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Medgenics: USD 7 million deal validates Biopump protein platform
October 25th, 2009 - Conference: BIO-Europe 2009 - Company: Medgenics
Medgenics Inc.

Medgenics Inc.

One week ahead of BIO-Europe 2009, Medgenics announced its first preclinical development and option agreement with what it described as a major international biopharmaceutical company that is a market leader in the field of hemophilia.

Constrained from naming his partner, CEO Andrew Pearlman told partneringNEWS that Company X jumped the queue for our development projects to sign a first stage standstill deal to prove the feasibility for Biopump to produce and deliver clotting protein Factor VIII for the sustained treatment of hemophilia.
Andrew Pearlman, CEO, Medgenics

Andrew Pearlman, CEO, Medgenics

Medgenics will receive USD 4 million during the year for standstill and development. Once our partner is convinced by the results we will receive an additional USD 3 million, including a period of exclusivity to negotiate a definitive commercialization agreement, he revealed.

What is significant in the agreement, Pearlman highlighted is that the pharmaceutical company is pursuing our disruptive technology. That is a significant vote of confidence for our unique technology, but also encouraging for other potential partners who are considering our approach.

Given that we are only commencing our program to develop a Biopump to produce Factor VIII, Pearlman added, the fact that a market leader in hemophilia has entered into this type of agreement clearly shows that the potential of the platform was obvious even at this early stage. It testifies to the promise of the Biopump technology for use in treating hemophilia, and further validates the belief that our platform can be applied to help treat many chronic diseases and will attract further interest from other major partners.

Pearlman will be joined at BIO-Europe 2009 by Medgenics Chairman, Eugene Bauer, Dean Emeritus of Stanford University School of Medicine.

Medgenics Biopump is a tissue-based platform technology that involves taking a toothpick size sliver from the inner layer of the patients skin, processing it to produce therapeutic proteins and re-injecting it under the patients skin where it delivers protein continuously for months.

To date, the Biopump has been proven in patients to provide sustained production of erythropoietin in treating the anemia of patients with chronic kidney disease for 612 months from a single administration. Biopumps producing interferon alpha for use in treating hepatitis C have also been demonstrated in the lab and in animals.

A special device is employed to perform a needle biopsy removing multiple tissue samples of about 30 mm-length under local anesthetic, typically from the patients lower abdomen.

Over a 10-day period the tissue samples are processed to introduce the specified gene that will produce the targeted protein and then verified that the protein is being produced at the required dose.

The company is developing an automated processing station that will work with disposable processing cassettes, one used for each patient, to generate up to 10 implantable tissue Biopumps. Typically, a few are used for the first treatment and the remainder can be cryo-stored for later use.

Biopump does not have the drawbacks of gene therapy, nor is it based on techniques that can only be performed by two people in the world or require technology as specialized as a NASA space capsule, he said.

This is being developed to be a practical, automated process that will be highly reliable and cost effective, said Pearlman. We believe it can be performed at any medical center, even at local centers, and perhaps even by trained nurse practitioners.

Medgenics plans to develop or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach USD 87 billion by 2010.

The platform potential is broad, presenting opportunities for sustained-action protein therapy for treatment of a range of chronic diseases currently treated with frequent, costly, and painful injections, such as diabetes, arthritis, anemia, multiple sclerosis, or pediatric growth hormone deficiency.

If the therapy is a peptide or a protein, Biopump can produce it, announced Pearlman.

This technology converges with the trend to drive down healthcare costs while at the same time improving patient health, he said, as it addresses the high rate of patient non-compliance with prescriptions, increases efficacy and safety, reduces side effects, and improves quality of life.
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Early-Stage Deals

29 October 2009

Life sciences | Medical devices | Haemophilia | Medgenetics | AIM | Israel | Collaboration
Medgenics in $7M deal to commericalise Biopump protein technology

Science|Business

Collaboration

Medgenics plc, a company based in Misgav, Israel and listed on the Alternative Investment Market in London, has signed a preclinical development and option agreement with an unnamed biopharmaceutical company. The deal will fund the preclinical development of Medgenics Biopump protein technology to produce and deliver the blood clotting protein Factor VIII for the sustained treatment of haemophilia.

Medgenics will receive $4 million to work with this partner for one year to test the feasibility of applying its Biopump for the continuous production and delivery of this clotting protein. Additional payments of $3 million are payable on certain technical milestones and if the partner exercises its option to extend the deal through to commercialisation.

The Biopump technology consists of a miniature device that contains the genes needed to generate specific proteins. The device is implanted in the body, where it produces a continuous supply of the protein. The Biopump has demonstrated success in the production of erythropoietin (EPO) in treating renal anemia and interferon alpha in treating Hepatitis C.

Andrew Pearlman, Chief Executive Officer of Medgenics, said, The fact that this agreement is for a new therapeutic application of our Biopump demonstrates the versatility of our platform technology. It further validates the belief that our platform can be applied to help treat many chronic diseases and will attract further interest from other major partners.

In a Phase I/II clinical study using a Biopump to produce and deliver EPO in patients with chronic kidney disease, a single administration was shown to provide effective anemia treatment for up to 12 months without any need for additional EPO injections. We believe our Biopump technology will address many of the current challenges in healthcare and provide an important advance for the treatment of chronic disease, said Pearlman, adding, While this first agreement is directed to the treatment of hemophilia, Medgenics is continuing its discussions with other potential partners with a view to signing additional agreements for other indications using different therapeutic proteins.
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