Pfizer returns rights to Pfenex for Lucentis biosimilar

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Pfizer ($PFE), which considers itself a worldwide leader in biosimilars, has a major commitment on that front. In fact, in June it just committed to a new $350 million biosimilar manufacturing facility in China.

But the pharma has reconsidered its Lucentis biosimilar as competition mounts and ended a development deal with small cap Pfenex ($PFNX). The San Diego, CA-based company said the decision was part of a “strategic review of the current therapeutic focus of its biosimilar pipeline” by Pfizer.

Lucentis (ranibizumab) is marketed by Roche ($RHHBY) and partner Novartis ($NVS), both of which reported declining sales for the intraocular anti-VEGF (vascular endothelial growth factor) to treat retinal diseases. Sales of the drug were about $3.5 billion last year, down from around $4 billion in 2014.

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Its sales are under pressure with the rapid adoption in recent years of competitor Eylea (aflibercept) from Regeneron ($REGN) and partner Bayer ($BAY). In 2015, global Eylea sales were up by almost 50% to hit $4.1 billion.

"We will consider strategic options for PF582 following the expeditious transition of the full development program back to Pfenex,” said Pfenex CEO Bertrand Liang in a statement.

Pfenex originally partnered its Lucentis biosimilar, PF582, with Hospira in a February 2015 collaboration. Under the deal, the company received $51 million up front in addition to the ability to receive up to another $291 million in development and sales milestones as well as a tiered double-digit royalty on net sales.

Pfizer gained rights to PF582 when it acquired Hospira in September 2015.

The company also reported Phase I/II data for PF582 as compared to Lucentis to treat VEGF inhibitor-naïve patients with neovascular age-related macular degeneration. The 25-patient, three-month study found that PF582 met its primary endpoint of similar safety and tolerability between PF582 and Lucentis monthly intravitreal injections.

Pfenex underscored its latest partnership with Jazz Pharmaceuticals ($JAZZ) that it disclosed late last month. It gained $15 million in upfront and option payments with a potential to receive up to $166 million in development, regulatory and sales milestones as well as tiered royalties on any global sales of resulting products.

In fact, it’s now making development under that deal its top priority over what had been its lead internal program, PF530, a biosimilar for Bayer’s Betaseron to treat multiple sclerosis that had about $900 million in sales last year.

"As part of the Jazz collaboration, we have the opportunity to efficiently develop a portfolio of hematology programs,” said Liang. “Given this productive collaboration and our recent pipeline review, we have decided to advance the assets that are part of the Jazz collaboration ahead of the PF530 biosimilar Betaseron opportunity and reduce the expenses associated with PF530."

Pfenex also reported positive early data for its anthrax vaccine, which is partnered with the U.S.'s Biomedical Advanced Research and Development Authority.

- here is the PF582 release
- and here is Pfenex's earnings release
- finally, here is the anthrax data release

Related Articles:
Pfenex eyes a $75M IPO to bankroll its biosimilars
Pfizer cuts some biosimilar ties with Celltrion after its $17B Hospira deal
Pfenex snags a $143.5M anthrax contract with the feds
Fast Pfenex unveils $52M partnership deal with Merck

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