KTE-C19 Commercial Readiness Planning Underway
SANTA MONICA, Calif., Feb. 24, 2016 (GLOBE NEWSWIRE) -- Kite Pharma, Inc.
(Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on
developing engineered autologous cell therapy (eACT™) products for the
treatment of cancer, today announced the formation of the company's
integrated commercial leadership team with the appointment of three
senior-level industry executives. The team will be responsible for all
aspects of commercial and medical affairs strategy, planning, and
analysis for the potential launch of KTE-C19, an investigational
engineered T cell therapy for patients with relapsed and/or refractory B
cell malignancies.
The new commercial and medical affairs leadership team includes Diane L. Parks, Senior Vice President, Marketing, Sales & Market Research; Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs; and Kimberly A. Metcalf, Vice President, Customer Engagement, Training & Development. The group will report to Shawn Tomasello, Kite's Chief Commercial Officer. Dr. Faust will also report to Jeff Wiezorek, M.D., M.S., Senior Vice President of Clinical Development.
"Commercial readiness is a top priority for Kite as we prepare for pivotal data from the ZUMA-1 study and potential U.S. regulatory filing for KTE-C19 this year," said Arie Belldegrun,
M.D., FACS, Chairman, President, and Chief Executive
Officer. "Such a potentially transformative therapy as KTE-C19 will
require a creative and strategic commercialization model to optimize
access and impact for patients. We believe this proven and accomplished
team, under the direction of Shawn Tomasello, can deliver on this promise."
"It is a privilege to welcome Diane, Elizabeth, and Kimberly to Kite," said Shawn Tomasello,
Chief Commercial Officer. "As a group, they bring the range of critical
skills and proven capabilities needed to prepare for commercialization.
They have been closely involved in the launch of several major oncology
therapies, and they understand how markets are reshaped by therapeutic
innovations that improve patient outcomes. Our team is already fully
engaged in market analysis and strategy development activities."
Diane L. Parks, Senior
Vice President, Marketing, Sales & Market Research
Ms. Parks joins Kite from Pharmacyclics, where she was Vice President of Marketing. During her tenure at Pharmacyclics, Ms. Parks
led the development and execution of all global marketing strategies
for IMBRUVICA®. Previously, she held senior leadership roles as Vice
President of Sales for Amgen, representing oncology and nephrology
products, and Senior Vice President of Specialty Biotherapeutics and
Managed Care at Genentech, where she led the launches of multiple products as well as commercial development of LUCENTIS® and RITUXAN®. Ms. Parks began her career at Marion Merrell
Dow. She holds a BS from Kansas State University and an MBA from Georgia State University.
Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs
Prior to joining Kite, Dr. Faust was Vice President of Medical Affairs at Pharmacyclics, during which time she planned and successfully executed four IMBRUVICA® launches for various indications. Before Pharmacyclics, Dr. Faust was Vice President of Clinical Sciences Research
at Celgene Corporation, serving as the national lead for oncology
Regional Medical Liaisons in the US, and as Senior Director of Medical
Affairs at
Gloucester Pharmaceuticals, which was acquired by Celgene in 2010. From 1995 to 2007, Dr. Faust
held roles of increasing responsibility in research, development, and
medical affairs at Amgen, including Executive Director, Oncology
Regional Medical Liaisons. Dr. Faust has co-authored numerous publications and was the former President-Elect for the Pacific Southwest Chapter of the American Medical Writers Association. She holds a BS in microbiology from Auburn University, a MA in biology from University of California Riverside, and a PhD in microbiology and molecular genetics from University of California Los Angeles.
Kimberly A. Metcalf, Vice
President, Customer Engagement, Training & Development
Ms. Metcalf most recently served as Vice President of Commercial Training and Administration at Pharmacyclics,
where she was responsible for developing and executing commercial and
medical affairs training including launch plans for IMBRUVICA®.
Previously, she spent eight years at Celgene Corporation where she
contributed significantly to building the commercial training department
and assumed roles of increasing responsibility in commercial training,
market access, and sales and marketing operations, including Executive
Director, US National and Regional Accounts. During her tenure at
Celgene, she launched POMALYST®, ISTODAX® and OTEZLA®. Ms. Metcalf began her career in biopharma at Pfizer. She holds a BS
from Northwestern University, an MBA from West Chester University, and a Master of Health Systems from The University of Medicine & Dentistry of New Jersey.
About Kite Pharma
Kite Pharma, Inc.,
is a clinical-stage biopharmaceutical company engaged in the
development of novel cancer immunotherapy products, with a primary focus
on engineered autologous cell therapy (eACT™) designed to restore the
immune system's ability to recognize and eradicate tumors. Kite is based
in Santa Monica, CA. For more information on Kite
Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
About KTE-C19
KTE-C19
is an investigational therapy in which a patient's T cells are
genetically
modified to express a CAR designed to target the antigen CD19, a protein
expressed on the cell surface of B cell lymphomas and leukemias. Kite
is currently enrolling four pivotal studies (also known as ZUMA studies)
for KTE-C19 in patients with various B cell malignancies. The U.S. Food and Drug Administration
has granted Breakthrough Therapy Designation status to KTE-C19, for the
treatment of patients with refractory diffuse large B cell lymphoma,
primary mediastinal B cell lymphoma, and transformed follicular
lymphoma. KTE-C19 has also secured Orphan Drug Designation in the U.S. for DLBCL and in the EU for various hematological indications.
About Kite's ZUMA Clinical Programs
Study | Phase | Indication | Status |
ZUMA-1NCT02348216 | Phase 2 Pivotal
(N=112) | Refractory DLBCL, PMBCL, TFL | Phase 2 enrolling |
ZUMA-2NCT02601313 | Phase 2 Pivotal (N=70) | Relapsed/refractory MCL | Phase 2 enrolling |
ZUMA-3NCT02614066 | Phase 1/2 Pivotal (N=75) | Relapsed/refractory Adult ALL | Phase 1/2 enrolling |
ZUMA-4NCT02625480 | Phase 1/2 Pivotal (N=75) | Relapsed/refractory Pediatric ALL | Phase 1/2 enrolling |
DLBCL = diffuse large B cell lymphoma |
PMBCL = primary mediastinal B cell lymphoma |
TFL = transformed follicular lymphoma |
MCL = mantle cell lymphoma |
ALL = acute lymphoblastic leukemia |
Cautionary Note on Forward-Looking Statements
This
press release contains forward-looking statements for purposes of the
safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. We may, in some cases, use terms such as "predicts,"
"believes,"
"potential," "proposed," "continue," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will," "should"
or other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Forward-looking statements
include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: the ability to advance multiple clinical trials of KTE-C19, to
obtain regulatory approval based on the studies of KTE-C19 and to
commercialize KTE-C19. Various factors may cause differences between
Kite's expectations and actual results as discussed in greater detail in
Kite's filings with the Securities and Exchange Commission, including without limitation in Kite's Current Report on Form 8-K filed with the SEC on December 22, 2015.
Any
forward-looking statements that we make in this press release speak only
as of the date of this press release. We assume no obligation to update
our forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press release.
CONTACT: Greg Mann
VP, Investor Relations
gmann@kitepharma.com
For Media: Justin JacksonBurns McClellan
(212) 213-0006
jjackson@burnsmc.com
Source: Kite Pharma, Inc.
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