AMRI (NASDAQ: AMRI) announced today that Bristol-Myers Squibb Company
(NYSE: BMY) has submitted a Clinical Trial Application (CTA) to the
Medical Products Agency (MPA) in Sweden for approval to initiate Phase I
studies on an AMRI compound exclusively licensed to Bristol-Myers
Squibb. Upon approval of the CTA by the MPA, Bristol-Myers Squibb may
begin Phase I testing in Sweden.
AMRI will receive a $4 million milestone payment from Bristol-Myers
Squibb as a result of the submission of this CTA per the collaborative
agreement between the two companies. This is the second AMRI compound
from this collaboration to be selected by Bristol-Myers Squibb for Phase
I testing. Bristol-Myers Squibb initiated a Phase I study on a separate
AMRI compound in Canada in 2008.
"We are pleased to announce the advancement of a second AMRI compound
toward a Phase I trial by Bristol-Myers Squibb,” said AMRI Chairman,
President and CEO Thomas E. D’Ambra. "We continue to remain excited
about the future prospects for this technology. This development
illustrates the ability of AMRI’s internal R&D programs to generate
valuable assets with commercial potential, creating longer term
significant value for AMRI and its stakeholders.”
"We again want to acknowledge and thank Bristol-Myers Squibb for their
investment, support and leadership in this collaboration, and in
particular, the research team responsible for progressing this series
from advanced preclinical stage to this most recent development,”
D’Ambra continued. "We look forward to further progress from our
collaboration.”
This is the fourth milestone payment in the on-going research
collaboration to develop improved treatments for depression and diseases
of the central nervous system (CNS) bringing the total milestone and
licensing fees earned to date to $17.5 million. The two companies will
continue to evaluate additional compounds.
Under the collaborative agreement, AMRI is potentially eligible to
receive up to $66 million per compound in development and regulatory
milestone payments for the first two compounds, and additional payments
of up to $22 million per compound on subsequent compounds. In addition,
AMRI will receive royalties on worldwide sales of commercialized
compounds.
About AMRI
Founded in 1991, AMRI provides scientific services, products and
technologies focused on improving the quality of life. AMRI works on
drug discovery and development projects and conducts manufacturing of
active ingredients and pharmaceutical intermediates for many of the
world’s leading healthcare companies. As an additional value added
service to its customers, the company is also investing in R&D in order
to expand its contract services and to identify novel early stage drug
candidates with the goal to outlicense to a strategic partner. With
locations in the U.S., Europe and Asia, AMRI provides customers with a
wide range of services, technologies and cost models.
AMRI Forward-Looking Statement
Statements in this press release that are not historical facts are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties.
These statements may be identified by forward-looking words such as
"may,” "could,” "should,” "would,” "potentially,” "will,” "intend,”
"expect,” "anticipate,” "believe” and "continue” or similar words.
Readers should not place undue reliance on our forward-looking
statements. The company’s actual results may differ materially from such
forward-looking statements as a result of numerous factors, some of
which the company may not be able to predict and may not be within the
company’s control. Factors that could cause such differences include,
but are not limited to (a) the company’s performance under the
collaboration with Bristol-Myers Squibb; (b) Bristol-Myers Squibb’s
continuous utilization of the company’s services at levels set forth in
the contract; (c) Bristol-Myers Squibb’s continued pursuit of programs
under which the company provides services; (d) delay or denial of
marketing approvals from the FDA resulting from, among other things,
adverse FDA decisions or interpretations of data that differ from
Bristol-Myers Squibb’s interpretations and that may require additional
clinical trials or potential changes in the cost, scope and duration of
clinical trials; and (e) the outcome of clinical work that will be
required to commercialize compounds, as well as those factors discussed
in the company’s Annual Report on Form 10_K for the year ended December
31, 2008 as filed with the Securities and Exchange Commission on March
13, 2009 and the company’s other SEC filings. The company does not
undertake any duty to and does not intend to update any forward-looking
statements contained in this press release after the date of this press
release.