Date: 2015-07-22
Type of information: Product acquisition
Compound: Digoxin immune fab (DIF)
Company: Amag Pharmaceuticals (USA - MA) Velo Bio (USA)
Therapeutic area: Women health
Type agreement: product acquisition
Action mechanism: polyclonal antibody. Digoxin immune fab (DIF) is a polyclonal antibody being developed for the treatment of severe preeclampsia in pregnant women. Elevated levels of endogenous digitalis-like factor (EDLF) have been found in the placental and maternal circulation of the majority of patients with preeclampsia, and the degree of elevation is correlated with disease severity. DIF is thought to bind to these factors, causing a decrease in serum EDLF levels and inhibition of their activity. A prior placebo-controlled Phase 2 study in 51 pregnant women with severe preeclampsia validated DIF\'s mechanism of action and was suggestive of clinical benefit in both mothers and their babies.
Disease: severe preeclampsia in pregnant women
Details: * On July 22, 2015, Amag Pharmaceuticals announced that it has entered into an agreement that grants Amag an exclusive option to acquire the rights to an orphan drug candidate at the conclusion of a Phase 2b/3a clinical trial. Digoxin immune fab (DIF) is a polyclonal antibody being developed for the treatment of severe preeclampsia in pregnant women. DIF has been granted both orphan drug and fast-track review designations by the FDA for the use in the treatment of severe preeclampsia. DIF has four issued patents, the longest of which provides protection through 2032. Under the option agreement, Velo will complete a dose ranging study and a Phase 2b/3a clinical study. Following conclusion of the DIF Phase 2b/3a study, Amag may exercise, extend or terminate the acquisition option. If Amag exercises its option to acquire DIF, it would pay an option fee and a potential U.S. approval milestone, totaling up to $75 million. Amag would also be responsible to pay any additional costs in pursuing FDA approval beyond the planned Phase 2b/3a clinical trial, as well as up to $250 million in sales milestone payments and single-digit royalties. The sales milestones are payable at annual product sales starting at $100 million up to $900 million. AMAG anticipates that results from the pivotal Phase 2b/3a study could be available as early as 2018.
Financial terms: AMAG will make an upfront payment of $10 million from cash on hand to Velo Bio, a privately held life-sciences company, for the option to acquire global rights to the DIF program.
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