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Oncothyreon and Array Announce Collaboration to Develop and Commercialize anti-HER2 Compound ARRY-380



  Oncothyreon and Array Announce Collaboration to Develop and Commercialize
                         anti-HER2 Compound ARRY-380

-Array to Hold Conference Call to Discuss Collaboration on May 30 at 10 a.m.
E.T.-

PR Newswire

SEATTLE and BOULDER, Colo., May 30, 2013

SEATTLE and BOULDER, Colo., May 30, 2013 /PRNewswire/ -- 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 anti-tumor activity. 

(Logo:  http://photos.prnewswire.com/prnh/20121029/LA02195LOGO)

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."

Conference Call Information

Array will hold a conference call on Thursday, May 30, 2013, at 10:00 a.m.
eastern time to discuss this collaboration. 

 Conference Call Information
Date:                         Thursday, May 30, 2013
Time:                         10:00 a.m. eastern time
Toll-Free:                    (800) 303-0442
Toll:                         (847) 413-3733
Pass Code:                    34997447
Webcast & Conference Call Slides:
http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-irhome

About ARRY-380

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 regimens.

About Oncothyreon

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
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 at
www.sec.gov.

Investor and Media Relations
Contact:                                                        
Julie
Rathbun                                                                                      
Rathbun Communications
206-769-9219
ir@oncothyreon.com

Array BioPharma Investor and Media Relations Contact: 
Tricia Haugeto
(303) 386-1193
thaugeto@arraybiopharma.com

SOURCE Array BioPharma Inc.; Oncothyreon Inc.

Website: http://www.oncothyreon.com
Website: http://www.arraybiopharma.com
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