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Agreements

Date: 2013-12-17

Type of information: Licensing agreement

Compound: PLX-PAD cells (PLacental eXpanded (PLX) cells)

Company: Pluristem Therapeutics (Israel) Cha Bio&Diostech (South Korea)

Therapeutic area: Cardiovascular diseases

Type agreement:

collaboration
licensing

Action mechanism:

The company\'s patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration.

Disease: peripheral artery disease, critical limb ischemia, intermediate claudication

Details:

* On December 17, 2013, Pluristem Therapeutics has announced that pursuant to the previously announced exclusive out-license and strategic partnership agreement with CHA Bio&Diostech, the details of which were announced on June 26, 2013. Pluristem and CHA entered into investment agreements pursuant to which Pluristem has issued to CHA 2,500,000 shares of its common stock in consideration for the issuance to Pluristem of 1,011,504 shares of CHA. This reflects a total consideration of $10.4 million, at a price of $4.16 per Pluristem common share, a premium of 26% over the closing price on December 16, 2013. The shares are subject to a lock up period of one year.
The previously announced agreement with CHA encompasses the use of Pluristem’s PLX-PAD cells in the treatment of two subsets of Peripheral Artery Disease (PAD) in South Korea: Intermittent Claudication (IC) and Critical Limb Ischemia (CLI). The first clinical study to be performed as part of the agreement will be a Phase II trial in IC which will run in parallel to the Phase II trial being conducted in the USA, Germany and Israel. As previously announced, this study was approved in November 2013 by South Korea’s Ministry of Food and Drug Safety (MFDS). Pursuant to the previously announced agreement with CHA, upon the first regulatory approval for a PLX product in South Korea, Pluristem and CHA Bio will establish a joint venture co-owned by the parties. The purpose of the joint-venture will be to commercialize PLX cell products in South Korea. Additionally, Pluristem will be able to use the data generated by CHA Bio to pursue the development of PLX product candidates outside of South Korea.
* On June 26, 2013, Pluristem Therapeutics has announced that its wholly owned subsidiary, Pluristem Ltd., has entered into an exclusive out-license and strategic partnership agreement with Cha Bio&Diostech for the use of Pluristem’s PLacental eXpanded (PLX) cells for peripheral artery disease (PAD), specifically in two indications: the treatment of Critical Limb Ischemia (CLI), and Intermediate Claudication (IC) in South Korea.
Under the terms of the agreement, Cha will perform and fund multiple clinical trials in South Korea for treating CLI and IC using PLX-PAD under the supervision of the Korea Food & Drug Administration (KFDA). Upon the first regulatory approval for a PLX product in South Korea, Pluristem and Cha will establish a joint venture (JV) co-owned by the parties. The purpose of the JV will be to commercialize PLX cell products in South Korea.
CHA Bio&Diostech Co., Ltd. is a leading biopharmaceutical company headquartered in South Korea with R&D focus in stem cells, cell therapeutics, medical device, and new drug development. The company is a member of CHA Health Systems Group, which comprise of medical university, medical centers and hospitals located in the US and Korea with in excess of two thousand beds under care, stem cell research centers, personal & preventive medicine and bio venture divisions. CHA Bio&Diostech has multiple stem cell R&D pipelines in therapeutic areas including Stargardt’s disease, age-related macular disease, Parkinson’s disease, Alzheimer disease, Cerebral Palsy and glioblastoma in mid to late development stages.

Financial terms:

While Cha will bear the costs of conducting the clinical trials for the agreed upon indications, Pluristem will continue to retain rights to its proprietary manufacturing technology and cell-related intellectual property. Additionally, Pluristem will be able to use the data generated by Cha to pursue the development of PLX product candidates outside of South Korea. The agreement contemplates adding products for indications beyond CLI and IC by mutual agreement and is intended to serve as the foundation of a broad based long-term partnership.
In addition, and upon the completion of certain milestones, which is expected by September 2013, Pluristem will issue to Cha 2,500,000 shares of its common stock in consideration for the issuance to Pluristem of 1,011,504 shares of Cha Bio&Diostech, which reflect a total consideration of $10 million for such Pluristem shares (based on average closing price of CHA common shares over the last 30 trading days) and accordingly valued at a price of $4 per each Pluristem share.

Latest news:

* On July 8, 2013, on the heels of announcing its strategic partnership agreement with Cha Bio&Diostech on June 26th, Pluristem Therapeutics has announced that Cha Bio&Diostech  has filed its first investigational new drug (IND) application for Pluristem’s PLacental eXpanded (PLX) cells with the Korean Food and Drug Administration (KFDA). This IND is for the use of PLX-PAD in the treatment of intermittent claudication (IC) and mirrors the clinical protocol implemented by Pluristem in its FDA supervised Phase II IC clinical trial in the United States.

Is general: Yes