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Ben Venue Laboratories cierra fabrica y no sirve Doxil (Jul 2011) // FDA aprueba lipodox un generico del Doxil ( Feb 2012 ) /// Marzo 2013 : Janssen Comunica que se Restablece el Suministro en EU .

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jonpi

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Aug 9 11 9:57 AM

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Ben Venue Laboratories (USA) ha experimentado dificultades en la producción que han retrasado la liberación de lotes de Caelyx al Mercado Europeo .


 

http://www.foxbusiness.com/industries/2011/07/21/jj-has-us-supply-shortage-cancer-drug-doxil/



 

21 Julio 2011 . Segun publica The Wall Street Journal .



 

Janssen consiguio los derechos mundiales de marketing para CAELYX(R) de Merck en Septiembre 2010 ... hasta esa fecha Caelyx tanto su marqueting como su comercialización en Europa dependian de Merck . Se trata del ya conocido Doxil que va combinado con Yondelis .

Janssen ha comunicado a la EMA (European Medicines Agency) la existencia de problemas de suministro de dicho medicamento que podrían provocar cortes intermitentes de suministro de Caelyx en varios países de la Unión Europea desde agosto de este año y que en algunos casos podrían continuar de forma intermitente hasta final de año. El fabricante de Caelyx (Ben Venue Laboratories USA) ha experimentado dificultades en la producción que han retrasado la liberación de lotes de Caelyx al mercado europeo.
La EMA ha recomendado que mientras dure esta situación temporal debe darse prioridad a la continuación del tratamiento de los pacientes actualmente tratados con Caelyx respecto al inicio del tratamiento de nuevos pacientes, debiendo en este último caso los oncólogos discutir con sus pacientes las opciones disponibles.

Por su parte, Janssen Cilag ha subrayado que está poniendo "todos sus esfuerzos" en administrar de la "manera más eficaz" las existencias disponibles y está en proceso de "restablecer sus operaciones".

...

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celtia

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Aug 9 11 10:43 AM


hola, neng.

es que ni una sola alegria, coño¡¡¡...


09/08/2011

  • 18:41   ZELTIA, S.A. Otros sobre negocio y situación financiera
    • Hecho relevante de ZELTIA, S.A.16 KB
    •   Janssen Cilag ha comunicado a la EMA que temporalmente podrían producirse cortes intermitentes de suministro de Caelyx. En cáncer de ovario la comercialización de Yondelis está autorizada actualmente en UE en combinación con Caelyx.

 

 

 

 

 

Comisión Nacional del Mercado de Valores

Att. Director del Área de Mercados

C/ Miguel Ángel 11, 1º

28010 Madrid

Madrid, a 9 de agosto de 2011

De conformidad con lo previsto en el artículo 82 de la Ley del Mercado de Valores, por la

presente se procede a comunicar el siguiente HECHO RELEVANTE:

“Según ha informado Pharma Mar, S.A., Janssen Cilag (filial de Johnson&Johnson que

comercializa Caelyx –doxorubicina liposomal pegilada, PLD- en Europa) ha comunicado a la

EMA (European Medicines Agency) la existencia de problemas de suministro de dicho

medicamento que podrían provocar cortes intermitentes de suministro de Caelyx en varios países

de la Unión Europea desde agosto de este año y que en algunos casos podrían continuar de

forma intermitente hasta final de año. El fabricante de Caelyx (Ben Venue Laboratories USA) ha

experimentado dificultades en la producción que han retrasado la liberación de lotes de Caelyx al

mercado europeo.

La EMA ha recomendado que mientras dure esta situación temporal debe darse prioridad a la

continuación del tratamiento de los pacientes actualmente tratados con Caelyx respecto al inicio

del tratamiento de nuevos pacientes, debiendo en este último caso los oncólogos discutir con sus

pacientes las opciones disponibles.

Según se ha anunciado, la EMA y Janssen Cilag están trabajando estrechamente para garantizar

que el normal suministro de Caelyx se reestablezca en el más corto plazo posible.

En la indicación de cáncer de ovario recurrente platino-sensible la comercialización de Yondelis

está autorizada actualmente en combinación con Caelyx en la Unión Europea desde finales de

2009. Janssen Cilag ha indicado que está poniendo todos sus esfuerzos en administrar de la

manera más eficaz el stock disponible de Caelyx y que dicho fabricante está en proceso de

reestablecer sus operaciones.”
ZELTIA, S.A.

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jonpi

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Feb 21 12 6:18 AM

Saludos .

USA Today : La FDA ha encontrado en la India un Farmaco para Substituir al DOXIL Temporalmente ... el LipoDOX .

Replacement found for cancer drug Doxil, in short supply .
 
http://yourlife.usatoday.com/health/story/2012-02-20/New-source-found-for-cancer-drug-Doxil-in-short-supply/53181806/1

Patients with ovarian cancer and other deadly tumors will regain access to an important chemotherapy drug, Food and Drug Administration officials told USA TODAY in an exclusive interview Monday.

The drug, Doxil, has been in short supply since last June. There are no generic versions of the drug, which is also used to treat multiple myeloma and AIDS-related Kaposi's sarcoma.

The agency says it will announce today that it has worked out a deal to temporarily import a replacement drug, called Lipodox, from an Indian company, says the FDA's Sandra Kweder. The FDA has previously inspected the company, Sun Pharma Global, which exports the drug to other companies.

"It's wonderful news," says Kweder, who says the deal will address the Doxil shortage "for the forseeable future."

Doxil is one of 287 drugs that have been in short supply this year, says the University of Utah's Drug Information Service, which has been monitoring the problem. That's up from 61 shortages in 2005, the FDA says.

The FDA announced last week that it had averted a much-feared shortage of a cancer drug called methotrexate. Preservative-free versions of that drug are used to treat children with acute lymphoblastic leukemia, or ALL. Because there are no substitutes, many doctors and patients were worried about a shortage after manufacturer Ben Venue Laboratories suddenly shut down its plant last November. Kweder says the FDA was able to avert that shortage by asking other makers of generic drugs to ramp up production. In a statement, Ben Venue said it will release a small amount of methotrexate from its inventory at the Ohio plant.

Laura Bredesen of Minneapolis, whose son Ben, 4, is being treated for ALL, says she's grateful he was able to get methotrexate last week. But, she says, she won't feel at ease until the next dose is "in the hospital's hands."

Given the growing number of drug shortages, Kweder acknowledges that "our work isn't done," and says the drug industry needs to make broader changes to halt this cycle. Because makers of generic drugs operate on thin profit margins, they often have no backup facilities to take over if one production line breaks down.

"The real solution is a shift in the industry to assuring good manufacturing practices … to prevent finding themselves in a critical juncture where they have no choice but to shut down."

In some cases, when plants close, "the things they shut down to fix are not new," Kweder says. "They've been trying to patch things together for some time."

salut .

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jonpi

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Feb 26 12 7:21 AM

Zeltia. La FDA aprueba temporalmente sustituto de Doxil/Caelyx
 
Valoración
  Jueves, 23 de Febrero del 2012 - 10:53:12
 



Desde el pasado mes de diciembre quedó interrumpido a nivel mundial el suministro de Caelyx (fármaco que se administra en combinación con Yondelis para el tratamiento del cáncer de ovario) después de que la FDA encontrase ciertas irregularidades en las plantas del fabricante de este fármaco, Ben Venue Laboratories.



La falta de suministro y las implicaciones que ello conlleva ha llevado a la FDA a buscar una solución alternativa, autorizando temporalmente la importación de Lipodox, fabricado por la hindú Sun Pharma y distribuido por Caraco Pharmaceutical, que empezará a suministrarse en las próximas semanas.

 

Valoración Ahorro Corporación: Noticia positiva para Zeltia, que podría ver solucionado la falta de Doxil/Caelyx en todos aquellos países FDA followers. En el caso de Europa, esperamos que la EMA siga un procedimiento similar al de la FDA, a pesar de que Doxorubicin SUN no fue aprobado por el organismo en 2011 para el tratamiento del cáncer de ovario en dosis de 50mg.

 

En cualquier caso, en el mismo procedimiento se incluía un ensayo con 30mg que dio resultados similares a los obtenidos con Caelyx, y en el fallo del comité se indicaba que Doxorubicin SUN no se autorizaba el uso con 50mn, pero podría ser utilizado en dosis inferiores para el tratamiento tanto del cáncer de ovario como de pecho y, en el tratamiento con Yondelis, Caelyx se utiliza en infusión de 30mg, lo que justificaría su aprobación temporal.

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jonpi

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Apr 12 12 8:08 AM

J&J Cree Posible que en Septiembre vuelva a Fabricarse el DOXIL . ( Bloomberg ) .


J&J Working to Boost Supply of Cancer Drug Doxil by September

Johnson & Johnson (JNJ) said it’s exploring ways to resume making the cancer medicine Doxil by September after a production shutdown at a supplier last year contributed to a shortage.

Boehringer Ingelheim GmbH (BING)’s Ben Venue Laboratories factory in Ohio stopped production in November after regulators questioned the product quality. Ben Venue said it may resume operations by the end of 2012. J&J plans to transfer the manufacturing to another supplier, said Lisa Vaga, a spokeswoman for the New Brunswick, New Jersey-based company.

J&J, the world’s second-largest seller of health-care products after Pfizer Inc., may be able to boost its supplies of the drug sooner by having Ben Venue formulate the medication, then transfer it to another company for the filling and packaging of the product, Vaga said in a telephone interview.

“We anticipate health authority approval would be in the September time frame, with limited amount of Doxil available shortly thereafter,” she said.

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jonpi

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Mar 12 13 11:51 PM

Comisión Nacional del Mercado de Valores .

 

Madrid, a 12 de marzo de 2013 .

 

De conformidad con lo previsto en el artículo 82 de la Ley del Mercado de Valores, por la

presente se procede a comunicar el siguiente HECHO RELEVANTE:

 

“Según ha comunicado Pharma Mar, S.A., Janssen Cilag, filial de Johnson&Johnson, le ha

informado que Caelyx –doxorubina liposomal pegilada, PLD- ya está disponible en Europa para

las pacientes de cáncer de ovario bajo el sistema “Managed Access”.

 

En la indicación de cáncer de ovario recurrente platino-sensible la comercialización de Yondelis

está autorizada actualmente en combinación con Caelyx en la Unión Europea desde finales de
2009”.

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jonpi

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Apr 27 13 12:07 AM

bon dia .


El próximo lunes

Sanidad informa del restablecimiento del suministro normal del antitumoral 'Caelyx'

Europa Press , viernes, 26 de abril de 2013, 16:08
MADRID, 26 (EUROPA PRESS)

http://www.lavozlibre.com/noticias/ampliar/748232/sanidad-informa-del-restablecimiento-del-suministro-normal-del-antitumoral-caelyx

La Agencia Española de Medicamentos y Productos Sanitarios, dependiente del Ministerio de Sanidad, ha informado del restablecimiento el próximo lunes del suministro normal del antitumoral doxorubicina liposomal pegilada, comercializado por Janssen Cilag como 'Caelyx', indicado para el tratamiento del cáncer de mama metastásico, del cáncer de ovario avanzado, del sarcoma de Kaposi asociado a sida y del mieloma múltiple.
El suministro normal del medicamento quedó interrumpido a nivel mundial a finales de diciembre de 2011 como consecuencia de problemas surgidos con el fabricante (Ben Venue Laboratories, EEUU). Desde entonces, la disponibilidad en España de 'Caelyx' ha sido limitada a aquellos pacientes que más se pudieran beneficiar del mismo por su eficacia y por la ausencia de alternativas.

Desde este lunes el suministro de 'Caelyx' se hará por los canales habituales, "quedando suspendido el plan de distribución y acceso controlado a través de la aplicación informática de medicamentos en situaciones especiales", plicado por la AEMPS, en colaboración con el titular de la autorización de comercialización.
Igualmente queda suspendida la importación de 'Lipodox' 2mg/ml con la que se han cubierto las necesidades de aquellos pacientes que, cumpliendo con los criterios previamente establecidos, no han podido ser cubiertos por el programa de acceso restringido para 'Caelyx'.

salut

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jonpi

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May 3 13 9:21 AM

29 Abr. 2013
Total disponibilidad de Yondelis en combinación con Caelyx para cáncer de ovario

Janssen Products (antes denominada Centocor Ortho Biotech Products) ha informado a Pharma Mar (Grupo Zeltia) del total reestablecimiento de Caelyx (doxorrubicina liposomal pegilada) en el Espacio Económico Europeo (EEE) y Suiza. Este fármaco se comercializa en combinación con Yondelis para el tratamiento del cáncer de ovario recurrente platino-sensible (COR).

En agosto 2011 PharmaMar fue informado por parte de Janssen Products que había comunicado a la EMA (European Medicines Agency) la existencia de problemas de suministro de dicho medicamento que podrían provocar cortes intermitentes de suministro de Caelyx en varios países del EEE y Suiza. El responsable de la fabricación de la tercera parte del total de la producción de Caelyx experimentó dificultades en la producción del fármaco que retrasó la liberación de lotes de Caelyx al mercado europeo.

Con esta noticia PharmaMar volverá a partir de ahora a generar ventas en cáncer de ovario.
Según el acuerdo de licencia entre PharmaMar y Janssen Products, PharmaMar tiene los derechos para comercializar Yondelis en Europa (incluida Europa del Este), mientras que Janssen Products, tiene los derechos para comercializar Yondelis en el resto del mundo, salvo Japón, país en el que Pharma Mar (Grupo Zeltia) y Taiho Pharmaceutical, mantienen un acuerdo de licencia para el desarrollo y comercialización de Yondelis.

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jonpi

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Oct 6 13 6:38 AM

http://www.crainscleveland.com/article/20131006/SUB1/310069992

Ben Venue closing adds to Doxil concerns
Shuttering of Bedford lab increases questions about future of popular cancer drug
By CHUCK SODER
4:30 am, October 6, 2013

It may be a while before ovarian cancer patients here and around the world have the option of being treated with Doxil.




Ben Venue Laboratories — the only company in the world that has been approved to make the popular cancer drug — announced last week it would shut down all production by the end of the year. It will lay off all its 1,100 employees in Bedford, starting this month and continuing into 2014.


Doxil's owner, Johnson & Johnson, already was predicting it would run out of the drug at some point this month because of manufacturing problems at the 75-year-old injectable drug maker, the largest employer in Bedford. Johnson & Johnson filed a lawsuit against Ben Venue in early September, saying the Bedford company breached its contract to make the drug.

The announcement that Ben Venue will cease production doesn't bode well for the future supply of Doxil.

Since 2011 — when Ben Venue announced that it temporarily would stop all manufacturing after inspections by domestic and foreign regulators identified dozens of quality-control issues at the Bedford complex — Johnson & Johnson has been saying it is working to move Doxil production to another company. That process takes time, though, because the manufacturing process is complex and highly regulated.

Officials from a few local hospitals said they are concerned about a shortage of Doxil. However, this shortage should be easier to handle than the previous Doxil shortage that occurred after Ben Venue temporarily stopped production two years ago.

Back then, there was no substitute for Doxil, so the U.S. Food and Drug Administration eventually started letting doctors use an imported drug that hadn't gone through the FDA's formal approval process.

In February 2013, the agency approved a generic version of Doxil. Officials from local hospitals said they still use the brand-name drug, but they also use the generic form, which should help them navigate the latest Doxil shortage.

Even so, they're not getting too comfortable. For instance, the MetroHealth System bought “a fair amount of Doxil” in late September, when Johnson & Johnson announced that it anticipated a shortage, said Jan Cover, pharmacy specialist for oncology at MetroHealth.

Even though there is a generic available, Ms. Cover said she's worried about whether there will be enough of the generic to go around as the supply of Doxil decreases and more doctors turn to the substitute drug.

“Once the supply of one goes down, it greatly impacts the amount available of the next agent,” she said.

Reducing the sting

The generic is made by Sun Pharmaceutical Industries Ltd. of Mumbai. Sun Pharma spokeswoman Mira Desai wouldn't say last Friday, Oct. 4, how much of the drug the company can produce. However, she noted the company has had time to prepare for the Doxil shortage, given how long Ben Venue has had issues producing it.

Sun Pharma makes both the generic version of Doxil and Lipodox, the branded Doxil substitute that was able to skip the FDA's formal approval process. The company employs 14,000 people and produces drugs at 20 manufacturing sites, according to Sun Pharma's website.

The plant that makes the Doxil generic “is one of the largest injectable drug plants in Asia,” Ms. Desai said.

The availability of a generic takes a lot of the sting out of the Doxil shortage, according to Steven Waggoner, division chief of gynecological oncology at University Hospitals Case Medical Center.

Even so, UH still uses a lot of Doxil. If an ovarian cancer patient at UH still needs treatment after undergoing surgery and chemotherapy with a different drug, they'll almost always go on Doxil, Lipodox or the generic drug.

Most of them go on Doxil, Dr. Waggoner said. Although the other drugs “are probably just as good,” UH doesn't want to tell patients they no longer can receive the popular product, especially if they're already being treated with it, he said.

“The last thing we want to do is cause added distress or emotional concern for the patient,” Dr. Waggoner said.

UH convened a committee to assess the shortage and determined it has a two-month supply of Doxil and its substitutes, Dr. Waggoner said. He “won't lose sleep” over it, adding that he's more concerned about a broader trend: Drug shortages are becoming “all too common,” he said.

That's why Chris Snyder's title at the Cleveland Clinic is “drug shortage pharmacist.”

Mr. Snyder said the Clinic did use Lipodox and now is using the generic Doxil, as well as the branded version. The generic costs a lot less than Doxil, but the Clinic still uses the name-brand drug because it can get it at a discount by negotiating, said Scott Knoer, chief pharmacy officer at the Cleveland Clinic.

Mr. Knoer said “there's always a risk” when the supply of one drug runs low, even if a substitute is available. However, now that there is a substitute, the Doxil shortage should be manageable, he said.

“If we got really concerned about every drug, we would never sleep,” he said.

Sustainability issues

As for Ben Venue, the company faces “systemic manufacturing challenges” and “cannot return to sustainable production,” according to a written statement from the company.

Ben Venue estimates the company would incur about $700 million in operating losses over the next five years if it were to fix its problems and keep making drugs at its Bedford complex. The company cited the age of its manufacturing operations — the company moved to Bedford in 1941, though it has added new facilities since then — as well as other remediation costs it would face for contributing to its decision to close the plant.

In 2011, the FDA filed two reports identifying 59 quality control issues at the plant. For instance, at the time, the agency said Ben Venue had failed either to figure out why metallic particles ended up in several batches of two drugs made at the plant or to fix the problem, which generated nine customer complaints between August 2006 and February 2010.

Despite the pending shutdown, the Ben Venue statement said the company “will work to help ensure that these critical medicines continue to reach the patients who need them.”

The written statement indicated that Ben Venue's parent company, Boehringer Ingelheim of Germany, recognizes the importance of Ben Venue's generic drug manufacturing division, which does business as Bedford Laboratories. The parent company “is exploring strategic options to try to continue the supply of these products to patients,” the statement said.

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