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Indivior said the Delaware District Court ruling meant it would
not be able to rely on patents to prevent Indian firm Dr.Reddy's
<REDY.NS> from making and marketing a generic alternative to
Suboxone Film unless the judgment is reversed on appeal.
Suboxone Film had an average market share in the United States
of 61 percent in 2016, Indivior said in a statement, and the
treatment accounted for 80 percent of its total revenues last
year.
Shares in Indivior were down 37.5 percent at 260.6 pence at 1000
GMT, after the ruling on patents for the Suboxone treatment
delivered by dissolvable film placed under the tongue rather
than by tablet. The fall meant the share price gains over the
year were wiped out.
Indivior, spun off from Reckitt Benckiser <RB.L> in 2014, said
it could not quantify the precise financial impact of generic
alternatives to Suboxone Film on revenues but said it "could
potentially result in a rapid and material loss of market share
for Suboxone Film in the U.S."
Indivior said that if pharmacies could substitute Suboxone Film
with a generic rival without direct consultation with the
patient it could lead to the treatment losing up to 80 percent
of its market share "within a matter of months".
Dr. Reddy's, whose shares gained 9 percent, bought the
abbreviated new drug application (ANDA) for a generic rival
treatment from Teva Pharmaceutical Industries <TEVA.TA> in June
2016 for $70 million.
THREAT TO FORECASTS
Dr Reddy's welcomed the verdict.
"The judgment reiterates our commitment to providing affordable
and innovative medicines that address the unmet and under-met
needs of patients around the world," it said.
The company gave no further details of the timing of a possible
rival treatment.
"Dr Reddy's still needs to obtain FDA approval. So even in the
best case, launch by Dr. Reddy's is at least a year away," said
Anubhav Aggarwal, an analyst with Credit Suisse.
Sales of Suboxone Film were higher in the first half of 2017 on
the same period a year ago, but market share fell slightly to 59
percent from 61 percent. Generic rivals in tablet form are
already on the market.
In September, 35 U.S. states and the District of Columbia filed
a lawsuit against Indivior alleging that it tried to keep
generic versions of a drug off the market.
The lawsuit by the states alleged that Indivior took steps to
get patients to switch to the oral strip version of Suboxone.
Indivior said in its statement on Friday it would "continue
vigorously defending its intellectual property."
Indivior did not make any immediate changes to its full-year
forecasts, but said the risk to the guidance related to the
launch of a generic suboxone film has increased.
The company raised its full-year revenue forecast by about 4
percent in July to a range of $1.09 billion to $1.12 billion.
"Guidance provided at 1H assumed no generic film launch; hence
there is increased risk around the guidance and we expect the
company to update the market if there is any change in the
visibility on the timing of a potential generic launch," said
James Vane-Tempest an analyst with Jefferies.
(Reporting b
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