Pfizer to expand Sayana Press contraceptive access to poor countries

Through this collaboration of organizations from the public and private sectors, Sayana Press will be sold for US $1 per dose to qualified purchasers, who can help enable the poorest women in these countries to have access to the contraceptive at reduced or no cost.

Sayana Press combines a long-acting, reversible, contraceptive with an all-in-one prefilled, single-use, non-reusable Uniject injection system that eliminates the need to prepare a needle and syringe.

The use of this delivery system allows the contraceptive to be administered by health workers to women at home or in other convenient settings. The training required is basic and straightforward. The contraceptive is indicated for the prevention of pregnancy. Each subcutaneous injection prevents ovulation and provides contraception for at least 13 weeks (+/- one week).

Sayana Press professional and patient information, including the risk of bone mineral density loss and other warnings and precautions for use, can be found.

"This is a great example of applying innovation to a Pfizer heritage product to help broaden access to family planning," said John Young, President, Pfizer Global Established Pharma Business.

"Pfizer saw an opportunity to address the needs of women living in hard-to-reach areas, and specifically enhanced the product’s technology with public health in mind. I’m so pleased with the leadership from the Bill & Melinda Gates Foundation, the Children’s Investment Fund Foundation and other collaborating organizations that are helping create a sustainable market through an approach that could be a model for other medicines."

More than 200 million women in developing countries want to delay pregnancy or prevent undesired pregnancy but are not using any method of contraceptioniii.

Since the landmark London Summit on Family Planning in July 2012, the global community has been working together toward an ambitious and achievable goal: to provide an additional 120 million women in the world’s 69 poorest countries with access to voluntary family planning information and services by 2020.

On November 3, Family Planning 2020 (FP2020) — the global initiative that carries this commitment forward — released its second progress report, which found that, in 2013, the number of women using modern contraceptives in the 69 focus countries increased by 8.4 million (compared to 2012) to 273 million.

The report estimates that overall modern contraceptive use in 2013 helped avert 77 million unintended pregnancies and 125,000 maternal deaths. The collaboration announced today will help contribute to the FP2020 effort by providing more women around the world with contraceptive access and options.

"When women are able to plan their families, they are more likely to survive pregnancy and child birth, to have healthier newborns and children, and to invest more in their families’ health and wellbeing," said Dr. Chris Elias, President of Global Development Programs at the Bill & Melinda Gates Foundation.

"We are proud to be part of this innovative public-private collaboration that will help more women around the world — even in remote areas — plan their lives and their futures."

Injectable contraceptives are a widely-used family planning method among women in developing countriesvi, where the lifetime risk for death due to a maternal cause can be as high as one in 15.

In many developing countries, women must return to a clinic or health post every three months for a new injection from a skilled health worker, limiting access in remote and other hard-to-reach areas. Accordingly, experts have identified the need for a contraceptive method that can be administered in low-resource, non-clinic settings.viii Because of its delivery technology, expanding access to Sayana Press could help fill this gap.

Sayana Press is approved by regulatory authorities in 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 the Asia Pacific region. Additional regulatory submissions are being pursued. Sayana® Press is not approved or available for use in the United States.

"Far too many women die or are harmed because of unwanted pregnancies," said Michael Anderson, Chief Executive Officer at the Children’s Investment Fund Foundation. "This important partnership expands the choice of affordable contraceptives. We believe this will further support CIFF’s mission of enabling more women and children to survive and thrive."

The consortium of public- and private-sector donors and aid organizations supporting this collaboration includes PATH, the United Kingdom’s Department for International Development (DFID), the United Nations Population Fund (UNFPA), and the United States Agency for International Development (USAID).

These organizations play an important role in ensuring that Sayana Press reaches women in the world’s poorest countries. In addition to assisting with procurement, this consortium will support country introductions and the delivery of Sayana Press to health facilities and community-based distribution networks.

At the country level, the organizations will also work with local governments with the goal of including injectable contraceptive methods in reproductive health plans and budgets, coordinate health worker trainings, and raise awareness about the availability of Sayana Press.

This agreement builds on the momentum of recent efforts undertaken by this same consortium of public and private organizations on an introduction program to help make Sayana Press available for the first time in five countries in sub-Saharan Africa (Burkina Faso, Niger, Senegal and Uganda), coordinated by PATH, and in South Asia (Bangladesh).

Since the introduction program launched in Burkina Faso in July 2014, approximately 75,000 Sayana Press units have been distributed to health facilities in the introduction countries, and approximately 2,500 health care providers have thus far been trained on Sayana Press administration.

In Burkina Faso alone, preliminary data from five out of 23 total districts and two local nongovernmental organization partners involved in the introduction program indicate that approximately 5,729 women are using Sayana® Press, and 1,659 of these women are new users of family planningix.