Dainippon takes aim at Spiriva with Elevation buy

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With Dainippon’s takeover of privately owned Elevation Pharmaceuticals, the respiratory field has one more big company seeking to bite a chunk out of Spiriva’s dominant share of the market for long-acting muscarinic agonist COPD treatments.

Dainippon did not have a major presence in respiratory disease, but it struck while the iron was hot, sealing the deal just over three months after Elevation reported positive phase IIb data with its lead project, nebulised glycopyrrolate. The deal will give Elevation’s private backers an immediate $100m – a reasonable return on the $60m they had put in over the past three years – with the potential for significantly more in future.

The glycopyrrolate project, EP-101, aims to treat the more severe stage of COPD, which represents 15-20% of the COPD population and thus forms only part of the $4.5bn LABA market controlled at present by Spiriva, the Pfizer/Boehringer Ingelheim blockbuster. Elevation was specifically targeting older and more ill patients who find it difficult to control their disease with handheld inhalers and who at present are limited to using shorter-acting nebulised drugs.

Technology play

Given that glycopyrrolate is an established product that several companies are developing in inhaled form for treating COPD, the takeover of Elevation is basically a technology play. Elevation claims that EP-101 is the only nebulised LAMA in development, and it uses the portable eFlow nebuliser licensed from the private German device company PARI Medical Holding.

In May Elevation revealed topline data from Golden-1, a 140-patient phase IIb trial comparing four doses of once-daily EP-101 against placebo and two open-label active controls – Spiriva and nebulised ipratropium. EP-101 showed statistically significant improvement in lung function versus placebo, as measured by FEV1, although neither the absolute numbers nor the results with Spiriva or ipratropium have yet been disclosed.

But it was enough for Dainippon to pull the trigger, offering an immediate $100m to Elevation’s private investors – Canaan Partners, TPG Biotech, Care Capital, Mesa Verde Venture Partners and Novo Ventures. Progress with EP-101 could add another $90m in development and $210m in commercial milestones, while the addition of new projects could account for a further $30m.

Elevation was founded in 2008, raised $30m in series A financing two years later and followed this up just last January with a $30m series B round. In addition to EP-101 it has two pipeline assets on the back burner: EP-102, an undisclosed LAMA/long-acting beta-agonist combination in phase I, and EP-103, an undisclosed LAMA/steroid combination that Elevation says has potential in COPD and asthma, but has yet to enter the clinic.

The takeover of Elevation is being routed through Sunovion, Dainippon’s wholly owned US subsidiary. This unit has its origins in Sepracor, the CNS/allergy-focused company bought by Dainippon in 2009 for $2.6bn; a year later the Japanese group’s original US subsidiary was merged into this entity, which was then renamed Sunovion.

ERS impact

Perhaps for maximum impact, the takeout of Elevation was announced two days before the European Respiratory Society’s annual conference got under way on September 1.

As is to be expected, numerous COPD projects are jostling for attention at this meeting, including one of Spiriva’s closest LAMA rivals, Seebri Breezhaler, and QVA149, both of which are being developed by Novartis under licence from the UK company Vectura. The former is a formulation of glycopyrrolate while the latter comprises glycopyrrolate plus indacaterol, a LABA.

Novartis is presenting 14 posters, including detailed results from the Ignite clinical programme of QVA149, which showed superior bronchodilation compared with indacaterol, glycopyrrolate, Spiriva and Glaxo’s Advair. Some of these analyses have highly significant p values. Peel Hunt analysts said these results, in the less-ill patient population, were the strongest phase III efficacy data head-to-head with Advair that they had seen.

While over the coming years Dainippon will attempt to make waves in seriously ill COPD patients, the QVA149 data could also give glycopyrrolate a strong foothold in those with few recent exacerbations.

To contact the writer of this story email Jacob Plieth in London at jacobp@epvantage.com

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