Par Pharmaceutical Licenses Rights To Zensana Oral Spray

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Zensana Oral Spray

Par Pharmaceutical Companies has acquired the North American commercial rights to Zensana (ondansetron HCl) Oral Spray from Hana Biosciences.

Ondansetron is used to prevent nausea and vomiting after chemotherapy, radiation and surgery, and following successful development and approval, Zensana could be among the first in its class of 5-HT3 antagonist anti-emetic therapies to be available in an oral spray form.

Under terms of the agreement, Par will make a $5 million equity investment in Hana. In addition, Hana would receive milestone payments and royalties on future sales of Zensana.

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Par also announced today that it has entered into an agreement with NovaDel Pharma, Inc., to collaborate in the reformulation of Zensana. Following completion of reformulation efforts already under way, Par will reconfirm the product's pharmacokinetic profile and resubmit the New Drug Application to the U.S. Food and Drug Administration. In addition, as part of Par's strategy to continue to concentrate resources on supportive care in AIDS and oncology, Par has returned to NovaDel the rights to NitroMist (nitroglycerin lingual aerosol), NovaDel's proprietary oral spray form of the drug used to treat angina pectoris.

Anti-emetic therapies constitute the largest segment of the supportive care market in the U.S., with annual sales estimated to exceed $2 billion. Ondansetron is by far the prescription leader in the category, with more than two million written annually.

"Zensana aligns well with Par's strategy to expand its presence in supportive care for oncology and AIDS patients," said John A. MacPhee, president of Par's branded division. "We're fortunate to be able to call upon NovaDel's, Hana's and our own scientific team's expertise to help bring this unique dosage form to market. For Par, this agreement provides an opportunity to take advantage of our core scientific competencies in formulation and bioequivalence while expanding our product pipeline. We expect Zensana to be an excellent alternative for patients having difficulty tolerating tablets and other forms of ondansetron."

In recent steps to build its supportive care portfolio, Par:

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