UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): April 6, 2015
Taxus Cardium Pharmaceuticals Group, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | 001-33635 | 27-0075787 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
11750 Sorrento Valley Rd., Suite 250, San Diego, California | 92121 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrants Telephone Number, Including Area Code: (858) 436-1000
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01. | Entry into a Material Definitive Agreement. |
On April 6, 2015, Taxus Cardium Pharmaceuticals Group Inc. (Taxus Cardium) entered into a term sheet with Dr. Reddys Laboratories Ltd. (NYSE: RDY) 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. The terms sheet outlines the principle agreements between the parties and is binding, but is expected to be superseded by a definitive agreement with more detailed terms.
The term sheet grants Dr. Reddys Laboratories an exclusive license to market and sell Generx® in Russia, the Commonwealth of Independent States (CIS), Venezuela, Vietnam and Myanmar (the Licensed Territories) for a period of ten years with two five-year renewal options. Dr. Reddys Laboratories Russian-based business unit currently markets and sells prescription productsin Russia. The term sheet grants Dr. Reddys Laboratories a right of first negotiation for the license rights to market and sell Generx® in up to 32 other countries in Latin America and the Association of Southeast Asian Nations. Taxus Cardium retains full commercialization rights for North America, Europe, Japan, China, the Middle East, and Africa. Taxus Cardium has established a wholly-owned operating unit Angionetics to manage for the worldwide commercialization of the Generx®.
As co-development partner, Dr. Reddys Laboratories will assist with physician and hospital relationships as well as patient recruitment to accelerate completion of international Phase 3 ASPIRE clinical study in Russia. Dr. Reddys 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. It has also agreed to assist with product registrations and regulatory compliance with local country health authorities in other jurisdictions in the Licensed Territories. Upon registration of Generx® in Russia, Taxus Cardium and Dr. Reddys Laboratories have agreed to share costs for a planned Phase 4 post-marketing clinical study, intended to expand the medical indications for which the product can be used.
The term sheet provides for Dr. Reddys Laboratories to pay upfront licensing fees on execution of the definitive agreement and upon registration of the Generx® product in Russia. Taxus Cardium will retain control over the manufacturing of Generx® and will supply it to Dr. Reddys Laboratories on a cost-plus basis. Dr. Reddys will pay to Taxus Cardium royalties on net sales of Generx®, with the percentage varying based on the degree of market penetration for the product in the relevant territory.
Taxus Cardium issued a press release announcing the entry into the term sheet with Dr. Reddys Laboratories on April 6, 2015. A copy of the press release is attached as Exhibit 99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) | Exhibits. |
Exhibit No. |
Description of Exhibit | |
99.1 | Press release issued on April 7, 2015. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Taxus Cardium Pharmaceuticals Group, Inc. | ||
By: | /s/ Christopher J. Reinhard | |
Christopher J. Reinhard | ||
Chief Executive Officer |
Date: April 9, 2015
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Exhibit 99.1
Press / Investor Contact:
Taxus Cardium Pharmaceuticals Group Inc.
Tel: (858) 414-1477
Email: InvestorRelations@cardiumthx.com
TAXUS CARDIUM ANNOUNCES AGREEMENT WITH
DR. REDDYS LABORATORIES TO CO-DEVELOP, MARKET & SELL
GENERX ANGIOGENIC MICROVASCULAR GENE THERAPY
IN CERTAIN INTERNATIONAL MARKETS
SAN DIEGO, CA April 7, 2015 Taxus Cardium Pharmaceuticals Group Inc. (trading symbol: CRXM) today announced that it has entered into a binding term sheet with Dr. Reddys 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. Reddys 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. Reddys 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. Reddys 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. Reddys 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. Reddys Laboratories also has a separate Hospital division and an OTC division.
About Dr. Reddys Laboratories
Dr. Reddys 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. Reddys 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. Reddys 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 hearts 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 Companys 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. Reddys 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.
For Terms of Use Privacy Policy, please visit 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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