Bayer/Onyx Pharma’s Nexavar Among MHLW’s Pre-Golden Week Approval Rush

Japan's Ministry of Health, Labor and Welfare's drug approval advisory body, the Pharmaceutical Affairs and Food Sanitization Council's second committee on new drugs April 27 recommended Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib) for approval for the additional indication of advanced hepatocellular carcinoma.

The recommendation comes with the same all-case surveillance post-marketing conditions previously applied to Nexavar when it was approved in Japan for advanced renal cell carcinoma in June 2006.

The additional indication of HCC was submitted by Bayer's Japanese subsidiary, Osaka-based Bayer Yakuh in September 2007, and was supported by Phase III trial results that showed the drug improved overall survival by three months compared to a control group. The MHLW granted the drug a fast-track review January 2008.

Approved in more than 60 countries worldwide, Nexavar is jointly developed and marketed by Bayer and California-based Onyx Pharmaceuticals in the U.S. According to a collaboration and co-promotion deal, the two firms equally share development costs as well as profits and losses. Everywhere else in the world except Japan, Bayer has exclusive marketing rights and the two firms split the profits. In Japan, Bayer foots all development expenses but receives royalties.

A multi-targeted anticancer agent, Nexavar targets both tumor cells and tumor vasculature by inhibiting members of two classes of kinases known to be involved in cell proliferation and angiogenesis. Bayer is investigating Nexavar's ability to target other tumors; sorafenib is currently being investigated in several ongoing trials in non-small cell lung cancer, breast cancer and other tumor types.

In order to raise R&D funding for clinical trials, Bayer signed a deal in March to provide partner Genzyme with full rights to oncologics Campath (alemtuzumab), Fludara (fludarabine) and Leukine (sargramostim). The deal could bring in as much as $650 million for the company to strengthen oncology business centered around Nexavar. (Also see "Genzyme Strengthens Oncology And MS Portfolios With Bayer Deal" - Pink Sheet, 3 Apr, 2009.)

However, Nexavar has recently had some difficulties. Bayer announced April 27 that a Phase III trial in patients with advanced melanoma was stopped for futility because results did not meet primary endpoints. (" (Also see "No Joy In Bayer/Onyx’s Phase III With Nexavar For Melanoma" - Pink Sheet, 27 Apr, 2009.))

In Japan, Bayer Yakuhin March 26 reported financial results for fiscal year 2008; the company achieved sales of ¥147,997 million, a 4.5 percent increase over the previous year.

Lilly's Alimta, Mitsubishi Tanabe's Valixa Among Other Approvals

On the same day, the committee also recommended two more drugs for approval: Lilly's Alimta , and Mitsubishi Tanabe's Valixa .

Eli Lily Japan obtained manufacturing and marketing approval for Alimta (pemetrexed) injection 100 mg and approval for Alimta injection 500mg for an additional indication to treat inoperable and progressive non-small cell lung cancer. The drug was previously approved in Japan in January 2007 to be used with cisplatin to treat malignant pleural mesothelioma. The post-market condition of all case surveillance will be applied to the new dosage (100mg) and the additional indication.

Mitsubishi Tanabe Pharma also obtained approval for antiviral Valixa(valganciclovir) tablets 450mg for an additional indication to treat cytomegalovirus infection caused by organ transplant and malignant tumors. Valixa was approved in 2004 to treat cytomegalovirus retinitis in AIDS patients in Japan. A post-market condition of all-case surveillance will be continuously applied to the additional application.

The three approvals came just days after a batch of as many as 12 drugs obtained approvals from the MHLW. (PharmAsia News April 29 2009)

The rush of approvals could be the Ministry's most recent effort to ease the drug lag right before the week-long Golden Week holidays in Japan, which begin April 29.

- Brian Yang ([email protected])