Funding to support initiation of first-line
study of brigatinib in ALK+ NSCLC and commercial launch readiness
for brigatinib
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that
it will receive $100 million in cash – $50 million upon deal
execution late yesterday and an additional $50 million in one year
– through a synthetic-royalty financing from PDL BioPharma, Inc.
(NASDAQ: PDLI) in exchange for paying PDL a mid-single-digit
royalty on future sales of Iclusig® (ponatinib) until PDL receives
a fixed internal rate of return (IRR). ARIAD also has an option, in
its discretion, to receive up to an additional $100 million at any
time between 6 and 12 months from the date of the agreement, in one
or two tranches on comparable terms.
ARIAD intends to use the base funds to conduct a front-line
trial of brigatinib, its investigational ALK inhibitor, in patients
with non-small cell lung cancer (NSCLC) and to support brigatinib
commercial readiness, as well as to continue its ongoing Iclusig
initiatives. ARIAD is on track to complete enrollment in the
pivotal ALTA trial of brigatinib in third quarter 2015, to file for
approval in the U.S. next year, and subject to regulatory approval,
to launch brigatinib by early 2017. Brigatinib has Breakthrough
Designation from the U.S. Food and Drug Administration.
“This financing allows us to accelerate initiation of the
front-line trial of brigatinib and to ensure launch readiness as
early as possible, while retaining strategic flexibility with
respect to partnering and long-term commercialization of
brigatinib,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.
“We are confident based on the latest clinical data on brigatinib
and other ALK‐inhibitors, that brigatinib may be an important new
cancer medicine for patients with ALK+ lung cancer. With the
funding provided by this royalty transaction, we expect to start
the front-line trial by early next year, ahead of our expected
filing for initial marketing approval of brigatinib in patients
with refractory ALK+ NSCLC.”
Dr. Berger added, “This synthetic-royalty financing allows us to
access the needed capital at low cost without selling any equity
and gives us the greatest flexibility in implementing our corporate
strategy.”
Royalty Interest Financing Terms
Pursuant to the agreement, ARIAD will pay PDL 2.5% of global net
revenues of Iclusig for the first year of the agreement, 5.0% after
the first year through the end of 2018, and 6.5% from 2019 until
PDL receives a specified very low double-digit IRR. The 6.5%
royalty rate would increase to 7.5% if the Company draws down more
than $150 million. In all cases, the royalty no longer is payable
once PDL receives its predefined IRR.
ARIAD may also buy out the royalty at any time by making a
payment to PDL that will, together with royalties paid, provide a
specified return to PDL. Furthermore, if after five years from
receiving each payment tranche, PDL has not received total payments
that are at least equal to the total amounts it has paid to ARIAD,
then ARIAD will be required to pay to PDL an amount equal to such a
difference.
Upon the occurrence of specified events, such as a change of
control of ARIAD, PDL has the right, but not the obligation, to
terminate the agreement by requiring ARIAD to repurchase the
revenue interests owed to PDL at a predefined price.
Houlihan Lokey acted as sole placement agent and financial
advisor for this synthetic-royalty financing transaction. Mintz,
Levin, Cohn, Ferris, Glovsky & Popeo, PC represented ARIAD in
this transaction.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD’s computational and structure-based drug-design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved
TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland,
Israel and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
- Treatment of adult patients with
T315I-positive chronic myeloid leukemia (chronic phase, accelerated
phase, or blast phase) or T315I-positive Philadelphia chromosome
positive acute lymphoblastic leukemia (Ph+ ALL).
- Treatment of adult patients with
chronic phase, accelerated phase, or blast phase chronic myeloid
leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor
(TKI) therapy is indicated.
These indications are based upon response rate. There are no
trials verifying an improvement in disease-related symptoms or
increased survival with Iclusig.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full prescribing information for complete boxed
warning
- Vascular Occlusion: Arterial and
venous thrombosis and occlusions have occurred in at least 27% of
Iclusig treated patients, including fatal myocardial infarction,
stroke, stenosis of large arterial vessels of the brain, severe
peripheral vascular disease, and the need for urgent
revascularization procedures. Patients with and without
cardiovascular risk factors, including patients less than 50 years
old, experienced these events. Monitor for evidence of
thromboembolism and vascular occlusion. Interrupt or stop Iclusig
immediately for vascular occlusion. A benefit risk consideration
should guide a decision to restart Iclusig therapy.
- Heart Failure, including fatalities,
occurred in 8% of Iclusig-treated patients. Monitor cardiac
function. Interrupt or stop Iclusig for new or worsening heart
failure.
- Hepatotoxicity, liver failure and
death have occurred in Iclusig-treated patients. Monitor hepatic
function. Interrupt Iclusig if hepatotoxicity is
suspected.
Please see the full U.S. Prescribing Information
for Iclusig, including the Boxed Warning, for additional
important safety information.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
About PDL BioPharma, Inc.
PDL manages a portfolio of patents and royalty assets,
consisting of its Queen et al. patents, license agreements with
various biotechnology and pharmaceutical companies, and royalty and
other assets acquired. To acquire new income generating assets, PDL
provides non-dilutive growth capital and financing solutions to
late-stage public and private healthcare companies and offers
immediate financial monetization of royalty streams to companies,
academic institutions, and inventors. PDL has invested
approximately $830 million to date. PDL evaluates its investments
based on the quality of the income generating assets and potential
returns on investment. PDL is currently focused on intellectual
property asset management, acquiring new income generating assets
and maximizing value for its shareholders.
PDL was founded in 1986 and is headquartered in Incline Village,
Nevada.
For more information, please visit www.pdl.com.
PDL BioPharma and the PDL BioPharma logo are considered
trademarks of PDL BioPharma, Inc.
This press release contains forward-looking statements. Any
statements contained herein which do not describe historical facts,
including, but not limited to, statements regarding: the
therapeutic potential of brigatinib; our plans for using the
proceeds from the financing transaction with PDL and the expected
benefits resulting therefrom; our ability to buy out our royalty
obligation to PDL; our strategic flexibility with respect to
partnering and commercializing brigatinib; and the expected timing
for commencing and completing clinical trials and for regulatory
filings for and commercial launches of our products and product
candidates, are forward-looking statements which are based on
management's expectations and are subject to certain factors, risks
and uncertainties that may cause actual results, outcome of events,
timing and performance to differ materially from those expressed or
implied by such statements. These factors, risks and uncertainties
include, among others: our ability to meet anticipated clinical
trial commencement and completion dates and regulatory filing dates
for our products and product candidates; the costs associated with
our research, development, manufacturing and other activities; the
adequacy of our capital resources and the availability of
additional funding; our ongoing and additional clinical trials of
brigatinib may not be successful or initiated, enrolled or
conducted in a timely manner; regulatory developments and safety
issues, including difficulties or delays in obtaining regulatory
and pricing and reimbursement approvals to market our products; our
ability to successfully commercialize and generate profits from
sales of Iclusig or our other product candidates, including
brigatinib, if approved; competition from alternative therapies;
manufacturing issues and those additional factors detailed in our
public filings with the U.S. Securities and Exchange Commission,
including our most recent Annual Report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release and we undertake no obligation to update or revise any of
these statements to reflect events or circumstances occurring after
this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release. All forward‐looking statements in this press release are
qualified in their entirety by this cautionary statement.
Iclusig® is a registered trademark of ARIAD Pharmaceuticals,
Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20150729005796/en/
ARIAD PharmaceuticalsFor InvestorsMaria Cantor,
617-621-2208Maria.cantor@ariad.comorKendra Adams,
617-503-7028Kendra.adams@ariad.comorFor MediaLiza Heapes,
617-620-4888Liza.heapes@ariad.com
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