e425
Filed by CytRx Corporation
pursuant to Rule 425 of the Securities Act of 1933, as amended
Subject Company: CytRx Corporation
Subject Companys Commission File No.: 000-15327
On June 9, 2008, CytRx Corporation issued the following press release:
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For Additional Information: |
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CytRx Corporation
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Innovive Pharmaceuticals, Inc. |
Porter Novelli Life Sciences
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Steven Kelly |
John Quirk (investors)
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212-716-1820 |
jquirk@pnlifesciences.com |
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212-601-8296 |
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Cory Tromblee (media) |
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617-897-8294 |
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ctromblee@pnlifesciences.com |
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CYTRX CORPORATION SIGNS DEFINITIVE AGREEMENT TO
ACQUIRE INNOVIVE PHARMACEUTICALS, INC.
Combined Company to Drive Stockholder Value with Commitment to Molecular Chaperone
Technology Platform and Near-Term Commercialization Opportunities in Oncology
Acquisition Subject to Customary Closing Conditions Including Innovive Stockholder Approval
Company to Host Conference Call at 9:00 AM EDT (6:00 AM PDT) Today to Discuss Transaction
LOS ANGELES (June 9, 2008) CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company engaged
in the development and commercialization of therapeutics based on molecular chaperone amplification
technology, today announced the signing of a definitive agreement to purchase Innovive
Pharmaceuticals, Inc., a publicly traded biopharmaceutical company with four clinical stage
oncology drug candidates. The combined company will have an attractive and expanded portfolio of
clinical development programs in oncology, Amyotrophic Lateral Sclerosis (ALS or Lou Gehrigs
disease), stroke recovery and diabetic foot ulcers. In addition, the combined company will own a
49% interest in RXi Pharmaceuticals (NASDAQ: RXII). Included in the acquired pipeline are North
American and European licensing rights to tamibarotene, a drug currently being sold in Japan for
the treatment of relapsed or refractory acute promyelocytic leukemia (APL). Tamibarotene is
presently in a pivotal Phase 2 clinical trial in APL, and CytRx anticipates that the acquisition
will accelerate the time to its first potential NDA filing by several years to 2010.
The Innovive acquisition is a compelling strategic fit for CytRx and is expected to provide
several key benefits. Innovive has an attractive oncology portfolio with the opportunity for
relatively near-term drug approval with low regulatory risk, said Steven A. Kriegsman, CytRx
President and CEO. This acquisition improves our potential for near-term revenue while maintaining
our longer-term emphasis on our molecular chaperone technology platform. The addition of this
pipeline leverages our significant expertise in oncology drug development. Moreover, the up-front
price we are paying, and the structure of the success-based milestones, affords CytRx stockholders
a significant opportunity for upside on our investment. We are confident that CytRx has the
financial and operational flexibility to manage the appropriate integration of these assets into
our existing portfolio. Following the completion of this transaction, we will undertake a
comprehensive strategic review of all Innovive assets to determine where we can maximize
stockholder value while managing financial risk.
Steven Kelly, Innovive President and CEO, stated, Innovives pipeline was designed to lower
clinical and regulatory risk by targeting diseases with well-understood clinical endpoints
providing a clear and established pathway to approval. Current market conditions, however, limited
our ability to fund ongoing clinical development as intended, and we recognized the need to find a
strong partner like CytRx to advance the four drug candidates. We are confident this acquisition by
CytRx will serve the best interests of cancer patients.
Leverages CytRx Oncology Expertise
Collectively, CytRxs management and its Board of Directors have brought numerous oncology drugs to
market. The senior managers and directors of CytRx who hold significant oncology experience
include: Joseph Rubinfeld, Ph.D., a director since July 2002 and world-renowned expert in the field
of oncology, who was one of the four initial founders of Amgen, Inc.; Max Link, Ph.D., Chairman of
the Companys Board of Directors since 1996, who served for a number of years as Chairman and CEO
of Sandoz Pharma and also serves as a director of Alexion Pharmaceuticals, Inc., Celsion
Corporation and Discovery Laboratories, Inc.; Jack R. Barber, Ph.D., Chief Scientific Officer, who
has significant R&D experience in oncology at Immusol and Viagene, where Dr. Barber most recently
served as Head of Oncology; and Shi Chung Ng, Ph.D., Senior Vice President of Research and
Development, who has substantial R&D experience at companies such as Abbott and ArQule, Inc., and
most recently served as Vice President of Molecular Oncology at Ligand Pharmaceuticals.
Update on Molecular Chaperone Development
We look forward to integrating the Innovive portfolio into CytRx as we continue to build upon our
molecular chaperone technology and pipeline, said Mr. Kriegsman. We are proceeding with our Phase
2 clinical trial of iroxanadine for diabetic foot ulcers, which is expected to begin in the first
quarter of 2009, subject to FDA clearance. Furthermore, scientists at our San Diego laboratory have
already identified possible next-generation chaperone-amplifying compounds to expand our pipeline.
In the field of oncology, CytRx has been applying molecular chaperone technology to the
identification of drug candidates by adapting its proprietary chaperone screening assay to identify
inhibitors (rather than amplifiers) of chaperone activity. Because certain chaperones appear to be
essential for cancer cells, CytRxs own internal molecular chaperone-inhibiting drug candidates may
form the basis of future oncology products.
CytRx also announced today that it plans to conduct additional preclinical toxicology studies of
arimoclomol, in development for ALS and stroke recovery, which are expected to take up to one year
to complete. Based on recent telephone discussions with the FDA regarding its clinical hold on
arimoclomol for ALS, CytRx anticipates that the planned Phase 2b clinical trial of arimoclomol will
remain on hold pending completion of this additional preclinical work. However, CytRx has not yet
received a formal determination letter from the FDA with respect to the ongoing clinical hold of
arimoclomol for ALS. In addition, CytRx anticipates that the time frame for initiating the
previously
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planned Phase 2 clinical trial of arimoclomol in stroke recovery will depend on the results of the
new preclinical toxicology studies and other factors.
Innovive Oncology Portfolio Highlights:
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Tamibarotene (formerly known as TM-411, TOS-80T, or Am-80), licensed to Innovive in North
America and Europe, is an oral, rationally-designed, synthetic retinoid originally
synthesized by the University of Tokyo in 1984. In April 2005, tamibarotene was approved in
Japan for use in relapsed/refractory APL. |
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The FDA has granted Orphan Drug Designation and Fast Track Designation
for the use of tamibarotene in patients with relapsed or refractory APL following
treatment with all-trans retinoic acid (ATRA) and arsenic trioxide. CytRx expects to
rely on Orphan Drug Designation and proprietary data for market exclusivity since
tamibarotene chemical matter is off-patent. |
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Innovive has a Special Protocol Assessment (SPA) in place with the FDA
for a pivotal Phase 2 clinical trial, known as STAR-1, which is evaluating the
efficacy and safety of tamibarotene for the treatment of relapsed or refractory APL.
The STAR-1 trial is currently ongoing and includes 31 clinical sites, 22 of which
are in Europe. CytRx believes that successful data from the STAR-1 trial and
supporting studies, in conjunction with data from the Japanese clinical trials, will
form the basis for a New Drug Application (NDA). |
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The efficacy of orally administered tamibarotene was demonstrated in two
Phase 2 studies conducted in Japan in a total of 63 Japanese subjects with APL. The
overall complete response rate in these subjects was 60%. In subjects experiencing
their first relapse, the overall complete response rate was 81%. |
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Innovive also retains an option to expand its licenses for the use of
tamibarotene in other fields in oncology, including multiple myeloma,
myelodysplastic syndrome and solid tumors in the U.S., and multiple myeloma,
myelodysplastic syndromes and solid tumors other than hepatocellular carcinoma in
Europe. |
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APL is apparently caused by a suppressive mutation of the Retinoic Acid
Receptor-alpha (RAR alpha) gene. Both tamibarotene and ATRA are thought to act by
restoring the normal activity of RAR alpha. However, of the three known RARs (RAR
alpha, -beta, and -gamma) tamibarotene has the highest affinity for the desired RAR
alpha, with considerably less affinity for RAR beta, and essentially no affinity for
RAR gamma. This selectivity may result in fewer side effects than ATRA, which
conversely has its highest affinity for RARs gamma and beta and its lowest
affinity for the desired RAR-alpha. These differences from ATRA provide a rationale
for the hypothesis that tamibarotene may be associated with less toxicities, which
may allow a future opportunity for tamibarotene to replace ATRA as a first-line
therapy for APL. |
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INNO-406 (formerly known as NS-187) is a potent, oral, rationally designed, dual Bcr-Abl
and Lyn-kinase inhibitor that is currently being planned as a third line treatment for
patients with Chronic Myeloid Leukemia (CML) or certain forms of Acute Myeloid Leukemia
(AML) that are refractory or intolerant of other approved treatments. In an international
Phase 1 clinical trial that is near completion, INNO-406 has resulted in complete clinical
responses with apparently fewer of the dose-limiting side effects observed with other
marketed drugs. INNO-406 has been granted Orphan Drug Status for the treatment of CML by the
FDA. Upon completion of the Phase 1 clinical trial, the Company anticipates evaluating
options for a Phase 2 protocol with the FDA in CML. |
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INNO-206 (formerly DOXO-EMCH) is a prodrug of the commonly prescribed chemotherapeutic
doxorubicin and was designed to reduce adverse events by preferentially targeting the tumor.
In a Phase 1 study, doses were administered at up to six times the standard dosing of
doxorubicin without an increase in observed side effects over those historically seen levels
with doxorubicin. Objective clinical responses were seen in patients with sarcoma, breast
and lung cancers. The Company anticipates evaluating options for a Phase 2 protocol with the
FDA. |
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INNO-305, a cancer vaccine immunotherapeutic, also known as WT1 (Wilms Tumor Antigen 1)
heteroclitic peptide immunotherapy, is in a Phase 1 clinical trial for the treatment of
subjects with AML and myelodysplastic syndrome (MDS) as well as subjects with non-small cell
lung cancer (NSCLC) and mesothelioma. INNO-305 was designed to have a unique ability among
WT1 peptide cancer immunotherapeutics to stimulate both CD8 and CD4 T-cells which may result
in a more robust immune response. |
Acquisition Improves CytRxs Strategic Position
CytRx management and its Board of Directors believe Innovive represents an excellent strategic
opportunity for the Company that may lead to significant stockholder value creation for the
following reasons:
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Relatively Low-Risk Market Opportunity: The near-term market opportunity for Innovives
tamibarotene in refractory APL in the U.S. alone is estimated to approach $20 million per
year with the market opportunity for an expanded label including refractory, maintenance
and front-line therapy expanding to up to $150 million in potential recurring revenue in the
U.S. and Europe. There are currently no approved third-line treatment options for refractory
APL patients. As mentioned, tamibarotene is currently approved as a drug in Japan and is in
a pivotal Phase 2 clinical trial in the U.S. that is subject to an SPA agreement with the
FDA. CytRx expects to use the data from the ongoing pivotal Phase 2 trial of tamibarotene in
APL and supporting studies in conjunction with previously generated safety data from
Japanese trials as the basis for a New Drug Application (NDA) which could be filed as early
as 2010. |
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Attractive Oncology Portfolio with Improvements Over Existing Therapies: In addition to
tamibarotene, Innovive has two clinical drug candidates poised for Phase 2 development and
one drug candidate that is in Phase 1 development. The portfolio has relatively low
regulatory risk in that the diseases are well-understood, clinical endpoints are
well-documented and established, and the regulatory pathway to drug approval is generally
fairly straightforward. Moreover, there is early evidence of clinical activity and safety in
both INNO-406 and INNO-206, in addition to tamibarotene, and each candidate has
differentiating characteristics that may represent improvements over existing therapies. In
addition, INNO-305 is an attractive cancer vaccine therapeutic that is in Phase 1
development. The addressable market opportunity for INNO-206 could be up to $5 billion, and
the Company believes the combined U.S. and European addressable market opportunity for
INNO-406 could be up to $400 million, and up to $150 million for INNO-305. |
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Creates Near-term Potential for NDA Filing: Through the Innovive acquisition,
tamibarotenes ongoing development may provide a relatively rapid path to commercialization.
Already approved in Japan, tamibarotene represents an attractive late-stage oncology product
candidate with significant differentiation from competitor agents. |
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Attractive Price: Since inception in 2004, Innovive has invested more than $41 million to
move its oncology product candidates forward through clinical development in the U.S. CytRx
may receive substantial benefits from this acquisition for an up-front cost of $3.0 million
payable in CytRx common stock plus the payment of Innovives current liabilities with any
future consideration only payable upon the achievement of sales milestones. |
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Chaperone Technology Platform Provides Longer-Term Opportunity: CytRx owns three
clinical-stage compounds based on its small molecule molecular chaperone co-induction
technology and is currently identifying additional pipeline candidates. Molecular chaperones
play a critical role in maintaining the health of every cell, and because of this, CytRxs
technology may be applicable to a wide range of diseases. The Company has announced plans to
commence a Phase 2 clinical trial of iroxanadine for diabetic foot ulcers in the first
quarter of 2009 subject to FDA clearance. |
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RXi 49% Equity Ownership Provides Independent Market Value: CytRx maintains a 49% equity
interest in RXi Pharmaceuticals, Inc. (NASDAQ: RXII), an RNAi company. CytRxs approximately
6.3 million shares have a current market value of approximately $54 million. |
Transaction Summary
CytRx has agreed to acquire Innovive for total consideration of approximately $21.3 million plus
the assumption of Innovives liabilities. The consideration has three components: 1) at the
completion of the transaction, the holders of Innovives fully
diluted shares of common stock will be entitled to receive in the
aggregate $3.0 million in CytRx common stock valued at a price of $0.94 per share, determined as the volume
weighted average price of CytRx common stock for the ten trading days immediately prior to the
signing of the definitive agreement on Friday, June 6; 2) CytRx will assume Innovive liabilities
and accrued expenses through the closing (as of today, current liabilities are approximately $3.7
million); and 3) CytRx will pay future performance-based milestone earn-outs to Innovive
stockholders of up to approximately $18.3 million payable in cash or stock at CytRxs discretion
upon the satisfactory completion of specific sales milestones for Innovive product candidates.
The transaction is expected to close in the third quarter of 2008 subject to customary closing
conditions including regulatory clearance, approval by stockholders representing a majority of
Innovive shares outstanding, and effectiveness of the registration statement that CytRx will file
with the U.S. Securities and Exchange Commission (SEC) relating to the CytRx common stock to be
paid as consideration to Innovives stockholders.
Conference Call and Webcast
CytRx Corporation will host a conference call and webcast today, Monday, June 9, 2008, at 9:00 A.M.
EDT (6:00 AM PDT) to discuss the Innovive transaction and review recent developments. Interested
participants and investors may access the teleconference call by dialing 877-591-4949 and/or
(U.S./Canada) or 719-325-4862 (international).
The webcast of the call can be accessed on the Investor section of CytRxs Web site at
http://www.cytrx.com/
Web participants are encouraged to go to the Web site 15 minutes prior to the start of the call to
register, download and install any necessary software. After the live webcast, a replay will remain
available in the Investors section of CytRxs Web site for 180 days.
A telephonic replay will also be available beginning at 12:00 Noon EDT for thirty days through
Wednesday, July 9, Midnight EDT. Access numbers for this replay are 888-203-1112 (U.S./Canada) and
719-457-0820 (international); participant code 9480407.
CytRxs press releases are also available at http://www.cytrx.com/
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the
development of high-value human therapeutics. The Company owns three clinical-stage compounds
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based on its small-molecule molecular chaperone co-induction technology. CytRx has a research and
development facility in San Diego. CytRx also has a 49% equity interest in RXi Pharmaceuticals
Corporation (NASDAQ: RXII). For more information on the Company, visit www.cytrx.com.
About Innovive Pharmaceuticals
Innovive Pharmaceuticals, Inc. acquires, develops and commercializes novel therapeutics addressing
significant unmet medical needs in the fields of oncology and hematology. The company has four drug
programs in clinical development: INNO-406, tamibarotene, INNO-206 and INNO-305, for the treatment
of chronic myelogenous leukemia, acute promyelocytic leukemia, small cell lung cancer, and acute
myelogenous leukemia, respectively. For additional information, please visit
www.Innovivepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that
could cause actual events or results to differ materially from the events or results described in
the forward-looking statements, including risks relating to the timing and the satisfaction of
conditions to completion of our proposed acquisition of Innovive Pharmaceuticals, Inc., and our
ability to achieve one or more of our objectives in undertaking the acquisition, the risk that
secured loan amounts advanced by us to Innovive cannot be repaid by Innovive if the acquisition is
not completed, the risk that the costs of our planned molecular chaperone amplification clinical
and preclinical programs and funding of Innovives operating expenses before and after the
acquisition will be greater than we anticipate and adversely affect our liquidity and require us to
obtain additional financing sooner than expected, risks relating to clinical development of the
product candidates of CytRx and Innovive, and the risks and uncertainties described in the most
recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and
current reports filed since the date of CytRxs most recent annual report. The business and
operations of RXi, as well as ownership of RXi shares, also are subject to risks and uncertainties,
including those set forth in the most recent annual and quarterly reports filed by RXi with the
Securities and Exchange Commission and current reports filed since the date of RXis most recent
annual report. All forward-looking statements are based upon information available to CytRx on the
date the statements are first published. CytRx undertakes no obligation to publicly update or
revise any forward-looking statements, whether as a result of new information, future events or
otherwise.
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In connection with the proposed transaction, CytRx will file with the SEC a registration statement
on Form S-4, which will include a preliminary prospectus/proxy statement of CytRx and Innovive
relating to the merger. INVESTORS AND STOCKHOLDERS ARE STRONGLY ADVISED TO READ THE PRELIMINARY
PROSPECTUS/PROXY STATEMENT WHEN IT BECOMES AVAILABLE, BECAUSE IT WILL CONTAIN IMPORTANT
INFORMATION. Investors and stockholders may obtain a free copy of the prospectus/proxy statement
(when available) and other documents filed by us and Innovive at the SECs website at
http://www.sec.gov.
This communication does not constitute an offer to sell or the solicitation of an offer to sell or
the solicitation of an offer to buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of such jurisdiction. No offering of securities will be
made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act
of 1933, as amended.
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This communication is not a solicitation of a proxy from any stockholder of Innovive. However,
CytRx, Innovive and their respective officers and directors may be deemed to be participants in the
solicitation of proxies from Innovive stockholders in connection with the proposed acquisition.
Information about the officers and directors of CytRx and their ownership of CytRx common stock is
set forth in the proxy statement for CytRxs 2008 Annual Meeting of Stockholders, which was filed
with the SEC on May 23, 2008. Information about the officers and directors of Innovive and their
ownership of Innovive common stock is set forth in Innovives most recent Annual Report on
Form 10-K, which was filed with the SEC on March 31, 2008 and amended on April 29, 2008. Investors
and stockholders may obtain additional information regarding the direct and indirect interests of
CytRx, Innovive and their respective officers and directors in the proposed acquisition by reading
the prospectus/proxy statement referred to above.
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