Last week, several major biotech companies --
) -- reported first quarter results.
The clear winner was Gilead with its hepatitis C virus (HCV)
treatment, Sovaldi bringing in sales of $2.3 billion in its first
full quarter on the market. Although a lot has been said about
the drug's high price, the sales figures show the high acceptance
level thanks to its strong efficacy profile. Earnings were way
above expectations. The only disappointing part was the company
not raising its guidance or providing specific guidance for
Biogen also came out with impressive sales on its oral
multiple sclerosis drug, Tecfidera, and raised its guidance for
2014. Alexion topped expectations thanks to Soliris and upped its
earnings guidance for 2014.
Meanwhile, Celgene's earnings were slightly
better-than-expected but revenues fell short of expectations. The
company maintained its guidance and announced an acquisition deal
which will add a late-stage Crohn's disease experimental drug to
Amgen's first quarter results were disappointing with the
company reporting a decline in earnings. Although revenues
increased from the year-ago period, they were well short of
expectations. Revenues also fell on a sequential basis with most
products recording a sequential decline.
Sinks on Disappointing Data:
Cytokinetics shares were severely punished with the company
reporting disappointing data on one of its lead pipeline
candidates, tirasemtiv. Tirasemtiv failed to achieve the primary
endpoint in a mid-stage study for amyotrophic lateral sclerosis,
often referred to as Lou Gehrig's disease. Moreover, results were
mixed where secondary endpoints were concerned. Investors
expressed their disappointment sending the shares down 64.7%.
With tirasemtiv failing in the phase IIb BENEFIT-ALS study,
the road ahead looks difficult and we expect investor focus to
shift to the company's other lead pipeline candidate -- omecamtiv
mecarbil for acute heart failure.
But here, too, the company has faced some disappointment as
last September, Cytokinetics and partner Amgen had reported that
omecamtiv failed to achieve the primary endpoint in a mid-stage
study. However, omecamtiv is currently in other studies and
positive results from these would provide a ray of hope to
Hyperion Boosts Orphan Drug Pipeline:
Hyperion, a company that specializes in orphan drug diseases, is
looking to boost its orphan drug portfolio by acquiring
Israel-based Andromeda Biotech Ltd. The lead candidate,
DiaPep277, is in late-stage development for new onset type I
diabetes, an orphan indication diagnosed in about 35,000 adults
every year across the U.S. and Europe. The acquisition could see
Hyperion paying up to $570.35 million in cash and stock apart
Spectrum Set to File NDA:
Spectrum looks set to file for FDA approval of its
Captisol-enabled melphalan which met the primary endpoint in a
pivotal phase II study conducted in the multiple myeloma
transplant setting. Shares were up 4% on the news. Approval could
lead to the product launch next year.
) Soars on Regulatory Update:
Sarepta's shares soared 39.3% on news that the company will file
for accelerated approval of eteplirsen, for Duchenne muscular
dystrophy (DMD), by year end. This is good news for the company
which had earlier been informed by the FDA (in Nov 2013) that its
NDA filing for eteplirsen would be premature.
Of course, conditions for a filing this year exist -- Sarepta
will have to conduct additional studies on the drug and gather
more data. DMD is a devastating and incurable muscle-wasting
disease that affects about one in every 3,500 boys born
Last 6 Months
The Week So Far:
OncoGenex Slumps on Late-Stage Data:
OncoGenex saw its shares losing more than half their value (down
60.3%) on news that the company's experimental prostate cancer
drug, custirsen, failed to meet the primary endpoint in a
) Cuts Guidance:
Less than a week before reporting first quarter results, Auxilium
announced a guidance cut mainly due to lower-than-expected Testim
revenues. The company cut its revenue guidance for 2014 by $70
million and now expects to break-even or report a loss of up to
$15 million this year instead of reporting net income of $45
million - $50 million.
Testim revenues are expected to decline to $11 million to 13
million in the first quarter from $45.5 million in the year-ago
period. Full year Testim sales are expected to be less than $85
million due to several factors like a shrinking testosterone
replacement therapy (TRT) gel market, lower Testim market share,
downward pressure on TRT gel scrips due to concerns regarding
safety, inventory destocking, and higher rebates.
Although Auxilium has been working on diversifying its revenue
base, Testim sales came in at $211.2 million in 2013, accounting
for 52.7% of the company's revenues in 2013.
EU Approves BioMarin's Vimizim:
Vimizim gained EU approval for Morquio A syndrome that is
estimated to affect 3,000 people in the developed world.
Amicus Up on Fabry Disease Data:
Amicus' experimental Fabry disease drug was found to be effective
in a late-stage study. Shares were up 20.7% on the news.
Athersys Plunges on Disappointing Data:
Athersys' shares plunged 51.3% on disappointing interim data from
mid-stage study on the administration of its MultiStem cell
therapy for the treatment of refractory ulcerative colitis
Later this week, companies like
) and BioMarin will be reporting results. The FDA will also issue
a response regarding
The Medicines Co.'s
) antiplatelet agent, Cangrelor.
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