Six days af­ter Genen­tech rolled out dis­ap­point­ing ear­ly-stage da­ta on its IDO1 drug GDC-0919 (navox­i­mod) in-li­censed from NewLink Ge­net­ics, the big Roche sub­sidiary is kick­ing it out of the pipeline.

NewLink $NLNK an­nounced that Genen­tech has hand­ed back all rights to the drug, though its dis­cov­ery part­ner­ship con­tin­ues. The can­cer drug spe­cial­ist is walk­ing away from a $1 bil­lion-plus deal that was inked with $150 mil­lion up­front.

NewLink’s shares cratered once again on the news, falling 31% by mid-morn­ing.

This is the lat­est in a se­ries of gut punch­es to NewLink, which was sent reel­ing last year and was forced to re­struc­ture in the wake of the fail­ure of its pan­cre­at­ic can­cer vac­cine. IDO, a hot tick­et in biotech now with In­cyte $IN­CY ev­i­dent­ly well in the lead, was sup­posed to be its path back.

The writ­ing, though, was on the wall when in­ves­ti­ga­tors re­port­ed that GDC-0919 de­liv­ered on­ly a 10% over­all re­sponse rate in all tu­mor types in a com­bi­na­tion study with Tecen­triq — a PD-L1 check­point that is al­so un­der a cloud since the big Phase III fail­ure in blad­der can­cer. Genen­tech is not known for pur­su­ing fu­tile work in can­cer.

NewLink was al­so forced to con­cede 6 days ago that its in-house IDO in­hibitor in­dox­i­mod failed a Phase II study for breast can­cer, mak­ing this a very bad, no good, aw­ful week for the biotech.

Charles Link Jr.

“We are ob­vi­ous­ly dis­ap­point­ed in this de­ci­sion,” said Charles J. Link, Jr., CEO of NewLink Ge­net­ics, in a state­ment. “We re­main com­mit­ted to ad­vanc­ing our IDO path­way in­hibitor in­dox­i­mod, which con­tin­ues to gen­er­ate ex­cit­ing da­ta in com­bi­na­tion with an­ti-PD-1 agents, can­cer vac­cines, and chemother­a­py in mul­ti­ple can­cer types in­clud­ing melanoma, prostate can­cer, acute myeloid leukemia, and pan­cre­at­ic can­cer.”

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.

Different therapeutic traits brandished by the three approved therapies for sickle cell disease all extend life expectancy, but their impact on quality of life is uncertain and their long-term cost-effectiveness is not up to scratch according to the thresholds considered reasonable by ICER, the non-profit concluded in a draft guidance report on Thursday.

Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.