Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries

On April 22, 2016, the President of Biolyse Pharma — a Canadian pharmaceutical company that specializes in the manufacture of oncology drugs — offered to supply the prostate cancer drug enzalutamide (Xtandi) to the Centers for Medicare & Medicaid Services (CMS) for $3 per pill ($12 per day; $4,383 per year). The Biolyse price for enzalutamide is 4-percent of the 2014 Medicare price, $69.41 ($277.64 per day; $101,408.01 per year), and lower than any other price in the world.

Biolyse is known for supplying 80-percent of the supply of the cancer drug paclitaxel in Canada, at 1-percent of the branded price. Biolyse also exports paclitaxel to other countries, including, for example, South Africa.

Brigitte Kiecken, the Biolyse President, offered to supply enzalutamide to the U.S. government at a fraction of the current price, if the National Institutes of Health agrees to exercise its worldwide, royalty-free license on the patents on enzalutamide, for use for Medicare and for U.S. supply of enzalutamide to developing countries. The federal government’s royalty-free right is a contractual right the federal government obtains when providing research grants and contracts. The rights, which can be used by anywhere in the world, either for or on behalf of the United States, are required by federal statute at 35 U.S.C. 202(c)(4), which reads in part:

(c) Each funding agreement with a small business firm or nonprofit organization shall contain appropriate provisions to effectuate the following:

…

(4) With respect to any invention in which the contractor elects rights, the Federal agency shall have a nonexclusive, nontransferrable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world . . . [emphasis added]

Karena Walter of the Fort Erie Times first reported on the Biolyse offer. (Link here).

The letter (PDF version here), as well as a cover letter sent by Biolyse consultant John Fulton to CMS and the NIH, is reproduced below and attached to this page:

Cover e-mail from John Fulton to Andy Slavitt at CMS

From: John R. Fulton
Date: Sat, Apr 23, 2016 at 10:27 PM
Subject: See attached: offer to supply low cost enzalutamide
To: Andy.Slavitt@cms.hhs.gov
Cc: Francis.Collins@nih.hhs.gov, Jamie Love

Andy Slavitt
Acting Administrator for the Centers for Medicare & Medicaid Services (CMS)
Via Email: Andy.Slavitt@cms.hhs.gov

Francis Collins, M.D., Ph.D.
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Via: Francis.Collins@nih.hhs.gov

Dear Administrator Slavitt and Director Collins,

I am a private biotechnology consultant representing Biolyse Pharma Corporation in St.Catharines Ontario. I have attached a letter from Bridgitte Kiecken, the President of Biolyse Pharma, offering to supply Medicare and programs with generic versions of enzalutamide, a drug to treat prostate cancer, at $3 per 40 mg tablet. In 2014, Medicare was paying $69.41 per tablet for Xtandi, the Astellas version of the drug, so the Biolyse offer involves dramatic savings to the U.S. government.

The federal government has a royalty free right to use the following three patents on this product: 7709517, 8183274 and 9123941. The Biolyse offer is contingent upon the federal government using the royalty free right to obtain less expensive supplies of the drug.

Separately, Biolyse Pharma would be interested in approaching the NIH to use its rights in the patents to supply affordable versions of enzalutamide in developing countries, including South Africa.

I would be interested in talking with your staff about this offer,

Sincerely,

John R. Fulton
BioNiagara
5 Garden Park Blvd.
St.Catharines, Ontario
Canada
L2R-5B8
905.932.7883
Biolyse@Biolyse.com

Letter from Brigitte Kiecken of Biolyse to Andy Slavitt of CMS.

Andy Slavitt

Acting Administrator for the Centers for Medicare & Medical Services [sic] (CMS)

April, 22nd, 2016

Dear Mr. Slavitt,

Biolyse Pharma is a Canadian company that specializes in the manufacturing as well as the development of sterile oncology drugs.

We are presently writing to express our willingness to supply a generic version of enzalutamide to prostate cancer patients in the United States and in the developing world.

Presently enzalutamide is sold under the name Xtandi by Astella [sic] Pharmaceuticals. It is our understanding, that in 2014, prostate cancer patients receiving reimbursement for their medication were paying an excess of $250 dollars [sic] for their daily regime of four tablets of 40mg of enzalutamide. Astella [sic] is presently selling in Canada and in other jurisdictions Xtandi for approximately 30% of what it is presently chargin in the United States. Biolyse Pharma would be able to supply enzalutamide for approximately $3.00 USD per tablet.

Medicare has a royalty free right in all three patents in the FDA orange book for enzalutamide. We believe we can have generic versions approved by the FDA in less than three years if CMS is willing to allow Biolyse Pharma to supply the drug using the U.S federal government’s worldwide royalty free license.

Sincerely,

[Signature]

Brigitte Kiecken
President