Mesoblast Limited (ASX:MSB) Market Exclusivity For Its Biologic Products Strengthened By New United States Health Care Act

Melbourne, April 6, 2010 AEST (ABN Newswire) - Australian regenerative medicine company and biologic innovator, Mesoblast Limited (ASX:MSB) (OTC:MBLTY), today provided an assessment on how the recently enacted United States Patient Protection and Affordable Care Act (HB 3590) is expected to have a positive impact on the commercial prospects for both Mesoblast and its United States-associated company, Angioblast Systems Inc.

The assessment indicates that the Act will facilitate a material increase in the long-term revenue projections for both companies for their biologic products in the United States, the world's largest market for regenerative medicines.

Of particular relevance to both companies is a key provision in the Act, which provides a biologic innovator with long-term exclusive market protection of its approved product against abbreviated approval of biosimilar biologic products by the United States Food and Drug Administration (FDA). A biosimilar product is deemed to be interchangeable with an already approved reference biologic based upon highly similar analytical studies, and clinical trials that demonstrate safety, purity and potency for the same indication.

The Act explicitly prohibits FDA approval of a biosimilar until 12 years after the date on which the reference biologic product is first approved. It further stipulates an additional 6 months of exclusivity for the use of reference biologic products in the paediatric population.

In addition, under the Act the innovator may receive a further 12 years of exclusivity from the date of approval of any subsequent biologic product which has a structure that has been modified to result in a change in safety, purity, or potency of the reference biologic.

Maintaining commercial exclusivity for its biologic products through a robust international patent portfolio is fundamental to Mesoblast's commercial strategies. The United States Patent and Trademark Office has already granted Mesoblast and Angioblast key composition-of-matter and manufacturing patents for their innovative cell therapy products. These patents provide exclusive commercial protection for the companies' reference biologic products in the United States through to at least 2019, with potential for significant patent life extension. Additional patents have been filed covering specific uses of the companies' biologic products that considerably extend the duration of patent protection.

The new provisions for biosimilar biological products within the Patient Protection and Health Care Affordability Act, which was signed into law 23 March 2010, now provides both Mesoblast and Angioblast with the potential to significantly extend commercial exclusivity for their cell therapy products in the United States well beyond initial patent expiration dates. This will serve to significantly increase long-term revenue projections for both companies, and to facilitate their strategic business partnerships.

Contact

Julie Meldrum Corporate Communications Director Mesoblast Limited Tel: +61-3-9639-6036 Mob: +61-419-228-128 Email: julie.meldrum@mesoblast.com www.mesoblast.com