MARKHAM, ON, and OSAKA, Japan, July 30 /CNW/ - 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
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(R) and Hectorol(R), 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.
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.
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
For more information, please visit www.cytochroma.com.
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.
For further information:
For further information: Cytochroma Investor Contact: Eric J. Messner,
Vice President, Commercial Operations, Tel: (847) 236-7707 ext. 238
(Bannockburn, IL), Tel: (905) 479-5306 ext. 338 (Markham, ON),
firstname.lastname@example.org; Cytochroma Media Contact: Robert Stanislaro (FD),
Tel: (212) 850-5657, email@example.com; Mitsubishi Tanabe Pharma
Corporation Contact: Corporate Communications Department, Yoshihisa Saso, PhD,
General Manager Tel: +81-6-6205-5211, firstname.lastname@example.org