The Friday Five – Five of the past week's pharma stories you can't afford to ignore...

AstraZeneca's spending spree continues

Pascal Soriot's revolution at AstraZeneca continues to gather pace, with the company having announced its second acquisition in two weeks. The purchase of Pearl Therapeutics will provide the company with a foothold in the development race for new chronic obstructive pulmonary disease (COPD) therapies; a competitive space, but one where AstraZeneca will seek to leverage its existing market presence, which is tied to Symbicort. Soriot's nearer-term strategy – i.e. integration of late-stage assets – continues to focus on therapeutic areas where AstraZeneca has a strong legacy, following its recent purchase of Omthera Pharmaceuticals in the cardiovascular space.

Can we expect more bolt-on acquisitions at the company? – most likely yes, argued Societe Generale analyst Stephen McGarry in a note to investors earlier this week. Will these types of deal be sufficient to support the rejuvenation of AstraZeneca? – that is a much harder question to answer. Some may argue that despite the broad perception that larger-scale M&A can frequently erode productivity, a more dramatic move by Soriot is required to turn the company's fortunes around.

The Avandia legacy

There is a broadly held view that the FDA's decision to re-evaluate the side-effect profile of GlaxoSmithKline's previous blockbuster diabetes therapy Avandia says more about the administration than the product. Does a positive vote to soften restrictions on the drug end an era of notable vigilance towards safety at the FDA, asked Forbes' Matthew Herper.

Perhaps, but the legacy of Avandia – and other high-profile market withdrawals such as Vioxx – is an administration that now asks different questions of the products that it is charged with evaluating. Results from cardiovascular outcomes studies required of diabetes treatments, which were approved subsequently to Avandia's significant market restrictions, will begin to read out this year (see below) and the rejection of Novo Nordisk's Tresiba in February would suggest that this approach to evaluating the safety of diabetes therapies has now extended from oral type 2 treatments to insulins.

"The shift to a greater level of conservatism by the FDA is beginning to swing back to a more normal level of scrutiny," Morningstar analyst Damien Conover told FirstWord. "However, there is no doubt that the overall risk concerns at the FDA are still higher now than 10 years ago," Conover added.

Biogen Idec's multiple sclerosis treatment Tecfidera remains the drug to watch – for both the right and wrong reasons

Having seen shares slide last week on the back of potential duplicity in script numbers, analysts suggested this week that prescription numbers are actually undervaluing the level of uptake as Biogen Idec cannot facilitate the supply of Tecfidera fast enough. In short, there is unlikely to be another drug with such a strong launch trajectory until the potential roll-out of Gilead Sciences' sofosbuvir for hepatitis C in early 2014.

While uptake of Tecfidera continues to soar in the US, however, concerns remain in Europe, where launch has been delayed while Biogen Idec continues to discuss data exclusivity provisions with European authorities.

In a potentially dramatic turn of events, Citi analysts suggested on Wednesday that patents held by Biogen Idec for Tecfidera (which would provide additional protection to data exclusivity granted by European authorities) may not be protective even if held up in court. This would intensify focus on Biogen Idec's discussions regarding data exclusivity, as if not granted, Tecfidera would appear to have very minimal protection from generics in Europe. The case remains one to watch, given the potential significant implication on the broader multiple sclerosis market.

FDA to demand more outcomes studies for diabetes products?

At a National Institute of Health (NIH) workshop held over Wednesday and Thursday, the FDA appeared to suggest that there is inconclusive and conflicting evidence to suggest that DPP-IV and GLP-1 agonist drug classes are associated with a higher risk of developing pancreatitis and pancreatic cancer.

Any concern regarding the side-effect profile of these drugs is unlikely to disappear overnight. However, the FDA's stance would appear to be a positive development for the likes of Merck & Co. and Novo Nordisk, note analysts. Manufacturers will be expected to initiate large, long-term studies designed to allay these safety concerns, noted Morgan Stanley analyst Peter Verdult.

With the FDA's approach towards the safety of diabetes very much in focus due to the administration's recent retrospective assessment of GlaxoSmithKline’s Avandia, data from ongoing cardiovascular outcome studies is expected to become available over the coming months, with results from AstraZeneca and Bristol-Myers Squibb's SAVOR trial (for Onglyza) anticipated later this month.

Vertex plots route to $10 billion cystic fibrosis franchise

Investor anticipation (and Vertex's share price value) has grown this week ahead of presentations that the company made at a meeting of the European Cystic Fibrosis Society (ECFS) on Thursday. Study results should provide incremental insight into whether Vertex can significantly expand the commercial footprint of its cystic fibrosis franchise – currently focused on Kalydeco. The Street's Adam Feuerstein suggested earlier this week that sales could expand ultimately to around $10 billion – thereby positioning Vertex as the dominant player in cystic fibrosis, akin to Gilead's virtual monopoly in the HIV space.

Kalydeco is currently approved for around 2000 patients with the G551D mutation, but as a monotherapy could soon be approved for use in a further 5000 patients with the R117H and non-G551D gating mutations.

Via his Twitter account, Feuerstein suggested on Thursday that additional data from Phase II studies presented at the ECFS conference evaluating combinational usage of Kalydeco and VX-809 in F508del homozygous mutation patients (around 30000) also appeared to be strong. As did preclinical, in vitro data for triple-therapy combinations designed to treat patients with the F508 heterozygous mutation.

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