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Drugmakers in Third Quarter Focus on Uptake of Newer Personalized Rx to Replace Older Versions

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Originally published Nov. 5.

Established personalized drugs, such as Roche's Herceptin (trastuzumab) and Novartis' Gleevec (imatinib), continued to bring consistent returns for drug sponsors in the third quarter, while the firms pushed for greater adoption of next-generation drugs that they hope will take the place of these earlier agents that are soon to face generic competition.

For the three months ended Sept. 30, 2013, Roche reported that its HER2-targeted breast cancer drug Herceptin brought in 4.6 billion Swiss Francs ($5.1 billion), a 6 percent increase in sales from the year-ago period. Roche recently garnered approval for Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine), two additional options for metastatic breast cancer patients whose tumors overexpress the HER2 protein. With the patent for Herceptin slated to expire next year in Europe and in four years in the US, Roche is hoping to maintain its leadership in the HER2-positive breast cancer space with these two drugs.

In the third quarter, Perjeta brought in sales of 186 million Swiss Francs globally, marking an increase of more than 500 percent from the previous year's quarter. From this total, 136 million Swiss Francs worth of Perjeta sales came from the US market, a 431 percent growth from the year-ago quarter. The US Food and Drug Administration approved Perjeta for the first-line treatment of HER2-positive metastatic breast cancer on Sept. 30, 2012, and the drug gained approval in Europe in March this year.

The FDA a month ago also granted accelerated approval for Perjeta in the neo-adjuvant setting, making it the first cancer drug to receive the agency's nod for this early-stage indication before patients receive surgery. This added indication, although for a smaller patient subset, will also help Roche grow its HER2-postive breast cancer franchise.

Kadcyla, meanwhile, had global sales in the third quarter of 156 million Swiss Francs, most of which were from the US. The FDA approved Kadcyla for later stages of HER2-positive metastatic breast cancer in February and the European Medicines Agency okayed it in September.

Similar to Roche, Novartis is also planning ahead for when Gleevec will completely lose patent protection, by pushing the sale of a newer chronic myeloid leukemia drug, Tasigna (nilotinib). For the three months ended Sept. 30, Novartis reported $1.1 billion in global sales of Gleevec, a 2 percent dip from Q3 2012 due to generic competition in certain ex-US markets. However, this was more than offset by a 25 percent increase in Tasigna sales, which contributed $315 million to Novartis' BCR-ABL franchise.

In a conference call to discuss the third quarter financial results, Novartis executives attempted to squelch investors' anxiety about generic competition for Gleevec. "I think there’s nothing to be concerned about there," David Epstein, head of Novartis' pharmaceutical division said during the call. "If you look at our ability to move the business from Gleevec to Tasigna, you see that Tasigna is a growing percentage of the business versus Gleevec, which is another good sign."

Gleevec is already facing generic competition in China and India. In the US, the patent for Gleevec's active ingredient is slated to expire in 2015, while the beta crystal formulation for the active ingredient will expire in 2019. In Europe, these patents expire in 2016 and 2018, respectively.

The market for CML treatments, which target the BCR-ABL transcripts that are the hallmarks of the illness, is an increasingly crowded one. Competitors to Gleevec and Tasigna include Pfizer's Bosulif (bosutinib) and Bristol-Myers Squibb's Sprycel (dasatinib). Less than a year ago, Ariad Pharmaceuticals had garnered FDA approval for Iclusig (ponatinib), which it touted as a treatment option for patients that had grown resistant to earlier treatment with tyrosine kinase inhibitors. However, due to serious safety concerns, Ariad temporarily halted sales of Iclusig last week (see related story, in this issue.)

"In terms of the Ariad safety issue, I think it just essentially means that there’s one less significant competitor in the market, which from our perspective is a good thing," Epstein told investors. He acknowledged that CML patients who become resistant to other TKIs do need alternative treatment options, and added that Novartis will update investors on the research it is conducting in this regard during its investor day.

Pfizer hasn't yet reported specific revenues of Bosulif. Third quarter sales for BMS' Sprycel grew by 20 percent from the comparable period in 2012 to $316 million. Following the decision to halt Iclusig sales, Ariad moved its third quarter earnings call from Nov. 6 to Nov. 12. In the second quarter, the company reported garnering nearly $14 million in Iclusig sales.

Newer PGx drugs that have recently entered the market for lung cancer and melanoma also showed strong growth in the third quarter. In non-small cell lung cancer, Roche's Tarceva (erlotinib) led the market netting 1 billion Swiss Francs in global sales and 473 million Swiss Francs in US sales, marking 5 percent and 12 percent growth, respectively, from last year's third quarter. Tarceva has benefitted from the fact that not only is the drug indicated for first-line NSCLC treatment in patients with EGFR-mutated tumors, but doctors can also prescribe it for all NSCLC patients with advanced or previously treated disease.

AstraZeneca's Iressa (gefitinib), an NSCLC drug for EGFR-mutated patients available only outside the US, saw a 12 percent increase in third quarter sales from the previous year to $165 million. Boehringer Ingelheim's Gilotrif (afatinib), approved by the FDA in July, will also compete with Tarceva and Iressa for the first-line EGFR-mutated NSCLC market. The company hasn't yet reported sales of the drug.

Between 10 percent and 20 percent of NSCLC tumors harbor EGFR mutations. Comparatively, Pfizer's Xalkori (crizotinib) is indicated for a much smaller subset of the NSCLC population, between 3 percent and 5 percent of those with ALK fusions. During the third quarter, Pfizer reported a 92 percent increase in revenues to $73 million for Xalkori. Adoption of the drug was similar across US and international markets, where Xalkori netted $35 million and $38 million in revenues, respectively.

In terms of PGx drugs for melanoma, Roche's BRAF inhibitor Zelboraf (vemurafenib) is the current market leader, bringing in 260 million Swiss Francs during the third quarter, up 65 percent year over year. Zelboraf may soon face competition, however, from two newly approved personalized treatments developed by GlaxoSmithKline, called Tafinlar (dabrafenib) and Mekinist (trametinib).

The FDA approved these treatments at the end of the second quarter as treatments for metastatic or unresectable melanoma patients with certain BRAF mutations. GSK reported Tafinlar sales of £4 million ($6 million) for the third quarter and £5 million over nine months. Mekinist brought in £3 million in the third quarter, GSK reported.

Finally, in the colorectal cancer market for patients with KRAS wild-type tumors, BMS's Erbitux (cetuximab) had $183 million in sales compared to $173 million in the third quarter of 2012. Erbitux is marketed as a treatment for KRAS wild-type colorectal cancer and head and neck cancer. Comparatively, Amgen's Vectibix (panitumumab), approved only for CRC patients who have a normal KRAS gene, brought in $107 million in sales, representing 22 percent growth from the year-ago period.

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