Pfenex Inc. announced the achievement of several significant milestones across their business portfolio. Theramex, the European commercialization partner for Pfenex and Adalvo (formerly Alvogen B2B), received a positive opinion for PF708 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Additionally, Adalvo recently entered into a commercialization agreement with a multinational pharmaceutical company to commercialize PF708, upon receipt of marketing authorization, in certain countries in Latin America. Merck recently announced that V114, its investigational 15-valent pneumococcal conjugate vaccine met safety and immunogenicity objectives in initial Phase 3 studies in adults. Also, Serum Institute of India announced its first supply agreement with UNICEF for Pneumosil, a 10-valent pneumococcal vaccine developed to address pneumococcal infection in low- and middle-income countries. Both V114 and Pneumosil contain CRM197 produced via license agreements to the Pfenex Expression Technology, pursuant to which Pfenex may earn development milestone payments and royalties on net product sales. StreetAccount issued a release that erroneously described Livogiva as a Teva product. In order to address this incorrect information, Pfenex asked the NYSE to temporarily halt trading in Pfenex’s stock. The Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for PF708, which will be branded in Europe as Livogiva (teriparatide injection), a biosimilar product candidate to the reference medicine Forsteo (teriparatide injection) indicated for uses including in postmenopausal women with osteoporosis who are at high risk for having bone fractures. The CHMP’s recommendation will now be considered by the European Commission, which typically issues a decision within 67 days of CHMP’s recommendation. If the European Commission affirms the CHMP opinion, it will grant a marketing authorization with unified labeling that is valid in the more than 25 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 (FDA) continues to evaluate for therapeutic equivalence to its reference drug Forteo. In addition, Pfenex announced Adalvo has partnered with a large, multinational pharmaceutical firm to commercialize PF708, upon receipt of marketing authorization, in Brazil, Columbia, Mexico, Ecuador, Paraguay, and Peru in Latin America. Serum Institute of India announced a new arrangement with UNICEF to supply ten million doses of Pneumosil, a 10-valent pneumococcal conjugate vaccine, annually for a period of ten years. The supply arrangement will allow low- and middle-income countries to access the drug. Pneumococcus bacterium is a leading cause of severe pneumonia and major cause of morbidity and mortality worldwide. The arrangement was contracted under UNICEF’s Vaccine Alliance’s Advance Market Commitment and represented the first such arrangement between UNICEF and a developing country manufacturer. Serum Institute currently has a license to the Pfenex Expression Technology for the production of the carrier protein CRM197 a key component of the Pneumosil vaccine. In accordance with the license agreement, Pfenex is eligible to receive royalties on net sales. Merck and Co. Inc. announced results from two initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine and were published via the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) online digital library. Merck also announced its plans to continue to work with the FDA and other regulatory authorities around the world on filing plans for licensure of this vaccine as additional data from the Phase 3 program become available. Merck currently has a license to the Pfenex Expression Technology for the production of the carrier protein CRM197 a key component of the V114 vaccine. In accordance with the license agreement Pfenex is eligible to receive milestone payments and royalties on net sales.