AVANT Immunotherapeutics, Inc. and Celldex Therapeutics, Inc. Announce Merger Agreement Monday October 22, 6:55 am ET
Creates NASDAQ-listed biopharmaceutical company with diversified pipeline addressing high-value indications within oncology, infectious and inflammatory diseases Conference Call Scheduled for October Monday, October 22, 2007 at 9:00 AM EDT
NEEDHAM, Mass. & PHILLIPSBURG, N.J.--(BUSINESS WIRE)--AVANT Immunotherapeutics, Inc. (NASDAQ: AVAN - News) 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 Technologyâ„¢, 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 [TP10?]. 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: o CDX-1307, a Phase 1 immunotherapy targeting the beta chain of human chorionic gonadotropin (ßhCG) for colorectal, pancreatic, bladder and breast cancers o 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: o CDX-1401, which targets proprietary tumor target antigens for multiple solid tumors, including breast, colon, lung and prostate cancers o 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. |