COMUNICADO: European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic

 
Consulta el estado del tiempo
Consulte el estado del Tráfico y del Tiempo para estos días >>
Consulta el estado del tráfico

COMUNICADO: European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic

Publicado 31/10/2016 8:02:01CET

Avelumab (also known as MSB0010718C) is an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to potentially engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab. In the JAVELIN Merkel 200 trial, treatment-related adverse events (AEs) occurred in 62 (70%) of 88 patients including fatigue and infusion-related reactions. Five grade 3 treatment-related AEs were reported in four of 88 patients and include two patients with lymphopenia and three patients with isolated laboratory abnormalities (elevated blood creatine phosphokinase, blood cholesterol, and hepatic aminotransferase).[1] There were no grade 4 treatment-related AEs or deaths related to treatment.[1] No patients in the trial discontinued treatment with avelumab permanently due to AEs; however, AEs leading to temporary treatment discontinuation of avelumab were anemia, diarrhea, and increased ALT in one patient each.[1]

About Merck-Pfizer Alliance  

Immuno-oncology is a top priority for Merck and Pfizer. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab, as a monotherapy, as well as combination regimens, and is striving to find new ways to treat cancer.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe [http://C:\Users\MSkorups\AppData\Local\Microsoft\Windows\Temporary InternetFiles\Content.Outlook\S5S6FFFP\www.merckgroup.com\subscribe ]  to register online, change your selection or discontinue this service.

For further details and press materials about Merck in oncology please visit www.merckgroup.com/en/media/media_center_oncology.html [http://C:\Users\MSkorups\AppData\Local\Microsoft\Windows\Temporary InternetFiles\Content.Outlook\S5S6FFFP\www.merckgroup.com\en\media\media_center_oncology.html ]

About Merck  

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of EUR 12.85 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Pfizer Inc.: Working together for a healthier world[(R) ]

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines, as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at http://www.pfizer.com. [http://www.pfizer.com ] In addition, to learn more, follow us on Twitter at @Pfizer [http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fpfizer&esheet=51356409&newsitemid=20160606005771&lan=en-US&anchor=%40Pfizer&index=4&md5=e87fe5c6856741051dc884b6867e3ffa ]  and @Pfizer_News [http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fpfizer_news&esheet=51356409&newsitemid=20160606005771&lan=en-US&anchor=%40Pfizer_News&index=5&md5=cf5e63756f6ab5c12fc077e5e90068e3 ] , LinkedIn  [https://www.linkedin.com/company/pfizer ]  and like us on Facebook at Facebook.com/Pfizer [http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2FPfizer&esheet=51356409&newsitemid=20160606005771&lan=en-US&anchor=Facebook.com%2FPfizer&index=7&md5=288d5bd99c7df784e0916061c5cfd713 ] .

Pfizer Disclosure Notice  

The information contained in this release is as of October 31, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about avelumab (MSB0010718C), including a potential indication for avelumab for the treatment of metastatic Merkel cell carcinoma (the "Potential Indications"), Pfizer's and Merck's immuno-oncology alliance involving anti-PD-L1 and anti-PD-1 therapies, and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates as well as the possibility of unfavorable study results; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in other jurisdictions for the Potential Indication or whether and when drug applications may be filed in any jurisdictions for any other potential indications for avelumab, combination therapies or other product candidates; whether and when the MAA for the Potential Indication or any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of avelumab, combination therapies or other product candidates; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2015, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.


 
Your Contacts

 
Merck

 
Media 
Gangolf Schrimpf 
+49-6151-72-9591

 
Investor Relations   
+49-6151-72-3321 

Pfizer

 
Media (US) 
Sally Beatty 
+1-212-733-6566

 
Media (EU) 
Lisa O'Neill 
+44-1737-331536

 
Investor Relations 
Ryan Crowe 
+1-212-733-8160 

Photo:
http://photos.prnewswire.com/prnh/20151207/293543LOGO 

http://photos.prnewswire.com/prnh/20161028/433902LOGO

Mejora la comunicación de tu empresa con Europa Press Comunicación

Este sitio web utiliza cookies propias y de terceros, puedes ver nuestra política de cookies -
Uso de cookies