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Morning brief: CAR-T competition hots up, Keytruda sales soar and more

A rapid round-up of pharma, biotech and healthcare news

NovartisCAR-T competition hots up

Competition within the CAR-T space is hotting up, with yesterday’s FDA approval of Novartis’ Kymriah in its second indication for adult patients with relapsed or refractory large B-cell lymphoma.

This means Kymriah will go head-to-head with Gilead’s Yescarta, approved in this patient population since October.

Gilead’s Q1 figures yesterday showed Yescarta exceeded expectations in its first full quarter on the market, achieving revenues of $40m, far ahead of the $16m expected by analysts.

By contrast, Kymriah achieved a much more modest $12m in its first quarter, although this reflects the much smaller patient population in its first indication, paediatric non-Hodgkin lymphoma (NHL).

Head-to-head comparisons between Yescarta and Kymriah in lymphoma suggests Gilead’s therapy has the edge in overall response rate (ORR), though Novartis claims it has achieved a 50% ORR in its trials, with data yet to mature.

Also coming to market is Juno’s JCAR017, which has shown best-in-class results in small-scale trials.

Questions about the profitability and sustainability of the CAR-T class remain, however. Commercial success may depend equally on who can establish the leanest manufacturing and drug administration supply chain, and who can strike the best novel pricing deals with US payers.

KeytrudaKeytruda sales soar, but investors are nonplussed

Merck presented its Q1 results yesterday, up 6% to $10bn and in line with expectations, with its earnings slightly better than anticipated.

Immunotherapy Keytruda, was once again the company’s star performer, achieving revenues of $1.46bn in the period, up an impressive 151%.

The drug is now approved in seven tumour types, including being the only checkpoint inhibitor approved in first-line treatment for non-small cell lung cancer.

However investors aren’t entirely happy, as they believe Merck has underperformed on returns to investors, and are concerned it is over-reliant on Keytruda.

CEO Kenneth Frasier has addressed these concerns by buying oncolytic virus specialists Viralytics for $394m, but is ruling out a sell-off of its animal health divison, or a mega-merger.

Read Merck’s Q1 results in full here

Brexit likely to hamper UK biotech, new report concludes

A new report by a pharma industry funded think tank says Brexit is likely to present the UK biotech sector with numerous new problems, with few if any upsides.

The report written for the Office of Health Economics by experts Sir Geoffrey Owen and Dr Michael Hopkins examines three questions: why the UK hasn’t produced large biotech firms to match the US; why UK biotechs haven’t brought their own blockbusters to market; and the implications of Brexit and the Life Sciences Strategy.

On Brexit, the authors conclude: “The industry faces a new set of challenges in Brexit, which could threaten funding and collaboration opportunities. The impact on supply chains remains undetermined, and the continued favourability of the UK as an investment opportunity is uncertain.”

Even without Brexit, Owen and Hopkins say the Life Sciences Strategy goal of creating four UK companies with a market capitalisation of more than £20bn in the next ten years is “ambitious”. They point out that Shire is the only company to fit this description to be built up so far, but which re-domiciled to Ireland for tax reasons.

Read the full report here

The report coincides with news that the UK Government is struggling to strike a deal on vital Brexit questions - the future of the border between Northern Ireland and the Republic of Ireland, and the larger question of what arrangement could replace the customs union.

The Government remains determined to exit the customs union, despite warnings that its plan will create new barriers to trade. Efforts by Prime Minister Theresa May to steer a middle course have been rejected by hardline Brexiteers in her Conservative party.

Read more on the BBC: Brexiteers tell Theresa May to drop customs partnership plan

Article by
Andrew McConaghie

2nd May 2018

From: Research, Sales, Regulatory



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