Pfenex Inc. (PFNX)

[Paullee]

PFenex Provides Update for PF708 Outside the United States
GlobeNewswire•October 11, 2019
New Exclusive Commercialization Agreements in South Korea, Canada, and Israel

Submission of Marketing Authorization Application for PF708 in Saudi Arabia

Potential approval of PF708 in the EU as early as the second half of 2020

SAN DIEGO, Oct. 11, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that its partner Alvogen has entered into exclusive commercialization agreements for PF708 with PharmBio Korea in South Korea, JAMP Pharma in Canada and Kamada Ltd. in Israel. Furthermore, Alvogen’s partner in the Middle East and North Africa (MENA) region, SAJA, submitted a Marketing Authorization Application (MAA) to the Kingdom of Saudi Arabia's Saudi Food and Drug Authority (SFDA). Additionally, the accepted MAA for PF708 under review by the European Medicines Agency (EMA) continues to make progress and Pfenex believes that PF708 could be approved in the European Union (EU) as early as the second half of 2020, pending marketing authorization by the European Commission under the EU centralized procedure and other factors.

“The new commercialization agreements in South Korea, Canada, and Israel, the filing of the PF708 MAA with the Saudi Food and Drug Authority, and the progress on Alvogen’s submission in Europe are important milestones for the PF708 commercialization program,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “These are just the latest steps forward in our global commercialization strategy for PF708 as we continue to build positive momentum with our commercial partner, Alvogen.”

Faysal Kalmoua, Executive Vice President of Alvogen’s Global Portfolio, added, “We are very pleased with the latest submissions for PF708 and new commercial agreements with our partners in Canada, South Korea and Israel. Through our strong marketing network and growing pipeline of biosimilars, we can continue to deliver on our mission to provide high quality, affordable healthcare for patients.”

Subject to applicable regulatory approvals, PF708 will be commercialized by PharmBio Korea in Korea, JAMP Pharma in Canada, and Kamada in Israel. Under the terms of the agreements, Alvogen will be responsible for overseeing the local activities through PharmBio Korea, JAMP Pharma and Kamada. Pfenex will be eligible to receive milestone payments and a percentage of net sales or transfer price.

PharmBio Korea was founded in 1999 by Mr. Bong-Kil Nam, its Chairman and CEO. With innovative marketing strategies and constructive partnerships, PharmBio Korea has developed a pipeline of innovative products and has licensed and marketed products in collaboration with pharmaceutical companies in the EU, Japan, and U.S.

JAMP Pharma is a private Canadian company that was established in 1988 in British Columbia. Its current headquarters is in Quebec. JAMP Pharma is a key player in the generic pharmaceutical industry and one of the fastest growing pharmaceutical companies in Canada.

Kamada Ltd. is a biopharmaceutical company specializing in the development, manufacture and marketing of proteins as pharmaceuticals. The Company's headquarters and laboratories are located in the park of Kiryat Weizmann Institute of Science in Rehovot, Israel.

About PF708

PF708 is approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. The FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk of fracture. Pursuant to the Development and License Agreement with Alvogen, Alvogen is responsible for commercializing and manufacturing PF708 in the U.S. and for fulfilling all regulatory requirements associated with maintaining the PF708 NDA. Alvogen also has exclusive rights to commercialize and manufacture PF708 in the 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 has been filed and accepted with the EMA using the biosimilar pathway with Forsteo® as the reference medicinal product and has been filed with the Kingdom of Saudi Arabia's Saudi Food and Drug Authority (SFDA). Forteo® and Forsteo® are approved and marketed by Eli Lilly companies for the treatment of osteoporosis in certain patients with a high risk of fracture. Forteo® and Forsteo® achieved $1.6 billion in global product sales in 2018.

About Pfenex Inc.

Pfenex is a development and licensing biotechnology company focused on leveraging its Pfenex Expression Technology® to develop and improve protein therapies for unmet patient needs. Using the patented Pfenex Expression Technology platform, Pfenex has created an advanced pipeline of potential therapeutic equivalents, vaccines, biologics and biosimilars. Pfenex’s lead product candidate is PF708, a therapeutic equivalent candidate to Forteo® (teriparatide injection). PF708 has been approved in the U.S. for the treatment of osteoporosis in certain patients at high risk of fracture, and marketing authorization applications are pending in other jurisdictions. In addition, Pfenex is developing hematology/oncology products in collaboration with Jazz Pharmaceuticals, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology. Pfenex also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein used in prophylactic and therapeutic vaccines.

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