Press review

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GSK needs more courage to make 'big bets' like Tesaro, says CEO Walmsley

LONDON, 17 Jan (APM) - The Sunday Times carried an interview with GlaxoSmithKline's chief executive Emma Walmsley in which she discussed the company's progress since she took over from Sir Andrew Witty in 2017, including the $5 billion acquisition of cancer specialist Tesaro.
She told the paper: "It was obvious we needed to bring a more performance edge to the company, more accountability and courage to make big bets like Tesaro . . . and to stop things that were a dilution of focus."
The paper said Walmsley has sharpened the company's focus on performance and instructed scientists to take swifter action in scrapping medicines that had little chance of commercial success.
"You have to put money with discipline and stop putting money in places that are not a priority and in a big multinational that can be challenging," said Walmsley.

AstraZenca faces $100 million hit after Epanova trial failure

AstraZeneca will face a $100 million hit after trials of heart disease drug Epanova showed it be ineffective in patients with mixed dyslipidaemia (MDL) who are at increased risk of cardiovascular disease, said the FT on Monday (APMHE 65799).
The paper quoted Mene Pangalos, executive vice president, biopharmaceuticals R&D, who said: "It was important to assess the potential benefit of Epanova in mixed dyslipidaemia. We are disappointed by these results, but we remain committed to addressing the needs of patients in the cardiovascular space where we have an extensive pipeline."

Gilead exploits tax loophole in Ireland

Gilead Sciences used a tax loophole in Ireland to move more than $30 billion to the U.S., according to The Times on Monday.
The paper said the most recent accounts for Gilead Biopharma, an Irish subsidiary of Gilead, show that it made a loss of $824 million in 2018.
However, the entity had built up a large amount of cash in previous years, recording profits of more than $16 billion in 2016 and almost $6 billion in 2017.
Gilead Biopharma, which is a holding company with no employees, did not pay any Irish corporate tax on these profits as it is domiciled in the Bahamas, which has a 0% tax rate.
The latest accounts show that during 2018 the company paid out a dividend of $30.4 billion to its parent company, Gilead Sciences, headquartered in the U.S.
The company was able to do this due to the 'double Irish' loophole that allowed multinationals to move their profits from high-tax countries to nations with a lower rate of tax.

NHS and Novartis partner on mass trial for cholesterol injection

England's NHS is to launch a mass trial of Novartis' 'vaccine' for high cholesterol that could replace daily statins, it was widely reported on Tuesday.
The Guardian said about 40,000 people with high 'bad' or low-density lipoprotein cholesterol will be invited to join the trial of inclisiran by NHS England via their GPs. Novartis will provide the injections free in exchange for the results of the five-year trial, which will be run by the NHS staff, added the paper.
The Times noted that the Department of Health said that if inclisiran were given to 300,000 people a year it could prevent 55,000 heart attacks and strokes and 30,000 deaths over a decade.
And the FT said the moves are intended to showcase the UK as an attractive destination for life sciences investment aid Brexit uncertainty.

NICE rejects Vitrakvi for reimbursement on NHS in England

The Daily Mail on Friday covers NICE's guidance rejecting Bayer's Bayer/Loxo Oncology's histology independent cancer drug Vitrakvi (larotrectinib) for routine reimbursement on the NHS in England (APMHE 65882).
The paper focused on previous pledges by NHS officials to fast track what they called 'game-changing' new gene-targeted cancer drugs.
It referenced Simon Stevens, the chief executive of NHS England, who said in June that the advantages of these new drugs was 'potentially huge' - and pledged that NHS patients would be 'among the first in the world to benefit'.
Despite this, NICE has now issued draft guidance rejecting the first of these drugs on grounds of cost, said the paper.
The drug costs £15,000 a month.

Melatonin should not be available on NHS for jet lag

The Guardian on Tuesday reported on a review by the UK's Drug and Therapeutics Bulletin that says the hormone melatonin should not be available on the NHS to help treat jet lag.
"We would suggest that melatonin for jet lag is added to the list of drugs that may not be ordered under a general medical services contract," says the review.
The team concluded the evidence suggests melatonin does have a modest effect on reducing the symptoms of jet lag. However, the authors said the evidence base for using the hormone for jet lag remains poor - and in any case jet lag goes away on its own within a few days and is not a major priority for the NHS.

Conservatives must learn from Orkambi access challenges

The Observer on Sunday carried an opinion piece from Diarmaid McDonald, the lead organiser of the campaign group Just Treatment and Achal Prabhala, the coordinator of the AccessIBSA project, on drug pricing in the UK.
They said the Conservative government must learn from the challenges of agreeing an access deal for Vertex's cystic fibrosis drug Orkambi.
"The Orkambi campaign took many years and cost lives in the process," said the article. "It should not have to be repeated. Instead, health secretary Matt Hancock, or his successor, should exercise their moral obligation to protect the health of NHS patients. They have the power to break medicine monopolies to rein in the greed of drug companies, and they must be prepared to use it."

High-price gene therapies set to challenge Europe's willingness to pay

The FT on Thursday featured an article on the willingness of European countries to pay for one-off gene therapies.
The paper said that two treatments are coming to market with a price tag of about $2 million: bluebird bio's Zynteglo for rare blood disorder beta thalassaemia and Novartis' Zolgensma for spinal muscular atrophy.
The companies justify the high prices for these one-off treatments, which tend to have a long-term effect, as existing treatments are giving over a longer period of time, said the FT. However, cash-strapped European health systems may struggle to pay for these new drugs, potentially affecting future investment in the field.
The FT spoke to Brad Loncar, chief executive of Loncar Investments, who said it was important the launches of Zolgensma and Zynteglo go well as investors need to be reassured there is a "robust commercial market".

Hikma's generics division in slowdown

The Times on Thursday reported that broker JP Morgan Cazenove downgraded its recommendation on Hikma Pharmaceuticals' shares to a "relative underweight" last week, noting that it believed a slowdown at the company's generics division over the next 12 months would more than offset growth in injectables, its largest unit.
The paper said the generics business is having to combat a double-digit percentage fall in market prices as the result of competition, particularly in U.S.
However, it added that Hikma is hopeful of approval for its version of Advair, GlaxoSmithKline's blockbuster inhaler drug.

FDA warns on Belviq cancer risk

The U.S. Food and Drug Administration (FDA) is warning that Eisai's weight-loss drug Belviq may increase the risk of cancer, the Daily Mail said on Wednesday.
The warning is based on a trial that was meant to evaluate whether the drug was safe to take for obese patients who were at risk of heart disease but, at the end of the study period, more participants had tumours after taking Belviq than a placebo.
"At this time, the cause of the cancer is uncertain and we cannot conclude that lorcaserin contributes to the cancer risk," the alert read.
"However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review."

U.S. biotech looking to drive down prices using 'me-too' drugs

The Financial Times at the weekend reported on a biotech called EQRx that is aiming to "upend the U.S. drug pricing system" by focusing on 'fast follow' drugs that use alternative but similar active ingredients as patented drugs.
These drugs, which are also known as 'me-too drugs', could offer a third way between high-priced branded medicines and cheaper generics, said the paper.
It spoke to EQRx's founder Alexis Borisy who said that these drugs are not new but that no company so far has used them as a means of competing on price.
"We see this as a fundamentally capitalistic enterprise. A business with a very, very nice rate of return," he said.
The story was also covered in The Times and the Daily Telegraph.

23andMe sells drug to Almirall

DNA analysis company 23andMe has become the world's first genetics testing firm to create a drug created from its customers' DNA samples, The Times said on Tuesday.
The paper said the company sold the rights to the drug to the Spanish pharmaceutical company Almirall for an undisclosed sum (APMHE 65787).
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