Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced that a Biologics License
Application (BLA) for inotuzumab ozogamicin has been accepted for filing
and granted Priority Review by the U.S. Food and Drug Administration
(FDA). Inotuzumab ozogamicin is being evaluated for the treatment of
adult patients with relapsed or refractory B-cell precursor acute
lymphoblastic leukemia (ALL).

Inotuzumab ozogamicin received Breakthrough Therapy designation from the
FDA in October 2015 for ALL. Priority Review status accelerates FDA
review time from 10 months to a goal of six months from the day of
acceptance of filing, and is given to drugs that may offer major
advances in treatment or may provide a treatment for which no adequate
therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for
a decision by the FDA is in August 2017.

“ALL that has recurred after, or is refractory to, first-line therapy is
a rapidly progressing and deadly disease,” said Mace Rothenberg, MD,
chief development officer, Oncology, Pfizer Global Product Development.
“Based on the positive results of the INO-VATE 1022 Phase 3 trial, we
believe inotuzumab ozogamicin, if approved, represents a new treatment
option for adult patients with relapsed or refractory B-cell precursor
ALL.”

In addition, a Marketing Authorization Application (MAA) for inotuzumab
ozogamicin in the same patient population is currently under review by
the European Medicines Agency (EMA).

The submissions are based on results from the Phase 3 INO-VATE 1022
trial, which enrolled 326 adult patients with relapsed or refractory
B-cell ALL and compared inotuzumab ozogamicin to standard of care
chemotherapy. The INO-VATE 1022 study had two independent primary
endpoints, complete response with or without hematologic remission
(CR/CRi) and overall survival (OS). Results from the trial were
published in The New England Journal of Medicine in June 2016.

About Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia
with a poor prognosis in adults.¹ The current foundational
treatment is intensive, long-term chemotherapy.² In 2017, it
is estimated that 5,970 cases of ALL will be diagnosed in the United
States, with about 2 in 5 cases occurring in adults.³
Approximately 20 to 40 percent of newly diagnosed adults with ALL are
cured with current treatment regimens.⁴ For patients with
relapsed or refractory adult ALL, the five-year overall survival rate is
less than 10 percent.⁵

About Inotuzumab Ozogamicin

Inotuzumab ozogamicin is an investigational antibody-drug conjugate
(ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell
surface antigen expressed on approximately 90 percent of B-cell
malignancies, linked to a cytotoxic agent.⁶ When
inotuzumab ozogamicin binds to the CD22 antigen on B-cells, it is
internalized into the cell, where the cytotoxic agent calicheamicin is
released to destroy the cell.⁷ The most common adverse events
(AEs) observed in clinical trials for inotuzumab ozogamicin were
cytopenias, including febrile neutropenia. Common nonhematologic
treatment-emergent AEs with inotuzumab ozogamicin included nausea,
headache and pyrexia. Additionally, veno-occlusive liver disease (VOD)
was observed more frequently in patients treated with inotuzumab
ozogamicin, especially those who went on to receive hematopoietic stem
cell transplantation.

Inotuzumab ozogamicin originates from a collaboration between Pfizer and
Celltech, now UCB. Pfizer has sole responsibility for all manufacturing
and clinical development activities for this molecule.

About Pfizer Oncology

Pfizer Oncology is committed to pursuing innovative treatments that have
a meaningful impact on those living with cancer. As a leader in oncology
speeding cures and accessible breakthrough medicines to patients, Pfizer
Oncology is helping to redefine life with cancer. Our strong pipeline of
biologics, small molecules and immunotherapies, one of the most robust
in the industry, is studied with precise focus on identifying and
translating the best scientific breakthroughs into clinical application
for patients across a wide range of cancers. By working collaboratively
with academic institutions, individual researchers, cooperative research
groups, governments and licensing partners, Pfizer Oncology strives to
cure or control cancer with its breakthrough medicines. Because Pfizer
Oncology knows that success in oncology is not measured solely by the
medicines you manufacture, but rather by the meaningful partnerships you
make to have a more positive impact on people’s lives.

Pfizer Inc.: Working together for a healthier world^®

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. For more information, please visit us at www.pfizer.com.
In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn,
YouTube,
and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release
is as of February 21, 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 inotuzumab
ozogamicin, an investigational oncology therapy, including its 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 trial commencement
and completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including unfavorable
new clinical data and additional analyses of existing clinical data;
whether and when applications for inotuzumab ozogamicin may be filed in
any other jurisdictions; whether and when the BLA, MAA and any other
such applications for inotuzumab ozogamicin may be approved by the FDA,
the EMA or other regulatory authorities, respectively, 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 inotuzumab ozogamicin; 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 www.sec.gov
and www.pfizer.com.

_______________________

¹ National Cancer Institute: Adult Acute Lymphoblastic
Leukemia Treatment (PDQ®) – General Information About Adult Acute
Lymphoblastic Leukemia (ALL). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1.
Accessed March 21, 2016.
² American Cancer Society:
Typical treatment of acute lymphocytic leukemia. Available at: http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment.
Accessed March 21, 2016.
³ American Cancer Society: What
are the key statistics about acute lymphocytic leukemia? Available at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics
. Accessed January 26, 2017.
⁴ Manal Basyouni A. et al.
Prognostic significance of survivin and tumor necrosis factor-alpha in
adult acute lymphoblastic leukemia.
doi:10.1016/j.clinbiochem.2011.08.1147.
⁵ Fielding A. et
al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia
(ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950.
⁶
Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in
Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical
Cancer Research. 2004; 10: 5327-5334.
⁷ DiJoseph JF.
Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin),
a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and
Rituximab against Non-Hodgkin’s B-Cell Lymphoma. Clin Cancer Res.
2006; 12: 242-250.

Image may be NSFW.
Clik here to view.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170221005530/en/