MedImmune and Infinity Pharmaceuticals Announce Cancer Drug Development and Worldwide Commercialization Agreement
28 Agosto 2006 - 8:00AM
PR Newswire (US)
- Alliance to Focus on Novel, Targeted Small Molecule Cancer
Therapeutics in Two Key Programs - GAITHERSBURG, Md. and CAMBRIDGE,
Mass., Aug. 28 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(NASDAQ:MEDI) and Infinity Pharmaceuticals, Inc. today announced
that they have entered into an agreement to jointly develop and
commercialize novel small molecule cancer drugs targeting Heat
Shock Protein 90 (Hsp90) and the Hedgehog cell-signaling pathway.
In preclinical studies, Hsp90 and the Hedgehog pathway appear to be
implicated in the growth and survival of a broad range of
blood-related and solid tumor types. IPI-504, the most advanced of
the drug candidates included in the agreement, is an Hsp90
inhibitor that has thus far been studied in two disease-focused
Phase 1 trials. "Hsp90 and Hedgehog are among the most attractive
targeted therapy opportunities in cancer research today, and the
Infinity programs have a very strong competitive position," said
Edward T. Mathers, MedImmune's executive vice president, corporate
development and venture. "With IPI-504, we have a promising drug
candidate with already-established preclinical in vivo proof of
concept and the potential to reach the market by 2010. In
collaboration with Infinity, we plan to accelerate development of
the intravenous formulation of IPI-504, as well as to expand into
additional tumor types. In addition, we expect to be able to
commence clinical testing of the next generation oral formulation
of IPI-504, as well as an oral formulation of a hedgehog inhibitor
within the next 12 to 18 months." Under the terms of the agreement,
MedImmune and Infinity will share equally all costs and profits
from the development and commercialization of any future products.
MedImmune will provide Infinity a one-time upfront payment of $70
million for co-exclusive, shared rights to the Hsp90 and Hedgehog
pathway product development programs. In addition, Infinity could
receive up to an additional $430 million in milestone payments
related to the companies' achieving certain late-stage clinical
development and sales targets for any future products resulting
from the collaboration. For each of the Hsp90 and Hedgehog pathway
programs, Infinity will retain primary responsibility for
discovery, preclinical development and translational clinical
development of products through proof-of-concept in humans.
MedImmune and Infinity will jointly conduct clinical development
through first product approval. MedImmune will lead worldwide
regulatory strategy as well as sales and marketing of resulting
products; Infinity retains an option to co-promote any future
products in the United States, contributing up to 35 percent of the
total promotional effort. "This collaboration with MedImmune allows
Infinity to accelerate and maximize the development of our most
advanced product candidates while enabling us to share fully in the
potential value creation of these products," said Adelene Q.
Perkins, Infinity's executive vice president and chief business
officer. "We believe that MedImmune's established clinical, sales,
and marketing capabilities are a strong complement to Infinity's
expertise in novel small molecule drug discovery and development."
About Hsp90 and IPI-504 IPI-504 is Infinity's proprietary small
molecule therapeutic drug candidate that, in preclinical studies,
potently and selectively inhibited Hsp90, thereby killing cancer
cells. Hsp90 is an emerging therapeutic target of interest for the
treatment of cancer. Proteins are the mainstay of structural and
signaling elements of all cells. Hsp90 functions to stabilize and
maintain the activity of proteins in the cancer cell, thereby
allowing a cancer cell to survive despite an abundance of misfolded
and unstable proteins. Inhibition of Hsp90 has broad therapeutic
potential for the treatment of patients with solid tumors and
blood-related cancers, including cancers that are resistant to
other drugs. IPI-504 preferentially targets and accumulates in
tumor tissues, sparing healthy tissues. In preclinical studies it
has demonstrated a broad potential to treat certain cancers as both
a single agent as well as in combination with existing anti-cancer
drugs. The water-based formulation of IPI-504 is easy to deliver as
an intravenous infusion. Infinity is currently conducting two Phase
1 clinical trials with intravenous formulations of IPI-504. In July
2005, Infinity initiated the first of these Phase 1 clinical trials
in refractory multiple myeloma. In December 2005, Infinity
initiated the second Phase 1 clinical trials with IPI-504 in
refractory gastrointestinal stromal tumors (GIST). Infinity has
also begun developing an oral formulation of IPI-504, which if
successful, could be a more convenient route of administration for
cancer therapy. About the Hedgehog Pathway The Hedgehog
cell-signaling pathway is normally active during embryonic
development regulating tissue and organ formation. However,
aberrant activation of the Hedgehog pathway in adults has been
implicated in many of the most deadly cancers, including pancreatic
cancer, prostate cancer, small cell lung cancer, breast cancer, and
certain brain cancers. The activation of this pathway is necessary
for many of these cancers to proliferate and survive. In addition
to the role that the Hedgehog pathway plays in enabling the
survival and proliferation of cancer cells, recent evidence also
points to an important role for the Hedgehog pathway in cancer stem
cells. Cancer stem cells are believed to be the progenitor cells
that allow tumors to survive despite treatment with conventional
chemotherapeutics agents. Infinity's most advanced drug candidates
are novel, proprietary systemically administered agents that have
demonstrated in preclinical studies the ability to potently and
selectively inhibit the Hedgehog pathway. Certain of these agents
have demonstrated efficacy in multiple preclinical animal models of
cancer as a single agent and are well tolerated in these models.
Impact to MedImmune's 2006 Financial Guidance The estimated 2006
financial impact of the Infinity agreement to MedImmune's
previously stated earnings guidance range of $0.30 to $0.35 per
diluted share, before stock option expense, is a reduction of
approximately $0.19 per diluted share, primarily due to the
one-time upfront payment of $70 million. However, the impact of
this transaction may be partially offset by gains MedImmune may
receive from other in-process business transactions that have the
potential to be successfully completed by the end of 2006. About
MedImmune, Inc. MedImmune strives to provide better medicines to
patients, new medical options for physicians, rewarding careers to
employees, and increased value to shareholders. Dedicated to
advancing science and medicine to help people live better lives,
the company is focused on the areas of infectious diseases, cancer
and inflammatory diseases. With more than 2,300 employees
worldwide, MedImmune is headquartered in Maryland. For more
information, visit the company's website at
http://www.medimmune.com/. About Infinity Pharmaceuticals, Inc.
Infinity Pharmaceuticals is an innovative cancer drug discovery and
development company that is seeking to leverage its strength in
small molecule drug technologies to discover, develop, and deliver
to patients first-in-class or best-in-class medicines for the
treatment of cancer and related conditions. The company announced
on April 12, 2006 a definitive agreement to merge with Discovery
Partners International, Inc. (NASDAQ:DPII). Additional Information
about the DPI-Infinity Merger and Where to Find It In connection
with the proposed merger between Discovery Partners International,
Inc. (DPI) and Infinity, on August 7, 2006, DPI filed an amended
registration statement on Form S-4 that contains a proxy
statement/prospectus, which registration statement has been
declared effective by the SEC. Investors and security holders of
DPI and Infinity are urged to read the proxy statement/prospectus
(including any amendments or supplements to the proxy
statement/prospectus) regarding the proposed merger because it
contains important information about DPI, Infinity and the proposed
merger. Security holders will be able to obtain a copy of the proxy
statement/prospectus, as well as other filings containing
information about DPI and Infinity, without charge, at the SEC's
Internet site (http://www.sec.gov/). Copies of the proxy
statement/prospectus can also be obtained, without charge, by
directing a request to Discovery Partners International, Inc., 9640
Towne Centre Drive, San Diego, CA 92121, Attention: Investor
Relations, Telephone: (858) 455-8600. Participants in the
Solicitation DPI and its directors and executive officers and
Infinity and its directors and executive officers may be deemed to
be participants in the solicitation of proxies from the
stockholders of DPI in connection with the proposed merger of DPI
with Infinity. Information regarding the special interests of these
directors and executive officers in the merger transaction is
included in the proxy statement/prospectus referred to above.
Additional information regarding the directors and executive
officers of DPI is also included in DPI's proxy statement for its
2006 Annual Meeting of Stockholders, which was filed with the SEC
on April 6, 2006. This document is available free of charge at the
SEC's web site (http://www.sec.gov/) and from Investor Relations at
DPI at the address described above. This announcement contains, in
addition to historical information, certain forward-looking
statements that involve risks and uncertainties, in particular,
related to the research and development of future small molecule
products. Such statements reflect the current views of MedImmune
and/or Infinity management and are based on certain assumptions.
Actual results could differ materially from those currently
anticipated as a result of a number of factors, including risks and
uncertainties discussed in MedImmune's filings with the U.S.
Securities and Exchange Commission and in the registration
statement on Form S-4 that was filed by DPI on May 24, 2006, and
subsequently amended, in connection with the proposed merger
between DPI and Infinity. There can be no assurance that such
development efforts will succeed, that the products will receive
required regulatory clearance or, even if such regulatory clearance
is received, that the subsequent products will ultimately achieve
commercial success. DATASOURCE: MedImmune, Inc. CONTACT: Media:
Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,
+1-301-398-4358, both of MedImmune, Inc.; or Media: Monique
Allaire, +1-617-453-1105, or Investors: John Evans,
+1-617-453-1254, both of Infinity Pharmaceuticals, Inc. Web site:
http://www.medimmune.com/ http://www.ipi.com/
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