MARQIBO® (vincristine sulfate liposomes injection)

Marqibo® is our lead asset intended to replace standard vincristine chemotherapy.

• Vincristine sulfate is widely used with more than 2 million doses per year to treat leukemias, lymphomas, myeloma, and solid tumors – a multi-billion market worldwide
• Standard vincristine has dosing, toxicity and rapid clearance limitations
• Marqibo's unique formulation facilitates marked dose intensification, PK optimization, and targeted vincristine delivery to and concentration in cancerous tissues

It has demonstrated compelling efficacy in adults with relapsed/refractory Philadelphia negative, Ph(-), acute lymphoblastic leukemia (ALL).

• 35% overall response rate in the 3rd – 6th line treatment setting
• 20% complete response rate with impressive median duration and survival

We are seeking accelerated approval in the US and submitted our NDA in July, 2011. We are seeking accelerated approval in the US and have a PDUFA date of May 13, 2012.

• Granted US FDA Orphan Drug and Fast Track Designations
• Granted EU EMA Orphan Drug Designation

MENADIONE TOPICAL LOTION

Menadione Topical Lotion is a first-in-class compound for treatment limiting skin toxicity associated with EGFR inhibitors for cancer therapies (e.g. Erbitux®, Tarceva®, and Vectibix®).

• Painful and treatment limiting rash occurs in up to 90% of treated patients within weeks of exposure and leads to treatment discontinuation in up to 30% of affected patients

Menadione Topical Lotion may prevent or mitigate the rash.

Phase 1 study completed demonstrating Menadione Topical Lotion is generally safe and well tolerated. The dose limiting toxicity and apparent maximum tolerated lotion strength were identified.

A Phase 2 study will be conducted by the Mayo Clinic.

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