Last week, hepatitis C virus (HCV) treatments were a focus area
with Merck's announcement regarding its intention to acquire
) grabbing eyeballs, especially given the hefty valuation. Needless
to say, Idenix shares shot up. Another company that benefited from
this news is
) which is now being touted as a potential takeover target thanks
to its HCV pipeline.
Idenix Skyrockets on Acquisition News:
Shares of Idenix skyrocketed 229.05% on news that the company will
be acquired by pharma giant, Merck. Merck's offer price of $24.50
per share in cash was more than three times the company's share
price before the offer was announced. The acquisition, slated to
close in the third quarter, is valued at about $3.85 billion. This
is an excellent deal for Idenix, which has had its share of
Good Times for Achillion:
Achillion's shares soared significantly over two consecutive days -
47.6% on speculation that it could be a takeover target like Idenix
and 83.3% on the lifting of a clinical hold on its NS3/4A protease
Sovaprevir was placed on clinical hold in Jun 2013 when elevated
liver enzyme levels were noted. However, a partial clinical hold
remains on multiple dose studies that may be conducted in healthy
volunteers - for this the company will need the FDA to review and
approve the protocol.
The lifting of the clinical hold is a huge positive for this
HCV-focused company and has raised expectations even further that
the company will be acquired. HCV is a hot development area for
pharma and biotech companies. More than 150 million people are
estimated to be HCV-infected across the world - this includes more
than 5 million people in the U.S.
With 75% of the HCV population remaining undiagnosed, the
commercial potential in this market is huge.
Receptos Gains on Promising Data:
Receptos' shares are up a whopping 36.8% on positive mid-stage data
on its experimental multiple sclerosis treatment, RPC1063. The
company reported an 86% reduction in brain lesions in both doses
evaluated in the study. The experimental drug is currently in phase
III studies and if approved will target the highly lucrative oral
multiple sclerosis market which currently has treatments like
Novartis' Gilenya and Biogen's Tecfidera among others.
) Soars on FDA Panel Vote:
Shares of Nektar were up more than 10% on a much-awaited FDA panel
vote. The FDA panel said that cardiovascular outcomes studies are
not needed for the peripherally-acting mu-opioid receptor
antagonist (PAMORA) class of drugs. Nektar's Movantik, which is
under FDA review for opioid-induced constipation (OIC) for patients
with chronic non-cancer pain, belongs to this class of drugs. The
panel recommendation is a major positive as it saves the company
from conducting additional studies which would have delayed the
approval process and increased the cost burden.
Geron Gains as FDA Lifts Partial Hold:
Geron's shares were up 21.15% on news that the FDA has lifted the
partial clinical hold on an investigator-sponsored study of
imetelstat. While the lifting of the partial clinical hold is a
step in the right direction, the full clinical hold on imetelstat
remains in place. Imetelstat is the only candidate in Geron's
pipeline - visibility as to when the company can commence its own
studies remains low. Even if imetelstat studies continue, concerns
about liver function test abnormalities could limit the commercial
potential of the candidate and restrict its long-term usage.
) Obesity Drug Approval Date Pushed Back:
Orexigen investors, who were gearing up for approval of the
company's obesity treatment, NB32, received a jolt last week with
the FDA pushing back the action date by three months to September.
Shares were down about 14.7%. The sell-off was maybe slightly over
done considering the delay was announced so that the company and
the agency can come to an agreement regarding post-marketing
Last 6 Months
*As of Jun 13, 2014
Dendreon CEO to Leave Mid-August: Dendreon, which is going
through challenging times, said that CEO John H. Johnson will be
leaving mid-August. Finding a replacement could prove challenging
considering the tough times faced by the company. Dendreon's sole
marketed product, Provenge, has been struggling to pick market
share. Provenge sales fell 12.8% in 2013 and the current run rate
implies sales will remain lackluster. More importantly, Dendreon
has some debt repayments due this year as well as in 2016. While
the current cash balance is sufficient to pay off the $27.7 million
due this year, the main concern is the debt repayment due in
Isis Earns Couple of Milestone Payments: Isis continues to
progress with its pipeline and earning milestone payments related
to the same. The company earned two milestone payments this week -
one from Biogen and the other from AstraZeneca both on the
initiation of phase I studies.
Natpara Advisory Panel Date Pushed Back: NPS Pharma said that
the advisory panel meeting for Natpara will be held tentatively on
Sep 12 instead of Jul 24. However, the FDA action date of Oct 24
remains the same. NPS Pharma is looking to get Natpara approved for
the treatment of hypoparathyroidism - this is a rare endocrine
disorder characterized by insufficient levels of parathyroid
Agios Gains on
) Move: Agios shares were up 5.9% as partner Celgene opted to
acquire development and commercialization rights to experimental
leukemia drug, AG-221.
Orphan Drug Status for
) Soliris: The FDA has granted orphan drug status to Soliris for
the treatment of myasthenia gravis (MG), a rare, debilitating
neurologic disorder. Soliris, Alexion's only marketed product, is
approved for two rare diseases - paroxysmal nocturnal
hemoglobinuria and atypical hemolytic uremic syndrome. Soliris is
being studied for several additional indications including MG.
GW Pharma Shoots Up: GW Pharma saw its shares shooting up 16.3%
on encouraging data on its experimental epilepsy treatment,
Vertex Down on Analyst Observations: With Vertex expected to
present data on its cystic fibrosis drug, Kalydeco, from two
important studies -- TRAFFIC and TRANSPORT -- soon, investors
remain jittery. So when Bernstein analyst Geoffrey Porges said that
these studies are likely to fail, it was not surprising to see the
shares go down 8.67%. Vertex, which recently disclosed that it will
no longer invest in its HCV portfolio, is betting heavily on its
cystic fibrosis franchise for growth.
Another Multiple Sclerosis Success for
): Biogen and parent AbbVie reported positive top-line phase III
results on their experimental multiple sclerosis drug, daclizumab.
With these results, the companies can now move ahead with
regulatory filings for the once-monthly treatment.
Endocyte-Merck Part Ways: Endocyte and Merck are parting ways
with the former regaining global rights to its experimental cancer
drug, vintafolide. Merck said that it does not intend to pursue
development of the candidate. Merck's decision does not really come
as a surprise - in May, Endocyte said that a phase III study
(PROCEED) being conducted with vintafolide will be halted on the
recommendation of a data safety monitoring board (DSMB).
Then a few days later, Endocyte and Merck withdrew their
marketing applications for vintafolide plus a couple of companion
imaging components in the EU.
The Good and Not-So-Good for Gilead: Gilead had two updates
about its blockbuster HCV drug, Sovaldi. First the good news
- Sovaldi plus ledipasvir performed exceedingly well in a phase III
study in Japan conducted in HCV patients. The combination will be
filed for approval in Japan by year end. The not-so good news is
that NICE (the National Institute for Health and Care Excellence),
the healthcare guidance body in the UK, has asked Gilead to provide
more information on Sovaldi.
Bluebird Gains on Positive Data: Bluebird started the week on a
positive note with shares shooting up 32.1% on positive data on its
experimental gene therapy, LentiGlobin BB305, for
Later this week, the FDA will decide whether it should approve
Cubist's experimental anti-infective drug - Sivextro. Chances of
gaining approval look high.
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