Pfenex : Adalvo announces positive CHMP opinion for Livogivatm (Teriparatide injection)
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06/29/2020 | 10:54am EDT
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(TM) (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.
About Adalvo
Adalvo is a global pharmaceutical company with a declared purpose to make a difference for patients around the world driven by our smart collaboration network and commitment to deliver highest quality differentiated products and services to our partners. Our business is fueled by our passion for relentless commitment to the customer network we serve. No half measures - we are always on target.
At Adalvo, we know that our customers like to be bigger, better and smarter in the dynamic pharmaceutical sector. That's why our approach is unique, customized and challenges the status quo that helps our partners achieve their business goals. We pride ourselves on helping our customers reach their goals - whether that's increasing revenues, pushing into new markets - we always play for the high score and to be on target for the partners we serve. While our clients are our highest priority, we're also committed to our purpose and our mission to accelerate the growth and development of our employees and local communities. We are Adalvo - a leading B2B pharmaceutical company.
