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Niagara company offers U.S. cheaper cancer drug

By Karena Walter, The Standard

Production supervisor Janelie Mercure works in one of the labs at  Biolyse Tuesday April 26, 2016 in St. Catharines.  Bob Tymczyszyn/St. Catharines Standard/Postmedia Network

Production supervisor Janelie Mercure works in one of the labs at Biolyse Tuesday April 26, 2016 in St. Catharines. Bob Tymczyszyn/St. Catharines Standard/Postmedia Network

A Canadian company says it can cheaply manufacture a U.S. prostate cancer drug that Democratic presidential candidate Bernie Sanders and other Washington lawmakers say currently costs Americans too much.

Biolyse Pharma of St. Catharines has written U.S. federal officials saying it’s willing to supply a generic version of enzalutamide for prostate cancer patients in the U.S. and in the developing world.

The drug is sold under the name Xtandi by Astellas Pharmaceuticals, which has come under fire for its pricing by two U.S. non-profit groups and a dozen members of Congress.

“We believe we can have generic versions approved by the FDA in less than three years,” Biolyse president Brigitte Kiecken wrote in a letter to Medicare on the weekend, “if (Centers for Medicare and Medical Services) is willing to allow Biolyse Pharma to supply the drug using the U.S. federal government’s worldwide royalty free licence.”

John Fulton, a private biotechnology consultant representing Biolyse, said Medicare paid US$69.41 per 40 mg tablet for Xtandi in 2014. Biolyse could supply a generic version for approximately US$3 per tablet.

The offer was penned after Fulton was approached by U.S. non-governmental organization Knowledge Ecology International (KEI) in Washington, D.C., about whether Biolyse could provide the drug if given permission by the U.S. federal government.

The St. Catharines company currently produces chemotherapy medicine Paclitaxel for injection to 80 per cent of the Canadian market. Fulton said Biolyse’s introduction of Paclitaxel to Canadians in 2001 brought the price for cancer patients down to one per cent of the original cost.

“Biolyse has already proven that they can produce and succeed at very low margins and are aiming to do so,” Fulton said.

KEI and the U.S. non-profit Union for Affordable Cancer Treatment petitioned the U.S. federal government’s National Institutes of Health and other departments in January asking they intervene to make the drug available at a lower price, given American taxpayer-funded grants went towards its research and development.

The petition said Astellas is charging Americans US$129,000 for the drug, which sells in Canada for US$30,000.

KEI director James Love, based in Washington, D.C., said having the $3 per pill figure from Biolyse will make the dispute a little more clear to some people.

“We’re going to encourage members of congress to contact the administrator of Medicare and ask them what the fiscal impact would be of accepting the $3 pill over what they’re currently paying,” Love said.

“We’re hoping our petition is granted a hearing and we’ve got support in Congress for that.”

Ultimately, Biolyse would have to be given assurances by the U.S. government that it won’t be sued for patent infringement before it can move forward.

Whether the U.S. will allow the Canadian company to produce the drug isn’t known, but there is a push on for changes to the industry.

On March 28, 12 U.S. senators and representatives, including Sanders, asked the National Institutes of Health to hold a public hearing on Xtandi.

The lawmakers’ letter said the U.S. Bayh-Dole Act of 1980 gives federal agencies the authority to licence a patent when the invention is not available to the public on “reasonable terms.”

“We do not think that charging U.S. residents more than anyone else in the world meets the obligation to make the invention available to U.S. residents on reasonable terms,” the letter said.

Astellas Pharma spokesman Tyler Marciniak said Tuesday the KEI petition uses wholesale acquisition prices, which don’t accurately reflect what U.S. payers or patients actually pay for Xtandi.

“Twenty thousand American men have received it in the last year alone, it’s widely available,” he said. “Most of them are paying less than $25 a month out of pocket. Affordable for patients from a U.S. perspective.”

Marciniak said 81 per cent of privately-insured patients in the U.S. paid $25 or less out of pocket while 79 per cent of publicly-insured patients paid nothing.

In 2015, 2,000 American men who didn’t have insurance, were underinsured or had annual incomes of $100,000 or less received Xtandi for free through an access program offered by the company.

But lobbying groups such as Universities Allied for Essential Medicines, which has chapters in Canada, said more generic competition is better.

“Generic competition always reduces prices, upwards of 90 per cent within a year or two or less,” said advocacy co-ordinator Paul Davis from headquarters in Boston.

The organization is urging U.S. presidential candidates, when in office, to direct the National Institutes of Heath to make publicly-financed health inventions freely available to people worldwide, he said.

“We’re concerned this medicine was invented substantially on the U.S. taxpayer dime and is being priced out of reach.”

kwalter@postmedia.com

Who is Biolyse?

- Based in St. Catharines at 59 Welland Vale Road

- Specializes in the manufacturing and development of sterile oncology drugs

- Currently produces Paclitaxel for the treatment of cancer, known for its mild side effects when compared to similar chemotherapy agents

- Supplies 80 per cent of the Canadian demand for Paclitaxel

- Employs about 20 people which will multiply when a second drug is launched

- Presently developing 30 products to assist in alleviating drug shortages in Canadian health care system

— from Biolyse Pharma

 



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