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Bayer's Nexavar suffers setback in liver cancer trial

World News | March 11, 2014


Kevin Grogan

Bayer's Nexavar suffers setback in liver cancer trial

Bayer and Amgen's Onyx Pharmaceuticals unit say that a late-stage trial of Nexavar as an adjuvant therapy for liver cancer did not meet its primary endpoint.

The Phase III trial evaluated Nexavar (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma who had no detectable disease after surgery. However the drug did not meet its primary endpoint of improving recurrence-free survival.

Bayer said safety findings were consistent with the known profile of Nexavar, which is already approved for advanced kidney and liver cancers and is a major earner for the group. Data from the study will be submitted for presentation at an upcoming scientific congress.

Joerg Moeller, head of global development at Bayer HealthCare, said "we are disappointed that the trial did not meet its primary endpoint. However, we remain committed to exploring the full potential of sorafenib in all stages of liver cancer".

Bayer passes on double-chin treatment

Meantime, Bayer is to sell back the non-North Amercian rights to a late-stage treatment for the reduction of submental fat (double chin) to Kythera.

The German group licensed the rights to ATX-101, a formulation of a purified synthetic version of deoxycholic acid, in 2010. However, "while we believe ATX-101 will fulfil an unmet global need, Bayer's strategic focus has evolved" since it licensed the drug, said Erica Mann, head of its consumer care division.

Under the new agreement, Bayer will receive $33 million in Kythera common stock, plus a $51 million promissory note, payable no later than 2024. The Leverkusen-headquartered major is also eligible to receive certain long-term sales milestone payments.

Ms Mann added that "our decision to take an equity position in Kythera is a testament to our belief in the potential for ATX-101". It is expected to be filed with the US Food and Drug Administration in the second quarter of 2014.

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