepam Formulation LONDON, United Kingdom, March 6, 2007 - Amarin Corporation plc (NASDAQ: AMRN)today announced the acquisition of a global license to develop and market anovel, nasal lorazepam formulation for the out-patient treatment of emergencyseizures in epilepsy patients, specifically status epilepticus (SE) and acuterepetitive seizures (ARS). This formulation utilises the patent protectedNanoCrystal(R) Technology from Elan Corporation, plc ("Elan", NYSE: ELN). SE and ARS have an estimated annual incidence in the United States of 150,000cases and up to 400,000 patients, respectively. There are approximately 40,000deaths in the United States each year associated with such emergency seizures. Rick Stewart, Chief Executive Officer of Amarin, commented, "The potential ofthis nasal lorazepam opportunity is significant in addressing this unmet medicalneed. A nasal product for seizure emergencies in the out-patient setting forepilepsy patients would represent an important treatment option. We believe thepotential annual sales for such a product could be up to $300 million in theUnited States. We are very excited about this opportunity as it fits neatly intoAmarin's neurology focused strategy." Paul Breen, Executive Vice President and Head Elan Drug Technologies stated, "Weare very pleased to execute this agreement with Amarin. This agreement continuesto validate the robustness and flexibility of our proprietary NanoCrystaltechnology. We look forward to working with Amarin and assisting them in theirefforts to develop a nasal formulation of lorazepam that will significantlybenefit patients". Diazepam rectal gel is the only treatment currently approved by the U.S. Foodand Drug Administration ("FDA") for seizure emergencies in the out-patientsetting. Diazepam gel's use is limited by its rectal route of administration.Consequently, an opportunity exists for the development of a product with a moreconvenient route of administration permitting broader out-patient treatment ofSE and ARS in both children and adults. Intravenous lorazepam is a first line oftreatment for SE and ARS in hospital emergency rooms in the United States. Development Programme Formulation of a NanoCrystal nasal lorazepam commenced in early 2006. Amarinplans to initiate a pharmacokinetic trial later this year with the objective ofcommencing efficacy trials in 2008. Elan will be responsible for completing thedevelopment of the NanoCrystal formulation, plus the manufacturing of clinicaland commercial supplies. Amarin is responsible for completing the final nasalformulation work, the clinical development programme, the regulatory approvalprocess and commercialisation. NanoCrystal Technology and Patent Protection Amarin has obtained a global licence for a number of Elan's patents and know-howrelating to Elan's proven NanoCrystal technology, including six issued patentsthat expire in 2019 and 2020, and two pending patents that expire in 2021 and2026, respectively. Strategic Fit Amarin's strategy is to commercialise novel neurology products for the treatmentof unmet medical needs for small, focused physician audiences. A successfullydeveloped nasal lorazepam will be promoted to a focused group of approximately500 neurologists and epileptologists. Transaction Terms In consideration of the grant of the license and ultimately commercial supply,Amarin will pay Elan success-based development, filing and approval milestonestotalling $5.2 million plus royalties on net sales. There is no initial licensepayment. In connection with this transaction, Amarin will also pay a third party,Neurostat Pharmaceuticals, Inc. ("Neurostat"), a finder's fee and similarpayments comprising upfront and contingent milestones totalling $0.6 millionplus warrants to purchase 175,000 Amarin shares with an exercise price of $1.79per share. Unmet Medical Need - Status Epilepticus and Acute Repetitive Seizures A seizure emergency is a prolonged seizure or continuous state of frequentlyoccurring seizures. One common type of seizure emergency is called statusepilepticus (SE). SE may be defined as a prolonged seizure lasting anywherebetween 10 and 30 minutes. SE is also defined by a series of repeated seizureswithout the return of consciousness between seizures. SE has an annual incidenceestimated at approximately 150,000 cases in the United States alone withapproximately 40,000 deaths per year. Another type of seizure emergency is acute repetitive seizures (ARS), which is about or cluster of seizures over a short period of time in which the patientregains consciousness between seizures. It is estimated that up to 400,000people in the United States suffer from ARS. Epilepsy is a very common disorder affecting approximately 0.5% of thepopulation and is characterized by seizures, which may vary from the briefestlapses of attention to muscle jerks to severe and prolonged convulsions. Theymay also vary in frequency, from less than one a year to several per day. About Amarin Amarin is committed to improving the lives of patients suffering from diseasesof the central nervous system. Our goal is to be a leader in the research,development and commercialization of novel drugs that address unmet patientneeds. Amarin has a late-stage drug development pipeline. Miraxon, Amarin's leaddevelopment compound, is in Phase III development for Huntington's disease("HD"), Phase II development for depressive disorders and is entering Phase IIadevelopment for Parkinson's disease. Amarin's core development pipeline alsoincludes the global rights to a novel oral formulation of apomorphine fortreating patients with advanced Parkinson's disease and a nasal formulation oflorazepam for treating emergency seizures. Miraxion for HD is being developed under a Special Protocol Assessment agreedwith the U.S. Food and Drug Administration ("FDA"), has been granted Fast Trackdesignation by the FDA and has received Orphan Drug designation in the U.S. andEurope. Amarin has its primary stock market listing in the US on NASDAQ ("AMRN") andsecondary listings in the UK and Ireland on AIM ("AMRN") and IEX ("H2E"),respectively. For press releases and other corporate information, visit the Amarin website athttp://www.amarincorp.com. Information on our website does not form part of thispress release. NanoCrystal(R) Technology is a registered trademark of Elan Pharma InternationalLimited, Ireland. For more information on Elan's NanoCrystal(R) Technology,please visit www.elan.com/EDT. Contacts:Amarin +44 (0) 207 907 2442Rick Stewart Chief Executive OfficerAlan Cooke Chief Financial Officerinvestor.relations@amarincorp.com Investors:Lippert/Heilshorn & Associates, Inc. +1 212 838 3777Anne Marie Fields Media:Powerscourt +44 (0) 207 236 5615Rory GodsonVictoria Brough Disclosure Notice The information contained in this document is as of March 6, 2007. Amarinassumes no obligation to update any forward-looking statements contained in thisdocument as a result of new information or future events or developments. Thisdocument contains forward-looking statements about Amarin's financial condition,results of operations, business prospects and products in research that involvesubstantial risks and uncertainties. You can identify these statements by thefact that they use words such as "will", "anticipate", "estimate", "expect","project", "forecast", "intend", "plan", "believe" and other words and terms ofsimilar meaning in connection with any discussion of future operating orfinancial performance or events. Among the factors that could cause actualresults to differ materially from those described or projected herein are thefollowing: the success of Amarin's research and development activities,including the Phase III trials with Miraxion in Huntington's disease; decisionsby regulatory authorities regarding whether and when to approve Amarin's drugapplications, as well as their decisions regarding labeling and other mattersthat could affect the commercial potential of Amarin's products; the speed withwhich regulatory authorizations, pricing approvals and product launches may beachieved; the success with which developed products may be commercialized;competitive developments affecting Amarin's products under development; theeffect of possible domestic and foreign legislation or regulatory actionaffecting, among other things, pharmaceutical pricing and reimbursement,including under Medicaid and Medicare in the United States, and involuntaryapproval of prescription medicines for over-the-counter use; Amarin's ability toprotect its patents and other intellectual property; claims and concerns thatmay arise regarding the safety or efficacy of Amarin's product candidates;governmental laws and regulations affecting Amarin's operations, including thoseaffecting taxation; Amarin's ability to maintain sufficient cash and otherliquid resources to meet its operating requirements; general changes in UK andUS generally accepted accounting principles; growth in costs and expenses; andthe impact of acquisitions, divestitures and other unusual items, includingAmarin's ability to integrate its acquisition of Amarin Neuroscience Limited. Afurther list and description of these risks, uncertainties and other matters canbe found in Amarin's Annual Report on Form 20-F for the fiscal year endedDecember 31, 2006, and in its Reports of Foreign Issuer on Form 6-K furnished tothe SEC. This information is provided by RNS The company news service from the London Stock Exchange