Pharmacyclics Triggers Fourth Milestone Payment for Enrollment of 5th Patient in Frontline Phase III CLL Study

Pharmacyclics Triggers Fourth Milestone Payment for Enrollment of 5th Patient
                       in Frontline Phase III CLL Study

PR Newswire

SUNNYVALE, Calif., April 11, 2013

SUNNYVALE, Calif., April 11, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq:
PCYC) announced today that the Phase III clinical trial (RESONATE™-2), a
monotherapy trial using ibrutinib versus chlorambucil in elderly patients with
newly diagnosed chronic lymphocytic leukemia / small lymphocyctic lymphoma
(CLL/SLL) has enrolled its fifth patient. The enrollment of the fifth patient
has subsequently triggered a fourth $50 million milestone payment obligation
from Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of
Johnson & Johnson, worldwide collaborator on ibrutinib in oncology.

This trial is a randomized, multicenter, open-label Phase III study of
ibrutinib (PCI-32765) as a monotherapy versus chlorambucil in patients 65
years or older with treatment-naïve CLL/SLL. The study design is in accord
with a Special Protocol Assessment (SPA). The study is designed to demonstrate
superiority of ibrutinib with the primary endpoint of progression-free
survival (PFS); the comparator is single agent chlorambucil. This global study
is planned to enroll 272 patients worldwide.

Further information about this trial can be found at www.clinicaltrials.gov:
NCT01722487 – "A Multicenter, Open-label, Phase 3 Study of the Bruton's
Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years
or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small
Lymphocytic Lymphoma (RESONATE™-2)."

About the Janssen Collaboration
As previously announced on December 8, 2011, Pharmacyclics entered into a
worldwide collaboration with Janssen to develop and commercialize ibrutinib, a
novel, oral, first-in-class Bruton's Tyrosine Kinase (BTK) inhibitor.
Pharmacyclics received from Janssen an upfront payment totaling $150 million
upon signing the contract. With the dosing of a fifth patient in the
RESONATE™-2 study, as announced today, a milestone payment of $50 million has
been earned. To date, $200M in milestones have been earned and Pharmacyclics
may receive up to an additional $625 million in development and regulatory
milestone payments; for total potential upfront and milestone payments of $975
million.

Following regulatory approval, both Pharmacyclics and Janssen will book
revenue and co-commercialize ibrutinib. In the US, Pharmacyclics will book
sales and take the lead role in US commercial strategy development. Both
Pharmacyclics and Janssen will share in commercialization activities. Outside
the United States, Janssen will book sales and perform commercialization
activities. Profits and losses from the commercialization activities will be
split 50/50 on a worldwide basis. Development and commercialization activities
under the collaboration will be managed through a shared governance structure.
Each company will lead development for specific indications as stipulated in a
global development plan. Except in certain cases, in general, development
costs are shared on a 40/60 basis (Pharmacyclics 40% and Janssen 60%).

About Ibrutinib
Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license
agreement in December 2011 to co-develop and co-commercialize ibrutinib.
Ibrutinib was designed to specifically target and selectively inhibit an
enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at
least three critical B-cell pro-survival mechanisms occurring in parallel –
regulation of apoptosis, adhesion, and cell migration and homing. Through
these multiple signals, BTK regulation helps to direct malignant B-cells to
lymphoid tissues, thus allowing access to a micro environment necessary for
survival.

The effectiveness of ibrutinib alone or in combination with other treatments
is being studied in several B-cell malignancies, including chronic lymphocytic
leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large
B-cell lymphoma, follicular lymphoma, Waldenström's macroglobulinemia and
multiple myeloma. To date five Phase III trials have been initiated with
ibrutinib and a total of 26 trials are currently registered on
www.clinicaltrials.gov.

About Pharmacyclics
Pharmacyclics^® is a clinical-stage biopharmaceutical company focused on
developing and commercializing innovative small-molecule drugs for the
treatment of cancer and immune mediated diseases. Our mission and goal is to
build a viable biopharmaceutical company that designs, develops and
commercializes novel therapies intended to improve quality of life, increase
duration of life and resolve serious unmet medical healthcare needs; and to
identify promising product candidates based on scientific development and
administrational expertise, develop our products in a rapid, cost-efficient
manner and pursue commercialization and/or development partners when and where
appropriate.

Presently, Pharmacyclics has three product candidates in clinical development
and several preclinical molecules in lead optimization. The Company is
committed to high standards of ethics, scientific rigor, and operational
efficiency as it moves each of these programs to viable commercialization.

The Company is headquartered in Sunnyvale, California and is listed on NASDAQ
under the symbol PCYC. To learn more about how Pharmacyclics advances science
to improve human healthcare visit us at http://www.pharmacyclics.com. 

NOTE: This announcement may contain forward-looking statements made in
reliance upon the safe harbor provisions of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, including statements, among others, relating to our future capital
requirements and the sufficiency of our current assets to meet these
requirements, our future results of operations, our expectations for and
timing of ongoing or future clinical trials and regulatory approvals for any
of our product candidates, and our plans, objectives, expectations and
intentions. Because these statements apply to future events, they are subject
to risks and uncertainties. When used in this announcement, the words
"anticipate", "believe", "estimate", "expect", "expectation", "goal",
"should", "would", "project", "plan", "predict", "intend" and similar
expressions are intended to identify such forward-looking statements. These
forward-looking statements are based on information currently available to us
and are subject to a number of risks, uncertainties and other factors that
could cause our actual results, performance or achievements to differ
materially from those projected in, or implied by, these forward-looking
statements. Factors that may cause such a difference include, without
limitation, our need for substantial additional financing and the availability
and terms of any such financing, the safety and/or efficacy results of
clinical trials of our product candidates, our failure to obtain regulatory
approvals or comply with ongoing governmental regulation, our ability to
commercialize, manufacture and achieve market acceptance of any of our product
candidates, for which we rely heavily on collaboration with third parties, and
our ability to protect and enforce our intellectual property rights and to
operate without infringing upon the proprietary rights of third parties.
Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results, performance or
achievements and no assurance can be given that the actual results will be
consistent with these forward-looking statements. For more information about
the risks and uncertainties that may affect our results, please see the Risk
Factors section of our filings with the Securities and Exchange Commission,
including our annual report on Form 10-K and quarterly reports on Form 10-Q.
We do not intend to update any of the forward-looking statements after the
date of this announcement to conform these statements to actual results, to
changes in management's expectations or otherwise, except as may be required
by law.

SOURCE Pharmacyclics, Inc.

Website: http://www.pharmacyclics.com
Contact: Ramses Erdtmann, SVP Investor Relations & Administration,
408-215-3325
 
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