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San Francisco Business Times on Sept. 11, 2017

'Somebody needs to step up': Drug exec starts nonprofit to hike access, lower costs

Jim Wilkins has been on the front lines — he knows there are cheaper ways to make drugs and get them into patients who have little or no access to fundamental medicines.

If only he had just a little more money, he says. Just $700,000 would allow the nonprofit he formed in 2015, called Fair Access Medicines, to tap an efficient strain of yeast to produce cheap insulin for diabetics struggling to keep pace with their disease.

The price tag is a fraction of a fraction of the $1 billion-plus cost that biotech industry places on the research and development of a typical drug. But after years of watching from the inside as drugmakers churned out medicines at relatively low costs, then opted to charge hundreds of dollars per pill, tablet or injection, Wilkins said more needs to be done to get drugs to needy people.

The problem became clear to the former manufacturing and development executive at South San Francisco-based Genentech Inc. and Alexion Pharmaceuticals Inc. during the Ebola crisis. The West African virus beginning in 2013 killed more than 11,000 people, and various government agencies, academic groups and small companies worked to develop therapies.

"They never went anywhere because pharma companies weren't interested in treating diseases outside their sweet spot of the U.S. and industrialized countries," Wilkins said.

"People know these drugs can be made for relatively cheap, and when companies charge huge dollars for things that have beeen around forever, somebody needs to step up."

Exactly how to do that is Wilkins' specialty. His career has been spent in manufacturing and process development, the critically necessary but unsexy parts of making drugs. He knows there are drugs that aren't protected by patents but remain expensive and out of the reach of large populations of patients.

Human insulin, for example, has been around as a recombinant protein since Genentech broke ground with it in the late 1970s. That work was licensed to Eli Lilly and Co. (NYSE: LLY) and approved by the Food and Drug Administration in 1982. Still, access can be limited by cost, leading some patients to skip doses.

"The controversy of drug pricing is real and it hits home in the United States, but also outside the U.S.," Wilkins said. "There are some countries that don't even get access to the drugs."

Insulin keeps blood sugar from getting too high or too low, and people with diabetes must take medication several times a day.

What Fair Access Medicines proposes is using a strain of yeast called pichia pastoris, which synthesizes the insulin protein in the cell before secreting it.

"It's a great system," Wilkins said, noting that a number of biologic drugs already use pichia pastoris. "You just have to purify it."

But that costs money — about $700,000, the way Wilkins figures it, to take into clinical trials, into the FDA approval process and to scale up by the end of 2018. Then FAM's insulin could hit the market at a tenth of the roughly $30-a-day cost of Lilly's insulin.

Besides Lilly, other large players in the insulin space include Denmark's Novo Nordisk (NYSE: NVO) and France's Sanofi (NYSE: SNY).

The price of their products have risen "way more than can be justified by anything," Wilkins said. "In general, they're making modifications to the insulin molecule to create rapid-acting and long-acting forms — it sounds good on the surface, but if you look at the actual benefit, it's marginal."

The changes also have the effect of extending the patent life on those forms of insulin.

Besides insulin, FAM also is working on a cheaper version of Daraprim, an infection-fighting drug for HIV patients. That drug was the one pharma executive Martin Shkreli two years ago proposed hiking the price by 5,000 percent.

FAM has about $2,000 in the bank, Wilkins said, but is having good discussions with potential donors, such as foundations.

"It's a pretty heavy lift to go out and try to raise money for something like this," Wilkins said. "It's not something that people are familiar with."

If they do know what Wilkins is talking about, they're much more familiar with the health and anti-poverty efforts of the $41 billion-asset Bill & Melinda Gates Foundation — led by Susan Desmond-Hellmann, the former Genentech exec and UCSF chancellor — or Médecins Sans Frontières, the France-based organization also known as Doctors Without Borders.

"Fund raising has been a challenge — to convince people that we're real and can do this," Wilkins said.

But Wilkins and cofounder Sanjay Jain, an advisor for vaccine development at the not-for-profit PATH Malaria Vaccine Initiative, have found big help with small things. Health care giant Bayer set aside space in its CoLaborator incubator in Mission Bay, giving the nonprofit access to shared equipment with startup biotech companies when it sets up shop there in October.

In fact, it was Bayer principal scientist Rick Harkins who not only offered the space but pointed him toward pichia pastoris.

FAM also is getting legal help from Silicon Valley law firm Wilson Sonsini Goodrich & Rosati, whose legendary startup partner, Vern Norviel, sits on the nonprofit's board.

The legal work is rigorous, said Wilson Sonsini associate Charlie Andres, who is FAM's technical and regulatory adviser. FAM, Andres said, must compare its way of making the protein to other methods and run through various functional tests to ensure that the drug has the same potency as branded insulin.

"We anticipate that once we start to do this, (makers of commercial insulin) will probably try to block us from doing it," Wilkins said. "It is a threat to their market."

But, for now, Wilkins is prepping to move into the Bayer CoLaborator space and to accelerate FAM's baseline mission.

"There's this whole notion that unless you charge a lot of money for your drug, you can't survive as a company. (The industry argues) that clinical trial costs are high — that's true," Wilkins said. "There are other factors that cost money, but the bottom line with pharma companies is they spend most of their profits on share buybacks and dividends."

"The prosperity's not trickling down to people in drugs," he said. "They're high priced and although insurers are paying the bill, many for some reason or another aren't getting access to something common."


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Oct. 27 – 29, 2017. Organized by Yale University, Academics Stand Against Poverty and Global Financial Integrity.

Onslaughts on the Poor: Corruption, Emissions, Violence

Dr. Jim Wilkins of Fair Access Medicines participated in a panel discussion entitled "Making Advanced Medicines Available to All."

 

Want more resources? 

Check out the rolling news from the American Diabetes Association's Stand Up For Affordable Insulin.