Infinity Amends PI3K-Delta,Gamma Agreement with Millennium

  Infinity Amends PI3K-Delta,Gamma Agreement with Millennium

Business Wire

CAMBRIDGE, Mass. -- December 24, 2012

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that the company
amended its development and license agreement with Millennium: The Takeda
Oncology Company and Takeda Pharmaceutical Company Limited (TSE:4502) for
Infinity’s phosphoinositide-3-kinase (PI3K) program. Under the amended
agreement, Infinity continues to retain full worldwide rights to IPI-145, a
potent, oral inhibitor of PI3K-delta and PI3K-gamma, as well as worldwide
rights to any future product candidates targeting PI3K-delta and/or
PI3K-gamma, and Millennium remains entitled to receive success-based
milestones and tiered royalties on future worldwide sales of products covered
by this agreement. In exchange for Infinity’s one-time payment of $15 million,
Millennium waived its right to opt into a 50-50 U.S. profit and loss-sharing
arrangement in the U.S. for any of Infinity’s PI3K inhibitors, including
IPI-145. In addition, Infinity paid Millennium the $5 million development
milestone for the August 2012 initiation of the Phase 2a clinical trial of
IPI-145 in patients with asthma.

“We believe that the potency of IPI-145 against both PI3K-delta and PI3K-gamma
contribute to its potential to become the best-in-class PI3K inhibitor,”
stated Lawrence Bloch, M.D., J.D., executive vice president, chief financial
officer and chief business officer of Infinity. “Infinity is focused on
rapidly advancing IPI-145 and additional follow-on PI3K product candidates
with the goal that patients, our shareholders and other financial
stakeholders, including Millennium, will benefit from their development and
commercialization.”

“We have had a successful relationship with Infinity since the December 2011
acquisition of Intellikine by Takeda Pharmaceutical Company Limited,” stated
Kyle Kuvalanka, vice president, business development and corporate strategy
and development of Millennium. “We look forward to Infinity’s continued
progress and to participating in the downstream value of its PI3K program
through future milestone and royalty payments.”

Terms of the Amendment to Development and License Agreement

Under the terms of the amended agreement, Infinity continues to retain
worldwide development and commercialization rights for its PI3K-delta,gamma
program. In exchange for Infinity’s one-time payment of $15 million,
Millennium waived its right to opt into a 50-50 U.S. profit and loss-sharing
arrangement and its right to participate in up to 30 percent of the detailing
effort in the U.S. for any of Infinity’s PI3K inhibitors. In addition,
Infinity paid Millennium the $5 million milestone for the August 2012
initiation of the Phase 2a trial of IPI-145 in patients with asthma.

For Infinity’s first two distinct PI3K product candidates, Millennium is
entitled to receive up to $15 million in remaining success-based development
milestones and up to $450 million in success-based approval and commercial
milestones, as defined in the original agreement. For all of Infinity’s
PI3K-delta and/or PI3K-gamma inhibitors covered under the agreement, Infinity
is obligated to pay Millennium tiered royalties on worldwide net sales ranging
from seven percent to 11 percent, which are the same royalty levels as those
specified under the original agreement.

About Infinity’s PI3K Program

The PI3Ks are a family of enzymes involved in multiple cellular functions,
including cell proliferation and survival, cell differentiation, cell
migration and immunity.^1 The PI3K-delta and PI3K-gamma isoforms are
preferentially expressed in leukocytes, where they have distinct and
non-overlapping roles in immune cell development and function. Targeting
PI3K-delta and PI3K-gamma may provide multiple opportunities to develop
differentiated therapies for the treatment of inflammatory diseases as well as
hematologic malignancies.

Infinity is developing a portfolio of novel PI3K-delta and/or PI3K-gamma
inhibitors in both inflammatory diseases and oncology. IPI-145 is currently
progressing in a Phase 1 trial in patients with advanced hematologic
malignancies and in a Phase 2a trial in patients with mild, allergic asthma.
Infinity is also planning to begin a Phase 2 trial of IPI-145 in patients with
rheumatoid arthritis in the first half of 2013. Infinity expects to name its
first follow-on PI3K development candidate by the end of this year and is
planning to complete nonclinical studies, which are designed to enable Phase 1
development, by the end of 2013.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative drug discovery and development company seeking to
discover, develop and deliver to patients best-in-class medicines for diseases
with significant unmet need. Infinity combines proven scientific expertise
with a passion for developing novel small molecule drugs that target emerging
disease pathways. Infinity’s programs focused on the inhibition of
phosphoinositide-3-kinase and heat shock protein 90 are evidence of its
innovative approach to drug discovery and development. For more information on
Infinity, please refer to the company’s website at www.infi.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include those regarding the therapeutic and commercial potential of
and potential clinical development plans for IPI-145, and announcement
Infinity’s first follow-on PI3K development candidate. Such statements are
subject to numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from the company’s current
expectations. For example, there can be no guarantee that Infinity will report
data in the time frames it has estimated, that any product candidate Infinity
is developing will successfully complete necessary preclinical and clinical
development phases or that development of any of Infinity’s product candidates
will continue. Further, there can be no guarantee that any positive
developments in Infinity’s product portfolio will result in stock price
appreciation. Management’s expectations and, therefore, any forward-looking
statements in this press release could also be affected by risks and
uncertainties relating to a number of other factors, including the following:
Infinity’s results of clinical trials and preclinical studies, including
subsequent analysis of existing data and new data received from ongoing and
future studies; the content and timing of decisions made by the U.S. FDA and
other regulatory authorities, investigational review boards at clinical trial
sites and publication review bodies; Infinity’s ability to obtain and maintain
requisite regulatory approvals and to enroll patients in its clinical trials;
unplanned cash requirements and expenditures; development of agents by
Infinity’s competitors for diseases in which Infinity is currently developing
its product candidates; and Infinity’s ability to obtain, maintain and enforce
patent and other intellectual property protection for any product candidates
it is developing. These and other risks which may impact Infinity, its
business and management’s expectations are described in greater detail under
the caption “Risk Factors” included in Infinity’s current report on Form 8-K
filed with theSecurities and Exchange Commission (SEC) onDecember 12, 2012,
and other filings filed by Infinity with the SEC. Any forward-looking
statements contained in this press release speak only as of the date hereof.
While Infinity may elect to update these forward-looking statements at some
point in the future, Infinity expressly disclaims any obligation to update any
forward-looking statements, whether as a result of new information, future
events or otherwise.

^1 Weinberg RA (2007) Cytoplasmic signaling circuitry programs many of the
traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK (Eds.) The biology of
cancer (pp. 179-183). New York, NY: Garland Science, Taylor & Francis Group.

Contact:

Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336
Jaren.Madden@infi.com
http://www.infi.com
 
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