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(RTTNews) – Shares of biopharmaceutical firm Medivation Inc. ( MDVN | Quote | Chart | News | PowerRating) have had a nice run-up over the past one year and currently trade around $37, representing a more than two-fold rise. The stock was trading around $23 when the company was profiled on our site last July.
The year 2010 could be a make or break year for Medivation as the results of a confirmatory late-stage study of its investigational drug Dimebon for Alzheimer’s disease are due in the first half.
… Read on to find out more about Medivation and the upcoming near term catalyst.
Incorporated in Delaware in October 1995, the company began operations on December 17, 2004 after acquiring Medivation Neurology Inc. Prior to June 8, 2005, Medivation’s corporate name was Orion Acquisition Corp II. The company’s investigational drugs include Dimebon, which is under late-stage studies for the treatment of Alzheimer’s disease and Huntington’s disease; and MDV3100, which is also under phase III development for the treatment of castration-resistant prostate cancer.
Dimebon – A potential game changer?
Dimebon was approved as an antihistamine to treat hay fever in Russia in 1983. The drug was sold over the counter there for many years before it was withdrawn from the market following the introduction of more selective treatments.
In October 2003, Medivation Neurology acquired the patent rights for the use of Dimebon and related compounds to treat neurodegenerative diseases from Selena Pharmaceuticals Inc. As mentioned earlier, Medivation is evaluating Dimebon as a potential treatment for Alzheimer’s disease and Huntington’s disease and the development programs for the two indications are partnered with Pfizer Inc. ( PFE | Quote | Chart | News | PowerRating).
Dimebon has a unique mechanism of action, distinct from currently available treatments. Unlike other drugs used to treat Alzheimer’s disease that focus on targets implicated in cognition and memory loss, such as cholinesterase inhibition or NMDA receptor antagonism, Dimebon potentially operates via a novel mitochondrial mechanism of action. It is still not clear how Dimebon works because in preclinical studies, treatment with Dimebon has shown an increase in a brain protein, known as beta amyloid, in animal models of Alzheimer’s. Beta amyloid is the main constituent of plaques found in the brains of people with Alzheimer’s and is thought to be a key player in the development and progression of the disease.
According to Alzheimer’s Association, about 5.3 million Americans suffer from Alzheimer’s disease and the number is expected to triple by 2050.
Till date, there has been no cure for Alzheimer’s, which is often referred to as ‘the long good bye’. Forest Laboratories Inc.s’ (FRX) Namenda, Sciele Pharma Inc.’s (SCRX) Cognex, Pfizer/Eisai’s Aricept, Novartis AG’s (NVS) Exelon, and Janssen-Ortho Inc.’s Razadyne are some of the drugs to treat Alzheimer’s.
The FDA-approved drugs, which are currently in the market, can slow the progression of symptoms of the disease like, memory loss, difficulty in communicating, impaired judgment and a loss of initiative. In clinical studies, researchers who evaluated Dimebon’s potential to improve patients’ thinking and memory ability, overall function, psychiatric and behavioral symptoms, and ability to perform daily activities, have found improvement in all the five outcome measures.
The development programs for Dimebon include the following pivotal trials in various stages of completion:
- A completed pivotal trial in mild-to-moderate Alzheimer’s disease, conducted in Russia, the results of which were published in The Lancet in 2008. According to the journal, in the double-blind, placebo-controlled trial, after both six months and a full year of treatment, the 183 patients with mild-to-moderate Alzheimer’s disease treated with Dimebon experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function.
- A confirmatory six-month phase III trial dubbed CONNECTION in patients with mild-to-moderate Alzheimer’s disease. The 6-month study enrolled 598 patients, exceeding the enrollment target of 525 patients in the United States, Europe, and South America. The top-line results from the trial are expected in the first half of 2010.
- A phase III safety study in 750 Alzheimer’s disease patients on a variety of background anti-dementia drugs, which has been fully enrolled.
- An ongoing twelve-month phase III trial dubbed CONCERT in 1050 mild-to-moderate Alzheimer’s disease patients who are taking Aricept, the leading approved Alzheimer’s disease medication.
- A phase III trial dubbed CONSTELLATION in patients with moderate-to-severe Alzheimer’s disease was initiated last November. The six-month double-blind, placebo-controlled study , which will assess the effects of adding Dimebon to Namenda, will enroll approximately 570 patients at about 80 sites in the United States, Canada and Europe.
- A phase III study dubbed CONTACT in patients with moderate-to-severe Alzheimer’s disease was also initiated last November. The six-month study, which will assess the potential benefits of adding Dimebon to ongoing treatment with Aricept, will enroll approximately 600 patients with moderate-to-severe Alzheimer’s disease and neuropsychiatric symptoms at 75 sites in Europe and South America.
According to the company, the first three studies – the Russian trial, CONNECTION trial and the safety trial should allow the potential early new drug application filing option for Alzheimer’s indication in 2010.
Market research firm Decision Resources expects Dimebon to be launched in 2012 and has pegged potential peak sales of the drug across the *seven markets at $1.5 billion. (*United States, France, Germany, Italy, Spain, the United Kingdom and Japan).
In addition to Alzheimer’s, Dimebon is tested as a potential treatment for Huntington disease. Huntington disease is a fatal genetic disease for which no medications are currently approved by the FDA to treat the cognitive impairment associated with the condition.
A six-month, double-blind, placebo-controlled phase III trial dubbed HORIZON was initiated last July and has a target to enroll approximately 350 patients with Huntington disease at approximately 50 sites in North America, Europe and Australia.
MDV3100 – For a niche market
MDV3100 is yet another investigational drug of Medivation, which is under phase III development in patients with castration-resistant prostate cancer, also known as hormone refractory prostate cancer, who have failed Taxotere-based chemotherapy.
Prostate cancer treatment remains an unmet medical need. According to the American Cancer Society, more than 2 million American men have prostate cancer, and it is the second leading cause of cancer death among men after lung cancer.
Usually hormone therapies like Bicalutamide or other standard anti-androgen treatments are used to treat prostate cancer. When the prostate cancer becomes metastasized or has spread to the bone or other organs, it will not respond to hormonal treatment and is called castration-resistant or hormone-refractory prostate cancer. The main alternatives available to men with castration-resistant prostate cancer include radiation, and chemotherapy drugs like Sanofi-Aventis’ (SNY) Taxotere in combination with steroid drug Prednisone. But these treatments are considered to have severe side effects.
In clinical studies, MDV3100 has not only demonstrated anti-tumor activity in patients who had become resistant to Bicalutamide or other standard anti-androgen treatments, but has also been generally well tolerated with fatigue being the most frequently reported adverse event. Dendreon Inc. (DNDN) has developed a treatment for advanced prostate cancer, which is pending regulatory decision. The FDA is expected to announce its decision on Dendreon’s Provenge on May 1.
The MDV3100 program is partnered with Tokyo-based Astellas Pharma Inc. The phase III trial of MDV3100 dubbed AFFIRM was initiated last September and is currently enrolling men with castration-resistant prostate cancer who were previously treated with Taxotere-based chemotherapy. The study is expected to enroll approximately 1,200 patients at sites in Europe, the United States, Canada, South America, Australia and South Africa. Last week, the company announced treatment of the first European patient in the AFFIRM trial.
Strategic partnerships
In September 2008, Medivation entered into an agreement with Pfizer to develop and commercialize Dimebon. Under the Pfizer Collaboration Agreement, which became effective in October 2008, Medivation received an up-front cash payment of $225 million in the fourth quarter of 2008. Medivation is also eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments.
The cost of developing and commercializing Dimebon for the United States market is shared by Pfizer and Medivation on a 60%/40% basis, with Pfizer assuming the larger share. The profits or losses resulting from the commercialization of Dimebon in the United States will also be shared by the two companies in the same proportion. Outside the United States, Pfizer bears all development and commercialization costs and will pay Medivation tiered royalties on the aggregate net sales of Dimebon.
In October 2009, Medivation inked an agreement with Astellas to develop and commercialize MDV3100. Under the Astellas Collaboration Agreement, Medivation received an up-front cash payment of $110.0 million last November. Medivation is required to share 10% of the up-front payment and any development milestone payments received under the Astellas Collaboration Agreement with the academic institution from which the company licensed its rights to MDV3100. Medivation is also entitled to receive up to $335.0 million in development milestone payments, plus up to an additional $320.0 million in commercial milestone payments.
The costs of developing and commercializing MDV3100 for the United States market are shared by Medivation and Astellas on a 50%/50% basis. The profits or losses resulting from the commercialization of MDV3100 in the United States will also be shared by the two companies in the same proportion. Astellas has the responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales.
Financials – Knowing the numbers
Medivation has no marketed drugs and has incurred losses since inception. As of September 30, 2009, Medivation had an accumulated deficit of $151.2 million. Last week, speaking at the J.P. Morgan Annual Healthcare Conference, Medivation CEO David Hung said that his company has a strong financial foundation with more than $275 million in cash.
According to Medivation, in less than 6 years, it has advanced 2 molecules – Dimebon and MDV3100 from preclinical stage to phase III programs for a total cost of a mere $175 million, thanks to the company’s cost-effective approach to drug development. That compares favorably with the average time of 10-15 years taken by Big Pharma to advance a single compound from preclinical testing to registration and total cost of around $800 million.
Closing Thoughts
There is more room on the upside for Medivation if the late-stage trial results of Dimebon due in the first half of this year pan out the way as expected. But that said, since the results of the clinical trial can be a make-or-break event, investing in the stock requires a high tolerance for risk and volatility.
http://www.dimebonalzheimers.com
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