Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the Treatment of Indolent Non-Hodgkin’s Lymphoma

  Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the
  Treatment of Indolent Non-Hodgkin’s Lymphoma

   -- Idelalisib Would Be First PI3K Delta Targeted Therapy Approved for a
Hematological Cancer and First New Class of Therapy Approved for iNHL in More
                               Than a Decade --

Business Wire

FOSTER CITY, Calif. -- September 11, 2013

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for approval of idelalisib, an investigational, targeted,
oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin’s
lymphoma (iNHL). The data submitted in this NDA support the use of idelalisib
for patients with iNHL that is refractory (non-responsive) to rituximab and to
alkylating-agent-containing chemotherapy.

Indolent non-Hodgkin’s lymphoma refers to a group of largely incurable
slow-growing lymphomas that run a relapsing course after therapy and lead
ultimately to life-threatening complications such as serious infections and
marrow failure. Most iNHL patients are diagnosed at an advanced stage of
disease, and median survival from time of initial diagnosis for patients with
the most common form of iNHL, follicular lymphoma, is 8 to 10 years. The
outlook for refractory iNHL patients is significantly poorer.

“Gilead is committed to advancing a pipeline of novel cancer therapies that
have the potential to improve the lives of patients,” said John C. Martin,
PhD, Chairman and Chief Executive Officer of Gilead Sciences. “Based on the
rate and duration of response observed to date in this highly refractory iNHL
patient population, we believe idelalisib could become an important new
therapy for patients who have limited treatment options.”

Gilead’s NDA for idelalisib is supported by data from a single-arm, open-label
Phase 2 study (Study 101-09) of 125 patients with iNHL refractory to rituximab
and to alkylating-agent-containing chemotherapy. In an interim data analysis
presented in June at the International Conference on Malignant Lymphoma in
Lugano, Switzerland, single-agent idelalisib achieved an overall response rate
of 53.6 percent, with a median duration of response of 11.9 months. Median
progression-free survival for all patients was 11.4 months. 89 percent of
patients experienced lymph node shrinkage. The most common Grade ≥3 adverse
events or laboratory abnormalities were diarrhea (10 percent), transaminase
elevations (measure of liver function, 13 percent) and neutropenia (26
percent).

Updated results from this study were included in the NDA filing and have also
been submitted for presentation at an upcoming scientific conference. Gilead
plans to file for regulatory approval of idelalisib in the European Union in
the fourth quarter of this year.

About Idelalisib

Idelalisib is an investigational, targeted, highly selective oral inhibitor of
phosphoinositide 3-kinase (PI3K) delta, a protein that is critical for the
activation, proliferation and survival of B lymphocytes. PI3K delta signaling
is hyperactive in many B-cell leukemias and lymphomas and drives
proliferation, survival and trafficking to lymphoid tissue. Idelalisib is
being developed both as a single agent and in combination with approved and
investigational therapies.

In addition to the Phase 2 iNHL study, Gilead’s clinical development program
for idelalisib includes two Phase 3 studies of idelalisib in combination with
approved therapies for patients with previously treated iNHL and three Phase 3
studies evaluating the drug in combination with approved therapies for
patients with previously treated chronic lymphocytic leukemia (CLL).
Combination therapy with idelalisib and GS-9973, Gilead’s novel spleen
tyrosine kinase (Syk) inhibitor, also is being evaluated in a Phase 2 trial of
patients with relapsed or refractory CLL, iNHL and other lymphoid and
hematological malignancies.

Additional information about clinical studies of idelalisib and Gilead’s other
investigational cancer agents can be found atwww.clinicaltrials.gov.
Idelalisib and GS-9973 are investigational products and their safety and
efficacy have not yet been established.

AboutGilead Sciences

Gilead Sciencesis a biopharmaceutical company that discovers, develops and
commercializes innovative therapeutics in areas of unmet medical need. The
company’s mission is to advance the care of patients suffering from
life-threatening diseases worldwide. Headquartered inFoster City, California,
Gilead has operations inNorth America,EuropeandAsia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that are subject to
risks, uncertainties and other factors, including the risk that Gilead will be
unable to file for regulatory approval in the European Union in the
anticipated timeline. In addition, the FDA and other regulatory agencies may
not approve idelalisib, and any marketing approvals, if granted, may have
significant limitations on their use. Additionally, clinical trials involving
idelalisib, including in combination with GS-9973 or other product candidates,
may produce unfavorable results. As a result, idelalisib may never be
successfully commercialized. Further, Gilead may make a strategic decision to
discontinue development of idelalisib if, for example, Gilead believes
commercialization will be difficult relative to other opportunities in its
pipeline. These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter endedJune 30, 2013, as filed
with theU.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead, and Gilead
assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at
www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead
Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact:

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Investors
or
Nathan Kaiser, 650-522-1853
Media
 
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