UCLA’s effort to patent a costly prostate cancer drug in India hurts the poor, critics say

Oct. 22, 2017 7 AM PT

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. Now, 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 the drug called enzalutamide, which is sold under the name Xtandi.

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

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

In 2015 — the final year Medivation was a stand-alone company and broke out its financial results — Medivation reported worldwide Xtandi sales of $1.9 billion, up 80% from the prior year, and $1.2 billion of those sales were in the U.S. market. The industry journal FiercePharma.com estimates global Xtandi sales could reach $4.78 billion by 2020.

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

UCLA currently gets no money from sales of the drug. The university and others involved in the drug’s discovery sold their royalty rights in early 2016 to a firm called Royalty Pharma for $1.14 billion, with $520 million going to UCLA itself. The school said it would use the cash for additional research, scholarships and fellowships.

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

India is home to a major generic-drug industry, and the activists 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.

They also believe that the generics would become more available in other countries if those nations knew that substantial generic supplies were available from India.

The activists assert that Medivation and Astellas 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, UACT’s acting director, said in a Sept. 20 letter to Dr. John Mazziotta, vice chancellor of UCLA Health Sciences.

“Astellas is pricing Xtandi for high-income countries and elites only in developing countries,” Ress wrote. “This is a direct consequence of UCLA management of its patent rights.”

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.

“The [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 activists.

UCLA, as part of its sale of its royalty rights, is entitled to possible additional payments if the drug’s future global sales reach a certain level. But in its statement to The Times, UCLA said it was “highly unlikely” that threshold would be reached “even if the patent in India is granted.”

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.

An additional 161,360 American men are expected to be diagnosed with prostate cancer this year, the society says.

A cancer patient typically takes four Xtandi pills a day or 120 a month, and 120 capsules in the U.S. market are priced at $11,463, according to the website GoodRx.com. That would be $137,556 for a year’s supply.

Prostate cancer is among those cancers “showing significant increase in incidence rates” in India and the prostate “is the second leading site of cancer among males in large Indian cities” including Delhi, according to the U.S. National Library of Medicine.

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

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

Medivation, UCLA and its partners already have made one attempt for a patent in India but it was denied by the Indian Patent Office. UCLA’s group is appealing to the Delhi High Court, an appeal the activists have urged the university to drop.

“What’s special about this case is the fact that the University of California is going against their own licensing policy by aggressively seeking a patent in India on this drug,” KEI Director James Love said.

That policy, as UCLA summarized in a statement to The Times, is “intended to facilitate all populations having access to medications and other products and services made possible by UCLA innovation.”

But UCLA also noted the “concerns about prescription drug pricing” among the activists and others and said it was willing to explore the problem further.

The school said “we are convening a working group to evaluate our approach to technology licensing in ways that benefit California, the nation and the developing world” while also continuing to give drug companies enough incentive to commercialize its discoveries, just as Medivation did with Xtandi.

In the meantime, the activists contend that a daily dose of Xtandi is selling in India for roughly 40 times a person’s daily income in that nation, which they called “excessive and shamefully unaffordable.”

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