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) December
22, 2005
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)
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
On
December 23, 2005,
Progenics Pharmaceuticals, Inc. and Progenics Pharmaceuticals Nevada, Inc.,
its
wholly-owned subsidiary, (“Progenics”) entered into an exclusive, worldwide
License and Co-Development Agreement (the “Wyeth Agreement”) with Wyeth
Pharmaceuticals, a division of Wyeth, and certain affiliates of Wyeth (“Wyeth”)
for the joint development and commercialization of methylnaltrexone (“MNTX”) for
the treatment of opioid-induced side effects, including constipation and
post-operative bowel dysfunction.
Under
the
terms of the Wyeth Agreement, Wyeth receives worldwide rights to MNTX, and
Progenics retains an option to co-promote the product in the United States.
The
companies will collaborate on the worldwide development of MNTX. The transaction
includes an upfront payment of $60 million to Progenics with as much as an
additional $356.5 million payable upon achievement of certain milestones.
Wyeth
will pay Progenics royalties on worldwide sales of MNTX and co-promotion
fees
within the United States. Additionally, Wyeth is responsible for all future
development and commercialization costs of MNTX.
The
Wyeth
Agreement includes three dosage forms, each of which is tailored to address
the
needs of specific clinical applications based on onset of action, predictability
of response, dosing flexibility and ease of use. The three MNTX product
candidates are:
| · |
Subcutaneous
injection for the treatment of intractable constipation in patients
with
advanced medical illness (“AMI”), including cancer and
AIDS;
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| · |
Intravenous
infusion for the treatment of patients with gastrointestinal tract
and
urinary dysfunction that commonly occurs after major abdominal
and
prolonged surgeries; and
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Oral
formulation for the treatment of opioid-induced constipation in
patients
with chronic pain, including those suffering from headaches, joint
pain,
lower-back pain, sickle-cell disease, muscle pain and other disorders
requiring opioid analgesics.
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Under
the
terms of the Wyeth Agreement, Wyeth will develop oral MNTX worldwide. Progenics
will lead the U.S. development of subcutaneous and intravenous MNTX, while
Wyeth
will lead development of these parenteral products outside the U.S. Wyeth
and
Progenics will pursue an integrated strategy to optimize worldwide development,
regulatory approval, and commercial launch of the three MNTX products, which
may
impact timelines previously disclosed by Progenics. Decisions regarding the
timelines for development of the three MNTX products will be made by the
Joint
Development Committee, consisting of members from both Wyeth and
Progenics.
The
Wyeth
Agreement contains provisions, which allow termination by either party upon
the occurrence of certain events.
Item
2.01 Completion of Acquisition or Disposition of Assets
On
December 22, 2005, Progenics Pharmaceuticals, Inc. (“Progenics” or the
“Company”) and its wholly-owned subsidiary, Progenics Pharmaceuticals Nevada,
Inc. (“Progenics Nevada”), acquired certain rights for its lead investigational
drug, methylnaltrexone (“MNTX”), from several of its licensors.
In
2001,
Progenics entered into an exclusive sub-license agreement with UR Labs,
Inc.
(“URL”) to develop and commercialize MNTX (the “MNTX Sub-license”), which
conferred on URL the rights to future payments resulting from development
of
MNTX under the MNTX Sublicense. In 1989, URL obtained an exclusive license
to
MNTX, as amended, from the University of Chicago (“UC”) under an Option and
License Agreement dated May 8, 1985, as amended (the “URL-Chicago License”). In
2001, URL also entered into an agreement with certain heirs of Dr. Leon
Goldberg
(the “Goldberg Distributees”), which provided them with the right to receive
payments based upon revenues received by URL from the development of the
MNTX
Sub-license (the “URL-Goldberg Agreement”).
On
December 22, 2005, Progenics and Progenics Nevada entered into an Agreement
and
Plan of Reorganization (the “Purchase Agreement”) by and among Progenics
Pharmaceuticals, Inc., Progenics Pharmaceuticals Nevada, Inc., UR Labs,
Inc. and
the shareholders of UR Labs, Inc. (the “URL Shareholders”), under which
Progenics Nevada acquired substantially all of the assets and assumed certain
of
the liabilities of URL, comprised of its rights and liabilities under the
URL-Chicago License, the MNTX Sub-license and the URL-Goldberg Agreement.
Those
transactions extinguished Progenics’ obligation to make royalty and other
payments to URL and obligated Progenics to continue to make such payments
to UC
under the URL-Chicago License.
On
December 22, 2005, Progenics and Progenics Nevada entered into an Assignment
and
Assumption Agreement with the Goldberg Distributees, under which Progenics
Nevada assumed all rights and obligations of the Goldberg Distributees
under the
URL-Goldberg Agreement, thereby extinguishing URL’s (and consequentially,
Progenics Nevada’s) obligations to make payments to the Goldberg
Distributees.
In
consideration for the assignment of the Goldberg Distributees’ rights and of the
acquisition of the assets of URL described above, Progenics issued, on
December
22, 2005, a total of 686,000 shares of its common stock and paid a total
of
$2,604,900 in cash (representing the opening market value, $22.85 per share,
of
114,000 shares of Progenics’ common stock on the date of the acquisition) to the
URL Shareholders and the Goldberg Distributees.
The
foregoing description of the Purchase Agreement is not complete and is
qualified
in its entirety by reference to the Purchase Agreement, which is filed
as
Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by
reference. The Company agrees to furnish supplementally a copy of any omitted
schedule to the Commission upon request.
Item.
3.02 Unregistered Sales of Equity Securities
On
December 22, 2005, Progenics Pharmaceuticals, Inc. (“Progenics”) issued a total
of 686,000 unregistered shares of its common stock (the “Offering”) and paid a
total of approximately $2.6 million in cash to several of its licensors
in
exchange for certain rights held by those licensors with respect
to its lead investigational drug, methylnaltrexone (“MNTX”).
In
2001,
Progenics entered into an exclusive sub-license agreement with UR Labs,
Inc.
(“URL”) to develop and commercialize MNTX (the “MNTX Sub-license”), which
conferred on URL the rights to future payments resulting from development
of
MNTX under the MNTX Sublicense. In 1989, URL obtained an exclusive
license to
MNTX, as amended, from the University of Chicago (“UC”) under an Option and
License Agreement dated May 8, 1985, as amended (the “URL-Chicago License”). In
2001, URL also entered into an agreement with certain heirs of Dr.
Leon Goldberg
(the “Goldberg Distributees”), which provided them with the right to receive
payments based upon revenues received by URL from the development of
the MNTX
Sub-license (the “URL-Goldberg Agreement”).
On
December 22, 2005, Progenics and Progenics Nevada entered into an Agreement
and
Plan of Reorganization (the “Purchase Agreement”) by and among Progenics
Pharmaceuticals, Inc., Progenics Pharmaceuticals Nevada, Inc., UR Labs,
Inc. and
the shareholders of UR Labs, Inc. (the “URL Shareholders”), under which
Progenics Nevada acquired substantially all of the assets and assumed
certain of
the liabilities of URL, comprised of its rights and liabilities under the
URL-Chicago License, the MNTX Sub-license and the URL-Goldberg Agreement.
Those
transactions extinguished Progenics’ obligation to make royalty and other
payments to URL and obligated Progenics to continue to make such payments
to UC
under the URL-Chicago License.
On
December 22, 2005, Progenics and Progenics Nevada entered into an Assignment
and
Assumption Agreement with the Goldberg Distributees, under which Progenics
Nevada assumed all rights and obligations of the Goldberg Distributees
under the
URL-Goldberg Agreement, thereby extinguishing URL’s (and consequentially,
Progenics Nevada’s) obligations to make payments to the Goldberg
Distributees.
We
conducted this Offering in accordance with the private placement exemption
set
forth in Rule 506 of Regulation D under Section 4(2) of the Securities
Act of
1933. The Offering was conducted without general solicitation or advertising.
The securities are non-transferable in the absence of an effective registration
statement under the Act or an available exemption therefrom, and all
certificates are imprinted with a restrictive legend to that effect.
Each
investor represented that each is an “accredited investor” under Rule 501(e) of
Regulation D under the Securities Act of 1933.
Item
9.01 Financial Statements and Exhibits.
(c)
Exhibits
Exhibit
No. Description
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10.1
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Agreement
and Plan of Reorganization by and among Progenics Pharmaceuticals,
Inc.,
Progenics Pharmaceuticals Nevada, Inc., UR Labs, Inc. and Shareholders
of
UR Labs, Inc., dated as of December 22,
2005.
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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, Vice President,
Finance
and
Operations and Treasurer
Date:
December 28, 2005