Pfenex and Alvogen Expand Development and Commercialization Collaboration for PF708

Pfenex Inc. and Alvogen Ltd. announced entering into agreements expanding their collaboration to develop and commercialize Pfenex’s lead product candidate, PF708, a proprietary teriparatide therapeutic equivalent candidate to Eli Lilly & Company’s Forteo/Forsteo, to the EU, to certain countries in Middle East and North Africa (MENA) the ROW territories (the latter defined as all countries outside of the EU, US and MENA, excluding Mainland China, Hong Kong, Singapore, Malaysia and Thailand). This collaboration leverages Alvogen’s established international experience and expertise in regulatory, IP and supply chain activities, as well as its established network of specialty marketing and sales pharmaceutical companies in these regions. Subject to applicable regulatory approvals, PF708 will be commercialized in Europe and Switzerland by Theramex, a leading global specialty pharmaceutical company dedicated to Women’s Health, in MENA by SAJA, a Tamer Group company, and in ROW by Alvogen’s current and/or future commercialization partners. Under the terms of the agreements, Alvogen will be responsible for the local activities through Theramex, SAJA and its other commercialization partners and for overseeing any clinical development, regulatory, litigation, commercial manufacturing and commercialization. Pfenex will be eligible to receive additional upfront and milestone payments of $2.5 million for EU and MENA and additional potential milestone payments for ROW. For EU, MENA and ROW, Pfenex may also be eligible to receive a gross profit split of up to 60% on product sales, depending on geography and cost of goods sold.

“Collaborating with Alvogen in Europe, MENA and ROW centralizes the development, regulatory and commercialization activities of PF708 and leverages Alvogen’s global supply chain and market access experience to maximize potential of commercial success in these markets. Combining these operational capabilities with the favorable financial terms of the agreements, makes partnering on regional commercialization for PF708 the optimal strategy,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “We believe working with Alvogen, coupled with the established and credible commercial partnerships with Theramex, Tamer Group (SAJA) and its other commercialization partners significantly enhances our commercialization strategy. We chose to expand our relationship with Alvogen on PF708 because the overall deal terms proposed were superior to the other regional players that we considered.”

“We continue to be excited by the market opportunity that PF708 offers as a therapeutic equivalent candidate to Forteo®. We believe this new collaboration in the EU, MENA and ROW will allow us to leverage our commercialization efforts in the U.S. and capture a larger piece of the teriparatide global market, which was approximately $1.6 billion in global sales in 2018,” stated Robert Wessman, Chief Executive Officer of Alvogen.

Anish Mehta, Chief Executive Officer at Theramex said, “As a leading women’s health company, we are delighted to be commercializing Pfenex’s proprietary teriparatide across Europe and Switzerland. The addition of teriparatide to our already broad portfolio of medications for the treatment of osteoporosis reinforces our commitment to helping women manage this potentially debilitating condition.”

“As part of SAJA’s long-stated vision to strategically invest in long-term partnerships with global pharma/biotech companies to bring solutions to patients in the MENA region, we are thrilled to welcome Pfenex/Alvogen as our new collaborator to bring new solutions to patients in the MENA region,” stated Riad Fanus, CEO of SAJA.

PF708 is being developed as a therapeutic equivalent to Forteo. In December 2018, we submitted our new drug application (NDA) for PF708 to the FDA and the FDA accepted the submission in February 2019, leading to potential launch in the U.S., if approved by regulators, as early as the fourth quarter of 2019, subject to regulatory approval and other factors. The NDA submission for PF708 is based on positive data from the PF708-301 Phase III clinical study announced in 2018, which showed comparable overall profiles between PF708 and Forteo after 24 weeks of daily injection in osteoporosis patients. In addition, the NDA includes data from the PF708-101 study, a single-dose, 2-way crossover study comparing the pharmacokinetics of PF708 and Forteo in healthy subjects.