Friday Five - The Pharma Week in Review

Strategic manoeuvres

Having reviewed its future over the past two years, Novartis confirmed this week plans to spin out Alcon, the eye-care division it acquired in a series of deals between 2008 and 2011 at a cost of approximately $50 billion. At most - if Alcon's ongoing recovery continues - analysts expect the company to be worth $25 billion once spun out.

Bernstein's Tim Anderson described the decision as removing an overhang from the stock and offering "probably as good an end to the Alcon story as [can] be expected." Analysts at Deutsche Bank wrote "the decoupling puts an end to what was an uncomfortable marriage of two good businesses that, in our view, had limited reason in being together - except in a quest for diversification and earnings bridging through patent expiries."

This decision sets up 2019 as a "critical transition year for Novartis," remarked Credit Suisse, highlighting that the Alcon spinout will coincide with generic entry for Gilenya and Afinitor, and major pipeline catalysts in the form of siponimod in multiple sclerosis and AVXS-101 in spinal muscular atrophy.

From the clinic

New Phase II data for Galapagos' GLPG2737, an experimental therapy for cystic fibrosis (CF) patients with the Class II F508del mutation, were not sufficient to retain AbbVie as a development partner. Confirmation the US Big Pharma has decided against proceeding with the development of a triple combination therapy for CF sent shares in the Belgian drugmaker down as much as 14 percent.

Analysis - ViewPoints: Galapagos once again fighting to keep AbbVie on board

Celgene and Acceleron Pharma reported that a Phase III study of the experimental drug luspatercept in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS) achieved its primary and key secondary endpoints, setting up US and European regulatory filings in the first half of 2019.

The MEDALIST trial evaluated luspatercept versus placebo in patients with IPSS-R very low, low or intermediate risk MDS with chronic anaemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent, ring sideroblast-positive and who require frequent red blood cell (RBC) transfusions. Results showed that luspatercept achieved a significant improvement in the primary endpoint of RBC transfusion independence of at least eight consecutive weeks during the first 24 weeks compared to placebo. 

Analysis - ViewPoints: Acceleron hands Celgene the must-win it desperately needed

Roche confirmed that a combination of its PD-L1 inhibitor Tecentriq and chemotherapy significantly improved progression free-survival in patients with triple negative breast cancer versus chemotherapy alone in the Phase III IMPassion-130 trial.

Analysis - ViewPoints: More good news for Roche’s Tecentriq strategy but caution necessary

Physician Intelligence

FirstWord discussed Celgene and Acceleron's MEDALIST data (see above) with a leading MDS expert; based on Phase II data she is not surprised at the positive results and thinks luspatercept also holds potential in other indications. More here.

We dig deeper into the recent approval of Array BioPharma's BRAF/MEK inhibitor combination in BRAF-mutation melanoma; can Braftovi/Mektovi compete with Novartis' market-leading Tafinlar/Mekinist combination? - see Physician Views: Assessing the potential role of Braftovi/Mektovi in BRAF-mutated melanoma.

Results from our latest snap poll will be available shortly.

Digging a little deeper

CEO Emma Walmsley is leading GlaxoSmithKline to another key inflection point.

Neovacs is hoping its lupus candidate has shown enough promise to attract a partner.

Taking competitive dynamics into account, Biohaven is accelerating its development plans for rimegepant in migraine.

Biogen continues to hedge its biosimilars bet.

Regulatory Recon

CAR-T therapies from Novartis and Gilead Sciences are nearing the market in Europe, sharpening the focus on pricing and payer attitudes.

The FDA approved Dermira's Qbrexza for the treatment of excessive sweating, an indication where Botox is sometimes used; but is there a market for this new topical therapy?

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