Protocols

Roivant bags China rights to Nabriva’s antibiotic; Singapore’s Aslan Pharma lines up an $86M IPO to fund pivotal cancer drug studies

Roivant Sciences is doubling down on infectious diseases and the China market with a licensing agreement with Nabriva Therapeutics $NBRV, which is expecting data from a second Phase III for its lead antibiotic lefamulin this spring. For $5 million upfront, an undisclosed Roivant subsidiary gets an exclusive license to develop and commercialize the community-acquired bacterial pneumonia treatment in mainland China, Hong Kong, Macau and Taiwan. Nabriva is also in for up to $90 million in milestones, as well as double-digit royalties on sales. “This partnership demonstrates our commitment to build out a robust pipeline of products in China in addition to derazantinib,” said Roivant founder and CEO Vivek Ramaswamy. “It is also indicative of our desire to develop treatments for infectious diseases beyond hepatitis B virus.” Lefamulin had aced its first pivotal PhIII trial, and the Dublin-based company is expected to file for regulatory approval in the US after the second readout.

Carl Firth

→ With its lead oncology drug in a pivotal study for biliary tract cancer and a slate of key catalysts coming up in other trials, Singapore-based Aslan Pharmaceuticals has filed for an IPO on Nasdaq, with plans to raise around $86 million. Helmed by Carl Firth — the former BD chief for AstraZeneca in Asia who owns 4.7% of the stock — Aslan is a small biotech with a global strategy to roll out its cancer drugs in China, the US and Europe. The lead is varlitinib, a pan-HER drug that is also in the clinic for gastric, breast and colorectal cancers. The company plans to trade under the $ASLN symbol, taking advantage of the current hot market for biotechs.

→ In another validation for AveXis’ gene therapy, Japan’s Ministry of Health, Labour and Welfare has granted AVXS-101 a SAKIGAKE Designation — essentially the Japanese equivalent of AveXis’ breakthrough therapy designation in the US. The badge would give the Chicago-based company $AVXS, which has offered compelling Phase I data for infants with spinal muscular atrophy, prioritized and speedy treatments in the review process.

→ Esperion $ESPR reported good news from a Phase II study of its experimental oral drug bempedoic acid, taken in addition to Amgen’s Repatha. The trial met the main goal of reducing cholesterol by 30% in patients with high cholesterol. Esperion’s eight-week trial tested a dose of 180 milligram of bempedoic acid taken alongside Repatha compared with a placebo in 58 patients. Repatha is a PCSK9 inhibitor, a new class of medicines that block a protein that stops low-density lipoprotein (LDL), or bad cholesterol, from being removed from the blood. Esperion plans to submit a marketing application in the US for the drug by the first quarter of 2019, according to a company statement.


With contribution by Brittany Meiling and John Carroll.


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Biotech Primer Toronto 2018

Head of DMPK, Director
Magenta Therapeutics Cambridge, MA
Research Scientist - Disease Biology & Cellular Pharmacology
Recursion Pharmaceuticals Salt Lake City
Sr/Medical Director, Medical Affairs
A Rare Disease Biotech New Brunswick, NJ
VP, Pharmacovigilance
Aeglea BioTherapeutics Austin, TX
Process Scientist/Lead
Tmunity Therapeutics Philadelphia, PA

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