UCLA’s effort to keep drug under patent draws protest

After scientists at UCLA created a breakthrough treatment for prostate cancer, it generated more than half a billion dollars for the university.

But deals struck with drugmakers also obligated university officials to help pursue patent protection for the drug around the world. Consumer activists claim that UCLA’s efforts are propping up the drug’s high prices — which can top $130,000 a year for a cancer patient in the U.S. — and keeping poor patients in less-developed nations from getting cheaper versions.

The university holds the patent on the chemical compounds its researchers developed that were used to create enzalutamide, which is sold under the name Xtandi.

In 2005, UCLA licensed the drug to San Francisco biotech firm Medivation, which sells the drug in partnership with Astellas Pharma of Japan.

Sales of the drug have skyrocketed since it received Food and Drug Administration approval in 2012.

In 2015, the final year Medivation was a standalone company, it reported worldwide Xtandi sales of $1.9 billion, up 80 percent from the prior year, and $1.2 billion of those sales were in the U.S. market. The online industry journal FiercePharma estimates that global Xtandi sales could reach $4.78 billion by 2020.

The drug’s potential was a major factor behind pharmaceutical giant Pfizer buying Medivation for $14 billion last year.

UCLA currently gets no money from sales of the drug. The university and others involved in the discovery sold their royalty rights in 2016 to a firm called Royalty Pharma for $1.14 billion.

Now UCLA and the companies are seeking a patent for the drug in India, sparking protests from two consumer groups, the Union for Affordable Cancer Treatment and Knowledge Ecology International.

India is home to a major generic-drug industry, and the groups believe that if UCLA and Xtandi’s makers drop their efforts to secure a patent there, it will pave the way for the manufacturing of cheaper, generic versions of the drug.

The groups say that the drug firms should not be allowed to sell Xtandi “at excessive, unaffordable prices in India,” because UCLA developed the drug “using taxpayer funds” through grants from the National Institutes of Health and the U.S. Army’s prostate cancer research program.

“This is a drug invented on government grants that has generated billions in sales since entering the market,” Manon Anne Ress, acting director of the Union for Affordable Cancer Treatment, said in a Sept. 20 letter to Dr. John Mazziotta, vice chancellor of UCLA Health Sciences.

But UCLA contends that the school — because it owns the intellectual property underlying the drug — is contractually obligated to help pursue patents overseas under its licensing agreement with Medivation.

UC regents “are obligated to use their best efforts to keep the patents licensed to Medivation from lapsing,” Mazziotta said in a Sept. 7 letter to the consumer groups.

Prostate cancer is the most common cancer among American men after skin cancer, and there were about 3.3 million American men who were living with a prostate cancer diagnosis as of Jan. 1, 2016, according to the most recent figures from the American Cancer Society.

A cancer patient typically takes four Xtandi pills a day, for a monthly cost of $11,463, according to the website GoodRx.

The activists last year asked the federal government to allow other companies to sell Xtandi at lower prices in the U.S. market, again arguing that UCLA scientists had used taxpayer-funded grants to discover the drug.

The government rejected the request and, with Xtandi sales protected, Medivation quickly became a takeover target. The sale to Pfizer followed a bidding war that more than doubled Medivation’s stock price.