FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review

PR67604

DARMSTADT, Germany and NEW YORK, Feb. 28 /PRNewswire=KYODO JBN/ --

                            Not intended for US and UK-based media

    - Second Biologics License Application accepted by the FDA for avelumab

    - Prognosis for urothelial carcinoma is currently poor, particularly when

the disease has metastasized

    Merck and Pfizer Inc.  today announced that the US Food and Drug

Administration (FDA) has accepted for Priority Review the Biologics License

Application (BLA) for avelumab*, as a treatment for patients with locally

advanced or metastatic urothelial carcinoma (mUC) with disease progression on

or after platinum-based therapy. The BLA was submitted by EMD Serono, the

biopharmaceutical business of Merck in the US and Canada. The FDA has set a

Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2017,

for avelumab in this indication.

    "Taken together with last year's filing for metastatic Merkel cell

carcinoma, this BLA acceptance confirms our rapid and continued progress in the

clinical development of avelumab," said Luciano Rossetti, M.D., Executive Vice

President, Global Head of Research & Development at the biopharma business of

Merck. "We continue to evaluate avelumab in cancers that have limited or

suboptimal treatment choices, such as metastatic or locally advanced urothelial

carcinoma, to hopefully be able to provide patients with new treatment options

for fighting their disease."

    Despite advances in the treatment of UC, the prognosis for patients remains

poor, particularly when the disease has metastasized. Bladder cancer makes up

approximately 90% of urothelial cancers and is the sixth most common cancer in

the US.[1],[2]

    "Advanced urothelial carcinoma remains a difficult-to-treat tumor, which is

why we are developing a comprehensive clinical development program that

involves Phase I and III trials designed to address this challenge," said Chris

Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-oncology, Early

Development and Translational Oncology, Pfizer Global Product Development.

"We're continuing to accelerate our urothelial carcinoma development program

and look forward to continuing our dialogue with the FDA."

    Avelumab is an investigational, fully human anti-PD-L1 antibody. The FDA's

Priority Review status reduces the review time from 10 months to a goal of six

months from the day of filing acceptance and is given to drugs that may offer

major advances in treatment or may provide a treatment where no adequate

therapy exists. In November 2016, the FDA accepted, and granted Priority Review

status to, the BLA for avelumab for the treatment of patients with metastatic

Merkel cell carcinoma.

    The international clinical development program for avelumab, known as

JAVELIN, involves at least 30 clinical programs, including nine Phase III

trials, and more than 4,000 patients evaluated across more than 15 tumor types.

In December 2015, Merck and Pfizer announced the initiation of a Phase III

study (JAVELIN Bladder 100) of avelumab in the first-line setting as a

maintenance treatment in patients with locally advanced or metastatic UC. This

trial is currently enrolling patients.

    *Avelumab is not approved for any indication in any market. This marks the

second acceptance of an application by the FDA to review the investigational

product, avelumab.

    References

    1) National Comprehensive Cancer Network. NCCN Guidelines Version 1.2017

Updates.  Bladder Cancer. Available from:       

https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Last

Accessed:       February 2017.

     2) Siegel RL, et al. Cancer Statistics, 2017. CA Cancer J Clin

2017;67:7-30. Available from: https://www.ncbi.nlm.nih.gov/pubmed/28055103.

Last Accessed: February 2017.

     3) American Cancer Society. Key Statistics for Bladder Cancer. Available

from:  https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html.

Last Accessed: February 2017.

    About Metastatic Urothelial Carcinoma

    Urothelial Carcinoma includes several tumors originating from the cells

lining the bladder, renal pelvis and urethra. While cancers outside of the

bladder are relatively uncommon, accounting for an estimated 10% of cases,

bladder cancer represents 90% of urothelial cancers and is the ninth most

common cancer globally.[1],[3] Worldwide, approximately 400,000 new cases of

bladder cancer are diagnosed and 150,000 deaths are attributed to this disease

each year.[3] The incidence and mortality of bladder cancer have remained

unchanged over the past 25 years.[3]

    About Avelumab

    Avelumab is a fully human antibody specific for a protein found on tumor

cells called PD-L1, or programmed death ligand-1. 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 and Pfizer announced

a strategic alliance to co-develop and co-commercialize avelumab. Common

adverse reactions include fatigue, musculoskeletal pain, diarrhea, nausea

peripheral edema, decreased appetite, and rash.  Immune-mediated adverse

reactions have also been reported.

    About Merck-Pfizer Alliance

    Immuno-oncology is a top priority for Merck and Pfizer Inc. 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 in combination

regimens, and is striving to find new ways to treat cancer.

    About EMD Serono, Inc.

    EMD Serono is the biopharmaceutical business of Merck in the US and Canada

- a leading science and technology company - focused exclusively on specialty

care. For more than 40 years, the business has integrated cutting-edge science,

innovative products and industry-leading patient support and access programs.

EMD Serono has deep expertise in neurology, fertility and endocrinology, as

well as a robust pipeline of potential therapies in oncology, immuno-oncology

and immunology as R&D focus areas. Today, the business has 1,200 employees

around the country with commercial, clinical and research operations based in

the company's home state of Massachusetts. http://www.emdserono.com

    All Merck Press Releases are distributed by e-mail at the same time they

become available on the Merck Website. Please go to

http://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

    http://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%2F

pfizer&esheet=51356409&newsitemid=20160606005771&lan=en-US&anchor=%40Pfizer&inde

x=4&md5=e87fe5c6856741051dc884b6867e3ffa ]  and @Pfizer_News

[http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2F

pfizer_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.c

om%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 February 28, 2017.

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 urothelial carcinoma (the "Potential Indication"), 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 and regulatory submission 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 and 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 BLA for the Potential Indication, the BLA and EU marketing

authorization application for avelumab for the treatment of metastatic Merkel

cell carcinoma or any such other 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.

[http://www.pfizer.com ]

(Logo: http://photos.prnewswire.com/prnh/20161028/433902LOGO )

(Logo: http://mma.prnewswire.com/media/472778/Merck_Logo.jpg )

Source:  Merck and Pfizer