2015: NIH refuses to give information about principals in company seeking exclusive license to HCV patents

Other KEI comments on NIH licenses are found here: http://keionline.org/nih-licenses

The NIH provided these responses to four questions about the HCV drug patent license it is considering. Note that for question 4, which asks for the "names, addresses or titles in the company (board of directors or shareholders)" of Virotas Biopharmaceuticals, LLC, the mysterious company seeking the exclusive license, the NIH refused to provide any information other than to say "Virotas Biopharmaceuticals, LLC is a privately held start-up company with founders experienced in drug development and commercialization." We have been trying to get information about the company for several weeks, and the NIH has been completely non-responsive.

---------- Forwarded message ----------
From: Carrera, Krysten (NIH/NIDDK) [E]
Date: Fri, May 1, 2015 at 4:43 PM
Subject: RE: questions for our researchers
To: "elizabeth.rajasingh"

Hi Elizabeth,

Thanks for your patience. Here are our answers to your questions.

Best,
Krysten Carrera

1) Is the compound referenced in the article, "Repurposing of the antihistamine chlorcyclizine and related compounds for treatment of hepatitis C virus infection," the same compound that is referenced in the Federal Register, "Prospective Grant of Exclusive License: Small Molecule Therapeutics Against Hepatitis C Virus Infection?”

The patent applications referenced in the Federal Register cover several new classes of compounds that have the potential of being a new treatment against the hepatitis C virus. One class is related to chlorcyclizine, the antihistamine compound described in the paper. This molecule is an over-the-counter drug that already is in the public domain.

2) Can you describe the next steps you will be taking to further this research? Does the compound appear to be a cure/game changer? Does it have the potential to be a low-cost form of treatment for Hep C patients?

In an FDA-approved clinical trial at the NIH Clinical Center, researchers are testing chlorcyclizine, one of the over-the-counter antihistamines described in the paper. The small study is evaluating the compound’s safety and identifying any side effects in people who have hepatitis C, and is also designed to assess whether this compound has any antiviral effect with a short-term dosing. This study will not determine whether this compound can be used to treat the hepatitis C virus. Currently we do not know if the drug has any effect in people infected with the virus. Even if the initial trial raises no serious safety concerns, FDA would require additional, larger clinical trials to further study safety and to determine efficacy of the drug to treat the hepatitis C virus. FDA would consider the results of the clinical trials before deciding if the drug should be approved for use in hepatitis C.

The NIH values partnerships with industry and academia to deliver groundbreaking technology and medical advances to the public as quickly as possible. These collaborations help innovative ideas become reality, leveraging resources and expertise from a variety of disciplines. The NIH contributes scientific knowledge and discoveries from the research it supports and does not control approval or pricing of drugs.

3) Is the NIH still funding research, specifically clinical trials, on this compound? If so, can you provide details on the cost of the clinical trials that the NIH is funding?

The clinical trial is a small phase 1b study supported by the NIH Intramural Research Program. The cost is part of the program’s operating budget and does not require additional funding.

4) Can you provide any information about the pharmaceutical company that is seek the exclusive license in the previously mentioned federal register notice, such as names, addresses or titles in the company (board of directors or shareholders)?

Virotas Biopharmaceuticals, LLC is a privately held start-up company with founders experienced in drug development and commercialization.