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
the Securities and Exchange Commission (SEC) on December 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.