E-DRUG: DNDi and Pharco to test affordable hepatitis C regimen
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DNDi and Pharco to test affordable hepatitis C regimen with support of Malaysian and Thai governments
Dear colleagues,
April 13, at the 2016 International Liver Congress in Barcelona, the
Drugs for Neglected Diseases initiative (DNDi) announced the recent signing
of licensing agreements and the forthcoming start of clinical trials which
we hope will bring about more affordable additional hepatitis C treatment
options for patients and clinicians.
Please find below the press release:
http://www.dndi.org/2016/media-centre/press-releases/dndi-pharco-hepc-malays
ia-thailand/
Also available is a short but comprehensive paper that outlines DNDis R&D
strategy and gives further details on the licensing deals and how these may
shake up the current access to HCV treatment landscape:
http://www.dndi.org/wp-content/uploads/2016/04/AlternativeRDStrategyHepC.pdf
Best,
Rachel
Drugs for Neglected Diseases initiative and Pharco Pharmaceuticals to test
affordable hepatitis C regimen with support of Malaysian and Thai
governments.
Potentially pan-genotypic combination of ravidasvir and sofosbuvir to be
tested in Malaysia and Thailand with target price of under $300
[English
<http://www.dndi.org/2016/media-centre/press-releases/dndi-pharco-hepc-malay
sia-thailand/>
Español
<http://www.dndi.org/2016/media-centre/press-releases/dndi-pharco-hepc-malay
sia-thailand-es/> ]
[Français
<http://www.dndi.org/2016/media-centre/press-releases/dndi-pharco-hepc-malay
sia-thailand-fr/>
Português
<http://www.dndi.org/2016/media-centre/press-releases/dndi-pharco-hepc-malay
sia-thailand-pt/> ]
The Drugs for Neglected Diseases initiative (DNDi) and the Egyptian drug
manufacturer Pharco Pharmaceuticals have signed agreements covering the
clinical testing and scale-up of a hepatitis C treatment regimen at a price
of just under $300.
If our clinical trials are successful, this regimen could become part of a
public health approach to treating hepatitis C that will be an alternative
to todays high drug prices and treatment rationing, said Dr Bernard
Pécoul, Executive Director of DNDi. An affordable cure for this deadly
disease that treats all strains, or genotypes, of the disease, is
essential to tackling the worldwide hepatitis C epidemic.
DNDi will be launching clinical trials to test a combination treatment of
the drug candidate ravidasvir and the registered hepatitis C drug sofosbuvir
in pan-genotypic patient populations in Malaysia and Thailand, as soon as
the necessary approvals are received. Ravidasvir is an NS5A inhibitor, one
of a new generation of direct-acting antivirals (DAAs) that are
revolutionizing the treatment of hepatitis C. In a Phase III clinical trial
in Egypt, conducted by Pharco.
<http://www.businesswire.com/news/home/20151116005444/en/Pharco-Pharmaceutic
als-Reports-Ravidasvir-Achieved-100-Cure>
ravidasvir showed cure rates of up to 100% in patients with genotype 4 when used in combination with sofosbuvir, which also is a DAA.
DNDi has licensed rights for ravidasvir in low- and middle-income countries
from Presidio Pharmaceuticals.
Pharco has agreed to supply DNDi with the combination sofosbuvir plus
ravidasvir for its clinical studies for $300 per course of treatment. For
the scale-up of this regimen, once approved, Pharco has agreed to set the
commercial price at $294 or less per treatment course.
Because of the high prices of new hepatitis C medicines, it has been almost
impossible for governments to provide access to treatment at the necessary
scale, said YB Datuk Seri Dr. S. Subramaniam, the Minister of Health in
Malaysia. We are pleased to support this project and hope data from these
studies will support our efforts to introduce this combination as soon as
possible and scale up to reach all patients in need.
DNDis Phase II/III studies in Malaysia and Thailand will be conducted with
the full cooperation of both governments and will compare sofosbuvir plus
ravidasvir with a current standard of care, sofosbuvir plus daclatasvir.
These studies will enroll approximately 1,000 participants and will evaluate
the efficacy, safety, and pharmacokinetics of the sofosbuvir plus ravidasvir
combination in patients with various levels of liver fibrosis, various
genotypes, and with/without HIV co-infection.
We are encouraged by the signing of these agreements as they will help
millions of people who are affected by chronic hepatitis C infection around
the world, said Dr. Amnuay Gajeena, Director General of the Department of
Disease Control in Thailand. Accessibility to affordable DAAs is key and
participation in this research will facilitate the process of scaling up
effective treatment of hepatitis C infection, and foster the prevention and
control of the disease.
Malaysia and Thailand are among the many middle-income countries that are
excluded from the voluntary licensing agreements that Gilead and
Bristol-Myers Squibb, the intellectual property holders of the hepatitis C
drugs sofosbuvir and daclatasvir, respectively, have concluded with generic
companies. Of the up to 150 million people infected with chronic hepatitis C
globally, approximately 75% live in middle-income countries.
Once these trials have been successfully completed and the safety and
efficacy data of this combination assessed, we will encourage governments to
design their national health strategies to use all options at their disposal
to gain access to life-saving DAAs, including price negotiation, voluntary
licensing, or the use of TRIPS flexibilities such as patent oppositions and
compulsory licensing, added Dr. Pécoul.
Before DAAs became available, hepatitis C treatment consisted of multiple
injections over a period of up to one year and frequently caused severe side
effects. Treatment was only successful 40-80% of the time. DAAs have
transformed treatment options for patients and clinicians, but multiple
barriers to access for patients exist, in particular, price. As with the
introduction and scale-up of antiretroviral therapy for HIV/AIDS over the
past 15 years, new and innovative public health approaches to HCV treatment
will require affordable access to DAAs.
"Egypt has the worlds highest hepatitis C prevalence, yet thanks to an
Egyptian Presidential program that aims to treat one million patients a
year, economies of scale have helped make DAAs affordable and are helping to
reach our goal of a world free from hepatitis C, said Dr. Sherine Helmy,
CEO of Pharco Pharmaceuticals. We hope that our collaboration with DNDi to
develop a combination treatment that costs $3.50 per day or less as
opposed to $1000 per day for only one pill will lead to widespread access
to safe, effective, and affordable treatment for hepatitis C patients around
the world.
Note to editors:
* Today, DNDi released a paper outlining its R&D strategy for
hepatitis C, An alternative Research and Development Strategy to Deliver
Affordable Treatments for Hepatitis C Patients
http://www.dndi.org/wp-content/uploads/2016/04/AlternativeRDStrategyHepC.pdf
DNDis paper describes how the race to approve blockbuster DAAs in the US
and the European Union has led to exorbitant drug prices and also has
neglected certain patient populations. Under the current R&D model, research
has prioritized genotypes which are predominant in high-income markets, and
has promoted competition rather than collaboration for the development of
optimal combinations for public health use.
* Further details of the terms of the non-exclusive license agreement
between DNDi and Presidio, including the lists of countries covered, are
provided in DNDis R&D strategy paper (see above).
* The Agreement on Trade-related Aspects of Intellectual Property
Rights (TRIPS) of the World Trade Organization (WTO) sets forth minimum
standards for intellectual property protection. TRIPS flexibilities refers
to fully legal steps governments can take to overcome intellectual property
barriers to access to medicines, including compulsory licensing, parallel
importation, etc. and were reaffirmed in the
<https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.>
November 2001 Declaration on the TRIPS Agreement and Public Health.
Press contacts:
Ilan Moss (on site at the International Liver Congress), DNDi North America:
+1 646 266 5216, imoss@dndi.org
Manisha Sharma, DNDi India: +91 9711 009 088,
msharma@dndi.org
Violaine Dällenbach, DNDi Europe: +41 22 906 92 47, +41 79 424 14 74,
vdallenbach@dndi.org
About DNDi:
A not-for-profit research and development organization, DNDi works to
deliver new treatments for neglected diseases, in particular leishmaniasis,
human African trypanosomiasis, Chagas disease, specific filarial infections,
paediatric HIV, mycetoma, and hepatitis C. Since its inception in 2003, DNDi
has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ),
nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping
sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy
for visceral leishmaniasis in Africa, a set of combination therapies for
visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole
for Chagas disease. DNDi has established regional disease-specific
platforms, which bring together partners in disease-endemic countries to
strengthen existing clinical research capacity, as well as to build new
capacity where necessary. <http://www.dndi.org/> www.dndi.org
About Pharco:
Pharco Pharmaceuticals, Inc. is the largest manufacturer of pharmaceuticals
in Egypt, focused on research, formulation, manufacturing and
commercialization of pharmaceutical products in the MENA region. Today,
Pharco employs over 8,000 employees, and has over 500M product sales
unitsranking as the leader in the Egyptian pharmaceutical market. Pharco
also exports to 47 countries around the world. Pharco works towards one
goal...to provide highly effective and safe pharmaceutical products to
patients at an affordable price. Pharco licensed ravidasvir hydrochloride,
formerly known as (PPI-668), from Presidio Pharmaceuticals, a San
Francisco-based clinical stage, specialty pharmaceutical company.
<http://pharco.org> http://pharco.org
"Rachel M. Cohen" <rachel.cohen72@gmail.com>