December 12, 2012
Gilead Sciences to Acquire YM BioSciences
- Adds Selective JAK Inhibitor to Growing Oncology and Inflammation Pipeline -
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
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.
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.
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
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
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 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
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
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