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

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).

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

SAN FRANCISCO and PARSIPPANY – 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 acritical 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 onMedicines360’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.

 

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: . 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 toMedicines360 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 aroundthe 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 offactors 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 intentor obligation to update these forward-looking statements. Statements in this press release attributed to Medicines360 or its representatives reflect the views of Medicines360 alone andshould 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 orarrangement 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 Lynchor 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 orindirectly) 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 bepublicly 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 (Dublintime) 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 1678 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.

 

General

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 Pricewaterhouse Coopers and Greenhill & Co and Bank of America Merrill Lynch in respect of certain merger benefit statements made inthe Rule 2.5 Announcement.

The release, publication or distribution of this announcement in or into certain jurisdictions maybe restricted by the laws of those jurisdictions. Accordingly, copies of this announcement andall 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).

M360 Media Contact

Sedef Onder – 212.884.9959/office or 212.464.7332/mobile

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical organization with a mission to catalyze equitable access to medicines and devices through product development, policy advocacy, and collaboration with global and US partners. Medicines360, through its subsidiary Impact RH360, launched the Avibela Project to expand access to hormonal IUDs in low- and middle-income countries. For more information, visit medicines360.org

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AVIBELA can be made available in the following 88 countries

  1. Algeria
  2. Angola
  3. Bangladesh
  4. Belize
  5. Benin
  6. Bhutan
  7. Botswana
  8. Burkina Faso
  9. Burundi
  10. Cambodia
  11. Cameroon
  12. Cape Verde
  13. Central African Republic
  14. Chad
  15. Comoros
  16. Costa Rica
  17. Cuba
  18. Democratic Republic of the Congo
  19. Djibouti
  20. Dominica
  21. Dominican Republic
  22. Egypt
  23. El Salvador
  24. Equatorial Guinea
  25. Eritrea
  26. Ethiopia
  27. Gabon
  28. Ghana
  29. Grenada
  30. Guatemala
  31. Guinea
  32. Guinea-Bissau
  33. Haiti
  34. Honduras
  35. India
  36. Indonesia
  37. Ivory Coast
  38. Jamaica
  39. Kenya
  40. Lao PDR
  41. Lesotho
  42. Liberia
  43. Libya
  44. Madagascar
  45. Malawi
  46. Malaysia
  47. Maldives
  48. Mali
  49. Mauritania
  50. Mauritius
  51. Mayotte
  52. Morocco
  53. Mozambique
  54. Myanmar
  55. Namibia
  56. Nepal
  57. Nicaragua
  58. Niger
  59. Nigeria
  60. Pakistan
  61. Panama
  62. Papua New Guinea
  63. Philippines
  64. Republic of the Congo
  65. Rwanda
  66. Sao Tome and Principe
  67. Senegal
  68. Seychelles
  69. Sierra Leone
  70. Somalia
  71. South Africa
  72. South Sudan
  73. Sri Lanka
  74. Kitts and Nevis
  75. Lucia
  76. Vincent & the Grenadines
  77. Sudan
  78. Swaziland
  79. Tanzania
  80. Thailand
  81. The Gambia
  82. Timor-Leste
  83. Togo
  84. Tunisia
  85. Uganda
  86. Vietnam
  87. Zambia
  88. Sri Lanka

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.