Chicago-area biotech sends 2nd drug to India’s regulators; Penny stock player spins out
Pharmazz is on its way to India’s drug regulator for the second time as its investigational treatment passed muster in a Phase III study in patients with acute ischemic stroke.
The Chicago suburbs-based biotech said its drug sovateltide led to better improvement than placebo on certain measurements of neurological outcomes.
Sovateltide led an improvement of ≥2 points on mRS and an increase of ≥6 points on NIHSS at day 90 in the trial of 158 adults in India. The modified Rankin scale looks at the degree of dependence in the daily activities of people post-stroke event, and the NIH stroke scale measures the stroke-related neurologic deficit.
Pharmazz expects to submit the drug for approval in India “shortly.” The 12-year-old biotech said the drug, licensed from Midwestern University in Downers Grove, IL, was well tolerated and had no drug-related adverse events. Pharmazz is also testing the drug in patients with Alzheimer’s.
The company already has one approved drug in India. The country’s regulator greenlit Lyfaquin, or centhaquine, in May 2020 for patients with hypovolemic shock. Centhaquine is also in clinical trials in patients with acute respiratory syndrome due to Covid-19, septic shock and other conditions. — Kyle LaHucik
Penny stock biotech spins out PhIII cancer candidate into new company
Citius Pharmaceuticals, a penny stock biotech, believes its shares are undervalued. And execs are hoping splitting the company into two will change that.
New Jersey-based Citius plans to spin off I/ONTAK — a Phase III recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments — into a new, publicly-traded company. The rest of the pipeline, including an experimental antibiotic lock solution named Mino-Lok, will remain at Citius.
“As Citius prepares for the commercialization of its two late-stage product candidates, I/ONTAK and Mino-Lok, we believe that the market has not adequately valued the potential of our recent I/ONTAK licensing agreement,” Leonard Mazur, chairman and CEO, said in a statement.
The yet-unnamed new company will be a pure-play oncology-focused drugmaker, he added, while Citius retains a diversified portfolio.
Citius licensed I/ONTAK from India’s Dr. Reddy’s Lab back in September. It is a reformulated version of ONTAK, which was previously FDA-approved for a rare form of non-Hodgkin lymphoma but ultimately withdrawn due to manufacturing issues. — Amber Tong
Switzerland’s Helsinn builds R&D hub in US as it ramps up clinical work
Having officially unveiled its new focus on targeted cancer therapies earlier this year, Helsinn — the Swiss pharma that built its name on supportive cancer care — is building a new R&D hub in the US to support the strategy.
The new unit, to be housed at its US subsidiary, will be tasked with the clinical work around a growing pipeline, Helsinn said.
The first of those will be infigratinib, the FGFR tyrosine kinase inhibitor it licensed from BridgeBio. As part of an updated deal, the development responsibility is moving from BridgeBio to Helsinn. — Amber Tong