Harleyman
11 years ago
YMI
Hot damn, some good news...finally.......a buyout of my YMI......
News for 'YMI' - (Gilead Sciences to Acquire YM BioSciences - Adds Selective JAK Inhibitor to Growing Oncology and Inflammation Pipeline -)
FOSTER CITY, Calif. & MISSISSAUGA, Ontario, Dec 12, 2012 (BUSINESS WIRE) --
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.
Harleyman
11 years ago
News for 'YMI' - (YM BioSciences Posts Phase I/II Data for JAK Inhibitor CYT387 in Myelofibrosis at ASH 2012)
Dec 12, 2012 (Close-Up Media via COMTEX) -- YM BioSciences Inc. reported
updated results from the 166 patient Phase I/II study of its JAK1/JAK2
inhibitor, CYT387, for the treatment of myelofibrosis.
According to a release, the results were presented this afternoon in an oral
session at the 54th Annual Meeting of the American Society of Hematology
underway in Atlanta, Georgia.
-68 percent durable 12-week transfusion independence response rate with a
maximal duration of response approaching three years and ongoing.
-The percentage of patients requiring transfusions decreased substantially, from
44 percent at baseline to below 10 percent at week 40 of treatment.
-37 percent durable spleen response per IWG-MRT with a maximal duration of
response of nearly 2.5 years and ongoing.
-The majority of subjects achieved a complete resolution or marked improvement
of common constitutional symptoms.
-The majority of adverse events were Grade 1.
"These data continue to demonstrate that treatment with CYT387 results in
significant, durable responses in transfusion dependency, splenomegaly and
constitutional symptoms," said Dr. Nick Glover, President and CEO of YM
BioSciences. "The benefits CYT387 produces are highly encouraging for patients
with myelofibrosis and underscore the clinical potential of this drug."
The Core Study consisted of nine 28-day treatment cycles where CYT387 was orally
self-administered, primarily at dosages of 150 mg once-daily (QD), 300 mg QD or
150 mg twice-daily (BID). Patients who tolerated and benefited from the drug
could continue to receive CYT387 for an indefinite period beyond the Core Study
in an Extension Study. The 300 mg QD dosing regimen has been selected for use in
the anticipated Phase III clinical development program.
The median follow-up time for patients in the Core Study and Extension Study is
16.9 months (range: 0.8 - 34.2 months; ongoing). During the Core Study, 42
patients (25 percent) discontinued the study, eight for possibly or probably
related adverse events, for an overall retention rate of 75 percent.
The majority of the 166 patients enrolled across the six study sites have
primary myelofibrosis (63 percent); 22 percent have post-polycythemia vera
myelofibrosis and 15 percent have post-essential thrombocythemia myelofibrosis.
Other patient characteristics include:
-DIPSS-Plus category: Int-1 - 10 percent; Int-2 - 62 percent; High - 28 percent
-RBC (Red blood cell) transfusion-dependent: 44 percent
-Palpable splenomegaly >10 cm: 79 percent
-Patients who had received previous therapies, including other JAK inhibitors
(13 percent) and IMiDs (9 percent).
Of the 68 evaluable patients who were transfusion dependent at baseline, 68
percent became transfusion independent for a minimum of 12 weeks during the Core
Study. The median duration of the transfusion-free period has not yet been
reached (range: 85 - 988 days, ongoing). Of the transfusion dependent patients
who did not achieve a full transfusion independence response, 23 percent
achieved at least a 50 percent reduction in transfusion requirement in any
3-month period.
The percentage of patients requiring transfusions decreased substantially during
the study, from 44 percent at baseline to below 10 percent at week 40 of
treatment.
Of the 28 evaluable patients who were transfusion dependent at baseline and
dosed at 300 mg QD, 75 percent have become transfusion independent for a minimum
of 12 weeks.
Three additional patients achieved a 12-week transfusion independence response
during the Extension Study.
Of the 145 patients evaluable for spleen response by palpation, 37 percent
achieved a response per IWG-MRT. The median duration of spleen response reported
was 744 days (range: 56 - 859 days, ongoing). Three additional subjects achieved
spleen response during the Extension Study.
During the Core Study, 50 percent of evaluable patients achieved more than a 50
percent maximal decrease in spleen size from baseline, with 87 percent achieving
more than a 25 percent maximal decrease.
Of the 51 patients who were evaluable for spleen response and dosed at 300 mg
QD, 39 percent achieved a response per IWG-MRT.
In the Core Study, 11 patients were evaluable for spleen response by MRI. The
response rate at six months was 45 percent by MRI (defined as a 35 percent
decrease in spleen volume) and the median splenic decrease from baseline at six
months was -41 percent by volume measured by MRI.
The majority of patients reporting constitutional symptoms at baseline
demonstrated a Complete Resolution or Marked Improvement of their symptoms,
including night sweats, pruritus and bone pain.
CYT387 is well tolerated in myelofibrosis patients for dosing periods currently
up to three years and ongoing. The majority of adverse events were Grade 1.
Common reported adverse effects include thrombocytopenia; transient, mild
dizziness; mild peripheral neuropathy; and abnormalities in
liver/pancreas-related laboratory tests. Treatment-emergent anemia and
neutropenia were rarely observed.
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.
More information:
www.ymbiosciences.com
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surf1944
11 years ago
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