BOULDER, Colo., Apr 07, 2011 (BUSINESS WIRE) --
Array BioPharma Inc. (NASDAQ: ARRY) announced today that a $10 million
clinical research milestone was achieved in its development
collaboration with Novartis. Array entered into an agreement with
Novartis in April 2010 for the worldwide development of the
small-molecule MEK inhibitors MEK162 (ARRY-162), its back-up, ARRY-300,
and other MEK inhibitors. The milestone was achieved after Novartis had
its first patient visit in a Phase 2 clinical trial.
The Phase 2 trial is an open-label study to assess the safety and
efficacy of MEK162 in patients with malignant cutaneous melanoma,
harboring BRAFV600E or NRAS mutations. The trial is designed to measure
the objective response rate to treatment with MEK162 when administered
orally as 45 mg twice-daily to patients. The trial will also evaluate
progression-free survival, safety and tolerability.
Under the terms of the agreement with Novartis, Array received initial
payments of $45 million. After payment of the $10 million milestone,
Array is eligible to receive an additional $412 million if certain
clinical, regulatory and commercial milestones are achieved. In
addition, Array is co-developing MEK162 with Novartis in one or more
specific indications and funding a portion of development costs. The
agreement provides Array with royalties on sales of approved drugs
outside of the U.S., with a higher royalty rate for U.S. sales provided
that Array meets its co-funding obligations. Array also has a
co-detailing right in the U.S. for approved drugs.
About MEK
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which
signals cancer cell proliferation and survival. MEK has been shown to be
frequently activated in cancer, in particular in tumors that have
mutations in the RAS and RAF pathways.
About MEK162 (ARRY-162) / MEK inhibitor for cancer
MEK162 has been well-tolerated, displayed favorable pharmacokinetic
properties, and demonstrated significant pharmacodynamic responses in
the completed and ongoing clinical trials. In addition, Array has
completed long-term preclinical regulated safety studies for MEK162.
Array has completed or is enrolling patients with solid tumors in an
ongoing multi-arm Phase 1 dose escalation and expansion trial. The dose
escalation trial and the first expansion arm in patients with biliary
tract cancer completed enrollment. Array is also currently enrolling
patients with KRAS-mutant colorectal cancer and BRAF-mutant colorectal
cancer in additional expansion arms of this trial. Novartis is currently
enrolling patients with BRAF-mutant or NRAS-mutant melanoma in a Phase 2
open label trial.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small molecule
drugs to treat patients afflicted with cancer, inflammatory and
metabolic diseases. Our proprietary drug development pipeline includes
clinical candidates that are designed to regulate therapeutically
important target proteins and are aimed at significant unmet medical
needs. In addition, leading pharmaceutical and biotechnology companies
collaborate with Array to discover and develop drug candidates across a
broad range of therapeutic areas. For more information on Array, please
go to www.arraybiopharma.com.
Array BioPharma Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our potential to earn future milestone and
royalty payments under our agreement with Novartis, the potential for
the results of ongoing preclinical and clinical trials to support
regulatory approval or the marketing success of a drug candidate and
future plans to progress and develop MEK162. These statements involve
significant risks and uncertainties, including those discussed in our
most recent annual report filed on form 10-K, in our quarterly reports
filed on Form 10-Q, and in other reports filed by Array with the
Securities and Exchange Commission. Because these statements reflect our
current expectations concerning future events, our actual results could
differ materially from those anticipated in these forward-looking
statements as a result of many factors. These factors include, but are
not limited to, the ability of our collaborators and of Array BioPharma
Inc. to meet objectives tied to milestones and royalties; risks
associated with our dependence on our collaborators for the clinical
development and commercialization of our out-licensed drug candidates;
our ability to continue to fund and successfully progress internal
research and development efforts and to create effective, commercially
viable drugs; our ability to effectively and timely conduct clinical
trials in light of increasing costs and difficulties in locating
appropriate trial sites and in enrolling patients who meet the criteria
for certain clinical trials; risks associated with our dependence on
third-party service providers to successfully conduct clinical trials
within and outside the United States; our ability to achieve and
maintain profitability and maintain sufficient cash resources; the
extent to which the pharmaceutical and biotechnology industries are
willing to in-license drug candidates for their product pipelines and to
collaborate with and fund third parties on their drug discovery
activities; our ability to out-license our proprietary candidates on
favorable terms; our ability to attract and retain experienced
scientists and management. We are providing this information as of April
7, 2011. We undertake no duty to update any forward-looking statements
to reflect the occurrence of events or circumstances after the date of
such statements or of anticipated or unanticipated events that alter any
assumptions underlying such statements.
SOURCE: Array BioPharma
Array BioPharma
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
