UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 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) October 9, 2009
Progenics
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-23143
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13-3379479
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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777
Old Saw Mill River Road, Tarrytown, New York
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10591
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code (914)
789-2800
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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 (see General
Instruction A.2. below):
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)
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o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
1.01 Entry into a Material Definitive Agreement;
Item
1.02 Termination of a Material Definitive Agreement.
On
October 9, 2009, Progenics Pharmaceuticals, Inc. and its subsidiaries, Progenics
Pharmaceuticals Nevada, Inc. and Excelsior Life Sciences Ireland Limited
(together, Progenics), entered into a Termination and Transition Agreement,
effective as of October 1, 2009, with Wyeth Pharmaceuticals, a division of
Wyeth, and its affiliates, Wyeth-Whitehall Pharmaceuticals, Inc., Wyeth-Ayerst
Lederle, Inc., and AHP Manufacturing B.V. (together, Wyeth), providing for the
termination of the December 23, 2005 License and Co-Development Agreement
between them and the transition to Progenics of responsibility for the
development and commercialization of RELISTOR®
methylnaltrexone bromide for the treatment of opioid-induced side effects,
including constipation and post-operative bowel dysfunction.
Under the
Termination Agreement, the 2005 Agreement and Wyeth’s license of Progenics
technology thereunder has terminated except as necessary for performance of
Wyeth’s obligations thereunder. Wyeth has granted to Progenics
a fully-paid up, irrevocable, exclusive (except as to Wyeth and its affiliates)
license to relevant technology generated by Wyeth alone or in conjunction with
Progenics during the course of their 2005 Agreement collaboration and during
Wyeth’s performance of its Termination Agreement obligations, and agreed not to
assert against Progenics or its affiliates, licensees or other third-party
business partners any patent rights owned by Wyeth or its affiliates that would
be infringed by unlicensed development or commercialization of
RELISTOR. Progenics controls filing, prosecution, abandonment and
enforcement against third party infringers of the patent rights related to its
technology and those licensed to it by Wyeth. Wyeth has also assigned
or agreed to assign to Progenics specified RELISTOR-related commercial
intellectual property, including trademarks, Internet domain names and
copyrights. Progenics has previously out-licensed rights to
subcutaneous RELISTOR in Japan to Ono Pharmaceutical Co., Ltd., and in
connection with the Termination Agreement, Progenics and Wyeth also terminated
certain agreements between them related to the Ono license.
Wyeth has
agreed to pay to Progenics the sum of $10 million in six quarterly installments
commencing not later than October 19 and ending January 31,
2011. Pursuant to the Termination Agreement, Wyeth will, at its
expense, continue certain ongoing development efforts for subcutaneous RELISTOR
through September 30, 2010, including conducting specified clinical studies, and
provide support for developing specified new delivery mechanisms, in accordance
with an agreed-upon development plan. Wyeth will continue to market and sell
RELISTOR worldwide, including the launch and promotion of the pre-filled syringe
presentation for which the parties have applied for regulatory marketing
approval, in accordance with an agreed-upon commercialization
plan. Wyeth will continue to market and sell RELISTOR through
September 30, 2010 in the United States and through December 31, 2010 in the
rest of the world other than Japan, subject to ex-U.S. country-by-country
extension, at Progenics’ option in certain circumstances, and ex-U.S.
country-by-country early transition, at Progenics’ option. Wyeth
shall continue to pay royalties as provided in the 2005 Agreement except that no
royalties shall be payable in respect of ex-U.S. sales made during (i) the
fourth quarter of 2010 to the extent that certain financial targets for such
quarter are not met or (ii) an extended international sale period in the subject
country.
The
parties will promptly transition from Wyeth to Progenics responsibility for
development of oral RELISTOR, including conduct of clinical trials, and will
transfer principal responsibility for regulatory submissions and interactions
for all other formulations and presentations of RELISTOR during and as part of
the transition. Wyeth will provide financial resources and/or other
assistance with respect to agreed-upon regulatory, manufacturing and supply
matters in addition to those described above, and Progenics will purchase
Wyeth’s remaining inventory of subcutaneous RELISTOR at the end of its sales
periods on agreed-upon terms and conditions. The Termination
Agreement also provides for transfer of development, manufacturing and
commercialization records and other materials, mutual releases between the
parties and indemnification, dispute resolution, non-disparagement and other
customary provisions.
Wyeth and
Progenics mutually agreed that the return of rights to the RELISTOR franchise at
this time was in the best interests of both companies. Progenics also
considered the termination and transition to be desirable from the standpoint of
removing uncertainty surrounding RELISTOR’s prospects in advance of the
recently-completed merger between Wyeth and Pfizer Inc.
The
foregoing summary of the Termination Agreement is qualified in its entirety by
reference to the text thereof, a redacted copy of which will be filed as an
exhibit to Progenics’ Annual Report on Form 10-K for the year ended December 31,
2009. The information in this Current Report on Form 8-K is also
subject to a number of risks and uncertainties, including those set forth or
referred to in the Disclosure Notice contained in Progenics’ press release
relating to the Termination Agreement, a copy of which has been filed as an
Exhibit to its Current Report on Form 8-K dated October 14, 2009. The
information contained in such release is incorporated by reference into these
Items 1.01 and 1.02 of this Current Report on Form 8-K.
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.
PROGENICS
PHARMACEUTICALS, INC.
By: /s/
ROBERT A.
MCKINNEY
Robert
A. McKinney
Chief Financial Officer, Senior Vice President,
Finance & Operations and Treasurer
Date: October 16,
2009