Chi-Med expands PhIII effort on savolitinib with AstraZeneca with amended royalty pact

Hong Kong-based Hutchison China MediTech has accelerated and expanded work on c-MET inhibitor candidate AZD6094 (savolitinib) through an amended license deal with AstraZeneca ($AZN) that covers a Phase III global trial.

In a release, Hutchison China MediTech, or Chi-Med, said the 2011 global licensing, development and commercialization agreement for savolitinib would be amended to add as much as $50 million over three years toward joint costs for the wider effort in return for potential higher royalties.

In June, Chi-Med received a $10 million milestone payment from AstraZeneca for candidate savolitinib after meeting Phase II targets in an expanded combination study on non-small cell lung cancer after initial results involving combinations with Tagrisso (osimertinib) or Iressa (gefitinib).

The initial $140 million deal, signed in 2011, saw AstraZeneca partner on the Chi-Med drug candidate. It included a $20 million upfront payment with a focus on China. Those terms remain, except for the royalty provisions the company said.

That effort and earlier work led to the amended pact, according to the release.

"Based on data from multiple Phase I/II studies, savolitinib has shown early clinical benefit as a highly selective c-Met inhibitor in a number of cancers," Chi-Med said in the release.

"As a consequence, savolitinib’s global development plan now covers multiple c-Met-driven solid tumor indications including non-small cell lung cancer (“NSCLC”), kidney, gastric and colorectal cancers."

Successful Phase III work could lead to a 5-percentage point increase to 18% in the global tiered royalty rate payable on savolitinib sales for Chi-Med across all indications--excluding China where Chi-Med is handling regulatory and other work, according to the company.

If total aggregate sales reach $5 billion, the agreement specifies a two-year period to step down to an ongoing royalty rate of 10.5% to 14.5%.

The Phase III effort will be the first pivotal study for c-Met-driven PRCC, the company said.

In March Chi-Med, also listed in London, raised $101.25 million on the Nasdaq in an initial public offering, making it the second China-focused biotech after BeiGene ($BGNE) to list in the U.S. this year.

- here's the release

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