4th Nov 2005 07:01
Vernalis PLC04 November 2005 4 November 2005 Vernalis Acquires Rights to Apokyn(R), a Marketed Drug for Advanced Parkinson's Disease, from Mylan Vernalis plc (LSE: VER, NASDAQ: VNLS) today announces that it has acquiredexclusive rights in North America to a marketed product, Apokyn(R). Apokyn(R)(apomorphine hydrochloride injection) is indicated for the acute, intermittenttreatment of hypomobility, "off" episodes ("end-of-dose wearing off" andunpredictable "on/off" episodes) associated with advanced Parkinson's disease.Apokyn(R) has been studied as an adjunct to other medications. • Apokyn(R) has been acquired from Mylan for a one-off cash payment of $23 million • Apokyn(R) was approved by the FDA as an Orphan Drug in April 2004, launched in the United States in July 2004 and has market exclusivity until 2011 • Apokyn(R) will be marketed in the United States directly by Vernalis' specialist neurology sales force • Apokyn(R) is used as an adjunct to other Parkinson's disease medicines and is the only therapy available in the United States for the acute, intermittent treatment of immobilising "off" episodes associated with Parkinson's disease • Apokyn(R) was designated an Orphan Drug to treat approximately 100,000 Parkinson's disease patients who experience the severe "on/off" motor fluctuations unresponsive to other therapies Apokyn(R) is a non-ergoline dopamine agonist used to treat immobilising "off"episodes in patients with advanced Parkinson's disease. "Off" episodes aredebilitating periods of complete or partial immobility which become increasinglycommon as Parkinson's disease progresses. Apokyn(R) injections can improvefunction within minutes in such patients, permitting them to walk, talk andperform normal activities more easily. In clinical trials conducted by Mylan,Apokyn(R) was shown to be effective in the acute, intermittent treatment of''off'' episodes, demonstrating a highly significant improvement in UnifiedParkinson's Disease Rating Scale (UPDRS) Part III motor scores at 20 minutes,with statistical improvements in some measures noted as early as 10 minutes.Apokyn(R) should not be used by patients taking certain anti-nausea drugs andthe most common side effects in clinical trials included, yawning, dyskinesias,sleepiness, nausea and/or vomiting, dizziness and runny nose. Vernalis has acquired the United States New Drug Application (NDA) andInvestigational New Drug (IND) Application and exclusive rights to market Apokyn(R) in North America, as well as certain know-how, marketing materials andtrademarks relating to Apokyn(R). In addition, Mylan has agreed to providecertain transitional services for up to twelve months, including supply chainmanagement and customer service assistance. Vernalis estimates sales of Apokyn(R) in North America in 2006 will be in therange of $6 million to $7.5 million; however, as part of the Apokyn(R)acquisition, Vernalis is committed to completing certain Phase IV studies ofApokyn(R) and these costs, together with the early marketing and promotionalcosts, mean that the Company does not expect the product to be cash generativeinitially. Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer commented"The sale of Apokyn(R), a product which requires a specialised sales force, isthe latest step in the strategies that we announced earlier this year, includingclosing Mylan Bertek. After careful consideration and the evaluation of a numberof companies, we're pleased to have selected Vernalis. This will be a keyproduct in their Parkinson's disease franchise and we believe Vernalis iscommitted to the long term success of Apokyn(R)." Simon Sturge, Chief Executive Officer of Vernalis said "Apokyn(R) is asignificant acquisition for Vernalis and provides a second marketed product,alongside frovatriptan, for our sales force to promote to specialistneurologists in North America. The addition of Apokyn(R) firmly establishes ourParkinson's disease franchise, which also includes V2006, being developed inpartnership with Biogen Idec on which we have retained co-promotion rights inthe United States." - ends - Enquiries:Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial OfficerJulia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959Jon ColesWendel Verbeek Notes to Editors About Parkinson's disease Parkinson's disease occurs when certain neurons in an area of the brain calledthe substantia nigra are damaged or destroyed. Normally, these nerve cellsrelease dopamine - a chemical that transmits signals to other nerves in thecorpus striatum. This signalling helps co-ordinate muscles to make smooth,controlled movements. Everyone loses some dopamine-producing neurons as a normalpart of aging; however people with Parkinson's disease lose half or more ofneurons in the substantia nigra. Although other brain cells also degenerate, thedopamine-containing cells are critical for normal posture and movement. People with Parkinson's disease often experience trembling, muscle rigidity,difficulty walking, and problems with balance and coordination. These symptomsgenerally develop over the age of 50; however, the disease also affects a smallpercentage of the younger population. The disease is progressive and the signsand symptoms become worse over time. Although Parkinson's disease may eventuallybe disabling, the disease often progresses gradually, and most people have manyyears of productive living after initial diagnosis. Unlike some other neurologic diseases, Parkinson's disease is amenable tosymptomatic treatment. For a number of years levodopa, commonly known as L-dopa,has been the cornerstone of Parkinson's disease treatment. However, L-dopa cancause intolerable side effects, and it is thought it can become less effectiveas the disease worsens, especially as new symptoms develop. As a result, newerdrugs are also being used, either alone or in combination with L-dopa. It is estimated that approximately 1.5 million people in the United States haveParkinson's disease. About Apokyn(R) Apokyn(R) was approved through the FDA's Orphan Drug route in April 2004 and isindicated for the acute, intermittent treatment of hypomobility, or ''off''episodes (end-of-dose wearing off and unpredictable "on/off" episodes)associated with advanced Parkinson's disease. "Off" episodes are debilitatingperiods of partial loss of movement or total immobility experienced by patientswith advanced Parkinson's disease. As Parkinson's disease progresses, patientsbegin to experience immobilising "off" episodes despite treatment with drugsused to increase or replace dopamine. Apokyn(R) is not used to prevent "off"episodes and it does not replace other Parkinson's disease medications, butrather treats an existing "off" episode when it occurs. As an acute, treatment,Apokyn(R) helps patients experiencing a debilitating "off" episode to walk, talkor move around easier. The intensity, duration and frequency of "off" episodesvary for each sufferer. Patients with Parkinson's disease lose motor controlduring "off" episodes, making routine tasks such as walking and even speakingextremely difficult. Patients with Parkinson's disease or their caregiversadminister Apokyn(R) via injection under the skin. The effectiveness of Apokyn(R) for the acute, intermittent treatment of "off"episodes associated with advanced Parkinson's disease was established in threerandomised controlled clinical trials. Patients who received Apokyn(R)demonstrated statistically significant improvement in the primary endpoint whichwas their Unified Parkinson's Disease Rating Scale part III (UPDRS) motor scoreat 20-minutes following injection of the drug compared to a placebo injection.There was also a statistically significant improvement in UPDRS at 10 minutes.The UPDRS is used by researchers and clinicians around the world to measuredisease severity in patients. Apokyn(R) should not be used by patients who arebeing treated with certain drugs to treat nausea and vomiting or irritable bowelsyndrome. These medications (including, for example, ondansetron, granisetron,dolasetron, palonesetron, and alosetron) are called 5HT3 antagonists orblockers. In addition, Apokyn(R) should not be used by patients who have anallergic reaction to the drug or its ingredients (notably sodium metabisulfite).Apokyn(R) should be injected under the skin only, and not into a vein. BecauseApokyn(R) can cause severe nausea and vomiting, it is taken with an oralmedicine that helps to prevent these effects. Apokyn(R) may lower blood pressure(orthostatic hypotension), cause fainting, and increase the risk of falling. Atrecommended doses minimal increases in QTC were observed. Caution should be usedwhen prescribing apomorphine with drugs that prolong the QT/QTC interval. Somepatients treated with Apokyn(R) may get sleepy during the day or fall asleepwithout warning while doing everyday activities. The most common side effects ofApokyn(R) are yawning, dyskinesias, nausea and/or vomiting, sleepiness,dizziness, runny nose, hallucinations, fluid retention, chest pain, increasedsweating, flushing, and an unusually pale complexion. About Apomorphine Apomorphine is a non-ergoline dopamine receptor agonist. Dopamine is animportant neurotransmitter in the basal ganglia structures of the brain, whichis key to producing smooth voluntary movement. Apomorphine has been marketed inEurope by Britannia Pharmaceuticals for a number of years as both a subcutaneousinjection and a continuous subcutaneous infusion using a small portable pump. About Vernalis Vernalis is a specialty pharmaceutical company focused on products marketed tospecialist neurologists. The company has two marketed products, frovatriptan andApokyn(R), and a development pipeline focused on neurology and central nervoussystem disorders. The company has five products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec and Serono. Vernalis is establishing a US commercial operation topromote Apokyn(R) and co-promote frovatriptan alongside its North Americanlicensing partner, Endo Pharmaceuticals, propelling the company towards its goalof becoming a sustainable, self-funding, R&D-driven, specialty pharmaceuticalcompany. For further information about Vernalis, please visit www.vernalis.com. Safe Harbour statement: this news release may contain forward-looking statementsthat reflect the Company's current expectations regarding future events.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the successfulintegration of completed mergers and acquisitions and achievement of expectedsynergies from such transactions, and the ability of the Company to identify andconsummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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