Infinity Amends PI3K-Delta, Gamma Agreement with Millennium

  Infinity Amends PI3K-Delta, Gamma Agreement with Millennium

Business Wire

CAMBRIDGE, Mass. -- August 4, 2014

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that the company
has purchased an option to buy out all future potential royalty payments due
to Millennium: The Takeda Oncology Company for sales in oncology of IPI-145,
Infinity’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and
PI3K-gamma.

In exchange for a one-time, upfront payment of $5.0 million, Infinity receives
an option to terminate its obligation to pay Millennium future royalties
related to the sale of IPI-145 in oncology. Infinity may exercise this option
by providing written notice and payment to Millennium of a one-time exercise
fee of $52.5 million on or before March 31, 2015. Exercise of the option does
not affect any other obligation under the Development and License Agreement,
including Infinity’s obligation to pay royalties on sales of IPI-145 outside
of oncology. If Infinity does not exercise the option, its royalty obligations
with respect to IPI-145 in oncology will remain in effect.

Assuming exercise of the option, Infinity’s obligation to pay Millennium
tiered royalties, ranging from seven percent to 11 percent, on worldwide net
sales of Infinity’s first two distinct PI3K product candidates will exclude
worldwide net sales of IPI-145 in oncology. Infinity will remain obligated to
pay milestones to Millennium for Infinity’s first two distinct PI3K product
candidates that gain approval, including IPI-145. The remaining milestones
comprise up to a total of $220 million in success-based regulatory milestones,
up to a total of $230 million in commercial milestones which are due once
certain sales thresholds have been met, and up to a total of $5 million in
development milestones.

About the Development of IPI-145 for the Treatment of Blood Cancers
Infinity is developing IPI-145, an oral inhibitor of Class I PI3K-delta,gamma.
The PI3Ks are a family of enzymes involved in multiple cellular functions,
including cell proliferation and survival, cell differentiation, cell
migration and immunity. The PI3K-delta,gamma isoforms are preferentially
expressed in leukocytes (white blood cells), where they have distinct and
mostly 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 hematologic malignancies
as well as inflammatory diseases.

In 2013, Infinity launched the DUETTS^TM program, a worldwide investigation of
IPI-145 in blood cancers. As part of the DUETTS program, patient enrollment is
ongoing in DYNAMO^TM, a Phase 2 monotherapy study designed to evaluate the
safety and efficacy of IPI-145 in patients with refractory indolent
non-Hodgkin lymphoma (iNHL) (ClinicalTrials.gov Identifier NCT01882803), and
DUO^TM, a Phase 3 monotherapy study designed to evaluate the safety and
efficacy of IPI-145 in patients with relapsed/refractory chronic lymphocytic
leukemia (CLL) (NCT02004522). DYNAMO+R^TM, a Phase 3 study of IPI-145 in
combination with rituximab in relapsed iNHL (NCT02204982), is expected to
start in 2014.

Additionally, a Phase 1 study of IPI-145 in patients with advanced blood
cancers is ongoing (NCT01476657).

About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to discovering,
developing and delivering best-in-class medicines to people with
difficult-to-treat diseases. Infinity combines proven scientific expertise
with a passion for developing novel small molecule drugs that target emerging
disease pathways. 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 company’s expectations about the
therapeutic and commercial potential of IPI-145 and the company’s expectations
and timelines for the future development of IPI-145. 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. Food and
Drug Administration 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 or intends to develop 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 management’s expectations are described
in greater detail under the caption “Risk Factors” included in Infinity’s
quarterly report on Form 10-Q filed with theSecurities and Exchange
Commission (SEC) onMay 6, 2014, and other filings filed by Infinity with
theSEC. Any forward-looking statements contained in this press release speak
only as of the date hereof, and Infinity expressly disclaims any obligation to
update any forward-looking statements, whether as a result of new information,
future events or otherwise.

Contact:

Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336
Jaren.Madden@infi.com
http://www.infi.com
 
Press spacebar to pause and continue. Press esc to stop.