WITH INDUSTRY'S GROWING KIDNEY MOMENT, EVEREST BEGINS BUILDING KIDNEY PORTFOLIO

BY ALLISON JOHNSON, STAFF WRITER - BIOCENTURY, June 9, 2019

Everest Medicines added its first therapy to a planned renal portfolio on Monday through a deal with Calliditas.

The therapy, Nefecon (PL-56, Nefigan), is in the Phase III Nefigard trial to treat IgA nephropathy. It is an enteric formulation of budesonide that down-regulates the kidney's inflammatory process.

The drug is the first Everest Medicines Ltd. (New York, N.Y.) plans to in-license for renal diseases, Everest President and CFO Ian Woo told BioCentury, though he declined to provide details on how and when it will build out the portfolio.

Everest’s inclusion of renal therapies adds to the momentum the kidney space has seen recently. Last month, Gilead Sciences Inc. (NASDAQ:GILD) and Goldfinch Biopharma Inc. (Cambridge, Mass.) signed a drug discovery deal for kidney diseases that included $104 million up front and up to $1.95 billion in milestones (see "Gilead's Goldfinch Deal Signals Renewed Optimism in Kidney Therapies").

Everest will pay Calliditas Therapeutics AB (SSE:CALTX) $15 million up front to receive exclusive rights to develop and commercialize Nefecon in China, Hong Kong, Macau, Taiwan and Singapore. Calliditas is eligible to receive $106 million in development, regulatory and commercialization milestones, plus royalties.

IgA nephropathy accounts for 40% of primary glomerular diseases in China, much more than in Western countries, but Woo said the estimated number of patients with the disease varies widely and declined to provide one.

Everest said it will consult with regulatory agencies to add China sites to the Nefigard trial, which could lead to an accelerated approval in the country. Nefigard began enrolling elsewhere worldwide in November and top-line data are expected in 2H20.

CBC Group (formerly C-Bridge Capital) established Everest in 2017 to in-license small molecule programs from the West and develop them in China or elsewhere in Asia, and Nefecon is the ninth product for the company, Woo said.

In April, Everest entered what it called the largest single-asset deal for Greater China rights, when it acquired rights to antibody-drug conjugate sacituzumab govitecan from Immunomedics Inc. (NASDAQ:IMMU) (see "With Immunomedics ADC Deal, Everest Bolsters Cancer Pipeline").

Between its deals with Calliditas and Immunomedics, Everest has paid $80 million in upfront payments.

In May, Everest hired Wende Chen in May as its chief commercial officer. Chen, who also serves as an operating partner at CBC, was VP of corporate affairs, market access and channel management at the Chinese unit of Roche (SIX:ROG; OTCQX:RHHBY).

View the press release here.