Sanofi and Sobi donate up to 500 million additional IUs of clotting factor to WFH Humanitarian Aid Program

  • Additional donation of factor therapy fulfills 2014 pledge to donate up to an unprecedented 1 billion IUs for humanitarian use
  • More than 75% of people with hemophilia have limited or no access to diagnosis and treatment, especially in the developing world
  • More than 17,200 people with hemophilia in over 40 countries have been treated with medicine provided by Sanofi and Sobi since donations to the WFH Humanitarian Aid Program began in 2015

CAMBRIDGE, Mass., June 14, 2020 /PRNewswire/ -- Sanofi and Sobi™, together with the World Federation of Hemophilia (WFH) and WFH USA, today announced an extension of their support of the WFH Humanitarian Aid Program with an additional donation of up to 500 million IUs of factor therapy for humanitarian use, fulfilling the 2014 pledge to donate up to an unprecedented 1 billion IUs over a ten-year period. Since the initial pledge to donate their medicine to the program, over 450 million IUs have been provided and over 17,200 people with hemophilia have been treated with factor donated by Sanofi and Sobi between 2015 and 2019. Additionally, the companies will continue to provide financial support for initiatives such as treatment, access and education programs for a period up to five years,

"Through this partnership with Sanofi and Sobi, our Founding Visionary Contributors, we have been able to significantly expand the reach of the WFH Humanitarian Aid Program, which is leading to a paradigm shift in the management of hemophilia in areas with limited or no access to treatment and care," said Alain Baumann, Chief Executive Officer, World Federation of Hemophilia. "With their continued support, we are confident that people with hemophilia in these countries will continue to receive much needed treatment that is both predictable and sustainable – the foundation of the WFH Humanitarian Aid Program. Our vision at WFH is treatment for all."

Significant unmet need in developing world
More than 75% of people with hemophilia have limited or no access to diagnosis and treatment, particularly in the developing world. People with severe hemophilia in these countries often do not survive to adulthood; those who do, often face a life of severe disability, isolation and chronic pain. The underlying physical and psychological toll of hemophilia can be significant without reliable access to care.

"Patients are at the center of all that we do, and our support of the WFH Humanitarian Aid Program, together with Sobi, builds on Sanofi Genzyme's legacy of helping patients around the world have access to the treatments they need," said Bill Sibold, Executive Vice President and Head of Sanofi Genzyme. "In the past five years, we have seen the life-changing impact a reliable supply of factor therapy can have for people in developing countries; access to prophylactic treatment for children, corrective surgeries, all helping to reduce the burden of this disease. We are honored to play our role in providing hope to those patients and families most in need."

"For lasting change to become a reality, we need to recognize that access to treatment is a fundamental human right. We are proud to do our part to address this critical health issue, in partnership with Sanofi," said Guido Oelkers, CEO and President at Sobi. "Partnership in reaching the goals is essential. We are pleased to see others following our lead and encourage more companies to join in the shift that the WFH and their local organizations have made possible and that we together can carry forward. Only through a broad long-term commitment to increase awareness, knowledge and access to treatments will the effect of our donation be sustainable and withstanding."

The WFH Humanitarian Aid Program has over the years made significant improvements in providing access to care. A predictable supply of factor therapy is essential to improving treatment and care. In addition, education programs for treaters and patients are critical initiatives helping to develop in-country capacities to improve diagnosis and treatment monitoring; all of which are needed to create a sustainable treatment environment which lead to better outcomes for patients. Sanofi and Sobi's continued support of the WFH Humanitarian Aid Program for up to five more years, provides for a potential total contribution up to 1 billion IUs of extended half-life factor therapy for a period up to ten years, with the continued opportunity to address the treatment gap and raise the standard of care in the developing world.

A far-reaching impact on hemophilia care
With the provision of a consistent supply of factor, corrective surgeries and prophylaxis treatment for young children have become possible. Since initial shipments of Sanofi and Sobi medicines to the WFH Humanitarian Aid Program began, the impact has been far reaching. Through 2019:

  • 450 million IUs of clotting factor have treated over 17,200 people in 42 countries
  • 900 children under the age of 10 are receiving prophylaxis treatment
  • More than 160,000 acute bleeds have been treated
  • More than 2,300 surgeries have taken place including those that were life- and limb-saving

Sanofi and Sobi believe all patients should have access to the treatment they need regardless of where they live.

About the WFH Humanitarian Aid Program
The WFH Humanitarian Aid Program improves the lack of access to care and treatment by providing much-needed support for people with inherited bleeding disorders in developing countries. By providing patients with a more predictable and sustainable flow of humanitarian aid donations, the WFH Humanitarian Aid Program makes it possible for patients to receive consistent and reliable access to treatment and care. None of this would be possible without the generous support of Sanofi Genzyme and Sobi, our Founding Visionary Contributors; Bayer, our Visionary Contributor; Grifols and Roche, our Leadership Contributors; and our Contributor, CSL Behring. The WFH and WFH USA collaborate to manage and control the WFH Humanitarian Aid Program. To learn more about the WFH Humanitarian Aid Program, visit www.treatmentforall.org

About Sobi
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,400 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi's revenues amounted to SEK 14.2 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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Sanofi forward looking statements:
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)

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