There were quite a few updates last week from biotech
companies, but all this was overshadowed by the biotech selloff
at the end of the week. The biotech sector, which has had an
incredibly good run over the last two years, tumbled on Friday
with the trigger being a letter issued to
) by lawmakers.
The letter basically questions Gilead's pricing of its
recently approved hepatitis C virus (HCV) treatment, Sovaldi. The
$84k price tag for a 12-week treatment period is considered too
expensive and has come under heavy criticism. Gilead's shares
were down 4.6%.
Sovaldi is a very important product in Gilead's portfolio and
has multi-billion dollar sales potential. Gilead has until Apr 3
to submit a response to the letter. We believe Gilead will
provide strong data supporting Sovaldi's efficacy as well as the
Meanwhile, the selloff that started with the weakness in
Gilead was fueled further by speculation about a biotech bubble.
While NASDAQ Biotechnology was down 4.4%, the NYSE ARCA Biotech
Index was down 3.9% on Friday.
Biotech ETFs were also severely affected with individual
stocks like Celgene (down 3.7%), Biogen (down 8.2%), Alexion
(down 7.9%), Amgen (down 3.2%) and Regeneron (down 5.4%)
declining on Friday. Companies like Biogen and Alexion were worst
hit as they have drugs like Tecfidera and Soliris, respectively,
which could come under the same pricing scrutiny.
Amgen Scores with Evolucumab… Again:
Amgen shares were up about 2.9% on positive data on its PCSK9
Evolocumab lowered bad cholesterol in patients suffering from
homozygous familial hypercholesterolemia (HoFH), a rare genetic
disease characterized by significantly high LDL-C levels which
increase cardiovascular risk in these patients, who are mostly
affected from an early age. These are the first phase III data on
a PCSK9 Inhibitor in HoFH patients. PCSK9 inhibitors work by
inhibiting PCSK9, a protein that reduces the liver's ability to
remove "bad" cholesterol from the blood.
The race to bring the first PCSK9 inhibitor to market is
heating up with companies like Sanofi, Regeneron and Pfizer
involved in the development of these drugs. But sometime back,
the FDA had raised concerns about neurocognitive adverse events
in the PCSK9 inhibitor class. These are events that are also
associated with the use of statins. Amgen is looking to file for
approval of evolocumab this year. The FDA will most likely ask
all these companies to evaluate neurocognitive adverse events in
) Soars on Vynfinit News:
Endocyte's investors had a lot to cheer about as the company
provided two positive updates on its key experimental drug,
Vynfinit. The first good news came from the EU with the
experimental drug receiving a positive opinion regarding its
conditional approval for a type of ovarian cancer.
Not just Vynfinit, a couple of companion imaging agents,
Folcepri and Neocepri, which will help identify patients suitable
for treatment with Vynfinit, also received a positive
recommendation. So, Endocyte could well be looking at its first
product approval in the coming months.
The second set of good news was positive data on Vynfinit from
a mid-stage study on non-small cell lung cancer (NSCLC) patients.
Both news validate the company's small molecule drug conjugates
(SMDC) platform. Shares were up a whopping 92.4%.
FDA Approves Celgene Blockbuster Hopeful:
Celgene gained FDA approval for Otezla for the treatment of
active psoriatic arthritis. With this approval, Otezla will be
entering a market dominated by products like Humira, Enbrel,
Remicade and Simponi among others. But Otezla comes with an edge
as it is the first oral treatment to be approved for this
That being said, the main potential of the drug is linked to
the broader psoriasis indication - a response from the FDA should
be out by September.
) Hit by Glaxo Setback:
Agenus shares were down 11.6% on news that GlaxoSmithKline's
MAGE-A3 failed to meet the primary endpoint in a phase III study
for non-small cell lung cancer. Agenus' QS-21 Stimulon adjuvant
was used for the experimental cancer vaccine.
Five Prime (
) Cuts $350M Deal with Bristol-Myers (
Five Prime Therapeutics saw it shares soar 22.6% on its
collaboration agreement with Bristol-Myers for the discovery,
development and commercialization of immuno-oncology treatments,
a hot therapeutic area.
Five Prime gets an upfront payment of $20 million as well as
research funding to the tune of up to $9.5 million. That's not
all - Bristol-Myers will acquire 4.9% of Five Prime's stock for
about $21 million (a 30% premium) and also pay up to $300 million
on the achievement of development, regulatory and sales based
milestones. Moreover, Five Prime will receive mid-single-digit to
low-double-digit tiered royalty payments on sales of products
commercialized under this agreement.
Immuno-oncology has been attracting a lot of interest with
several companies pursuing treatments in this area.
Biogen Faces Delay in Plegridy Approval Date:
Biogen, well known for its strong presence in the multiple
sclerosis (MS) market, is facing a delay in the approval process
for its experimental MS drug, Plegridy. The FDA has extended the
review period by three months. This means that a response from
the FDA should now be out in the second half of the year instead
of mid-14 as had been expected earlier.
The delay in Plegridy's approval date should not be a matter
of major concern. The important thing is that the FDA has not
asked for additional studies to be conducted.
Last 6 Months
What's Up with
Intercept, which saw its shares skyrocketing 281% earlier this
year, seems to be on a rollercoaster ride with shares first
declining 11.9% at the beginning of last week and then regaining
6.8%. Share price movement was driven by negative and positive
updates on the company's lead pipeline candidate, obeticholic
First the bad news: Intercept disclosed that adverse cardiac
events were observed in the mid-stage FLINT study which was
conducted to evaluate OCA for the treatment of nonalcoholic
steatohepatitis (NASH) -- a serious chronic liver disease caused
by excessive fat accumulation in the liver. This is the same
study that was halted earlier this year by a Data Safety
Monitoring Board as the primary endpoint was met.
According to the latest update from the company, the DSMB
expressed concerns regarding hyperlipidemia and the occurrence of
serious cardiovascular events, both of which were higher in
patients receiving OCA compared to placebo though not
statistically significantly different. Shares were down 11.9% on
Then came the good news that OCA met the primary endpoint in a
phase III study (POISE) that was conducted in patients with
primary biliary cirrhosis (PBC). Investors reacted positively to
this news and sent the shares up 6.8%.
) Files for Chemo-Naïve Population:
Medivation and partner Astellas are looking to get the label for
their prostate cancer treatment, Xtandi, expanded into the
chemo-naïve patient population.
Expansion into the pre-chemo setting will be a major positive
for Medivation. The 17-month delay in the time to initiation of
chemotherapy should help Xtandi gain share once it is approved
for the pre-chemo patient population.
) Woes Continue
: Geron, which saw its shares sinking on a full clinical hold
being placed by the FDA on its sole pipeline candidate,
imetelstat, said that the FDA has now placed a partial clinical
hold on an investigator-sponsored study on imetelstat. This means
that new patients cannot be enrolled in the study which is being
conducted by Mayo Clinic.
) Backs out of AVEO Collaboration:
Biogen returned rights to experimental cancer drug, AV-203, to
AVEO Oncology. Biogen, which had rights to territories outside
North America, is not the first company to terminate its
agreement with AVEO. Last month, Astellas backed out of its
agreement with AVEO for the development of another oncology
The next few days will be pretty busy with several FDA
advisory panels scheduled to review experimental drugs like
) Afrezza (type I or type II diabetes) and
) antibiotic tedizolid.
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