Pfenex Gets FDA Seal of Approval For Amgen's Forteo Biosimilar

Shares of the micro-cap biotech Pfenex Inc PFNX, which pulled back ahead of the PDUFA date for its Forteo biosimilar PF708, were advancing Monday amid a positive outcome for the binary event.

FDA Hurdle Crossed

The FDA has approved its NDA for PF708 under the 505(b)(2) regulatory pathway, with Amgen, Inc. AMGN's Forteo as the reference drug.

PF708 has been indicated to treat osteoporosis in certain patients at high risk for fracture.

"The FDA's approval of PF708 marks a major milestone in Pfenex's history as our first approved commercial product and further validates our Pfēnex Expression Technology platform," CEO Eef Schimmelpennink said in a statement. 

The company said it now looks ahead to continue working with its commercialization partner Alvogen to launch the drug in the U.S.

Cost-Effective Alternative To Forteo

Amgen's Forteo had global sales of $1.6 billion in 2018.

PF708 has the potential to significantly enhance patient access to a therapy as a cost-efficient alternative to Forteo, according to Pfenex. 

Pfenex is seeking a therapeutically equivalent designation to Forteo that would permit automatic substitution of PF708 for Forteo in many states.

For this purpose, the company is conducting a comparative human factor study between the two drugs based on a mandate from the FDA. The company expects to submit the final study report to the FDA as early as the second half of October.

Milestone Payment Kicks In

The FDA approval has made Pfenex eligible to receive a $2.5-million milestone payment from Alvogen.

The company expressed confidence in partner Alvogen's plans for a commercial launch.

"To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating," according to Pfenex. 

Stock To Revisit Recent Highs?

Given the weakness in the runup to the PFUFA catalyst, it is likely the stock will gain some traction on the positive news.

It remains to be seen if the stock can attract enough buying to retest its mid-September high of $10.20.

The data for therapeutic equivalence rating and the commercial launch plans for PF708 could be key for the trajectory of the stock.

Pfenex shares were trading 9.12% higher at $8.14 at the time of publication. 

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