SAN DIEGO, April 7, 2015 /PRNewswire/ -- Taxus Cardium
Pharmaceuticals Group Inc. (trading symbol: CRXM) today announced
that it has entered into a binding term sheet with Dr. Reddy's
Laboratories Ltd. (NYSE: RDY) for an exclusive territorial license
covering the co-development, marketing and sales of the Generx®
[Ad5FGF-4] angiogenic microvascular gene therapy Phase 3 product
candidate for patients with refractory angina, and myocardial
ischemia due to cardiac microvascular insufficiency (CMI).
The agreement initially covers certain territories and
international markets, including Russia, the Commonwealth of Independent States
(CIS), Venezuela, Vietnam and Myanmar, and provides the right of first
refusal for Dr. Reddy's Laboratories to negotiate additional
exclusive license agreements to market and sell the Generx gene
therapy product candidate in over 30 other countries in
Latin America and the Association
of Southeast Asian Nations.
Angionetics Inc., a wholly-owned operating unit of Taxus
Cardium, is now responsible for the worldwide commercialization of
the Generx gene therapy product candidate. Angionetics retains
the full Generx commercialization rights for North America, Europe, Japan, China,
the Middle East, and Africa. It is planned that Angionetics will
advance forward as a company independent from Taxus Cardium and
seek to externally finance the Generx U.S.-based FDA-cleared AWARE
Phase 3 clinical study, the international ASPIRE Phase 3 clinical
development program and additional U.S.-based and international
clinical studies for other potential Generx medical
indications.
As an international co-development partner, Dr. Reddy's
Laboratories will assist with local country patient recruitment and
relationship building with key opinion leaders to accelerate the
Angionetics' international Phase 3 ASPIRE clinical
study. Positive safety and efficacy findings from the ASPIRE
study were announced at the Annual 2014 Biotechnology Industry
Organization Conference following completion of a
protocol-specified interim data analysis. In addition, Dr.
Reddy's Laboratories will assist with product registrations and
regulatory compliance with local country health authorities.
The agreement provides economic support that will be used to
advance the international Phase 3 clinical study, a cost sharing
arrangement for a planned Phase 4 post-marketing clinical study
(intended to expand product labeling), and volume-based royalties
on net sales. Dr. Reddy's Laboratories' Russian-based business
unit markets and sells prescription products through its team of
medical representatives and managers who promote the products to
physicians across Russia.
Additionally, Dr. Reddy's Laboratories also has a separate Hospital
division and an OTC division.
About Dr. Reddy's Laboratories
Dr. Reddy's
Laboratories Ltd. (NYSE: RDY) is an integrated pharmaceutical
company, committed to providing affordable and innovative medicines
for healthier lives. Through its three businesses, Pharmaceutical
Services & Active Ingredients, Global Generics, and Proprietary
Products, Dr. Reddy's offers a portfolio of products and services
including APIs, custom pharmaceutical services, generics,
biosimilars and differentiated formulations. Major therapeutic
areas of focus are gastro-intestinal, cardiovascular, diabetology,
oncology, pain management and anti-infectives. Dr. Reddy's operates
in markets across the globe. Major markets include the United States, Russia and CIS, and India. For more information, visit
www.drreddys.com.
About Angionetics Inc.
Angionetics, an operating unit
of Taxus Cardium Pharmaceuticals Group, is a late-stage
biotechnology company that is developing new and innovative gene
therapy-based, cardiovascular therapeutics. Angionetics is focused
on the development and commercialization of novel DNA-based
therapeutics designed to promote the heart's innate natural
capacity to modulate the formation and growth of cardiac
microvascular circulation to enhance blood flow (perfusion) in
patients with a variety of ischemia-driven disease conditions and
refractory angina and myocardial ischemia due to cardiac
microvascular insufficiency (CMI), and other cardiovascular disease
conditions. For more information, visit www.angionetics.com.
Angionetics' lead product candidate, Generx® (alferminogene
tadenovec [Ad5FGF-4]), is a first in class, single-dose, disease
altering therapeutic specifically targeted to the cardiac
micro-vasculature. The Generx gene therapy product candidate is
designed to stimulate and augment the formation of new biologic
structures that increase the coronary microvascular network, to
enhance cardiac perfusion, and improve cardiac performance, as
measured by exercise tolerance and the occurrence and severity of
myocardial ischemia-driven angina. Current therapies for patients
with refractory angina and CMI are limited to pharmacologic
anti-anginal medications to relieve angina chest pain, which are
dosed daily or episodically and can cause adverse side effects, and
surgical and percutaneous interventions that address large vessel
coronary artery disease. Angionetics' product candidates are
designed to easily fit within the current practice of medicine, as
single-dose treatments, which are administered by interventional
cardiologists using standard cardiac catheters, during an
approximately one-hour, out-patient, angiogram-like procedure which
is conducted in a hospital or medical center.
In November 2014, Taxus Cardium
reported the formation of Angionetics, which is now responsible for
the worldwide commercialization of the Generx gene therapy product
candidate, and retains the full commercialization rights for
North America, Europe, Japan, China,
the Middle East, and Africa.
It is planned that Angionetics will seek to externally finance the
Generx clinical development program and operate as a company
independent from Taxus Cardium. For more information about Taxus
Cardium, visit the Company's website www.cardiumthx.com.
Forward-Looking Statements
Except for statements of
historical fact, the matters discussed in this press release are
forward looking and reflect numerous assumptions and involve a
variety of risks and uncertainties, many of which are beyond our
control and may cause actual results to differ materially from
expectations. For example, there can be no assurance that the
Company will complete a final agreement with Dr. Reddy's
Laboratories with respect to a final territorial license to market
and sell Generx, based on the binding term sheet as reported in
this press release, and that results or trends observed in any one
clinical study or procedure will be reproduced in subsequent
studies or in actual use; that new clinical studies will be
successful or will lead to approvals or clearances from health
regulatory authorities, or that approvals in one jurisdiction will
help to support studies or approvals elsewhere; that the company
can attract suitable commercialization partners for our products or
that we or partners can successfully commercialize them; that our
product or product candidates will not be unfavorably compared to
competitive products that may be regarded as safer, more effective,
easier to use or less expensive or blocked by third party
proprietary rights or other means; that the products and product
candidates referred to in this report or in our other reports will
be successfully commercialized and their use reimbursed, or will
enhance our market value; that new product opportunities or
commercialization efforts will be successfully established; that
third parties on whom we depend will perform as anticipated; that
we can raise sufficient capital from partnering, monetization or
other fundraising transactions to maintain our stock exchange
listing or adequately fund ongoing operations; or that we will not
be adversely affected by these or other risks and uncertainties
that could impact our operations, business or other matters, as
described in more detail in our filings with the Securities and
Exchange Commission. We undertake no obligation to release publicly
the results of any revisions to these forward-looking statements to
reflect events or circumstances arising after the date hereof.
Copyright 2015 Taxus Cardium Pharmaceuticals
Group Inc. All rights reserved.
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www.cardiumthx.com.
Cardium Therapeutics®,
Generx®, Cardionovo®, Tissue Repair™,
Excellagen®, Excellarate™, Genedexa™, and
LifeAgain™, are trademarks of Cardium Therapeutics, Inc., Tissue
Repair Company or LifeAgain Insurance Solutions Inc. Other
trademarks belong to their respective owners.
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