AMAG PHARMACEUTICALS,INC. (NASDAQ:AMAG) Files An 8-K Completion of Acquisition or Disposition of Assets
Item 2.01 Completion of Acquisition or Disposition of Assets.
As previously disclosed, on February13, 2017, AMAG
Pharmaceuticals,Inc. (AMAG) and Endoceutics,Inc. (Endoceutics)
entered into a license agreement (the License Agreement) to which
Endoceutics has granted to AMAG rights to IntrarosaTM
(prasterone), an FDA-approved product for the treatment of
moderate-to-severe dyspareunia (pain during sexual intercourse)
(the Licensing Transaction). Following the satisfaction of the
conditions to closing under the License Agreement, the Licensing
Transaction closed on April3, 2017 (the Effective Date).
Under the terms of the License Agreement, Endoceutics has granted
to AMAG the right to develop and commercialize pharmaceutical
products containing dehydroepiandrosterone (DHEA), including
Intrarosa, at dosage strengths of 13 mg or less per dose and
formulated for intravaginal delivery (the Product), excluding any
dosage strengths over 13 mg per dose and combinations with other
active pharmaceutical ingredients, in the United States for the
treatment and prevention of vulvar and vaginal atrophy (VVA) and
female sexual dysfunction (FSD) (the Field).
Subject to the terms of the License Agreement, Endoceutics has
agreed to conduct clinical studies for the Product to support an
application for regulatory approval for the Product for use in
FSD in the United States. AMAG and Endoceutics have agreed to
share the direct costs related to such studies based upon a
negotiated allocation with AMAG funding up to $20.0 million. AMAG
may, with Endoceutics consent (not to be unreasonably withheld,
conditioned or delayed), conduct any other studies of the Product
in the Field anywhere in the world for the purpose of obtaining
or maintaining regulatory approval of or commercializing the
Product in the Field in the United States. All data generated in
connection with the above described studies would be owned by
Endoceutics and licensed to AMAG to the License Agreement.
Endoceutics has granted to AMAG the exclusive right to
commercialize the Product in the Field in the United States,
subject to the terms of the License Agreement, including the
final decision making authority with respect to commercial
strategy, pricing and reimbursement and other commercialization
matters. AMAG has agreed to use commercially reasonable efforts
to market, promote and otherwise commercialize the Product in the
Field in the United States. Endoceutics has the right to directly
conduct, itself or through its affiliates or subcontractors,
additional commercialization activities for the Product in the
Field in the United States, which scope of activities will be
agreed to by the parties acting reasonably and in good faith, and
has the right to conduct activities related generally to the
field of intracrinology, in each case, subject to AMAGs right to
withhold approval in certain instances.
to the terms of the License Agreement, promptly following the
Effective Date, AMAG made an upfront cash payment of $50.0
million and issued 600,000 shares of unregistered common stock to
Endoceutics, 300,000 of which is subject to a 180-day lock-up
provision, and the other 300,000 of which is subject to a
one-year lock-up provision. AMAG has also agreed to make a
payment of $10.0 million to Endoceutics on the first anniversary
of the Effective Date and up to $10.0 million upon the delivery
of launch quantities of the Product. AMAG has also agreed to pay
tiered royalties to Endoceutics equal to a percentage of net
sales of the Product in the United States ranging from mid-teens
(for calendar year net sales up to $150 million) to mid twenty
percent (for any calendar year net sales that exceed $1 billion)
(such royalty rate to be dependent on the aggregate net sales of
the Product) for the commercial life of the Product, with
deductions for generic competition and third party payments and
after the later of (i)the expiration date of the last to expire
of a licensed patent containing a valid patent claim and (ii)ten
years after the first commercial sale of the Product in the Field
in the United States. Endoceutics is also eligible to receive
certain sales milestone payments, including a first sales
milestone payment of $15.0 million, which would be triggered when
Intrarosa annual net U.S. sales exceed $150.0 million, and a
second milestone payment of $30.0 million, which would be
triggered when annual net U.S. sales of Intrarosa exceed $300.0
million. If annual net U.S. sales of Intrarosa exceed $500.0
million, there are additional sales milestone payments totaling
up to $850 million, which would be triggered at various sales
thresholds.
In connection with the License Agreement, AMAG and Endoceutics
entered into a manufacturing and supply agreement (the Supply
Agreement) on the Effective Date, to which Endoceutics, itself or
through affiliates or contract manufacturers, has agreed to
manufacture and supply the Product to AMAG and will be AMAGs
exclusive supplier of the Product in the United States, subject
to certain rights for AMAG to manufacture and supply the Product
in the event of a cessation notice or supply failure (as such
terms are defined in the Supply
Agreement). Under the Supply Agreement, Endoceutics will
maintain at all times a second source supplier for the
manufacture of DHEA and the drug product and identify, validate
and transfer manufacturing intellectual property to the second
source supplier within two years of the Effective Date. The
Supply Agreement shall remain in effect until the termination
of the License Agreement, unless terminated earlier by either
party for an uncured material breach or insolvency of the other
party, or by AMAG if it exercises its rights to manufacture and
supply the Product following a cessation notice or supply
failure.
Under the License Agreement, except as permitted under the
License Agreement or the Supply Agreement, and except for any
compounds or products affecting the melanocortin receptor
pathway, including without limitation, bremelanotide
(collectively, Excluded Product), AMAG is not be permitted to
research, develop, manufacture, or commercialize (i)DHEA for
delivery by any route of administration anywhere in world,
(ii)any compound (including DHEA) or product for use in VVA
anywhere in the world, or (iii)commencing on the date of an
approval of the Product for the treatment of FSD in the United
States and continuing for the remainder of the term of the
License Agreement, any compound (including DHEA) for use in FSD
(each, a Competing Product). Any compound or product for use in
FSD that would be a Competing Product in the United States but
that (i)does not contain DHEA and (ii)was acquired or licensed
or for which the research, development, manufacture or
commercialization of such compound or product is initiated by
AMAG or its affiliates, in each case, prior to the date of an
approval of the Product for the treatment of FSD in the United
States, will be an Excluded Product and will not be subject to
the exclusivity obligations under the License Agreement in the
treatment of FSD, subject to certain restrictions in the
License Agreement. These noncompete restrictions are subject to
certain exclusions relating to the acquisition of competing
programs.
AMAG and Endoceutics have made customary representations and
warranties and have agreed to certain customary covenants. The
License Agreement expires on the date of expiration of all
royalty obligations due thereunder unless earlier terminated in
accordance with the License Agreement. The License Agreement
may be terminated by either Party for material breach that is
either uncured after a 90-day notice period, or if such breach
cannot be cured within such 90-day period, if the breaching
party does not commence appropriate and material actions to
cure such breach within the notice period and continue to
diligently cure such breach for a period not to exceed 90 days,
in either case, subject to tolling or determination of the
arbitrators, if dispute resolution procedures are initiated
within 30 days of the termination notice. AMAG has the ability
to elect not to terminate the License Agreement in the case of
a material breach, in which case future milestone and royalty
payments owed to Endoceutics would be reduced by a negotiated
percentage or by an amount determined by arbitration. Either
party may terminate under certain situations relating to the
bankruptcy or insolvency of the other party. AMAG may terminate
the License Agreement for a valid business reason upon 365 days
prior written notice to Endoceutics; or upon 60 days written
notice in the event AMAG reasonably determines in good faith,
after due inquiry and after discussions with Endoceutics, that
AMAG cannot reasonably continue to develop or commercialize any
Product as a result of a safety issue regarding the use of the
Product. AMAG may also terminate the License Agreement upon 180
days notice if there is a change of control of AMAG and the
acquiring entity (alone or with its affiliates) is engaged in a
competing program (as defined in the Licensed Agreement) in the
United States or in at least three countries within the
European Union.
Endoceutics has represented that the historical research and
development costs incurred to date by Endoceutics and its
affiliates (including any third party costs and expenses) in
connection with the Product are approximately CAD $19.6 million
(approximately USD $15.0 million) since January1, 2014,
including (i)CAD $10,127,220 (approximately USD $7.7 million)
during the twelve months ended December31, 2014, (ii)CAD
$4,896,520 (approximately USD $3.8 million) during the twelve
months ended December31, 2015, and (iii)CAD $4,559,816
(approximately USD $3.5 million) during the twelve months ended
December31, 2016. AMAG did not assume any liabilities
(including contingent liabilities), acquire any physical
assets, or hire or acquire any employees from Endoceutics in
connection with the License Agreement.
The foregoing is only a summary of the material terms of the
License Agreement and Supply Agreement and does not purport to
be a complete description of the rights and obligations of the
parties under such agreements. The foregoing summary is
qualified in its entirety by reference to the available text of
the License Agreement and Supply Agreement, redacted copies of
which are filed with this Current Report on Form8-K as
Exhibit10.1 and Exhibit10.2, respectively. AMAG has determined
that the Licensing Transaction does not involve the acquisition
of a business and AMAG does not believe that the amount paid
would be deemed to exceed 10% of AMAGs total assets on a
consolidated basis; however, AMAG is filing this Form8-K to
provide investors with disclosure as if Item 2.01 of Form8-K
were applicable. This filing should not be deemed an admission
by AMAG that the closing of the Licensing Transaction triggers
required disclosure under Item 2.01 of Form8-K.
Forward Looking Statements
This Current Report on Form8-K and the materials furnished
herewith contain forward-looking information about AMAG within
the meaning of the Private Securities Litigation Reform Act of
1995 and other federal securities laws. Any statements
contained herein and therein which do not describe historical
facts, including, among others, statements regarding each
partys respective performance of its obligations under the
License Agreement and the Supply Agreement, including with
respect to funding additional clinical trials and conducting
commercialization activities; anticipated clinical development
plans and costs for Intrarosa to support regulatory approval of
FSD; the timing and amounts of future milestone and royalty
payments; and expected investment amounts by AMAG in the
potential FSD label expansion and those statements in the
materials furnished herewith that are designated as
forward-looking statements 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)the
possibility that AMAG will not realize the expected benefits of
the transaction, including the anticipated market opportunity
and the ability of its current or expanded sales force to
successfully commercialize Intrarosa; (2)the possibility that
significant safety or drug interaction problems could arise
with respect to Intrarosa; (3)the ability of AMAG to drive
awareness of dyspareunia and the potential benefits of
Intrarosa; (4)uncertainties regarding the manufacture of
Intrarosa; (5)uncertainties relating to patents and proprietary
rights associated with Intrarosa in the United States; (6)that
the cost of the transaction to AMAG will be more than planned
and/or will not provide the intended positive financial
results; (7)that AMAG or Endoceutics will fail to fully perform
their respective obligations under the License Agreement or the
Supply Agreement; (8)uncertainty regarding AMAGs ability to
compete in the dyspareunia market in the United States; and
(9)other risks identified in AMAGs Securities and Exchange
Commission (the Commission) filings, including its Annual
Report on Form10-K for the year ended December31, 2016, and
subsequent filings with the Commission. AMAG cautions you not
to place undue reliance on any forward-looking statements,
which speak only as of the date they are made. 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.
AMAG Pharmaceuticals is a registered trademark of AMAG
Pharmaceuticals,Inc. IntrarosaTM is a trademark of
Endoceutics,Inc.
Item 3.02 Unregistered Sales of Equity
Securities.
to the License Agreement described in Item 2.01 of this Current
Report on Form8-K, which description is incorporated herein by
reference, AMAG issued 600,000 shares of unregistered AMAG
common stock to Endoceutics on April5, 2017. The issuance of
these shares to Endoceutics was not registered under the
Securities Act of 1933, as amended (the Securities Act) in
reliance upon an exception from registration to Regulation S
promulgated under the Securities Act.
Item 7.01. Regulation FD.
The following information and Exhibit99.1 attached hereto shall
not be deemed filed for purposes of Section18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities
Act of 1933, as amended, except as expressly set forth by
specific reference in such filing.
On April4, 2017, the Company issued a press release, entitled
AMAG Pharmaceuticals Announces Closing of Exclusive Licensing
Agreement with Endoceutics for U.S. Rights to IntrarosaTM
(prasterone), announcing that it had closed the Licensing
Transaction. A copy of such press release is furnished as
Exhibit99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits.
|
Exhibit Number |
|
Description |
|
10.1 |
License Agreement, by and between AMAG |
|
|
10.2 |
Manufacturing and Supply Agreement, by and between AMAG |
|
|
99.1 |
Press release entitled AMAG Pharmaceuticals Announces |
* Certain confidential information contained in this exhibit
was omitted by means of redacting a portion of the text and
replacing it with [***]. This exhibit has been filed separately
with the Commission without any redactions to a Confidential
Treatment Request under Rule24b-2 of the Securities and
Exchange Act of 1934, as amended.
Filed herewith
Furnished herewith
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/ Joseph D. Vittiglio |
|
|
Joseph D. Vittiglio General Counsel and Senior Vice |
||
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Date: April5, 2017 |
EXHIBITINDEX
|
Exhibit Number |
|
Description |
|
10.1 |
License Agreement, by and between AMAG |
|
|
10.2 |
Manufacturing and Supply Agreement, by and between AMAG |
|
|
99.1 |
Press release entitled AMAG Pharmaceuticals Announces |
* Certain confidential information contained in this exhibit
was omitted by means of redacting a portion of the text and
replacing it with [***]. This exhibit has been filed separately
with the Commission without any redactions
About AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG)
AMAG Pharmaceuticals, Inc. is a pharmaceutical company. The Company’s segment is the manufacture, development and commercialization of products and services for use in treating various conditions, with a focus on maternal health, anemia management and cancer supportive care. Its offerings focus on maternal health, anemia management and cancer supportive care, including its product, Makena (hydroxyprogesterone caproate injection); services related to the collection, processing and storage of umbilical cord blood stem cell and cord tissue units operated through Cord Blood Registry (CBR); its product, Feraheme (ferumoxytol), for intravenous (IV) use, and MuGard Mucoadhesive Oral Wound Rinse. It is engaged in the development of Digoxin immune fab, a polyclonal antibody for the treatment of severe preeclampsia in pregnant women. Makena is a drug indicated to reduce the risk of preterm birth in women pregnant with a single baby having a history of singleton spontaneous preterm birth. AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG) Recent Trading Information
AMAG PHARMACEUTICALS, INC. (NASDAQ:AMAG) closed its last trading session down -0.70 at 21.70 with 922,242 shares trading hands.