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DRAXIMAGE(R)’s generic Sestamibi Approved for launch in USA

May 4, 2009

Exclusive distribution agreement in place with GE Healthcare

NOIDA, India, May 4 /PRNewswire/ – Jubilant Organosys Ltd, headquartered in India, announced today that its subsidiary in the United States, DRAXIMAGE LLC has received US Food and Drug Administration (FDA) approval for the Company’s Abbreviated New Drug Application (ANDA) for DRAXIMAGE(R)’s generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite(R).

DRAXIMAGE(R) Sestamibi, is a generic kit used in the preparation of Technetium (Tc-99m) Sestamibi injection – a diagnostic cardiac imaging agent used in Myocardial Perfusion Imaging (MPI), to evaluate the flow of blood to the heart. The MPI market size is currently estimated at USD 400 million.

Jubilant, through its subsidiary in the US, has an exclusive distribution agreement with GE Healthcare to distribute and sell DRAXIMAGE(R)’s generic Sestamibi through GE Healthcare’s nuclear pharmacy network in the US.

Commenting on the development, Shyam S. Bhartia, Chairman, and Hari S. Bhartia, Co-Chairman of Jubilant Organosys said: “We are very excited to receive the USFDA approval of one of our key radiopharma products which strengthens our position in this business. We are ready to launch DRAXIMAGE(R) Sestamibi in the market and will see a steady flow of revenues from this product from Q1 FY10. As we are the second generic player in the market and there is very limited competition,we expect moderate price erosion for this product.”

The DRAXIMAGE(R)’s generic Sestamibi USFDA approval is a significant milestone for the Company’s radiopharma business. Along with the earlier approvals in Canada and distribution agreement with Guerbet for Europe, the Company is well positioned to capture a significant market share for this product in the regulated markets. Going forward the Company plans to introduce this product in the Asian markets, Australia and rest of the world.

GE Healthcare is regarded as a strong player in the nuclear medicine market. It has a very strong network of nuclear pharmacies across the US with a considerable market share in the MPI segment.

DRAXIMAGE(R) Sestamibi is the only generic Tc-99m for MPI, to be marketed by GE, thus complementing GE’s product and service offerings to their customers. The initial term of the distribution agreement is for a minimum of three years post approvals and the product is expected to be launched shortly.

About Jubilant Organosys

Jubilant Organosys Ltd. is an integrated pharmaceutical industry player, one of the largest custom research and manufacturing services (CRAMS) and drug discovery and development services companies out of India. The company has a presence across the pharmaceutical value chain for products and services such as proprietary products ,exclusive synthesis, active pharmaceutical ingredients, contract manufacturing of sterile injectables (liquids and lyophilized) products, non-steriles (ointments, creams and liquid) and radiopharmaceuticals, drug discovery services, medicinal chemistry services, clinical research services, generic dosage forms and healthcare. Jubilant Organosys has geographically diversified manufacturing facilities at ten locations worldwide. Together, these help Jubilant cater to 150 customers across more than 50 countries around the world.

For more information: visit www.jubl.com

About Draximage

DRAXIMAGE, develops, manufactures and markets diagnostic and therapeutic radiopharmaceuticals for the global nuclear medicine marketplace.

Products include a proprietary line of lyophilized technetium-99m kits (MAA, MDP, DTPA and Sestamibi) used in several medical imaging procedures. DRAXIMAGE is also a leading supplier of I-131 radiopharmaceuticals in North America, used for the diagnosis and treatment of thyroid disorder and cancer. Products in development comprises “next generation” Rubidium-82 and Technicium-99m generators. DRAXIMAGE products are exported worldwide, with regulatory approval in USA, Canada, parts of Europe and South-East Asia.

For more information: visit www.draximage.com

Cardiolite(R) is a registered trademark of Lantheus Medical Imaging

Disclaimer:

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Statements in this document relating to future status, events, or circumstances, including but not limited to statements about plans and objectives, the progress and results of research and development, potential product characteristics and uses, product sales potential and target dates for product launch are forward-looking statements based on estimates and the anticipated effects of future events on current and developing circumstances. Such statements are subject to numerous risks and uncertainties and are not necessarily predictive of future results. Actual results may differ materially from those anticipated in the forward-looking statements. Jubilant Organosys may, from time to time, make additional written and oral forward looking statements, including statements contained in the Company’s filings with the regulatory bodies and its reports to shareholders. The Company assumes no obligation to update forward-looking statements to reflect actual results, changed assumptions or other factors.

SOURCE DRAXIS Specialty Pharmaceuticals Inc.


Source: newswire



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