SAN FRANCISCO, May 10 /PRNewswire-FirstCall/ – Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the first quarter ended March 31, 2010.
“After thorough review of all available dimebon data, including the disappointing CONNECTION results, Medivation remains committed to determining whether dimebon may offer clinical benefit to Alzheimer’s and Huntington disease patients,” said David Hung, MD, president and chief executive officer of Medivation. ”We will continue to enroll patients in the 12-month Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s patients and the six-month Phase 3 HORIZON study in Huntington disease, and will stop our two ongoing Phase 3 trials in moderate-to-severe Alzheimer’s disease. In reaching this conclusion, we considered all dimebon data generated thus far, including the negative CONNECTION data, the clinical benefit seen in two prior dimebon trials in mild-to-moderate Alzheimer’s disease and Huntington disease, the excellent safety and tolerability profile in all dimebon trials to date covering more than 2,000 patients, the preclinical data consistently showing that dimebon is pharmacologically active, and the potential risks and returns of continuing development for Alzheimer’s and Huntington diseases. We believe both the CONCERT and HORIZON studies offer independent pathways to registration, and we will be meeting with the Food and Drug Administration this quarter to discuss the CONNECTION data and obtain guidance on our proposed regulatory path forward.”
“We also continue to make progress on our MDV3100 program,” continued Dr. Hung. “This year we and our partner Astellas expect to complete enrollment in the Phase 3 AFFIRM trial in advanced prostate cancer patients and to initiate three new trials in earlier-stage prostate cancer, including a second Phase 3 trial. Our cash position remains strong and, based on current assumptions, we expect our cash to last beyond 2012, without regard to whether Pfizer elects to remain in our dimebon collaboration. We also expect to have reported top-line data from the CONCERT, HORIZON and AFFIRM trials by the end of 2012.”
Recent Accomplishments and Anticipated Milestones
Dimebon (latrepirdine*)
- Completed an analysis of data from the Phase 3 CONNECTION trial in patients with mild-to-moderate Alzheimer’s disease, and confirmed that dimebon did not show clinical benefit in this trial. The analysis did not identify any systematic issues with the conduct of the trial or with the drug product that would explain the results.
- Continued to enroll patients in CONCERT, with the goal of completing patient accrual in 2010. This 12-month randomized, double-blind, placebo-controlled Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil.
- Continued to enroll patients in HORIZON, with the goal of completing patient accrual in 2010. This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition in patients with Huntington disease.
- Agreed with our partner Pfizer to discontinue the CONSTELLATION and CONTACT Phase 3 trials in patients with moderate-to-severe Alzheimer’s disease. These trials were part of a label expansion strategy for dimebon, which can be revisited at a later time if the results of the ongoing CONCERT trial warrant.
*Latrepirdine is the proposed generic name for dimebon.
MDV3100
- Announced publication in The Lancet of positive efficacy data from the Phase 1-2 trial of MDV3100 in advanced prostate cancer patients. MDV3100 demonstrated anti-tumor activity as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. MDV3100 was generally well-tolerated in this trial at doses up to and including 240 mg/day.
- Continued to enroll patients in the AFFIRM trial, with the goal of completing patient accrual in 2010. This randomized, double-blind, placebo-controlled Phase 3 survival trial is evaluating 160 mg/day of MDV3100 in men with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
- Obtained issuance of a U.S. patent claiming MDV3100′s composition of matter. The term of this patent runs through 2027, and under current law is eligible for up to five years’ patent term extension based on time spent pursuing regulatory approval to market MDV3100.
- On track to initiate three new MDV3100 trials in earlier-stage prostate cancer this year: a Phase 3 trial in men with chemotherapy-naive castration-resistant prostate cancer; a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 1 trial in hormone-naive patients. Initiation of the Phase 3 trial would trigger a $10 million milestone payment under our collaboration agreement with Astellas.
Corporate
- Implemented a 20 percent workforce reduction to focus resources on the prioritized CONCERT and HORIZON dimebon trials and expanded development of MDV3100.
First Quarter 2010 Financial Results
Revenue for the first quarter of 2010 was $15.7 million, consisting of partial recognition of the non-refundable up-front payments of $225.0 million received from Pfizer in the fourth quarter of 2008 and $110.0 million received from Astellas in the fourth quarter of 2009. Both up-front payments were recorded as deferred revenue upon receipt and are being recognized on a straight-line basis over the estimated performance period of the Company’s obligations under the applicable collaboration agreement, which the Company presently expects to complete in the second quarter of 2013 for the Pfizer collaboration and in the fourth quarter of 2014 for the Astellas collaboration.
For the three months ended March 31, 2010, total operating expenses were $33.4 million, compared with total operating expenses of $22.1 million for the same period in 2009. These figures include non-cash stock-based compensation expense of $3.5 million in the quarter ended March 31, 2010, compared with $2.6 million for the same period in 2009.
Beginning in October 2008, Pfizer became responsible for 60 percent of all dimebon-related development and commercialization costs in the U.S., and 100 percent of such costs outside the U.S. Beginning in October 2009, Astellas became responsible for 50 percent of all MDV3100-related development and commercialization costs in the U.S. (other than costs for clinical trials supporting development in both the U.S. and either Europe or Japan, including the ongoing Phase 3 AFFIRM trial and the two additional trials in earlier-stage prostate cancer we expect to initiate in 2010, which are borne two-thirds by Astellas and one-third by Medivation) and 100 percent of such costs outside the U.S. The parties make quarterly true-up payments as necessary to ensure that each bears its applicable share of costs. For the first quarter of 2010, the net true-up payments payable to Medivation were $4.6 million and $6.1 million under the Pfizer and Astellas collaborations, respectively. Medivation presents these cost-sharing true-up payments in the applicable expense line of its consolidated statement of operations.
Medivation reported a net loss for the quarter ended March 31, 2010, of $17.5 million, or $0.51 per share, compared with a net loss of $5.6 million, or $0.19 per share, for the same period in 2009.
Cash, cash equivalents and short-term investments at March 31, 2010, totaled $255.5 million, compared with $278.2 million at December 31, 2009.
2010-12 Financial Outlook
Medivation currently expects that total operating expenses for 2010, net of cost-sharing payments from Pfizer and Astellas, will be between $105 and $115 million. This forecast includes approximately $13.5 million of non-cash stock-based compensation expense. We also expect to receive a $10 million milestone payment from Astellas in 2010 upon initiation of the second Phase 3 study of MDV3100.
Medivation believes that its existing cash resources are adequate to fund its currently budgeted operations beyond 2012, without regard to whether Pfizer elects to remain in the dimebon collaboration. By the end of 2012, the Company expects to have reported top-line data from the CONCERT trial in mild-to-moderate Alzheimer’s disease, the HORIZON trial in Huntington disease, and the AFFIRM trial in castration-resistant prostate cancer patients who have failed chemotherapy.
Conference Call Information
To participate by telephone in today’s live call beginning at 4:30 p.m. Eastern Time, please call 877-303-2523 from the U.S. or +1-253-237-1755 internationally. In addition, the live conference call is being webcast and can be accessed on the “Events and Presentations” page of the “Investor Relations” section of the Company’s website at www.medivation.com. A replay also will be available for 30 days following the live call.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. In September 2008, Medivation announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is conducting a clinical development program that includes CONCERT, a Phase 3 trial assessing dimebon in patients with mild-to-moderate Alzheimer’s disease, and HORIZON, a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered into a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for both early- and late-stage prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. Additional trials in earlier-stage prostate cancer will begin in 2010. For more information, please visit us at www.medivation.com.
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