Seattle Genetics Inc. (Seagen) pulled the final thread out of a tie-up that's been unraveling for weeks by consenting to terminate the license agreement it forged in February with Immunomedics Inc. for the late-stage development, manufacturing and commercialization of IMMU-132 (sacituzumab govitecan) in multiple indications. The potential $2 billion deal called for $250 million up front and an equity investment of up to $57 million, or up to a 9.9 percent stake in Immunomedics, putting Bothell, Wash.-based Seagen in the driver's seat of the antibody-drug conjugate (ADC), which is set to begin a phase III trial in metastatic triple-negative breast cancer (mTNBC).
New-generation therapies for hepatitis C virus (HCV) have been wildly successful – so much so that they've caused a conundrum at market leader Gilead Sciences Inc., whose drugs Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg) and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) have produced high cure rates in patients with chronic HCV, leading to slumping sales. (See BioWorld Today, May 3, 2017.)
New-generation therapies for hepatitis C virus (HCV) have been wildly successful – so much so that they've caused a conundrum at market leader Gilead Sciences Inc., whose drugs Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg) and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) have produced high cure rates in patients with chronic HCV, leading to slumping sales. (See BioWorld Today, May 3, 2017.)
After a year of gathering feedback from regulators following completion of its phase II study, Soligenix Inc. said it reached accord with the FDA to advance SGX-942 (dusquetide) into a pivotal phase III study to treat oral mucositis in head and neck cancer (HNC) patients treated with chemoradiation (CRT).
Following a dismal year-end 2016 showing that pushed shares of Gilead Sciences Inc. to a three-year low, analysts were looking for signs of a business turnaround in 2017. Alas, for the Foster City, Calif.-based biopharma, that proved not to be the case.
Hope springs eternal in Alzheimer’s disease (AD), and Neurotrope Inc. sought to keep that aspiration alive when reporting top-line data from its phase II study of bryostatin-1 in patients with moderate to severe AD.
Formed three years ago, privately held Medeor Therapeutics Inc. is moving its lead cellular immunotherapy candidate, MDR-101, directly into a pivotal phase III study, with its investigational new drug (IND) application cleared by the FDA along with agreement to a special protocol assessment (SPA).
Bridgebio Pharma Inc. disclosed the second company in its growing portfolio of subsidiaries targeting genetic diseases, endowing Eidos Therapeutics with $27 million to advance its lead compound, AG-10, for the treatment of transthyretin (TTR) amyloidosis.
Despite a tepid response from payers to first approvals in the protein convertase subtilisin/kexin type 9 (PCSK9) drug class, The Medicines Co. (MDCO) plans to move aggressively into a pivotal phase III program for its candidate, inclisiran (formerly PCSK9si and ALN-PCSsc), after reaching agreement with the FDA on a study design to support submission of a new drug application (NDA), expected around year-end 2019.
Cowen and Co. analyst Eric Schmidt summed up the sentiment of analysts on Biogen Inc.'s first-quarter financials, headlining a note on the company's "solid" performance with the observation that the spinal muscular atrophy (SMA) drug Spinraza (nusinersen) was "sprinting out of the gates."
