Trial flops see Pfizer cut GlycoMimetics pact, Merck ax KalVista research deal

Axe and chopping block
Two pharmas cut ties with two biotechs. (Pixabay/sierramurray)

Two Big Pharmas have decided to walk away from two small biotech deals after disappointing trial results: Pfizer from GlycoMimetics and Merck from KalVista Pharmaceuticals.

First up, Pfizer: The New York-based giant penned a deal with GlycoMimetics all the way back in 2011, teaming up with the biotech on its lead drug program for sickle cell disease and promising up to $340 million in a broad array of milestones and an unspecified upfront payment.

The partnership brought Pfizer to development of GMI-1070, an inflammation inhibitor that researchers had been testing in phase 2 for the painful vaso-occlusive crises that threaten the organs of sickle cell patients.

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Pfizer gained worldwide commercial rights to the treatment under the deal, with GlycoMimetics staying in charge of the midstage trial and then turning it over to the development team at Pfizer for further studies.

But, very quietly, GlycoMimetics announced through a Securities and Exchange Commission (SEC) filing that Pfizer is walking away from the deal.

The SEC filing said: “On February 5, 2020, GlycoMimetics received written notice from Pfizer of Pfizer’s termination of the License Agreement by and between the Company and Pfizer, dated October 7, 2011, as amended effective April 5, 2020.

“Upon termination, all rights and licenses granted to Pfizer under the License Agreement will terminate and Pfizer will return to the Company the rights to develop and commercialize the products subject to the License Agreement, including [sickle cell disease candidate] rivipansel, and will grant the Company a non-exclusive license to use the intellectual property developed by Pfizer in connection with its development of such products, subject to the terms of the License Agreement.

“The Company will work with Pfizer to effectuate any necessary transition activities regarding the subject matter of the License Agreement, and will be determining what, if any, next steps to take with respect to the rivipansel program after reviewing the Phase 3 data more completely.”

It added that it will not be hit by any termination penalties as a result.

RELATED: GlycoMimetics shares nearly cut in half as Pfizer-partnered phase 3 drug flops

This will not come as a major surprise, given that last year, the pivotal phase 3 for rivipansel failed its primary and key secondary endpoints in the so-called RESET trial, crushing GlycoMimetics shares.

And Pfizer wasn’t the only Big Pharma cutting ties with a biotech: Yesterday, Anglo-American biotech KalVista Pharmaceuticals said Merck was “not moving forward” with the company on its intravitreal diabetic macular edema (DME) candidate KVD001 (nor with future oral DME molecules).

In a press release, and not just a SEC filing, KalVista CEO Andrew Crockett said: ““We appreciate Merck’s willingness to work with us on the advancement of plasma kallikrein inhibitors for DME, and we respect their decision not to move forward.

“However, we believe that the efficacy signal observed supports the relevance of this target, and that there is a clear market opportunity for KVD001 and oral plasma kallikrein inhibitors in patients with this disease. Our focus in DME has always been to develop products that help patients protect their vision, and we will continue in this pursuit.”

Merck paid $37 million upfront to the biotech back in 2017 for the DME hopeful, with around $760 million tied in biobucks.

KalVista, which is also working on meds for hereditary angioedema, did not say why Merck was walking away from the deal, but in an echo of the Pfizer situation, KalVista’s kallikrein inhibitor KVD001 came up short in a phase 2 last year.

The midstage test was set up in patients who were poor responders to previous treatment with anti-VEGF therapy. The primary efficacy endpoint in the trial was change in best corrected visual acuity compared to a sham therapy, but it failed to hit statistical significance. No significant differences were seen in the secondary endpoints of central subfield thickness or the diabetic retinopathy severity scale.

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