GSK licenses Ionis' experimental hep B treatments in up to $262M deal
GSK $GSK may have walked away from two of Ionis’ $IONS antisense drugs (including the now-approved Tegsedi) in 2017 — but the British drugmaker held on as a partner to the biotechnology company’s experimental hepatitis B treatments.
On Tuesday, GSK exercised its option to license Ionis’ drugs — IONIS-HBVRx and IONIS-HBV-LRx — following positive mid-stage data. In return, Ionis receives up to $262 million in milestone payments, including a $25 million license fee. In addition, Ionis is also eligible to receive tiered royalties on net sales. Now, GSK is responsible for all development, regulatory and commercialization activities and costs for the two drugs.
Hep B is transmitted through contact with blood and bodily fluids of an infected person and is a highly infectious virus, 50 to 100 times more infectious than HIV — even slight lapses in infection control can result in patient-to-patient transmission. The chronic infection, which affects more than 200 million globally, can lead to life-threatening health conditions, including cirrhosis, liver failure and liver cancer. Current treatments that are effective in reducing circulating virus in the blood, do not efficiently inhibit antigen production and secretion, which are associated with poor prognosis.
The antisense drugs are engineered to address the root cause of the disease — by reducing the production of viral proteins associated with hep B infection and replication, including hep B surface antigen, which is found in both acute and chronic infections. Meanwhile, GSK already sells a hep B vaccine called Engerix-B.
Ionis has a myriad of big pharma partnerships under its belt, including Roche, Biogen, Bayer and AstraZeneca. Under chief Stanley Crooke, who founded the company about thirty years ago, Ionis has honed a model in which it develops antisense products for a plethora of indications, de-risks them in the clinic and then secures a pharma partner to conduct pivotal trials and commercialize. In return, the company profits from a steady stream of upfront and milestone payments, as well as royalties. Last December, Crooke disclosed plans to transition to the role of executive chairman in 2020.
Under research chief Hal Barron, GSK has been working on conjuring up some excitement for its pipeline by largely focusing on oncology, although other areas that are underserved are also of interest. In an interview with the Financial Times in July, he said that taking “smart risks” in R&D is how he sees the once glacial giant transforming its research work. “(O)nce you start fearing failure, you become so conservative that you end up basically moving towards things that are obviously going to work and therefore likely to be not very innovative . . . And, ultimately, it’s a death spiral.”
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