Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, March 5-9, 2018, we had thoughts on the following: Xeljanz ulcerative colitis nod Jaks up sales potential; pipeline pressure grows for German Merck; Zebra’s latest CE mark allows it into the brain; Zafgen’s prospects get a little sweeter; Pharming impresses, but its tailwind will weaken; Clearside up on eye jab success; Philips and Hologic become bosom buddies.
These snippets were previously published daily via twitter.
Xeljanz ulcerative colitis nod Jaks up sales potential
March 9, 2018
Xeljanz’s unanimous thumbs-up from a US FDA advisory panel in ulcerative colitis appears to assuage any safety concerns – at least for now. Other Jak inhibitors like Abbvie’s upadacitinib have been linked with thrombotic events, but Pfizer’s drug has so far escaped largely unscathed. While briefing documents pointed out that there were still question marks over Xeljanz’s long-term safety, this was not enough to give the panellists pause, setting the drug up for approval by June – which would make it the first oral therapy and Jak inhibitor to get the go-ahead in ulcerative colitis. Xeljanz, which is already marketed for rheumatoid and psoriatic arthritis, is forecast to bring in $2.3bn by 2022, with $290m of this coming from ulcerative colitis, according to EvaluatePharma sellside consensus. Despite several new entrants on the horizon, the space is still set to be dominated by monoclonal antibodies, which have their own safety issues, including an increased risk of infection. Fears about the Jak class do not appear to have put Pfizer off – it has three more in development, including two that are in phase II in ulcerative colitis: the Jak3 inhibitor PF-06651600 and the TYK2 & Jak1 inhibitor PF-06700841.
Pipeline pressure grows for German Merck
March 8, 2018
Merck KGaA’s claims that its pharma pipeline is in the best shape ever are contradicted by a glance at its top prospects. The German company is under pressure after a disappointing fourth quarter marked by declining sales of its ageing stars, Rebif, Erbitux and Gonal-f. But there are also doubts about its near-term hopes, Mavenclad and Bavencio, which Merck expects to have “double-digit million euro sales” this year. The former is launching into a stagnant multiple sclerosis market, while there are fears that the latter might be less effective than its PD-(L)1 rivals after last month’s lung cancer trial failure. Today Merck’s chief exec, Stefan Oschmann, described Merck’s partnership with Pfizer on Bavencio as “very solid”, but if Pfizer decides otherwise Merck would be high and dry. The other pipeline prospects highlighted on today’s earnings call are some way away from the market: Merck is not ruling out a filing for tepotinib based on phase II data, while the BTK inhibitor evobrutinib posted its first positive phase II data yesterday, in MS, but analysts were keen to hear how the project had performed against Tecfidera. Merck will have to make do with what it has for now: it has ruled out any major acquisitions until the end of this year, unless these can be financed by divestitures.
Zebra’s latest CE mark allows it into the brain
March 7, 2018
Zebra Medical Vision’s Analytics Engine recalls Heartflow’s FFRct system in that both analyse medical images using artificial intelligence to diagnose problems relating to blood flow. But, where Heartflow is focused on the coronary arteries, Zebra is looking at a number of tissues, and its system has now gained European approval for the detection of intracranial haemorrhages. Zebra’s website suggests that the system can work with X-ray, CT and MRI scans to make these determinations. The Engine itself was CE marked last June for use with CT data to pick up signs of fatty liver, excess coronary calcium, emphysema, low bone density and vertebral compression fractures, but this is its first approval for an algorithm that can be used in the acute care setting. The company’s funding has come from a range of slightly unusual sources: in 2016 it closed a $12m round led by the venture arm of the Utah-based not-for-profit health system Intermountain Healthcare, and since its founding in 2012 other investors have included Salesforce founder Marc Benioff and the crowdfunding platform Ourcrowd. Unless the company can ramp sales of its system quickly it will likely need more capital soon; with approvals under its belt it might now be a more appealing proposition to traditional VCs.
Zafgen’s prospects get a little sweeter
March 7, 2018
After the failure of its obesity project beloranib, Zafgen needs a phase II hit with its next-generation MetAP2 inhibitor ZGN-1061 – and investors have interpreted the early signs as promising. The company’s stock jumped 5% in premarket trading after executives said yesterday that an interim analysis of the study, in diabetes, showed a statistically significant benefit with the highest 0.9mg dose at eight weeks. Still, there are reasons to be cautious about ZGN-1061, and the real test will come with the 12-week data, which are due mid-year. For one, the 0.05mg and 0.3mg doses did not reach a p value below 0.05 at eight weeks on the primary endpoint, change in HbA1c versus placebo. Zafgen did not give more details but said the data indicated a dose response. Secondly, the company is expanding the phase IIa trial to include a 1.8mg dose, which was used in a phase I trial but was then shelved – at the time, Zafgen blamed a lack of dose response on dosing above the threshold for efficacy. At least ZGN-1061 appears to be better tolerated than beloranib, which was abandoned after patient deaths that sent the company’s stock into a slump from which it has yet to recover.
Pharming impresses, but its tailwind will weaken
March 7, 2018
Pharming has delivered an impressive turnaround with its hereditary angioedema (HAE) candidate Ruconest, after buying the product back from unenthusiastic marketing partners. 2017 sales in the US, where Pharming took Ruconest back from Valeant in late 2016, look to have to have tripled year on year to €84m ($95m); in Europe, where various territories were reclaimed from Swedish Orphan Biovitrum, sales more than doubled to €5m. However, the small Dutch drug developer has benefited from major tailwinds in the US – manufacturing problems took Shire’s market-leading therapy, Cinryze, out of the market for three months, while a newly launched competitor from CSL encountered teething problems. For investors who have driven Pharming shares to a five-year high the burning question is the extent to which the company’s marketing efforts can drive growth when these much bigger rivals regain steam. Another red flag is the impact of Shire’s hotly awaited HAE antibody, lanadelumab, which is due an FDA verdict in August. The sellside is apparently modelling little impact on Ruconest sales in the coming years, but this is surely a highly optimistic view. Pharming deserves praise for its performance last year, but there are bigger challenges ahead.
Clearside up on eye jab success
March 6, 2018
Success in phase III for its corticosteroid therapy could mean that Clearside Biomedical ends up with the sole approved product for macular oedema associated with non-infectious uveitis, enabling it to charge a possible premium price of up to $1,400 per injection, according to Stifel analysts. CLS-TA is a suspension of triamcinolone acetonide delivered to the back of the eye via the suprachoroidal space, which sits between the white of the eye and the choroid – the deeper vascular layer. In its pivotal Peachtree trial in 160 patients with macular oedema associated with non-infectious uveitis, 47% of those given two 4mg doses of CLS-TA gained at least 15 letters in best corrected visual acuity between baseline and week 24, compared with 16% of patients who underwent a sham procedure. The drug had a low rate of intraocular pressure elevation – 11.5% – compared with 25-35% seen in trials of implanted products such as Allergan’s Ozurdex and Alimera Sciences’ Iluvien, a potential differentiating factor. A US approval application is set for the fourth quarter of 2018, the company said. Clearside’s shares closed up 32% yesterday.
Philips and Hologic become bosom buddies
March 5, 2018
With the imaging sector about to undergo a striking change with the emergence of the Healthineers from Siemens’ shadow, other groups are banding together. Philips and Hologic have kicked off a non-exclusive global partnership under which the Dutch company will sell Hologic’s mammography technologies, including its 3Dimensions breast tomosynthesis system, pictured below. These will be combined with the devices Philips already has – ultrasound, MRI, CT, and X-ray systems – as well as informatics and the provision of maintenance and upgrade services, a crucial way to encourage repeat custom. Philips is a veteran of these kinds of deals, with one such being its partnership with Heartflow under which the latter’s coronary artery blood flow imaging system is sold to hospitals. In a highly competitive space this kind of collaboration, allowing customers to buy the systems they need for screening and diagnosis from a single provider, could become more common. If nothing else, it’s cheaper than an acquisition.