Merrimack Pharma (MACK) Announces Generic Doxorubicin Hydrochloride Liposome Injection ANDA Accepted for Review by U.S. FDA

October 31, 2016 7:31 AM EDT
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Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for generic doxorubicin hydrochloride (HCI) liposome injection submitted by its partner Actavis LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.). This is the first product developed by Merrimack under a partnership agreement with Actavis LLC pursuant to which Merrimack is responsible for the development and commercial supply of bulk drug product and Actavis LLC is responsible for fill/finish activities, regulatory approvals and commercialization in the United States.

Doxorubicin HCl liposome injection is marketed as DOXIL® in the United States by Janssen Products LP, a Johnson & Johnson company. The approved indications for the product are ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma. DOXIL generated approximately $600 million annually in global revenue prior to Johnson & Johnson's 2011 manufacturing disruption, which resulted in the placement of DOXIL on the FDA's drug shortage list. While DOXIL was on the drug shortage list, the FDA approved a generic version of doxorubicin HCl liposome injection marketed by Sun Pharma Global FZE, and both products now share the U.S. market. If approved, Merrimack is eligible to receive a royalty rate in the mid-twenties of net profits on sales of doxorubicin HCl liposome injection under the agreement with Actavis.

"We are pleased to have achieved this important milestone with our partner, Actavis," said Gary Crocker, Chairman of Merrimack's Board of Directors and interim President and CEO. "This collaboration leverages Merrimack's proven expertise in the development of liposomal products and provides the opportunity to maximize the use of our state-of-the-art commercial liposomal manufacturing facility. It also could allow us, if the product is approved, to generate an additional revenue stream to not only offset costs but meaningfully improve earnings. We look forward to the FDA's review of Actavis's ANDA filing and providing further support as Actavis navigates the regulatory approval process."

Merrimack is a leader in the development and manufacturing of nanoliposomal products. In addition to the generic doxorubicin HCl liposome injection for which the ANDA was just accepted, Merrimack has developed or is developing several novel therapeutic candidates. Merrimack's first commercial product, ONIVYDE® (irinotecan liposome injection), is a novel liposomal formulation of irinotecan that was approved by the FDA in the United States in October 2015.



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