BOULDER, Colo.--(BUSINESS WIRE)--Jul. 19, 2012--
Array BioPharma Inc. (NASDAQ: ARRY) announced today that an $8.5 million
milestone was achieved in its collaboration with Amgen. Array entered
into an agreement with Amgen in December 2009 for the worldwide
development of the small-molecule glucokinase activator (GKA) program,
including AMG 151. The milestone was achieved after Amgen reached a
pre-defined patient enrollment level in a Phase 2a clinical trial.
The Phase 2a trial is a randomized, double-blind, placebo-controlled
study of AMG 151 in combination with metformin in patients with Type 2
diabetes. The primary endpoint is change in fasting plasma glucose
levels from baseline to end of treatment. Amgen continues to advance the
trial and seeks to enroll approximately 224 patients.
Under the agreement, Amgen paid an up-front fee of $60 million. Array is
also entitled to receive up to approximately $658 million in additional
aggregate milestone payments if all clinical and commercialization
milestones specified in the agreement for AMG 151 and at least one
backup compound are achieved. Array will also receive royalties on sales
of any approved drugs developed under the agreement.
About Diabetes
According to the Centers for Disease Control, approximately 26 million
Americans have diabetes. Current therapies for this progressive disease
are insufficient or have unwanted side-effects creating a need for the
development of novel therapeutic approaches.
About Glucokinase Activation and AMG 151
Glucokinase activators, such as AMG 151, represent a promising new class
of drugs for the treatment of Type 2 diabetes. Glucokinase is the enzyme
that acts as a glucose sensor in the pancreas and liver. The activation
of glucokinase lowers glucose levels by enhancing the ability of the
pancreas to sense glucose, which leads to increased insulin production.
Simultaneously, GKAs increase the net uptake of blood glucose by the
liver. In multiple well-established preclinical models of Type 2
diabetes, AMG 151 was highly efficacious in controlling both fasting and
non-fasting blood glucose, with rapid onset of effect and maximal
efficacy within five to eight once daily doses. In these studies, when
combined with existing standard-of-care drugs (metformin, Januvia®
(sitagliptin) or Actos® (pioglitazone), AMG 151 provided additional
glucose control, which reached maximal efficacy after five to seven days
of once-daily dosing. AMG 151 did not increase body weight, plasma
triglycerides or total cholesterol, whether used as monotherapy or in
combination with other diabetes drugs.
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 and inflammatory diseases.
Array has four core proprietary clinical programs: ARRY-614 for
myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for
pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded
clinical programs including two MEK inhibitors in Phase 2 clinical
trials: selumetinib with AstraZeneca and MEK162 with Novartis. 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 Amgen, 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 AMG 151. 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;
the ability of Array or our collaborators 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 July 19, 2012. 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
