Company Update (NASDAQ:MDVN): Medivation Inc Announces CHMP Positive Opinion to Include New Data in European Label for XTANDI(R)

Medivation Inc (NASDAQ:MDVN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a type II variation to include data from the head-to-head TERRAIN trial of enzalutamide versus bicalutamide in the European label for XTANDI® (enzalutamide) capsules.

The positive CHMP opinion is based on results from the TERRAIN study, which enrolled 375 patients in North America and Europe with metastatic prostate cancer whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy or following surgical castration. The trial showed statistically significant progression free survival (PFS) improvement with enzalutamide versus bicalutamide [median PFS 15.7 months vs 5.8 months, HR = 0.44 (95% CI: 0.34, 0.57), p < 0.0001].The median time on treatment in the TERRAIN trial was 11.7 months in the enzalutamide group versus 5.8 months in the bicalutamide group. Grade 3 or higher cardiac adverse events were reported in 5.5% of enzalutamide-treated patients versus 2.1% of bicalutamide-treated patients; the higher rate in the enzalutamide group may be partly due to the twice longer duration of treatment in that group. Two seizures were reported in the enzalutamide group and one in the bicalutamide group. The most common side effects occurring during treatment and more common in the enzalutamide-treated versus bicalutamide-treated patients included fatigue, hot flush, hypertension, diarrhea, weight decreased and pain in extremity. These results were published in Lancet Oncology in January 2016.

“We are very pleased with the CHMP’s decision to update the XTANDI label to include these data,” said David Hung, M.D., founder, president & chief executive officer of Medivation. “TERRAIN was the first and largest head-to-head trial comparing enzalutamide against bicalutamide in the treatment of patients with metastatic CRPC.”

“We are pleased that the CHMP has recommended inclusion of the TERRAIN data in the European label for XTANDI,” said Claire Thom, Pharm D., senior vice president and oncology therapeutic head, Astellas.

The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the 28 countries of the European Union. The CHMP’s positive recommendation does not change indications or contradictions, meaning that no European Commission decision is needed for this variation before implementation of the update to the Summary of Product Characteristics. The label update will take effect immediately and will be applicable in all of the European Union.

XTANDI is approved in the European Union for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated and for the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy. (Original Source)

Shares of Medivation closed yesterday at $47.09, up $3.17 or 7.22%. MDVN has a 1-year high of $67.67 and a 1-year low of $26.41. The stock’s 50-day moving average is $38.05 and its 200-day moving average is $40.18.

On the ratings front, Medivation has been the subject of a number of recent research reports. In a report released yesterday, Canaccord Genuity analyst John Newman reiterated a Hold rating on MDVN, with a price target of $45, which represents a slight downside potential from current levels. Separately, on April 4, UBS’s Matt Roden reiterated a Buy rating on the stock and has a price target of $50.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, John Newman and Matt Roden have a total average return of -11.8% and 16.5% respectively. Newman has a success rate of 28.0% and is ranked #3756 out of 3784 analysts, while Roden has a success rate of 66.7% and is ranked #154.

The street is mostly Bullish on MDVN stock. Out of 12 analysts who cover the stock, 7 suggest a Buy rating and 5 recommend to Hold the stock. The 12-month average price target assigned to the stock is $49.94, which implies an upside of 6.1% from current levels.

Medivation, Inc. is a biopharmaceutical company, which is focused on the rapid development and commercialization of novel therapies to treat serious diseases for which there are limited treatment options. The company was founded by Clarence Patrick Machado and David T. Hung in October 1995 and is headquartered in San Francisco, CA.


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