LONDON, 23 Aug (APM) - Gilead Sciences is moving to challenge patents held by the U.S. government on the preventive use of HIV drug Truvada, which is known as PrEP, amid criticism it used publicly-funded research to bring the drug to market at too steep a price, the Financial Times reported on Wednesday.
The company said on Wednesday it strongly believes that the patents granted to U.S. Health and Human Services (HHS) for two prophylactic uses of the drug are not valid.
Gilead's petition to the U.S. Patent and Trademark Office is to request a so-called inter partes review, which re-examines the claims in a patent to determine if they are valid. If the proceeding is instituted, determinations are usually reached within a year.
The Financial Times reported on Sunday that the company did not apply for exclusivity for the preventive use of the drug in the U.S. and that it could owe the U.S. government at least $1billion in royalties and damages.
Gilead said it disagreed with the premise that royalties or damages were due, and that its patents for Truvada covered all uses of the drug, and that it did not obtain new patents for the PrEP indication.
Gilead has been under political pressure to justify the high cost of the drug — which can run to $20,000 a year in the U.S. — and if used by more people, could wipe out the HIV epidemic.
Gilead did not apply for exclusivity for HIV drug Truvada in 2012
Meanwhile, the FT at the weekend reported on federal documents that show Gilead Sciences did not apply for exclusivity for HIV drug Truvada to be used as a preventative treatment in 2012.
The paper referenced activist and legal experts who say this lack of exclusivity for the drug means that Gilead's effective monopoly for pre-exposure prophylaxis (PrEP) treatment in HIV is invalid and that generics could be made available.
Novartis exec sold shares worth 925,400 Swiss francs before news of Zolgensma data manipulation investigation
A Novartis executive sold 925,400 Swiss francs worth of shares 18 days before U.S. regulators launched an investigation into data manipulation on test for the gene therapy Zolgensma, the FT said on Monday.
The paper said the transaction was made on 19 July by an unnamed individual, according to a regulatory filing at the Swiss stock exchange (APMHE 64091
Brexit awareness campaign may lead to drug shortages
UK Prime Minister Boris Johnson's plans for a £100 million no-deal awareness campaign may lead to shortages of medicines before the UK leaves the EU on 31 October, The Times said on Monday.
The paper referenced a report given to MPs that warns of "extreme spikes" in demand and that purchases of "key goods" could cause shortages before the Brexit deadline.
UK government likely to exceed budget target by £8 billion this year
The government is on course to overshoot its budget target by at least £8 billion this year after extra spending on the National Health Service (NHS) and preparations for a no-deal Brexit cut the surplus in July.
According to a Wednesday report in The Guardian, public finances were down by £2.2 billion compared with July 2018 to leave a £1.3 billion surplus last month. The decrease was almost entirely accounted for by rises in central government spending, much of it on staff salaries, as Whitehall departments stepped up hiring to cope with the impact of Brexit.
Perrigo expects Ireland tax bill case to be heard in April
U.S. pharma Perrigo expects its €1.64 billion tax case in Ireland to be heard in spring next year, the Sunday Times said.
The company's chief executive Murray Kessler said in its second-quarter earnings call that the Irish courts have set a date of April 2020 for the hearing.
The claim relates to Perrigo's acquisition of Ireland-based Elan in 2013 and the sale of Elan's 50% interest in Tysabri to Biogen, for which it received an upfront payment of $3.25 billion.
The sale was charged at a corporation tax rate of 12.5% but authorities in Ireland claim it should have been taxable at 33%.
Merck & Co and Francis Crick researches new drugs for motor neurone disease
The FT on Tuesday covered a collaboration between UK biomedical research centre the Francis Crick Institute and Merck & Co on finding the cause of motor neurone disease, also known as ALS.
The paper spoke to Rickie Patani, the project leader, who said his lab at Crick was already producing results that might lead the way to new medicines.
Bayer agrees $7.7 billion sale of animal health business to Elanco
The FT on Tuesday reported on Bayer agreeing to sell its animal health unit to sector specialist Elanco for $7.6 billion, as the German pharmaceuticals and chemicals group sells off assets in the face of mounting legal claims linked to its "disastrous $63 billion acquisition of Monsanto". (APMHE 64103
The proposed deal will create the second-biggest player in the animal medicines sector by revenues, leap-frogging Merck and Boehringer Ingelheim, but remaining behind Zoetis, the industry leader that was spun out of Pfizer in 2013, the paper said.
Setback for AstraZeneca as Imfinzi fails in Phase III in NSCLC
AstraZeneca on Wednesday disclosed a setback for one of its key cancer treatments, saying a trial involving immunotherapy drug Imfinzi was no more effective than regular chemotherapy at treating advanced lung cancer, the FT reported. (APMHE 64111
AstraZeneca said the results of a trial dubbed 'Neptune' — which combined Imfinzi with another medicine tremelimumab — had not delivered the hoped-for results with previously untreated stage IV lung cancer.
Daily 'polypill' cuts risk of heart disease by up to 40%
A daily pill combining four cheap cardiovascular medicines substantially reduces the risk of serious heart disease in the first large clinical trial for the combination, the FT and The Guardian reported on Thursday.
An international team led by Tehran University of Medical Sciences in collaboration with the University of Birmingham in the UK followed 6,840 middle-aged people in north-eastern Iran over five years. Half took a daily polypill and the rest received only healthy lifestyle advice, the FT said.
The findings, published in The Lancet, showed 201 major cardiovascular events, notably heart attack, stroke and heart failure, among those who took the polypill and 310 in the non-using control group. Taking polypills cut the risk of such cardiovascular events by 40% in people with no history of heart disease and by 20% in those with previous symptoms.
British healthcare system letting down older people on medley of medicines, says charity
About 2 million elderly people in the UK are on at least seven different medications and at risk of potentially life-threatening harm from interactions between the drugs or side-effects from pills that are no longer right for them, The Guardian reported on Thursday, quoting a new report from charity Age UK.
Older people are being let down by a healthcare system that is allowing medicines to do more harm than good, the report says. One in five prescriptions for elderly people living at home are inappropriate, it adds. Care home residents take an average of at least eight medicines, with a one in 10 risk of a mistake when the drugs are prescribed or given to them.
More is not always better, The Guardian quoted the report as saying. Doctors tend to add new tablets each time an elderly person develops another health condition, but without stopping the old ones.
UK biotech Juvenescence raises $100 million
The FT on Monday said that UK biotech Juvenescence has completed a $100 million funding round and is now valued at $500 million.
The company is focused on increasing human longevity, said the paper.
It spoke to the company's chair Jay Mellon who said: "The bottom line is that the science is catching up with aspiration of everyone on the planet to live in robust health for as long as possible."