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GSK/Merck & Co cut HPV vaccine prices for poor
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GSK & Merck press release below news articles
pharmatimes.com World News | May 10, 2013
GlaxoSmithKline and Merck & Co have slashed the price on their respective human papillomavirus vaccines to protect millions of girls in the developing world against cervical cancer.
The drugs giants have teamed up with the Global Alliance for Vaccines and Immunisations which will distribute Merck's Gardasil and GSK's Cervarix and has procured the vaccines for around $4.50 a dose. GAVI notes that the same vaccines can cost more than $100 in developed countries and the previous lowest public sector price was $13 per dose.
The not-for-profit organisation said that of the 275,000 women in the world who die of cervical cancer every year, more than 85% are in low-income countries, where the incidence of HPV infection is higher and there is little access to screening and treatment. GAVI chief executive Seth Berkley noted that "a vast health gap currently exists between girls in rich and poor countries. With [these] programmes we can begin to bridge that gap".
He added that by 2020 "we hope to reach more than 30 million girls in more than 40 countries". GAVI will start the HPV vaccines project in Kenya this month followed by Ghana, Laos, Madagascar, Malawi, Niger, Sierra Leone and Tanzania.
MSF not impressed
The move has not been unanimously welcomed, however. Kate Elder, vaccine policy adviser at Medecins Sans Frontieres, said that "it's really disappointing that pharmaceutical companies haven't offered GAVI a much better deal". She added that "the price is unjustifiably high and will add to the already spiralling vaccination costs faced by low-income countries".
While the price is much lower than that paid by developed countries, it will still cost nearly $14 to fully protect a girl against HPV, as three doses are given, Ms Elder noted. She added that it is "a lost opportunity to negotiate for a truly low price".
GSK teams up with Save the Children
Meantime, GSK has entered into a "unique partnership" with the Save the Children charity "to save the lives of one million children" in Africa.
Among the key initiatives are the transformation of an antiseptic (chlorhexidine) used in GSK's Cordosyl mouthwash into a product to cleanse the umbilical cord stump of new-borns to prevent serious infection and the roll-out of a powder-form of an antibiotic in child friendly doses to help fight pneumonia. Save the Children will be involved in helping GSK to develop medicines for children and have a seat on a new paediatric R&D board "to accelerate progress on innovative life-saving interventions for under- fives" and improve access in the developing world.
The partnership will initially run two programmes in Sub Saharan Africa Ð Democratic Republic of Congo and Kenya. GSK chief executive Sir Andrew Witty said "I hope this partnership inspires GSK employees and sets a new standard for how companies and NGOs can work together towards a shared goal".
His counterpart at Save the Children, Justin Forsyth, said that in the past, his charity "may not have embarked on a collaboration with a pharmaceutical company like GSK. But we believe we can make huge gains for children if we harness the power of GSK's innovation, research and global reach".
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Merck, GSK cut price of cervical cancer shots for poor countries
By Kate Kelland
LONDON | Thu May 9, 2013 7:17am EDT
(Reuters) - Drugmakers Merck and GlaxoSmithKline have cut the price of cervical cancer shots in a deal that will deliver them to poor countries for less than $5 a dose.
The new record low price for human papillomavirus (HPV) vaccines should mean millions of girls in developing countries can be protected against the disease, the Global Alliance for Vaccines and Immunisations (GAVI) said on Thursday.
"By 2020 we hope to reach more than 30 million girls in more than 40 countries," Seth Berkley, the group's chief executive, said in a statement announcing the price deal.
More than 85 percent of cervical cancer deaths are in poorer countries and globally, 275,000 women a year die of the disease. That means it kills more women worldwide than childbirth, according to GAVI, claiming a life every two minutes.
GAVI, a non-profit group that funds bulk-buy vaccine programs for poor countries, will deliver the cut-price shots.
It said in February that Ghana, Kenya, Laos, Madagascar, Malawi, Niger, Sierra Leone and Tanzania would be the first countries to get support in pilot projects.
The vaccines - Merck's Gardasil and GSK's Cervarix - can cost more than $100 in developed countries and have been introduced in immunization campaigns in rich regions like the United States and Europe in recent years.
They are generally given to girls aged around eight or nine and over to protect them against the human papillomavirus that causes almost all cervical cancers.
A study published in 2011 found that since 1980, new cervical cancer cases and deaths have dropped substantially in rich countries - mostly due to better screening and earlier detection - but increased sharply in poor regions. Sub-Saharan Africa has 22 percent of all cervical cancer cases worldwide.
"Developing countries bear an increasing burden of cervical cancer and it is only right that our girls should have the same protection as girls in other countries," said Richard Sezibera, former Health Minister of Rwanda and a GAVI board member.
The U.S. drugmaker Merck said it expects to supply around 2.4 million doses of Gardasil at $4.50 per dose to GAVI-eligible countries between 2013 to 2017. British rival GSK said its Cervarix shot would cost $4.60 per dose.
Yet critics said the deal was still far too expensive for many poor countries - particularly since the vaccines need to be given as three doses to ensure full protection against HPV.
"It will still cost nearly $14 to fully protect a girl against HPV," said Kate Elder of the international charity Medecins Sans Frontieres (MSF).
"It's really disappointing that pharmaceutical companies haven't offered GAVI a much better deal."
MSF said Merck made $1.63 billion and GSK more than $416 million from their HPV vaccines in 2012 alone. It accused the companies of "seeking to maximize their profits on the backs of developing countries".
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GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant], Merck's HPV Vaccine, Available to Developing Countries through UNICEF Tender
Merck press release Thursday, May 9, 2013 7:20 am EDT
"This partnership highlights Merck's commitment to working closely with GAVI to ensure broad and sustained access to GARDASIL in the world's poorest countries, where the burden of cervical cancer is greatest."
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company has been awarded a significant portion of the UNICEF human papillomavirus (HPV) vaccine tender, and will provide sustained supply of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] to GAVI-eligible countries. This agreement follows the GAVI Alliance's earlier announcement that HPV vaccines would be included in its portfolio for the first time. GAVI is expected to support the introduction of HPV vaccination in 28 countries by the end of 2017.
Through this initial tender award, Merck expects to supply approximately 2.4 million doses of GARDASIL to GAVI-eligible countries between 2013 to 2017 to help meet vaccine demand for countries already approved or recommended for approval by GAVI for HPV vaccine demonstration projects and national introductions. Additional awards by UNICEF are anticipated as vaccine demand increases.
"It is essential that every young girl around the world have access to HPV vaccines. Today's decision by UNICEF is an important step forward," said Julie L. Gerberding, M.D., president, Merck Vaccines. "This partnership highlights Merck's commitment to working closely with GAVI to ensure broad and sustained access to GARDASIL in the world's poorest countries, where the burden of cervical cancer is greatest."
"A vast gap currently exists between girls in rich and poor countries. With today's announcement of GAVI's programmes we can begin to bridge that gap to help protect girls against cervical cancer no matter where they are born," said Dr. Seth Berkley, CEO of the GAVI Alliance. "By 2020 we hope to reach more than 30 million girls in more than 40 countries. This is a transformational moment for the health of women and girls across the world. We thank the manufacturers for working with us to help make this happen."
Following a 2009 report, the World Health Organization recommended that routine HPV vaccination be included in national immunization programs to help prevent cervical cancer and other HPV-related diseases. It is estimated that approximately 500,000 women develop cervical cancer annually around the world, with about 85 percent of cases occurring in developing countries. Cervical cancer is the third most common type of cancer among women worldwide. High-risk HPV types 16 and 18 cause about 75 percent of cervical cancers, 70 percent of vaginal cancers, 40 to 50 percent of vulvar cancers and 80 percent of anal cancers.
GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] is indicated in the United States for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved for use in boys and men 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
Important information about GARDASIL
GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.
GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal and anal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, or anal intraepithelial neoplasia.
GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.
Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal and anal cancers caused by HPV Types 16 and 18.
Select safety information for GARDASIL
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.
Because vaccines may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
GARDASIL is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.
Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.
About GARDASIL
GARDASIL is approved for use in more than 125 countries. To date, more than 111 million doses have been distributed worldwide; however, it is not known how many doses have been administered.
Other Merck access efforts for GARDASIL in the developing world
Merck is pursuing a systematic and thoughtful approach to improve access to GARDASIL in the developing world through four key pillars: innovation, partnerships, pricing and implementation. Key efforts include:
· In September 2012, Merck announced it will donate 460,000 doses of GARDASIL over a two-year period to the Republic of Uganda to help the Ministry of Health launch a HPV vaccination program in 12 districts in the country. The program represents the first phase of Uganda's national rollout plan for HPV vaccination.
· In April 2011, the Government of Rwanda, Merck and QIAGEN launched a comprehensive cervical cancer prevention program in Rwanda incorporating both HPV vaccination and HPV testing, the first program of its kind in Africa. In its initial year, an estimated 93 percent of eligible girls 12 to 15 years of age in Rwanda were vaccinated with three doses of GARDASIL.
· In 2010 Merck partnered with the Royal Government of Bhutan and the Australian Cervical Cancer Foundation to launch a six-year national vaccination program with GARDASIL for appropriate girls and young women between the ages of 12 and 18 in Bhutan. Merck provided GARDASIL to the program partners at no cost in the first year and for the remaining five years is providing it at an access price.
· In 2009 Merck also announced a partnership with QIAGEN N.V. focused on increasing access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world. This initiative was the first time a vaccine manufacturer and a molecular diagnostics company collaborated to help address the burden of cervical cancer with a comprehensive approach.
· Merck has also donated more than one million doses of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] through the GARDASIL Access Program, which was established in 2007 to help enable organizations and institutions in eligible lowest income countries to gain operational experience designing and implementing HPV vaccination projects.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Merck Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2012 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Please see Prescribing Information for GARDASIL® at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and Patient Information for GARDASIL at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.
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GSK enters new commitment with the GAVI Alliance to supply cervical cancer vaccine for girls in the world's poorest countries
GSK press release Issued: Thursday 9 May 2013, London UK
GlaxoSmithKline (GSK) today announced a new commitment to the GAVI Alliance to supply its cervical cancer vaccine as part of a new long term programme to help protect girls against cervical cancer in the world's poorest countries. To start the programme and over the next two years, GSK will supply doses of Cervarix® (Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)) to four new GAVI demonstration projects at a significantly discounted price of $4.60 per dose.
Christophe Weber, President and General Manager, GSK Vaccines said: "Cervical cancer is a significant issue especially in poorer countries where the availability of screening is limited. We are pleased to be expanding our commitment to GAVI by delivering our Cervarix® vaccine to help protect girls in the developing world. This continues our significant commitment to make our vaccines accessible to as many people as possible, no matter where in the world they live. We hope that this will help reduce the burden of cervical cancer and positively impact future generations."
"A vast gap currently exists between girls in rich and poor countries. With GAVI's programmes we can begin to bridge that gap so that all girls can be protected against cervical cancer no matter where they are born," said Dr Seth Berkley, CEO of the GAVI Alliance. "By 2020 we hope to reach more than 30 million girls in more than 40 countries. This is a transformational moment for the health of women and girls across the world. We thank the manufacturers for working with us to help make this happen."
The approved GAVI demonstration programmes will begin over the coming months and will help build vital experience in delivering cervical cancer vaccines to girls aged 9 years and over. The demonstration programmes will enable the countries to evaluate their ability to roll out national immunisation programmes.
GSK currently supplies more than 80% of its total vaccine volumes to developing countries and is a long-standing partner with GAVI. This latest commitment adds to existing agreements to supply up to 480 million doses of its pneumococcal vaccine to GAVI over the next 10 years and 132 million doses of its rotavirus vaccine to GAVI over the next five years.
GSK's commitment to GAVI-eligible countries
GSK has a long relationship with GAVI and has agreements in place to provide Rotarix™ (rotavirus vaccine, live, attenuated) and Synflorix™ (pneumococcal polysaccharide conjugate vaccine (adsorbed)) to GAVI at significantly reduced prices to help accelerate access to vaccines in developing countries.
GSK is widely recognised for having sustainable access strategies for its vaccines and was again named number one on the Access to Medicines Index in 2012.
About cervical cancer
Cervical cancer is a significant problem in developing countries and it is estimated that, by 2030, 474,000 women per year will die of cervical cancer.1 Worldwide, cervical cancer is the second most common cancer in women with an estimated 529,000 new cases and 275,000 deaths in 2008.2 More than 85% of this global disease burden occurs in developing countries.2 With population growth and ageing, the number of cervical cancer cases is expected to increase 1.5 fold by 2030.3
About Cervarix®
· Cervarix® is a vaccine that helps protect girls and women against cervical cancer4
· In clinical trials, the most common adverse events after vaccination with Cervarix® were injection site reactions (such as pain, redness, swelling), headache, muscle pain and fatigue4
· Since its launch in 2007, Cervarix® has become available in 126 high, middle and low income countries around the world5
· In 2009, Cervarix® was awarded prequalification status by the World Health Organization enabling UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries at affordable prices
· To date, over 36 million doses of Cervarix® have been distributed5
· The vaccine is manufactured at GSK Vaccines HQ in Wavre, Belgium
· Cervarix® is a registered trademark of the GlaxoSmithKline group of companies and Rotarix™ and Synflorix™ are trademarks of the GlaxoSmithKline group of companies.
GlaxoSmithKline Ð one of the world's leading research-based pharmaceutical and healthcare companies Ð is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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