daytrading sept 29 morning, page-33

JIMO i think some money may be going into BIOS sorry if too long but if bored something to read

STRATEGIC ALLIANCE INVOLVING ADULT STEM CELL PRODUCTS

Sydney - Thursday - September 29: (RWE Aust Business News)

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OVERVIEW

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MESOBLAST (MSB) is going from strength to strength in regenerative medicine.

The company this week announced it had entered into a strategic alliance with the Lonza Group for clinical and long-term commercial production of Mesoblast's off-the-shelf (allogeneic) adult stem cell products.

The alliance will provide Mesoblast with significant commercial advantages, including certainty of capacity to meet long-term global supply of its proprietary Mesenchymal Precursor Cell (MPC) products.

Lonza will supply Mesoblast's clinical and long-term commercial MPC product needs globally.

Mesoblast can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for Mesoblast's marketed products.

In return, Mesoblast will purchase agreed quantities of marketed products from the facility.

Mesoblast can exercise its right to buy out this manufacturing facility at a pre-agreed purchase price two years after the facility receives regulatory approval.

Mesoblast will have exclusive access to Lonza's cell therapy facilities in Singapore for the manufacture of allogeneic cell therapy products, subject to certain exceptions.

Lonza will utilise its proprietary intellectual property to facilitate reductions in Mesoblast's manufacturing costs and help enable development of enhanced second generation products.

Meanwhile, Mesoblast has received clearance from the European Medicines Agency (EMA) to begin a 225-patient multi-centre Phase 2 clinical trial in Europe for its lead cardiovascular product Revascor in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack.

Revascor is an allogeneic adult stem cell product derived from Mesoblast's MPC platform technology.

The placebo-controlled Phase 2 trial, AMICI (Allogeneic Mesenchymal precursor cell Infusion in myoCardial Infarction), has been approved under Europe's voluntary harmonisation procedure and will initially recruit patients at multiple European sites, including in the United Kingdom, The Netherlands and Belgium.

Trial recruitment is subsequently expected to involve sites in additional European nations as well as Australia, and the United States.

The primary endpoint of the study will be safety and efficacy at six months in heart attack patients who will receive either Revascor at one of two doses or placebo.

Durability of effect will additionally be monitored for up to 36 months.

Heart attacks remain the biggest killer of people in the industrialised world.

Every year, over 1.7 million people have a heart attack in Europe, and over 1.1 million in the United States.

Most of these patients undergo an early angioplasty of the blocked artery accompanied by implantation of a metal stent to keep the artery open long-term.

However, a significant number of the surviving patients subsequently become disabled with heart failure.

Revascor is injected by a simple intracoronary infusion at the same time as the angioplasty and stent procedure, within 12 hours of the heart attack.

SHARE PRICE MOVEMENTS

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Shares of Mesoblast yesterday climbed 9c to $7.89, recovering from a recent downturn. Rolling high for the year is $9.95 and low $2.29. Earnings per share is 41.79c while price/earnings ratio is 18.88. The company has 280.4 million shares on issue with a market cap of $2.167 billion. Ferret first drew investors attention to the stock in August 2009 when the shares stood at $1.18.

In pre-clinical trials, a simple intracoronary infusion of off-the-shelf MPCs increased the number of blood vessels in the infarcted region, prevented scar formation, and significantly improved heart muscle function after a heart attack, preventing heart failure.

"The pre-clinical data were very compelling, and formed the basis for this innovative clinical trial," said the study's Principal Investigator, Professor Eric Duckers, Interventional Cardiologist, Head of Molecular Cardiology and Associate Professor, Thoraxcenter, Erasmus University Hospital in The Netherlands.

"We are excited to be pioneering a novel and minimally invasive clinical approach that has the potential to greatly improve the quality of life for patients suffering acute heart attacks."

BACKGROUND

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Mesoblast is a Melbourne-based biotechnology company, which listed on the ASX on December 16, 2004.

The company is a world leader in commercialising biologic products for the broad field of regenerative medicine.

Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult MPCs.

It has established proof-of-concept with its technology and is now progressing Phase 2 clinical trials in the US for spine fusion applications and a Phase 2 trial in Melbourne for the prevention of knee osteoarthritis.

This year the company intends to launch its first product for the treatment of non-union bone fractures in Australia.

Mesoblast owns 38.4 per cent of US-based associate company, Angioblast Systems, which is applying the same adult stem cell technology for the treatment of heart disease, with three Phase 2 trials underway in the US.

It is also conducting a Phase 2 trial for expansion of cells using MPCs in bone marrow transplantation procedures.

In July Mesoblast received approval to commercially manufacture adult stem cell products from the Australian Therapeutic Goods Administration (TGA).

Under this licence, Mesoblast will make commercially available to doctors and hospitals across Australia manufactured MPC products for a patient's own, or autologous, use in the repair and regeneration of their damaged tissues.

The cells will be manufactured under an agreement between Mesoblast and the TGA-licensed contractor Cell Therapies Pty Ltd.

Mesoblast will initially target major bone repair markets, including long bone fractures after trauma, stress fractures following sporting injury, and vertebral fractures due to osteoporosis.

At the time, Mesoblast's CEO Professor Silviu Itescu said the approval was a major validating step in the company's history.

"It underscores the robustness of our manufacturing process and the excellent safety profile of our products in patients.

"To our knowledge, this is the first culture-expanded adult stem cell product that has received manufacturing approval anywhere in the world," he said.

Professor Itescu said that TGA approval will mean early revenue generation for Mesoblast, faster product adoption and branding, and accrual of clinical outcome data for use by the company in subsequent local and international filings for product registrations.

In addition, it will position Australia as a global leader in the use of regulated stem cell therapies.

Last December Mesoblast formed a strategic alliance with global biopharmaceutical company Cephalon Inc to develop and commercialise its novel adult stem cell therapeutics for degenerative conditions of the cardiovascular and central nervous systems.

These conditions include congestive heart failure and acute myocardial infarction, stroke, Parkinson's disease and Alzheimer's disease.

The alliance also extends to products for augmenting bone marrow transplantation in cancer patients.

Cephalon, which has a 19.9 per cent stake in Mesoblast, is funding all late-stage clinical development costs worldwide for the specific products, as well as all sales and marketing costs.

Mesoblast retains all manufacturing rights and will sell finished products to Cephalon on a transfer price basis.