GlaxoSmithKline’s Tyverb poised for launch in the UK
pharmafile | February 27, 2008 | News story | Research and Development |
GlaxoSmithKline says its new breast cancer drug Tyverb is ready for launch and could be prescribed to the first UK patients by March.
The launch will be crucial to GSK and Tyverb represents a potential new blockbuster for the company, but analysts believe the company will have a tough battle in gaining a foothold in the competitive breast cancer field.
Tyverb has been licensed in Europe as a third-line treatment that will only be given to patients that do not first respond to Herceptin.
But GSK will look to compete directly with the top-selling Herceptin in the medium-term as it accumulates data on its new drug.
Tyverb and Herceptin target the same group of patients, which make up around 25-30% of all women suffering from breast cancer. Both medicines are designed to block the effect of HER2, a gene found in this group of patients and associated with breast cancer that grows faster and spreads to other organs more quickly.
Tyverb could prove to have several advantages over Herceptin. First, it is a pill rather than an intravenous drug, making it easier to use and potentially cheaper to produce. It may also carry fewer safety risks to patients – Tyverb has been licensed in Europe for use with Roche's chemotherapy treatment Xeloda, and the combination has shown less cardiotoxicity in patients compared to those on Herceptin.
Tyverb also targets additional markers – HER1, HER3 and HER4, which may prove significant in fighting the disease.
GSK is also predicted to make Tyverb slightly cheaper than Herceptin. The company is yet to put a price on Tyverb, but in the US (where the drug is named Tykerb) it costs around a hundred dollars less than Herceptin for a month's treatment.
If this is reflected in UK prices, Tyverb could become a cheaper option for the NHS prescribers with strict budgetary targets.
But even with the advantages, analysts at Datamonitor say Herceptin is so well established that GSK will have to fight hard to win a share of the market.
Around 40-50% of patients with HER2 positive breast cancer do not respond to Herceptin regimens – and the majority of those who do respond to Herceptin plus chemotherapy will develop progressive disease within one year of starting treatment. It is these women, whose disease is progressing and who fail to respond to Herceptin that will benefit first from Tyverb.
Considering the current licenses, Datamonitor have forecast sales of the two drugs in five major EU countries. In 2016 they believe Herceptin will achieve annual sales of $3.4 billion – over three times more than predicted revenues for GSK's drug.
GSK must gather sufficient clinical data to widen Tyverb's licence and employ effective marketing techniques to pull ahead, according to the analysts.
In the UK, NICE approval will also be crucial for the new drug. It has just been added to NICE's latest appraisal list, but it could be two years before any appraisal is finalised, despite efforts to speed up reviews of cancer treatments.
Roche has in its own pipeline a successor to Herceptin, a drug called R1273 or pertuzumab. Currently in phase II, the drug is the first in a new class called HER2 dimerisation inhibitors. Herceptin and Tyverb have already been combined in an early stage trial, and now a three-way combination with the new pertuzumab is also expected in the near future.
