- Adds Selective JAK Inhibitor to Growing Oncology and
Inflammation Pipeline -
FOSTER CITY, CA AND
MISSISSAUGA, ON, Dec. 12, 2012 /CNW/ - Gilead Sciences, Inc.
(Nasdaq: GILD) and YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM)
announced today that the companies have signed a definitive
agreement under which Gilead will acquire YM for U.S.$2.95 per share in cash. The transaction
has received the unanimous approval of YM's Board of Directors, and
values YM at approximately U.S.$510
million, with YM reporting C$125.5
million in cash and cash equivalents as of September 30, 2012. Gilead plans to fund the
acquisition with cash on hand. The transaction is expected to
close in the first quarter of 2013.
YM's lead drug candidate, CYT387, is an
orally-administered, once-daily, selective inhibitor of the Janus
kinase (JAK) family, specifically JAK1 and JAK2. The JAK
enzymes have been implicated in a number of disorders including
myeloproliferative diseases, inflammatory disorders and certain
cancers. YM has reported positive results from a Phase 1/2
clinical trial of CYT387 in 166 patients with myelofibrosis, a
life-threatening myeloproliferative disease. Pending
completion of the acquisition, Gilead intends to initiate a pivotal
Phase 3 clinical trial of CYT387 in myelofibrosis in the second
half of 2013.
"This acquisition represents an opportunity to
add a complementary clinical program in the area of hematologic
cancers to our growing oncology portfolio," said Norbert W. Bischofberger, PhD, Gilead's
Executive Vice President, Research and Development and Chief
Scientific Officer. "Based on promising Phase 2 data, we
believe CYT387 could provide important clinical benefit for
patients with myelofibrosis, including potential improvements with
regard to anemia and decreased dependence on blood
transfusions. We look forward to advancing CYT387 into a
Phase 3 study as quickly as possible and to exploring its potential
in other myeloproliferative diseases with significant unmet medical
need."
Myelofibrosis is a progressive, chronic bone
marrow disorder in which the marrow is replaced by fibrous scar
tissue, making it difficult for the bone marrow to sufficiently
produce blood cells, leading to anemia (low red blood cell count)
and thrombocytopenia (low blood platelet count), severe
constitutional symptoms and spleen enlargement. JAK
inhibitors modulate cytokine-stimulated intracellular signalling
and decrease the circulating levels of proinflammatory cytokines
associated with the pathogenesis of myelofibrosis.
"This agreement represents a positive outcome
both for myelofibrosis patients and for our shareholders. Gilead
has the research and development capabilities and the resources
needed to more fully realize the potential of CYT387 as a
therapeutic advance for myelofibrosis patients and potentially for
other indications," said Dr. Nick
Glover, President and CEO of YM.
"Since our acquisition of CYT387 nearly three
years ago, YM has made great progress in advancing CYT387 through
the clinical, regulatory, manufacturing and business development
processes. While Gilead's acquisition will end a long, varied
and interesting journey for YM, we are pleased to have this
transaction crystallize the present value of
this important therapeutic candidate," said Mr.
David Allan, Chairman of YM.
In recent years, Gilead has sought to expand its
R&D expertise in the area of oncology through the appointment
of leading cancer researchers and clinicians, the establishment of
external scientific partnerships and through strategic
acquisitions. Gilead's lead compound in oncology, idelalisib
(formerly referred to as GS-1101), is an investigational,
first-in-class specific inhibitor of the phosphoinositide-3 kinase
(PI3K) delta isoform. Five Phase 3 studies of idelalisib in
chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin's
lymphoma (iNHL) are progressing.
Gilead is also conducting Phase 2 clinical
trials of simtuzumab (formerly referred to as GS-6624), an
investigational monoclonal antibody (mAb) candidate targeting the
human lysyl oxidase-like 2 (LOXL2) protein, in myelofibrosis,
colorectal cancer, pancreatic cancer and certain fibrotic
diseases.
CYT387, idelalisib and simtuzumab are
investigational products and their safety and efficacy have not yet
been established.
Terms of the Transaction
Under the terms of the agreement, upon closing of the proposed
transaction, shareholders of YM will receive U.S.$2.95 per common share in cash, and holders of
warrants and stock options will receive a cash payment equal to the
difference between U.S.$2.95 and the
exercise price of such warrant or stock option. The proposed
transaction will be completed through a plan of arrangement under
the provisions of the Companies Act (Nova
Scotia).
The transaction will require the approval of YM
shareholders at a special meeting of YM shareholders, to be held as
soon as reasonably practicable and in any event on or before
February 11, 2013. In addition
to YM's shareholder approval, closing of the transaction is subject
to the satisfaction of certain other customary conditions,
including court approval of the transaction, and applicable
government and regulatory approvals, including expiration or
termination of the waiting period under the United States Hart
Scott Rodino Antitrust Improvements Act, and the review period
under the Competition Act (Canada). The approval of Gilead
shareholders is not required in connection with the proposed
transaction.
The arrangement agreement contains customary
non-solicitation provisions, but permits YM, in certain
circumstances, to terminate the arrangement and accept an
unsolicited superior proposal, subject to fulfilling certain
conditions.
BofA Merrill Lynch and Bloom Burton & Co.
serve as financial advisors, and Gowling Lafleur Henderson LLP,
Heenan Blaikie LLP and Dorsey & Whitney LLP serve as legal
advisors to YM in connection with the transaction. Gilead is
advised by Wilson Sonsini Goodrich
& Rosati, Professional Corporation and Blake Cassels and Graydon LLP.
About YM
YM BioSciences Inc. is a drug development company primarily
focused on advancing CYT387, an orally administered inhibitor of
both the JAK1 and JAK2 kinases, which have been implicated in a
number of hematological and immune cell disorders including
myeloproliferative neoplasms and inflammatory diseases as well as
certain cancers. Positive interim results have been reported from a
Phase 1/2 trial of CYT387 in 166 patients with myelofibrosis. In
addition, YM has several preclinical programs underway with
candidates from its library of novel compounds identified through
internal research conducted at YM BioSciences Australia.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company's mission is to advance the
care of patients suffering from life-threatening diseases
worldwide. Headquartered in Foster
City, California, Gilead has operations in North America, Europe and Asia
Pacific.
YM Forward-Looking Statement
This press release may contain forward-looking statements, which
reflect YM's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may
cause actual results, events or developments to be materially
different from any future results, events or developments expressed
or implied by such forward-looking statements. Such factors
include, but are not limited to, shareholder approval of the
proposed Arrangement; YM's ability to obtain court, regulatory, and
other approvals in connection with the proposed Arrangement;
uncertainties as to the timing of the Arrangement; the satisfaction
of the conditions precedent to the completion of the Arrangement,
including that a governmental entity may prohibit, delay or refuse
to grant approval for the consummation of the Arrangement; changing
market conditions; the successful and timely completion of clinical
studies; the establishment of corporate alliances; the impact of
competitive products and pricing; new product development;
uncertainties related to the regulatory approval process or the
ability to obtain drug product in sufficient quantity or at
standards acceptable to health regulatory authorities to complete
clinical trials or to meet commercial demand; and other risks
detailed from time to time in YM's ongoing quarterly and annual
reporting. Except as required by applicable securities laws, YM
undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Gilead Forward-Looking Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors.
All statements other than statements of historical fact are
statements that could be deemed forward-looking statements,
including all statements regarding the intent, belief or current
expectation of the companies' and members of their senior
management team. Forward-looking statements include, without
limitation, the ability of Gilead to advance YM's product pipeline,
including CYT387, the possibility that Gilead will be unable to
initiate a Phase 3 trial of CYT387 in myelofibrosis as currently
anticipated; the possibility of unfavorable results of clinical
trials of CYT387, idelalisib and simtuzumab; the expected timing of
the completion of the transaction; and the ability to complete the
transaction considering the various closing conditions, including
that a governmental entity may prohibit, delay or refuse to grant
approval for the consummation of the transaction. Investors
are cautioned that any such forward-looking statements are not
guarantees of future performance and involve risks and
uncertainties and are cautioned not to place undue reliance on
these forward-looking statements. Actual results may differ
materially from those currently anticipated due to a number of
risks and uncertainties. Risks and uncertainties that could
cause the actual results to differ from expectations contemplated
by forward-looking statements include: the effects of the
transaction on relationships with employees, customers, other
business partners or governmental entities; other business effects,
including the effects of industry, economic or political conditions
outside of the companies' control; actual or contingent
liabilities; and other risks and uncertainties detailed from time
to time in Gilead's Report on Form 10-Q and for the quarter ended
September 30, 2012. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
Additional Information and Where to Find
It
Further information regarding the transaction will be contained in
an information circular that YM will prepare and mail to its
shareholders in connection with the YM shareholders' meeting, with
closing expected to occur in the first quarter of 2013. YM
shareholders are urged to read the information circular once it
becomes available, as it will contain important information
concerning the proposed transaction. YM shareholders may
obtain a copy of the arrangement agreement, information circular,
and other meeting materials when they become available at
www.sec.gov and www.sedar.com.
This press release is for informational purposes
only. It does not constitute an offer to purchase shares of
YM or a solicitation or recommendation statement under the rules
and regulations of the United States Securities and Exchange
Commission or other applicable laws.
For more information on Gilead Sciences,
please visit the company's website at www.gilead.com, follow Gilead
on Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
For more information on YM BioSciences, please
visit the company's website at www.ymbiosciences.com or contact
James Smith, VP Corporate Affairs at
905.361.9518 or jsmith@ymbiosciences.com
SOURCE YM BioSciences Inc.