Medicines360, a non-profit pharmaceutical company, and Actavis, Inc., a leading global specialty pharmaceutical company, have signed a partnership agreement to support Medicines360's mission to reduce cost as a barrier to accessing women's birth control. This partnership will make the Intrauterine Device (IUD) available in the US commercially and at a very low price in US public sector clinics.

As part of this agreement, Actavis has licensed the US commercial rights for the Medicines360 LNG20 Intrauterine Device (IUD). Medicines360 retains rights to market the product in the US public sector, including family planning clinics that provide services to low-income women. LNG20, originally developed by Uteron Pharma SPRL in Belgium, is designed to initially deliver 20 mcg of levonorgestrel per day for the indication of long term contraception, and is currently in phase III clinical trials in the United States. Pending US Food and Drug Administration (FDA) approval, the LNG20 IUD could be launched in the US as early as 2014.

"Addressing unmet needs of underserved women is the reason Medicines360 exists," said Victoria Hale, PhD, Medicines360 founder & CEO. "The belief that companies have to choose between serving the public sector and making money is a fallacy but we're setting out to demonstrate the ways in which this is possible. It doesn't have to be a money-losing proposition or perpetually financed through philanthropy. IUDs in general have been shown to be a very effective contraceptive, but have been too expensive for most women. My motivation is to provide access to effective birth control options regardless of a person's income.  Actavis shares our vision of a world in which a woman's access to birth control is not compromised by lack of education, product availability or price. Having control over if and when she becomes pregnant empowers a woman to make choices that positively impact her life and the lives of others," continued Dr Hale.  "We believe in partnering and by leveraging Actavis' expertise in development, distribution and manufacturing, we are better prepared to address a primary unmet healthcare need for many American women."

According to Guttmacher Institute, annually, half of all pregnancies in the US are unplanned, with over 40 per cent of those ending in abortions. Many of these are attributed to women who are uninsured or under-insured and living at or near the federal poverty line. IUDs are long-acting, reversible and highly effective in preventing pregnancy. However, for women without adequate medical coverage, the up-front cost of an IUD, along with misinformation, continues to create barriers. As a result, IUD use in the US lags considerably, relative to other nations.

"Ensuring patient access to affordable generic pharmaceuticals and specialty brand products that provide consumers with additional treatment options is fundamental to Actavis' history of leadership in pharmaceuticals. Medicines360's business model, which is unique in ensuring access and affordability, represents a continuation of our commitment to these shared principles," said Fred Wilkinson, president, Actavis Specialty Brands. "Contraception is a critical component in the basic healthcare status of women. The addition of this IUD to our line of currently available and pipeline products affords Actavis the unique opportunity to provide enhanced access as well as educate the public on the benefits of each form of contraception."

Under terms of this exclusive agreement, Actavis acquires the rights to market, sell and distribute LNG20 in the private sector commercial markets in the US and Canada for a payment of approximately $50 million. Actavis will pay Medicines360 additional milestone payments totalling up to $125 million plus royalties on annual net sales. All monies received by Medicines360 from this partnership will go toward driving down the product's cost in the public sector and future product development. This reciprocity structure, along with educational offerings, will increase contraceptive access for all women.

In January 2013, Actavis, Inc. acquired Belgium based, Uteron Pharma SPRL, which developed the levonorgestrel IUD product. The product is currently pending approval in several EU countries, with potential launch in 2013, and is in late phase III development for the US market. A patent portfolio covers this product until 2031. Actavis has marketing rights in Western Europe and other regions and is partnered with Gedeon Richter in certain European countries. Medicines360 had previously acquired the commercial rights from Uteron for the IUD in the US and certain other countries.

Actavis, Inc. is focused on developing, manufacturing and distributing generic, brand and biosimilar products.