Friday Five - The pharma week in review (11 July 2019)

Dovato data

Can physicians be persuaded that using two-drug HIV treatment regimens is safer and equally efficacious as three- and four-drug therapies?

This is the challenge facing ViiV Healthcare and its majority stakeholder GlaxoSmithKline. The UK pharma giant has prioritised development of two-drug products like Dovato (which combines dolutegravir and lamivudine) in a bid to defend market share against resurgent competitor Gilead Sciences.

Dovato is approved in the US and European markets for treatment-naïve patients and ViiV announced positive top-line results this week from the TANGO study, confirming that patients who switched from a three-drug regimen maintained viral suppression with Dovato at six months.

Infectious disease specialists based in the EU5 who we snap-polled earlier this week provided a positive assessment of Dovato's clinical profile. Long-term data confirming a lack of disease resistance will be critical in determining the overall success of this strategy, however.

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Pfizer and Sangamo deliver haemophilia A update

Partners Pfizer and Sangamo Therapeutics kept up the pressure on other front runners in the haemophilia A gene therapy field by announcing positive updated results for their own investigational product - SB-525 - last weekend.

Though it remains unclear when registration-supporting data for SB-525 will be available, the latest results go some way to validating Pfizer's decision to partner up with Sangamo. BioMarin Pharmaceutical remains in poll position from a regulatory standpoint, though quite how the gene therapy field will evolve if and when multiple products reach the market remains unclear.

Further uncertainty is provided by yet another delay to Roche's proposed acquisition of Spark Therapeutics.

Roche, which markets the haemophilia A treatment Hemlibra, is looking to move into the gene therapy field via its acquisition of Spark, though it is facing an increased level of scrutiny from the US Federal Trade Commission, which appears to be concerned about potential future anti-competitive behaviour

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BioNTech raises cash and expectations

German-based BioNTech announced this week that it has raised $325 million via a Series B financing round, with the proceeds to be used to advance the company's therapeutics pipeline and manufacturing infrastructure. BioNTech noted that the financing is "one of the largest single private funding rounds for a biotechnology company in European history."

In January last year, BioNTech raised $270 million via a Series A financing, with chief business officer Sean Marett noting Tuesday that in combination with payments from partners, it has raised a total of $1.4 billion. The company has collaborations with a number of drugmakers, including Eli Lilly, Genmab, Pfizer, Roche and Sanofi, to develop patient-specific immunotherapies for the treatment of cancer and other diseases.

"BioNTech has executed on a highly disruptive business strategy that aims to change the treatment paradigm for cancer patients," remarked Chairman Helmut Jeggle, adding "we value the continued participation of our existing investors and welcome new investors to this powerful global syndicate representing North America, Asia and Europe."

Earlier this year, a report suggested that BioNTech, which was spun out of the University of Mainz in 2008, was weighing an initial public offering in the US, valuing the company at about $5 billion. "There are a number of options for us and we are continuously evaluating all of them," Marett remarked Tuesday, adding "we are still early in the private funding cycle, having just completed our Series B round, but things can change rapidly in our industry."

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US drug pricing proposals remain in flux

The White House confirmed on Thursday that proposals to ban rebates paid by drug companies to pharmacy benefit managers (PBMs) under Medicare have been scrapped.

The proposal was unveiled in January and was designed to reduce list prices, though projections showed the rule change could have potentially cost the federal government more than $170 billion over the next decade. It had been opposed by PBMs.

The government remains committed to reducing US drug prices, but saw another initiative stall this week; on Monday a federal court ruled against a proposal that would have forced pharmaceutical companies to disclose drug list prices in television advertisements.

Late last week, President Trump also reiterated that his administration is working on an executive order to cap the price the US government pays for certain drugs at the lowest price paid in a basket of other countries.

This proposal could have more serious implications for pharma than initial stock reaction suggests, wrote analysts at Bernstein in a note to investors, though experts said it may only apply to a small subset of drugs initially. Details at this stage are scarce.

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No flies on ICER

The Institute for Clinical and Economic Review (ICER) has released its preliminary list of potential assessment topics for 2020. More here.

Based on anticipated new drug approvals by the FDA next year, the list includes AstraZeneca and Daiichi Sankyo's breast cancer treatment trastuzumab deruxtecan, bluebird bio's beta thalassaemia gene therapy Zynteglo, Vertex Pharmaceuticals' anticipated new cystic fibrosis therapy (comprising the agents VX-445, tezacaftor and ivacaftor), BioMarin's haemophilia A gene therapy valoctocogene roxaparvovec, Sage Therapeutics' post-partum depression therapy Zulresso and Novartis' wet age-related macular degeneration therapy brolucizumab. ICER also plans a class review of available ulcerative colitis therapies.

A recent FirstWord ExpertViews report concluded that "ICER is now a loud voice on the value of a drug in the US and manufacturers cannot afford to ignore what the agency is doing." Its proactive-ness in reviewing the cost effectiveness of new medicines as close to US market approval as possible has been key in driving payer adoption of its recommendations. "Manufacturers should prepare to be increasingly asked by payers for price discounts based on ICER's value-based price benchmarks," the report concludes.

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