[Ip-health] Niagara company offers U.S. cheaper cancer drug (generic version of Xtandi at $3 per tab). Doggett calls for hearing on march-in request

Jamie Love james.love at keionline.org
Wed Apr 27 06:12:09 PDT 2016

As reported in this story, Biolyse, a drug manufacturer from Canada, has
written to Andy Slavitt, the Acting Administrator for the Centers for
Medicare & Medicaid Services (CMS), and offered to supply Medicare with
generic versions of enzalutamide, a prostate cancer drug, for $3 per
tablet, if Biolyse can supply under the federal government's worldwide
royalty free license to the patents.  (Rights under 35 USC 202(c)(4), which
are separate from the march-in rights under 35 USC 203).

The current supplier for Medicare is Astellas, selling the drug under the
brand name of Xtandi, for $88.48 in the private market, and in 2014, $69.41
per 40 mg tablet to Medicare.

KEI and UACT have filed a march-in case with the NIH and the Army, and also
urged the NIH to use the royalty free rights in the Xtandi patents, on the
grounds that the $353+ per day price is both excessive and discriminatory,
pointing out that prices outside the United States are much lower, even
though the NIH and Army funded the drug's development.   (See

The Biolyse offer make more concrete the costs of not exercising the
federal government's rights in the patents.  At $3 per tab, Medicare alone
would save more than a half billion per year.

Separately, yesterday, at an event on drug pricing organized by the Center
for American Progress (CAP), Rep Lloyd Doggett called for the NIH to hold a
hearing on the Xtandi march-in request.
https://www.youtube.com/watch?v=hVtAMGPu4KU  (March-in comments at 9:44).



Niagara company offers U.S. cheaper cancer drug
By Karena Walter, The Standard
Tuesday, April 26, 2016 7:10:46 EDT PM
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

Related Stories
Who is Biolyse?

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

“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

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 at 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

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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