Presentación en ASCO de los datos del estudio de Revlimid en pacientes no tratados con leucemia linfocítica crónica (CLL)

June 10, 2010 By Leave a Comment

BOUDRY, Suiza–(Business Wire)–
RESUMEN #6508

Celgene International Sàrl (NASDAQ:CELG) ha anunciado hoy que los investigadores
han presentado los datos de un estudio de Fase II iniciado por investigadores de
lenalidomida (REVLIMID) en pacientes no tratados con leucemia linfocítica
crónica en la reunión anual de la American Society of Clinical Oncology (ASCO).

Los resultados del estudio de Fase II de un único grupo han desvelado que con un
seguimiento promedio de 23 meses, la tasa de respuesta global (OR) para 60
pacientes evaluables fue del 62% y el 15% de los pacientes consiguieron una
respuesta completa (CR/CRi). En un seguimiento promedio, no se ha conseguido una
tasa de supervivencia libre de progresión y la tasa de supervivencia global ha
sido del 90%.

Los eventos adversos de grado 3 o 4 más comunes registrado en el estudio han
sido neutropenia (38% de ciclos), thrombocitopenia (14% de ciclos) y anemia (<1%
de ciclos). Se observaron infecciones de grado 3-4 en el 15% de los pacientes.

Los pacientes del estudio eran mayores de 65 años y no habían recibido
tratamiento para CLL y se les administró 5 mg/día de lenalidomida durante los
primeros 56 días de tratamiento y después se ajustó a 25 mg/día con incrementos
de 5 mg en los días 1-21 de cada ciclo (28 días), según fuera tolerado.

Estos datos corresponden a un estudio de investigación. REVLIMID no cuenta con
la aprobación para la comercialización para el tratamiento de pacientes con CLL
no tratada.

Acerca de REVLIMID

REVLIMID es un compuesto IMiDs. REVLIMID y otros compuestos IMiDs continúan
siendo evaluados en más de 100 ensayos clínicos. La línea de compuestos IMiDs
está protegida por un conjunto integral de solicitudes de patentes de propiedad
intelectual, aprobadas y pendientes, en los Estados Unidos, la UE y otras
regiones, lo que incluye patentes de composición química y de uso.

El uso de REVLIMID en combinación con dexametasona, en prácticamente 50 países,
incluida Europa, América, Medio Oriente y Asia, está aprobado para el
tratamiento de pacientes con mieloma múltiple que han recibido al menos un
tratamiento previo, y en Australia y Nueva Zelanda, está aprobado en combinación
con dexametasona para el tratamiento de pacientes cuya enfermedad ha progresado
después de una terapia.

REVLIMID también está aprobado en los Estados Unidos, Canadá y varios países de
América Latina, así como Malasia e Israel, para anemia con dependencia
transfusional debida a síndromes mielodisplásicos (MDS) de riesgo bajo e
intermedio 1 asociados con la supresión de la anomalía cromosómica 5q, con o sin
anomalías cromosómicas adicionales. En la actualidad se están evaluando las
Solicitudes de Autorización de Comercialización en otros países.

REVLIMID (lenalidomida) en combinación con dexametasona se prescribe para el
tratamiento de pacientes con mieloma múltiple que han recibido al menos un
tratamiento previo.

REVLIMID (lenalidomida) se prescribe para el tratamiento de la anemia con
dependencia transfusional producto de síndromes mielodisplásicos (MDS) de riesgo
bajo e intermedio 1 asociados con la supresión de la anomalía cromosómica 5q,
con o sin anomalías cromosómicas adicionales.

Información de seguridad importante

ADVERTENCIAS:

1. POSIBILIDAD DE DEFECTOS CONGÉNITOS.

La lenalidomida es un análogo de la talidomida. La talidomida es un conocido
teratógeno humano que provoca graves defectos congénitos con riesgo de muerte.
Si la lenalidomida se toma durante el embarazo, puede causar defectos congénitos
o la muerte del feto. Se debería advertir a las mujeres que eviten quedar
embarazadas mientras estén tomando REVLIMID (lenalidomida).

Pacientes masculinos: Se desconoce si la lenalidomida está presente en el semen
de los pacientes que reciben la droga. Por lo tanto, los hombres a los que se
administra REVLIMID (lenalidomida) siempre deben usar preservativos de látex
durante el contacto sexual con mujeres en edad reproductiva, incluso si se han
sometido a una vasectomía exitosa.

Requisitos especiales de prescripción

Debido a esta potencial toxicidad y para evitar la exposición del feto a
REVLIMID (lenalidomida), REVLIMID (lenalidomida) sólo se vende bajo un programa
especial de distribución restringida. En EE.UU., este programa se denomina
“RevAssist”. Según este programa, sólo los médicos recetantes y farmacéuticos
registrados en el programa pueden recetar y administrar el producto. Además,
REVLIMID (lenalidomida) sólo se debe vender a pacientes registrados que reúnen
todas las condiciones del programa RevAssist.

2. TOXICIDAD HEMATOLÓGICA (NEUTROPENIA Y TROMBOCITOPENIA).

Este medicamento está asociado a la neutropenia y la trombocitopenia. Durante el
estudio principal, al ochenta por ciento de los pacientes con síndromes
mielodisplásicos con eliminación del cromosoma 5q se les tuvo que aplicar un
retraso/disminución de la dosis. El treinta y cuatro por ciento de los pacientes
debieron recibir un segundo retraso/disminución de dosis. En el 80% de los
pacientes que participaron en el estudio se observó toxicidad hematológica de
grado 3 ó 4. En el caso de los pacientes con síndromes mielodisplásicos con
eliminación del cromosoma 5q, se debería controlar semanalmente el recuento
sanguíneo total durante las primeras 8 semanas de la terapia y al menos
mensualmente de allí en más. Es posible que los pacientes necesiten interrumpir
y/o disminuir la dosis. Los pacientes pueden necesitar el uso de hemoderivados
y/o factores de crecimiento. (ver DOSIS y ADMINISTRACIÓN)

3. TROMBOSIS VENOSA PROFUNDA Y EMBOLISMO PULMONAR.

Este medicamento ha demostrado tener un alto riesgo de trombosis venosa profunda
(TPV) y embolismo pulmonar (EP) en pacientes con mieloma múltiple que fueron
tratados con una terapia combinada de REVLIMID (lenalidomida). Se recomienda a
los pacientes y médicos estar atentos a los signos y síntomas de tromboembolia.
Se debería indicar a los pacientes que recurran a la atención médica si
desarrollan síntomas como disnea, dolor en el pecho, o inflamación de brazos o
piernas. Se desconoce si la terapia de anticoagulación profiláctica o
antiagregante recetada conjuntamente con REVLIMID (lenalidomida) puede reducir
la posibilidad de tromboembolia venosa. La decisión de tomar medidas
profilácticas se debe tomar con cuidado después de evaluar los factores de
riesgo de cada paciente en particular.

Puede obtener información sobre REVLIMID (lenalidomida) y el programa RevAssist
en Internet, en www.REVLIMID.com, o llamando al número gratuito del fabricante
1-888-423-5436.

MÁS ADVERTENCIAS: TOXICIDAD HEMATOLÓGICA

Mieloma múltiple

– En los estudios combinados de mieloma múltiple, las toxicidades hematológicas
grado 3 y 4 eran más frecuentes en pacientes que recibían un tratamiento con la
combinación de REVLIMID (lenalidomida) y dexametasona que en pacientes que
tenían un tratamiento a base de dexametasona únicamente.

– Los pacientes bajo tratamiento deberían ser sometidos a un control de su
recuento sanguíneo completo cada 2 semanas durante las primeras 12 semanas y
luego mensualmente.

– Es posible que los pacientes necesiten interrumpir y/o disminuir la dosis.

CONTRAINDICACIONES:

Embarazo categoría X:

– La lenalidomida está contraindicada en mujeres embarazadas y mujeres en edad
reproductiva. Cuando no hay alternativa, las mujeres en edad reproductiva pueden
recibir un tratamiento con lenalidomida, siempre y cuando se tomen las medidas
adecuadas para evitar el embarazo.

Hipersensibilidad:

– REVLIMID (lenalidomida) está contraindicada en todo paciente que haya
demostrado ser hipersensible al fármaco o sus componentes.

PRECAUCIONES:

Angioedema, síndrome de Stevens-Johnson y necrólisis epidérmica tóxica

– Se ha registrado angioedema y reacciones dermatológicas graves, entre las que
se incluyen el síndrome de Stevens-Johnson (SJS) y la necrólisis epidérmica
tóxica (NET). Estos casos pueden ser mortales. A los pacientes con antecedentes
de erupción grado 4 asociada con el tratamiento de talidomida no se les debería
administrar REVLIMID (lenalidomida). Se debería considerar la interrupción o
suspensión de REVLIMID (lenalidomida) en caso de erupción cutánea grado 2-3.
REVLIMID (lenalidomida) se debe suspender en caso de angioedema, erupción grado
4, dermatitis exfoliativa o ampollar, o si se prevé SJS o NET, y no se debería
reanudar después de la suspensión por estas reacciones.

Síndrome de lisis tumoral

– La lenalidomida tiene actividad antineoplásica y, por lo tanto, puede dar
lugar a complicaciones del síndrome de lisis tumoral. Los pacientes con riesgo
de síndrome de lisis tumoral son aquéllos con una alta incidencia de tumores
antes del tratamiento. Estos pacientes se deberían controlar de cerca y adoptar
medidas adecuadas.

Insuficiencia renal:

– Dado que el riñón excreta la lenalidomida principalmente sin cambios, se
recomienda ajustar la dosis inicial de REVLIMID (lenalidomida) para garantizar
una exposición adecuada a la droga en pacientes con insuficiencia renal moderada
o grave (CLcr< 60 mL/min) y en pacientes con diálisis.

– Dado que es más probable que los pacientes mayores de edad experimenten una
disminución de las funciones renales, se debería tener cuidado en la selección
de la dosis y sería conveniente controlar la función renal.

Madres en período de lactancia: Se desconoce si REVLIMID (lenalidomida) se
excreta en la leche humana.

– Debido a la posibilidad de reacciones adversas en bebés en período de
lactancia, se debería decidir si suspender la lactancia o el medicamento,
teniendo en cuenta la importancia del medicamento para la madre.

EFECTOS ADVERSOS:

Mieloma múltiple

– En el grupo bajo tratamiento con REVLIMID (lenalidomida)/dexametasona, a 151
pacientes (45%) se les interrumpió al menos una vez la dosis, con o sin
reducción de la dosis de REVLIMID (lenalidomida), en comparación con el 21% del
grupo bajo tratamiento con placebo/dexametasona.

– De estos pacientes que experimentaron una interrupción de la dosis, con o sin
reducción, el 50% del grupo bajo tratamiento de REVLIMID
(lenalidomida)/dexametasona se sometió a al menos otra interrupción de la dosis,
con o sin reducción, en comparación con el 21% del grupo bajo tratamiento con
placebo/dexametasona.

– La mayoría de los efectos adversos y los efectos adversos grado 3/4 eran más
frecuentes en pacientes con MM que recibieron una combinación de REVLIMID
(lenalidomida)/dexametasona en comparación con placebo/dexametasona.

Otros efectos adversos observados en pacientes con mieloma múltiple (REVLIMID
(lenalidomida)/dexametasona vs. dexametasona/placebo): estreñimiento (39% vs.
19%), fatiga (38% vs. 37%), insomnio (32% vs. 37%), calambres musculares (30%
vs. 21%), diarrea (29% vs. 25%), neutropenia (28% vs. 5%), anemia (24% vs. 17%),
astenia (23% vs. 25%), pirexia (23% vs. 19%), náuseas (22% vs. 19%), dolor de
cabeza (21% vs. 21%), edema periférico (21% vs. 19%), mareos (21% vs. 15%),
disnea (20% vs. 15%), temblor (20% vs. 7%), pérdida de peso (18% vs. 14%),
trombocitopenia (17% vs. 10%), erupciones (16% vs. 8%), dolor de espalda (15%
vs. 14%), hiperglucemia (15% vs. 14%) y debilidad muscular (15% vs. 15%).

Síndromes mielodisplásicos

– La trombocitopenia (61,5%; 91/148) y la neutropenia (58,8%; 87/148) fueron
los efectos adversos que se observaron más frecuentemente en la población con
MDS con eliminación del cromosoma 5q.

Otros efectos adversos observados en pacientes con MDS con eliminación del
cromosoma 5q (REVLIMID (lenalidomida)): diarrea (49%), prurito (42%), erupción
(36%), fatiga (31%), constipación (24%), náuseas (24%), nasofaringitis (23%),
artralgia (22%), pirexia (21%), dolor de espalda (21%), edema periférico (20%),
tos (20%), mareos (20%), dolor de cabeza (20%), calambre muscular (18%), disnea
(17%) y faringitis (16%).

DOSIS Y ADMINISTRACIÓN:

– La dosis se mantiene o modifica sobre la base de las conclusiones clínicas o
de laboratorio. Se recomienda modificar la dosis para controlar la neutropenia o
trombocitopenia grado 3 ó 4, u otra toxicidad grado 3 ó 4 que se determine que
esté relacionada con REVLIMID (lenalidomida).

– En el caso de otras toxicidades grado 3 ó 4 que se determine que están
relacionadas con REVLIMID (lenalidomida), mantener el tratamiento y comenzar
nuevamente en el siguiente nivel de dosis inferior cuando la toxicidad sea
inferior o igual al grado 2.

Por favor lea todo el prospecto informativo, incluidas las ADVERTENCIAS
resaltadas, CONTRAINDICACIONES, PRECAUCIONES y EFECTOS ADVERSOS.

Acerca de la leucemia linfocítica crónica

La leucemia linfocítica crónica (CLL) es la forma más común de los cuatro tipos
principales de leucemia. La incidencia global de CLL es de aproximadamente
cuatro casos cada 100.000. Con el tiempo, las células CLL se multiplican y
desplazan a los linfocitos normales de la sangre, médula ósea, nódulos
linfáticos y bazo, lo que produce una incapacidad para luchar contra las
infecciones, creando respuestas de anticuerpos normales. En la actualidad la CLL
no tiene cura.

Acerca de Celgene International Sàrl

Celgene International Sàrl, ubicada en Boudry, cantón de Neuchâtel, Suiza, es
una filial propiedad al 100% y sede internacional de Celgene Corporation.
Celgene Corporation, con sede en Summit, Nueva Jersey, es una compañía
farmacéutica mundial integrada que se dedica principalmente al descubrimiento,
desarrollo y comercialización de terapias innovadoras para el tratamiento del
cáncer y enfermedades inflamatorias mediante la regulación de proteínas y genes.
Para obtener más información, visite el sitio web de la Compañía:
www.celgene.com.

El presente comunicado contiene ciertas declaraciones prospectivas que
comprenden riesgos, obstáculos, incertidumbres y otros factores conocidos y
desconocidos que están fuera del control de la Compañía. Los resultados reales,
el rendimiento o los logros de la Compañía pueden ser sustancialmente diferentes
a los previstos en estas declaraciones prospectivas. Los factores que pueden
hacer que los resultados reales, el rendimiento y los logros difieran de los
previstos en las declaraciones prospectivas se incluyen en las presentaciones de
la Compañía ante la Comisión de Bolsa y Valores de los Estados Unidos, como los
informes de los Formularios 10-K, 10-Q y 8-K. Dados estos riesgos e
incertidumbres, se le advierte no confiar demasiado en las declaraciones
prospectivas.

“El comunicado en el idioma original, es la versión oficial y autorizada del
mismo. La traducción es solamente un medio de ayuda y deberá ser comparada con
el texto en idioma original, que es la única versión del texto que tendrá
validez legal”.

Celgene International Sàrl
Kevin Loth
Director de Relaciones Externas
+41 32 729 86 21

Copyright Business Wire 2010

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , ,

Daten von Studie über Revlimid® bei unbehandelten Patienten mit chronischer lymphozytischer Leukämie (CLL) auf der ASCO-Tagung vorgelegt

June 9, 2010 By Leave a Comment

BOUDRY, Schweiz–(Business Wire)–
ABSTRACT #6508

Celgene International Sàrl (NASDAQ:CELG) gab heute bekannt, dass Wissenschaftler
Daten einer industrieunabhängigen Phase-II-Studie über Lenalidomid (REVLIMID)
bei Patienten mit nicht vorbehandelter chronischer lymphozytischer Leukämie auf
der Jahrestagung der American Society of Clinical Oncology präsentiert haben.

Die einarmige Phase-II-Studie ergab, dass sich die Gesamtansprechrate (OR) bei
einer Nachuntersuchung von 60 beurteilbaren Patienten nach durchschnittlich 23
Monaten auf 62 Prozent belief und 15 Prozent der Patienten eine
Komplettremission (CR/CRi) erzielten. Nach der mittleren Nachbeobachtungszeit
war die mittlere progressionsfreie Überlebensdauer noch nicht erreicht und die
Gesamtüberlebensrate lag bei 90 Prozent.

Die häufigsten nachteiligen Ereignisse 3. bis 4. Grades, die während der Studie
auftraten, waren Neutropenie (38 % der Behandlungszyklen), Thrombozytopenie (14
% der Behandlungszyklen) und Anämie (< 1 % der Behandlungszyklen). Bei 15
Prozent der Patienten traten Infektionen 3. bis 4. Grades auf.

Die an der Studie teilnehmenden Patienten waren mindestens 65 Jahre alt und mit
nicht vorbehandelter CLL diagnostiziert. Sie erhielten während der ersten 56
Behandlungstage 5 mg Lenalidomid täglich und wurden danach je nach
Verträglichkeit in 5-mg-Schritten auf bis zu 25 mg pro Tag an Tagen 1 bis 21
jedes Zyklus (28 Tage) auftitriert.

Diese Daten stammen aus einer experimentellen Studie. REVLIMID hat keine
Marktzulassung zur Behandlung von Patienten mit nicht vorbehandelter CLL.

Über REVLIMID®

REVLIMID ist ein IMiDs®-Wirkstoff. REVLIMID und andere immunomodulatorische
Substanzen (IMiDs) werden in über 100 andauernden klinischen Studien untersucht.
Die IMiDs-Pipeline ist durch ein umfassendes urheberrechtliches Portfolio von
erteilten und angemeldeten Patenten in den USA, der EU und anderen Regionen
geschützt, einschließlich Zusammensetzungs- und Nutzungspatente.

REVLIMID ist in fast 50 Ländern, darunter die Europäische Union, alle Teile
Amerikas, der Nahe Osten und Asien, in Kombination mit Dexamethason für die
Behandlung von Patienten mit multiplem Myelom zugelassen, die mindestens eine
frühere Therapie durchgemacht haben. In Australien und Neuseeland ist REVLIMID
in Kombination mit Dexamethason für die Behandlung von Patienten zugelassen,
deren Erkrankung nach einer Therapie weiter fortschritt.

In den USA, Kanada und mehreren lateinamerikanischen Ländern sowie Malaysia und
Israel besitzt REVLIMID außerdem die Zulassung für transfusionsabhängige Anämie
aufgrund von MDS der niedrigen oder intermediate-1-Risikoklasse, das mit einer
zytogenetischen Fehlbildung mit Deletion am Chromosom 5q und mit oder ohne
weitere zytogenetische Abnormalitäten in Verbindung gebracht wird. In einer
Reihe weiterer Länder werden Zulassungsanträge derzeit geprüft.

REVLIMID® (Lenalidomid) ist in Kombination mit Dexamethason für die Behandlung
von Patienten mit multiplem Myelom indiziert, die sich mindestens einer
Vorbehandlung unterzogen haben.

REVLIMID® (Lenalidomid) ist für die Behandlung von Patienten mit
transfusionsabhängiger Anämie aufgrund eines myelodysplastischen Syndroms (MDS)
der Risikoklasse niedrig oder intermediär-1 indiziert, das mit einer
zytogenetischen 5q-Deletionsanomalie mit oder ohne zusätzliche zytogenetische
Anomalien einhergeht.

Wichtige Sicherheitsinformationen

WARNHINWEISE:

POTENZIELLE MISSBILDUNGEN WÄHREND DER SCHWANGERSCHAFT

Lenalidomid ist ein Analog von Thalidomid. Thalidomid ist als fruchtschädigend
(teratogen) beim Menschen bekannt und verursacht schwere lebensbedrohliche
Missbildungen bei Ungeborenen. Wird Lenalidomid während der Schwangerschaft
eingenommen, kann es zu Missbildungen oder zum Tode des ungeborenen Kindes
führen. Frauen im gebärfähigen Alter sollte bei Einnahme von REVLIMID®
(Lenalidomid) von einer Schwangerschaft abgeraten werden.

Männliche Patienten:Es ist nicht bekannt, ob Lenalidomid im Sperma von
Patienten, die das Arzneimittel einnehmen, nachgewiesen werden kann.Darum
sollten Männer, die REVLIMID® (Lenalidomid) einnehmen, bei jedem Sexualkontakt
mit Frauen im gebärfähigen Alter stets ein Latex-Kondom benutzen, selbst wenn
sie sich einer erfolgreichen Vasektomie unterzogen haben.

Spezielle Verschreibungsbedingungen

Aufgrund dieser potenziellen Reproduktionstoxizität und zur Verhinderung von
Geburtsschäden durch Kontakt von Ungeborenen mit REVLIMID® (Lenalidomid) gelten
für REVLIMID® (Lenalidomid) Vertriebsbeschränkungen. In den USA wird dieses
Programm als „RevAssist®” bezeichnet, und das Produkt darf nur von entsprechend
registrierten Ärzten verschrieben und von registrierten Apothekern ausgegeben
werden. Außerdem darf REVLIMID® (Lenalidomid) nur an registrierte Patienten
ausgegeben werden, die alle Kriterien des RevAssist®-Programms erfüllen.

HÄMATOLOGISCHE TOXIZITÄT (NEUTROPENIE UND THROMBOZYTOPENIE)

Dieses Arzneimittel wird mit signifikanter Neutropenie und Thrombozytopenie in
Verbindung gebracht.Bei 80 Prozent der MDS-Patienten mit 5q-Deletion musste in
der Hauptstudie eine Verzögerung/Verringerung der Dosis vorgenommen werden. Bei
34 Prozent der Patienten musste die Dosis ein zweites Mal verzögert bzw.
verringert werden. Bei 80 Prozent der Studienprobanden wurde eine hämatologische
Toxizität 3. oder 4. Grades beobachtet. Bei Patienten unter Therapie für
5q-del-MDS sollte das Blutbild in den ersten 8 Therapiewochen wöchentlich,
danach mindestens vierwöchentlich überwacht werden. Bei diesen Patienten kann
eine Unterbrechung und/oder Verringerung der Dosis notwendig sein. Die Patienten
benötigen unter Umständen zusätzliche Blutprodukte und/oder Wachstumsfaktoren.
(Siehe unter „DOSIERUNG und VERABREICHUNG”).

TIEFE VENENTHROMBOSE UND LUNGENEMBOLIE

Dieses Arzneimittel zeigte ein deutlich erhöhtes Risiko der tiefen
Venenthrombose (TVT) und Lungenembolie (LE) bei Patienten mit multiplem Myelom,
die mit der REVLIMID® (Lenalidomid)-Kombinationstherapie behandelt wurden.
Patienten und Ärzten wird deshalb angeraten, auf die Anzeichen und Symptome von
Thromboembolien zu achten. Patienten sind anzuweisen, sich beim Auftreten von
Symptomen wie Atemlosigkeit, Schmerzen in der Brust oder Anschwellen von Armen
oder Beinen in ärztliche Behandlung zu begeben. Es ist nicht bekannt, ob
zusammen mit REVLIMID® (Lenalidomid) verordnete prophylaktische koagulations-
oder plättchenhemmende Therapie das Risiko venenthromboembolischer Ereignisse
verringern kann. Die Entscheidung für prophylaktische Maßnahmen ist nach
eingehender Prüfung der zugrundeliegenden Risikofaktoren der einzelnen Patienten
zu treffen.

Informationen über REVLIMID® (Lenalidomid) und das RevAssist®-Programm erhalten
Sie im Internet unter www.REVLIMID.com oder telefonisch unter der (in den USA)
gebührenfreien Rufnummer des Herstellers: 1-888-423-5436.

WEITERE WARNHINWEISE: HÄMATOLOGISCHE TOXIZITÄT

Multiples Myelom

* In den gemeinsam betrachteten Studien zum multiplen Myelom traten
hämatologische Toxizitäten 3. und 4. Grades bei Patienten, die mit der
Kombination von REVLIMID® (Lenalidomid) und Dexamethason behandelt wurden,
häufiger auf als bei Patienten, die nur Dexamethason erhielten.
* Bei Patienten, die sich dieser Therapie unterziehen, sollte daher das
komplette Blutbild in den ersten 12 Wochen vierzehntäglich, danach monatlich
überwacht werden.
* Bei diesen Patienten kann unter Umständen die Unterbrechung und/oder
Verringerung der Therapiedosis erforderlich sein.

KONTRAINDIKATIONEN:

Schwangerschaftskategorie X:

* Bei schwangeren und schwangerschaftsfähigen Frauen ist Lenalidomid
kontraindiziert. Sollte keine Alternative bestehen, können Frauen im
gebärfähigen Alter mit Lenalidomid behandelt werden, sofern angemessene
Schwangerschaftsverhütung angewandt wird.

Überempfindlichkeit:

* REVLIMID® (Lenalidomid) ist bei allen Patienten kontraindiziert, die eine
Überempfindlichkeit gegen das Arzneimittel oder seine Inhaltsstoffe gezeigt
haben.

VORSICHTSMASSNAHMEN:

Angioödem, Stevens-Johnson-Syndrom und Lyell-Syndrom (toxische epidermale
Nekrolyse)

* Angioödem und schwere dermatologische Reaktionen, einschließlich
Stevens-Johnson-Syndrom (SJS) und Lyell-Syndrom (TEN) wurden berichtet. Diese
Reaktionen können tödlichen Ausgang nehmen. Patienten mit einer Vorgeschichte
von Hautausschlägen 4. Grades in Verbindung mit Thalidomidtherapie sollten
REVLIMID® (Lenalidomid) nicht einnehmen. Bei Hautausschlägen 2. bis 3. Grades
ist die Unterbrechung oder das Absetzen von REVLIMID® (Lenalidomid) in Betracht
zu ziehen. Bei Angioödem (Quincke-Ödem), Hautausschlägen 4. Grades, exfoliativer
Dermatitis, bullösen Hautausschlägen oder bei Verdacht auf SJS oder TEN ist
REVLIMID® (Lenalidomid) abzusetzen und nach derartigen Reaktionen nicht wieder
aufzunehmen.

Tumorlyse-Syndrom

* Lenalidomid weist eine antineoplastische Wirkung auf. Daher können
Komplikationen des Tumorlyse-Syndroms auftreten. Das Risiko des
Tumorlyse-Syndroms besteht insbesondere bei Patienten mit einer hohen
Tumorbelastung vor der Therapie. Diese Patienten sind engmaschig zu überwachen
und es sind geeignete Vorsichtsmaßnahmen zu treffen.

Nierenfunktionsstörung:

* Da Lenalidomid hauptsächlich unverändert über die Nieren ausgeschieden wird,
werden Anpassungen der REVLIMID®-Anfangsdosis (Lenalidomid) empfohlen, um eine
geeignete Arzneimittelmenge bei Patienten mit moderater oder schwerer (CLcr < 60
ml/Min) Nierenfunktionsstörung und bei Dialyse-Patienten sicherzustellen.
* Da die Nierenfunktion eher bei älteren Patienten abnimmt, ist die Dosierung
bei diesen sehr sorgsam zu wählen, und eine Überwachung der Nierenfunktion ist
anzuraten.

Einnahme während der Stillzeit: Es ist nicht bekannt, ob REVLIMID® (Lenalidomid)
über die Muttermilch ausgeschieden wird.

* Aufgrund potenzieller nachteiliger Reaktionen bei Säuglingen ist entweder das
Absetzen des Arzneimittels oder das Abstillen in Betracht zu ziehen, wobei die
Bedeutung des Arzneimittels für die Mutter zu berücksichtigen ist.

NACHTEILIGE REAKTIONEN:

Multiples Myelom

* In der REVLIMID® (Lenalidomid)/Dexamethason-Behandlungsgruppe wurde bei 151
Patienten (45 %) mindestens eine Dosisunterbrechung mit oder ohne
Dosisverringerung von REVLIMID® (Lenalidomid) vorgenommen im Vergleich zu 21 %
der Placebo/Dexamethason-Behandlungsgruppe.
* Bei den Patienten, bei denen die Dosis mit oder ohne Dosisverringerung einmal
unterbrochen wurde, erfolgte bei 50 % der REVLIMID®
(Lenalidomid)/Dexamethason-Behandlungsgruppe mindestens eine weitere
Dosisunterbrechung mit oder ohne Dosisverringerung, verglichen mit 21 % in der
Placebo/Dexamethason-Behandlungsgruppe.
* Die meisten unerwünschten Nebenwirkungen und nachteiligen Ereignisse 3. oder
4. Grades traten bei MM-Patienten, die die Kombination von REVLIMID®
(Lenalidomid)/Dexamethason erhielten, häufiger auf als bei der
Placebo/Dexamethason-Gruppe.

Weitere nachteilige Ereignisse, die bei Patienten mit multiplem Myelom berichtet
wurden (REVLIMID® (Lenalidomid)/Dexamethason vs. Dexamethason/Placebo):
Verstopfung (39 % vs. 19 %), Müdigkeit (38 % vs. 37 %), Schlaflosigkeit (32 %
vs. 37 %), Muskelkrämpfe (30 % vs. 21 %), Durchfall (29 % vs. 25 %), Neutropenie
(28 % vs. 5 %), Anämie (24 % vs. 17 %), Asthenie (23 % vs. 25 %), Fieber (23 %
vs. 19 %), Übelkeit (22 % vs. 19 %), Kopfschmerzen (21 % vs. 21 %), peripheres
Ödem (21 % vs. 19 %), Schwindel (21 % vs. 15 %), Dyspnoe (20 % vs. 15 %),
Zittern (20 % vs. 7 %), Gewichtsverlust (18 % vs. 14 %), Thrombozytopenie (17 %
vs. 10 %), Hautausschlag (16 % vs. 8 %), Rückenschmerzen (15 % vs. 14 %),
Hyperglykämie (15 % vs. 14 %) und Muskelschwäche (15 % vs. 15 %).

Myelodysplastische Syndrome

* Thrombozytopenie (61,5 %; 91/148) und Neutropenie (58,8 %; 87/148) waren die
am häufigsten berichteten nachteiligen Ereignisse, die bei den Probanden mit
Del-5q-MDS beobachtet wurden.

Weitere nachteilige Reaktionen bei Del-5q-MDS-Patienten (REVLIMID®
(Lenalidomid)): Durchfall (49 %), Juckreiz (42 %), Ausschläge (36 %), Müdigkeit
(31 %), Verstopfung (24 %), Übelkeit (24 %), Nasopharyngitis (23 %),
Gelenkschmerzen (22 %), Fieber (21 %), Rückenschmerzen (21 %), peripheres Ödem
(20 %), Husten (20 %), Schwindel (20 %), Kopfschmerzen (20 %), Muskelkrämpfe (18
%), Dyspnoe (17 %) und Pharyngitis (16 %).

DOSIERUNG UND VERABREICHUNG:

* Die Dosierung wird auf der Basis klinischer und Laborergebnisse beibehalten
oder modifiziert. Dosierungsmodifikationen werden zur Bewältigung von
Neutropenie oder Thrombozytopenie 3. oder 4. Grades oder anderer Toxizitäten 3.
oder 4. Grades empfohlen, die nach ärztlicher Einschätzung im Zusammenhang mit
REVLIMID® (Lenalidomid) stehen.

* Beim Auftreten anderer Toxizitäten 3. oder 4. Grades, die nach ärztlicher
Einschätzung im Zusammenhang mit REVLIMID® (Lenalidomid) stehen, ist die
Therapie zu suspendieren und nach dem Abklingen der Toxizität auf Grad 2 oder
weniger mit der nächstniedrigeren Dosierungsmenge wieder aufzunehmen.

Bitte beachten Sie die ausführlichen Verschreibungsinformationen, einschließlich
gerahmte WARNHINWEISE, KONTRAINDIKATIONEN, VORSICHTSMASSNAHMEN und NACHTEILIGE
REAKTIONEN

Über chronische lymphozytische Leukämie

Von den vier Hauptarten der Leukämie ist CLL die häufigste. Die Gesamtinzidenz
von CLL beläuft sich auf etwa vier in 100.000. Bei der Krankheit vermehren sich
die CLL-Zellen im Laufe der Zeit und verdrängen die normalen Lymphozyten im
Blut, dem Knochenmark, den Lymphknoten und der Milz, womit sie den Körper
außerstande versetzen, Infektionen durch normale Antikörperreaktionen zu
bekämpfen. Derzeit gilt CLL als unheilbar.

Über Celgene International Sàrl

Celgene International Sàrl, ansässig in Boudry im Schweizer Kanton Neuenburg,
ist eine 100-prozentige Tochtergesellschaft und der internationale
Hauptgeschäftssitz der Celgene Corporation. Die Celgene Corporation mit
Hauptsitz in Summit, New Jersey, ist ein integriertes, globales
Biopharmaunternehmen, das sich hauptsächlich auf die Entdeckung, Entwicklung und
Vermarktung innovativer Therapien zur Behandlung von Krebs und
Entzündungskrankheiten durch Gen- und Proteinregulierung konzentriert. Weitere
Informationen finden Sie auf der Website des Unternehmens unter:
www.celgene.com.

Diese Mitteilung enthält bestimmte zukunftsbezogene Aussagen, die bekannte und
unbekannte Risiken, Verzögerungen, Ungewissheiten und andere Faktoren
beinhalten,über die das Unternehmen keine Kontrolle hat. Die tatsächlichen
Ergebnisse, Leistungen oder Errungenschaften des Unternehmens könnten sich
maßgeblich von den Darstellungen dieser zukunftsbezogenen Aussagen
unterscheiden. Wichtige Faktoren, aufgrund derer tatsächliche Ergebnisse,
Leistungen oder Errungenschaften maßgeblich von den zukunftsbezogenen Aussagen
abweichen könnten, sind in den Pflichtmitteilungen des Unternehmens an die
US-Börsenaufsicht SEC enthalten, z. B. den vom Unternehmen eingereichten
Formularen 10-K, 10-Q und 8-K. Angesichts dieser Risiken und Ungewissheiten wird
der Leser gewarnt, sich nicht übermäßig auf die zukunftsbezogenen Aussagen zu
verlassen.

Die Ausgangssprache, in der der Originaltext veröffentlicht wird, ist die
offizielle und autorisierte Version. Übersetzungen werden zur besseren
Verständigung mitgeliefert. Nur die Sprachversion, die im Original
veröffentlicht wurde, ist rechtsgültig. Gleichen Sie deshalb Übersetzungen mit
der originalen Sprachversion der Veröffentlichung ab.

Celgene International Sàrl
Kevin Loth
Director of External Relations
+41 32 729 86 21

Copyright Business Wire 2010

Filed Under: International News Tagged With: , , , , , , , , , , , , ,

Data From Pivotal Phase 2 RALLY Trial Show Marqibo Produced Compelling Single-Agent…

June 8, 2010 By Leave a Comment

Data From Pivotal Phase 2 RALLY Trial Show Marqibo Produced Compelling
Single-Agent Anti-Leukemic Efficacy in Advanced Relapsed/Refractory Adult Ph(-)
Acute Lymphoblastic Leukemia

SOUTH SAN FRANCISCO, Calif., June 7, 2010 (GLOBE NEWSWIRE) —

— Marqibo administered as third-, fourth-, fifth-, and sixth-line
single-agent therapy
— 35% overall response rate with a predictable and manageable toxicity
profile
— 20% complete response (CR) and CR with incomplete blood count recovery
(CRi) rate
— 5.3 month median CR/CRi duration and 7.4 month median survival in
responders

Hana Biosciences Inc., (OTCBB:HNAB), today announced complete data from its
pivotal, Phase 2 RALLY clinical trial for Marqibo(R) (vincristine sulfate
liposome injection) for the treatment of relapsed/refractory adult Philadelphia
chromosome-negative acute lymphoblastic leukemia (ALL). Results from the RALLY
trial demonstrated compelling evidence of single-agent, anti-leukemic activity
in an advanced, heavily pre-treated, adult ALL population.

An analysis of the 65 evaluable subjects demonstrated an overall response in 35
percent of the subjects and a complete response (CR) or CR with incomplete blood
count recovery (CRi) in 20 percent of the subjects. The estimated median overall
survival in complete responders was 7.4 months, with five patients having an
overall survival greater than one year. The estimated median duration of CR/CRi
was 5.3 months. Ten patients treated with Marqibo went on to receive a
potentially life-saving stem cell transplant. There were no unexpected
toxicities.

“We believe these data position Marqibo as an effective treatment for
relapsed/refractory adult ALL patients with limited to no current options, as
efficacy was demonstrated in second and third salvage settings, as third-
through fifth-line therapy, and in both B- and T-lineage ALL,” said Anne Hagey,
M.D., Chief Medical Officer of Hana Biosciences. “Based upon these data, we are
moving forward with our plan to initiate a rolling NDA submission with the hopes
of bringing a much needed therapy to patients with no standard treatment
options. In addition, the complete RALLY results reinforce our belief that
Marqibo has the potential to be an important and useful stand-alone therapy in
relapsed adult leukemia. We look forward to additional and continued development
in combination therapy in leukemia and lymphomas.”

“The results of the RALLY trial demonstrate a clinically meaningful benefit for
patients who have relapsed multiple times or who have progressed following two
or more prior lines of therapy,” said Susan O’Brien, M.D., Professor of Medicine
in the Leukemia Department at the University of Texas, MD Anderson Cancer Center
and RALLY study lead investigator. “Based on historical data with single-agent
therapy, one would have expected no more than a 4 percent CR/CRi rate in such an
advanced leukemia population. Marqibo’s CR/CRi rate of 20 percent would be an
extremely important step forward in the treatment of adult ALL”

Phase 2 RALLY Clinical Trial Design and Results

The pivotal Phase 2 RALLY clinical trial enrolled a total of 65 evaluable
patients at 22 sites in the United States, Canada, Germany, and Israel. The
primary objective of the RALLY clinical trial was to assess the efficacy of
single-agent, weekly Marqibo (2.25 mg/m2 with no dose cap) as assessed by
achievement of CR or CRi. Secondary objectives included assessments of duration
of CR/CRi, overall survival (OS), safety and pharmacokinetics. Independent
response assessment remains ongoing at the present time. Marqibo was dosed
weekly based on actual body surface area without the dose capping applied to
standard vincristine sulfate. The study population is defined as Philadelphia
chromosome-negative adult patients in second or greater relapse, or those
patients who relapsed following two lines of anti-leukemia chemotherapy,
including those who have previously undergone stem cell transplantation.

An overall response rate (ORR) as determined by CR, CRi, partial remission, and
bone marrow blast count normalization without blood count recovery was reported
by investigators in 23 of 65 subjects for an ORR of 35 percent, with 13 of 65
subjects (20 percent) experiencing a CR or CRi. Marqibo enabled successful stem
cell transplantation in 10 patients after dosing. The median OS in the 65
subjects is estimated to be 4.6 months (range 0.1-21.6) using Kaplan-Meier
methodology. The safety profile of Marqibo is predictable, manageable, and
similar to standard vincristine sulfate. The early death rate, defined as death
occurring within the first 14 days on study, was 4.6 percent (3 of 56 subjects)
and occurred due to progressive ALL.

The Company anticipates locking the data base and commencing a rolling NDA
submission in the near future.

ASCO Presentation

The complete data from the pivotal Phase 2 RALLY trial will be presented in an
oral podium presentation by Susan O’Brien M.D. (Abstract #6507) at 11:45 am on
Monday, June 7 at the American Society of Clinical Oncology (ASCO) Annual
Meeting being held in Chicago, Illinois, June 4-8, 2010.

About Marqibo(R) (vincristine sulfate liposome injection)

Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of
vincristine sulfate, a widely-used chemotherapy, which has shown promising
anti-cancer activity in patients with ALL, non-Hodgkin’s lymphoma, Hodgkin’s
disease, and melanoma in several clinical trials. Marqibo is designed to enhance
the penetration and concentration of vincristine sulfate at sites of active
cancer and facilitate dose-intensification compared to standard vincristine
formulations. Unlike standard vincristine, Marqibo is dosed based on actual
patient body surface area without the need for dose capping.

Hana Biosciences has received orphan drug and fast track designations for
Marqibo for the treatment of adult ALL from the U.S. Food and Drug
Administration. Marqibo has also received orphan drug designation in adult ALL
from the European Medicines Evaluation Agency.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing
and commercializing new, differentiated cancer therapies designed to improve and
enable current standards of care. The company’s lead product candidate,
Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The
Company has additional pipeline opportunities some of which, like Marqibo,
improve delivery and enhance the therapeutic benefits of well characterized,
proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Hana Biosciences can be found at
www.hanabiosciences.com.

The Hana Biosciences, Inc. logo is available at

http://www.globenewswire.com/newsroom/prs/?pkgid=3290

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements are often,
but not always, made through the use of words or phrases such as “anticipates,”
“expects,” “plans,” “believes,” “intends,” and similar words or phrases. These
forward-looking statements include without limitation, statements regarding, the
timing, progress and anticipated results of Hana’s planned development and
regulatory activities relating to Marqibo, including its proposed NDA filing and
whether such filing will be accepted for review or approved by the FDA;
statements regarding the potential of Marqibo to replace existing therapies and
the expected benefits Marqibo may have for patients with relapsed ALL compared
to existing therapies. Such statements involve risks and uncertainties that
could cause Hana’s actual results to differ materially from the anticipated
results and expectations expressed in these forward-looking statements. These
statements are based on current expectations, forecasts and assumptions that are
subject to risks and uncertainties, which could cause actual outcomes and
results to differ materially from these statements. Among other things, there
can be no assurances that any of Hana’s clinical and regulatory development
efforts relating to Marqibo will be successful; that even if an NDA for Marqibo
is accepted by the FDA, that it will be approved; that the data of the clinical
trials of Marqibo will be sufficient to support approval by the FDA of an NDA
for Marqibo; that Hana will have completed all other activities necessary for
the filing of an NDA or other submission with the FDA; that the results of the
clinical trials of Marqibo will support Hana’s claims or beliefs concerning
Marqibo’s safety and effectiveness; that its existing patent and other
intellectual property rights will be adequate; and that Hana will be able to
secure the additional capital necessary to fund the activities required to
complete the proposed NDA submission and other clinical and regulatory
activities relating to Marqibo. Additional risks that may affect such
forward-looking statements include Hana’s need to raise additional capital to
fund its product development programs, including Marqibo, to completion, Hana’s
reliance on third-party researchers to develop its product candidates, and its
lack of experience in developing and commercializing pharmaceutical products.
Additional risks are described in the company’s Annual Report on Form 10-K for
the year ended December 31, 2009 and in the Company’s Form 10-Q for the three
month period ended March 31, 2010. Hana assumes no obligation to update these
statements, except as required by law.

CONTACT: Hana Biosciences, Inc.
Investor & Media Contacts:
Investor Relations Team
(650) 588-6641
investor.relations@hanabiosciences.com

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , ,

Sri Lanka beats New Zealand by 7 wickets, CRI

May 24, 2010 By Leave a Comment

LAUDERHILL, Florida (AP) Nuwan Kulasekera and Lasith Malinga shared seven wickets as Sri Lanka beat New Zealand by seven wickets in a Twenty20 cricket international Sunday, leveling the two-match series at 1-1. Kulasekera took three wickets for four runs from three overs and Malinga four wickets for 12 runs as Sri Lanka dismissed New Zealand for 81 runs in 17.3 overs.

Nathan McCullum top-scored with an unbeaten 36 while captain Daniel Vettori added 27 for New Zealand. Tillakaratne Dilshan made an unbeaten 33 and Thissara Perera 24 as Sri Lanka reached its winning target after having three wickets down in the 16th over.

New Zealand beat Sri Lanka by 29 runs on Saturday the first major cricket international played in the United States.

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , ,

Butt dismisses allegations of match-fixing, CRI

May 24, 2010 By Leave a Comment

ISLAMABAD (AP) Pakistan Cricket Board chairman Ijaz Butt has dismissed allegations of match-fixing against national team players. Butt told reporters in the eastern city of Lahore on Sunday that if any of his subordinates raises the issue of match-fixing, “he is talking nonsense.

” In a leaked video recording of an inquiry committee hearing, Pakistan team coaches raised suspicions about the performance of wicketkeeper Kamran Akmal during the winless tour of Australia earlier this year. Then-coach Intikhab Alam said that he was flabbergasted after Akmal missed a run out of Shane Watson in the Sydney test and later heard suggestions of match-fixing.

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , ,

Report: Akmal wants coaches to apologize, CRI

May 24, 2010 By Leave a Comment

ISLAMABAD (AP) Pakistan news reports say wicketkeeper Kamran Akmal wants an unconditional apology from his former coaches for accusing him of match-fixing during this year’s winless tour of Australia. Akmal was quoted by leading Urdu-language daily Jang on Sunday as saying both Intikhab Alam and Aqib Javed should apologize to him unconditionally, otherwise he will take court action against them.

Both Alam and Javed raised suspicions of match fixing in a leaked video of the Pakistan Cricket Board’s inquiry committee. Alam had said he was flabbergasted after Akmal missed a run out of Shane Watson during the Sydney test and later heard stories of match fixing.

Akmal was talking to the newspaper before leaving for commitments in England.

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , ,

”Everybody Draw Mohammed Day” triggers Facebook row

May 20, 2010 By Leave a Comment

Washington, May 20 (ANI): The ”Everybody Draw Mohammed Day” on Facebook, which was a cartoonist”s call to action against censorship, has snowballed into a controversy leading to death threats, a court order and a call for a boycott of the social networking site.

Seattle-based cartoonist named Molly Norris started the campaign in a bid to protest against Comedy Central”s decision to censor an episode of ‘South Park’ that depicted Muhammad in a bear costume.

The network took the decision after an Islamic extremist website warned of retaliation against the show”s creators, Matt Stone and Trey Parker

And to protest against the decision, Norris created a poster with likenesses of Muhammad as a domino, a teacup and a box of pasta.

Thus, she declared May 20 as ‘Everybody Draw Mohammed Day!’— and her efforts quickly went viral, spawning several Facebook pages with thousands of followers dedicated to the event.

They also prompted a “protest” movement by thousands of other Facebook users opposed to it.

While Norris herself has withdrawn from the cause, but she is glad her efforts encouraged others to speak out.

“I just thought that Viacom or Comedy Central had overreacted to a veiled threat from a tiny blog or website that not many people even belong to, and I think it just set a precedent for a slippery slope in censorship,” Fox News quoted Norris as saying.

“If artists have to be afraid of what they draw, then what’s the point of even living here? That”s what really bothered me,” she added.

As of May 19, more than 41,000 Facebook users associated themselves to one page dedicated to the event, and a similar page was “liked” by at least 4,400 users.

Meanwhile, over 56,000 users joined a Facebook page opposing it.

And in Pakistan, a court on Wednesday ordered the government to block Facebook pages associated with the campaign until May 31.

Muslims consider any depiction of the Prophet Muhammad to be blasphemous, and it is a crime punishable by death.

“The court also has ordered the foreign ministry to investigate why such a competition is being held,” said Azhar Siddique, a representative of the Islamic Lawyers Forum who filed a petition in the Lahore High Court.

Organizers of the Facebook page protesting the drawing campaign are calling for users to boycott the social networking site for the company”s inaction against the ‘Everybody Draw Mohammad’ pages.

Some say the campaign is nothing more than a way to incite Muslims.

A Facebook spokesman told FoxNews.com it has no plans to censor any of the pages associated with the campaign or the counter-campaign, though threats will be removed. (ANI)

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , ,

Suspended IPL chief replies to corruption charges, CRI

May 16, 2010 By Leave a Comment

MUMBAI, India (AP) Suspended Indian Premier League chief Lalit Modi’s official response to the corruption allegations against him was delivered in six large boxes to the Board of Control for Cricket in India. Modi’s lawyer delivered the thousands of pages of documents late Saturday, meeting a deadline which had been extended by five days.

Modi followed it up with a confident posting on Twitter. “It’s best to allow my colleagues time to go thru my reply,” Modi said in a tweet late Saturday.

“We spent weeks putting it,” together. The BCCI is investigating Modi over his involvement in the initial bids for the Rajasthan Royals and Kings XI Punjab at the inaugural IPL auctions in 2008, in a broadcast deal and in the awarding of two new IPL franchises last month.

Modi was the powerbroker in establishing the lucrative IPL and then turning it into a multi-billion dollar enterprise, which has led to an explosion of interest in the shortest form of international cricket. Modi’s lawyer Mehmood S. Abdi declined to elaborate on the contents of the six cartons delivered to BCCI Chief Administrator Ratnakar Shetty, but told reporters he was confident that the charges against Modi would be dropped.

“The charges were based on allegations and gossip. BCCI can never prove it.

We are confident that all the charges against Modi will be dropped,” Abdi said. He added: “The reply has been written in simple prose and BCCI president Shashank Manohar, who himself is a lawyer, will need only a few hours to go through it.

” Shetty did not comment on the documents or what the next step in the proceedings was likely to be, saying only that “there is a procedure in the BCCI and the president will follow that.” Modi was initially supposed to answer the corruption allegations by May 10, but was given additional time to reply after he asked the board for additional documents.

Modi has been barred from participating in the operation of the IPL, the BCCI or any of its committees. A vice president of the BCCI, Modi has said his running of the IPL was completely transparent and denied any corruption.

An investigation led by Shetty into IPL records had already shown “a lot of documents missing,” BCCI president Manohar said last month.

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , ,

New Zealand-Sri Lanka Florida match abandoned, 1st Ld-Writethru, CRI

May 16, 2010 By Leave a Comment

WELLINGTON, New Zealand (AP) One of three Twenty20 cricket internationals between New Zealand and Sri Lanka to be played in Florida next week has been canceled because of concerns over inadequate floodlighting. New Zealand Cricket said Sunday the scheduled first match of a three-match series at Central Broward Regional Park in Fort Lauderdale on Thursday, and a match between the United States and Jamaica, have been scrapped because lighting at the stadium was not of sufficient quality for international cricket.

New Zealand and Sri Lanka will meet in day matches at the Broward County stadium on Saturday and Sunday, May 22 and 23, while the United States and Jamaica will likely play a 50-overs international, NZC chief executive Justin Vaughan said. “Ideally the inaugural game would have been a night game on Thursday,” Vaughan said.

“The lights at the stadium are fine for most levels of cricket, but they need to be of a higher standard for the playing and broadcast of international cricket. “Added to this, there is a high probability of rain and thunderstorms in the region on Thursday which added weight to our decision.

Because of these factors, we have decided, along with our partner USA Cricket, to focus all of the attention on the weekend.” The Jamaica-U.S. match is expected to be played Friday.

The New Zealand players were “tremendously excited” to be involved in helping promote international cricket in the United States, he said.

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , ,

Younis’ appeal against indefinite ban deferred, CRI

May 16, 2010 By Leave a Comment

ISLAMABAD (AP) Pakistan batsman Younis Khan’s appeal against indefinite suspension from the national team has been deferred until May 29. Younis’ lawyer Mohammad Ahmed Qayyum said Saturday that arbitrator Irfan Qadir has adjourned his client’s appeal.

Younis is among six Pakistan cricketers appealing against punishments imposed for indiscipline or poor performance during a tour to Australia earlier this year. Only former captain Mohammad Yousuf, who has retired from international cricket, has not filed an appeal.

Filed Under: International News Tagged With: , , , , , , , , , , , , , ,

Dravid, Dhoni say IPL will survive scandal, 2nd Ld-Writethru, CRI

April 29, 2010 By Leave a Comment

DUBAI, United Arab Emirates (AP) Senior India players Rahul Dravid and Mahendra Singh Dhoni believe the Indian Premier League will survive the current corruption scandal. Former IPL commissioner Lalit Modi has been suspended pending investigations of alleged corruption related to bidding for two of the clubs, television broadcast deals and other matters.

He has denied any wrongdoing. Former India captain Dravid, who plays for the Royal Challengers in the IPL, was hopeful the lucrative Twenty20 league would sort out the mess for the benefit of fans and said Wednesday that it would not affect players.

“I’m sure they’ll do what is right for the game,” Dravid told The Associated Press on the sidelines of the SportAccord convention in Dubai. “It’s important.

The people of India love their cricket,” he said. “This league has been hugely popular and they deserve a well organized and good run league.

I hope going ahead that will be the case.” India captain Dhoni agreed, saying: “The IPL is here to stay.

” “Not one individual but a few brains will have to work together to ensure it stays innovative.” Dhoni led Chennai Super Kings to win the eight-team IPL competition last week, defeating Sachin Tendulkar’s Mumbai Indians in the final.

“He (Modi) was part of it for the first three years, we have grown and with each season we have come up with something better,” he said. “I’m sure they will come up with something that is good for everyone involved.

“We need to be patient and we certainly have enough time because the next edition is a year away.” Dravid said this year’s league was one of the best, with competitive matches all the way to the final.

But he acknowledged that it would have been better to see the cricket on the back sports pages, rather than the front news sections. “From a players perspective, it’s not nice there are negative things about anything you play in,” he said.

Still, he said the IPL and the booming popularity of Twenty20 cricket generally was bringing more money into the sport and attracting new classes of fans in India and beyond. “What we are seeing in India is there are a lot more women and children getting hooked on the game,” Dravid said.

“That is great for the game. It brings new audiences and new revenue which should hopefully benefit the other, more traditional forms of games.

It gives players more opportunity to earn a decent living and showcase their talent.” Meanwhile, Bal Thackeray, leader of India’s Hindu nationalist party Shiv Sena, criticized the Board of Control for Cricket in India for appointing Chirayu Amin as interim chairman on Monday.

“Modi has been replaced by another big shot industrialist,” Press Trust of India quoted Thackeray as saying. Thackeray suggested that former test cricketers like Sunil Gavaskar, Ravi Shastri who are on the IPL’s governing council or Ajit Wadekar should have been considered for the post.

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , ,

Pak terms US drone strikes ‘futile’, claims Laden is in Afghanistan

July 12, 2009 By Leave a Comment

London, July 12 (ANI) : Claiming that no top Al-Qaeda leader is present inside its territory, Pakistan has termed the continuous US drones attacks in its ‘lawless’ tribal areas along the Afghanistan border as ‘futile’.

The Pakistan Prime Minister’s Advisor on Interior Affairs, Rehman Malik, has claimed that neither bin Laden nor any ‘big fish’ of Al-Qaeda were present in Pakistan.

Malik said Laden could not have escaped the Pakistan Army if he happened to be in the country.

“If Osama was in Pakistan, we would know, with all the thousands of troops we have sent into the tribal areas in recent months,” The Times quoted Malik, as saying.

He claimed that bin Laden is hiding in Afghanistan itself.

“According to our information, Osama is in Afghanistan, probably Kunar, as most of the activities against Pakistan are being directed from Kunar,” said Malik.

Malik insisted that the drone strikes were a waste of time, as the Al-Qaeda leadership was in eastern Afghanistan.

“They’re getting mid-level people not big fish. And they are counterproductive because they are killing civilians and turning locals against our government. We try to win people’s hearts, then one drone attack drives them away,” he said.

Malik’s statement came a day after a US Senator asked Islamabad to accept its ‘tacit approval’ of the drone hits.

Senator Carl Levin, told a Congressional hearing that the attacks would not have taken place without the ‘tacit approval’ of the Pakistani leadership, so it was wrong on Islamabad’s part to blame the US for the missile hits.

“For them to look the other way or to give us the green light privately and then to attack us publicly leaves us, it seems to me, at a very severe disadvantage and loss with the Pakistani people,” said Levin.

Officials said that despite Pakistan’s double faced attitude on the issue, the US is working to develop a new strategy to reduce stirring tension between both the countries.

Pakistan has been criticizing the Obama administration for the drone strikes against the insursents in the tribal areas, saying that the attacks are proving ‘counterproductive’ in its war on terror, as they had killed far more civilians than militants.

Official Pakistani sources claimed that since 2006, the drones have killed 700 civilians and only 14 militants. (ANI)

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Chinese boy, 2, is world’s youngest smoker

June 27, 2009 By Leave a Comment

Melbourne, June 25 (ANI): A two-year-old Chinese boy is the world’s youngest smoker.

And it was Tong Liangliang’s dad who taught him how to spark up between tantrums and milky vomits.

Liangliang’s dad said his son was born with a hernia, and being too young for an operation, has taken up smoking to help him deal with the pain.

“The father wasn’t aware how serious the toddler’s habit had become until the child began to increase the number of cigarettes he smoked per day,” News.com.au quoted news agency CRI as saying.

However, The Guinness Book of World Records may not accept the feat, as it has refused such requests before on the grounds that it “promoted a harmful habit”. (ANI)

Filed Under: International News Tagged With: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

New design for cheaper and more efficient white light LEDs

April 8, 2009 By Leave a Comment

Washington, Apr 8 (ANI): In a bid to produce cheap and efficient white light for use in homes and offices, scientists at the Chinese Academy of Sciences have taken a major step towards developing a new type of light emitting diode (LED) made from inexpensive, plastic like organic materials.

Designed with a simplified “tandem” structure, the new LEDs can produce twice as much light as a normal LED, including the white light desired for home and office lighting.

“This work is important because it is the realization of rather high efficiency white emission by a tandem structure,” said Dongge Ma, who led the research.

Found in everything from brake lights to computer displays, LEDs are more environmentally friendly and much more efficient than other types of light bulbs, like incandescent bulbs and compact fluorescent bulbs, which waste much part of its energy as heat.

LEDs, on the other hand, are made from thin wafers of material flanked by electrodes and turn 20 to 50 percent, or even more, of the input energy into light. They also concentrate a lot of light in a small space.

While LEDs can easily be manufactured to produce light of a single colour — like red-with applications such as traffic lights and auto brake lights. But for indoor lighting, “natural” white light is needed.

This quality is measured by the colour-rendering index (CRI), which assigns a value based on the light source’s ability to reproduce the true colour of the object being lit. For reading light, a CRI value of 70 or more is optimal.

LEDs can produce white light by combining a mixture of blue, green, and red light, or by sending coloured light through a filter or a thin layer of phosphors-chemicals that glow with several colours when excited. But, these solutions increase costs.

Thus, to make inexpensive LEDs that can produce white light on their own, the researchers firstly built LEDs from organic, carbon-based materials, like plastic, rather than from more expensive semiconducting materials such as gallium, which also require more complicated manufacturing processes.

Then, they demonstrated, for the first time, an organic white-light LED operating within only a single active layer, rather than several sophisticated layers.

In fact, they even showed that by putting two of these single-layer LEDs together in a tandem unit, it was possible to achieve even higher efficiency.

The authors said that their LED could achieve a CRI rating of nearly 70-almost good enough to read by.

Progress in this area promises further reduction in the price of organic LEDs.

The study has been published in the latest issue of Journal of Applied Physics, published by the American Institute of Physics (AIP). (ANI)

Filed Under: Entertainment News Tagged With: , , , , , , , , , , , , , , , , , , , , ,