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): June 6, 2013

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.)

100 Hayden Avenue
Lexington, Massachusetts	02421
(Address of principal executive offices)	(Zip Code)

(617) 498-3300

(Registrant’s telephone number, including area code)

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:

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

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

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

¨  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.

On June 6, 2013, AMAG Pharmaceuticals, Inc. (the “Company”) entered into a License Agreement with Access Pharmaceuticals, Inc. (“Access”).  Pursuant to the License Agreement, Access has granted to the Company an exclusive, royalty-bearing license, with the right to grant sublicenses, to certain intellectual property rights, including know-how, patents and trademarks, to use, import, offer for sale, sell, manufacture and commercialize MuGardTM mucoadhesive rinse (“MuGard”) in the United States and its territories (the “U.S. Territory”) for the management of all diseases or conditions of the oropharyngeal cavity, including mucositis.  In addition, Access has assigned to the Company all of its right, title and interest in MuGard-related internet and social media outlets and other sales, marketing and promotional materials currently owned or controlled by Access as Access will no longer commercialize, market, promote, sell or make public communications relating to MuGard in the U.S Territory, except as may be agreed to by the Company.  Under the License Agreement, the Company must use commercially reasonable efforts to commercialize MuGard in the U.S. Territory.

In consideration for the license, the Company will pay Access an upfront license fee of $3.3 million.  The Company has also agreed to pay to Access royalties on future sales of MuGard until the later of (a) expiration of the licensed patents or (b) the tenth anniversary of the first commercial sale of MuGard in the U.S. Territory (the “Royalty Term”).  These tiered, double-digit royalty rates decrease after the expiration of the licensed patents and are subject to off-set against certain Company expenses.  After the expiration of the Royalty Term, the license shall become a fully paid-up, royalty-free and perpetual license in the U.S. Territory.

Access will continue to manufacture MuGard and the Company and Access have agreed to enter into Quality and Supply Agreements under which the Company will purchase MuGard inventory from Access. The Company’s inventory purchases will be at the price actually paid by Access to purchase it from a third-party plus a mark-up to cover administration, handling and overhead.

Access is responsible for maintenance of the licensed patents at its own expense, and the Company retains the first right to enforce any licensed patent against third party infringement.  In addition, the License Agreement specifies arrangements relating to product complaints and recalls, regulatory events, quality inspections and transition services.  Access and the Company agree that during the term of the License Agreement, they will not, directly or indirectly, research, develop, market, sell or commercialize any medical devices that directly compete with MuGard for the treatment of any diseases or conditions of the oropharyngeal cavity in the U.S. Territory.  Further, the Company and Access generally agree to indemnify each other and their respective affiliates for damages resulting from the respective party’s (a) willful misconduct or negligence, (b) manufacture, commercialization, use or other disposition of MuGard as provided in the License Agreement, or (c) breach of the License Agreement.

Under the terms of the License Agreement, neither party may assign the License Agreement without the prior written consent of the other party other than in connection with the acquisition of such party.  The License Agreement terminates at the end of the Royalty Term, but is subject

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to early termination by the Company for convenience and by either party upon an uncured breach by or bankruptcy of the other party.

The foregoing description of the License Agreement is qualified in its entirety by reference to the available text of the License Agreement, a redacted copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013.

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Item 9.01.  Financial Statements and Exhibits.

(d)  Exhibits.

The Company hereby furnishes the following exhibit:

99.1Press Release dated June 10, 2013.

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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 thereunto duly authorized.

AMAG PHARMACEUTICALS, INC.
By:	/s/ Scott B. Townsend
General Counsel and Senior Vice President of Legal Affairs
Date: June 10, 2013

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EXHIBIT INDEX

Exhibit Number

99.1Press Release dated June 10, 2013.

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EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

AMAG Pharmaceuticals Obtains US Commercial Rights to MuGard™

A Prescription Oral Rinse to Manage Oral Mucositis

Expands AMAG’s Product Offerings for Hematology/Oncology Patients and Clinics

Lexington, MA (June 10, 2013) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has licensed the US commercial rights to MuGard™, a marketed product for the management of oral mucositis, from Access Pharmaceuticals, Inc. (OTCBB: ACCP). MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients developing the condition each year.

“Oral mucositis can be a frequent and problematic side effect of both chemotherapy and radiation therapy for cancer patients,” said Greg Madison, chief commercial officer of AMAG. “We believe that MuGard could become a category leader in the hands of our skilled sales force and that our experienced commercial team, our relationships with hematology/oncology practices and our partnerships with key group purchasing organizations can help drive significant growth of this brand.”

“I am pleased to announce this license agreement with AMAG Pharmaceuticals, as we believe that expansion of reach is critical to the commercial success of MuGard,” said Jeffrey B. Davis, president and chief executive officer of Access Pharmaceuticals, Inc. “AMAG’s domestic presence, resources and strategic emphasis on expansion of product offerings in complementary therapeutic areas makes them ideally suited to enhance commercialization of MuGard here in the US.”

Under the terms of the license agreement, AMAG will pay Access an upfront license fee of $3.3 million in exchange for exclusive commercial rights to MuGard in the US.  AMAG will also purchase existing MuGard inventory from Access and will pay a tiered, double-digit royalty on net sales of MuGard to Access.

“We are pleased to announce the addition of MuGard to the AMAG portfolio, a product that can truly help the many patients who might suffer from oral mucositis,” commented William Heiden, AMAG’s president and chief executive officer. “MuGard will provide immediate incremental top-line growth and it meets all of our previously defined deal criteria, as a nice tuck-in product with good upside potential and intellectual property runway. Our business development team continues to diligently work on numerous additional product opportunities, and this license represents a solid first step on the path of building a multi-product specialty pharmaceutical company.”

AMAG expects that MuGard will provide attractive gross margins to the company with minimal additions to its operating costs. AMAG will provide a complete update to its financial guidance in connection with reporting its second quarter financial results. The company expects MuGard to be accretive to earnings in 2014.

June 10, 2013 AMAG Pharmaceuticals, Inc. Page | 1 of 2

Leerink Swann LLC served as financial advisor to AMAG.

About MuGard

MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration.

About AMAG

AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that markets Feraheme® and MuGard™ in the United States. Along with driving organic growth of its products, AMAG intends to expand its portfolio with additional commercial-stage specialty products. The company is seeking complementary products that leverage the company’s commercial footprint and focus on hematology and oncology centers and hospital infusion centers. For additional company information, please visit www.amagpharma.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding: the company’s intent to drive growth of MuGard; the impact of MuGard on the company’s financial results; and the company’s plans to seek complementary commercial products to add to its portfolio 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: (1) uncertainties regarding our and Takeda’s ability to successfully compete in the intravenous iron replacement market both in the US and outside the US, including the EU, (2) uncertainties regarding our ability to compete in the oral mucositis market, (3) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme/Rienso in the broader IDA indication both in the US and outside of the US, including the EU, (4) the possibility that significant safety or drug interaction problems could arise with respect to Feraheme/Rienso or MuGard, (5) uncertainties regarding the manufacture of Feraheme/Rienso or MuGard, (6) uncertainties relating to our patents and proprietary rights, both in the US and outside of the US, (7) the risk of an Abbreviated New Drug Application (ANDA) filing following the FDA’s recently published draft bioequivalence recommendation for ferumoxytol, and (8) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

We disclaim 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.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.; MuGard is a trademark of Access Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. Contact

Amy Sullivan, 617-498-3303

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