Where next for data transparency in the EU?
The European Medicines Agency (EMA) was expected to present a new formalised clinical trial transparency policy to its management board on Thursday (June 12), amid concerns from transparency advocates that final guidance sways too far from its original proposals and is designed to placate industry concerns.
With two pharmaceutical companies – AbbVie and InterMune – having recently dropped legal cases against the EMA over its proposed transparency policy, the AllTrials campaign posted a note on Tuesday asking whether the European regulator has made a 'backroom deal' with industry. The EMA argues that its revised proposals represent a necessary compromise.
The EMA's revised policy has also recently come under fire from the European Union Ombudsmen Emily O' Reilly and the European Member of Parliament Glenis Willmott. Meanwhile, the German Institute for Quality and Efficiency in Healthcare (IQWiG) issued a humorous press release focusing on the technical limitations of physically viewing trial data via the EMA's proposed policy.
The EMA Management Board announced June 12 agreement on the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes.
Will Merck & Co.'s Hep C strategy pay off?
Merck & Co. revived the 2011/2012 trend for hepatitis C-focused M&A this week when it announced it would acquire Idenix Pharmaceuticals for $3.9 billion; the deal representing a significant 250 percent premium on the company's share price at the close of trading last week.
The hepatitis C strategy being implemented by Merck's head of R&D Roger Perlmutter appears to be driven by two key themes; the hepatitis C market will not be saturated by the launch of new therapies any time soon (despite the stellar launch of Gilead's Sovaldi) and there remain considerable opportunity for pan-genotype all oral treatments that benefit from an even shorter duration of therapy, perhaps as little as four weeks. See ViewPoints: Merck & Co. puts Gilead squarely in its crosshairs
To achieve its goals, Perlmutter has pinpointed Idenix's IDX21437 – a nucleotide inhibitor in the same class as Sovaldi – as integral to reducing therapy duration. Gilead's success in hepatitis C to date has been driven not only by the lofty price it paid to secure Pharmasset in late 2011, but the status of Sovaldi as the only nucleotide inhibitor which has not been derailed by safety concerns by the time it reached late stage testing.
Just 24 hours later – and with great timing – Achillion Pharmaceuticals confirmed that an FDA clinical hold on its NSA5 inhibitor sovaprevir had been lifted and it had initiated a Phase II study for ACH-3422, its own nucleotide inhibitor. Achillion's share price rocketed by 83 percent on Tuesday, fuelled largely one must assume by the possibility that M&A fever in the hepatitis C market may enjoy a sustained revival. Analysts at Baird noted that Merck was not the only "enthusiastic bidder" for Idenix.
What will be learnt at this weekend's annual meeting of the American Diabetes Association?
The annual meeting of the American Diabetes Association (ADA) – June 13-17 in San Francisco – is expected to further discussion around a number of key commercial themes that will impact both the insulin and non-insulin therapy markets over the next few years (and which have been previewed by FirstWord this week).
These include further development in the basal insulin market, including scrutiny of full data for Eli Lilly's biosimilar insulin glargine product, how full head-to-head data for Lilly and Boehringer Ingelheim's dulaglutide will shape its commercial potential versus Novo Nordisk's Victoza and the presentation of initial data for DPP-4 and SGLT-2 inhibitor combinations; developed by AstraZeneca and Eli Lilly/Boehringer Ingelheim.
FirstWord is also polling endocrinologists ahead of the ADA on five key commercially-focused questions this week, including their opinion on dulaglutide versus Victoza, necessary pricing discount for a biosimilar Lantus product and potential future usage of DPP-4/SGLT-2 inhibitor combinations. Further details of this poll and its analysis can be found HERE
Is M&A providing a new take on the drug pricing debate?
Allergan's rejection of a second takeover offer from Valeant this week had an intriguing subplot; the assertion from Allergan that Valeant may be too reliant on aggressive price increases in driving its current and future sales growth performance.
Allergan's primary criticism is that Valeant has not created strong, organic growth, noted Stiefel analyst Annabel Saimmy, while Wells Fargo analyst Larry Biegelsen highlighted its assertion that "growth for many Valeant products has been price driven while volume has been declining". Significantly, argues BMO Capital's David Marris, Allergan's rejection has sharpened focus onto Valeant and what it is worth; its questioning of growth metrics clear evidence of this.
As evidenced by the particularly bullish revenue forecasts projected by AstraZeneca in the face of Pfizer's recent pursuit, defensive plays may sometimes push expectations or throw a curveballinto the mix. Nevertheless, Allergan's assessment of Valeant's pricing strategy is particularly interesting in the 'post-Sovaldi' era and provides some evidence that pharma itself is now recognising that the pricing elasticity of the past is unlikely to last forever.
Which pharma companies are most reliant on their largest product franchise?
This week's FirstWord List revisits how dependent the 15 largest pharma companies are on their best selling product franchises – a brief study which reveals the average dependency ratio is around 25 percent.
Lead product dependency rates may have shifted less than expected versus a decade ago, but they do provide a useful snapshot of the challenges faced by the top 15 companies over the next 5 to 10 years. GlaxoSmithKline's efforts to launch new products in the asthma and COPD markets partly to offset likely generic competition for Advair are in notable contrast to Roche's less urgent need to 'upgrade' on Rituxan, for example, given its biologic status.
The full list and analysis can be read HERE
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