PharmExec Blog

Two 'Most Promising' New Drugs Face Setbacks in US

Two of the drugs named “most promising” in Thomson Reuters’ recent quarterly report hit snags in the US, despite European approval.

Those two products – AstraZeneca’s Brilique (Brilinta in the US), a blood thinner, and Pharming’s Ruconest (Rhucin in the US) – were held up during FDA’s review process. Brilique (ticagrelor), AstraZeneca’s leading pipeline drug, was approved last December for patients in the EU with acute coronary syndromes, which includes a high risk of heart attack.

In the US, however, AstraZeneca received a complete response letter from FDA in December, addressing concerns about ticagrelor’s efficacy in American subjects, and requesting additional data from the company’s PLATO trials. AstraZeneca said in a reply to FDA that differences in efficacy across geographies were the result of interactions with high-dose aspirin. The company, and most analysts, expect ticagrelor to gain FDA approval this July. Brilique/Brilinta is a direct competitor of Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix, a blockbuster drug several times over, but Plavix faces patent expiration in the US next year, and has already gone off-patent in some European countries. Thomson Reuters Pharma put global sales of Brilique/Brilinta at $185 million in 2011, and an estimated $1 billion by 2014.

Pharming’s Ruconest/Rhucin, a drug extracted from the milk of transgenic rabbits, was approved in the European Economic Area (EEA) – which includes the EU plus Iceland, Liechtenstein and Norway – but FDA rejected its biologics license application in late February, citing insufficient clinical trial data. FDA did grant an orphan designation for the product. Pharming, a biopharma based in the Netherlands, developed Ruconest/Rhucin, a recombinant human C1 inhibitor, to treat a rare genetic disease called hereditary angioedema (HAE), which causes swelling. The drug is the company’s first to reach the commercial stage.

Marketing partners on Ruconest/Rhucin include Santarus in the US, Laboratorios del Dr. Esteve in Spain, Portugal, Greece and Andorra, and Swedish Orphan Biovitrum International (SOBI) for all other European companies. Saloni Shah, managing editor, drug information at Thomson Reuters, said in an email that Ruconest is an example of companies coming together to “offer new hope to HAE” patients. Approximately 1 in 30,000 people worldwide suffers from HAE, according to Pharming estimates.

The other three top new approvals singled out by Thomson Reuters include Forest Laboratories’ Teflaro, an injectable for bacterial pneumonia and infections; Halaven, a breast cancer drug from Eisai; and Kombiglyze XR, a combination pill for diabetes, from AstraZeneca and Bristol-Myers Squibb (BMS). Teflaro is expected to generate global sales of $514 million by 2015, and Halaven, a late stage drug for patients with metastatic breast cancer who have received at least two prior chemotherapy regimens, is expected to generate sales of $414.6 million by 2014, according to Thomson Reuters Pharma estimates.

AstraZeneca and BMS’s Kombiglyze XR, an extended-release drug combining saxagliptin, the active ingredient in AstraZeneca and BMS’s Onglyza, and metformin, the active ingredient in BMS’s Glucophage, is set to pull in close to half a billion dollars by 2015, according to Thomson Reuters Pharma. Shah said the drug “offers patients the ideal medication: a once-a-day oral tablet which combines two existing drugs, making disease management easier.”

Other drugs to keep an eye on, according to Thomson Reuters’ “The Ones to Watch” report, include Phase 3 treatments such as ArTiMist, a malaria drug developed by Star Medical and Eastland Medical Systems, ChimeriVax Dengue, a Sanofi Pasteur drug for dengue virus infection, and Merck’s V-212, for chickenpox and shingles, among others. The report, published in February, covered new drug approvals and pipeline candidates through then end of December, 2010.

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