56 NGOs ask US Government enable export of low cost generic versions Xtandi to developing countries

17 OCTOBER 2016

CONTACT: Zack Struver, zack.struver@keionline.org, +1-202-332-2670, or Paul Davis, pdavis@keionline.org, +1-202-332-2670

Note: Letter from Biolyse to HHS here: /wp-content/uploads/28-sept-2016-biolyse-to-hhs-letter.pdf
Letter from NGOs to HHS here: /wp-content/uploads/17-oct-2016-civil-society-letter-xtandi.pdf

Washington, DC — Today, over 50 patient, senior citizen, global health, development, social justice, and faith groups urged the United States Government to use its rights in a federally funded patented invention, and accept the request by a Canadian generic drug manufacturer (Biolyse Pharma) to enter into an agreement to manufacture and export an affordable version of the taxpayer-funded prostate cancer drug enzalutamide to South Africa and other countries with low per-capita incomes relative to the United States.
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Harvoni & Sovaldi, Xtandi in Top 20 Costliest Medicare Drugs

The Associated Press recently released a chart from the Centers for Medicare and Medicaid Services’ Office of the Actuary that outlines spending for the top 20 costliest drugs to Medicare in 2015 after reaching Medicare’s catastrophic spending threshold: http://www.nytimes.com/aponline/2016/07/25/us/ap-us-medicare-pricey-drugs-glance.html.

UPDATE: The AP also released another story, on July 24, 2016, outlining the overall program costs of catastrophic spending and explaining various spending increases: http://www.nytimes.com/aponline/2016/07/24/us/politics/ap-us-medicare-pricey-drugs.html.

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S. Ward Casscells, Pentagon Medical Chief, Praised Army Role in Xtandi Development

Dr. S. Ward Casscells took the stage at the 2011 Innovative Minds in Prostate Cancer Today (IMPaCT) Meeting as a prostate cancer patient, a doctor, an Army Reserve colonel, and the former top doctor for the Pentagon. There, he praised the central role of the Department of Defense in bringing important prostate cancer medicines to market, including Xtandi (referred to by its experimental name, MDV3100), an expensive prostate cancer drug that was funded from basic research through phase I and II clinical trials by taxpayer and charitable funds. Continue Reading

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NIH to taxpayers — we don’t care about high prices in US for Xtandi

National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
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Rep. Lloyd Doggett keynote address at CAP drug pricing event highlights Xtandi, federal funding of pharmaceutical R&D

On April 26, 2016, Congressman Lloyd Doggett (D-Texas) delivered the keynote address at a panel discussion on drug pricing at the Center for American Progress, where he addressed the Federal government’s role in subsidizing drug development, ensuring affordable access at reasonable prices for U.S. citizens, industry practices related to monopoly pricing, and legislative solutions to promote rational and affordable drug prices.


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Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries

On April 22, 2016, the President of Biolyse Pharma — a Canadian pharmaceutical company that specializes in the manufacture of oncology drugs — offered to supply the prostate cancer drug enzalutamide (Xtandi) to the Centers for Medicare & Medicaid Services (CMS) for $3 per pill ($12 per day; $4,383 per year). The Biolyse price for enzalutamide is 4-percent of the 2014 Medicare price, $69.41 ($277.64 per day; $101,408.01 per year), and lower than any other price in the world.

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