16:18:00 Today AMGN Amgen Highlights Data to Be Presented at American Society of Hematology Annual Meeting
Amgen Highlights Data to Be Presented at American Society of Hematology Annual
Meeting
--Final Results From The Largest And Longest Study Of Nplate(R) For The Treatment
Of Adult Chronic ITP To Be Presented --Amgen Expands Amgen FIRST STEP(TM) Program
Co-Pay Coupon Benefits To Help Patients With Out-of-Pocket Costs For Neulasta(R)
And Nplate(R)
THOUSAND OAKS, Calif., Dec. 2, 2010 /PRNewswire via COMTEX/ -- Amgen (AMGN) today
announced that it will present data from several key Nplate(R) (romiplostim)
studies at the 52nd Annual Meeting and Exposition of the American Society of
Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla. Results from six studies
evaluating Nplate in adult patients with chronic immune (idiopathic)
thrombocytopenic purpura (ITP) add to the growing body of data supporting the use
of Nplate in this setting, including the final efficacy and safety results from
the largest and longest study of Nplate in adult chronic ITP. Amgen will also
present data for other marketed products including Neulasta(R) (pegfilgrastim)
and Aranesp(R) (darbepoetin alfa).
"The complete results from a 5-year open-label extension study of Nplate in the
adult chronic ITP setting show that Nplate increases and sustains platelet counts
in these patients and that adverse event rates were consistent with those
reported in previous studies," said Sean Harper, M.D., senior vice president,
Global Development and Chief Medical Officer at Amgen. "This is the largest and
longest study of Nplate in this setting, and reinforces the potential of Nplate
as a long-term treatment option."
Amgen also announced the expansion of its Neulasta FIRST STEP(R) Program to its
newly established co-pay coupon umbrella program, the Amgen FIRST STEP(TM)
Program for commercially insured patients. The Amgen FIRST STEP(TM) Program will
feature the Nplate FIRST STEP(TM) Program and Neulasta FIRST STEP(R) Programs.
The Amgen FIRST STEP(TM) Program is significant among oncology commercial co-pay
coupon programs, as it is the first program under the medical benefit with no
income eligibility requirement. The program is intended to help eligible patients
meet their deductible, co-insurance, and/or co-payment requirements under the
medical benefit for Neulasta and Nplate. Under this program, eligible patients
will incur no out of pocket costs for their first Nplate or Neulasta treatment
associated with a new treatment regimen and will pay a maximum of $25 for
subsequent injections. More information, eligibility requirements, restrictions
and limitations about the co-pay coupon program are available at
AmgenFIRSTSTEP.com.
SELECTED ABSTRACTS OF INTEREST INCLUDE:
Abstracts are available on the ASH website at http://www.hematology.org and
updated data will be presented at the meeting.
Nplate ITP Data
Long-Term Efficacy and Safety of Romiplostim Treatment of Adult Patients with
Chronic Immune Thrombocytopenia (ITP): Final Report from an Open-Label Extension
Study
(Abstract No. 68; Oral Presentation; Sunday, Dec. 5, 4:45 p.m. EST, room 230)
The Effects of Romiplostim or Standard of Care (SOC) on Splenectomy and Treatment
Failure of Patients Who Had Immune Thrombocytopenia (ITP) for Less Than or Equal
to One Year
(Abstract No. 3702; Poster III-481; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall
A3/A4)
Analysis of Mortality Rates During Romiplostim Clinical Studies of Patients (Pts)
with Immune Thrombocytopenia (ITP)
Abstract No. 3701; Poster III-480; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall
A3/A4)
Patient Quality of Life (QoL) in Nonsplenectomized Immune Thrombocytopenia (ITP)
Patients Receiving Romiplostim or Medical Standard of Care (SOC)
(Abstract No. 569; Oral Presentation; Monday, Dec. 6, 3:45 p.m. EST, Room 340)
Evaluation of Romiplostim in a Randomized Placebo-Controlled Phase 3 Study of a
Japanese Population with Chronic Immune Thrombocytopenia (ITP)
(Abstract No. 3704; Poster III-483; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall
A3/A4)
Impact Assessment of Immunogenicity of Romiplostim in Subjects with Immune
Thrombocytopenic Purpura (ITP)
Abstract No. 2517; Poster II-397; Sunday, Dec. 5, 6:00 p.m.-8:00 p.m. EST, Hall
A3/A4)
Nplate MDS Data
Update from an Open-Label Extension Study Evaluating the Long-Term Safety and
Efficacy of Romiplostim in Thrombocytopenic Patients (Pts) with Myelodysplastic
Syndromes (MDS)
(Abstract No. 1885; Poster I-865; Saturday, Dec. 4, 5:30 p.m.-7:30 p.m. EST, Hall
A3/A4)
Associations Between Platelet Count and Survival and Disease Progression in
Thrombocytopenic Patients with Myelodysplastic Syndromes
Abstract No. 2905; Poster II-785; Sunday, Dec. 5, 6:00 p.m. EST, Hall A3/A4)
Neulasta
Pegfilgrastim Use Associated with Lower Risk of Hospitalization Than Filgrastim
Use: A Retrospective US Claims Analysis
(Abstract No. 3801; Poster III-580; Monday, Dec. 6, 6:00 PM-8:00 p.m. EST, Hall
A3/A4)
Underreporting of Myelotoxicity with Emerging Regimens for Selected Hematologic
Malignancies
(Abstract No. 1501; Poster I-481; Saturday, Dec. 4, 5:30 p.m.-7:30 p.m. EST, Hall
A3/A4)
Clinic Staff Time and Labor Costs Associated with Administering Pegfilgrastim as
Compared with Filgrastim to Patients Receiving Myelosuppressive Chemotherapy:
Results of a Health Economic Model
(Abstract No. 1515; Poster I-495; Saturday, Dec. 4, 5:30 p.m.-7:30 p.m. EST, Hall
A3/A4)
Aranesp
Real-Life Cost Analysis of Anemia Treatment with Erythropoiesis Stimulating
Agents In Cancer Patients Receiving Chemotherapy
(Abstract No. 3811; Poster III-590; Monday, Dec. 6, 6:00 p.m.-8:00 p.m. EST, Hall
A3/A4)
About Adult ITP
In patients with ITP, platelets - blood elements needed to prevent bleeding - are
destroyed by the patient's own immune system. Recent data also suggest that low
platelet counts in the blood may be caused by the inability of the body's natural
processes to produce platelets. Low platelet counts leave adult ITP patients open
to sudden serious bleeding events. The risk for serious bleeding events increases
when platelet counts drop to less than 30,000 platelets per microliter; normal
counts range from 150,000 to 400,000 platelets per microliter. ITP has
historically been considered a disease of platelet destruction although recent
data suggest that the body's natural platelet production processes in ITP are
unable to compensate for low levels of platelets in the blood. Increasing the
rate of platelet production may address low platelet levels associated with ITP.
Some other available treatments (e.g., corticosteroids, immunoglobulins) are
often unsuitable for long-term use due to tolerability issues and poor
predictability of response.Surgical therapy (removal of the spleen) can be an
option for many adult patients with chronic ITP, but does not work in all cases,
and can be contraindicated in certain cases.Currently, there are approximately
90,000 adult chronic ITP patients in Europe and the United States (U.S.). ITP
affects about twice as many adult women as men.
About Nplate
Nplate is the first platelet producer approved in the European Union (EU),
Canada, Australia, Russia, Switzerland, Mexico and the U.S. Nplate also has
received orphan designation for chronic ITP in the U.S. (2003), the EU (2005),
Switzerland (2005), Japan (2006) and Mexico (2010).
Nplate is the first FDA approved treatment specifically for adult chronic ITP. It
is also being investigated for potential use in children ages 12 months to 18
years old with persistent severe thrombocytopenia, myelodysplastic syndromes
(MDS) and chemotherapy-induced thrombocytopenia (CIT).
In the U.S., Nplate is indicated for the treatment of thrombocytopenia in
patients with chronic immune ITP who have had an insufficient response to
corticosteroids, immunoglobulins or splenectomy. Nplate should be used only in
patients with ITP whose degree of thrombocytopenia and clinical condition
increases the risk for bleeding. Nplate should not be used in an attempt to
normalize platelet counts.
In the EU, Nplate is indicated for the treatment of splenectomized adult chronic
ITP patients who are refractory to other treatments (e.g. corticosteroids,
immunoglobulins). Nplate may be considered as a second-line treatment for adult
non-splenectomized ITP patients for whom surgery is contraindicated.
Nplate was named as a recipient of the U.S. Prix Galien 2009 "Best Biotechnology
Product" award and also received the 2009 Scrip Awards for "Best New Drug."
Nplate has also been honored with numerous awards throughout the EU, including a
2010 Prix Galien in France in the category of "Drugs for Rare Diseases." In
September 2010, Nplate was awarded the 2010 International Prix Galien Award, an
award granted every two years which recognizes the "best of the best" selected
from previous national Prix Galien award recipients.
For more information about Nplate, please visit http://www.Nplate.com.
Important U.S. Nplate Safety Information
Serious adverse reactions associated with Nplate in clinical studies were bone
marrow reticulin deposition and worsening thrombocytopenia after Nplate
discontinuation. Additional risks include bone marrow fibrosis,
thrombotic/thromboembolic complications, lack or loss of response to Nplate, and
hematological malignancies and progression of malignancy in patients with a
pre-existing hematological malignancy or MDS. Nplate is not indicated for the
treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other
than chronic ITP.
In the U.S., Nplate is available only through a restricted distribution program
called Nplate(R) NEXUS (Network of Experts Understanding and Supporting Nplate
and Patients) Program.
In the placebo-controlled studies, headache was the most commonly reported
adverse drug reaction.
Important EU Nplate Safety Information
The most common side effects are headache, fatigue, arthralgia, myalgia,
injection site bruising, injection site pain, oedema peripheral, dizziness,
muscle spasms, nausea, contusion, diarrhea, bone marrow disorder, influenza-like
illness, insomnia and pruritus.
Reoccurrence of thrombocytopenia and bleeding after cessation of treatment and
increased bone marrow reticulin have been associated with Nplate treatment in the
clinical trials. Thrombotic/thromboembolic complications, progression of existing
hematopoietic malignancies or MDS, and effects on red and white blood cells are
all potential risks associated with Nplate treatment. As with all therapeutic
proteins, patients may develop antibodies to the therapeutic protein.
About Neulasta and NEUPOGEN(R)
Neulasta is indicated to decrease the incidence of infection, as manifested by
febrile neutropenia, in patients with nonmyeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with a clinically significant
incidence of febrile neutropenia.
Neulasta is not indicated for the mobilization of peripheral blood progenitor
cells for hematopoietic stem cell transplantation.
NEUPOGEN (filgrastim) is indicated to decrease the incidence of infection' as
manifested by febrile neutropenia' in patients with nonmyeloid malignancies
receiving myelosuppressive anti-cancer drugs associated with a significant
incidence of severe neutropenia with fever.
Please refer to the Important European Product Safety Information section for
approved indications in the EU.
Important U.S. Product Safety Information
Do not administer Neulasta or NEUPOGEN to patients with a history of serious
allergic reactions to pegfilgrastim or filgrastim. NEUPOGEN is contraindicated in
patients with known hypersensitivity to E. coli-derived proteins, such as
filgrastim.
Serious allergic reactions, including anaphylaxis, can occur in patients
receiving Neulasta or NEUPOGEN. Permanently discontinue Neulasta or NEUPOGEN in
patients with serious allergic reactions.
Splenic rupture, including fatal cases, can occur following the administration of
Neulasta and NEUPOGEN.
Acute respiratory distress syndrome (ARDS) can occur in patients receiving
Neulasta or NEUPOGEN.
Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis
requiring hospitalization, has been reported in healthy donors undergoing
peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN.
Hemoptysis resolved with discontinuation of NEUPOGEN.
Bone pain and pain in extremity occurred at a higher incidence in
Neulasta-treated patients as compared with placebo-treated patients. In clinical
trials involving NEUPOGEN, bone pain was most frequently reported adverse event.
Important European Product Safety Information
For full prescribing information please see the Summary of Product
Characteristics for each product.
NEUPOGEN is indicated for reduction in duration of neutropenia and incidence of
febrile neutropenia after established cytotoxic chemotherapy for malignancy (with
the exception of chronic myeloid leukaemia and myelodysplastic syndromes);
reduction in duration of neutropenia in patients undergoing myeloablative therapy
followed by bone marrow transplantation considered to be at increased risk of
prolonged severe neutropenia. The safety and efficacy of NEUPOGEN are similar in
adults and children receiving cytotoxic chemotherapy. NEUPOGEN is indicated for
mobilisation of peripheral blood progenitor cells (PBPCs); long-term treatment to
increase neutrophil counts and reduce incidence and duration of infection-related
events in patients with severe congenital, cyclic, or idiopathic neutropenia
treatment of persistent neutropenia in patients with advanced HIV infection.
NEUPOGEN is contraindicated in patients with hypersensitivity to filgrastim or
excipients. Not to be used for escalation of cytotoxic chemotherapy doses above
established regimens or administered to patients with severe congenital
neutropenia (Kostman's Syndrome) with abnormal cytogenetics.
Administer NEUPOGEN with caution in secondary AML. Safety and efficacy of
NEUPOGEN not established inde novoAML patients < 55 years with good
cytogenetics (t(8;21), t(15;17) and inv(16)). The onset of pulmonary signs
(cough, fever, dyspnoea) in association with radiological signs of pulmonary
infiltrates and deterioration in pulmonary function may be preliminary signs of
Acute Respiratory Distress Syndrome (ARDS). Discontinue NEUPOGEN and give
appropriate treatment.
Other adverse events of special importance associated with NEUPOGEN include GvHD
and fatalities in patients receiving G-CSF after allogeneic bone marrow
transplantation, very rare cases of splenic rupture reported in healthy donors
and patients, and hypersensitivity-type reactions in cancer patients. NEUPOGEN
should be permanently discontinued in patients who experience a serious allergic
reaction. NEUPOGEN is not recommended in period 24 hours before to 24 hours after
chemotherapy. Neulasta is indicated for the reduction in the duration of
neutropenia and the incidence of febrile neutropenia in patients treated with
cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid
leukaemia and myelodysplastic syndromes).
Neulasta is contraindicated in patients with hypersensitivity to pegfilgrastim or
excipients.
Neulasta should not be used in patients with MDS, CML and secondary AML. The
safety and efficacy of Neulasta administration inde novoAML patients aged < 55
years with cytogenetics t(15;17) have not been established.
Neulasta should be discontinued following preliminary signs of ARDS. Spleen size
should be carefully monitored and caution exercised when administering in
patients with sickle cell disease. Safety and efficacy of Neulasta for
mobilisation of blood progenitor cells in patients or healthy donors has not been
adequately evaluated.
Other adverse events of special importance associated with Neulasta include bone
pain, allergic-type reactions including anaphylaxis (pegfilgrastim should be
permanently discontinued in patients who experience a serious allergic reaction)
and very rare cases of splenic rupture including fatal cases. Neulasta should be
administered approximately 24 hours after administration of cytotoxic
chemotherapy.
About Aranesp
Aranesp was approved by the FDA in 2001 for the treatment of anemia associated
with chronic renal failure (CRF) for patients on dialysis and patients not on
dialysis. The European Commission granted marketing authorization for the same
indication in 2001 and subsequently updated it for CRF patients with symptomatic
anemia in 2008.
In 2002, the FDA approved Aranesp for the treatment of anemia caused by
concomitantly administered chemotherapy in patients with nonmyeloid malignancies.
The European Commission authorized the treatment of anemia caused by
concomitantly administered chemotherapy in patients with non-haematological
malignancies in 2002 and extended it to include non-myeloid malignancies in
patients receiving chemotherapy in 2003.
Important U.S. Product Safety Information
Aranesp is indicated for the treatment of anemia due to the effect of
concomitantly administered chemotherapy based on studies that have shown a
reduction in the need for red blood cell transfusions in patients with
metastatic, non-myeloid malignancies. Studies to determine whether Aranesp
increases mortality or decreases progression-free/recurrence-free survival are
ongoing.
Aranesp is not indicated for use in patients receiving hormonal agents,
therapeutic biologic products, or radiotherapy unless receiving concomitant
myelosuppressive chemotherapy.
Aranesp is not indicated for patients receiving myelosuppressive therapy when the
anticipated outcome is cure due to the absence of studies that adequately
characterize the impact of Aranesp on progression-free and overall survival.
Aranesp use has not been demonstrated in controlled clinical trials to improve
symptoms of anemia, quality of life, fatigue, or patient well-being.
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC
EVENTS, STROKE AND INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
Cancer:
ESAs shortened overall survival and/or increased the risk of tumor progression or
recurrence in some clinical studies in patients with breast, non-small cell lung,
head and neck, lymphoid, and cervical cancers.
To decrease these risks, as well as the risk of serious cardio- and
thrombovascular events, use the lowest dose needed to avoid red blood cell
transfusion.
Because of these risks, prescribers and hospitals must enroll in and comply with
the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp, EPOGEN(R)
or PROCRIT(R) to patients with cancer. To enroll in the ESA APPRISE Oncology
Program, visit http://www.esa-apprise.com/ or call 1-866-284-8089 for further
assistance.
Use ESAs only for treatment of anemia due to concomitant myelosuppressive
chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive therapy when the
anticipated outcome is cure.
Discontinue following the completion of a chemotherapy course.
ESAs are contraindicated in patients with uncontrolled hypertension.
Important European Product Safety Information
For full prescribing information please see the Summary of Product
Characteristics.
Aranesp is indicated for treatment of symptomatic anaemia in adult cancer
patients with non-myeloid malignancies receiving chemotherapy.
Aranesp is contraindicated in patients with poorly controlled hypertension.
Controlled clinical trials have not shown significant benefits attributable to
the administration of epoetins when haemoglobin concentration is increased beyond
the level necessary to control symptoms of anaemia and to avoid blood
transfusion.
In controlled clinical studies, use of Aranesp and other ESAs have shown:
shortened time to tumour progression in patients with advanced head and neck
cancer receiving radiation therapy when administered to target Hb > 14 g/dL;
ESAs are not indicated for use in this patient population
shortened overall survival and increased deaths attributed to disease progression
at 4 months in patients with metastatic breast cancer receiving chemotherapy when
administered to target Hb 12-14 g/dL
increased risk of death when administered to target Hb of 12 g/dl (7.5 mmol/l) in
patients with active malignant disease receiving neither chemotherapy nor
radiation therapy; ESAs are not indicated for use in this patient population.
In some clinical situations blood transfusion should be the preferred treatment
for the management of anaemia in patients with cancer. The decision to administer
recombinant erythropoietins should be based on a benefit-risk assessment with the
participation of the individual patient, which should take into account the
specific clinical context. Factors that should be considered in this assessment
should include the type of tumour and its stage; the degree of anaemia;
life-expectancy; the environment in which the patient is being treated; and
patient preference.
In patients with solid tumours or lymphoproliferative malignancies, if Hb >12
g/dL, the dose should be reduced/held to minimise the potential risk of
thromboembolic events.
Discontinue use after the end of chemotherapy.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe and effective
medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have
changed the practice of medicine, helping millions of people around the world in
the fight against cancer, kidney disease, rheumatoid arthritis and other serious
illnesses. With a deep and broad pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve people's lives. To
learn more about our pioneering science and our vital medicines, visit
http://www.amgen.com.
Forward-Looking Statements
This news release contains forward-looking statements that are based on
management's current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual results to differ
materially from those described.All statements, other than statements of
historical fact, are statements that could be deemed forward-looking statements,
including estimates of revenues, operating margins, capital expenditures, cash,
other financial metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or practices,
reimbursement activities and outcomes and other such estimates and
results.Forward-looking statements involve significant risks and uncertainties,
including those discussed below and more fully described in the Securities and
Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent
annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form
8-K.Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional
information on the uncertainties and risk factors related to our business.Unless
otherwise noted, Amgen is providing this information as of Dec. 2, 2010 and
expressly disclaims any duty to update information contained in this news
release.
No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. Discovery or identification of new product
candidates or development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain; consequently, there
can be no guarantee that any particular product candidate or development of a new
indication for an existing product will be successful and become a commercial
product. Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the human body
cannot be perfectly, or sometimes, even adequately modeled by computer or cell
culture systems or animal models. The length of time that it takes for us to
complete clinical trials and obtain regulatory approval for product marketing has
in the past varied and we expect similar variability in the future. We develop
product candidates internally and through licensing collaborations, partnerships
and joint ventures. Product candidates that are derived from relationships may be
subject to disputes between the parties or may prove to be not as effective or as
safe as we may have believed at the time of entering into such relationship.
Also, we or others could identify safety, side effects or manufacturing problems
with our products after they are on the market. Our business may be impacted by
government investigations, litigation and products liability claims. We depend on
third parties for a significant portion of our manufacturing capacity for the
supply of certain of our current and future products and limits on supply may
constrain sales of certain of our current products and product candidate
development.
In addition, sales of our products are affected by the reimbursement policies
imposed by third-party payors, including governments, private insurance plans and
managed care providers and may be affected by regulatory, clinical and guideline
developments, domestic and international trends toward managed care and health
care cost containment as well as U.S. legislation affecting pharmaceutical
pricing and reimbursement. Government and others' regulations and reimbursement
policies may affect the development, usage and pricing of our products. In
addition, we compete with other companies with respect to some of our marketed
products as well as for the discovery and development of new products. We believe
that some of our newer products, product candidates or new indications for
existing products, may face competition when and as they are approved and
marketed. Our products may compete against products that have lower prices,
established reimbursement, superior performance, are easier to administer, or
that are otherwise competitive with our products. In addition, while we routinely
obtain patents for our products and technology, the protection offered by our
patents and patent applications may be challenged, invalidated or circumvented by
our competitors and there can be no guarantee of our ability to obtain or
maintain patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful products or
maintain the commercial success of our existing products. Our stock price may be
affected by actual or perceived market opportunity, competitive position, and
success or failure of our products or product candidates. Further, the discovery
of significant problems with a product similar to one of our products that
implicate an entire class of products could have a material adverse effect on
sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release relating to new
indications for our products is preliminary and investigative and is not part of
the labeling approved by the FDA for the products. The products are not approved
for theinvestigational use(s) discussed in this news release, and no conclusions
can or should be drawn regarding the safety or effectiveness of the products for
theseuses. Only the FDA can determine whether the products are safe and effective
for these uses. Healthcareprofessionals shouldrefer to and rely upon the
FDA-approved labeling for the products, and not the information discussed in this
news release.
Contact: Amgen, Thousand Oaks
Megan Fox: +1 805-447-1423 (U.S. media, oncology)
Carrie Deverell: +41 41 3690 308 (European media)
Arvind Sood: +1 805-447-1060 (Investors)
SOURCE Amgen
Copyright (C) 2010 PR Newswire. All rights reserved
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