Press Release:
CYTOCHROMA AND MITSUBISHI TANABE FORM
PARTNERSHIP FOR CHRONIC KIDNEY DISEASE THERAPIES
IN U.S. AND ASIA
Markham, Ontario,
Canada and Osaka, Japan — July
30, 2008 — Cytochroma and Mitsubishi Tanabe
Pharma Corporation (“MTPC”) today announced that
the companies have signed a license agreement under which
Cytochroma granted MTPC an exclusive license in the U.S.
and Asia, including Japan, to develop and commercialize CTA018,
Cytochroma’s novel vitamin D analog. CTA018 is
entering Phase II development in Canada for the treatment
of secondary hyperparathyroidism (“SHPT”) in
patients with chronic kidney disease (“CKD”). The
agreement also grants MTPC access to certain follow-on compounds
to CTA018 for the same territories, with Cytochroma retaining
all rights to CTA018 and these follow-on compounds in all
regions outside the U.S. and Asia.
Cytochroma’s President and CEO, Charles W. Bishop, PhD,
stated, “Mitsubishi Tanabe is a world-class company,
which will provide Cytochroma with significant resources and
pharmaceutical know-how, thereby facilitating the development
and commercialization of CTA018 in the U.S. and Asia. The
formation of this partnership is a landmark event for Cytochroma
and represents an important validation of our novel approach
to treating secondary hyperparathyroidism in CKD patients.”
MTPC’s President and Representative Director,
Natsuki Hayama, stated, “I am excited with this synergistic
partnership that combines the unique strengths of Cytochroma,
a North American-based specialty pharmaceutical company, with
Mitsubishi Tanabe, a Japan-based global pharmaceutical company. Cytochroma’s
management team has an extensive and successful track record
in developing and commercializing products for CKD patients
in North America. A partnership with Cytochroma not only
enhances Mitsubishi Tanabe’s product pipeline in the
U.S. and Asia, but also enables us to access Cytochroma’s
valuable expertise for the development of our own commercialization
platform in the U.S.”
Under the terms of the agreement, Cytochroma
has granted MTPC an exclusive license to develop, manufacture
and commercialize CTA018 in the United States and Asia. Cytochroma may
receive up to a total of CDN $105 million, which includes an
upfront payment, milestone payments, and an equity investment. In
exchange for the equity investment, MTPC will receive a certain
number of Cytochroma’s Class C shares. MTPC and
Cytochroma will jointly develop and commercialize CTA018 in
the United States. In Asia, including Japan, MTPC has
full rights and responsibilities for product development, approval,
and commercialization of CTA018, and will pay Cytochroma a
royalty on sales.
CTA018 Injection was well tolerated in Phase
I clinical evaluations where it produced clinically meaningful
reductions in blood levels of intact parathyroid hormone (“iPTH”)
after less than two weeks of administration. Excessive
levels of iPTH cause calcium to be released from bone and into
the blood, increasing the risk of bone disease (renal osteodystrophy)
and calcification of vascular and other soft tissues.
Cytochroma’s
management team has extensive experience in successfully developing
and commercializing new vitamin D therapies for the CKD market,
including Zemplar® and
Hectorol®, currently the two leading vitamin D hormone
therapies used to treat SHPT in the U.S. Cytochroma’s
therapies are designed to treat disorders related to abnormal
or insufficient vitamin D metabolism in CKD patients, including
SHPT. These new products will address target markets
that are expected to grow significantly, reaching more than
$1.4 billion annually by 2013 in North America. The Company
has three lead product candidates in development for CKD patients:
CTA018 and CTAP201 are being developed for the treatment of
SHPT, while CTAP101 is being developed for the treatment of
vitamin D insufficiency.
About CTA018
CTA018 is the first compound in
a new class of active vitamin D analogs having a novel dual
mechanism of action. CTA018
is designed to be a strong activator of the vitamin D signaling
pathway as well as a potent inhibitor of CYP24, the intracellular
enzyme responsible for catabolism of vitamin D hormones. Based
on its mechanism of action, CTA018 is expected to be more effective
in treating SHPT and safer than currently available therapies. This
compound was specifically designed by Professor Gary H. Posner,
Ph.D. and is protected under patents and patent applications
exclusively licensed to Cytochroma Inc. from the Johns Hopkins
University.
About Chronic Kidney Disease
According to the
National Kidney Foundation, more than eight million patients
in the U.S. suffer from moderate CKD (Stages 3 and 4) to severe
CKD (Stage 5). Stages 3 and 4 CKD
are characterized by progressively decreasing kidney function
as measured by glomerular filtration rate. In Stage 5
CKD, kidney function is altogether absent and patients require
regular dialysis or kidney transplant for survival. An
estimated 70-90% of CKD patients have vitamin D insufficiency,
which can lead to SHPT and resultant debilitating bone diseases. Mounting
evidence continues to link vitamin D insufficiency with progression
of CKD and death. CKD is caused most frequently by diabetes
or hypertension, both of which are consequences of a growing
obesity epidemic in countries worldwide.
About Secondary
Hyperparathyroidism
Secondary hyperparathyroidism (“SHPT”) is a condition
commonly associated with chronic kidney disease (“CKD”)
patients in which the parathyroid glands secrete excessive
amounts of parathyroid hormone (“PTH”). This
excess PTH secretion arises as a result of impaired kidneys
that are neither able to produce sufficient quantities of active
vitamin D hormone, nor maintain a state of balance (homeostasis)
between calcium and phosphate in the body. The low levels
of active vitamin D hormone and lack of homeostasis between
calcium and phosphate is detected by the parathyroid gland,
which, in turn, continues to secrete PTH, resulting in excessive
levels of PTH in the body. Excessive levels of PTH cause
calcium to be released from bone and into the blood, leading
to softening of the bones (osteomalacia), and calcification
of vascular tissues. SHPT affects approximately 90% of
severe, and 40-60% of moderate CKD patients.
About Cytochroma
Cytochroma is a clinical stage
specialty pharmaceutical company focused on developing and
commercializing proprietary products to treat and prevent the
clinical consequences of vitamin D insufficiency and SHPT associated
with CKD. The Company’s
vitamin D-based therapeutics are designed to safely and effectively
treat patients with Stage 3, 4 or 5 CKD. In addition,
Cytochroma is developing novel therapies to treat hyperphosphatemia
in these same patients.
About
Mitsubishi Tanabe Pharma Corporation (“MTPC”)
Mitsubishi
Tanabe Pharma Corporation is a research-driven global pharmaceutical
company based in Japan. It specializes
in the fields of cardiovascular and metabolic diseases, brain
and nerve diseases, and renal and urinary system diseases.
The company was established through the merger of Tanabe Seiyaku
Co., Ltd. and Mitsubishi Pharma Corporation in October 2007. MTPC
commits to bring its innovation to the patients around the
world, and plans to build a commercialization presence in U.S. MTPC
is currently developing two Phase III clinical candidates in
the U.S. and EU; MP-146 for CKD and MCI-196 for hyperphosphatemia.
For
more information, please visit www.mt-pharma.co.jp
Cytochroma Investor Contact:
Eric J. Messner, Vice President, Commercial Operations
Tel: +1 (847) 236-7707 ext. 238 (Bannockburn, IL)
Tel: +1 (905) 479-5306 ext. 338 (Markham, ON)
eric.messner@cytochroma.com
Cytochroma Media Contact:
Robert Stanislaro (FD)
Tel: +1 (212) 850-5657
robert.stanislaro@fd.com
Mitsubishi Tanabe Pharma Corporation Contact:
Corporate Communications Department
Yoshihisa Saso, PhD, General Manager
Tel: +81-6-6205-5211
saso.yoshihisa@mv.mt-pharma.co.jp
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