Pfenex said today it will regain full rights to PF582, a biosimilar version of Genentech’s eye treatment Lucentis® (ranibizumab injection) it had been developing with Hospira, after the Pfizer subsidiary ended a collaboration inked last year that could have generated up to $342 million for Pfenex.

In a statement, Pfenex said Hospira’s decision followed a strategic review of the therapeutic focus of its biosimilar pipeline.

“We will consider strategic options for PF582 following the expeditious transition of the full development program back to Pfenex,” the company’s CEO Bertrand C. Liang said in a statement. “Pfenex's development capabilities, leveraging our Pfenex Expression Technology® platform, has allowed us to advance a diverse portfolio of product candidates, including PF582, which we believe will create significant value for our shareholders.”

Hospira last year teamed up with Pfenex to develop and commercialize PF582 exclusively, agreeing to pay Pfenex $51 million upfront, up to $291 million tied to achieving development and sales-based milestones, plus tiered double-digit royalties on net sales of the Lucentis biosimilar.

The deal came just 5 days after Hospira announced that it had agreed to be acquired by Pfizer, a deal completed in September of last year for about $15 billion.

Pfenex today also released positive results from a Phase I/II trial. The first-in-human study met its primary objective of demonstrating similar safety and tolerability, as well as consistent pharmacological activity, between PF582 and Lucentis.

With respect to safety, Pfenex said, there were no meaningful differences in intraocular pressure at any timepoint, no imbalances in local or systemic adverse events, and no unexpected safety or tolerability findings.

As for efficacy, Pfenex added that there were no meaningful differences in best-corrected visual acuity, or in the decreases in central retinal thickness between PF582 and Lucentis at any timepoints.

In the Phase I/II trial, Pfenex enrolled 25 vascular endothelial growth factor (VEGF)-inhibitor naïve patients with neovascular age-related macular degeneration (AMD), of which 13 received PF582, while 12 received Lucentis. All patients received three monthly intravitreal injections. The study’s primary endpoint was safety and tolerability of PF582 compared to that of Lucentis in patients with neovascular AMD.

Pfenex disclosed the trial results and PF582 update along with releasing second-quarter results. The company finished Q2 with a net loss of $10.166 million, compared with a year-ago net loss of $5.983 million, on revenue that rose 37% year-over-year, to $3.135 million.

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