Snippet roundup: Two approvals, two setbacks and a price war

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

This week, July 31 to August 4, 2017, we had thoughts on the following: Abbvie starts a new hep C price war; FDA panel says no to J&J’s Plivensia; new data Spark haemophilia A hope; Agios joins biotech’s high table; mismatch between Opdivo and Keytruda approvals could be a moot point; Boston Scientific’s dissolving stent vanishes; Kite claims the upper hand over Novartis in Europe.

These snippets were previously published daily via twitter.

Abbvie starts a new hep C price war

August 4, 2017

Abbvie, not content with an eight-week treatment duration for its pan-genotypic hepatitis C therapy Mavyret, has priced the product aggressively in its bid to gain market share. With a list price of $26,400 per patient for the eight-week regimen, Abbvie has undercut Gilead’s Harvoni and Epclusa, even once discounts are factored in. For example, Harvoni’s list price is around $63,000 for an eight-week course, but its net cost is closer to $30,000. Gilead should remain competitive in genotype 1 patients eligible for this short-duration Harvoni regimen, but patients with other genotypes are likely to move to Mavyret, Leerink analysts believe – these populations are currently treated with 12-week products like Epclusa or Gilead’s new salvage therapy Vosevi, making them less convenient as well as more costly. After a brief respite in its second quarter, when sales exceeded expectations, it looks like Gilead’s hepatitis C headache is back.

FDA panel says no to J&J’s Plivensia

August 3, 2017

The danger signs were already there, so yesterday’s decision by an FDA advisory committee not to endorse J&J’s IL-6 rheumatoid arthritis drug, sirukumab, over safety concerns was not a shock. The regulator voted 11-2 against approval after it was revealed that 34 of the 35 trial deaths occurred in patients taking sirukumab, now trademarked Plivensia. This imbalance could be another reason behind partner GlaxoSmithKline’s surprise move last month to end its co-development and co-commercialisation deal with J&J. Plivensia had been forecast to report global sales of $1.2bn in 2022, and yesterday’s vote will be a blow to J&J’s efforts to bolster a faltering pipeline. The group had previously identified Plivensia as one of 11 potential blockbusters to help it revive growth in the face of biosimiliars and pricing pressure for some of its biggest products. The question now will be what happens to Plivensia? With two other IL-6 MAbs already approved the regulator has options in this setting, and is unlikely to go against the panel’s recommendation. It is also hard to see European regulators not taking an equally tough stance on the asset, leaving J&J, which will have to conduct further trials, with a painful go/no-go decision.

New data Spark haemophilia A hope

August 3, 2017

Spark Therapeutics has already set out its stall as the gene therapy company to beat in haemophilia B – and encouraging, albeit early, data in haemophilia A have now set up an intriguing battle with Biomarin. The latter is ahead in terms of development, with phase III trials of BMN 270 slated to begin by the end of the year, but results from the first two patients treated with Spark’s SPK-8011 were enough to send that company’s share price up 20% yesterday. The lowest dose of SPK-8011 led to stable factor VIII expression levels of 11% and 14% – Leerink analysts had previously said that 10-12% would represent a successful outcome. The hope is that dose escalation could lead to even better responses – something hinted at by Spark, which said a third patient receiving a higher dose had “proportionally higher” factor activity levels. More detailed data should be available at the Ash meeting in December; Spark will need to replicate the latest results in a larger number of patients, while maintaining safety, if it wants to become a player in haemophilia A, which accounts for around 80% of the overall haemophilia market.

Agios joins biotech’s high table

August 2, 2017

The US green light for enasidenib marks Agios as another in a small group of biotech companies boasting an approved drug, including Tesaro, Clovis and Puma. What else do these groups have in common? They are all periodically mentioned as potential acquisition targets. Still, with a $2.8bn market cap Agios might look as overpriced as its peers, and moreover there is only really one logical buyer – Celgene, which already holds a 15% stake. Enasidenib has sellside consensus 2022 revenue forecasts of $302m, according to EvaluatePharma, and it is not immediately clear what Celgene would gain by buying out 100% of an asset that it already controls subject to a royalty. Perhaps enasidenib’s approval will be seen as validating Agios’s other assets, including ivosidenib and AG-348; the latter is also partnered with Celgene, but an earlier deal on the former was scrapped last year. Speedy FDA action marks enasidenib as another approval for AML, specifically in the 10-15% subgroup of patients harbouring an IDH2 mutation. The stage is now set for regulatory action on two other potential treatments for this once intractable blood cancer: Pfizer’s Mylotarg and Jazz’s Vyxeos. (Note: this was approved on August 3, the day after this snippet was published.)

Mismatch between Opdivo and Keytruda approvals could be a moot point

August 2, 2017

Sharp-eyed biopharma investors will have noticed that yesterday’s approval for Bristol-Myers Squibb’s Opdivo in MSI-H and MMRd tumours was limited to colorectal cancer. This contrasts with Merck & Co’s Keytruda, which in May got the first ever US green light not to specify a cancer type – instead targeting any tumours that were MSI-H (microsatellite instability-high) or carried MMRd (DNA mismatch repair deficiency). Still, this might not make a huge difference practically, since MSI-H and MMRd tumours mainly comprise a subset of colorectal cancers. Opdivo’s approval was based on the Checkmate-142 trial, which was limited to colorectal cancer patients, whereas Keytruda’s relied on five studies, three of which (comprising just 30 patients) did not specify cancer type. Clinicatrials.gov reveals several studies looking at MSI-H and MMRd tumours, including some of Opdivo beyond colorectal cancer, but most are investigator-initiated. One interesting company-sponsored trial, however, involves Lilly’s anti-PD-L1 asset LY3300054, and includes MSI-H solid tumours of unspecified type.

Boston Scientific’s dissolving stent vanishes

July 31, 2017

Prompted by the woes of Abbott’s bioresorbable stent Absorb – the device was pulled from the European market in April following high rates of events including heart attacks and thrombosis – Boston Scientific has decided to can development of its own similar product, Renuvia. Boston will not even wait for full data from Renuvia’s current clinical trial, a 30-patient Australian study called Fast, instead deciding that the performance of dissolving stents has been so disappointing that there is no real market for them any more. In reaching this decision it differs from four companies. Abbott is still selling Absorb in the US, where it remains the sole marketed product, and three others are actively selling their devices in Europe – Biotronik, Elixir Medical and Reva Medical. Another group is trying to break through: Amaranth Medical has three bioresorbable scaffolds in development, Aptitude, Magnitude and Fortitude. The first of these is awaiting European CE mark. But these are smaller companies than Boston, and clearly believe that staking a claim even in a small and possibly shrinking market is worth their while.

Kite claims the upper hand over Novartis in Europe

July 31, 2017

Kite might be two months behind Novartis in the US, but today it claimed to have beaten its rival to the punch on the other side of the Atlantic, saying its submission for KTE-C19 represented the first ever CAR-T therapy to be filed with the EU regulator. Europe, of course, represents relatively slim pickings versus the US, owing to a likely tougher reimbursement climate, and EvaluatePharma’s sellside consensus bears this out. Investors fixated on first-to-market dynamics should bear in mind that Novartis filed CTL019 in the US without even making an announcement, so a stealth EU submission might likewise already have been made, though this would contradict the Swiss firm’s EU filing timeline, which specified “late 2017”. An important aspect of Kite’s submission specifies that the KTE-C19 CAR-T cells will be manufactured at its US commercial facility, El Segundo, next to Los Angeles airport. Novartis has said its Morris Plains, New Jersey, plant can meet global demand for CTL019, though its EU filing is expected to include data from a German contract manufacturer, the Fraunhofer Institute, as back-up.

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