LUGANO, Switzerland and
SAN DIEGO, Jan. 11, 2018 /PRNewswire/ -- Helsinn, a Swiss
pharmaceutical group focused on building quality cancer care
products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company
focused on the clinical development of novel therapies for cancer,
today announced that the European Medicines Agency (EMA) has
granted Orphan Drug Designation to pracinostat, an investigational
drug candidate currently in a Phase 3 study in combination with
azacitidine for the treatment of acute myeloid leukemia (AML) in
adult patients unfit to induction chemotherapy.
The orphan drug designation is based on the scarcity of
treatments for patients suffering from AML and on positive Phase 2
study results (see below) that were presented at the American
Society of Hematology (ASH) Annual Meeting, in December 2016.
The EMA orphan drug designation is a status assigned to a
medicine intended for use against a rare condition in the European
Union (prevalence of the condition in the European Union must not
be more than 5 in 10,000). The designation allows pharmaceutical
companies to benefit from incentives offered by the EU to develop a
medicine for the treatment, prevention or diagnosis of a disease
that is life threatening or a chronically debilitating rare
disease. These include 10 years of market exclusivity once
approved, alongside a range of other regulatory advantages.
Riccardo Braglia, Helsinn
Group Vice Chairman and CEO, commented: "Helsinn is pleased
with the decision of the EMA to grant orphan drug designation to
pracinostat. This decision encourages us to continuously dedicate
significant resources to accelerate our clinical trial program,
with a goal of helping patients who are fighting rare and
difficult-to-treat diseases, such as AML and, at present, have very
few treatment options. Following the positive Phase 2 clinical
trials of pracinostat for patients with AML, Helsinn has recently
initiated the Phase 3 program."
"This designation from the EMA recognizes the potential that
pracinostat holds in addressing a significant unmet need for those
suffering with AML," said Daniel P.
Gold, Ph.D., President and Chief Executive Officer of MEI
Pharma. "This represents another important milestone in the
global development strategy for pracinostat."
1st patient randomized in Phase 3
trial:
In August of 2017, Helsinn and MEI Pharma announced that the
first patient has been dosed in the pivotal Phase 3 study of the
investigational agent pracinostat in combination with Azacitidine
in adults with newly diagnosed acute myeloid leukemia (AML) who are
unfit to receive intensive induction chemotherapy. The primary
endpoint of the study is overall survival. Secondary endpoints
include, among others, morphologic complete remission (CR) rate,
cytogenetic complete remission and complete remission without
minimal residual disease.
Phase 2 study results for pracinostat for the treatment of
AML:
Results from a Phase 2 open-label, single-arm, multicenter study
of pracinostat and azacitidine in 50 patients aged ≥ 65 years with
newly diagnosed AML not eligible for induction chemotherapy showed
a median overall survival of 19.1 (95%CI: 10.0-26.5) months,
one-year survival of 62% and a CR rate of 42%. These results were
presented at the American Society of Hematology (ASH) Annual
Meeting in December 2016.
About AML
AML is the most common acute leukemia
affecting adults, and its incidence is expected to continue to
increase as the population ages. The American Cancer Society
estimates about 21,380 new cases and 10,590 deaths from AML in the
U.S. for 2017; the average age of a patient with AML is about 67
years. According to the Surveillance of Rare Cancers in
Europe project, the incidence of
AML in Europe is 3.7 per 100,000.
There are currently no drugs approved in the U.S. to treat AML in
patients who are unfit for intensive induction chemotherapy, though
hypomethylating agents are recommended by the National
Comprehensive Cancer Network (NCCN) guidelines. In the EU,
Azacitidine is approved for the treatment of adult patients who are
not eligible for hematopoietic stem cell transplant (HSCT) with AML
with >30% marrow blasts according to the World Health
Organization (WHO) classification, and decitabine is approved the
treatment of adult patients with newly diagnosed de novo or
secondary AML, according to the World Health Organisation (WHO)
classification, who are not candidates for standard induction
chemotherapy.
About Pracinostat
Pracinostat is an oral histone
deacetylase (HDAC) inhibitor that is in late-stage clinical
development. The U.S. Food and Drug Administration has granted
Breakthrough Therapy Designation for pracinostat in combination
with Azacitidine for the treatment of patients with newly diagnosed
AML who are ≥75 years of age or unfit for intensive chemotherapy.
In August 2016, Helsinn and MEI
Pharma entered into an exclusive license, development and
commercialization agreement for pracinostat in AML and other
potential indications. Under the terms of the agreement, Helsinn is
granted a worldwide exclusive license to develop, manufacture and
commercialize pracinostat, and is primarily responsible for funding
its global development and commercialization. Pracinostat is under
clinical investigation and has not been approved by any health
authority worldwide.
About the Helsinn Group
Helsinn is a privately owned
pharmaceutical group with an extensive portfolio of marketed cancer
care products and a robust drug development pipeline. Since 1976,
Helsinn has been improving the everyday lives of patients, guided
by core family values of respect, integrity and quality. The Group
works across pharmaceuticals, biotechnology, medical devices and
nutritional supplements and has expertise in research, development,
manufacture and the commercialization of therapeutic and supportive
care products for cancer, pain and inflammation and
gastroenterology. In 2016, Helsinn created the Helsinn Investment
Fund to support early-stage investment opportunities in areas of
unmet patient need. Since 2012, Helsinn has been coordinating
clinical and regulatory activities in China from Beijing and in 2017 established an office in
Shanghai to pursue commercial
activities. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in
Switzerland, Ireland, and the U.S., as well as a product
presence in approximately 190 countries globally.
For more information, please visit www.helsinn.com.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a
San Diego-based oncology company
focused on the clinical development of novel therapies for cancer.
The Company's portfolio of drug candidates includes pracinostat, a
late-stage oral HDAC inhibitor that is partnered with Helsinn
Healthcare, SA. MEI Pharma's clinical development pipeline also
includes ME-401, a highly differentiated oral PI3K delta inhibitor
currently in a Phase Ib study in patients with relapsed/refractory
chronic lymphocytic leukemia (CLL) or follicular lymphoma, and
voruciclib, an oral, selective CDK inhibitor shown to suppress
MCL1, a known mechanism of resistance to BCL2 inhibitors. The
Company is also developing ME-344, a novel mitochondrial inhibitor
currently in an investigator-sponsored study in combination with
bevacizumab for the treatment of HER2-negative breast cancer. For
more information, please visit www.meipharma.com.
Helsinn Group and MEI Pharma Forward-Looking
Statements
Under U.S. law, a new drug cannot be marketed
until it has been investigated in clinical studies and approved by
the FDA as being safe and effective for the intended use.
Statements included in this press release that are not historical
in nature are "forward-looking statements" within the meaning of
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. You should be aware that our actual results
could differ materially from those contained in the forward-looking
statements, which are based on management's current expectations
and are subject to a number of risks and uncertainties, including,
but not limited to, our failure to successfully commercialize our
product candidates; costs and delays in the development and/or FDA
approval, or the failure to obtain such approval, of our product
candidates; uncertainties or differences in interpretation in
clinical trial results; our inability to maintain or enter into,
and the risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution
of any products; competitive factors; our inability to protect our
patents or proprietary rights and obtain necessary rights to third
party patents and intellectual property to operate our business;
our inability to operate our business without infringing the
patents and proprietary rights of others; general economic
conditions; the failure of any products to gain market acceptance;
our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry
practice; and one-time events. We do not intend to update any of
these factors or to publicly announce the results of any revisions
to these forward-looking statements.
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SOURCE MEI Pharma, Inc.