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Theravance seals potential $1bn deal with J&J

Published on 08/02/18 at 10:01am

The JAK inhibitor field is beginning to heat up – AbbVie is soon to enter Phase 3 with its predicted best-in-class therapy, Gilead is working with Galapagos on a potential rival and Celgene started the year off with a $1.1 billion upfront deal for Impact Biomedicine, gaining them access to its JAK2 inhibitor.

Johnson & Johnson is the latest to join the field, with a prospective $1 billion deal with Theravance Biopharma. The deal is a tentative one, with $100 million being delivered upfront and the option to buy into the late-stage development of Theravance’s candidate, TD-1473. Should it opt-in, Janssen will shoulder 67% of the costs of any Phase 3 programs and pay an extra $200 million to gain the rights to the development of the pan-JAK inhibitor.

Janssen is playing it cautious by waiting on the results from Phase 2 trials into ulcerative colitis and Crohn’s disease but the payoff could be significant if Theravance’s unique angle on treatment is found to be effective and safe.

TD-1473 has been developed as an oral treatment that only becomes active in the small and large intestines – this means that the treatment should suppress inflammation only in those areas, avoiding systemic exposure.

“Internally, we have been very excited about the potential of TD-1473 to serve as a transformational medicine designed to offer the proven therapeutic activity of JAK inhibitors without the safety concerns associated with systemic JAK exposure. We believe this transaction can accelerate the development of TD-1473 and maximize the potential value of the program to Theravance Biopharma,” said Rick E Winningham, Chairman and Chief Executive Officer of the Theravance Biopharma group. “Janssen's expertise and experience from multiple clinical development programs in both ulcerative colitis and Crohn's disease, across a range of mechanisms of action, will be important in the development, regulatory, and commercial path forward for this program.”

If systemic exposure can be avoided, it opens up a pathway for Theravance to increase the dosage of the treatment, potentially making it more effective at treating inflammatory intestinal diseases compared to rivals.

Clearly Janssen believes this method of delivery is worth gambling on; should development prove successful, the two companies would co-commercialise in the US and Janssen would take ex-US rights and Theravance would be in line to receive double-digit tiered royalties on sales.

Ben Hargreaves

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