Friday Five - The week in review

The UK's pharma boost

One post-Brexit concern emanating from the UK bio-pharma industry is loss of ground to the US and Chinese markets.

Thus there was cause for celebration when just days after it was announced the European Medicines Association will move from London to Amsterdam as a result of Brexit – and on the same day the UK government unveiled an industrial strategy on how the country can build on its economic strengths, with a particular focus on the life sciences sector – Merck & Co. confirmed it will open a new UK-based research centre backed with investment worth $1.3 billion. The facility, which will also become Merck's new UK headquarters, will support 950 jobs, including 150 which are new.

But perhaps the UK government was too eager to claim it had successfully convinced Merck to make this investment. It quickly came to light the US pharma giant has been reviewing its global R&D strategy for more than two years and made the decision some time ago, although the company said it was happy to coordinate its announcement and is looking forward to working with the UK government.

Merck noted to FirstWord that "whilst the UK has a world class science base which attracts companies such as ours, there remain many challenges in relation to patients’ access to medicines, " adding "this hinders the creation of a more competitive environment in which to drive investment, jobs and growth for the future. They are hopeful the government's new industrial strategy "offers the opportunity to deliver a stable and holistic approach to life sciences that recognises the full value of innovative medicines from early stage research all the way through to adoption."

AstraZeneca's China JV

If China is to secure a bigger proportion of global pharma investment at the expense of the established development hubs, recently proposed regulatory reforms are likely to play an important role in opening the market up to multinational players.

However, barriers to entry will continue to exist in the short term and AstraZeneca looks to be making the most of any opportunity it has to extend its current leadership of the Chinese market among the Big Pharma peer set. This week it announced formation of a joint venture with the Chinese Future Industry Investment Fund (FIIF) – more here

Teva unveils structure reforms

Teva announced Monday a new organisation and leadership structure, including the departure of head of global R&D Michael Hayden, in an effort to "achieve better commercial focus and drive value creation."

Under the reorganisation, Teva's commercial businesses of generics and specialty medicines will be integrated into one organisation operating through the three regions of North America, Europe and growth markets. In addition, the former generic R&D and specialty R&D organisations will be combined into one global research group.

"Our new company structure will enable stronger alignment and integration between R&D, operations and the commercial regions, allowing us to become a more agile, lean and profitable company," Schultz remarked. The executive added "it remains our absolute priority to stabilise the company's operating profit and cash flow in order to improve our financial situation."

Analysts at Credit Suisse described the plan as an "encouraging development," but wrote "we need to hear the overarching strategy that management has developed, and the detailed plans to enact that strategy, before we can properly estimate the potential impact of management’s plans." Noting that new management has been tasked with reshaping the company on multiple occasions in recent years, they note "the Board has said they will work with Schultz on whatever plan he comes up with, but until we see that commitment backed up by action, we maintain our current outlook."

Complex generics remain a target for the FDA

Speeding up approvals for complex generics is now squarely in the FDA's crosshairs, with commissioner Scott Gottlieb making a statement on November 28 to further advance the agency's strategy of leveraging competition to bring down drug prices. Though no names were specified, the initiative is clearly bad news for companies like Mylan and Allergan, which have been long fending off generic competition for their complex- and aging- products. 

The FDA had already been making it a point to speed generic approvals, with Gottlieb offering up increased competition as a mechanism of driving down drug prices- a rare and aggressive stance for an FDA official, particularly one appointed by a Republican administration. The strategy is already having an effect, with the FDA handing down record approvals this year- 92 generic applications got the green light in October, marking a four-year high – more here

Prescribers run the rule over new approvals

Johnson & Johnson has secured European approval for Tremfya, its follow-up to the psoriasis treatment Stelara. Dermatologists we polled this week are impressed with its data, but the competition in this market has been amped by the launch of Novartis' Cosentyx – more here.

Facing up to renewed competition from Gilead in the HIV market next year, ViiV Healthcare – majority owned by GlaxoSmithKline – has succeeded in bringing a new doublet therapy (Juluca) to market in the US; HIV specialists are unconvinced, however, that two-drug regimens will gain much share at the expense of triple combos.

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