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Spectrum Pharmaceuticals, Inc.

Drug Names(s): INX-0076, Optisomal topotecan, Topotecan Liposomes Injection, Topotecan OPTISOME

Description: Optisomal topotecan (Topotecan Liposomes Injection, TLI) is a novel sphingomyelin/cholesterol liposomal(OPTISOME) encapsulation of topotecan HCl (TPT).

TPT, a semi-synthetic derivative of camptothecin (CPT), is approved forthe treatment of refractory ovarian, small cell lung (SCLC), and cervical cancers. The cytotoxicity of TPT and other CPT analoguesis related to duration of systemic exposure to drug. OPTISOMES have been designed to prolong drug circulation time in blood,increase drug delivery to the tumor, and improve the therapeutic index of the encapsulated drug. Additionally, optisomalencapsulation is designed to maintain TPT in the active lactone form. The pharmacokinetic (PK) disposition of OPTISOMEencapsulated drug is dictated by the liposome, which alters the plasma PK profile and tissue distribution of the drug. Once thedrug is released from the liposome, the PK disposition will be the same as after administration of the non-liposomal formulation of the drug.

Deal Structure: Inex (Tekmira) and Hana (Talon)
In March 2006, Inex signed a Letter of Intent to license three products from its Targeted Chemotherapy pipeline to Hana Biosciences. Inex has granted Hana a worldwide license to develop and commercialize Marqibo, Alocrest, and INX-0076. Upon closing of the transaction, Hana will pay Inex US$11.5 million in an upfront payment, consisting of cash and Hana shares. Inex will receive an additional US$30.5 million if development and regulatory milestones are achieved and will also receive royalties on product sales. Hana will be responsible for all future development of the three products including all future expenses.

In April 2007, Inex was reorganized as Tekmira.

In September 2010, Tekmira announced that is has amended its license agreement with Hana Biosciences. Under the terms of the amendment, Hana will make a US$5.75 million payment to Tekmira in consideration for reducing certain future payments associated with the product...See full deal structure in Biomedtracker

Partners: Arbutus Biopharma Corporation

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