Collaborative Development and
Worldwide License Agreement for
PCI-32765 between Janssen
Biotech and Pharmacyclics
Janssen Biotech announced that
it has executed an agreement
with Pharmacyclics to jointly
develop and market the
anti-cancer compound PCI-32765.
This compound is an orally
active, small molecule inhibitor
of Bruton’s tyrosine kinase (Btk),
an essential element of the
B-cell antigen receptor (BCR)
signaling pathway. BCR signaling
is a critical pathway required
for tumor expansion and
proliferation, and PCI-32765
exerts its anti-tumor function
by blocking BCR signaling and
thereby inducing cell death. A
number of Phase I and II studies
with PCI-32765 are ongoing
across a panel of B-cell
malignancy disorders, including
CLL, MCL, and DLBCL.
According to the terms of the
agreement, the companies have
entered into a worldwide 50/50
profit–loss agreement, sharing
development and
commercialization activities.
Janssen has made an upfront
payment of $150 M, which will be
recorded in the fourth quarter,
and will make additional
payments on the basis of the
achievement of certain
development and regulatory
milestones. This transaction is
expected to have a dilutive
impact to Johnson & Johnson’s
2011 earnings per share of
~$0.04–$0.05.
Source:
Pharmacyclics
Exelixis Licenses PI3K-Delta
Program to Merck
Exelixis announced that it has
granted to Merck, known as MSD
outside of the US and Canada, an
exclusive worldwide license to
its PI3K-delta research and
development program, including
XL499, the company’s most
advanced pre-clinical PI3K-delta
inhibitor and other related
compounds. PI3K-delta is a
member of the class 1 family of
phosphoinositide-3 kinases and
is predominantly expressed in
cells of the immune system.
Selectively targeting PI3K-delta
has shown potential in the
treatment of certain lymphomas.
Under the terms of the
agreement, Merck will have a
worldwide exclusive license and
sole responsibility to research,
develop, and commercialize
compounds originating from the
program. Merck will make an
upfront payment of $12 M to
Exelixis, and Exelixis will be
eligible for potential
development and regulatory
milestone payments for multiple
indications of up to $239 M.
Exelixis will also be eligible
for potential combined sales
performance milestones and
royalties on net sales of
products emerging from the
agreement. Milestones and
royalties are payable on
compounds emerging from Exelixis’
PI3K-delta program or from
certain compounds that arise
from Merck’s internal discovery
efforts targeting PI3K-delta
during a certain duration.
Source:
Exelixis
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Aeterna
Zentaris Announces Collaboration
with Ventana Medical Systems to
Develop Companion Diagnostic in
Cancer for AEZS-108
Aeterna Zentaris announced that
it has entered into a
collaboration agreement with
Ventana Medical Systems, a
member of the Roche Group, to
develop a companion diagnostic
for the immunohistochemical
determination of luteinizing
hormone–releasing hormone (LHRH)
receptor expression, for the
company’s doxorubicin LHRH-targeted
conjugate compound AEZS-108.
AEZS-108 represents a new
targeting concept in oncology:
using a hybrid molecule composed
of a synthetic peptide carrier
and a well-known chemotherapy
agent, doxorubicin. AEZS-108 is
the first intravenous drug in a
clinical study that directs a
chemotherapy agent specifically
to LHRH receptor–expressing
tumors, resulting in more
targeted treatment with less
damage to healthy tissues. The
product has successfully
completed Phase II studies for
the treatment of endometrial and
ovarian cancers and is also in
Phase II trials in prostate and
bladder cancers.
Source:
Aeterna Zentaris
SFJ Pharma
Announces Agreement with Pfizer
to Develop Axitinib for Adjuvant
Treatment of RCC
SFJ Pharma announced that it has
entered into a collaborative
development agreement with
Pfizer to conduct a Phase III
clinical trial in Asia of
Pfizer’s investigational agent
axitinib for the adjuvant
treatment of patients at high
risk of recurrent renal cell
carcinoma (RCC) following
nephrectomy. Axitinib is an
oral, selective inhibitor of
VEGF receptors 1, 2, and 3,
which can influence tumor
growth, vascular angiogenesis,
and progression of cancer.
Axitinib is currently under
review by the US FDA, the EMA,
the Japanese Ministry of Health,
Labor and Welfare, and several
other regulatory agencies
worldwide as a treatment for
advanced RCC.
Under the terms of the
agreement, SFJ will provide the
funding and clinical development
supervision to generate clinical
data necessary to submit
axitinib for review by
regulatory authorities for the
adjuvant treatment of patients
at high risk of recurrent RCC
following nephrectomy. SFJ will
be eligible to receive milestone
payments under the agreement. In
addition, if approved, Pfizer
intends to commercialize
axitinib for this indication,
and SFJ will receive earn-out
payments under the agreement.
Axitinib is also being
investigated in a randomized
Phase III clinical trial in
patients with treatment-naive as
well as previously treated
advanced RCC.
Source:
SFJ Pharma
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