K********g
发帖数: 9389 | 1 看看解冻开盘后，价格能到多少，奶奶的。可不要Sell on news哦，也让我挣点钱吧 | b*****h
发帖数: 783 | 2 猜18－20.。。。
【在 K********g 的大作中提到】
: 看看解冻开盘后，价格能到多少，奶奶的。可不要Sell on news哦，也让我挣点钱吧
| y********o
发帖数: 1588 | 3 真的假的，老牛说说
【在 b*****h 的大作中提到】
: 猜18－20.。。。
| a****g
发帖数: 8131 | 4 link to news, thanks
【在 K********g 的大作中提到】
: 看看解冻开盘后，价格能到多少，奶奶的。可不要Sell on news哦，也让我挣点钱吧
| b*****h
发帖数: 783 | 5 JAK2 inhibitor 特效药，是这个类型的第一个新药。market 光目前这个indicator应
该800M－1B。
【在 y********o 的大作中提到】
: 真的假的，老牛说说
| y********o
发帖数: 1588 | 6 FDA Approves Incyte`s Jakafi (ruxolitinib) for Patients with Myelofibrosis <
INCY.O>
http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u
http://www.businesswire.com/news/home/20111116006131/en
- First and Only FDA-Approved Treatment For Potentially Life-Threatening
Blood
Cancer
- Product Available Next Week; Incyte Establishes Comprehensive Patient
Assistance Program
- Conference Call Scheduled, Today at 12:30 PM ET
WILMINGTON, Del.--(Business Wire)--
Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and
Drug
Administration (FDA) has granted marketing approval for Jakafi (ruxolitinib)
for
the treatment of patients with intermediate or high-risk myelofibrosis (MF),
including primary MF, post-polycythemia vera MF and post-essential
thrombocythemia MF. Patients with intermediate and high-risk MF represent 80
to
90 percent of MF patients. Jakafi (JAK-ah-fye) is the first and only product
to
be approved by the FDA for MF, and the first in a new class of drugs, known
as
JAK inhibitors, to be approved for any indication. Jakafi is an oral JAK1
and
JAK2 inhibitor.
http://mms.businesswire.com/bwapps/mediaserver/ViewMedia?mgid=3
Jakafi(TM) (ruxolitinib) is the first and only product to be approved by the
FDA
for myelofibrosis, and the first in a new class of drugs, known as JAK
inhibitors, to be approved for any indication. (Photo: Business Wire)
"The availability of Jakafi is a significant medical advancement for people
living with myelofibrosis, a debilitating disease," stated Paul A. Friedman,
M.D., President and Chief Executive Officer of Incyte. "This milestone marks
a
tremendous achievement for Incyte because a scientific discovery from our
research laboratories has become the first JAK inhibitor to reach the market
and
provide a clinical benefit to patients."
MF is a progressive, potentially life-threatening blood cancer with limited
treatment options.1 Patients with MF suffer a high disease burden
characterized
by bone marrow failure, enlarged spleen (splenomegaly) and debilitating
symptoms
including fatigue, severe itching (pruritus), night sweats, bone pain, and
early
satiety (a feeling of fullness), leading to impaired quality of life.2 The
enlarged spleen and debilitating symptoms of MF are linked to dysregulated
signaling in the Janus kinase (JAK) pathway.3,4
"Today`s FDA approval of Jakafi has the potential to transform the way we
treat
myelofibrosis," said Srdan Verstovsek, M.D., Ph.D., Associate Professor,
Department of Leukemia, Division of Cancer Medicine, The University of Texas
MD
Anderson Cancer Center and the principal investigator of the COMFORT-I
pivotal
trial. "In this Phase III clinical trial, we observed significant reductions
in
spleen size and significant improvements in symptoms. Importantly, these
benefits were achieved early on, most within a month, and tended to be
durable
during treatment. In contrast, most of the patients who received placebo saw
their spleens increase and their symptoms worsen."
"We are very excited about the first FDA approval of a treatment for MF. Not
only is this a new therapy, but it brings additional education, awareness
and
attention to a profoundly debilitating disease," stated Robert Rosen,
President
of MPN Research Foundation.
Phase III Clinical Trial Data
The FDA approval was based on results from two randomized Phase III trials
(COMFORT-I and COMFORT-II), which demonstrated that patients treated with
Jakafi
experienced significant reductions in splenomegaly (enlarged spleen).
COMFORT-I
also demonstrated improvements in symptoms as measured by the modified
Myelofibrosis Symptom Assessment Form (MFSAF) v.2.0 electronic diary and the
MFSAF Total Symptom Score (TSS) comprised of six specific symptoms (
abdominal
discomfort, pain under the left ribs, an early feeling of fullness, night
sweats, bone and muscle pain and itching) all of which contributed to the
overall benefit. Most patients taking placebo experienced worsening of these
same parameters.
The COMFORT-I trial, conducted by Incyte, compared Jakafi to placebo in 309
patients with primary MF, post-polycythemia vera MF and post-essential
thrombocythemia MF. The trial met the primary endpoint, showing that 41.9%
of
patients treated with Jakafi experienced a 35% or greater reduction in
spleen
volume at 24 weeks, compared with 0.7% of patients taking placebo (p<0.0001)
. A
35% reduction in spleen volume correlates to approximately a 50% reduction
in
spleen size on palpation. At week 24, the percentage of patients with a
greater
than or equal to 50% improvement in the TSS was 45.9% and 5.3% in patients
treated with Jakafi and placebo, respectively (p<0.0001), with a median time
to
response of less than four weeks.
The COMFORT-II trial, conducted by Novartis, Incyte`s collaboration partner
outside of the U.S., compared Jakafi to best available therapy in 219
patients
with primary MF, post-polycythemia vera MF and post-essential
thrombocythemia
MF. This trial also met the primary endpoint, showing that 28.5% of patients
treated with Jakafi experienced a 35% or greater reduction in spleen volume
at
48 weeks, compared with 0% of patients in the best available therapy arm
(p<0.0001).
The most common adverse reactions in both studies were thrombocytopenia and
anemia. These events were manageable and rarely led to discontinuation of
Jakafi
treatment. The most common non-hematologic adverse reactions were bruising,
dizziness, and headache.
Please see Important Safety Information below, and the full Prescribing
Information for Jakafi at www.jakafi.com or www.incyte.com.
Indication, Usage and Dosing
Jakafi is indicated for treatment of patients with intermediate or high-risk
myelofibrosis, including primary MF, post-polycythemia vera MF and
post-essential thrombocythemia MF. Intermediate and high-risk MF patients
include anyone over the age of 65 or who have or have had any of the
following:
anemia, constitutional symptoms, elevated white blood cell or blast counts
or
platelet counts less than 100 X 109/L.1,5
The recommended starting dose for most patients is either 15 mg or 20 mg
given
orally twice daily based on the patient`s platelet count. Dosage should be
adjusted based on safety and efficacy. A blood cell count must be performed
before initiating therapy with Jakafi and complete blood counts should be
monitored every 2-4 weeks until doses are stabilized.
Important Safety Information
Treatment with Jakafi can cause hematologic adverse reactions, including
thrombocytopenia, anemia and neutropenia, which are each dose-related
effects,
with the most frequent being thrombocytopenia and anemia. A complete blood
count
must be performed before initiating therapy with Jakafi. Complete blood
counts
should be monitored as clinically indicated and dosing adjusted as required.
The
three most frequent non-hematologic adverse reactions were bruising,
dizziness
and headache. Patients with platelet counts less than 200 X 109/L at the
start
of therapy are more likely to develop thrombocytopenia during treatment.
Thrombocytopenia was generally reversible and was usually managed by
reducing
the dose or temporarily withholding Jakafi. If clinically indicated,
platelet
transfusions may be administered. Patients developing anemia may require
blood
transfusions. Dose modifications of Jakafi for patients developing anemia
may
also be considered. Neutropenia (ANC <0.5 X 109/L) was generally reversible
and
was managed by temporarily withholding Jakafi. Patients should be assessed
for
the risk of developing serious bacterial, mycobacterial, fungal and viral
infections. Active serious infections should have resolved before starting
Jakafi. Physicians should carefully observe patients receiving Jakafi for
signs
and symptoms of infection (including herpes zoster) and initiate appropriate
treatment promptly. A dose modification is recommended when administering
Jakafi
with strong CYP3A4 inhibitors or in patients with renal or hepatic
impairment
[see Dosage and Administration]. Patients should be closely monitored and
the
dose titrated based on safety and efficacy. There are no adequate and
well-controlled studies of Jakafi in pregnant women. Use of Jakafi during
pregnancy is not recommended and should only be used if the potential
benefit
justifies the potential risk to the fetus. Women taking Jakafi should not
breast-feed. Discontinue nursing or discontinue the drug, taking into
account
the importance of the drug to the mother.
Patient Assistant Program: IncyteCARES
Incyte has established IncyteCARES (Connecting to Access, Reimbursement,
Education and Support), a comprehensive program that provides reimbursement
support and educational resources for patients. Incyte is committed to
providing
financial assistance for patients in need who qualify for the available
support
programs. A toll-free number has been established to provide support
regarding
benefit verification, prior authorization and assistance with appeals.
IncyteCARES also offers patient educational materials, resources and access
to
trained nurse professionals to answer questions regarding the program.
Jakafi will be available in the United States next week through a number of
specialty pharmacies. Patients can access information about Jakafi and the
IncyteCARES program by calling 1-855-4-Jakafi (855-452-5234) or visiting
www.jakafi.com.
About Myelofibrosis
Myelofibrosis (MF) is a potentially life-threatening blood cancer that
belongs
to a group of diseases referred to as myeloproliferative neoplasms (or MPNs)
. MF
has a poor prognosis and limited treatment options.1 While the exact
prevalence
of MF is uncertain, and estimates vary widely, based on extensive market
research, Incyte believes MF affects about 16,000 to 18,500 people in the U.
S.6
About the MPN Research Foundation
The primary mission of the MPN Research Foundation is to promote, fund and
support the most innovative and effective research into the causes,
treatments,
and potentially the cure for essential thrombocythemia, polycythemia vera
and
myelofibrosis. For more information, go to
http://www.mpnresearchfoundation.org/.
About the Incyte-Novartis Collaboration
In 2009, Incyte entered into a worldwide collaboration and license agreement
with Novartis. Incyte retained exclusive rights for the development and
commercialization of ruxolitinib (INCB424) in the United States. Novartis
received exclusive rights to the development and potential commercialization
of
ruxolitinib in all hematology-oncology indications outside of the United
States.
Conference Call Information
Incyte will hold a conference call today at 12:30 PM ET to discuss the FDA
approval of Jakafi, its price, and Incyte`s patient assistance program. To
access the conference call, please dial 877-407-8037 for domestic callers or
201-689-8037 for international callers. When prompted, provide the
conference
identification number, 383585.
If you are unable to participate, a replay of the conference call will be
available for thirty days. The replay dial-in number for the U.S. is
877-660-6853 and the dial-in number for international callers is 201-612-
7415.
To access the replay you will need the conference account number 278 and the
identification number 383585.
The conference call will also be webcast live and can be accessed at
www.incyte.com under Investor Relations, Events and Webcasts.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company
focused on developing and commercializing proprietary small molecule drugs
for
oncology and inflammation. For additional information on Incyte, please
visit
www.incyte.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set
forth in
this press release, including statements with respect to Jakafi having the
potential to transform the way physicians treat myelofibrosis and Jakafi
being
available in the United States next week through a number of specialty
pharmacies, are all forward-looking statements within the meaning of the "
safe
harbor" provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and uncertainties that
may
cause actual results to differ materially, including unanticipated
developments
in and risks related to the efficacy or safety of Jakafi, the results of
further
research and development, the acceptance of Jakafi in the marketplace, risks
related to market competition, risks and uncertainties associated with sales,
marketing and distribution requirements, risks associated with Incyte`s
dependence on its third party manufacturers and other risks detailed from
time
to time in Incyte's filings with the Securities and Exchange Commission,
including its Quarterly Report on Form 10-Q for the quarter ended September
30,
2011. Incyte disclaims any intent or obligation to update these forward-
looking
statements.
Links to third party websites or pages are provided for convenience only.
Each
website is subject to its own terms of use, and Incyte encourages you to
consult
these policy statements. Incyte has no control over third party sites and
does
not endorse or recommend these sites, and expressly disclaims any
responsibility
for the accuracy of content or opinions set forth in any third party website
or
your use of that information.
1. Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring
system for primary myelofibrosis based on a study of the International
Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113:2895
-2901.
2. Mesa RA, Niblack J, Wadleigh M, et al. The burden of fatigue and
quality of life in myeloproliferative disorders (MPDs): an international
internet-based survey of 1179 MPD patients. Cancer. 2007;109:68-76.
3. Levine RL, Pardanani A, Tefferi A, Gilliland DG. Role of JAK2 in the
pathogenesis and therapy of myeloproliferative disorders. Nat Rev Cancer.
2007;7:673-683.
4. Vannucchi AM, Guglielmelli P, Tefferi A. Advances in understanding
and management of myeloproliferative neoplasms. CA Cancer J Clin. 2009;59:
171-191.
5. Gangat N, Caramazza D, Vaidya R, et al. DIPSS Plus: A Refined Dynamic
International Prognostic Scoring System for Primary Myelofibrosis That
Incorporates Prognostic Information From Karyotype, Platelet Count, and
Transfusion Status. J Clin Oncol. 2011;29(4):392-397.
6. Data on File. Incyte Corporation.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50075108&lang=e | y********o
发帖数: 1588 | 7 擦，赶紧改订单去，谢谢啊
【在 b*****h 的大作中提到】
: JAK2 inhibitor 特效药，是这个类型的第一个新药。market 光目前这个indicator应
: 该800M－1B。
| b*****h
发帖数: 783 | 8 biotech 最怕追高。。。
【在 y********o 的大作中提到】
: 擦，赶紧改订单去，谢谢啊
| a****g
发帖数: 8131 | 9 靠 老牛不是说是12月初的panel吗
【在 K********g 的大作中提到】
: 看看解冻开盘后，价格能到多少，奶奶的。可不要Sell on news哦，也让我挣点钱吧
| y********o
发帖数: 1588 | 10 没，前几天发现这只股票，这几天逢低买入了，一听你说把之前便宜的卖单赶紧改了，
呵呵
BTW，这个大概等多久才开始交易？一般情况，谢谢
【在 b*****h 的大作中提到】
: biotech 最怕追高。。。
| K********g
发帖数: 9389 | | K********g
发帖数: 9389 | 12 12月3号的NDA哦
提前出结果了
【在 a****g 的大作中提到】
: 靠 老牛不是说是12月初的panel吗
|
|
