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Pioneering the Nonprofit Pharmaceutical Industry

Medicines360 is a nonprofit women’s health pharmaceutical company in San Francisco. As a nonprofit, we answer to our mission: to remove cost as a barrier to health by developing and providing quality, affordable women’s health products. We were founded in 2009 and brought our first product to the U.S. market in 2015.

We’re proud of our success in bringing products to the market through innovative partnerships. We have partnered with a for-profit biopharmaceutical company in the U.S. to offer our product to 340B-enrolled clinics and hospitals at a price substantially below the 340B ceiling price set by statute. We believe that our efforts have resulted in estimated savings to 340B-enrolled sites and the low-income and uninsured patients they serve of $54 million since April 2015.*

We’re also working to help ensure that women in low- and middle-income countries have access to our product through our Avibela Project, in partnership with organizations including WCG Cares, Population Services International, Marie Stopes International, and DKT International.

Our unique nonprofit pharmaceutical model allows us to focus on the most vulnerable patients:

  1. Uninsured: 8.5% of Americans (27.5 million people) were uninsured for the full 2018 calendar year. Because these patients often pay out-of-pocket, they are particularly sensitive to cost. Development of low-cost options can be the difference between access and no access to the medications these patients may need.
  2. Underinsured: Even with insurance, many Americans cannot afford the medicines they need. Patients frequently cite the high out-of-pocket cost of prescription drugs for not taking medicines as scheduled or not being able to get them in the first place. In addition, some insured people have no coverage for certain preventative services. For these patients, lower drug costs are critical to enable access.

Components of Medicines360’s pioneering mission-driven approach include the following:

  1. Our nonprofit business model. Medicines360 is a Medical Research Organization, a public charity exempt from Federal income tax under Section 501(c)(3) of the U.S. Tax Code. We operate exclusively for charitable purposes and benefit from the oversight of an independent board of directors. By removing traditional shareholder profit requirements, we can focus on public benefit as our bottom line.
  2. Expertise in drug-device product design and development. We have experience in scaling clinical trials to study our product in subjects that accurately reflect the U.S. population. We also have ongoing research and development activities involving other women’s health products.
  3. Our public sector engagement. Medicines360’s engagement team focuses on the public sector, ensuring that 340B-enrolled clinics and hospitals have the information and resources needed to care for their patients. We estimate over 1,500 340B sites have accessed our product for the women they serve.
  4. Knowledge of pharmaceutical and public health policy. Through our experience bringing a product to market as a nonprofit pharmaceutical company, we have identified potential changes to complex federal and state policies that could expand affordable access to medicines for women.

American drug pricing is a complex and bipartisan issue, with both Democrats and Republicans evaluating ways to reduce spending. In 2018, The U.S. Department of Health and Human Services issued the American Patients First blueprint, a comprehensive plan to bring down prescription drug prices and out-of-pocket costs.

Over the last ten years, we’ve thrived at the intersection of nonprofit public health, pharmaceutical research and development, and health policy. Medicines360 is positioned to build on our wealth of experience and leverage our expertise to increase access to medicines for all Americans.

* Data on file. Medicines360: San Francisco, CA.

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