The Friday Five – 5 key issues in pharma this week

Does Actavis hold the M&A key?

An increasingly incestuous M&A landscape in the specialty pharmaceutical sector has undergone further development in the past week, with Actavis seemingly poised to play an integral role in how this game unfolds.

The company acquired Durata Therapeutics at a cost of $675 million this week, in a deal designed to boost its infectious disease portfolio. Crucially, however, this outlay will not prevent Actavis from undertaking larger acquisitions, suggested analysts.

Salix Pharmaceuticals announced it was abandoning a deal to acquire Cosmo Pharmaceuticals and has positioned itself as a takeover target by encouraging Actavis to make a bid. However, Actavis is also reportedly considering a second offer for Allergan, which remains the subject of a long-running hostile approach from Valeant Pharmaceuticals.

Valeant itself is rumoured to be increasing its own offer for Allergan, while Allergan management continues to fight against the approach, lifting its full-year earnings guidance on Thursday.

Should Actavis agree to acquire Allergan – with many analysts arguing the deal is a compelling one for both companies – it could have broader implications, casting doubt on Actavis as a potential target for Pfizer and putting another acquisition target into play if Actavis was to subsequently jettison its generics business.

Further reading:

ViewPoints: Will Actavis emerge as Allergan's white knight?

ViewPoints: Actavis buying Durata ups the ante in the ABSSSI space, and could spark more M&A among anti-infective players

ViewPoints: Teva sharpens focus, but stays on the sidelines

ViewPoints: Inversion diversion or cold feet? – Salix walks away from Cosmo and beckons Actavis

Amgen debuts Phase III biosimilar data

The biosimilar antibody space has witnessed a number of watershed moments in recent years, most notably the approval of Celltrion and Hospira's Remsima, a biosimilar version of Johnson & Johnson and Merck & Co.'s Remicade, in Europe last year.

Big Pharma's potential presence in the market gained a little more momentum this week, when Amgen announced its first Phase III data for a biosimilar monoclonal antibody (MAb) programme; ABP501, a biosimilar version of AbbVie's Humira.

Whether this data pushes Amgen to the front of the queue in terms of the biosimilar Humira opportunity remains unclear (and is characteristic of the secrecy surrounding biosimilar development programmes). However, analysts at Bank of America Merrill Lynch were suitably bullish to suggest a regulatory submission at the end of next year/in early 2016, while Amgen expects to launch its first biosimilar in 2017 (Humira loses patent exclusivity in 2016 in the US and in 2018 in the EU).

Amgen's manufacturing capabilities, coupled with an existing sales force that promotes the rival TNF-inhibitor product Enbrel, should position the company competitively in the biosimilar Humira market, argue analysts.

Furthermore, with biosimilar developers always looking for evidence to indicate how this opportunity will play out, a number of interesting developments were discussed at length at a recent conference in London, which was attended by FirstWord.

Use of a switching study, a proactive move to promote biosimilar usage, may in fact have limited uptake of Celltrion and Hospira's Remsima in Norway, a prominent test case market for biosimilar MAb products, while debate continues to rage on the use non-proprietary names for biosimilar products.

Further reading:

ViewPoints: Amgen becomes first Big Pharma to unveil Phase III biosimilar antibody data

ViewPoints: The 'INNs' and outs of biosimilar naming

ViewPoints: Has Norway's NOR-SWITCH study slowed down the adoption of biosimilar infliximab?

Gilead on top as Bristol-Myers Squibb's Hep C strategy turns sour

This week is expected to provide a watershed moment for the hepatitis C market, with the FDA due to approve Gilead Sciences' fixed-dose combination of Sovaldi and ledipasvir (it has a PDUFA date of October 10), a therapy anticipated to further revolutionise the treatment of this disease.

Late-breaking abstracts released this week ahead of next month's American Association for the Study of Liver Diseases (AASLD) meeting also provided further clues as to how the hepatitis C market could evolve over the next five to 10 years.

The abstracts delivered net positive sentiment in favour of Gilead, concluded Bernstein analyst Geoffrey Porges, and confirm that Merck & Co. has become an increasingly credible player in hepatitis C, driven in part by its acquisition of Idenix earlier this year. He adds that while AbbVie will exert short-term competitive pressures on Gilead, the AASLD abstracts also highlight limitations within their portfolio.

Uncertainty continues to surround the future of Johnson & Johnson in the hepatitis C market, despite its recent acquisition of Alios BioPharma, and Bristol-Myers Squibb, which announced this week it would withdraw an application for a two-product combination in the US market deemed by the company not competitive enough versus Gilead and AbbVie's soon-to-be approved offerings.

Bristol-Myers Squibb remains in the hepatitis C game for now and will continue to develop a triple-combination therapy. However, data released ahead of AASLD for the combination is "somewhat disappointing," remarked Porges, with Bank of America Merrill Lynch describing the data as being "solid," but "meaningfully behind the competition when the focus will be shifting towards shorter-duration pan-genotypic regimens".

Pre-AASLD sentiment towards the data looks likely to prompt further speculation that Bristol-Myers Squibb will acquire Achillion Pharmaceuticals in order to enhance its drug development optionality in the hepatitis C space.

Further reading:

ViewPoints: Early winners and losers from upcoming AASLD meeting begin to emerge

ViewPoints: Will Bristol-Myers Squibb brave another M&A move in hepatitis C?

ViewPoints: Is Alios deal Johnson & Johnson's play for longevity in hepatitis C market?

FDA approval trends analysed

An intriguing new analysis published in Drug Discovery Today reveals that the FDA (and its various predecessors) approved 1453 new molecular entities (NMEs) between 1827 and the end of 2013. The modern FDA was created in 1938, prior to which only a very small number of products were approved (including morphine and aspirin).

For today's pharmaceutical industry, analysis of NME approval rates in recent decades make for the most interesting (and confirmatory) reading. The 1990s, for example, represent a 'golden era' for industry innovation (if looking beyond the number of me-too launches) when the NME approval rate averaged at close to 35 new products a year. That said, the FDA approved a staggering 55 NMEs in 1997 – an uncharacteristically large number of approvals, which clearly had a positive impact on the average approval rate for this decade. Having dropped to below an average of 25 NME approvals per year between 2000-2010, the rate has encouragingly crept up towards 35 NMEs per year since 2011.

The analysis also reveals that the number of companies granted at least one NME approval by the FDA peaked at over 100 in 2004, but has subsequently declined to around 90, due in part to industry's continued fascination with M&A. This trend towards consolidation is best exemplified by Pfizer's 'ownership' of 198 NMEs. Merck & Co. has received the most NME approvals from the FDA, with 63.

An antidote for further growth – Can Portola deliver?

The Factor Xa inhibitors – a novel class of oral anticoagulant – represent one of the pharmaceutical industry's most successful new drug class launches; Bayer and Johnson & Johnson's Xarelto continues to lead the field, and act as one of the sector's fastest growing products, while Bristol-Myers Squibb and Pfizer's Eliquis continues to pick up the commercial pace despite a slower-than-expected launch.

However, a key question is whether the availability of an associated antidote product – one that could reverse the effects of a Factor Xa inhibitor in cases where severe bleeding has occurred or if a patient requires surgery – would boost sales of this blockbuster class even further. Portola Pharmaceuticals, the company leading this charge, recently unveiled positive Phase III data for its Factor Xa inhibitor andexanet alfa.

In response, FirstWord polled cardiologists and general practitioners based in the US and EU5 markets to ascertain how the availability of an antidote would impact their use of factor Xa inhibitors; the results make for positive reading, for Bayer and Johnson & Johnson in particular.

Further reading:

Physician Views Poll Results: Can Portola's reversal agent act as a growth catalyst for novel anticoagulants?

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