CHICAGO – As most sessions in the American Society of Clinical Oncology (ASCO) meeting dealt with clinical testing of drugs, discovery of biomarkers and diagnostic techniques, other key findings rolled out that addressed another aspect of cancer, important but less often spoken about in therapeutic circles: the psychological distress of people afflicted with the disease.
In what CEO Dinesh Patel called a “front-end-loaded deal that is significant from now through successful completion of phase II trials,” Protagonist Therapeutics Inc. sealed a deal potentially worth $990 million with Janssen Biotech Inc., one of the Janssen Pharmaceutical companies of New Brunswick, N.J.-based Johnson & Johnson (J&J), for the co-development and commercialization of PTG-200.
After the success – but not absolute home run – by Shire plc with its injectable kallikrein inhibitor, lanadelumab, for hereditary angioedema (HAE), investor hopes swelled for Biocryst Pharmaceuticals Inc.'s oral BCX-7353, which underwent its second interim analysis of its three-part, dose-ranging phase II APeX-1 trial in the same indication with the same mechanism of action.
Wall Street scrambled to figure out the consequences of word from Amgen Inc. and partner UCB SA regarding the 4,100-patient phase III ARCH study with bone-forming agent Evenity (romosozumab) that turned up a surprise safety signal not seen in the previous FRAME experiment in more than 7,000 patients. "Romo nomo?" asked Leerink analyst Geoffrey Porges in a research report.
Santhera Pharmaceuticals AG's latest European holdup in getting the label expanded for Raxone (idebenone) did not dampen the enthusiasm of RBC Capital analyst Matthew Eckler, who allowed that the news "adds a wrinkle to the story" but predicted the nod for Duchenne muscular dystrophy (DMD).
As abstracts rolled out for next month's American Society of Clinical Oncology (ASCO) meeting in Chicago, Glycomimetics Inc. whetted the appetite for more data from an ongoing phase II trial with E-selectin antagonist GMI-1271 in acute myeloid leukemia (AML).
As developers of similar drugs sought signs of hope – despite negative safety signals – in the otherwise-favorable top-line phase III data with transthyretin (TTR) antisense inhibitor inotersen in familial amyloid polyneuropathy (FAP), Ionis Pharmaceuticals Inc. called out during its conference call one would-be competitor's candidate by name: patisiran, the RNAi therapy from Alnylam Pharmaceuticals Inc.
What chief business officer Curt Herberts called a "highly competitive process, with multiple parties expressing strong interest" in Sangamo Therapeutics Inc.'s hemophilia A program ended with Pfizer Inc. emerging as the best suitor in a deal that could be worth more than $500 million for gene therapy SB-525 as well as potentially other candidates.
With the migraine prevention space heating up, Eli Lilly and Co.'s Eric Pearlman told BioWorld Today that "having multiple options available and multiple voices trying to convey [the] message is a good thing for the patients" happy to see late-stage candidates make their ways toward market.
With phase II trials ongoing in chronic obstructive pulmonary disease (COPD) and low testosterone in obese men, Mereo Biopharma Group plc is launching a potentially pivotal phase IIb experiment called Asteroid testing BPS-804 in adults with the rare genetic disorder osteogenesis imperfecta (OI), also known as brittle bone disease.
