Pharmaceutical Patient Assistance Programs Expand throughout the World
Over the last few months, several pharmaceutical companies have announced new donations and programs regarding vaccines, as well as increasing access to medicines for important diseases. Below is a summary of some of these activities and we will try to update the story as we come across other announcements.
GlaxoSmithKline
In late July, GlaxoSmithKline (GSK) announced that it would increase its commitment to the GAVI Alliance to provide vaccines to developing countries, helping to protect millions more children against infectious diseases. Under this new agreement, GSK will provide an additional 240 million doses of Synflorix™ to developing countries over the next ten years, helping protect up to 80 million more children from pneumococcal diseases such as meningitis and pneumonia.
This builds on the 480 million doses of the vaccine that GSK has already committed to GAVI through the Advance Market Commitment (AMC) framework, which is designed to bring heavily discounted vaccines to children living in the world’s poorest countries.
GSK provides GAVI with a broad portfolio of vaccines including: Synflorix which protects against pneumococcal disease; Rotarix™ vaccination for rotavirus, a common cause of diarrhoea; Cervarix® which helps protect girls against cervical cancer caused by human papilloma virus; and a combined vaccination for diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b.
With this new vaccine supply agreement extension, GSK is committed to provide more than 850 million vaccine doses that will help protect up to 300 million children and adolescent girls in the developing world from these diseases by 2024.
Christophe Weber, President and General Manager of Vaccines, GSK said: “Since its creation, GAVI and its support for the Advance Market Commitment has made a tremendous impact, saving millions of children’s lives. Pneumococcal disease however continues to cause death and suffering in our world’s poorest countries. We are proud to extend our commitment to GAVI to help save millions more children from this deadly disease.”
GSK has committed to provide the additional 240 million doses of Synflorix to GAVI at $3.40 per dose, a small fraction of developed world prices.
To date, more than 50 million doses of the vaccine have been delivered to GAVI countries, including Uganda, Mozambique, Madagascar, Kenya, Ethiopia and Pakistan. Zambia is the most recent country to include the vaccine in its national immunisation programme under the AMC in July 2013.
Roche
In early August, Roche announced that it entered into an agreement with the Medicines Patent Pool to increase access to Valcyte (valganciclovir), a key medicine to treat cytomegalovirus (CMV). CMV is a viral infection that can result in loss of vision and greater risk of death in people living with HIV. This infection affects around 1 in 10 people living with HIV in low-and middle-income countries.
The supply agreement between the Medicines Patent Pool and Roche will substantially improve access to an easy-to-take oral medicine to treat CMV, Valcyte – by making it up to 90% cheaper in 138 developing and emerging countries than it is currently available. The Medicines Patent Pool and Roche will consider adding more countries to the initial scope if there is a need and will also explore licensing and technology transfer as a second step to help local production of Valcyte and increase access to Valcyte in developing countries.
“The agreement announced today will make an oral treatment for CMV available at lower prices, to help break a cycle of lack of screening and treatment in many countries. With medicines available, HIV treatment providers can work on wider diagnosis and treatment and prevent avoidable blindness in people living with HIV,” said Greg Perry, Executive Director of the Medicines Patent Pool.
“This agreement demonstrates how working together can improve the availability of treatments for people in resource-limited countries. Roche is committed to making Valcyte available to patients suffering from HIV-related CMV infections in developing countries. Our aim is to provide access to affordable Valcyte that is produced under quality conditions and increase the number of people who access and benefit from our products,” said Daniel O’Day, COO of Roche Pharma.
Treatment of CMV is typically difficult to administer, requiring several injections to the eye. This requires hospitalisation of patients and care by highly trained staff , which are often not sufficiently available in developing countries. The oral treatment Valcyte is an alternative, but due to a number of reasons, including lack of screening and high prices, patients in developing countries have not been able to receive it.
This lower price should also help create a new market for Valcyte, stimulating greater treatment of CMV. With Roche now supplying lower-cost Valcyte, governments, treatment providers and funders can ramp up efforts to ensure screening for CMV becomes part of routine HIV care and people can access treatments to preserve their sight and extend their lives.
CMV infection is a preventable disease caused by cytomegalovirus (CMV) that attacks the retina of the eye in patients with suppressed immune systems, such as those infected with advanced-stage HIV. CMV is no longer a problem in industrialized countries, but still affects 10.1% (8.7% to 11.4%) of people living with HIV in low- and middle-income countries mainly in Asia, and to a lesser extent in Latin America and Africa1.
Roche has also agreed to license another medicine for use in HIV-related medicines to the Medicines Patent Pool, saquinavir, in case the need arises.
Sanofi
Sanofi announced that it has started producing its experimental dengue vaccine, the most advanced against the tropical disease, in a move to keep its lead over competitors ahead of the product’s likely launch in 2015, reported Reuters.
The mosquito-borne disease is a threat to nearly 3 billion people and is caused by four types of virus, none of which confers immunity from the others. Sanofi’s vaccine could generate sales of over $1 billion if successful, the article noted.
Guillaume Leroy, who heads the dengue vaccine project at Sanofi Pasteur, the French group’s vaccine unit, told reporters the group would be able to supply 100 million doses a year.
Sanofi Pasteur, which has been working on the project for 20 years, has kick-started production ahead of receiving authorization from regulators to ensure it will be the first company to launch this type of vaccine. Other drug companies are also working on dengue vaccines but Sanofi’s product is several years ahead.
“Production time is rather long, it takes two years to produce this vaccine,” said Anthony Quin, who heads Sanofi Pasteur’s manufacturing site in Neuville-sur-Saone, eastern France, where the group has invested 300 million euros ($391 million). “It was decided in 2009 to gain time to be ready to launch it in the market as soon as possible,” he added.
Dengue is the world’s fastest-spreading tropical disease and represents a “pandemic threat”, infecting an estimated 50 million people across all continents, according to the World Health Organization (WHO). Transmitted by the bite of female mosquitoes, dengue is occurring more widely due to increased movement of people and goods – including carrier objects such as bamboo plants and used tires – as well as floods linked to climate change.
Data released last year from a test in Thailand showed Sanofi’s vaccine failed to protect against one type of dengue virus, but confirmed for the first time that a safe dengue vaccine was possible.
Making a mixed dengue vaccine containing four different virus strains can produce uneven results, underscoring the complexity of a disease that scientists have been trying to develop a vaccine against for more than 70 years.
Sanofi, however, has said it would wait for data from two late-stage trials to get a better understanding of the vaccine. Around 45,000 people in Asia and Latin America are taking part in these tests, with results due in late 2013 and 2014.