* Roche hit by a run of sour news
* Biosimilar rivals massing on the horizon
* CEO has insisted Roche will continue growth
By John Miller
ZURICH, July 19 (Reuters) - A run of disappointing drug
trials at Roche ROG.S has left analysts suggesting the view
from its new 41-storey office building in Basel has become more
clouded, with little chance of management now upgrading its
growth forecast next week, when it reports first-half earnings.
Moreover, the first of a threatened flood of biosimilar
copies of Roche's $22-billion-per-year trio of cancer drugs,
Rituxan, Avastin and Herceptin, have now been approved in Europe
and the United States.
Chief Executive Severin Schwan has long contended he can
boost sales despite these new biosimilar drug launches, largely
by developing new drugs to treat other diseases. urn:newsml:reuters.com:*:nL8N19E45E
But Roche has just seen its new immunotherapy treatment
Tecentriq fail a bladder cancer trial, even though a similar
drug from rival Merck MERK.NS shone in a separate study.
urn:newsml:reuters.com:*:nL8N1IC120 urn:newsml:reuters.com:*:nL2N1IJ24U
That flop was closely followed by unimpressive data from
Roche's Aphinity study that showed combining Roche's two breast
cancer drugs Herceptin and Perjeta produced only a modest
additional benefit.
As a result Kepler Cheuvreux analyst David Evans, last month
cut his forecasts for peak Perjeta sales to $1.5 billion, from
$3.5 billion previously. urn:newsml:reuters.com:*:nL1N1IY1G5
"Apart from the underwhelming Aphinity data, Roche has had
some other setbacks," Evans said in a note, citing the Tecentriq
failure and the approvals of rival biosimilars - near copies of
branded drugs derived from living organisms that cannot be
exactly duplicated but show the same effectiveness.
"Their impact in the second half might limit Roche's chances
of upgrading 2017 guidance," he said.
Roche now sees 2017 sales growth at a low- to
mid-single-digit percentage, with core earnings per share
growing in line with sales.
This year, the share price is up just 4.7 percent, half
local rival Novartis's rise and among the laggards in the Stoxx
600 Europe healthcare sector index 0#.SXDP , up 6.3 percent,
despite some good news on Roche's development pipeline.
The U.S. Food and Drug Administration's approval of Ocrevus,
the first regulator-backed drug against primary progressive
multiple sclerosis, in March set the stage for Roche's next
blockbuster. urn:newsml:reuters.com:*:nL2N1H6024
Additionally, Roche's investigational haemophilia drug
emicizumab is seen topping $1.5 billion in sales by 2022 as it
wrests business from rival Shire SHP.L , Thomson Reuters data
shows. urn:newsml:reuters.com:*:nL8N1K121F
Another of Roche's biosimilar-busting hopefuls, Alecensa,
demonstrated better results than Pfizer's PFE.N Xalkori
against lung cancer, paving the way for use in early treatment
of the disease.
Roche also contends the Herceptin-Perjeta data is not as
dire as some judge it and believes it still reinforces its case
with regulators that the two medicines should be used together
to keep breast cancer from returning.
"Our view is shared by many experts," a Roche spokesman
said.
STRATEGY TEST
But meanwhile the threat of cheaper biosimilars displacing
Roche's existing big-selling medicines is becoming a reality,
with knock-offs from Novartis NOVN.S , Celltrion 068270.KQ
and Mylan MYL.O now coming on line urn:newsml:reuters.com:*:nL4N1K548V.
Novartis's Rituxan copy was approved in Europe last month,
and managers there said this week they expected biosimilars to
steadily win over patients from the originals. urn:newsml:reuters.com:*:nL8N1JG0OL
"It's only two weeks in," Novartis's Sandoz generics unit
head Richard Francis said, of Rituxan's European launch. "But
the reception we're seeing from physicians and payers and key
stakeholders is very positive."
A Roche spokesman said the arrival of biosimilars is no
surprise, but analysts remain concerned.
"Roche has $22 billion of revenues exposed to biosimilars,"
said Tim Race, a Deutsche Bank analyst, in a note. "The rapid
pace of innovation, particularly in oncology, means we have a
lower than historical level of visibility that Roche can
maintain its market leadership."
($1 = 0.9541 Swiss francs)
(Reporting by John Miller; Editing by Greg Mahlich)
((J.Miller@thomsonreuters.com; +41 58 306 7734; Reuters
Messaging: j.miller.thomsonreuters.com@reuters.net))
Keywords: ROCHE GROWTH/