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MESO Gains After Hours, PFNX Gets It Back, CHRS' Humira Biosimilar Meets Goals

Pharma 080916

Coherus BioSciences Inc.'s (CHRS) ongoing phase III clinical study of CHS-1420, a biosimilar candidate to Humira, has met its primary equivalence endpoint. Humira is AbbVie's (ABBV) flagship drug.

The study demonstrated similarity between CHS-1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12. Both CHS-1420 and Humira were similarly well tolerated with similar safety profiles in the study.

Humira is approved by the FDA for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. The drug garnered sales of over $14 billion last year.

CHRS closed Monday's trading at $30.04, up 3.16%.

Shares of Mesoblast Ltd. (MESO) were up over 16% in extended trading on Monday, following positive phase II trial results of a single intravenous infusion of the company's proprietary allogeneic Mesenchymal Precursor Cell product candidate, MPC-300-IV in biologic refractory rheumatoid arthritis.

MPC-300-IV was well tolerated and demonstrated a dose-related improvement in the trial.

The company noted that the phase II results support the potential of its allogeneic cell therapy to be positioned as a first-line treatment option for biologic refractory patients, where there is a clear need for safe and effective treatments.

MESO closed Monday's trading at $4.28, down 0.70%. In after-hours, the stock gained 16.59% to $4.99.

Pfenex Inc. (PFNX) is all set to regain the full rights to PF582, a biosimilar candidate to Lucentis, from Pfizer Inc. (PFE).

Pfizer is returning the rights following strategic review of the current therapeutic focus of its biosimilar pipeline.

Pfenex entered into a collaboration with Hospira last February to develop and commercialize PF582 in a deal valued at $342 million. Pfizer gained rights to PF582, following the acquisition of Hospira last September.

Lucentis, marketed by Genentech, a subsidiary of Roche, is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
In 2015, sales of Lucentis were down 15% to 1.52 billion Swiss francs compared to 2014.

PFNX closed Monday's trading at $10.48, up 12.45%.

SIGA Technologies Inc. (SIGA.OB) has received approval from its Data Safety Monitoring Board to complete enrollment in the second and final cohort of healthy subjects for the phase III clinical study for its lead drug candidate, TPOXX, for the treatment of orthopoxvirus infections.

This phase III study is wholly funded by the Biomedical Advanced Research and Development Authority, or BARDA, and the company anticipates submitting the complete New Drug Application for TPOXX by the end of 2017.

SIGA.OB closed Monday's trading at $2.17, down 1.36%.

Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO) has relaunched its generic ofloxacin otic solution to treat bacterial ear infections.

The product was temporarily discontinued in April 2015 due to an issue concerning the active pharmaceutical ingredient supplier, which has been resolved.

The shipping of ofloxacin otic solution began on August 1, 2016 and will be available at most major retailers across the U.S., added the company.

VRX closed Monday's trading at $22.45, up 2.23%.

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