SEATTLE, WA and BOULDER, CO, May 30, 2013 /CNW/ - Oncothyreon Inc.
(NASDAQ: ONTY) and Array BioPharma Inc. (NASDAQ: ARRY) today announced
that they will collaborate to develop and commercialize ARRY-380, an
orally active, reversible and selective small-molecule HER2 inhibitor.
HER2, also known as ErbB2, is a receptor tyrosine kinase that is
over-expressed in breast cancer and other cancers such as gastric and
ovarian cancer. Array previously completed a Phase 1 clinical trial of
ARRY-380 in patients with heavily pre-treated metastatic breast cancer
which demonstrated that the compound was well tolerated and had
Oncothyreon has agreed to pay Array an upfront fee of $10 million upon
initiation of the collaboration. Under the agreement, Oncothyreon will
fund and conduct the clinical development of ARRY-380 through a defined
set of combination proof-of-concept trials in patients with metastatic
breast cancer, including patients with brain metastases. ARRY-380 has
demonstrated superior activity, based on overall survival, compared to
Tykerb® (lapatinib) and to the investigational drug, neratinib, in an
intracranial HER2+ breast cancer xenograft model. This provides a
strong rationale to explore whether ARRY-380 can provide benefit to
patients with brain metastases, which occur in approximately one-third
of women with metastatic HER2+ breast cancer.
Oncothyreon and Array intend to jointly conduct Phase 3 development
supported by the proof-of-concept studies, with each party retaining
the right to opt out of further development and commercialization in
exchange for a significant royalty. Array is responsible for worldwide
commercialization of the product. Oncothyreon has a co-promotion right
in the U.S., and the two companies will share the cost of U.S.
commercialization, including any profit, equally. Outside of the U.S.,
Oncothyreon will receive a double-digit royalty on net sales intended
to approximate a fifty percent profit share, and the two companies will
share equally the proceeds from any sublicense of marketing rights.
"We are pleased to expand our pipeline of oncology products in
development through this collaboration with Array," said Robert L.
Kirkman, M.D., President and Chief Executive Officer of Oncothyreon.
"As the only selective small-molecule inhibitor of HER2 in clinical
development, we believe ARRY-380 has the potential to significantly
enhance the care of women with metastatic breast cancer."
"We believe ARRY-380 has the potential to be a very important long-term
treatment option for patients living with breast cancer," said Ron
Squarer, Chief Executive Officer, Array BioPharma. "We are pleased to
have a partner in Oncothyreon to advance the drug through these
important proof-of-concept studies and beyond."
ARRY-380 is an orally active, reversible and selective HER2 inhibitor.
In multiple preclinical tumor models, ARRY-380 was well tolerated and
demonstrated significant dose-related tumor growth inhibition that was
superior to Herceptin® (trastuzumab) and Tykerb. Additionally, in
these models, ARRY-380 demonstrated synergistic or additive tumor
growth inhibition when dosed in combination with the standard-of-care
therapeutics Herceptin or Taxotere® (docetaxel).
A Phase 1 trial of ARRY-380, with both dose-escalation and expansion
components, has been completed in 50 patients, 43 of whom had HER2+
metastatic breast cancer. All HER2+ breast cancer patients had
progressed on a trastuzumab-containing regimen. In addition, over 80%
had been treated with lapatinib, with many having progressed on
therapy. In this study, ARRY-380 demonstrated an acceptable safety
profile; treatment-related adverse events were primarily Grade 1.
Because ARRY-380 is selective for HER2 and does not inhibit EGFR, there
was a low incidence and severity of treatment-related diarrhea, rash
and fatigue. Additionally, there were no treatment-related cardiac
events or Grade 4 treatment-related adverse events reported. The
maximum tolerated dose of ARRY-380 established in this Phase 1 trial
was 600 mg twice daily (BID). Twenty-two HER2+ breast cancer patients
with measurable disease were treated with ARRY-380 at doses ≥ 600 mg
BID. In this heavily pretreated patient population, there was a
clinical benefit rate (partial response [n = 3] plus stable disease for
at least 6 months [n = 3]) of 27%. Notably, two of the patients with
partial responses during treatment with ARRY-380 had confirmed
progressions while on prior lapatinib- and trastuzumab-containing
Oncothyreon is a biotechnology company specializing in the development
of innovative therapeutic products for the treatment of cancer.
Oncothyreon's goal is to develop and commercialize novel synthetic
vaccines and targeted small molecules that have the potential to
improve the lives and outcomes of cancer patients. For more
information, visit www.oncothyreon.com.
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. Array is evolving into a
late-stage development company and currently expects significant
progress toward generating data to support our upcoming Phase 3 /
pivotal trial decisions. Novartis expects to begin Phase 3 trials
evaluating Array-invented MEK162 in NRAS- and BRAF-mutant melanoma in
2013. In addition, Array expects to begin a Phase 3 trial evaluating
MEK162 in low-grade serous ovarian cancer under the license agreement
with Novartis in 2013. AstraZeneca expects to begin Phase 3 or pivotal
registration trials with selumetinib (an Array-invented drug) in
non-small cell lung cancer and thyroid cancer during the second half of
2013. Three other Array-invented drugs are also approaching Phase 3 or
pivotal trial decisions which are expected by the end of 2013. These
include Array's wholly-owned drugs, ARRY-520 and ARRY-614, and one
partnered program, danoprevir (with InterMune/Roche). For more
information on Array, please go to www.arraybiopharma.com.
Oncothyreon Forward-Looking Statements
In order to provide Oncothyreon's investors with an understanding of its
current results and future prospects, this release contains statements
that are forward-looking. Any statements contained in this press
release that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes," "anticipates,"
"plans," "expects," "will," "intends," "potential," "possible" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements include Oncothyreon's
expectations regarding potential royalties, profits and other payments
that may be received or paid by Oncothyreon in the future, anticipated
clinical and other product development and marketing activities related
to ARRY-380 and the costs and responsibilities of those activities,
expected benefits and market potential for ARRY-380 and success of
activities to obtain market approval and sales.
Forward-looking statements involve risks and uncertainties related to
Oncothyreon's business and the general economic environment, many of
which are beyond its control. These risks, uncertainties and other
factors could cause Oncothyreon's actual results to differ materially
from those projected in forward-looking statements, including those
predicting the timing, duration and results of clinical trials, the
timing and results of regulatory reviews, the safety and efficacy of
our product candidates, and the indications for which our product
candidates might be developed. There can be no guarantee that the
results of preclinical studies or clinical trials will be predictive of
either safety or efficacy in future clinical trials. Although
Oncothyreon believes that the forward-looking statements contained
herein are reasonable, it can give no assurance that its expectations
are correct. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement. For a detailed description
of Oncothyreon's risks and uncertainties, you are encouraged to review
the documents filed with the securities regulators in the United States
on EDGAR and in Canada on SEDAR. Oncothyreon does not undertake any
obligation to publicly update its forward-looking statements based on
events or circumstances after the date hereof.
Array BioPharma Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about potential royalties, profits and other
payments that may be received or paid by Array in the future, the
potential for the results of ongoing clinical trials to support further
development, regulatory approval or the marketing success of ARRY-380,
anticipated clinical and other product development and marketing
activities related to ARRY-380 and the costs and responsibilities of
those activities, expected benefits and market potential for ARRY-380,
and the success of activities to obtain market approval and sales.
These statements involve significant risks and uncertainties, including
those discussed in the most recent annual report filed on Form 10-K,
quarterly reports filed on Form 10-Q, and other reports filed by Array
with the Securities and Exchange Commission. Because these statements
reflect current expectations concerning future events, 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 Array and Oncothyreon to continue to
fund and successfully progress research and development efforts with
respect to ARRY-380; risks associated with dependence on collaborators
for the clinical development and commercialization of out-licensed drug
candidates, including ARRY-380; the 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; and risks associated with
dependence on third-party service providers to successfully conduct
clinical trials within and outside the United States. Array is
providing this information as of May 30, 2013 and undertakes 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.
Additional information relating to Oncothyreon can be found on EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
Additional information relating to Array BioPharma can be found on EDGAR
SOURCE: Oncothyreon Inc.
For further information:
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Array BioPharma Investor and Media Relations Contact: