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Diving sheet:
- Janssen Biotech, of Johnson & Johnson, will end Friday a development and license agreement whose potential value will reach nearly $ 1 billion for Geron's imetelstat, an anticancer drug once considered a blockbuster potential.
- Geron CEO John Scarlett said his company would go ahead without the pharmaceutical giant, pursuing several clinical trials on the telomerase inhibitor. Biotechnology plans to launch a phase 3 study in mid-2019. The two pharmacists announced the end of the contract on Thursday morning.
- Investors in Geron seemed to jump with Janssen, as Geron's share price was down 71% in the open market.
Dive Insight:
J & J and Geron began collaborating with imetelstat in December 2014, when Janssen paid $ 35 million to biotech company Menlo Park, California.
The partnership gave the J & J subsidiary worldwide rights for the development and commercialization of Imetelstat.
The costs of phase 2 testing in myelodysplastic syndrome (MDS) and myelofibrosis (MF) were evenly distributed in the contract, with a potential value of up to $ 935 million with milestone payments and commercial development.
But Janssen was looking for a flagship drug in imetelstat that could generate significant revenue, said George Zavoico, senior equity analyst at B. Riley FBR, in an interview with BioPharma Dive.
In recent years, the markets of MDS and MF have become more fragmented with differentiation of chromosomal abnormalities and levels of risk. From Janssen's point of view, the reduced market share led to the decision that additional investments were no longer worth the potential yield, Zavoico noted.
"They do not think it will be a blockbuster anymore," he said.
But while Janssen is absent, Geron, as a small biotech, does not need a blockbuster, added Zavoico, who gave a rough estimate of the order of 100 to 150 million dollars to develop this drug. Geron has little choice but to plow ahead. Imetelstat is his only product candidate.
The company said on September 27 that it had $ 183 million worth of cash and marketable securities by the end of August, which it says will be enough to support its plan to launch a test of phase 3 next year. In its last annual report, Geron said it had 15 full-time and three part-time employees. Only two were involved in R & D.
With the departure of Janssen and his financial support, Geron raised his 2018 financial forecast of operating expenses from $ 30 million to $ 37 million. The company has not ventured far into the details for next year.
"It is a bit early to talk about the direction for 2019 at this point," said financial director Olivia Bloom Thursday to investors. "I think we need to have a better idea of what will be the whole transition plan and the timing of the study launch."
The company's latest quarterly ranking exposed the risk of Janssen leaving, noting that this would seriously damage business and commercial prospects and significantly delay or halt Imetelstat's development.
The managing director of Geron has never given up the possibility of joining a company for imetelstat, but said the company was focusing on "a plan to regain full control".
"Right now, we are focused on having total control over the product," said Scarlett, "then talking to other partners who may be interested, and I think many of them will be interested in the opportunities. offered by the former United States. "
Geron intends to present data from his Phase 2 MDS study at the American Society of Hematology conference in December.
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