NEW YORK--(BUSINESS WIRE)--Pfizer Inc., the Bill & Melinda Gates Foundation, and the Children’s Investment Fund Foundation (CIFF) today announced a multi-year extension of their collaboration to further broaden access to Pfizer’s all-in-one injectable contraceptive, Sayana® Press (medroxyprogesterone acetate), for women most in need in some of the world’s poorest countries. Sayana Press will now be available to qualified purchasers at a guaranteed price of US $0.85 per dose, a reduction from the previous price of US $1.00 per dose.
A consortium of organizations from the public and private sector first collaborated in 2014 to assess demand for Sayana Press. Initial pilots conducted in Niger, Senegal and Uganda demonstrated strong demand for Sayana Press among younger women: up to 34 percent of doses administered across these three countries were to women between the ages of 20 and 24. Sayana Press is also attracting women who have never before used contraceptives, with 24- 42% of doses given across the pilots received by new users of family planning1.
By working together to expand the range of contraceptive options available, more women in more countries have had access to Sayana Press every year. By the end of 2016, 6.4 million units of Sayana Press were shipped to 20 developing world countries, potentially reaching more than 1.5 million women – up from 350,000 women at the end of 20142. Pfizer is continuing to make investments in its manufacturing facilities to meet the expected increase in market demand.
“Our hope is that more women in the developing world will now have access to Sayana Press, as an option, to meet their specific family planning needs,” said John Young, President, Pfizer Essential Health. “We have seen the impact of our work with the Bill & Melinda Gates Foundation, the Children’s Investment Fund Foundation and other collaborating organizations, and look forward to our continued efforts to enable wider availability of Sayana Press. By improving access to contraceptive options, we can help empower women most in need to better plan their families.”
Sayana Press combines a longer-acting, reversible contraceptive with the BD Uniject™ injection system developed by BD (Becton, Dickinson & Company). This all-in-one prefilled, single-use, auto-disable system eliminates the need to prepare a needle and syringe. It also allows the contraceptive to be administered by a health worker outside of a clinical setting, or it can be self-injected if approved locally and after health care worker instruction.
“BD is honored to join Pfizer, the Bill and Melinda Gates Foundation, and CIFF in empowering women to manage such an important aspect of their lives,” said Renuka Gadde, Vice President of Global Health for BD. “We commend their efforts to scale the program so that women in all parts of the world can be offered the choice to plan and space their families.”
The unmet need for contraception remains high. An estimated 225 million women in developing countries would like to delay or prevent pregnancy but are not using any method of contraception3. Common reasons for this include difficulty travelling to health facilities, social barriers, and lack of knowledge around what contraceptive methods are available.4 Because of its unique contraceptive delivery technology – enabling the product to be compact, discreet, and easily transportable – Sayana Press can be provided in low-resource, non-clinic settings, potentially transforming the way in which women can access and receive their preferred method of contraception.
Several global efforts are underway to expand voluntary family planning services and contraceptive options for women in developing countries, so they are able to time and space their pregnancies. This commitment is a central focus of Family Planning 2020, a global partnership to ensure that by 2020, an additional 120 million women have the ability to access and voluntarily use a method of modern contraception. According to the 2016 FP2020 progress report, for the first time, more than 300 million women are using modern contraceptives across the 69 countries where progress is measured. As a result, an estimated 82 million unintended pregnancies were prevented and 124,000 maternal deaths were averted between July 2015 and July 20165.
“Contraceptives are highly cost-effective health investments which save lives. If every girl and woman who wanted to use modern contraception was able to, we could prevent 170,000 maternal deaths and around 1.6 million newborn deaths each year6. The sub-cutaneous injectable contraceptive is an important innovation, which can reach new and younger users who often face high barriers to accessing comprehensive choices. Increasing access and choice of affordable contraceptives are crucial parts of this important collaboration,” said Alvaro Bermejo, Executive Director at the Children’s Investment Fund Foundation.
The consortium of public- and private-sector donors and aid organizations supporting this effort includes BD, the United Kingdom’s Department for International Development (DFID), UNFPA, the United Nations Population Fund, and the United States Agency for International Development (USAID). These organizations play an important role in ensuring that women in the world’s poorest countries have access to a full range of contraceptive options. In addition to assisting with procurement, this consortium supports country introductions and the delivery of a range of high quality modern contraceptive options, including subcutaneous injectable contraceptives. At the country level, the organizations also work with local governments with the goal of including modern contraceptives in reproductive health plans and budgets, coordinating health-worker trainings to improve quality counselling and services, and raising awareness about the availability of a variety of modern contraceptive options.
“We know that when women have a range of contraceptive options to time and space their pregnancies, they’re more likely to find one that suits their needs,” said Dr. Chris Elias, President of Global Development Programs at the Bill & Melinda Gates Foundation. “New innovations in contraceptive technology are needed to expand the number of methods available to women and adolescents so they can take charge of their health and their futures.”
About Sayana Press
Sayana Press combines a longer-acting, reversible, contraceptive with the all-in-one prefilled, single-use, auto-disposable BD Uniject™ injection system that eliminates the need to prepare a needle and syringe. The contraceptive is indicated for the prevention of pregnancy. Each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- one week). The product can be stored without refrigeration. Sayana Press professional and patient information, including the risk of bone mineral density loss and other warnings and precautions for use, including in adolescents, can be found here7.
Sayana Press is approved by regulatory authorities in more than 40 countries across the European Union and in a number of FP2020 focus countries. These countries include Bangladesh, Burkina Faso, Kenya, Niger, Nigeria, Senegal and Uganda, as well as additional markets in Latin America and within Asia Pacific. Additional regulatory submissions are being pursued. Sayana Press is not approved or available for use in the United States.
Sayana Press is also approved for administration by self-injection in 17 countries in both the developed and developing worlds.
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has nearly 50,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit bd.com.
Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
Children’s Investment Fund Foundation
CIFF is the world’s largest philanthropy that focuses specifically on improving children’s lives. We know that the returns on smart investments in areas such as children’s early development and adolescent girls are especially high. So we aim to play a catalytic role as a funder and influencer to deliver urgent and lasting change at scale. Areas of work include improving children and adolescents' health, nutrition, deworming, welfare and smart ways to slow down and stop climate change. More information at ciff.org.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of May 8, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information related to Sayana Press and its potential benefits that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when any applications for Sayana Press or label updates for Sayana Press may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities may approve such applications and any other applications that are pending for Sayana Press, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Sayana Press; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
i PATH. Monitoring Sayana Press Pilot Introductions. Available at: http://www.path.org/publications/files/RH_sayana_press_pilot_intro_2017.pdf. Accessed: May 2, 2017.
ii Data on file at Pfizer Inc. Where a woman is assumed to have used 4 doses of the total units shipped in 2014; where each woman is assumed to have used 4 doses of the total number shipped (2014-2016).
iii World Health Organization. Family Planning/Contraception Fact Sheet. Available at: http://who.int/mediacentre/factsheets/fs351/en/. Accessed: February 22, 2017.
iv UNFPA. Family Planning. Available at: https://www.unfpa.org/family-planning. Accessed: February 23, 2017.
v Family Planning 2020. Momentum at the Midpoint: 2015-2016. Available at: http://progress.familyplanning2020.org/page/introduction/executive-summary-1. Accessed: February 23. 2017.
vi Guttcmaher Institute. Adding it Up: The Costs and Benefits of Investing in Sexual and Reproductive Health 2014.
vii electronic Medicines Compendium (eMC). Sayana Press SPC. Available at: http://www.medicines.org.uk/emcmobile/medicine/27798. Accessed: February 22, 2017.