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Paion

Remimazolam set for commercialisation in 2019

Update | Pharmaceuticals & healthcare | 14 Aug 2017

Paion is well positioned to commercialise Remimazolam in 2019 for procedural sedation (via partner Cosmo Pharmaceuticals in the US) and general anaesthesia (Japan); successful Phase III studies confirmed an excellent safety profile and shorter procedure times than midazolam. Paion is conducting additional Phase I studies to further assess abuse potential of remimazolam, which will guide its scheduling under the Controlled Substances Act in the US. Cosmo has advised that it expects to file for US approval in H218 vs prior guidance of a mid-2018 filing. The recent EUR 8m capital raise has extended the funding runway for current activities to at least H219. We adjust our valuation to EUR 245m (vs EUR 240m) or EUR 4.02/share.

Paion

One hand on the prize

Outlook | Pharmaceuticals & healthcare | 21 Nov 2016

Paion has reported positive data from the first pivotal US study of its ultra-short-acting sedative remimazolam in procedural sedation. Induction and recovery from sedation was faster for remimazolam than the widely used drug midazolam, showing remimazolam could speed patient throughput in colonoscopy screening. Paion out-licensed US rights to Cosmo Pharmaceuticals for c €20m cash, €42.5m milestones and a 20-25% royalty. A second pivotal study is expected to complete recruitment in Q217. Our valuation moves to €208m (€3.74/share) vs €203m (€3.65/share) as higher US/Canada uptake is partially offset by uncertainty about EU development.

Paion

First filings later this year

Outlook | Pharmaceuticals & healthcare | 14 May 2018

In December 2017 Paion granted Mundipharma an exclusive licence to develop and commercialise its ultra-short-acting sedative/anaesthetic remimazolam in Japan. Paion is on track to file for approval in both Japan (for general anaesthesia, GA, via Mundipharma) and the US (in procedural sedation via partner Cosmo Pharmaceuticals) within the next 12 months. It plans to initiate a GA Phase III trial in Europe in H218 and intends to self-commercialise remimazolam if it gains marketing approval in Europe. Anticipated filing milestones of EUR 9.5m would extend the funding runway into H219 and beyond top-line data from the EU Phase III expected mid-2019. We increase our valuation to EUR 269m or EUR 4.40 per share, from EUR 260m or EUR 4.25 per share.

Paion

Colonoscopy Phase III success prompts US deal

Update | Pharmaceuticals & healthcare | 05 Jul 2016

Paion reported positive top-line results from its Phase III colonoscopy trial and promptly out-licensed US rights to Cosmo Pharmaceuticals. The deal brings c €20m of cash (including a €9.6m share purchase), €42.5m potential milestones and a 20-25% royalty. The next goal is end of recruitment in the bronchoscopy Phase III expected in late 2016/early 2017, with results two to three months later. We lift our valuation to €203m (vs €193m); the share issue sees our per-share valuation fall to €3.65/share (vs €3.81/share).

Paion

Pivotal colonoscopy results mid-year

Update | Pharmaceuticals & healthcare | 17 May 2016

Paion is approaching an important catalyst, with results from the US colonoscopy Phase III trial of remimazolam due to report mid-year. Filing for US approval is expected to be end 2017 at the earliest, as recruitment in the confirmatory bronchoscopy trial continues to be moderate. Partnering discussions for Japan are not expected to conclude until H216 at the earliest; we assume Japan filing in H217. We trim our valuation to €193m or €3.81/share (vs €203m or €4.01/share), with a launch date 12 months later in the US and Japan partly offset by lower forecast expenditure.

Paion

Executive interview – Paion

Edison TV: | Pharmaceuticals & healthcare | 10 Dec 2018

CEO Dr Wolfgang Söhngen provides an overview of Paion’s core technology, Remimazolam, an ultra-short-acting intravenous benzodiazepine sedative/anaesthetic. He also discusses the group’s strategy including partnership deals with Cosmo and Mundipharma and the path to market for Paion’s products.

Paion

Filings in US and Japan in next six months

QuickView | Pharmaceuticals & healthcare | 19 Nov 2018

Paion and partner Cosmo took an important step towards a US filing for itsultra-short-acting sedative/anaesthetic remimazolam, with the completionof a successful pre-NDA meeting in July. Filing in Japan (via partnerMundipharma) is expected before the end of 2018. Paion progressedtowards its goal of self-commercialising remimazolam in Europe with theinitiation of a Phase III study in general anaesthesia (GA) in July. Thecompany is funded beyond top-line data from the EU Phase III trialexpected in 2019. Our valuation is €283m or €4.44 per share.

Paion

Near-term filings in the US and Japan on track

Update | Pharmaceuticals & healthcare | 12 Nov 2018

Paion is approaching several important milestones, with partners on track to file for approval of remimazolam in the US, Japan and Russia in the next few months. Its Phase III study of remimazolam in general anaesthesia (GA) in Europe is progressing well and is on track to complete recruitment in 2019, while partner R-Pharm recently completed a successful Phase III in GA in Russia. The filings will be an important step towards establishing Paion as a leader in acute and critical care. We have made minor revisions to the timing of R&D expenditure in line with revised guidance and rolled forward our DCF model, which lifts our valuation to EUR 291m or EUR 4.56/share.

Paion

Progressing towards filings in US and Japan

Update | Pharmaceuticals & healthcare | 13 Aug 2018

Paion and partner Cosmo took an important step towards a US filing for its ultra-short-acting sedative/anaesthetic remimazolam, with the completion of a successful pre-NDA meeting in July. Filing in Japan (via partner Mundipharma) is expected before the end of 2018. Paion took a step towards its goal of self-commercialising remimazolam in Europe with the initiation of a Phase III study in general anaesthesia (GA) in July. The company is funded beyond top-line data from the EU Phase III trial expected in 2019. We lift our valuation to EUR 283m or EUR 4.44 per share.

Paion

US and Japan filings and EU Phase III on track

Update | Pharmaceuticals & healthcare | 10 Nov 2017

Paion remains on track to file for approval of Remimazolam in 2018 for procedural sedation (via partner Cosmo Pharmaceuticals in the US) and general anaesthesia (GA) in Japan. Remimazolam’s excellent safety profile and shorter procedure times than midazolam are expected to drive uptake if it gains market approval. Preparations are underway for an EU Phase III study for GA in general surgery patients to start in 2018 (subject to funding). Recently granted formulation and dosing patents will strengthen market exclusivity in the EU and Japan until 2033, which sees us lift our valuation to EUR 260m (vs EUR 245m) or EUR 4.25/share.

Paion

Positive data in bronchoscopy Phase III

Update | Pharmaceuticals & healthcare | 07 Jul 2017

Paion announced positive top-line results from the confirmatory Phase III trial of remimazolam for procedural sedation in bronchoscopy, adding to the positive results of a Phase III colonoscopy trial. It is currently conducting additional Phase I studies to further assess abuse potential as the final step of its US clinical development program. Paion is on track to file for approval in both the US (in procedural sedation via partner Cosmo Pharmaceuticals) and Japan (for general anaesthesia) by mid-2018. With the successful completion of the Phase III program for procedural sedation we increase our valuation to EUR 240m (vs EUR 214m) or EUR 4.13 per share.

Paion

On track for two filings by mid-2018

Update | Pharmaceuticals & healthcare | 12 May 2017

Paion has completed patient recruitment in its pivotal bronchoscopy study of its ultra-fast-acting sedative remimazolam. Results are likely by mid-2017 and, if positive, would put it on track to file for US approval for procedural sedation in mid-2018. Paion is also preparing a dossier for a filing for general anaesthesia (GA) in Japan in a similar time frame. It has also outlined a programme that could see it restart Phase III studies in GA in Europe (estimated cost €20-25m). Paion has sufficient cash to fund operations beyond end 2018, but would need additional funds to complete the Europe development programme. We leave our valuation unchanged at €214m ahead of the key bronchoscopy trial results.