GSK breathes more easily after Sandoz exit
pharmafile | March 24, 2010 | News story | Sales and Marketing | Advair, Sandoz, generics, vectura
Sandoz has exited a deal to launch a generic rival to GSK’s top selling respiratory drug Advair.
Sandoz, the generics arm of Novartis, had been planning to launch VR315 for asthma and COPD in the US in alliance with Vectura, but has now returned the rights to the UK biotech company.
VR315 is an inhaled combination therapy for asthma and COPD that is being developed as a generic product using the GyroHaler dry powder inhaler delivery device.
Vectura has never disclosed which active ingredients will be used, but it is believed to be a generic copy of Advair, which is a combination of beta-agonist salmeterol and corticosteroid fluticasone.
The withdrawal of Sandoz from the deal is a blow to Vectura, but good news for GSK, which is likely to face less intense competition from the new rival drug.
Analysts believe Sandoz pulled out because of uncertainties about how the drug could be approved through existing FDA regulatory pathways; VR315’s inhaler is a new, patented device, while the active ingredient will be a generic copy – a mix which could complicate its approval.
Vectura will receive a $9.5 million cash payment and a $25 million loan facility following the revised deal with Sandoz.
The companies still have an agreement for the drug in Europe, where Sandoz will be fully responsible for its development, manufacture and commercialisation, but Vectura now faces marketing the drug in the US on its own.
Dr Chris Blackwell, chief executive of Vectura, put a brave face on the news, saying it would press ahead with the drug’s commercialisation for the US market.
“Together with Sandoz’s partnership in Europe, VR315 has the potential to be a significant new product in the DPI market,” he said. “We are confident that we have the high level of expertise required to develop and successfully commercialise inhaled products, and with a robust balance sheet, we believe we have the ability to gain an enlarged share of a major market opportunity.”
Shares in GSK rose slightly on the news, while Vectura dropped. GSK’s follow-up to Advair (Relovair) is currently in its final phase III trials.
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