It was a good week for biotech stocks with several companies
faring well and
) emerging as a big winner. Most of the share gains were based on
important news flowing in from the EU on Friday.
Biogen Jumps on Tecfidera EU Update:
The biggest gainer last week was Biogen. On Friday, Biogen
received a huge boost with its oral multiple sclerosis (MS)
treatment, Tecfidera, gaining new active substance (NAS)
designation in the EU. Shares jumped 13.15% on the news and hit a
52-week high of $289.97 that day. The NAS designation is very
important for Biogen as the company had delayed the EU launch of
Tecfidera until it gained stronger patent protection.
NAS designation basically means that Tecfidera will have 10
years of regulatory exclusivity in the EU. So Biogen can now
launch Tecfidera in the EU (once approved) without worrying about
generic competition entering the market in the near future. EU
approval should come shortly - the CHMP has already given a
Tecfidera is the hottest new entrant in the U.S. multiple
sclerosis market. The product, launched in early Apr 2013, is
already off to a strong start in the U.S. bringing in sales of
$478 million and is the leading oral multiple sclerosis therapy
in the U.S. (according to IMS). Given the strong U.S. launch,
it's reasonable to expect a similar launch trajectory in the EU.
Not surprisingly, Tecfidera estimates are rising and the product
is set to bring in multi-billion dollar sales for Biogen over the
next few years.
Gilead Hits 52-Week High on CHMP Opinion:
) was at the receiving end of some positive news with the CHMP
giving a favorable opinion regarding the approval of the
company's hepatitis C virus (HCV) candidate, Sovaldi.
Importantly, the recommendation is in favor of a wide label which
increases the commercial potential of the candidate, once
The vote came ahead of expectations -- Gilead shares were up
3.7% and reached a 52-week high of $75.21 on Friday. Meanwhile,
it should be smooth sailing for Sovaldi in the U.S. as well where
it has already received a positive opinion. Expectations are high
for FDA approval early next month. The commercial potential for
Sovaldi is huge - there is major unmet need in the HCV market and
several patients have postponed treatment as they wait for new
and improved options like Sovaldi to enter the market. Sovaldi
has multi-billion dollar sales potential.
Last week, Gilead also gained EU approval for HIV drug,
Vitekta. However, the regulatory path has not been as smooth in
the U.S. where the FDA refused to grant approval earlier this
Celgene Also Hits 52-Week High:
Another biotech major,
), hit a 52-week high last week, once again on news from the EU.
Celgene's oncology treatment, Abraxane, which is already approved
for a wide range of indications, received a favorable opinion
from the CHMP for pancreatic cancer. Shares were up about 3% and
Celgene hit a 52-week high of $164.00 on Friday.
Is BioMarin the Next Acquisition Target?
) Vimzin coming a step closer to gaining FDA approval, rumors
regarding the company being an acquisition target surfaced again.
Last week, Vimzin, which is under regulatory review for the
treatment of patients with the lysosomal storage disorder Morquio
A syndrome, was backed by the FDA's advisory panel.
Given BioMarin's promising orphan drug portfolio, the company
is viewed an attractive acquisition target. Some of the names
being tossed around as potential bidders include Roche, Glaxo,
Pfizer and Sanofi. However, valuation could be an issue and it
remains to be seen whether any of these companies will be willing
to shell out a huge premium. BioMarin shares gained 6.2% during
the latter half of last week and expectations remain high for
Last 6 Months
Amgen Gets Nexavar Label Expanded:
) and partner Bayer scored a new indication for oncology drug,
Nexavar. Nexavar, which was previously approved for liver and
kidney cancer, can now be used for thyroid cancer as well. The
news came out after market close on Friday.
Regeneron RA Drug Hits Study Goals
) and partner Sanofi's experimental rheumatoid arthritis (RA)
drug, sarilumab fared well in a phase III study. Results from the
SARIL-RA-MOBILITY study showed that patients treated with
sarilumab+MTX experienced an improvement in disease signs and
symptoms and physical function along with inhibited progression
of joint damage.
Regeneron also gained approval in Japan for the use of Eylea
in macular edema following central retinal vein occlusion
A Glimmer of Hope for Ariad
: Ariad, which has been struggling of late due to negative
updates on its sole marketed product, Iclusig, has something to
cheer about with EU regulators saying that Iclusig can remain on
the market. Of course, tough restrictions will be imposed for
continued marketing of the product. This scenario is quite
different from the situation at home where the company had to
temporarily suspend marketing of the product. Shares were up
35.7% on the EU update.
Vertex Investors Applaud Incivo Monetization
: Investors reacted favorably to Vertex Pharma's monetization of
Incivo royalties, sending the shares up 4.4%. The company sold
its product royalty rights to its hepatitis C virus (HCV)
treatment, Incivo, to partner Janssen. The $152 million cash
inflow should come in handy for Vertex Pharma's cystic fibrosis
pipeline development efforts.
Amarin Shares Slide on FDA Refusal to Accept Appeal
: Amarin's shares lost 10% with the FDA refusing to accept the
company's appeal for a review of the agency's rescission of a
special protocol assessment (SPA) agreement. The SPA agreement
was for the ANCHOR study supporting a supplemental new drug
application (sNDA) for Zavesca. The FDA will deliver a decision
by Dec 20 and as things stand, chances of approval for the
additional indication look low. Amarin will most likely have to
provide cardiovascular outcomes data so that its cholesterol
management drug can be used in a broader patient population.
The Week So Far:
Orexigen's Heavyweight LIGHT Data
: Orexigen shares have gained more than 10% so far this week on
positive interim data on Contrave (obesity candidate) from the
Light Study. Orexigen could well be on the path to FDA approval
for Contrave by Jun 2014.
Cubist Surges on Study Data
: Shares of
) jumped 8% earlier this week with the company reporting
promising phase III data on its experimental antibiotic -
ceftolozane/tazobactam for complicated urinary tract
Merrimack Shoots Up on Phase II Data
: Merrimack shares gained 11.46% on encouraging phase II data on
its experimental breast cancer drug MM-121. The company also
announced a nanotechnology deal with Actavis.
With the market closed tomorrow for Thanksgiving, we do not
expect much news flow over the rest of the week.
Want the latest recommendations from Zacks Investment
Research? Today, you can download
7 Best Stocks for the Next 30 Days.
Click to get this free report >>
AMGEN INC (AMGN): Free Stock Analysis Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis
BIOMARIN PHARMA (BMRN): Free Stock Analysis
CUBIST PHARM (CBST): Free Stock Analysis
CELGENE CORP (CELG): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
REGENERON PHARM (REGN): Free Stock Analysis
To read this article on Zacks.com click here.