Biogen’s dramatic U-turn
In a dramatic turn of events Biogen announced its intention to file aducanumab with the FDA early next year, seeking its approval as a disease-modifying treatment for Alzheimer’s disease.
Having previously announced in March that aducanumab had failed two Phase III studies, Biogen says a futility analysis carried out last December was incorrect. New data, evaluating a higher dose of aducanumab, showed one of Biogen’s studies met its primary endpoint with positive results seen for a relevant subset of patients in the second trial.
The FDA would appear to have given Biogen some encouragement to file a regulatory application for aducanumab, though whether it approves it is another matter.
Zolgensma quick out of the traps
Novartis unveiled its third quarter results this week, revealing higher than expected sales for its spinal muscular atrophy (SMA) gene-therapy treatment Zolgensma. The company confirmed that around 100 patients in the US have been treated with Zolgensma in the commercial setting since its approval in late May, putting to bed any lingering concerns that FDA scrutiny of early-stage data used to support Novartis’ regulatory application would have an impact on initial adoption.
Uptake of Zolgensma frames a challenge for Biogen, which saw revenues for its SMA therapy Spinraza grow on a global basis but flat-line in the US. Both Zolgensma and Spinraza face potential competition from Roche and PTC Therapeutics’ oral SMA treatment next year.
A rapid regulatory turnaround for Vertex
Vertex may be courting controversy in some markets for the price it charges for its cystic fibrosis therapies but its scientific endeavours received an important endorsement this week when the FDA approved its latest offering - the triple drug combination Trikafta - five months ahead of schedule and just three months after regulatory filing in the US.
The successive roll out of new CF therapies from Vertex’s pipeline has steadily expanded the addressable population these drugs are effective in, with Trikafta expanding this share from 50% to 90% of CF sufferers.
Analysis - ViewPoints: Vertex snags a triple play
This progress warrants a premium, says Vertex, which has priced Trikafta at $311,000 per patient per year. This represents a notable increase over the cost of Vertex’s older double-drug combinations Symdeko and Orkambi suggesting that controversy around the price of drugs - even those that are genuine game-changers in certain disease areas - is here to stay.
Avastin unlocks IO potential in liver cancer
Roche delivered an important update for its immunotherapy Tecentriq in liver cancer this week, confirming that when used in combination with Avastin it prolongs overall survival - versus chemotherapy - in previously untreated patients with unresectable disease. Analysts at Deutsche Bank describe this indication as a potnetial blockbuster opportunity, if Roche can implement a successful regulatory and commercialisation strategy in the Chinese market (where liver cancer prevalence is approximately ten times higher than western markets).
They note that the biggest competitive threat could come from Merck & Co. which is currently evaluating Keytruda in combination with the tyrosine kinase inhibitor Lenvima, with Phase III results expected from mid-2020 onwards. Response rates for this pairing demonstrated in earlier-stage trials, have suitable raised expectations.
China growth continues to impress at AstraZeneca
The growth trajectory of AstraZeneca’s key oncology franchises continues to impress, shaping Pascal Soriot’s recovery narrative at the UK drugmaker. Equally - if not more - impressive is AstraZeneca’s persistent ability to grow sales in the Chinese pharmaceutical market, which increased 40% year-on-year for the third quarter of 2019.
Asked about the sustainability of this performance as new reimbursement policies kick in, Soriot conceded the Chinese market offers a mix of risk and opportunity and described AstraZeneca’s outlook here as exciting. The reality is that mid-teen or slightly higher rates of growth are more likely in the future but AstraZeneca remains uniquely positioned among Big Pharma in China with a broad portfolio of products including various new innovative drugs such as Tagrisso, Brilinta and Farxiga which continue to gain traction.
AstraZeneca was also keen to highlight sales in emerging markets outside of China, which grew 15% year-on-year in Q3, saying this performance better represents the company’s position in these territories versus growth during the first half of the year which was skewed by the impact of divestments.
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