XBiotech (NASDAQ:XBIT) +1.8% after-hours following news it closed the sale of its True Human antibody bermekimab to Johnson & Johnson’s Janssen Biotech unit.
XBIT says it received $750M and could receive as much as another $600M upon completion of certain commercialization authorizations if Janssen pursues bermekimab indications outside of dermatology.
XBIT says it remains free to use its True Human antibody discovery program to develop other therapeutics and commercialize them for all non-dermatological diseases.
Acceleron Pharma teams up with Fulcrum Therapeutics in pulmonary diseases
Acceleron Pharma (XLRN -0.7%) inks a collaboration and license agreement with Fulcrum Therapeutics (FULC) aimed at identifying small molecules designed to modulate specific pathways associated with an undisclosed pulmonary disease indication.
The partnership will leverage Fulcrum’s know-how in identifying drug targets based on genetic pathway modulation with Acceleron’s expertise in TGF-beta superfamily signaling.
Acceleron will have access to Fulcrum’s proprietary product engine and target identification platform and will be responsible for all development and commercialization activities for identified candidates.
Under the terms of the agreement, Fulcrum will receive $10M upfront, up to $295M in milestones for the first commercialized product, up to $143.5M in milestones for subsequent products and mid-single-digit-to-low-double-digit royalties on net sales.
Urovant files U.S. application for vibegron for overactive bladder
Urovant Sciences (NASDAQ:UROV) has submitted its marketing application to the FDA seeking approval to use 75 mg of vibegron for the once-daily treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Under the terms of the agreement, Sumitomo Dainippon Pharma will provide Urovant with a $300M low interest, interest-only, five-year term loan facility, with no repayments due until the end of the term.
The proceeds from this facility will be used to repay existing debt, fund ongoing development projects, fund commercial launch of vibegron if approved by the FDA, and for general corporate purposes.
Health Canada grants licence amendment to MediPharm Labs’ Ontario facility
MediPharm Labs (OTCQX:MEDIF) has received a licence amendment from Health Canada allowing for production to begin in the recently expanded area of its specialized manufacturing facility in Barrie, Ontario.
This amendment increases MediPharm’s licensed facility footprint by around three times, or 16,746 sq. ft., to a total of approx. 25,000 sq. ft.
The expanded facility will, upon applicable GMP approvals, enable MediPharm to directly increase its GMP capacity for the international medical market and will immediately allow to produce greater quantities of GMP product.
