Vectura is due a $5 million milestone payment from Novartis released by the Swiss drug giant’s filing of QVA149 (indacaterol maleate/glycopyrronium bromide) with the European Medicines Agency.
QVA149 is an investigational inhaled, once-daily, fixed-dose combination of the Seebri Breezhaler (licensed to Novartis in April 2005) and Novartis’ Onbrez Breezhaler (indacaterol), designed to treat adults suffering from chronic obstructive pulmonary disease (COPD).
COPD represents a multi-billion dollar market that is expected to see continued growth, and analysts seem pretty confident that the product will garner European approval.
Julie Simmonds, analyst at Canaccord Genuity, noted that both components within the combination QVA149 have already been approved individually in the region, and “conservatively” estimates that the product “could generate peak sales of $1.6 billion”.
Stefan Hamill at Peel Hunt also highlighted its reduced risk profile.
“This is one of least risky drugs in our universe…both of QVA’s individual components are approved in Europe, its device is approved, and it met all of its primary endpoints in Phase III studies, meeting the ‘combination rule’ of superiority over individual components”.
This, he points out, contrasts with GlaxoSmithKline’s rival product Zephyr, “where neither the device nor either of the individual components (vilanterol and umeclidinium) are approved and where the combination rule was not consistently met in Phase III studies”.
Novartis also confirmed that it continues to expect submission of QVA149 in Japan in 2012 and to the FDA in late 2014.
Shire signs Italian research deal
Elsewhere, in other good news Shire announced that it has entered into a long-term, multi-indication research pact with Italian biomedical charitable group Fondazione Telethon, for research carried out at the Telethon Institute of Genetics and Medicine (TIGEM).
This move will facilitate research on 13 undisclosed rare disease indications, and Shire is hoping that it will add multiple, novel therapeutic candidates into its early stage pipeline.
The UK drugmaker is stumping up $22 million over five years for several research projects addressing a number of different lysosomal storage disorders and neurodegenerative diseases.
