Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, September 5-9, 2016, we had thoughts on the following: Parp for the course for Gilead?; Futura shoots up with erectile dysfunction gel success; Retrophin’s Duet hits a flat note; if Allergan buys into gene therapy, is gene therapy mainstream?; and Trevo approval is a masterstroke for Stryker.
These snippets were previously published daily via twitter.
Parp for the course for Gilead?
September 9, 2016
It is looking increasingly likely that Gilead had tried and failed to buy Medivation, which as well as having the blockbuster Xtandi boasts a phase III Parp inhibitor, talazoparib, but which ultimately fell for $14bn to Pfizer. And judging by comments at the Wells Fargo conference yesterday Gilead is still on the lookout for a Parp inhibitor. “We would absolutely be willing to take the risk and enter [the Parp] area,” said Gilead’s chief scientific officer, Norbert Bischofberger, as long as the chemistry, biology and toxicology were clear, and the asset was “meaningfully differentiated”. Two late-stage Parp developers, Tesaro and Clovis, spiked on the statement, closing yesterday up 7% and 15% respectively. Clovis was additionally helped by confirmation from the US FDA that there would be no advisory panel meeting to consider its rucaparib filing – presumably because the mechanism of action is known and AstraZeneca’s Lynparza is already on the market.
Futura shoots up with erectile dysfunction gel success
September 8, 2016
It’s been a long time coming but Futura Medical is finally firming up its erectile dysfunction strategy with a phase III win for its MED2002 gel. The data could support approval of the gel, also known as Eroxon – which seems to get to work faster than existing oral drugs like Lilly’s Cialis and Pfizer’s Viagra. In the MED2002 study, 82% of men with mild ED had onset of action within 10 minutes and 54% within five. Existing ED pills can take around an hour to take effect. The glyceryl trinitrate gel also appears to be safe in ED patients taking other nitrate drugs, which are commonly used in angina and cannot be taken alongside the likes of Viagra. MED2002 has been in late-stage studies since 2006 and along the way lost GlaxoSmithKline and SSL as partners. Although Futura will be celebrating a long-fought victory, it faces a battle against generic PDE5 inhibitors, which are set to make the branded ED market increasingly flaccid in the coming years. Futura claims that the overall sector is worth around $5bn.
Retrophin’s Duet hits a flat note
September 7, 2016
Topline data from the phase II Duet study of Retrophin’s sparsentan in focal segmental glomerulosclerosis are in and looking good – good enough to drive Retrophin’s stock up 40% so far today. The primary endpoint, reduction in proteinuria compared with irbesartan at eight weeks, was met when all three doses of sparsentan were pooled. However, none of the doses individually showed a significant improvement. Investors seeking clarity on whether there was a dose response, or whether the data would be good enough for an early FDA filing, were none the wiser after a conference call earlier. Management said they had hoped to see a 50% improvement in proteinuria and in fact the results were substantially better than that, and insisted that Retrophin had the data to make a case for advanced filing. The lack of therapy options for this rare disease might improve its chances with the regulator.
If Allergan buys into gene therapy, is gene therapy mainstream?
September 6, 2016
Allergan’s $60m ante into the gene therapy game through a takeout of RetroSense Therapeutics will take the speciality pharma group out of its comfort zone, but at least it is familiar with the therapy area. Michigan-based RetroSense has been working on restoring vision in patients with retinitis pigmentosa and dry age-related macular degeneration, and ophthalmological drugs are a focus of Allergan’s. The lead project, RST-001, employs the gene channelrhodopsin-2 to regenerate photoreceptors in retinal cells. In August the group completed a low-dose cohort in retinitis pigmentosa patients in which no inflammation or ocular adverse events were seen and biological activity was confirmed – a mid-dose cohort was planned. For Allergan this is a big technological leap forward: Its ophthalmology portfolio consists of steroids, immunomodulators and anti-inflammatories.
Trevo approval is a masterstroke for Stryker
September 5, 2016
Stryker has reiterated its position as the leader in the niche space of clot retrieval products for ischaemic stroke with the de novo FDA clearance of two Trevo devices. The transcatheter devices are indicated for the retrieval of a blood clot in the brain to reduce paralysis, speech difficulties and other stroke disabilities. The Trevo products were previously cleared in the US for the treatment of patients unable to receive or unresponsive to tissue plasminogen activator (t-PA), and may now be used along with t-PA, reaching a broader group of patients. Stryker came by the devices through its $135m 2011 acquisition of Concentric Medical, and now has more such products on the US market than the other two players combined.
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