INNOVIVE Pharmaceuticals Acquires Exclusive North American Rights to Tamibarotene, a Treatment for Acute Promyelocytic Leukemia;
December 08 2006 - 7:00AM
PR Newswire (US)
NEW YORK, Dec. 8 /PRNewswire-FirstCall/ -- INNOVIVE Pharmaceuticals
(OTC:IVPH) (BULLETIN BOARD: IVPH) today announced that it acquired
exclusive North American rights to develop and commercialize
Tamibarotene, a novel synthetic retinoid for the treatment of acute
promyelocytic leukemia (APL), a type of acute myeloid leukemia.
Tamibarotene was specifically designed to address challenges of APL
resistance and the high rate of toxicity among patients treated
with all-trans retinoic acid (ATRA). ATRA is the current standard
of care for first-line treatment of APL in combination with
chemotherapeutic agents. Current National Comprehensive Cancer
Network guidelines also recommend that patients undergo one to two
years of maintenance therapy with ATRA following disease remission.
However, ATRA therapy is associated with toxicities, including
retinoic acid syndrome (RAS), a serious and sometimes fatal
complication that occurs in up to 25 percent of patients.
Additionally, many patients develop resistance to treatment with
ATRA. Tamibarotene is currently approved in Japan for treatment of
recurrent APL. In a pivotal study, the effectiveness of orally
administered Tamibarotene was evaluated daily for eight weeks in 39
Japanese patients with APL, including treatment-naive and
previously treated patients. The overall response rate in these
patients was 61.5 percent. In patients with recurrent disease the
overall response rate was 81 percent. RAS was reported in 7.3
percent of patients. An additional Phase III study is currently
underway in Japan comparing ATRA to Tamibarotene for the
maintenance treatment of APL. In conjunction with data from the
Japanese studies, data from INNOVIVE's pivotal study of
Tamibarotene, which is expected to be completed in 2007, are
expected to form the basis of a New Drug Application (NDA) with the
U.S. Food and Drug Administration (FDA). The company expects to
initiate a pivotal clinical study of Tamibarotene in the U.S. in
the first half of 2007 in refractory APL, and to file an NDA with
the FDA in early 2008. If Tamibarotene is approved and successfully
commercialized for refractory treatment of APL in the U.S., it
should not only generate revenue for the company but also should
enable INNOVIVE to offset the cost of building regulatory and
commercialization infrastructures that are expected to serve as the
foundation for the potential launch of additional compounds in the
company's hematology pipeline, including INNO-406. "We expect a
rapid path to approval for Tamibarotene which would provide us the
opportunity to establish our regulatory and commercial
infrastructures that could then be leveraged for the rest of our
portfolio, including INNO-406 for the treatment of chronic
myelogenous leukemia," said Steven Kelly, President and CEO of
INNOVIVE Pharmaceuticals. Under the terms of the agreement,
INNOVIVE acquired the exclusive North American license from TMRC,
Co., Ltd. to develop and commercialize Tamibarotene for treatment
of APL, with an option to include within the license the use of
Tamibarotene in other fields in oncology including multiple
myeloma, myelodysplastic syndrome and solid tumors. TMRC received
an upfront fee and will be eligible to receive payments upon
achievement of certain development, regulatory and sales
milestones, in addition to royalties on potential net sales. About
APL Acute promyelocytic leukemia (APL) is a specific type of acute
myeloid leukemia characterized by the t(15;17) translocation which
fuses the PML gene on chromosome 15 to the retinoic acid receptor
(RAR) alpha gene on chromosome 17. About INNO-406 INNO-406
(formerly known as NS-187) is an orally bioavailable, rationally
designed, dual Bcr-Abl and Lyn-kinase inhibitor currently in Phase
I clinical studies. According to a study published in the journal
Blood (Dec. 1, 2005), INNO-406 is 25 to 55 times more potent than
imatinib in vitro, and at least 10 times as effective as imatinib
mesylate in suppressing the growth of Bcr-Abl bearing tumors.
INNO-406 has demonstrated activity in 12 of 13 imatinib-resistant
cell lines. In addition to its Bcr-Abl inhibitory properties,
INNO-406 inhibits Lyn kinase. Upregulation of Lyn kinase activity
is a well recognized cause of imatinib resistance. Lyn kinase
activation has also been documented in a variety of solid tumors,
including prostate cancer. About INNOVIVE Pharmaceuticals INNOVIVE
Pharmaceuticals, Inc. acquires, develops and commercializes novel
therapeutics addressing significant unmet medical needs in the
fields of oncology and hematology. In addition to the acquisition
of Tamibarotene, the company has three drug programs in clinical
development, INNO-406, INNO-206, and INNO-305, for the treatment of
chronic myelogenous leukemia, small cell lung cancer, and acute
myelogenous leukemia. For additional information visit
http://www.innovivepharma.com/. DATASOURCE: INNOVIVE
Pharmaceuticals CONTACT: Steve Kelly, President and CEO of INNOVIVE
Pharmaceuticals, +1-212-716-1820; or Media & Investor
Relations, Rachel Lipsitz of Porter Novelli Life Sciences,
+1-619-849-5378, for INNOVIVE Pharmaceuticals Web site:
http://www.innovivepharma.com/
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