AstraZeneca, Amgen look east
Recent weeks have showcased the importance of the Chinese pharmaceutical market to AstraZeneca's future growth intentions.
The company's recent third-quarter results once again showed an impressive performance in China and AstraZeneca announced this week three new initiatives to support its commitment to the market.
These include the creation of a $1-billion fund in collaboration with the state-owned investment bank China International Capital Corporation (CICC) to support domestic companies and partners. AstraZeneca will also create a new global R&D centre and an artificial intelligence (AI) innovation, both in Shanghai. More here.
Late last week, Amgen also announced it will acquire a 20.5% stake in the Chinese drug developer BeiGene as part of a collaborative agreement to expand its oncology footprint in the country.
Biogen backs biosimilars strategy
Biogen reached an agreement with its existing biosimilars joint venture partner Samsung Bioepis, which gives it exclusive rights to market the latter's ophthalmology biosimilar candidates, SB11 referencing Roche's Lucentis (ranibizumab) and SB15 referencing Regeneron Pharmaceuticals' Eylea (aflibercept), in major global markets, including the US, Canada, Europe, Japan and Australia. More on the deal here.
Analysts at Bernstein said they expect Lucentis and Eylea biosimilars to enter the US market in 2022 and 2024, respectively. Biogen is likely to be one of three or four early market entrants in both cases and they model combined global sales from SB11 and SB15 of around $800 million in 2025. Biosimilar versions of Eylea could prove particularly disruptive, they note.
Analysts at Credit Suisse described Biogen's decision to expand its biosimilars franchise as a "reasonable strategic move given the ability to generate lower-risk cash flows," despite its requirement to share profits with Samsung Bioepis. Biogen's innovative R&D pipeline could be considered higher risk (with potential higher reward) versus its competitors.
The lowdown on Vumerity
Similarly, Biogen will be hoping to prop up revenue from its multiple sclerosis portfolio - in the face of an increasingly competitive marketplace - with the recent approval and pending launch of Vumerity in the US market.
Amarin's AdCom moves into view
Amarin's Vascepa will be the subject of an eagerly anticipated FDA advisory committee meeting next week, when the purified fish oil product is assessed by experts as a potential treatment for lowering cardiovascular risk in patients with high triglycerides. A positive vote in favour of Vascepa would pave the way for potential approval in this indication by year end, although sales of the drug have steadily increased since positive data from the REDUCE-IT study were unveiled in late 2018.
During the company's third-quarter earnings call on Wednesday, Amarin management revealed they have already received a draft copy of briefing notes from the FDA, which will be released publicly ahead of the AdCom meeting next week. Numerous analysts were moved to highlight, therefore, that management comments around expectations for the AdCom are telling, with key topics (in addition to efficacy and safety) likely to be potential triglyceride level cut-offs included in any potential label and the impact of mineral oil (used as placebo) on the REDUCE-IT data.
Further reading…Physician Views snap poll results: Prescriber feedback supports Amarin's bullish projections for Vascepa and KOL Views Results: Vascepa outpaces questions about placebo to score big win in REDUCE-IT, says leading cardiologist.
The countdown to ASH
Abstracts were released ahead of next months' annual meeting of the American Society of Haematology (ASH) this week, sharpening focus on what will be closely watched at the last major oncology meeting of 2019.
This will include various approaches at targeting BCMA for the treatment of multiple myeloma (including various CAR-Ts, bispecifics and GlaxoSmithKline's antibody-drug conjugate) and new data for AstraZeneca's Calquence; which has been touted by the company as a bigger than modelled threat to AbbVie and Johnson & Johnson's blockbuster Imbruvica franchise.
Celgene - soon to become part of Bristol-Myers Squibb - may prove to be one company to watch in the bispecific space, based on data unveiled this week, with Regeneron Pharmaceuticals also looking to make a mark with REGN 4548.
Outside of multiple myeloma, Celgene will also be using the ASH meeting to demonstrate the value of its CD19-targeting CAR-T, and its ability to present a commercial threat for Yescarta and Kymriah. The company will present pivotal data from the diffuse large B-cell lymphoma (DLBCL) cohort of the TRANSCEND study, where analysts will be watching for an improved safety profile over the approved CAR-Ts.
While multiple myeloma will likely to be the battleground indication for more established players at ASH, the market-mover award went to Constellation Pharmaceuticals; the biotech doubled its market cap over results suggesting that it could have a place in the first-line myelofibrosis landscape alongside Incyte's Jakafi (ruxolitinib).
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