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PGx Drugs Xalkori, Zelboraf Show Strong Growth in First Quarter of 2013


In the first quarter of this year, pharmacogenetically targeted cancer drugs Xalkori and Zelboraf had marked increases in revenues from the previous year's quarter.

Meanwhile, during the first three months of this year, several newly launched PGx drugs in Roche's pipeline are starting to generate revenues.

Pfizer reported a 212 percent increase in worldwide revenues in the first quarter for personalized non-small cell lung cancer drug Xalkori (crizotinib) from the year-ago period. In the first quarter of 2013, the drug brought in $53 million in revenues, up from $17 million in the comparable quarter last year. Of the $53 million in revenues, the drug netted $28 million in the US in the first quarter, up from $14 million a year ago. Outside of the US, Xalkori revenues during the quarter were $25 million, up from $3 million a year ago.

Xalkori is a NSCLC treatment for patients whose tumors harbor ALK rearrangements, which comprise between 3 percent and 5 percent of NSCLC patients. The US Food and Drug Administration approved the drug in mid-2011.

Pfizer broke out drug revenues from developed European regions including Western Europe, Finland, and Scandinavian countries; from other developed markets around the rest of the world, including Australia, Canada, Japan, New Zealand, and South Korea; and from emerging markets, including but not limited to parts of Asia, Latin America, the Middle East, Eastern Europe, Africa, Turkey, and Central Europe. Xalkori earned $12 million in revenues from developed European countries, $10 million from other developed areas around the world, and $3 million from emerging markets.

Currently, Xalkori is the only pharmacogenetically targeted drug paired with a companion diagnostic in Pfizer's pipeline. The company, however, is working on other drug/test combination products. Earlier this year, Agilent subsidiary Dako and Pfizer inked a deal to collaborate on multiple projects to advance companion tests for Pfizer's drugs (PGx Reporter 2/13/2013).

Pfizer's molecularly targeted leukemia drug Bosulif (bosutinib) was granted conditional marketing authorization by the European Commission in January. The FDA approved the drug late last year for patients with chronic phase, accelerated phase, and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia who have received treatment with one or more tyrosine kinase inhibitors and who are non-responsive to Gleevec (imatinib), Tasigna (nilotinib), and Sprycel (dasatinib). The company didn't break out revenues from this drug in the first quarter earnings report.

Meanwhile, Roche reported total sales of 84 million Swiss Francs ($90 million) for the melanoma drug Zelboraf (vemurafenib), a 154 percent increase from the previous year's first quarter. Zelboraf is indicated for melanoma patients whose tumors harbor BRAF V600E mutations. The drug brought in 32 million Swiss Francs in the US market, marking a 19 percent increase from the first quarter of 2012, as well as 46 million Swiss Francs from Europe and 6 million Swiss Francs in other international markets, marking a more than 500 percent jump in revenues in both of those regions.

The FDA approved Zelboraf and a companion BRAF mutation test in mid-2011. Approximately 50 percent of melanoma tumors harbor mutations in the BRAF gene.

"Zelboraf has established itself as the standard of care for BRAF mutation-positive metastatic melanoma in key markets such as the US, the UK, and Germany," Roche said in a statement announcing its first-quarter financial results. "Future growth is expected to come from reimbursement approval in markets such as France, Spain, Italy, and Australia, as well as new launch countries."

In recent months, Roche subsidiary Genentech has developed and garnered regulatory approval for several personalized cancer drugs, including Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine), which have started to bring in revenues. Perjeta, in combination with another personalized breast cancer drug Herceptin (trastuzumab) and docetaxel, is a treatment for HER2-positive breast cancer patients with metastatic or locally recurrent, unresectable disease, who haven't received anti-HER2 treatments or chemotherapy for their advanced stage cancer.

The FDA approved Perjeta, alongside several companion tests, in June 2012. The drug had worldwide sales of 50 million Swiss Francs in the first quarter, 44 million Swiss Francs from the US, 5 million Swiss Francs from Europe, and 1 million Swiss Francs from other international markets.

Kadcyla was approved by the FDA in February as a treatment for HER2-positive metastatic breast cancer patients who have received prior treatment with another HER2-targeted drug, Herceptin, and a taxane chemotherapy. The drug is an antibody-drug conjugate in that it combines Herceptin with the chemotherapy DM1 via a stable linker. Since its approval, Kadcyla brought in 18 million Swiss Francs, all of which came from the US market.

Herceptin, Roche/Genentech's original personalized medicine breast cancer drug, is still a top seller for the company. The drug had sales of 1.6 billion Swiss Francs in the first quarter of this year, an 11 percent increase from the year ago period. Roche attributed the revenue growth to increased use in the US, Brazil, and in China. Between 15 percent and 20 percent of all breast cancers tumors overexpress the HER2 protein.

Although Roche has not yet garnered approval in the US for Tarceva (erlotinib) as a NSCLC treatment for patients with EGFR mutations, the drug did receive a positive decision as a first-line treatment in EGFR-mutated NSCLC from the EC two years ago. As such, some portion of the drug's 336 million Swiss Francs in first-quarter worldwide sales is likely due to use of Tarceva in the PGx-defined population, but Roche hasn't broken out that figure.

Astellas, an affiliate of OSI Pharmaceuticals, and Genentech jointly market Tarceva in the US as a treatment for advanced NSCLC and advanced pancreatic cancer. Astellas announced in January that it had submitted with the FDA a supplemental NDA for Tarceva for first-line treatment of NSCLC in patients with EGFR mutations and that Roche had at the same time submitted a companion EGFR mutation test to pick out best responders to the drug.

Separately, Amgen and Bristol-Myers Squibb both market metastatic colorectal cancer drugs for patients without KRAS-mutation positive tumors. Between 30 percent to 50 percent of colorectal cancers harbor KRAS mutations, and therefore, cannot receive these drugs.

In the first quarter, Amgen's Vectibix (panitumumab) garnered $87 million in worldwide sales compared to $90 million from the previous year, marking a 3 percent decrease. BMS's Erbitux (cetuximab) – a treatment for KRAS wild-type colorectal cancer and head and neck cancer -- brought in $162 million in first quarter worldwide sales, a 9 percent dip from $179 million during the same period last year.