[Ip-health] NIH refuses to give information about principals in company seeking exclusive license to HCV patents

Claire Cassedy claire.cassedy at keionline.org
Tue May 5 09:28:43 PDT 2015


http://keionline.org/node/2219

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

Submitted by James Love [1] on 5. May 2015 - 12:24

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 informaiton
other than to say "Virotas Biopharmaceuticals, LLC is a privately held
start-up company with founders experienced in drug development and
commercialization."

---------- 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.



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