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Pfenex Expects To Be Alone With Teriparatide

Not Expecting Teva Entry Until Later Next Year

Executive Summary

Pfenex believes it and commercial partner Alvogen could enjoy an extended period as the only direct competitor to Eli Lilly’s Forteo teriparatide reference brand in the US.

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Pfenex And Alvogen Launch US Teriparatide

Pfenex marketing partner Alvogen has introduced the firm’s Bonsity version of teriparatide in the US. Representing the first Pfenex-developed product to hit the market, the launch comes as the companies are still awaiting a formal equivalence designation from the FDA.

Pfenex And Alvogen Suffer Teriparatide Setback

Pfenex and partner Alvogen have suffered a setback on their PF708 teriparatide in the US, after the country’s Food and Drug Administration asked for more information to support a long-awaited designation of therapeutic equivalence to the Forteo brand.

Pfenex Still Waiting For FDA Teriparatide Equivalence Designation

Hailing the past year as a "transformational period" in which "we moved towards being a business with an FDA-approved product nearing commercialization," Pfenex ended 2019 in profit and with cash in the bank, as it eyes the potential for a monopoly in the follow-on teriparatide market.

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