Unwanted by AbbVie and Infinity, battered Verastem gets an OK for duvelisib and a second shot at success
Verastem $VSTM is getting its proverbial second chance.
Once battered, bruised and left on the ropes after the complete failure of the initial strategy mapped by Christoph Westphal, the executive team at Verastem snapped up a tarnished star as Infinity happily handed off its perfectly approvable — but commercially unexciting — PI3K drug duvelisib for exactly nothing up front.
Today, the FDA did its part, handing over an accelerated approval for the drug, which will now be sold as Copiktra, the only gamma/delta inhibitor on the market for third-line cases of chronic lymphocytic leukemia/small lymphocytic lymphoma. And the agency also offered up a tandem OK as a 3rd-line therapy for follicular lymphoma.
Further hampering its market potential, the FDA is stamping the label with a black box warning of 4 potentially lethal toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.
Oncologists often call for new therapies that they can consider for dying, drug resistant patients. And now they have another one.
At one stage, AbbVie handed over $275 million upfront to partner on this drug, only to walk away when it proved to be another PI3K with severely limited commercial potential. AbbVie’s discard, though, still looked plenty good to Verastem, which retains high hopes for making something real out of this.
Verastem has a market cap of $657 million.
“Patients living with CLL/SLL or FL are in need of additional treatment options, and new therapies such as Copiktra are crucial because each patient’s treatment journey is unique,” said Meghan Gutierrez, the CEO of the Lymphoma Research Foundation.