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Adalvo announces positive CHMP opinion for Livogivatm (Teriparatide injection)

29 June 2020

New commercialization agreement in Latin America announced with a large, multinational pharmaceutical firm.

Adalvo today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Livogiva™ (teriparatide injection), previously referred to as PF708, a biosimilar product candidate to the reference medicine Forsteo® (teriparatide injection) indicated for use in postmenopausal women with osteoporosis who are at high risk of having bone fractures. The CHMP’s recommendation will now be considered by the European Commission.

Adalvo (on behalf of Alvogen) and Pfenex enterered into an exclusive agreement in June 2018, granting Adalvo/Alvogen exclusive rights to commercialize Pfenex’s lead drug candidate, PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®, in the United States.

“We are excited by the potential market opportunity that Livogiva, if granted marketing authorization by the European Commission, may offer as a biosimilar to Forsteo® and the potential to enhance patient access to this important product. The marketing authorization, if granted, would represent our first marketing authorization for a biosimilar productapproval and underlines significant market access capabilities for Adalvo that deals with complex product filings and registrations in global markets. We are also pleased to announce our partnership with a leading commercial player in the LATAM region to commercialize PF708, upon granting of applicable marketing authorizations, to potentially offer an alternative solution to patients in additional countries.”

Anil Okay

General Manager of Adalvo

If the European Commission affirms the CHMP opinion, it will grant a centralized conditional marketing authorization, with unified labeling that is valid in the 27 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. The version of Livogiva that is approved for marketing in the United States is Teriparatide Injection (previously referred to as PF708, as well as Bonsity), which the U.S. Food and Drug Administration continues to evaluate for therapeutic equivalence to its reference drug Forteo®.

“Both the positive opinion from CHMP and the new commercialization agreement in Latin America represent important progress toward the global licensure and commercialization of PF708, which has the potential to improve patient access to this important drug throughout the world. Our work would not have been possible without the efforts of our global commercialization partner, Adalvo/Alvogen”

Eef Schimmelpennink

Chief Executive Officer of Pfenex

PF708 is a biosimilar product candidate to Forsteo®, which achieved $253 million in sales in the E.U. and $1.4 billion globally in 2019.

About PF708

PF708 was approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug, and commercially launched as Teriparatide Injection. Teriparatide Injection is indicated, among other uses, for the treatment of osteoporosis in certain patients at high risk for fracture. Pursuant to the Development and License Agreement with Alvogen, Pfenex has transferred the new drug application (NDA) for Teriparatide Injection to Alvogen, and Alvogen is responsible for manufacturing and commercializing the product in the U.S. and for fulfilling all regulatory requirements associated with maintaining the Teriparatide Injection NDA. Alvogen also has exclusive rights to commercialize and manufacture PF708 in the European Union (EU), certain countries in the Middle East and North Africa (MENA), and the Rest of World (ROW) territories (the latter defined as all countries outside of the EU, U.S. and MENA, excluding Mainland China, Hong Kong, Singapore, Malaysia and Thailand). A marketing authorization application for PF708, which will be branded in Europe as Livogiva, has been filed and accepted with the EMA using the biosimilar pathway with Forsteo® as the reference medicinal product, and the CHMP has issued a positive opinion; and a marketing authorization application for PF708 has been filed with the Kingdom of Saudi Arabia's SFDA.

Forteo® and Forsteo® are approved and marketed by Eli Lilly and Company for the treatment of osteoporosis in certain patients with a high risk for fracture.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern Pfenex's future expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, statements regarding the future potential of Pfenex’s developed products, product candidates, and the company in general, including the potential to obtain marketing authorization in the European Union for Livogiva ™ (teriparatide injection), previously referred to as PF708;, the potential to improve patient access; and expected market sizes and opportunities for Livogiva. Pfenex's expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors, including: the European Commission may not affirm the CHMP opinion and grant a centralized marketing authorization; the FDA may not grant an “A” therapeutic equivalence designation for Teriparatide Injection; Pfenex’s ability to successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates or may require Pfenex to conduct additional clinical trials or modify ongoing clinical trials or regulatory pathways; challenges related to commencement, patient enrollment, completion, and analysis of clinical trials; Pfenex's ability to manage operating expenses; impacts related to the COVID-19 pandemic; Pfenex's ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives; Pfenex's dependence on third parties for development, manufacture, marketing, sales and distribution of products; unexpected expenditures; litigation and other proceedings regarding intellectual property rights; and difficulties in obtaining and maintaining intellectual property protection for its product candidates. Information on these and additional risks, uncertainties, and other information affecting Pfenex's business and operating results is contained in Pfenex’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.