Glaxo Gears Up a Blockbuster

Income Investor pick GlaxoSmithKline (NYSE:GSK) finally received word yesterday that its anti-cancer drug Tykerb can kick off its sales process in the European Union -- where it will be called "Tyverb," to the chagrin of writers and their editors.

Tykerb is one of Glaxo's most important new compounds, one which the company hopes will replace sales declines from other top drugs like diabetes treatment Avandia. Tykerb was approved for marketing in the U.S. early last year as a treatment for late-stage breast cancer.

Glaxo received preliminary EU approval for Tyverb to treat breast cancer late last year, but suffered a slight hiccup in the approval process, after it later noticed that patients on the drug were experiencing a higher level of liver-related sided effects. Glaxo and the EU regulatory authorities spent a couple of weeks reviewing this data, then issued a second preliminary approval for the drug in April.

Yesterday's final approval likely means that Glaxo will start marketing Tyverb in the U.K. and Germany soon, while it negotiates reimbursement rates in all five of the largest EU pharmaceutical markets. Sales of Tykerb have gotten off to a good start in the U.S. and elsewhere, with revenue from the drug reaching $102 million last year.

Tykerb competes with compounds like Genentech's (NYSE:DNA) very successful Herceptin as a treatment for breast cancer. It's currently approved for patients who fail after taking Herceptin and chemotherapy, but Glaxo hopes to expand Tykerb into earlier-stage patient populations, too.

Glaxo's pipeline of cancer treatments is undeservedly underrated compared to oncology behemoths like Genentech, Novartis (NYSE:NVS), and Pfizer (NYSE:PFE). It now has Tykerb approved for sale in most major pharmaceutical markets around the world, a drug candidate in phase 3 testing that could compete with Genentech's Avastin, and a very strong partnership with discovery-stage powerhouse Exelixis (NASDAQ:EXEL). While some of Glaxo's top compounds are on the decline, at least it has some interesting anti-cancer drugs to hopefully recoup their losses.