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Snippet roundup: Gilead’s Parp interest, Futura and Retrophin get data boost

Snippet roundup: Gilead’s Parp interest, Futura and Retrophin get data boost

Source EP Vantage
Company Gilead SciencesAbbVieAllerganAngion BiomedicaAstraZenecaBeiGeneBioMarin PharmaceuticalClovis OncologyEisaiEli LillyFortress BiotechFutura MedicalGlaxoSmithKlineIMPACT TherapeuticsJeil PharmaceuticalJiangsu Hengrui MedicineJohnson & JohnsonKanion PharmaceuticalMedivationMedtronicMerck & CoMitsubishi Tanabe PharmaNerviano Medical SciencesNewgenpharmPenumbraPfizerRetrophinRetroSense TherapeuticsSSLStrykerTESAROTeva Pharmaceutical Industries 
Tags Comment, Trial Results, USA, Full Approval, Medtech, Gene Therapy, Sensory Organs, Oncology, Genito-Urinary, Central Nervous System, Cardiovascular, Acquisition, Free Content
Date September 09, 2016


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  ViagraMED2002  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.