Up to 12 years of market exclusivity if
approved for both adult and pediatric use
NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") announced
today that the European Medicines Agency (EMA), has awarded orphan
drug designation to DengueCide™, the Company’s drug candidate for
the treatment of dengue and dengue hemorrhagic fever. Dengue Fever
is a mosquito-borne disease that, according to the WHO, affects
approximately 400 million people per year. Dengue Hemorrhagic
Fever, a subset of the disease that can occur after reinfection
with another strain of the same virus, has a case fatality rate of
up to 20%.
This orphan drug designation enables several benefits for the
Company’s dengue drug development program. These benefits include
“protocol assistance,” or specific scientific advice that can speed
up the drug development program, as well as certain fee reductions,
for drug approval(s) under EMA.
More importantly, an approved orphan medicine in the EMA
countries is expected to benefit from ten years of marketing
exclusivity protection. An additional two years of exclusivity can
be obtained if the drug development has complied with an agreed
pediatric investigation plan, with a total of twelve years of
market exclusivity for a drug that is approved for both adult and
pediatric usage. Further information on the incentives offered can
be found at the EMA website http://www.ema.europa.eu.
Applications for orphan designation are examined by the European
Medicines Agency's Committee for Orphan Medicinal Products (COMP),
using a network of international experts. This designation is
recognized by all 27 countries within the European Union.
The Company has previously reported that DengueCide was awarded
orphan drug status by the US FDA. The Company has also recently
reported the renewal of its evaluation agreement for DengueCide and
next generation dengue therapeutics with the Dr. Eva Harris
Laboratory at the University of California, Berkeley.
In the USA, orphan drug designation qualifies NanoViricides for
certain tax credits and marketing incentives under the Orphan Drug
Act. In addition, the Company will qualify for the waiver of
certain FDA fees if and when it files the New Drug Application
(NDA) for DengueCide with the FDA. Further, the Company will also
be eligible for a “Priority Review Voucher” (PRV) from the US FDA
when the Company files a NDA for DengueCide.
“Our dengue drug development programs have been accelerated in
order to take advantage of these benefits,” said Eugene Seymour,
MD, MPH, CEO of the Company. DengueCide is in pre-clinical
development at present. If the pre-clinical development is
successful, the Company will need to file an “Investigational New
Drug” (IND) application to the US FDA and perform human clinical
trials. If the human clinical trials are successful, then the
Company has to file a NDA to the FDA to obtain approval to market
the drug. There is no guarantee that DengueCide will successfully
result in an NDA or a marketable drug product.
If the Company receives a Priority Review Voucher, it can be
applied to accelerate the review of another one of our own drugs or
it can be sold to another pharmaceutical company for a
consideration. Priority review means that the FDA aims to render a
decision on the NDA in 6 months. In contrast, the FDA aims to
complete a standard review in about 10 months, and it often takes
even longer. The estimated economic value of a PRV depends upon the
drug class, and could be as high as a few hundred million dollars,
according to Duke economists (Ridley et al. 2006; Grabowski et al. 2009).
(https://faculty.fuqua.duke.edu/~dbr1/voucher/).
The Company engaged the consulting firm Coté Orphan Consulting
(COC), headed by Dr. Tim Coté, to assist with our DengueCide orphan
drug applications to both the US FDA and the EMA.
DengueCide is a nanoviricide® that has shown very high
effectiveness in an animal model of dengue virus infection. These
animal studies were conducted in the laboratory of Dr. Eva Harris,
Professor of Public Health and Infectious Diseases at the
University of California, Berkeley. Professor Harris has developed
a mouse model of antibody-dependent-enhancement (ADE) of dengue
infection that simulates dengue hemorrhagic fever (DHF/DHSS) using
a special laboratory mouse strain called AG129. In humans DHF/DHSS
is associated with a high fatality rate. In this model, infection
with a dengue virus, when the mice are left untreated, is 100%
fatal. In contrast, in the same study, animals treated with
NanoViricides' DengueCide achieved an unprecedented 50% survival
rate.
There is currently neither an effective drug treatment nor a
vaccine for dengue virus infection. No vaccine or drug candidate
has succeeded in clinical trials towards approval as of this date
in spite of significant development efforts. Several dengue virus
vaccine clinical trials are ongoing. Previously, a drug called
poly-IC-lC received an orphan designation in 2003 for dengue
treatment in the USA. This drug is supposed to act as an immune
booster and is in several clinical trials. Three additional
treatments for dengue fever are found in a search of the clinical
trials database
(http://clinicaltrials.gov/ct2/results?term=dengue&pg=5&show_xprt=Y).
These include chloroquine, balapiravir (Roche), and celgosivir.
The Company continues to advance its injectable and oral
FluCide™ broad-spectrum anti-influenza drug candidates towards
clinical trials. Both of these drug candidates have shown extremely
high effectiveness and substantial superiority to Tamiflu®, the
standard of care, in the unrelated influenza virus types H1N1 and
H3N2 in a high lethality animal model.
About Dengue and Dengue Hemorrhagic
Fever
Dengue fever, a very old disease, has reemerged in the past 20
years with an expanded geographic distribution of both the viruses
and the mosquito vectors, increased epidemic activity, the
development of hyper-endemicity (the co-circulation of multiple
serotypes), and the emergence of dengue hemorrhagic fever in new
geographic regions. In 2013, this mosquito-borne disease is one of
the most important tropical infectious diseases globally, with an
estimated 400 million cases of dengue fever, over one million cases
of dengue hemorrhagic fever, and 50,000-100,000 deaths annually.
Dengue virus occurs in four primary serotypes although a fifth
serotype has been reported recently in Indonesia. There have been
recent outbreaks in both Florida and Texas. Puerto Rico had 30,000
cases of dengue this past summer. For the first time, the mosquito
vector, Aedes Aegypti has also been found in California. Although
the disease is endemic in many tropical parts of the world, it is
considered an orphan disease in the USA and Europe. (From Clinical
Microbiology Reviews).
NanoViricides Pipeline
NanoViricides is developing broad-spectrum anti-influenza drugs
as part of its rich drug pipeline. The Company believes that its
FluCide™ drug candidates will be effective against most if not all
influenza viruses, including the H7N9 bird flu, H3N2 or H1N1
epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as
novel influenza viruses. This is because FluCide is based on the
Company’s biomimetic technology, mimicking the natural sialic acid
receptors for the influenza virus on the surface of a nanoviricide®
polymeric micelle. It is important to note that all influenza
viruses bind to the sialic acid receptors, even if they rapidly
mutate. The FluCide drug candidates have already shown strong
effectiveness against H1N1 and H3N2 influenza viruses in highly
lethal animal models. The injectable FluCide drug candidates have
shown 1,000X greater viral load reduction as compared to
oseltamivir (Tamiflu®), the current standard of care, in a highly
lethal influenza infection animal model. The Company believes that
these animal model results should translate readily into
humans.
NanoViricides has also developed an oral drug candidate against
influenza. This oral version is also dramatically more effective
than TamiFlu in the animals given a lethal influenza virus
infection. This oral FluCide may be the very first nanomedicine
that is effective when taken by mouth. In addition, NanoViricides
has developed drug candidates against HIV/AIDS, Herpes, and Ocular
Viral Diseases that have shown strong effectiveness in relevant
animal and/or cell culture models.
About Cote Orphan Consulting - Expertly Guiding Orphans Through
the FDA
COC was established by Tim Coté, MD, MPH, as a consulting
service to pharmaceutical companies working in the area of rare and
neglected diseases. Dr. Coté was the Director of the Office of
Orphan Product Development (OOPD) at the FDA, from 2007 to 2011. In
this role heading OOPD at the Agency, he was responsible for the
implementation of the Orphan Drug Act, a system of grants and drug
development incentives designed to create therapies for 6,000+ rare
diseases. He served as the Chief Medical Officer (CMO), National
Organization for Rare Disorders (NORD), Washington, DC, after
leaving the US FDA. He has held several other illustrious positions
with increasing responsibilities during his career, including CDC
Country Director for Rwanda, Senior Research Investigator in the
Viral Epidemiology Branch of the National Cancer Institute, and
Branch Chief, Therapeutics and Blood Safety, CBER, FDA. He is
currently Professor of Regulatory Practice at the Keck Graduate
Center, Claremont, CA, in addition to his role as the Principal at
COC.
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating
special purpose nanomaterials for viral therapy. The Company's
novel nanoviricide® class of drug candidates are designed to
specifically attack enveloped virus particles and to dismantle
them. The Company is developing drugs against a number of viral
diseases including H1N1 swine flu, H5N1 bird flu, seasonal
Influenza, HIV, oral and genital Herpes, viral diseases of the eye
including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue
fever, and Ebola virus, among others.
This press release contains forward-looking statements that
reflect the Company's current expectation regarding future events.
Actual events could differ materially and substantially from those
projected herein and depend on a number of factors. Certain
statements in this release, and other written or oral statements
made by NanoViricides, Inc. are “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. You should not
place undue reliance on forward-looking statements since they
involve known and unknown risks, uncertainties and other factors
which are, in some cases, beyond the Company's control and which
could, and likely will, materially affect actual results, levels of
activity, performance or achievements. The Company assumes no
obligation to publicly update or revise these forward-looking
statements for any reason, or to update the reasons actual results
could differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future. Important factors that could cause actual
results to differ materially from the company's expectations
include, but are not limited to, those factors that are disclosed
under the heading "Risk Factors" and elsewhere in documents filed
by the company from time to time with the United States Securities
and Exchange Commission and other regulatory authorities. Although
it is not possible to predict or identify all such factors, they
may include the following: demonstration and proof of principle in
pre-clinical trials that a nanoviricide is safe and effective;
successful development of our product candidates; our ability to
seek and obtain regulatory approvals, including with respect to the
indications we are seeking; the successful commercialization of our
product candidates; and market acceptance of our products.
FDA refers to US Food and Drug Administration. EMA refers to the
European Union’s office of European Medical Agency.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
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