Full Press Release Details
Immediate Release: April 16, 2008
| Pfizer Media Contact : | AVANT Investor Contact: | |
| Shreya Jani | Una Ryan | |
| (212) 733-4889 | President and CEO | |
| (781) 433-0771 | ||
| Pfizer Investor Contact : | ||
| Jennifer Davis | Ronald C. Newbold | |
| (212) 733-0717 | SVP, Business Development | |
| (908) 454-7120 x312 | ||
| AVANT Media Contact: | ||
| Dan Budwick | ||
| BMC Communications | ||
| (212) 477-9007 x14 |
PFIZER AND AVANT ENTER INTO LICENSING AND DEVELOPMENT AGREEMENT
FOR NOVEL THERAPEUTIC VACCINE CANDIDATE FOR BRAIN CANCER
YORK and NEEDHAM, MA (April 16, 2008) Pfizer, Inc. (NYSE: PFE) and
AVANT Immunotherapeutics (Nasdaq:
AVAN), acting through its wholly-owned subsidiary Celldex Therapeutics, Inc. today
announced that they have entered into an agreement under which Pfizer will be
granted an exclusive worldwide license to a therapeutic cancer vaccine
candidate, CDX-110, in Phase 2 development for the treatment of glioblastoma
multiforme (GBM). This agreement also gives Pfizer exclusive
rights to the use of EGFRvIII vaccines in other potential indications.
which has been granted both Fast Track and Orphan Drug designations by the U.S.
Food and Drug Administration (FDA), is an investigational immunotherapy that
targets the tumor-specific molecule EGFRvIII, a functional variant of the
epidermal growth factor receptor (EGFR), which is a protein that has been well
validated as a target for cancer therapy in certain tumor types.
is only expressed in cancer cells and not in normal tissue and is a transforming
oncogene that can directly
to cancer cell growth, as it does in about 40 percent of GBM tumors.
are excited about the potential for CDX-110 and intend to partner with AVANT
and academic physician-scientists to investigate this novel vaccine candidate
with the hope of providing patients and doctors with a new treatment option for
this devastating disease, said Dr. Briggs Morrison, Senior Vice President
for Clinical Development at Pfizer.
the licensing and development agreement, Pfizer will make an upfront payment to
AVANT of $40 million and will make a $10 million equity investment in AVANT.
Pfizer will fund all development costs for these programs. AVANT is also
eligible to receive milestone payments exceeding $390 million for the
successful development and commercialization of CDX-110 and additional EGFRvIII
vaccine products, as well as double-digit royalties on any product sales.
The agreement is subject to approval under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976 (as amended) and is expected to close in the second
advances the therapeutic potential for CDX-110, particularly for patients with
GBM. We are very pleased to initiate
this relationship to expand our clinical development activities for GBM and
toward other cancers, said Ron Newbold, Ph.D., Senior Vice President of Business Development
of AVANT Immunotherapeutics. Una Ryan,
CEO of AVANT, added, We see this as an important milestone for the immunotherapy
field, and we look forward to Pfizer s commitment to help even more cancer
patients in the future.
is designed to induce or enhance the body s immune responses against EGFRvIII
resulting in destruction of tumor cells that express the variant receptor. Early efficacy and
data from single arm Phase 2 clinical trials of CDX-110 in combination with the
current standard treatment for patients with GBM are very encouraging. Progression-free survival and overall
survival data from these trials compare very favorably with historical control
data. A randomized Phase 2 trial is
is the most common and aggressive form of primary brain tumor, with very poor
prognosis. There are an estimated 10,000
new cases of GBM annually in the United States, which predominantly affects
adults aged 45 to 70. The current standard treatment for patients with GBM
includes surgical resection, radiotherapy with concurrent temozolomide and then
adjuvant temozolomide chemotherapy.
About Pfizer Inc
Pfizer discovers and develops innovative medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality healthcare and health system support.
AVANT Immunotherapeutics, Inc.
Immunotherapeutics and Celldex Therapeutics combined during the first quarter
of 2008. AVANT is a NASDAQ-listed
company discovering and developing innovative vaccines and targeted
immunotherapeutics for the treatment of cancer, infectious and inflammatory
diseases. AVANT focuses on the use of tumor-specific targets and human
monoclonal antibodies (mAbs) to precisely deliver therapeutic agents through
its novel targeted immunization approach. In addition, AVANT is exploiting
its access to proprietary human antibody technology for development of
therapeutic monoclonal antibodies (mAbs).
AVANT s deep product pipeline consists of products in varying stages of
development. Identification of the potential of EGFRvIII in
diagnosis, prevention and therapy was based on the collaborative efforts of Dr. Bert
Vogelstein and Dr. Albert Wong at Johns Hopkins University and Dr. Darell
Bigner at Duke University. Application
of this discovery toward the development of the CDX-110 vaccine was further
advanced by Dr. John Sampson and his colleagues at the Duke University
Brain Tumor Center in collaboration with Dr. Amy Heimberger at the MD
Anderson Cancer Center. AVANT also has
several product candidates in its development pipeline including:
a product based on its proprietary APC Targeting Technology , which
is in two Phase 1 clinical trials for patients with advanced pancreatic,
bladder, breast and colon cancer;
a complement inhibitor, in development for transplantation and other
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.
AVANT has three commercialized products, including Rotarix (partnered
with GSK) for the prevention of rotavirus infection and two human food safety
vaccines for reducing salmonella infection in chickens and eggs. Additional
information on AVANT Immunotherapeutics, Inc. can be obtained through its
web site http://www.avantimmune.com.
more information on Pfizer or AVANT please visit www.pfizer.com or
DISCLOSURE NOTICE: The information contained in this release is as of April 16,
2008. Pfizer assumes no obligation to update any forward-looking statements
contained in this release as the result of new information or future events or
release contains forward-looking information about a license agreement between
Pfizer Inc. and AVANT Immunotherapeutics relating to a therapeutic cancer
vaccine candidate, CDX-110, and other potential vaccines and the potential
benefits thereof. This information involves substantial risks and uncertainties
including, among other things, the satisfaction of the condition to closing the
agreement; the uncertainties inherent in research and development activities;
decisions by regulatory authorities regarding whether and when to approve any
drug applications that may be filed for CDX-110 and other potential vaccines as
well as their decisions regarding labeling and other matters that could affect