Snippet Roundup: Wins For AcelRx, Foamix And SGLT2 Developers

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Includes: ACRX, AZN, CELG, FOMX, INTRA, MRK, PFE
by: EP Vantage

Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.

This week, September 12-16, 2016, we had thoughts on the following: Ertu ditto: second SGLT2 win of the week; Intarcia (INTRA) builds cash pile for diabetes implant launch; Pfizer (NYSE:PFE) taps OncoImmune in immuno-oncology; AcelRx (NASDAQ:ACRX) finally accelerates; Crispr Therapeutics third out the gate in IPO race; Foamix (NASDAQ:FOMX) bounces back with rosacea win; waiting game continues with Celgene’s (NASDAQ:CELG) Crohn’s data.

These snippets were previously published daily via Twitter.

Ertu ditto: second SGLT2 win of the week

September 16, 2016

AstraZeneca (NYSE:AZN) had its SGLT2 success on Monday, and now it is Pfizer and Merck’s (NYSE:MRK) turn. A phase III win for ertugliflozin in type 2 diabetes positions the two groups to submit US approval applications for the project as well as for two fixed-dose combinations, one with Merck's DPP-4 inhibitor Januvia and another with metformin, by the end of this year. Presented at the EASD meeting, data from the 463-patient Vertis Sita2 study showed that both the 5mg and 15mg doses of ertu met the primary and all secondary endpoints. Patients were on a background of Januvia and stable metformin. Vertis Sita2 is part of the Vertis trial program – nine phase III trials in a total of 12,600 type 2 diabetics. Data from Vertis Mono and Vertis Factorial were released in June; results of the other six trials are yet to emerge.

Intarcia builds cash pile for diabetes implant launch

September 16, 2016

Intarcia Therapeutics has several challenges ahead – but raising cash is not one of them. Its latest funding round, of $215m, should help see it through the next two to three years and the launch of its implant ITCA 650, which secretes the diabetes drug Bydureon over a year so patients can avoid regular injections. First, though, Intarcia has to get approval of ITCA 650, which it plans to submit to the FDA in the next couple of months. Perhaps an even bigger issue will be getting the go-ahead from payers, particularly as once-weekly GLP-1 agonists become the norm. Intarcia will hope that improved convenience as well as a better side-effect profile will help it gain market share. If ITCA 650 fails to catch on, the company will not be able to blame a lack of resources. Intarcia secured a $75m credit facility in May, and expects to close a second larger financing by the end of the year, as well as getting $100m on filing in the form of a milestone from a royalty and equity convert financing.

Pfizer taps OncoImmune in immuno-oncology

September 16, 2016

Five years after selling one anti-CTLA4 antibody to AstraZeneca, Pfizer is taking a step back into the class with a deal with OncoImmune for its preclinical asset ONC-392. The agreement, worth up to $250m in up-front and potential milestones, is presumably heavily backend-loaded, giving Pfizer a relatively low-risk bet – albeit a very early-stage one. The group had previously been developing another anti-CTLA4, tremelimumab, but sold most of its rights to AstraZeneca in 2011 in a move that now looks a little hasty. However, tremelimumab’s main promise seems to be as part of a combination therapy, specifically with Astra’s PD-L1 inhibitor durvalumab. Perhaps Pfizer, which has a phase III anti-PD-L1 project in the shape of avelumab, wants easy access to an anti-CTLA-4 MAb to study its own combos. NC-392 – which OncoImmune says could have a lower incidence of immune-related toxicities versus the likes of Yervoy – has an agreed upon, but undisclosed, time limit to prove its worth. If it fails Pfizer might have problems finding another CTLA4-targeting MAb: the late-stage pipeline looks sparse.

AcelRx finally accelerates

September 13, 2016

The pain relief specialist AcelRx Pharmaceuticals at last has a clearer path to the FDA for one of its projects, after reporting positive results from a third phase III study of its sublingual sufentanil ARX-04. The company plans to file an NDA by the end of the year and will hope that it gets the go-ahead before it runs out of cash; AcelRx expects to end the year with $70-75m and a quarterly burn rate of around $10m, chief financial officer Timothy Morris said on a conference call. It had hoped for earlier approval of ARX-04, which delivers sufentanil via a single-use dispenser, but the FDA asked for more data during a pre-NDA meeting last December. This followed a similar request for the group’s lead asset, Zalviso, another sufentanil-device combination, in March 2015. Zalviso is available in Europe but is still not approved in the US, where AcelRx is conducting the IAP312 study – the main drain on its finite resources.

Crispr Therapeutics third out the gate in IPO race

September 13, 2016

The $90m that Crispr Therapeutics plans on raising is the smallest debut so far for a Crispr genome editing-focused company, but it says something that the group is even thinking about braving the current markets. This year there have only been 21 US healthcare IPOs compared with 35 at this point in 2015. Crispr Therapeutics has been given a fighting chance to get away thanks to the high profile collaborations it has inked with big companies including Bayer and Vertex. It also counts the corporate arm of Celgene as a current investor. Celgene alongside new investors contributed to a pre-IPO $140m series B funding round – another factor that would have comforted potential new investors. Its IPO life jacket assured, what could make Crispr Therapeutics, and others of its ilk, founder is the inability to deliver on the big promises that the genome editing technology has made about its role in curing multiple diseases.

Foamix bounces back with rosacea win

September 13, 2016

Foamix Pharmaceuticals’ phase II success with its minocycline foam FMX103 in rosacea sets it up for the main event: phase III results with its lead compound, FMX101, in acne in the first half of next year. More positive data could tempt a partner or acquirer – but Foamix will no doubt suffer from the continuing absence of Valeant (VRX) from the M&A scene. The phase II rosacea win with FMX103 pushed Foamix’s stock up 16% yesterday to a one-year high. The Israeli company believes that the project could become the drug of choice for the skin disorder, which is currently treated with topical antimicrobials, or oral and topical antibiotics. Minocycline is also an antibiotic, but Foamix’s foam formulation, which makes it more easily spread and absorbed, could differentiate it from other products, Barclays analysts reckon. Foamix puts the potential rosacea market at $1.2bn – which would involve a big expansion from its current value.

Waiting game continues with Celgene’s Crohn’s data

September 12, 2016

The muted reaction of Celgene shares to today’s news that its Crohn’s project GED-0301 showed improvements in baseline disease at 12 weeks says it all: the best is yet to come. On the surface the preliminary data for the oral asset look encouraging, and there will be those wanting potentially cheaper alternatives to anti-TNF’s. However, any real hint of future success for GED-0301 will come with more detailed data later this year. Watchers will be focusing on whether previously impressive remission rates have been sustained, and will want to see that the level of mucosal healing of the antisense agent either remains superior to, or is at least equivalent to, biologics. Full data could be unveiled at the United European Gastroenterology Week in October – opening up GED-0301 to potential comparisons with phase II endoscopy data from Gilead’s filgotinib.