Last week, three biotech majors,
) touched new 52-week highs as they continued to benefit from
positive updates in the EU, announced in the previous week.
Orexigen Gains on LIGHT Data:
) presented positive interim data on its obesity candidate,
Contrave, from the Light study last week. A goal set by the FDA
was achieved in the study with no new safety signals
With the encouraging cardiovascular outcomes data in hand,
Orexigen is set to seek FDA approval for Contrave, again (the FDA
had refused to approve Contrave earlier), and could well be on
the path to approval by Jun 2014. What makes this even more
interesting is that the FDA had earlier refused to approve
Contrave due to concerns regarding the candidate's cardiovascular
The Light data will also come in handy in answering any
questions that may be posed by the EU regulatory authorities
where Contrave is currently under review.
Shares were up 9.3% immediately after the data was released
and up 20% by the end of the week. The Light data means a lot to
Orexigen which will most likely be the third entrant in the
obesity market in recent times. Belviq and Qsymia, two recently
launched drugs, are yet to make a mark in the highly lucrative
Contrave, with its efficacy profile and the Light data, could
well become a success story in the obesity market. Currently,
chances of gaining FDA approval by June look pretty good, and
partner Takeda is already preparing for commercialization. An
additional bonus would be EU approval, potentially in the second
half of 2014, where Belviq and Qsymia are yet to be approved.
There could also be more partnership deals round the corner.
So Orexigen has a lot going for it - possible regulatory
approvals, extensive data, a strong marketing partner, additional
partnership deals - this is definitely a stock to watch out
Cubist Hits 52-Week High:
) jumped 8% with the company reporting promising phase III data
on its experimental antibiotic - ceftolozane/tazobactam for
complicated urinary tract infections. Ceftolozane/tazobactam met
the primary endpoint of statistical non-inferiority compared to
levofloxacin. In fact, even though the study was not conducted to
demonstrate superiority, results indicated statistical
superiority over levofloxacin.
The safety profile also looked fine and was consistent with
earlier studies. Up next is data from a phase III study in
patients with complicated intra-abdominal infections - this
should be out later this month and expectations are high for
Last 6 Months
The Week So Far:
OncoMed Shoots Up on Celgene Deal
: Biotech major Celgene inked a deal with
) for the joint development and commercialization of up to six
anti-cancer stem cell candidates from OncoMed's biologics
pipeline. OncoMed shares jumped 97.9% on the news. The deal
is a major achievement for OncoMed which went public earlier this
year in July.
Conatus Gains on Orphan Drug Status
: Shares of Conatus Pharmaceuticals were up 18.1% after the FDA
granted Orphan Drug Status to experimental drug, emricasan.
Lexicon Slips on Phase II Data
) pipeline candidate, LX1033, failed to achieve statistical
significance in the primary endpoint of a phase II study for
diarrhea-predominant irritable bowel syndrome (IBS-d). Shares
were down 4.7%.
Gilead's Patent Issues
: Gilead is facing a couple of lawsuits regarding its
experimental hepatitis C drug, sofosbuvir. Idenix Pharmaceuticals
is claiming that the candidate infringes its patents. The
lawsuits come just a few days ahead of the FDA action date for
sofosbuvir (Dec 8), when approval is largely expected.
Biogen Faces Another Delay
: The FDA action date for Biogen's hemophilia B candidate,
Alprolix, has been pushed back by three months, which means the
company will most likely be able to launch Alprolix later in the
first half of 2014 provided it gains approval. This is the second
delay being faced by Biogen where its hemophilia pipeline is
Later this week, the FDA is slated to deliver a decision on
Auxilium Pharma's Xiaflex for the Peyronie's disease indication
and on Gilead's sofosbuvir. Both are binary events to watch out
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