Eye on Pharma: Pfenex May Resume Biosimilar Development on Ranibizumab and Pegfilgrastim

The Center for Biosimilars Staff

In Pfenex’s fourth-quarter 2017 investor call, Evert Schimmelpennink, CEO, president, secretary, and director, hinted that Pfenex may be ready to resume work on 2 biosimilar candidates whose programs had been on hiatus.

In Pfenex’s fourth-quarter 2017 investor call this month, Evert Schimmelpennink, CEO, president, secretary, and director, hinted that Pfenex may be ready to resume work on 2 biosimilar candidates whose programs had been on hiatus.

Previously, in its 2017 third-quarter call held in November 2017, Pfenex announced the company’s “decision to pause development activities” for PF582, a ranibizumab biosimilar referencing Lucentis, and PF529, a pegfilgrastim biosimilar referencing Neulasta, after a strategic review of both costs and development timelines for the drugs.

In this month’s call, Schimmelpennink said, “We continue to believe that the most prudent path for the development is a collaboration with a strategic development partner. As that business development process continues, we continue to seek partners with whom we would advance those programs.” Halting development of the 2 programs lowered research and development costs to $7.2 million in the fourth quarter of 2017 compared with $10.7 million in the same period in 2016, said Schimmelpennink.

Pfenex previously partnered with Hospira on the ranibizumab biosimilar candidate, but after Pfizer acquired Hospira in 2016, Pfizer terminated the collaboration.

Pfenex did not address its progress on the third biosimilar its pipeline, a pegaspargase candidate referencing Oncaspar. The company’s lead products include PF708, a “therapeutic equivalent candidate” to teriparatide (Forteo) for the treatment of osteoporosis, and 2 novel anthrax vaccine candidates, Px563L and RPA563, which it is developing through a contract with the US government.

In addition, the company continues to develop hematology and oncology products in collaboration with Jazz Pharmaceuticals. Under Pfenex’s agreement with Jazz, Pfenex received upfront and option payment totaling $15 million, and may be eligible to receive payments of up to $166 million based on achievements of certain development, regulatory, and sales milestones.