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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): July 31, 2006
EPIX Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
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000-21863 |
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04-3030815 |
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(Commission File Number) |
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(IRS Employer Identification No.) |
161 First Street, Cambridge, Massachusetts 02142
(Address of Principal Executive Offices) (Zip Code)
(617) 250-6000
(Registrants Telephone Number, Including Area Code)
(Former Name or 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 (see General
Instruction A.2. below):
þ 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 8.01. Other Events.
On April 3,
2006, EPIX Pharmaceuticals, Inc. (EPIX) entered into an Agreement and Plan of
Merger with Predix Pharmaceuticals Holdings, Inc. (Predix), and EPIX Delaware, Inc., a
wholly-owned subsidiary of EPIX (Merger Sub), as amended on July 10, 2006 (the Merger
Agreement). Pursuant to the Merger Agreement, Predix will be merged with and into Merger Sub (the
Merger), with Merger Sub continuing after the Merger as the surviving corporation. In addition
to the initial merger consideration, the Merger Agreement provides that Predix stockholders, option
holders and warrant holders are entitled to receive an additional milestone payment of $35 million
upon the achievement of certain clinical or strategic milestones. EPIXs Annual Meeting of
Stockholders and Predixs Special Meeting of Stockholders have been scheduled for August 15, 2006,
at which the stockholders of each company will consider and vote on the approval of the Merger.
The joint proxy statement/prospectus seeking approval for the transaction was mailed to EPIXs and
Predixs stockholders on or about July 18, 2006.
Milestone Achieved under Merger Agreement
On July 31, 2006,
Predix entered into an exclusive worldwide license agreement with Amgen Inc.
(Amgen) to develop and commercialize products based on Predixs preclinical compounds which
target the G-Protein Coupled Receptor sphingosine-1-phosphate receptor-1 (S1P1), and compounds
and products that may be identified by or acquired by Amgen and that are active against the S1P1
receptor. Under the license agreement, Predix will receive a $20 million upfront payment and
royalties on future net sales of products developed in the collaboration, if any. In addition, if
and when specified milestones relating to the development, regulatory approval and sales of
products from the collaboration are achieved, Predix could receive up to an aggregate of $287.5
million in milestone payments from Amgen.
The EPIX
board of directors has determined that Predixs entry into the agreement with Amgen
resulted in the achievement of a milestone event pursuant to the terms of the Merger Agreement.
Accordingly, in addition to the initial merger consideration, Predix stockholders, option holders
and warrant holders will be entitled to the milestone payment under the Merger Agreement in the
aggregate amount of $35 million.
Pursuant
to the terms of the Merger Agreement, each Predix stockholder will receive 1.239411
shares of EPIX common stock upon completion of the Merger, subject to adjustment, including for any
reverse stock split, if implemented, for each share of Predix common stock or preferred stock (on
an as-converted to Predix common stock basis) that they own, and cash in lieu of fractional shares.
In addition, subject to the option of the EPIX board of directors to defer the payment of a
portion of the milestone as discussed below, on or before October 29, 2006, each Predix
stockholder, option holder and warrant holder will now also receive their pro rata portion of the
milestone payment. At the option of the non-Predix members of the combined companys board of
directors, the milestone payment may be paid either:
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in cash, shares of EPIX common stock or any combination thereof with the number
of shares to be issued determined based on the five-day average closing price of EPIX |
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common stock on The NASDAQ Global Market ending on the trading day that is ten days
prior to the payment date; or |
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ii. |
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$20 million payable in accordance with the preceding clause (i) above and $15
million payable on the date that is 12 months after the payment of the initial $20
million in shares of EPIX common stock, with the number of shares to be issued
determined based on 75% of the 30-day average closing price of EPIX common stock on The
NASDAQ Global Market ending on the trading day that is ten days prior to the payment
date. If, as a result of the 49.99% limitation described below, the entire $15 million
payment cannot be made in shares of EPIX common stock, the balance will be paid in cash
plus interest calculated from the milestone payment date at a rate of 10% per year. |
The EPIX
board of directors has until the payment date to elect whether to make the milestone
payment in cash or shares of EPIX common stock, and whether to defer payment of a portion of the
milestone pursuant to clause (ii) above. In no event, however, may the milestone be paid in shares
of EPIX common stock to the extent that such shares would exceed 49.99% of the outstanding shares
of EPIX common stock immediately after such milestone payment, when combined with all shares of
EPIX common stock issued in the Merger and issuable upon exercise of all Predix options and
warrants assumed by EPIX in the Merger. Although the EPIX board of directors has not determined
whether to pay the milestone in cash or EPIX common stock, it is anticipated that, based on the
timing of the achievement of the milestone and the aggregate ownership of EPIX common stock by the
former Predix stockholders immediately following the Merger, all or a substantial portion of the
milestone payment will be paid in cash.
Assuming
full payment of the milestone in cash, EPIX estimates that cash, cash equivalents and
marketable securities on hand upon the completion of the Merger and after the payment of the
milestone, together with expected revenue from the sale of Vasovist and reimbursement of clinical
costs by Schering AG, will be sufficient to fund the combined companys operations through the end
of 2007. If, however, EPIX considers other opportunities or changes its planned activities, it may
require additional funding before currently expected.
Predixs License Agreement with Amgen
On July 31,
2006, Predix entered into an exclusive license agreement with Amgen to develop and
commercialize compounds based on Predixs preclinical compounds which act on the S1P1 receptor and
compounds and products that may be identified by or acquired by Amgen and that are active against
the S1P1 receptor. The S1P1 receptor is a biological receptor that is associated with certain
autoimmune diseases, such as rheumatoid arthritis and multiple sclerosis.
Pursuant to
the license agreement, Predix granted Amgen an exclusive worldwide license to
Predixs intellectual property and know-how related to the S1P1 receptor for the commercialization
of S1P1 compounds and products. Amgen has limited rights to sublicense its rights under the
license. In return for the license, Amgen has agreed to pay Predix a nonrefundable, up-front
payment of $20 million and royalties based on aggregate annual net sales of all S1P1 receptor
modulating products developed by Amgen under the license agreement. In addition, Predix may be
eligible for up to an aggregate of $287.5 million of nonrefundable
milestone payments to Predix that
relate to milestones associated with the commencement of clinical
trials, regulatory approvals and annual net sales thresholds of the products under the license
agreement. These royalty rates and milestone amounts are subject to
reduction in the event that,
among other things:
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Amgen is required to obtain third-party rights to develop and commercialize a product
that incorporates a Predix compound; and |
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Amgen develops and commercializes products that are not covered by Predixs intellectual
property rights licensed to Amgen, such as for example, S1P1 modulating products that may
be acquired by Amgen from a third party. |
Generally, Amgens royalty obligation
under the agreement terminates on a product-by-product and
country-by-country basis upon the later of (a) the expiration or termination of the last claim
within the patents (whether such patents are Predix patents licensed to Amgen or are owned or
in-licensed by Amgen) covering such product and (b) ten years following the first commercial sale
of the product.
The agreement
expires when all of Amgens royalty obligations have terminated. During the
first 15 months of the agreement, Predix will design, discover and develop, at its own cost,
additional compounds that modulate the S1P1 receptor and that are within the same family of
compounds as those identified in Predixs patent applications licensed to Amgen under the
agreement. Amgen will have access to these additional compounds to further its development efforts
under the agreement while Predix is still performing or working on its design, discovery or
development efforts. Predix may undertake additional research under the agreement, at its own
expense, as approved by a joint steering committee formed pursuant to the agreement. Predix has
responsibility and control for filing, prosecution or maintenance for any of Predixs patents
licensed to Amgen for 24 months or until start of Phase I clinical trials for the first product
developed under the agreement, at which time, responsibility and control of such patents transfers
to Amgen. Amgen has responsibility and control for filing, prosecution or maintenance for all
other patents covered by the agreement, including patents jointly developed under the agreement.
Amgen will have final decision-making authority on all other research matters and will be
responsible for non-clinical and clinical development, manufacturing, regulatory activities and
commercialization of the compounds and products developed under the license agreement, at its own
expense. Predix has the option to co-promote one product from the collaboration in the United
States for one indication to be jointly selected by Predix and Amgen. Amgen will direct the
promotional strategy of the parties and will compensate Predix for its efforts and results in
co-promoting the specified product.
The parties
each have the right to terminate the agreement upon a material uncured breach by
the other party and Amgen has the right to terminate the agreement for convenience upon varying
periods of at least three months advance notice. Upon a termination of the agreement, depending
upon the circumstances, the parties have varying rights and obligations with respect to the grant
of continuing license rights, continued commercialization rights and continuing royalty
obligations, in each case with respect to the three categories of products within the collaboration
(generally, products covered by Predixs intellectual property licensed to Amgen, products
discovered by Amgen and products in-licensed or otherwise acquired by Amgen).
Predix
estimates that upon its receipt of the $20 million upfront payment by Amgen under the
agreement, its cash, cash equivalents and marketable securities will be sufficient to fund its
operations, on a stand-alone basis, through the end of 2006 based on Predixs current plans,
expense rates, targeted timelines and its view regarding the progression of its product candidates
through clinical trials. The license granted under this agreement does not affect Predixs rights
to continue development and commercialization, alone or in collaboration with a third party, of the
compounds and products within its other existing research and development programs, including, but
not limited to, the PRX-00023, PRX-03140, PRX-08066 and PRX-07034 clinical programs.
Predix expects
that a substantial portion of its near term, and possibly long term, revenues
will be generated from its agreement with Amgen. If Amgen were to terminate this agreement, fail
to meet its obligations or otherwise decrease its commitment thereunder, Predixs future revenues
could be materially adversely affected and the development and commercialization of Predixs S1P1
discovery program would be interrupted. In addition, if Predix and Amgen do not achieve some or
any of the development and regulatory milestones, or Amgen does not achieve certain net sales
thresholds as set forth in the agreement, Predix will not fully realize the expected benefits of
the agreement. Further, the achievement of the various milestones under the agreement depend on
factors that are outside of Predixs control and most are not expected for several years, if at
all. Predixs receipt of revenues under its agreement with Amgen will be directly affected by the
level of efforts of Amgen and Predix cannot control whether Amgen will devote sufficient resources
to development or commercialization of the technology under the agreement or whether Amgen will
elect to pursue the development or commercialization of alternative products or services.
Disagreements with Amgen could delay or terminate the continued development and commercialization
of the licensed products by Amgen or result in litigation, any of which could have a material
adverse affect on Predixs business, financial condition and results of operations. If Predixs
agreement with Amgen is terminated prior to expiration, Predix would be required to enter into
other strategic relationships or find alternative ways of continuing its S1P1 program. Predix
cannot guarantee that it would be able to enter into a similar agreement with another company with
sufficient drug development capabilities to commercialize this technology, and its failure to do so
could materially and adversely affect its ability to generate revenues.
On July 31,
2006, Predix issued a press release announcing the execution of its agreement with
Amgen. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) |
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The following exhibits are furnished with this report: |
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Exhibit Number |
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Description |
99.1
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Press Release issued by Predix Pharmaceuticals Holdings, Inc. dated July 31, 2006 |
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.
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EPIX Pharmaceuticals, Inc.
(Registrant)
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Date: July 31, 2006 |
/s/ Robert B. Pelletier |
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Robert B. Pelletier |
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Executive Director of Finance
and
Principal Accounting Officer |
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