Perrigo (PRGO) announced that it has entered into a licensing agreement with a subsidiary of Merck & Co (MRK) for the exclusive rights in the United States to pursue regulatory approval for a non-prescription, over-the-counter Nasonex Nasal Spray. Under the terms of the agreement, Perrigo holds exclusive rights to market, sell, and distribute a non-prescription version of Nasonex OTC in the United States following Perrigo’s receipt of all necessary regulatory approvals. Financial terms of the licensing agreement were not disclosed.
Thursday, August 9, 2018
BeiGene initiates new Phase 3 trial of tislelizumab in China for NSCLC
BeiGene dosed the first patient in a Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy, as a potential first-line treatment in China for patients with Stage IIIB or IV squamous non-small cell lung cancer, or NSCLC. Tislelizumab is also being studied in global Phase 3 trials in solid tumors, including second-line NSCLC, first-line hepatocellular carcinoma, and second-line esophageal squamous cell carcinoma; two global Phase 2 trials in previously treated advanced hepatocellular carcinoma and relapsed/refractory mature T- and natural killer-cell lymphomas; a Phase 3 trial in China in non-squamous NSCLC; and two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin’s lymphoma and second-line urothelial cancer. The trial is designed to compare progression-free survival .
Emergent BioSolutions to acquire PaxVax
PaxVax announced that it has entered into a definitive agreement to be acquired by Emergent BioSolutions. PaxVax is majority owned by an affiliate of Cerberus Capital and Ignition Growth Capital is a minority shareholder in the company. The agreement will create a significant focus on protecting against emerging and overlooked infectious diseases through the development and commercialization of novel specialty vaccines, while ensuring uninterrupted supply of Vaxchora and Vivotif. PaxVax has integrated capabilities across R&D, manufacturing and commercial operations that add value to Emergent’s core business. The combined company will support the development of even more vaccines in areas of significant unmet need, with a commitment to addressing emerging and recalcitrant global health threats. PaxVax marketed assets include Vaxchora, the only FDA approved and Advisory Committee on Immunization Practice, or ACIP, recommended vaccine for protection against cholera, a disease caused by Vibrio cholerae serogroup O1, and Vivotif, an oral vaccine for typhoid fever that is currently licensed for sale in 27 countries. The acquisition is subject to customary closing conditions, including U.S. antitrust regulatory approval, and is expected to close in Q4.
Nektar to report additional data in coming months, says Mizuho
Mizuho analyst Difei Yang reiterates a Buy rating on Nektar Therapeutics with a $103 price target following last night’s Q2 results. Data readouts of NKTR-214 remain the main catalyst for the shares, Yang tells investors in a research note. She points out that management expects to present data at a number of conferences in the coming months, including melanoma data at the Society for Immunotherapy of Cancer on November 7-11. While details on additional data in other indications “were sparse,” data should be announced over the coming six-to-eight months, Yang contends.
Diplomat Pharmacy selloff creates good entry point, says JPMorgan
After hosting investor meetings with management, JPMorgan analyst Lisa Gill says the recent pullback in shares of Diplomat Pharmacy provides a good entry point. The meetings were positive with management highlighting the growth opportunities in both the specialty and pharmacy benefit management businesses, Gill tells investors in a research note. Further, she viewed the company’s commentary as favorable around the potential impact of President Trump’s drug price blueprint. The analyst reiterates an Overweight rating on Diplomat Pharmacy with a $27 price target.
Amneal cuts FY18 adjusted EPS view to 90c-$1.00 from 95c-$1.10
Consesus for FY18 EPS is $1.02. Lowers FY18 adjusted EBITDA view to $580M-$620M from $600M-$650M. Still sees 2018 CapEx $80M-$100M.
Endo price target raised to $19 from $11 at Citi
Citi analyst Liav Abraham raised her price target for Endo International to $19 saying the Q2 results validated her Buy thesis, which is predicated on “solid execution” across the core businesses and the opportunity inherent in the company’s CCH cellulite opportunity. She sees more upside in shares of Endo and keeps a Buy rating on the shares.
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