SAN FRANCISCO and PARSIPPANY, N.J., June 11, 2013 /PRNewswire/ -- 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.
"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 U.S and Canada for a payment of approximately $50 million. Actavis will pay Medicines360 additional milestone payments totaling 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. For more information on Medicines360's business model, see: youtube.com/watch?v=zQZZ16ihqlA.
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.
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. GCA Savvian Advisors served as exclusive financial advisor to Medicines360 in this transaction.
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.
Statement Required by the Irish Takeover Rules
The directors of Warner Chilcott accept responsibility for the information contained in this announcement relating to Warner Chilcott and its Associates and the directors of Warner Chilcott and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the directors of Warner Chilcott (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.
The directors of Actavis accept responsibility for the information contained in this announcement other than that relating to Warner Chilcott and its Associates and the directors of Warner Chilcott and members of their immediate families, related trusts and persons connected with them. To the best of the knowledge and belief of the directors of Actavis (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.
Deutsche Bank Securities Inc. is acting exclusively for Warner Chilcott as financial advisor and is not acting as financial advisor to anyone else in connection with the matters referred to in this announcement and will not be responsible to anyone other than Warner Chilcott for providing the protections afforded to clients of Deutsche Bank and for providing advice in relation to the Acquisition, the contents of this announcement or any transaction or arrangement referred to herein.
BofA Merrill Lynch and Greenhill & Co. are acting exclusively for Actavis and no one else in connection with the matters referred to in this announcement and will not be responsible to anyone other than Actavis for providing the protections afforded to clients of BofA Merrill Lynch or Greenhill & Co and for providing advice in relation to the acquisition of Warner Chilcott, the contents of this announcement or any transaction or arrangement referred to herein.
Dealing Disclosure Requirements
Under the provisions of Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2007, as amended (the "Irish Takeover Rules"), if any person is, or becomes, 'interested' (directly or indirectly) in, 1% or more of any class of 'relevant securities' of Warner Chilcott or Actavis, all 'dealings' in any 'relevant securities' of Warner Chilcott or Actavis (including by means of an option in respect of, or a derivative referenced to, any such 'relevant securities') must be publicly disclosed by not later than 3:30 p.m. (Dublin time) on the business day following the date of the relevant transaction. This requirement will continue until the date on which the Scheme becomes effective or on which the 'offer period' otherwise ends. If two or more persons co-operate on the basis of any agreement, either express or tacit, either oral or written, to acquire an 'interest' in 'relevant securities' of Warner Chilcott or Actavis, they will be deemed to be a single person for the purpose of Rule 8.3 of the Irish Takeover Rules.
Under the provisions of Rule 8.1 of the Irish Takeover Rules, all 'dealings' in 'relevant securities' of Warner Chilcott by Actavis or 'relevant securities' of Actavis by Warner Chilcott, or by any of their respective 'associates' must also be disclosed by no later than 12 noon (Dublin time) on the 'business' day following the date of the relevant transaction.
A disclosure table, giving details of the companies in whose 'relevant securities' 'dealings' should be disclosed, can be found on the Irish Takeover Panel's website at www.irishtakeoverpanel.ie.
'Interests in securities' arise, in summary, when a person has long economic exposure, whether conditional or absolute, to changes in the price of securities. In particular, a person will be treated as having an 'interest' by virtue of the ownership or control of securities, or by virtue of any option in respect of, or derivative referenced to, securities.
Terms in quotation marks are defined in the Irish Takeover Rules, which can also be found on the Irish Takeover Panel's website. If you are in any doubt as to whether or not you are required to disclose a dealing under Rule 8, please consult the Irish Takeover Panel's website at www.irishtakeoverpanel.ie or contact the Irish Takeover Panel on telephone number +353 1 678 9020 or fax number +353 1 678 9289.
No Profit Forecast / Asset Valuations
No statement in this announcement constitutes a profit forecast for any period, nor should any statement be interpreted to mean that earnings or earnings per share will necessarily be greater or lesser than those for the relevant preceding financial periods for Actavis or Warner Chilcott or New Actavis as appropriate. No statement in this announcement constitutes an asset valuation.
This release should be read in conjunction with the full text of the Rule 2.5 Announcement issued by Actavis and Warner Chilcott on May 20, 2013. Appendix I to the Rule 2.5 Announcement contains further details of the sources of information and bases of calculations set out in the Rule 2.5 Announcement; Appendix II to the Rule 2.5 Announcement contains definitions of certain expressions used in this release and in the Rule 2.5 Announcement; Appendix III to the Rule 2.5 Announcement contains the Conditions of the Acquisition and the Scheme; and Appendix IV sets out the reports from PricewaterhouseCoopers and Greenhill & Co and Bank of America Merrill Lynch in respect of certain merger benefit statements made in the Rule 2.5 Announcement.
The release, publication or distribution of this announcement in or into certain jurisdictions may be restricted by the laws of those jurisdictions. Accordingly, copies of this announcement and all other documents relating to the Acquisition are not being, and must not be, released, published, mailed or otherwise forwarded, distributed or sent in, into or from any Restricted Jurisdiction. Persons receiving such documents (including, without limitation, nominees, trustees and custodians) should observe these restrictions. Failure to do so may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, the companies involved in the proposed Acquisition disclaim any responsibility or liability for the violations of any such restrictions by any person.
Any response in relation to the Acquisition should be made only on the basis of the information contained in the Scheme Circular or any document by which the Acquisition and the Scheme are made. Actavis Shareholders and Warner Chilcott Shareholders are advised to read carefully the formal documentation in relation to the proposed transaction once the Scheme Circular has been dispatched.
The Rule 2.5 announcement is made pursuant to Rule 2.5 of the Irish Takeover Rules.
Pursuant to Rule 2.6(c) of the Irish Takeover Rules, the Rule 2.5 Announcement will be available to Actavis employees on Actavis' website (www.actavis.com) and Warner Chilcott employees on Warner Chilcott's website (www.wcrx.com).
SOURCE Actavis, Inc.