[Ip-health] FT: Pharma groups to ramp up output of virus drug Dexamethasone

Thiru Balasubramaniam thiru at keionline.org
Wed Jun 17 09:12:07 PDT 2020


Coronavirus treatment
Pharma groups to ramp up output of virus drug Dexamethasone
Cheap generic drug is first to significantly cut mortality in patients with
severe symptoms

Donato Paolo Mancini and Anna Gross in London 32 MINUTES AGO

Pharmaceutical companies are preparing to ramp up the mass production of a
cheap generic drug that UK scientists say is the first treatment to
significantly cut mortality in severe coronavirus patients.

India-based Cipla, one of the world’s largest generics drug manufacturers,
said it would “immediately” resume production of the tablet form of the
drug dexamethasone after a trial by Oxford university found it reduced the
death rate for seriously ill Covid-19 patients on ventilators by one-third.

“We make eye drops of dexamethasone and we will start tablets for India any
day now,” its chairman Yusuf Hamied told the Financial Times.

Hikma Pharmaceuticals, a large dexamethasone manufacturer, said demand for
the drug had risen “substantially” since the results of the Oxford trial
became public on Tuesday. Aché, the biggest dexamethasone producer in
Brazil, said it expected demand to increase significantly and is examining
whether it will have to ramp up production beyond the 1.9m pills it
produces each month.

The dexamethasone trial has been hailed as a significant breakthrough in
the fight against Covid-19, with Martin Landray, an Oxford professor and
deputy chief investigator of the so-called Recovery trial, heralding it as
of “instant global importance”.

Soumya Swaminathan, World Health Organization chief scientist, told the FT
that the drug — which costs as little as 20p per treatment course in India
— could “become ‘standard-of-care’ for a subset of patients” suffering from
the virus. Standard-of-care drugs are baseline treatments to which other
drugs are compared in trials.

Dexamethasone cut the death rates for patients receiving oxygen by
one-fifth and it reduced the total 28-day virus mortality rate by 17 per
cent, according to the UK trial.

The race to find an effective vaccine or treatment for the virus has thrown
geopolitical tensions into stark relief, as powerful governments jostle for
priority access amid fears that poorer countries could lose out. But
because dexamethasone, which was first produced in the 1950s, has been
around for decades and is off-patent, anybody with access to the
ingredients can mass-produce it.

“It is two mg [of the active ingredient] a tablet. So from 1g, you make 500
tablets. From 1kg, you make 500,000 tablets. For dexamethasone, there is no
problem — any quantity can be produced,” said Mr Hamied.

Dexamethasone is routinely prescribed by doctors for a range of conditions,
such as skin disease, arthritis and bowel disorders, which means it can be
prescribed for so-called “off-label” use.


Sandoz, a subsidiary of Swiss pharma giant Novartis, said it was a small
player in the dexamethasone market, but was evaluating the situation. The
European Medicines Agency said it was aware of the positive trial results.

The only other drug to have shown some effect in the management of severe
Covid-19 patients in randomised trials is Gilead Sciences’ remdesivir,
which is protected by patents. The drug, which is currently the standard of
care in the US, has shown positive effects in how long patients need to
stay in hospital, but the evidence in mortality is not statistically

Gilead, which has previously come under scrutiny for its pricing practices,
has struck deals with manufacturers outside of the US to allay those
concerns, and said that it would not seek to profit from it, at least for
the first period of the pandemic.

Matt Hancock, UK health secretary who this week trumpeted the Oxford trial,
said on Wednesday that the country has 240,000 doses in stock and on order,
which makes it immediately available to use by the health service.

Additional reporting by Stephanie Findlay in New Delhi

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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