8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): December 29, 2014

AMAG PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

001-10865	04-2742593
(Commission File Number)	(IRS Employer Identification No.)

1100 Winter St.
Waltham, Massachusetts	02451
(Address of principal executive offices)	(Zip Code)

(617) 498-3300

(Registrant’s telephone number, including area code)

(Former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01.  Entry into a Material Definitive Agreement.

Item 1.02. Termination of a Material Definitive Agreement.

AMAG Pharmaceuticals, Inc. (the “Company”) and Takeda Pharmaceutical Company Limited (“Takeda”) are parties to that certain License, Development and Commercialization Agreement, dated March 31, 2010 (as amended on June 25, 2012, the “License Agreement”), pursuant to which Takeda has been commercializing Feraheme® (ferumoxytol) (under the trade name Rienso® outside of the U.S. and Canada) (the “Product” or “Feraheme/Rienso”) in Canada, the European Union (the “EU”) and Switzerland.  Following a business review, Takeda has reprioritized its product portfolio and informed the Company that ferumoxytol no longer fits with Takeda’s current strategy. As a result, the Company and Takeda mutually agreed to terminate the License Agreement and transition the commercialization of the Product to the Company.  In connection therewith, on December 29, 2014, the Company and Takeda entered into a termination agreement detailing the terms and conditions of such termination and outlining certain transitional services that Takeda will be providing to the Company to facilitate the transition of the Product to the Company (the “Termination Agreement”).  Pursuant to the Termination Agreement, the Company and Takeda have agreed to effectuate the termination of the License Agreement on a rolling basis, whereby the termination will be effective for a particular geographic territory (e.g., countries under the regulatory jurisdictions of Health Canada, the European Medicines Agency (the “EMA”) and SwissMedic) upon the earlier of effectiveness of the transfer to the Company or a Withdrawal (as defined below) of the marketing authorization for such territory, with the final effective termination date to be on the third such effective date (each, a “Termination Date” and, collectively, the “Termination Dates”).

Under the License Agreement, the Company granted exclusive rights to Takeda to develop and commercialize Feraheme/Rienso as a therapeutic agent in Europe, certain Asia-Pacific countries (excluding Japan, China and Taiwan), Canada, India and Turkey in exchange for an upfront payment, certain milestone payments and tiered double-digit royalties on net product sales in certain agreed-upon territories.  Under the License Agreement, except under limited circumstances, the Company retained the right to manufacture Feraheme/Rienso and maintained responsibility for conducting, and bearing the costs related to, certain pre-defined clinical studies with the costs of future modifications or additional studies to be allocated between the parties according to an agreed-upon cost-sharing mechanism.

In connection with each Termination Date and in accordance with the terms of the Termination Agreement, Takeda is obligated, with respect to the applicable terminated territory, to transfer and assign to the Company all applicable regulatory materials and approvals and certain product data, inventory, third party contracts intellectual property rights and know-how to the Company, and to grant to the Company an exclusive license for certain Takeda technology used and applied to commercialize the Product in the applicable territory.  The Termination Agreement also details the regulatory activities each party is required to perform in connection with transferring the marketing authorization from Takeda to the Company in each of the territories and the allocation of the costs of such activities.  The parties agree to use commercially reasonable efforts to transfer all required activities to the Company on a territory-by-territory basis within 60 days after the applicable Termination Date (subject to a 30-day extension upon the Company’s request and Takeda’s consent).  In addition, Takeda is obligated pursuant to the Termination Agreement to provide transition assistance to the Company, at no cost to the Company, for up to 180 days after each Termination Date for the applicable termination territory.  With Takeda’s consent (which shall not be unreasonably withheld or delayed), the Company may extend the transition services period for a terminated territory for a period of time reasonably necessary to complete any services that cannot be reasonably transitioned to the Company during the initial 180-day period, which extension will not exceed an additional 180 days.  If the Company requests, and Takeda agrees to conduct, additional transition services after the end of the applicable transition

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services period, as may be extended, the Company will reimburse Takeda’s fully burdened costs for such additional services plus 5%.  The Termination Agreement also provides that if the marketing authorization for the Product is suspended in a particular territory and the parties are prevented from completing the transfer of such marketing authorization to the Company within 120 days after such suspension due to applicable laws or any regulatory requirements or restrictions, or if the Company does not fulfill its obligations to initiate marketing authorization transfer by the agreed-upon, territory-specific deadline, Takeda will have the right, in Takeda’s sole discretion, to withdraw such marketing authorization (a “Withdrawal”).

In consideration for the early termination of the License Agreement and the activities to be performed by the Company earlier than contemplated under the License Agreement, and in lieu of any future cost-sharing and milestone payments contemplated by the License Agreement, Takeda agreed to make certain payments to the Company, subject to certain terms and conditions, including up to approximately $6.7 million in connection with clinical study obligations, pharmacovigilance activities, regulatory filings and support, commercialization and back-office support and distribution expenditures and a $3 million milestone payment payable subject to certain regulatory conditions.

In connection with the termination, the Company expects to accelerate the recognition of $43.4 million related to the remaining deferred revenue received by the Company for upfront and milestones achieved to date which the Company expects to recognize within the next 12 months.  In addition, the Company expects to recognize product sales to Takeda and the related cost of goods totaling $2.7 million and $2.4 million, respectively, that were previously deferred, within the next 12 months.  The Company will assume any post-marketing obligations of Takeda as part of the Termination Agreement, including costs that otherwise would have been Takeda’s obligation under the License Agreement for the ongoing pediatric studies and the initiated multi-center clinical trial to be conducted to determine the safety and efficacy of repeat doses of Feraheme/Rienso for the treatment of iron deficiency anemia in patients with hemodialysis dependent chronic kidney disease.

Additionally, the Supply Agreement, dated February 7, 2014, by and between the Company and Takeda Pharmaceuticals International, GMBH A/S (“GMBH”), an affiliate of Takeda (the “Supply Agreement” and, together with the License Agreement, the “Agreements”), which continues in effect until the expiration or termination of the License Agreement, will also terminate as of the respective Termination Date in the applicable geographic territory.  The Supply Agreement was entered into in connection with the License Agreement and provides the terms on which the Company sells Feraheme/Rienso to Takeda to meet Takeda’s requirements for commercial use of the product in the licensed territory.  The Supply Agreement provides pricing terms and also provides that Takeda will reimburse the Company for certain capital expenditures and shall pay the Company a per-vial manufacturing fee.

There is no early termination penalty for the Company associated with the termination of the Agreements and there is no material relationship between Takeda (or GMBH) and the Company or its affiliates other than in respect of the Agreements and the Termination Agreement.

The foregoing summary of the material terms of the Agreements and the Termination Agreement does not purport to be complete and is qualified in its entirety by reference to the License Agreement that was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 6, 2010, the Amendment to the License Agreement filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 29, 2012, the Supply Agreement that was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 5, 2014 and the Termination Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2014 (or as an exhibit to an earlier filing), which are incorporated herein by reference.

Item 8.01.  Other Events.

A copy of the Company’s and Takeda’s joint press release announcing entry into the Termination Agreement is filed as Exhibit 99.1 to this Current Report on Form 8-K.

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Item 9.01.  Financial Statements and Exhibits.

(d)  Exhibits.

The Company hereby files the following exhibit:

Exhibit Number	Description
99.1	Joint press release, dated December 29, 2014.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AMAG PHARMACEUTICALS, INC.
By:	/s/ Scott B. Townsend
	Scott B. Townsend General Counsel and Senior Vice President of Legal Affairs
Date: December 29, 2014

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EXHIBIT INDEX

Exhibit Number	Description
99.1	Joint press release, dated December 29, 2014.

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EX-99.1

Exhibit 99.1

News Release

AMAG Pharmaceuticals and Takeda Announce Mutual Termination of Agreement to License,

Develop and Commercialize Ferumoxytol in Ex-U.S. Territories, Including Europe

WALTHAM, Mass. and OSAKA, Japan December 29, 2014 -  AMAG Pharmaceuticals (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (Takeda) announced today that they have entered into an agreement to mutually terminate the March 2010 license, development and commercialization agreement, which granted Takeda exclusive rights to market ferumoxytol in Canada, the European Union (EU) and Switzerland, as well as certain other geographic territories (under the trade name Rienso® outside of Canada where the product’s trade name is Feraheme®).

Under the terms of the termination agreement, AMAG will regain all worldwide development and commercialization rights for Feraheme/Rienso.  Takeda will make a payment to AMAG in connection with the termination and will provide certain transition services to AMAG for up to 180 days after the marketing authorization transfer in each territory.  In addition, both parties will undertake a transfer of the regulatory files for the product in each respective territory, and Takeda will not participate in any future development or commercialization activities.

Takeda has been commercializing Feraheme in Canada and Rienso in the EU for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). In both of these territories, Takeda has submitted applications to expand the product’s current label to include all patients with IDA regardless of underlying cause.  AMAG will be assessing various alternative commercialization strategies for Feraheme in Canada and Rienso in the EU based, in part, on the pending regulatory decisions which are expected in 2015.

About Feraheme® (ferumoxytol)/Rienso

Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult CKD patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by five issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book, the last of which expires in June 2023.

Ferumoxytol received marketing approval in Canada in December 2012, where it has been marketed by Takeda as Feraheme, and in the European Union in June 2013 where it has been marketed by Takeda as

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Rienso.  Ferumoxytol received marketing approval in Switzerland in August 2013.

Feraheme/Rienso is contraindicated in patients with known hypersensitivity to Feraheme/Rienso or any of its components. Serious hypersensitivity reactions, including anaphylactic-type reactions, have been reported in patients receiving Feraheme/Rienso. Serious adverse reactions of clinically significant hypotension have been reported in the post-marketing experience of Feraheme/Rienso.

For additional U.S. product information, including full prescribing information, please visit www.feraheme.com.

About AMAG

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on maternal health, anemia and cancer supportive care. The primary goal of AMAG and its maternal health division, Lumara HealthTM, is to bring to market therapies that provide clear benefits and improve patients’ lives. In addition to continuing to pursue opportunities to make new advancements in patients’ health and to enhance treatment accessibility, AMAG intends to continue to expand and diversify its portfolio through the in-license or purchase of additional pharmaceutical products or companies. For additional company information, please visit www.amagpharma.com.

AMAG PHARMACEUTICALS® is a registered trademark of AMAG Pharmaceuticals, Inc. LUMARA HEALTH™ is a trademark of Lumara Health Inc.

AMAG Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including among others, statements regarding Takeda’s payments and services to AMAG, worldwide development and commercialization rights for Feraheme/Rienso for IDA and/or CKD, the transfer of regulatory files by Takeda in each respective territory and AMAG’s assessment of commercialization strategies for Feraheme/Rienso in Canada and the EU are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

Such risks and uncertainties include, among others: (1) limitations on AMAG’s ability to invest in the development and commercialization of Feraheme/Rienso outside the U.S., especially in light of AMAG’s being highly leveraged, (2) AMAG may not be able to successfully commercialize Feraheme/Rienso using alternate strategies in Canada and the EU, or may choose not to do so, (3) uncertainties regarding the likelihood and timing of potential approval of Feraheme/Rienso in the U.S., the EU and Canada in the broader IDA indication in light of the complete response letter AMAG received from the FDA informing

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AMAG that its supplemental new drug application (sNDA) for the broader indication could not be approved in its present form and stating that AMAG has not provided sufficient information to permit labeling of Feraheme/Rienso for safe and effective use for the proposed broader indication and similar concerns raised by European and Canadian regulators, (4) the possibility that following review of post-marketing safety data, including reports of serious anaphylaxis, cardiovascular events, and death, and/or in light of the label changes requested by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) and confirmed by the Committee for Medicinal Products for Human Use (CHMP), the FDA, European or Canadian regulators will request additional technical or scientific information, new studies or reanalysis of existing data, on-label warnings, post-marketing requirements/commitments or risk evaluation and mitigation strategies (REMS) in the current CKD indication for Feraheme/Rienso, or cause Feraheme/Rienso to be withdrawn from the market, and the additional costs and expenses that will or may be incurred in connection with such activities, (5) whether AMAG’s proposed label changes will be acceptable to the FDA or other regulatory authorities and what impact such changes, or such additional changes as U.S. and/or non-U.S. regulators may require, will have on sales of Feraheme/Rienso, (6) AMAG’s ability to successfully compete in the IV iron replacement market both in the U.S. and outside the U.S. as a result of limitations, restrictions or warnings in Feraheme’s/Rienso’s current or future label, including the changes recommended by PRAC and confirmed by CHMP that Rienso be administered to patients by infusion over at least 15-minutes (replacing injection) and that it be contraindicated for patients with any known history of drug allergy, (7) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso and in turn affect sales or AMAG’s ability to market the product both in the U.S. and outside of the U.S., (8) AMAG’s patents and proprietary rights both in the U.S. and outside the U.S., (9) the risk of an Abbreviated New Drug Application (ANDA) filing for Feraheme, especially following the FDA’s draft bioequivalence recommendation for ferumoxytol published in December 2012, (10) the impact on sales if AMAG disseminates future Dear Healthcare Provider letters in the U.S., Europe, Canada or other markets, (11) AMAG’s ability to execute on its long-term strategic plan or to realize the expected results from its long-term strategic plan, (12) the possibility that AMAG will not realize expected synergies and other benefits from its acquisition of Lumara Health, as well as AMAG’s ability to pursue additional business development opportunities, especially in light of AMAG’s being highly leveraged and (13) other risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 and subsequent filings with the SEC. Any of the above risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. Use of the term “including” in the two paragraphs above shall mean in each case “including, but not limited to.” AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

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AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Takeda Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda’s plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “assume,” “continue,” “seek,” “pro forma,” “potential,” “target,” “forecast,” “guidance,” “outlook” or “intend” or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda’s business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

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Contact:

AMAG Pharmaceuticals, Inc.:

Katie Payne, 617-498-3303

Takeda Pharmaceuticals Company Limited:

Corporate Communications Dept.

+81-3-3278-2037

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