Actavis and Medicines360 Announce Partnership to Advance Women’s Access to Affordable IUDs

Actavis Acquires U.S. Commercial Rights for LNG20 Intrauterine Device (IUD)

SAN FRANCISCO & PARSIPPANY, N.J.--()--Medicines360, a non-profit pharmaceutical company, and Actavis, Inc., a leading global specialty pharmaceutical company, today announced a historic partnership to support Medicines360’s mission to reduce cost as a barrier to accessing women’s birth control. The Medicines360 and Actavis partnership will make the IUD available in the U.S. commercially and at a very low price in U.S. public sector clinics. As part of this agreement, Actavis has licensed the U.S. commercial rights for the Medicines360 LNG20 Intrauterine Device (IUD). Medicines360 retains rights to market the product in the U.S. public sector, including family planning clinics that provide services to low-income women. LNG20, originally developed by Uteron Pharma S.P.R.L. 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 U.S. Food and Drug Administration (FDA) approval, the LNG20 IUD could be launched in the U.S. 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 U.S. are unplanned, with over 40 percent 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 U.S. lags considerably, relative to other nations.

Under terms of this exclusive agreement, Actavis acquires the rights to market, sell and distribute LNG20 in the private sector commercial markets in the U.S and Canada for a payment of approximately $50 million. Actavis will pay Medicines360 additional milestone payments totaling up to nearly $125 million plus royalties on annual net sales. All monies received by Medicines360 from this partnership will go toward driving down the product’s costs in the public sector and future product development. This reciprocity structure, along with educational offerings, will increase contraceptive access for all women. For more information on Medicines360’s business model, see: www.youtube.com/watch?v=zQZZ16ihqlA.

“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.”

In January 2013, Actavis, Inc. acquired Uteron Pharma S.P.R.L., based in Liege, Belgium, 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 U.S. 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 U.S. and certain other countries.

About Medicines360

Medicines360 is a non-profit pharmaceutical company and social enterprise. Funded by an anonymous donor, we are working toward self-sustainability through commercial sales revenue by developing innovative, affordable, and sustainable medical solutions for women. Profit is a means of achieving our mission, not our motive; we exist to meet the medical needs of all women. For press release and more information, visit: www.medicines360.org. Observations regarding risks and benefits of LNG20 made to date are consistent with those expected of a levonorgestrel eluting IUD.

About Actavis, Inc.

Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. Actavis has global headquarters in Parsippany, New Jersey, USA.

Operating as Actavis Pharma, Actavis develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty Brands is Actavis’ global branded specialty pharmaceutical business focused in the Urology and Women's Health therapeutic categories. Actavis Specialty Brands also has a portfolio of five biosimilar products in development in Women’s Health and Oncology. Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.

For press release and other company information, visit Actavis' Web site at http://www.actavis.com.

Forward Looking Statement

Statements contained in this press release that refer to Actavis' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. For instance, any statements in this press release concerning prospects related to Actavis' strategic initiatives, product introductions and anticipated financial performance are forward-looking statements. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actavis' performance, at times, will differ from its goals and expectations. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; the impact of competitive products and pricing; the timing and success of product launches; risks and uncertainties normally incident to the pharmaceutical industry, including product liability claims and the availability of product liability insurance on reasonable terms; market acceptance of and continued demand for Actavis' products; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Actavis' and its third parties' facilities, products and/or businesses; changes in the laws and regulations, including Medicare, Medicaid, and similar laws in foreign countries affecting, among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and Actavis' Annual Report on Form 10-K for the year ended December 31, 2012. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Statements in this press release attributed to Medicines360 or its representatives reflect the views of Medicines360 alone and should not be considered or construed as statements of Actavis, Inc.

Contacts

MEDICINES360:
Sedef Onder, 212-884-9959
or
ACTAVIS:
Investors:
Lisa DeFrancesco, 862-261-7152
or
Media:
Charlie Mayr, 862-261-8030

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Contacts

MEDICINES360:
Sedef Onder, 212-884-9959
or
ACTAVIS:
Investors:
Lisa DeFrancesco, 862-261-7152
or
Media:
Charlie Mayr, 862-261-8030