Pfenex Announces U.S. Commercial Launch of Teriparatide Injection

Pfenex announced its commercialization partner, Alvogen, has launched Teriparatide Injection in the United States. Teriparatide Injection (also referred to as PF708 and Bonsity™) is a prescription medicine approved for several uses, including in postmenopausal women with osteoporosis who are at high risk for having bone fractures.

Teriparatide Injection is the first teriparatide product since Forteo® (teriparatide injection) approved for this use. The Alvogen product is pharmaceutically equivalent to Forteo (that is, has the same active ingredient in the same strength, dosage form and route of administration) and has been shown to have comparable bioavailability. These characteristics allowed the product to be approved under a 505(b)(2) NDA for which Forteo was the reference drug. It may provide a lower-cost teriparatide option4 for increasing bone density in patients at high risk for fracture5, and is FDA-approved for the same indications as Forteo, which means it can be used for the same patients as Forteo, including new patients and those currently responding to treatment.

“We are pleased to announce the availability of Teriparatide Injection in pharmacies - the first new FDA-approved teriparatide, which provides an alternative to Forteo,” said Pfenex CEO Eef Schimmelpennink. “As the first Pfenex-developed product to reach the market, this marks an important milestone for the company and delivers on the promise of the Pfenex Expression Technology platform.”

“Alvogen is excited to bring this critical product to patients in need of a lower-cost alternative to Forteo,” said Lisa Graver, President of Alvogen, Inc. “We are happy to partner with Pfenex to bring this product to market.”