Zantac pulled off shelves due to cancer scare; The end of the road for Motif Bio
→ GSK is recalling its heartburn medicine Zantac, sold generically as ranitidine, from all markets after the FDA found it contains “‘unacceptable’ levels of probable cancer-causing impurity.” The drug is one of several blood pressure and heart failure medications that have been pulled off the sheves since last year due to concerns about carcinogenic material introduced in the manufacturing process. Four Zantac prescription-only medicines are involved: a syrup, an injection and tablets of 150 and 300 milligram (mg) dosages. But the over-the-counter versions, which are produced by a different company, would not be affected, according to the UK’s Medicines and Healthcare products Regulation Agency.
→ 2019 has not been kind to Motif Bio, who was planning to launch and rollout its drug iclaprim, but was halted by a February complete response letter from the FDA that sent its stock crashing into penny stock territory. The company is now waving the white flag after hearing back from a meeting with the FDA. The short answer: they will need years and loads of cash — that they don’t have — in order to complete a trial. CEO Graham Lumsden had this to say: “We now have confirmation of what will be required to progress iclaprim towards a potential approval. The Company is working hard to find a partner or other entity to complete the HABP/VABP Phase III trial, commercialise iclaprim and ensure the best outcome for shareholders in Motif Bio.”
→ While Themis, backed by its partner Merck, was gearing up for a Phase III trial of its chikungunya vaccine last month, Emergent BioSolutions leapfrogged ahead with the announcement that its chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate has been granted EMA PRIME designation. The vaccine is intended to prevent the disease caused by the chikungunya virus infection, an illness that spreads through mosquito bites. No vaccine or treatment is currently available.
→ Citing “adverse market conditions,” ADC Therapeutics took an unexpected U-turn at the NYSE last week, but that hasn’t stopped the company from inking a collaboration with cancer-focused Avacta Group. Under the agreement, Avacta will provide Affirmer drug conjugates to be used against three undisclosed cancer targets. It will also provide these to ADC to aim its proprietary cytotoxic warheads (PBDs) at the site of the tumor.
→ With larger pharma companies turning to more lucrative prospects, smaller companies like MGB Biopharma have taken up most of the work in combatting the evergrowing threat of antibiotic resistance. MGB revealed a Phase IIa clinical trial update of its bactericidal antibiotic, MGB-BP-3, for the treatment of clostridium difficile-associated disease (CDAD) — an infection of the large intestine that is the most frequent cause of diarrhea in hospitals and care homes.
The company says that “the first cohort of patients has now completed treatment with the lowest dose and results indicate high efficacy and good tolerability of MGB-BP-3.” They’ve begun recruitment for the next cohort, with topline results from both Canada and the US anticipated in early 2020.
→ OncoSec, a late-stage intratumoral immuno-oncology company, announced an investment and option deal with Grand Decade, a subsidiary of China Grand Pharmaceutical (CGP). CGP and its affiliate Sirtex will invest $30 million in OncoSec. In exchange, CGP and Sirtex will receive a controlling share in OncoSec. The deal gives GCP an exclusive license to OncoSec’s current and future products and sets a minimum for price-per-share should CGP seek to acquire the rest of the company within the next year.