Posted on 7 months ago by Gerry Kennedy
Perhaps the biggest hallmark of 2016-going-into-2017 is the sense of hesitation and uncertainty as the industry waits with bated breath in the wake of the two biggest and most indisputable game-changers, not just for pharma, but for the world: Brexit and Trump. As we sit in the eye of the storm and they loom on the horizon, many industry figures are finding it difficult to strategise accurately for the future.
Throughout the year we asked for insight on these titanic events and what they might mean from a number of legal teams including Morgan Lewis, finnCap and BonelliErede. Be sure not to miss UK Biopharma and life after Brexit and The impact of Brexit on the pharmaceutical industry: Some preliminary considerations.
In the new year, companies will have to tread carefully until we better understand where these new factors will take us. Look out for our focus on how president Trump could shake up the industry in the upcoming issue of Pharmafocus.
The Mylan EpiPen scandal brought the issue of price hiking back into the public eye, and all the controversy that comes with it. After it was revealed that the company had raised the price of its flagship auto-injector by 400% since 2008, an indignant industry watched as CEO Heather Bresch was called before US lawmakers to explain the decision along with her own almost-700% pay rise over the same period. To calm the controversy, the company has finally launched a generic alternative, months late and still flashing a hefty price tag.
The wider issue featured heavily during the US presidential race as Clinton and Trump clashed over ways to curb outrageous pricing, and since then, former-democrat candidate and Vermont senator Bernie Sanders has led the charge against big pharma’s unjust measures, calling out Sanofi, Lilly and Novo for allegedly colluding to raise their prices. And as Trump was named president, price control measure proposition 61 was defeated by popular vote. We delved into the pricing crisis facing the US in our feature Price hiking: US pharma’s elephant in the room.
The problem has also been rife in the UK, as NHS suppliers were investigated over hiking the price of the drugs they provided by as much as 1000%, while Pfizer broke records by being hit with a massive £84.2 million fine for overcharging the health service by 2600%.
This is a problem that never went away and is only now being placed under harsh scrutiny, so expect more pricing scandals to erupt in the coming year.
Collaboration in the digital sector
2016 was characterised by a number of high-profile collaborations between tech and pharma giants in a bid to harness new and developing technologies to supercharge R&D, pharmacovigilance and more. In the latter half of the year, Google and its parent company Alphabet stepped into the pharma ring forming partnerships with GSK and Sanofi, while IBM forged alliances with Teva, Celgene and Quest Diagnostics.
Even Facebook chairman and CEO Mark Zuckerberg took centre stage in the industry, launching his $3 billion Chan Zuckerberg Health Initiative alongside his wife Priscilla Chan with a remit to “cure, prevent or manage all disease within [their] children’s lifetime”. The initiative also managed to snatch up former chair of AstraZeneca’s genomics advisory panel Cornelia Bargmann as its president of science.
Looking forward to 2017, expect these types of deals to become the norm as the industry increasingly recognises the value and warms to the adoption of powerful new technologies.
Bigger mergers and acquisitions
2016 saw, after much deliberation, the biggest-ever acquisition by a German firm across any industry, the massive $66 billion Bayer-Monsanto deal, and ripples are still felt throughout the pharma world. Its long-term effects are still being determined, but we asked Winckworth Sherwood to analyse its potential impact and what it means for the industry, which you can find here: Looking back at the biggest deal of 2016: Bayer-Monsanto.
Acquisitions are just a part of the industry’s lifeblood, but as the precedent of increasingly larger deals is set, pharma companies may be seen to dig deeper in their pockets in future when looking to seize vital portfolio-expanding assets.
Vaccine R&D for the developing world and beyond
In the past year, the devastation wrought by recent outbreaks of zika, ebola and dengue in developing parts of the world has seen pharma companies rushing to both calm and capitalise on the crises.
2016 saw the roll-out of the world’s first public immunisation programme against the dengue virus, courtesy of Sanofi. The company also announced its intention to co-author a vaccine for zika with the US government, later securing $43 million for its development.
The wildly different nature of developing markets and the challenges they present prompted GSK to pitch a global biopreparedness unit to pre-emptively tackle outbreaks in non-lucrative areas, while a new UN declaration to help fight the rising threat of drug-resistant infection saw signatures from 193 countries. With the issue taking centre stage in global affairs while remaining a crisis issue, it will surely remain something the big players will be keeping an eye on in the coming months.
Movement towards more equitable attitudes
Another trend seen throughout the year was the shift by pharma companies to take up fairer, more consumer-friendly values through pledges to keep prices low or commit to more ethical practices.
Allergan CEO Brent Saunders outlined the company’s new “social contract” with its consumers, with pricing, quality and safety of its products playing core roles. Novo Nordisk later pledged no higher than single-digit price increases on its products, and GSK vowed to put a stop to its previous practice of paying doctors to promote its products.
This new attitude is increasingly becoming the expected standard with debates on the topic burning tirelessly; earlier in the year, we looked at these discussions in depth with our feature The ethical battle for the future of pharma. As the big players go on record with these commitments, the pressure is on for their rivals to follow suit, so expect more companies to make it clear they will be pursuing more equitable practices in 2017.
Competition in the immuno-oncology sphere
2016 was a big year for immuno-oncology, particularly for Bristol-Myers Squibb’s Opdivo – it dominated sales and indications, that is until the surprise failure in October of Opdivo as first-line treatment for lung cancer patients. Later that month, Keytruda was found to be more effective than chemotherapy in first-line treatment of lung cancer patients with high expression of the protein PD-L1. In the same month, Keytruda was then given approval by the FDA for use in the same indication.
It is battle that will continue into 2017, with a fight between the lead medications expected over new indications whilst new players also come to the fore. As yet, Tecentriq has not entered into the field with as much force but positive results are boosting sales. On top of this, the new field is exploding with research as everyone tries to enter the game. Pfizer has also recently announced a partnership with IBM Watson Drug Discovery to try find new targets within immuno-oncology. 2017 is expected to reveal far more research and a far more competitive field.
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