22.10.2007 10:55:00
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AVANT Immunotherapeutics, Inc. and Celldex Therapeutics, Inc. Announce Merger Agreement
AVANT Immunotherapeutics, Inc. (NASDAQ: AVAN) and Celldex Therapeutics,
Inc., a privately-held company, announced today the signing of a
definitive merger agreement. The merger creates a NASDAQ-listed,
fully-integrated and diversified biopharmaceutical company with a deep
pipeline of product candidates addressing high-value indications
including oncology and infectious and inflammatory diseases. The
all-stock transaction, approved by both companies’
Boards of Directors, will combine the two companies under the name
AVANT, and is currently expected to close in the first quarter of 2008.
Celldex and AVANT shareholders will own 58% and 42% of the combined
company on a fully diluted basis, respectively. Closing of the merger is
contingent upon a vote of approval by AVANT’s
current shareholders at a special meeting of shareholders expected to
take place in the first quarter of 2008.
The combination of AVANT and Celldex results in a substantial pipeline
of product development candidates and technology platforms focused on
harnessing the human immune system, including monoclonal antibodies and
vaccines. In 2008, the combined company will have three compounds in
mid- to late-stage clinical development and six additional candidates in
earlier-stage development. The pipeline will be fueled internally
through the identification of new candidates based on Celldex’s
proprietary APC Targeting Technology™,
which utilizes human monoclonal antibody (mAb) technology to directly
target the immune system and AVANT’s
innovative vector vaccine delivery, manufacturing and preservation
technologies. The combined company expects to announce several upcoming
milestones during 2008 related to these product candidates, including
the following:
Phase 2b data on CDX-110 in glioblastoma multiforme (GBM), one of the
most aggressive forms of brain cancer
Phase 2 data on infectious disease candidate Ty800 for protection
against Salmonella typhi, the cause of typhoid fever
Phase 1 data on CDX-1307 in colorectal, pancreatic, bladder and breast
cancers
Initiation of multiple Phase 1 trials for oncology, infectious and
inflammatory disease treatment candidates
Initiation of additional novel therapeutic mAb programs
"This proposed merger of AVANT and Celldex
builds a fully-integrated, late-stage biopharmaceutical company
addressing a broad spectrum of serious diseases in significant markets,”
said Dr. Una Ryan, President and CEO of AVANT. "Merging
with Celldex adds value to our existing programs and results in a robust
pipeline, including several later-stage product candidates with
near-term catalysts in infectious diseases and oncology. The combined
company will have multiple products advancing in tandem, mitigating risk
and creating a strong, diversified company focused on clinical progress
and value creation.” "This transaction forms a publicly-traded
company built on our mutual expertise in developing novel immunotherapy
products and backed by a widely applicable technology platform based on
human monoclonal antibodies,” said Charles
Schaller, Chairman of Celldex. "Since Celldex
was spun out of Medarex as an independent private company, we have
successfully progressed our lead oncology program into a Phase 2/3
randomized study, and advanced our first APC Targeted program into two
Phase 1 trials. The merger with AVANT brings together an exceptional
management team with successful experience in all aspects of drug
development. In addition, this transaction extends our cGMP
manufacturing capabilities, which will provide greater efficiency and
flexibility to advance our current and future product candidates.” 2008 Product Pipeline:
Later-stage product candidates include:
CDX-110, a Phase 2/3 cancer immunotherapy targeting EGFRvIII, a
functional variant of the epidermal growth factor (EGFR), in
glioblastoma multiforme (brain cancer)
CholeraGarde®, a
Phase 2 single-dose oral vaccine for protection against cholera
Ty800, a Phase 2 single-dose oral vaccine for protection against Salmonella
typhi, the cause of typhoid fever
Earlier-stage product candidates include:
ETEC/Cholera, entering Phase 1 in 2008 as a single-dose oral vaccine
for protection against enteric disease
Two products based on APC Targeting Technology:
CDX-1307, a Phase 1 immunotherapy targeting the beta chain of
human chorionic gonadotropin (ßhCG)
for colorectal, pancreatic, bladder and breast cancers
CDX-2401, an HIV prophylactic vaccine expected to enter Phase 1 in
2008 as part of our Bill & Melinda Gates Foundation funded
collaboration with Rockefeller University
Two preclinical candidates:
CDX-1401, which targets proprietary tumor target antigens for
multiple solid tumors, including breast, colon, lung and prostate
cancers
TP10, an anti-inflammatory product in development for wet and dry
age-related macular degeneration (AMD), transplant or other
inflammatory disease
The combined company also has a commercialized product, Rotarix®,
a novel, two-dose oral vaccine against rotavirus in collaboration with
GlaxoSmithKline. Rotarix has been approved in over 90 different
countries worldwide, including the European Union, and is currently
under review by the U.S. Food and Drug Administration with a response
expected in the second half of 2008. Upon the U.S. launch of Rotarix,
the combined company will receive a $10 million milestone payment from
Paul Royalty Fund.
Details of the Proposed Transaction
The estimated value of the combined company is approximately $115
million, based on the closing price of AVANT’s
stock on October 19, 2007. AVANT will issue shares of AVANT common stock
to Celldex stockholders such that Celldex stockholders will own
approximately 58% of the combined company on a fully diluted basis and
AVANT stockholders will own approximately 42% on a fully diluted basis.
We will be instituting a reverse stock split to ensure our compliance
with NASDAQ's listing requirements, the exact size of which is still
being evaluated. The reverse stock split will be subject to a vote of
approval from AVANT shareholders. The merger agreement has been approved
by both Boards of Directors and requires approval by AVANT’s
stockholders. AVANT expects to file a Form S-4 and related proxy
statement with the U.S. Securities and Exchange Commission and any other
necessary regulatory filings. Depending on the review process of the
regulatory agencies, the companies currently expect the merger to close
in the first quarter of 2008. Upon closing of the transaction, the
combined company’s shares are expected to
trade on the Nasdaq Capital Market under the symbol "AVAN.”
AVANT was advised by Needham & Company, LLC and Goodwin Procter LLP, and
Celldex was advised by Brean Murray, Carret & Co., LLC and Lowenstein
Sandler PC.
Management and Organization
Following the closing, the combined company will have offices in
Massachusetts and New Jersey, including manufacturing facilities in Fall
River, MA. As a result, AVANT/Celldex will bring proprietary
manufacturing of Celldex programs in-house for added cost-savings.
Executive management of the combined company will be as follows:
Una Ryan, PhD: President and Chief Executive Officer; current
President and Chief Executive Officer of AVANT
Anthony Marucci: Executive Vice President, Corporate Development;
current Vice President, Chief Financial Officer, Treasurer and
Secretary of Celldex
Chip Catlin: Senior Vice President and Chief Financial Officer;
current Senior Vice President and Chief Financial Officer of AVANT
Tibor Keler, PhD: Senior Vice President and Chief Scientific Officer;
current Chief Scientific Officer, Vice President of Research and
Discovery of Celldex
Thomas Davis, MD: Senior Vice President and Chief Medical Officer;
current Chief Medical Officer, Vice President of Clinical Development
of Celldex
Ronald Newbold, PhD: Senior Vice President, Business Development;
current Vice President, Business Development of Celldex
The combined company’s Board of Directors
will consist of four AVANT directors and four Celldex directors. The
Chairman of the Board will be Charles Schaller, past Chairman of Medarex.
Conference Call Information
A joint conference call will be held on Monday, October 22 at 9:00 AM
EDT to discuss the proposed merger agreement and the combined business
and strategic overview of the merged companies. The conference call may
be accessed by visiting www.avantimmune.com
or www.celldextherapeutics.com.
The webcast and telephonic replay will be available following the filing
of the conference call transcript with the SEC.
Callers may also access the call with the following dial-in information:
Domestic phone number: 1-888-396-2384 Passcode: 20038122
International phone number: 1-617-847-8711 Passcode: 20038122
Callers may access the replay with the following dial-in information:
Domestic phone number: 1-888-286-8010 Passcode: 66818661
International phone number: 1-617-801-6888 Passcode: 66818661
About AVANT Immunotherapeutics, Inc.:
AVANT Immunotherapeutics, Inc. is a Massachusetts-based NASDAQ-listed
company discovering and developing innovative vaccines and therapeutics
that harness the human immune system to prevent and treat disease. AVANT’s
innovative bacterial vector delivery technologies with unique
manufacturing and preservation processes offer the potential for a new
generation of vaccines. AVANT has three commercialized products,
including Rotarix®
for the treatment of rotavirus and two human food safety vaccines for
reducing salmonella infection in chickens and eggs. AVANT also has four
product candidates in its development pipeline, an anti-inflammatory
agent, TP10, and three candidates based on its oral, rapidly-protecting,
single-dose and temperature-stable vaccine technology, including
combination vaccines for travelers, the military and global health needs.
About Celldex Therapeutics, Inc.:
Celldex Therapeutics, Inc. is an innovative, privately-held New
Jersey-based biopharmaceutical company—spun-out
of Medarex, Inc. (NASDAQ: MEDX)—developing
targeted immunotherapeutics for the treatment of cancer, infectious and
inflammatory diseases. Celldex focuses on the use of tumor-specific
targets and human monoclonal antibodies (mAbs) to precisely deliver
therapeutic agents through its novel ‘targeted
immunization’ approach. Celldex’s
deep product pipeline consists of products in varying stages of
development, with its lead candidate currently undergoing evaluation in
a Phase 2/3 clinical trial in newly diagnosed glioblastoma multiforme,
one of the most aggressive forms of brain cancer. Celldex is also
running clinical trials for several products based on its proprietary
APC Targeting Technology™,
which delivers fully human monoclonal antibodies directly to patients to
target and stimulate dendritic cells and macrophages—key
cells within the immune system.
Additional Information about the Merger and Where to Find It
This communication contains "forward-looking”
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements are typically preceded by words
such as "believes,” "expects,” "anticipates,” "intends,” "will,” "may,” "should,”
or similar expressions. These forward-looking statements are subject to
risks and uncertainties that may cause actual future experience and
results to differ materially from those discussed in these
forward-looking statements. Important factors that might cause such a
difference include, but are not limited to, costs related to the Merger,
failure of AVANT’s stockholders to approve
the Merger; AVANT’s or Celldex’s
inability to satisfy the conditions of the Merger; AVANT’s
inability to maintain its NASDAQ listing; the risk that AVANT’s
and Celldex’s businesses will not be
integrated successfully; the combined company’s
inability to further identify, develop and achieve commercial success
for new products and technologies; the possibility of delays in the
research and development necessary to select drug development candidates
and delays in clinical trials; the risk that clinical trials may not
result in marketable products; the risk that the combined company may be
unable to successfully secure regulatory approval of and market its drug
candidates; the risks associated with reliance on outside financing to
meet capital requirements; risks associated with Celldex’s
new and uncertain technology; risks of the development of competing
technologies; risks related to the combined company’s
ability to protect its proprietary technologies; risks related to
patent-infringement claims; risks of new, changing and competitive
technologies and regulations in the U.S. and internationally; and other
events and factors disclosed previously and from time to time in AVANT’s
filings with the Securities and Exchange Commission, including AVANT’s
Annual Report on Form 10-K for the year ended December 31, 2006. The
companies do not undertake any obligation to release publicly any
revisions to such forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
This communication may be deemed to be solicitation material in respect
of the proposed merger of AVANT and Celldex. In connection with the
proposed merger, AVANT and Celldex intend to file relevant materials
with the SEC, including AVANT’s joint
registration statement/proxy statement on Form S-4. SHAREHOLDERS OF
AVANT ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC,
INCLUDING AVANT’S PROXY STATEMENT, BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.
Investors and security holders will be able to obtain the documents free
of charge at the SEC's web site, http://www.sec.gov,
and AVANT shareholders will receive information at an appropriate time
on how to obtain transaction-related documents for free from AVANT. Such
documents are not currently available.
Participants in the Solicitation
The directors and executive officers of AVANT and Celldex may be deemed
to be participants in the solicitation of proxies from the holders of
AVANT common stock in respect of the proposed transaction. Information
about the directors and executive officers of AVANT is set forth in the
proxy statement for AVANT’s most recent
10-K, which was filed with the SEC on March 16, 2007. Investors may
obtain additional information regarding the interest of AVANT and its
directors and executive officers, and Celldex and its directors and
executive officers in the proposed transaction by reading the proxy
statement regarding the acquisition when it becomes available.
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