Pfenex and Alvogen to Partner on Teriparatide Follow-on

Pfenex and Alvogen announced this week that they have entered into agreements to develop and commercialize PF708, a follow-on teriparatide product referencing Forteo, for the treatment of osteoporosis, in the European Union, some countries in the Middle East and North Africa, and other territories.

Subject to regulatory approval, the drug will be commercialized in the European Union and Switzerland by Theramex, in the Middle East and North Africa by SAJA, and in the remaining territories by Alvogen’s current and future commercialization partners.

Under the agreement, Alvogen will assume responsibility for the local activities carried out by Teramex, SAJA, and other commercialization partners, and will oversee clinical development, regulatory submissions, litigation, manufacturing, and commercialization activities. Pfenex may be eligible to receive a gross profit split of up to 60% on sales of the product.

Pfenex is currently awaiting regulatory approval for its drug, and in the United States, it submitted an application to the FDA for consideration in December 2018. Whereas in the European Union, subsequent-entry versions of teriparatide are regulated as biosimilars, in the United States, they are treated as follow-on products. Although many products treated as drugs by the FDA (like insulins and hormones) will be regulated as biologics beginning on March 23, 2020, teriparatide is not on the FDA’s preliminary list of products that will make that transition. Thus, the Pfenex product is expected to remain a follow-on in the US context.

As such, Pfenex has submitted an 505(b)(2) New Drug Application (NDA) rather than an abbreviated Biologics License Application for the product. A key feature of 505(b)(2) NDAs is that the pathway allows manufacturers to submit their drug products for FDA review by including data collected by the reference product sponsor, although, like the biosimilar approval pathway, the follow-on must be shown to be similar to the reference through bioanalytical testing, preclinical studies, and clinical trials.

In Pfenex’s case, it submitted a data package that included a 24-week study in 181 patients with osteoporosis. The study’s primary end point was the incidence of antidrug antibodies (ADAs) at week 24, and it found no differences in the number of patients who developed ADAs while taking the reference drug or while taking PF708.

Pfenex says that it expects to be able to launch PF708 in the United States as early as the fourth quarter of 2019.