Infinity Pharmaceuticals Inc. : Infinity Regains Worldwide Rights to PI3K, FAAH and Early Discovery Programs
07/18/2012| 06:35am US/Eastern
Recommend:
- Infinity, Purdue and Mundipharma Conclude Strategic Alliance
Restructuring -
- Purdue Pharma L.P. Makes $27.5 Million Equity Investment; Infinity
Has Cash Runway Through Key Data Inflection Points for IPI-145 and
Retaspimycin HCl -
- Encouraging Early Data of IPI-145 in Patients with Hematologic
Malignancies Informs Trial Expansion -
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced it has
restructured its strategic alliance with Mundipharma International
Corporation Limited and Purdue Pharmaceutical Products L.P. by mutual
agreement. With this restructuring, Infinity regains worldwide rights
for its phosphoinositide-3-kinase (PI3K) program, its fatty acid amide
hydrolase (FAAH) program and its early discovery programs. IPI-145, the
company's potent, oral inhibitor of PI3K-delta and -gamma, is currently
progressing in a Phase 1 trial in patients with advanced hematologic
malignancies.
"Regaining worldwide rights to all of our programs, particularly our
PI3K program, is an important, value creating development for Infinity,"
said Adelene Q. Perkins, president and chief executive officer of
Infinity. "Our strategic alliance with Mundipharma and Purdue has been
key in building the company, and we are pleased that they will now
participate in the value of our PI3K program as a more significant
Infinity equity holder, together with our other investors."
Infinity today announced the expansion of its Phase 1, open-label,
dose-escalation trial of IPI-145 in patients with advanced hematologic
malignancies. This expansion cohort will evaluate the safety,
pharmacokinetics and efficacy of IPI-145 administered at 25 mg twice
daily (BID) in patients with chronic lymphocytic leukemia, indolent
non-Hodgkin's lymphoma or mantle cell lymphoma. There have been
confirmed investigator assessments of clinical response at the lowest
dose levels, including 15 mg BID and less. To date, IPI-145 has been
well tolerated and dose-escalation remains ongoing. The maximum
tolerated dose (MTD) of IPI-145 has not yet been determined, and
additional expansion cohorts are planned once the MTD is reached.
Infinity expects to present data from this trial at a medical meeting in
the second half of 2012.
In addition, the company plans to initiate a Phase 2 trial of IPI-145 in
patients with asthma as well as a Phase 2 trial in patients with
rheumatoid arthritis in the second half of 2012.
Transaction Terms
Under the terms of the termination
agreements with Purdue and Mundipharma, Infinity has reacquired all
worldwide development and commercialization rights for its PI3K, FAAH
and early discovery programs, and Mundipharma will no longer provide
research and development funding to Infinity. Mundipharma and Purdue are
entitled to receive royalties on product sales for programs previously
included in the strategic alliance, at rates ranging from one to four
percent.
Infinity also entered into a stock purchase agreement with Purdue Pharma
L.P. (PPLP) under which Infinity will issue and sell 1,896,552 shares of
its common stock, at a price of $14.50 per share, for aggregate proceeds
to Infinity of $27.5 million. Infinity will also issue 3,520,013 shares
of Infinity common stock, at the same price per share, to repay the
principal and accrued interest outstanding under the $50 million line of
credit made available by PPLP. These equity purchases are subject to the
expiration or termination of the applicable waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and
the satisfaction of other customary closing conditions. Upon completion
of these equity purchases, PPLP, together with certain associated
entities, would hold approximately 28 percent on a combined basis of
Infinity's fully diluted common stock outstanding. In addition, PPLP and
the associated entities have agreed to vote any shares held by them in
accordance with the voting recommendations put forth by Infinity's Board
of Directors, subject to certain exceptions for shares held by the
associated entities prior to entry into the stock purchase agreement
with respect to votes on major corporate transactions and charter
amendments. Further, Mundipharma's Board observation rights have
terminated.
Additional Pipeline Update: Retaspimycin HCl
Infinity also
announced today that its Phase 2, randomized, double-blind,
placebo-controlled trial of retaspimycin hydrochloride (HCl) in
combination with docetaxel in patients with non-small cell lung cancer
(NSCLC) is enrolling ahead of schedule. Infinity now anticipates
completing enrollment in this trial this Fall and expects to report data
from the trial in the first half of 2013. Retaspimycin HCl is an
intravenously administered, potent and selective heat shock protein 90
(Hsp90) inhibitor.
Financial Guidance
In the absence of additional funding or
business development activities and based on Infinity's current
operating plans, the company expects that its current cash and
investments, together with proceeds from the planned equity investment
of $27.5 million by PPLP, are sufficient to fund its planned operations
into the second half of 2013, after data from the current trials of
IPI-145 in patients with advanced hematologic malignancies and of
retaspimycin hydrochloride plus docetaxel in patients with NSCLC have
been obtained. The company expects to provide updated 2012 financial
guidance when it reports its second quarter 2012 financial results,
currently planned for August 7, 2012.
Conference Call Information
Infinity will host a conference
call today, Wednesday, July 18, 2012, at 8:30 a.m. ET to discuss the
agreement and provide an update on it PI3K program. A live webcast of
the conference call can be accessed in the "investors/media" section of
Infinity's website at www.infi.com.
To participate in the conference call, please dial 1-877-316-5293
(domestic) or 1-631-291-4526 (international) five minutes prior to start
time. An archived version of the webcast will be available on Infinity's
website for 30 days.
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 the heat shock protein 90, phosphoinositide-3-kinase and
fatty acid amide hydrolase 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. These statements involve risks and
uncertainties that could cause actual results to be materially different
from historical results or from any future results expressed or implied
by such forward-looking statements. Such forward-looking statements
include the expectation that Infinity will report results from the Phase
1 clinical trial of IPI-145 in patients with hematologic malignancies in
the second half of 2012 and be able to expand this study in additional
patient populations following identification of the maximum tolerated
dose, will begin Phase 2 development of IPI-145 in asthma and rheumatoid
arthritis in the second half of 2012, will complete enrollment of the
clinical trial evaluating retaspimycin hydrochloride and docetaxel this
Fall and to report data therefrom in the first half of 2013, has cash
runway into the second half of 2013 and will provide updated financial
guidance during its second quarter financial results call planned for
August 7, 2012, and that we will be able to complete the transactions
contemplated in the securities purchase agreement with PPLP and the
associated entities. These forward looking statements also include those
articulating our belief that having global development commercialization
rights is a key strategic opportunity to create shareholder value, and
that we expect to create such value in the future. Such statements are
subject to numerous 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 any product
candidate Infinity is developing will successfully complete necessary
preclinical and clinical development phases, that development of any of
Infinity's product candidates will continue, or that positive data seen
in any clinical trial will be replicated in a larger patient population
or in subsequent trials. Further, there can be no guarantee that any
positive developments in Infinity's product portfolio will result in
stock price appreciation. Management's expectations could also be
affected by risks and uncertainties relating to: 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, the U.S. Federal Trade Commission and other regulatory
authorities, investigational review boards at clinical trial sites and
publication review bodies; Infinity's ability to enroll patients in its
clinical trials; unplanned cash requirements and expenditures, including
in connection with business development activities; 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 management's expectations are described in
greater detail under the caption "Risk Factors" included in Infinity's
quarterly report on Form 10-Q for the quarter ended March 31, 2012,
filed with the Securities and Exchange Commission on May 8, 2012. 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.
Infinity Pharmaceuticals, Inc.
Jaren Irene Madden,
617-453-1336
Jaren.Madden@infi.com
http://www.infi.com
or
Media:
Cara
Amoroso, 202-729-4013
Cara.Amoroso@fkhealth.com
© Business Wire 2012
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