Friday Five - The pharma week in review (4 Apr 2019)

Novartis secures a flagship approval in China

Novartis is aiming to make significant strides in the Chinese pharmaceutical market, signalled CEO Vas Narasimhan this week, partly driven by the approval of new products that are already blockbusters in western markets.

His comments coincided with Chinese approval of Cosentyx for the treatment of moderate-to-severe plaque psoriasis, which becomes the first ‘novel’ biologic to be approved in the country for this indication.

Providing further evidence of key regulatory reforms that are accelerating new drugs from multinational players to the market, Novartis submitted Cosentyx to the Chinese FDA at the end of last year. “There has been a tangible change in how health authorities are working to get urgently needed drugs to patients and Cosentyx is a great example of this, Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology and China Region Development Head, told FirstWord in an April 4 interview. Novartis estimates there are approximately 6 million patients with moderate-to-severe psoriasis in China.

Novartis also announced a deal to acquire IFM Tre - which specialises in anti-inflammatory R&D - for $310 million. Read ViewPoints: Novartis grabs another shot at anti-inflammatory pipeline with IFM Tre

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AACR in focus

Opportunities don’t only exist for multinational companies in China.

Speaking the American Association of Cancer Research (AACR) annual congress this week Richard Pazdur, director of the FDA’s Oncology Center of Excellence, called on Chinese drug developers to seek approval their PD-1 and PD-L1 inhibitors in the US market as a first step in bringing down the price of drugs in this class.

Pazdur noted that if data are of a sufficiently quality the FDA would be happy to approve Chinese PD-(L)1 inhibitors on the basis of Chinese clinical trial results.

Elsewhere at the ACCR congress, this year’s meeting did not contribute the level of practice-changing data presented 12 months ago but did deliver important incremental updates in a number of areas…

ViewPoints: AACR19 - Amgen's preclinical debut of its KRAS 'holy grail'

ViewPoints: AACR19 - Chi-Med data could add compelling coda to AstraZeneca's Tagrisso narrative

ViewPoints: AACR19 - New data confirm the threat of Astellas' Xospata to Novartis' Rydapt in AML

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AstraZeneca targets new breast cancer opportunity

AstraZeneca is betting a significant amount of money that Daiichi Sankyo’s antibody drug conjugate (ADC) trastuzumab deruxtecan will help to drive the next phase of growth for its oncology portfolio.

It is data for the ADC in heavily pre-treated HER2 positive breast cancer patients that has attracted AstraZeneca, though it ultimately sees the largest commercial opportunity for trastuzumab deruxtecan potentially coming from patients with breast cancer who test positive for HER2 low status.

Further reading - ViewPoints: AstraZeneca speculates big to take on Roche and carve out a new breast cancer market

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New options in MS - what’s the low down?

The FDA has recently approved two new therapies for multiple sclerosis - Novartis’ Mayzent and Merck KGaA’s Mavenclad - both of which can be used to treat patients with secondary progressive disease.

Read our KOL interview to see how these two products may disrupt the MS treatment landscape and see the results of our snap-poll with feedback from 44 US-based neurologists on the clinical merits of Mayzent.

For more expert opinion… KOL Views Results: Leading RA expert questions filgotinib’s efficacy and not yet sold on safety as a differentiator

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More momentum for gene therapies

bluebird bio has moved a step closer to launching its transfusion dependent β-thalassaemia (TDT) gene therapy Zynteglo (formerly LentiGlobin) in Europe following a positive opinion from the CHMP.

The company has learnt valuable lesson from previous gene therapy launches in Europe, bluebird’s head of European operations Andrew Obenshain told FirstWord, which will primarily result in a sufficient number of treatment centres being operational in each of the region’s major markets by the time reimbursement of Zynteglo is finalised.

bluebird unveiled plans in January to negotiate payment for the therapy in instalments over a five year period; a move which concerned some analysts (wary that full revenues may not be realised) but which the company appears committed to.

See ViewPoints: bluebird gets greenlight for gene therapy in Europe and could soon put the company’s novel pricing strategy into play

Meanwhile in the US… ICER says price for Biogen's Spinraza, estimated value for Novartis' Zolgensma are too high

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