Vernalis Acquires Rights to Apokyn®, a Marketed Drug for Advanced Parkinson’s Disease, from Mylan
04 November 2005
Vernalis plc (LSE: VER, NASDAQ: VNLS) today announces that it has acquired exclusive rights in North America to a marketed product, Apokyn®. Apokyn® (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease. Apokyn® has been studied as an adjunct to other medications.
- Apokyn® has been acquired from Mylan for a one-off cash payment of $23 million
- Apokyn® 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® will be marketed in the United States directly by Vernalis’ specialist neurology sales force
- Apokyn® 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® 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
Vernalis has acquired the United States New Drug Application (NDA) and Investigational New Drug (IND) Application and exclusive rights to market Apokyn® in North America, as well as certain know-how, marketing materials and trademarks relating to Apokyn®. In addition, Mylan has agreed to provide certain transitional services for up to twelve months, including supply chain management and customer service assistance.
Vernalis estimates sales of Apokyn® in North America in 2006 will be in the range of $6 million to $7.5 million; however, as part of the Apokyn® acquisition, Vernalis is committed to completing certain Phase IV studies of Apokyn® and these costs, together with the early marketing and promotional costs, mean that the Company does not expect the product to be cash generative initially.
Robert J. Coury, Mylan’s Vice Chairman and Chief Executive Officer commented “The sale of Apokyn®, a product which requires a specialised sales force, is the latest step in the strategies that we announced earlier this year, including closing Mylan Bertek. After careful consideration and the evaluation of a number of companies, we’re pleased to have selected Vernalis. This will be a key product in their Parkinson’s disease franchise and we believe Vernalis is committed to the long term success of Apokyn®.”
Simon Sturge, Chief Executive Officer of Vernalis said “Apokyn® is a significant acquisition for Vernalis and provides a second marketed product, alongside frovatriptan, for our sales force to promote to specialist neurologists in North America. The addition of Apokyn® firmly establishes our Parkinson’s disease franchise, which also includes V2006, being developed in partnership with Biogen Idec on which we have retained co-promotion rights in the United States.”
View the announcement (PDF - 103KB).
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Enquiries:
Vernalis plc +44 (0) 118 977 3133
Simon Sturge, Chief Executive
Tony Weir, Chief Financial Officer
Julia Wilson, Head of Corporate Communications
Brunswick Group +44 (0) 20 7404 5959
Jon Coles
Wendel Verbeek
Notes to Editors
About Parkinson’s disease
Parkinson's disease occurs when certain neurons in an area of the brain called the substantia nigra are damaged or destroyed. Normally, these nerve cells release dopamine - a chemical that transmits signals to other nerves in the corpus striatum. This signalling helps co-ordinate muscles to make smooth, controlled movements. Everyone loses some dopamine-producing neurons as a normal part of aging; however people with Parkinson's disease lose half or more of neurons in the substantia nigra. Although other brain cells also degenerate, the dopamine-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 symptoms generally develop over the age of 50; however, the disease also affects a small percentage of the younger population. The disease is progressive and the signs and symptoms become worse over time. Although Parkinson’s disease may eventually be disabling, the disease often progresses gradually, and most people have many years of productive living after initial diagnosis.
Unlike some other neurologic diseases, Parkinson's disease is amenable to symptomatic treatment. For a number of years levodopa, commonly known as L-dopa, has been the cornerstone of Parkinson's disease treatment. However, L-dopa can cause intolerable side effects, and it is thought it can become less effective as the disease worsens, especially as new symptoms develop. As a result, newer drugs 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 have Parkinson’s disease.
About Apokyn®
Apokyn ® was approved through the FDA's Orphan Drug route in April 2004 and is indicated 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 debilitating periods of partial loss of movement or total immobility experienced by patients with advanced Parkinson's disease. As Parkinson's disease progresses, patients begin to experience immobilising "off" episodes despite treatment with drugs used to increase or replace dopamine. Apokyn® is not used to prevent "off" episodes and it does not replace other Parkinson's disease medications, but rather treats an existing "off" episode when it occurs. As an acute, treatment, Apokyn® helps patients experiencing a debilitating "off" episode to walk, talk or move around easier. The intensity, duration and frequency of "off" episodes vary for each sufferer. Patients with Parkinson's disease lose motor control during "off" episodes, making routine tasks such as walking and even speaking extremely difficult. Patients with Parkinson's disease or their caregivers administer Apokyn® via injection under the skin.
The effectiveness of Apokyn® for the acute, intermittent treatment of "off" episodes associated with advanced Parkinson's disease was established in three randomised controlled clinical trials. Patients who received Apokyn® demonstrated statistically significant improvement in the primary endpoint which was their Unified Parkinson's Disease Rating Scale part III (UPDRS) motor score at 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 measure disease severity in patients. Apokyn® should not be used by patients who are being treated with certain drugs to treat nausea and vomiting or irritable bowel syndrome. These medications (including, for example, ondansetron, granisetron, dolasetron, palonesetron, and alosetron) are called 5HT 3 antagonists or blockers. In addition, Apokyn® should not be used by patients who have an allergic reaction to the drug or its ingredients (notably sodium metabisulfite). Apokyn® should be injected under the skin only, and not into a vein. Because Apokyn® can cause severe nausea and vomiting, it is taken with an oral medicine that helps to prevent these effects. Apokyn® may lower blood pressure (orthostatic hypotension), cause fainting, and increase the risk of falling. At recommended doses minimal increases in QTC were observed. Caution should be used when prescribing apomorphine with drugs that prolong the QT/QTC interval. Some patients treated with Apokyn® may get sleepy during the day or fall asleep without warning while doing everyday activities. The most common side effects of Apokyn® are yawning, dyskinesias, nausea and/or vomiting, sleepiness, dizziness, runny nose, hallucinations, fluid retention, chest pain, increased sweating, flushing, and an unusually pale complexion.
About Apomorphine
Apomorphine is a non-ergoline dopamine receptor agonist. Dopamine is an important neurotransmitter in the basal ganglia structures of the brain, which is key to producing smooth voluntary movement. Apomorphine has been marketed in Europe by Britannia Pharmaceuticals for a number of years as both a subcutaneous injection and a continuous subcutaneous infusion using a small portable pump.
About Vernalis
Vernalis is a specialty pharmaceutical company focused on products marketed to specialist neurologists. The company has two marketed products, frovatriptan and Apokyn®, and a development pipeline focused on neurology and central nervous system disorders. The company has five products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec and Serono. Vernalis is establishing a US commercial operation to promote Apokyn® and co-promote frovatriptan alongside its North American licensing partner, Endo Pharmaceuticals, propelling the company towards its goal of becoming a sustainable, self-funding, R&D-driven, specialty pharmaceutical company. For further information about Vernalis, please visit www.vernalis.com .
Safe Harbour statement: this news release may contain forward-looking statements that reflect the Company's current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process , the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.
