Apart from the usual study results, last week's top stories
include the lifting of clinical holds for two experimental
treatments as well as the granting of fast track and orphan drug
status to a couple of candidates.
Down on Safety Concerns
: Clovis' shares slumped 19.9% on safety concerns about its
experimental lung cancer treatment, CO-1686. Clovis had presented
encouraging data on the treatment at the annual meeting of the
American Society of Clinical Oncology (ASCO). However, about 22% of
patients were found to have high sugar, which is associated with
diabetes. Clovis is trying to bring its cancer treatment ahead of
AstraZeneca which has a similar candidate in its portfolio. But
safety concerns could put a lid on progress.
Another Hemophilia Win for Biogen
): Biogen now has another hemophilia treatment in its portfolio
with the FDA approving Eloctate (hemophilia A). Hemophilia A, a
rare, chronic, genetic disorder under which blood clotting ability
is impaired, can lead to recurrent and extended bleeding episodes.
Earlier this year, Biogen's hemophilia B treatment Alprolix was
approved in the U.S. A convenient dosing schedule (supported by a
longer duration of action and a suitable safety profile) could help
these products capture share from existing products in the
FDA Lifts Clinical Hold, Halozyme
) Soars: The FDA lifted its clinical hold on Halozyme's mid-stage
study on PEGPH20 for pancreatic cancer. This removes uncertainty
regarding this program which had run into trouble earlier this year
due to safety concerns. The study will continue under a revised
protocol. Shares were up 12%.
Partial Clinical Hold on Ariad
) Study Lifted: Ariad's investors finally had something to cheer
about with the FDA lifting a partial clinical hold on the company's
phase II study of Iclusig in patients with refractory metastatic
and/or unresectable gastrointestinal stromal tumors. New patients
can now be enrolled in this study. Ariad also presented initial
data which indicate Iclusig's anti-tumor activity in patients with
advanced GIST, particularly in patients with KIT exon 11 mutations.
Shares were up 7.4%.
Fast Track Status for GW Pharma
: GW Pharma gained fast track status for its experimental
treatment, Epidiolex, for Dravet syndrome. Shares were up 4.6%.
Fast track designation is usually granted to drugs being developed
for the treatment of serious conditions, which have unmet medical
need. Dravet syndrome is a rare and catastrophic form of childhood
epilepsy, for which no cure exists at present.
With the designation, the development and review process could be
speedier with more frequent and timely communication and meetings
with the FDA. The candidate could also be granted priority review.
Orphan Drug Designation for Momenta's Necuparanib
: The FDA granted orphan drug status to Momenta's experimental
pancreatic cancer treatment, necuparanib. This designation is given
to drugs being developed for rare diseases/disorders which affect
less than 200,000 people in the U.S. The development of treatments
for pancreatic cancer is extremely tough and challenging.
Incentives that come with orphan drug status include federal
grants, tax credits, waiver of PDUFA filing fees and seven-year
marketing exclusivity following approval.
Hetlioz Accepted for EU Review
: Vanda saw its shares soaring (25.3%) on news that its marketing
application for insomnia treatment, Hetlioz, has been accepted for
review in the EU. EU approval would boost the product's sales
potential quite a bit. Non-24-hour sleep-wake disorder, the
indication for which the company is seeking approval, is estimated
to affect about 130,000 people in the EU.
Incyte's Immunotherapy Looks Promising
: Incyte presented encouraging data on its immunotherapy INCB24360.
42% of melanoma patients being treated with '360 plus Yervoy
achieved an objective response and 75% achieved disease control.
Complete response was achieved by one patient. These results look
good and support continued development of the combination.
Puma Plunges on Data
: Puma's shares plunged 25.3% on data from a breast cancer study on
PB272 (neratinib). The efficacy results were modest with the
incidence of diarrhea being pretty high.
The Week So Far
The week so far has been highly eventful with the highlight being
Merck's announcement that it will acquire
) for $24.50 per share, more than three times the company's value
before the deal was announced.
Idenix Shoots Up on Acquisition News
: Idenix's shares skyrocketed 229.05% on news that it will be
acquired by pharma giant, Merck.
FDA Pushes Back
: Orexigen had a major regulatory event lined up today - the FDA
was supposed to deliver a decision regarding the approval status of
its experimental obesity treatment - NB32. However, the action date
has been pushed back by three months to Sep 11.
Dendreon CEO to Leave Mid-August
: Dendreon, which is going through challenging times, said that CEO
John H. Johnson will be leaving mid-August.
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 inhibitor, sovaprevir.
Shoots Up on Promising Data
: Receptos' shares are up a whopping 36.8% on positive mid-stage
data on its experimental oral multiple sclerosis treatment,
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 the earlier expected date
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
hyperparathyroidism - this is a rare endocrine disorder
characterized by insufficient levels of parathyroid hormone.
Vertex has an important pipeline event coming up - highly awaited
results from two pivotal phase III studies (TRAFFIC and TRANSPORT)
in cystic fibrosis patients should be out shortly. Positive results
would allow Vertex to file for U.S. and EU approval in the second
half of the year.
Meanwhile, next week, the FDA will decide whether it should approve
Cubist's experimental anti-infective drug - Sivextro. Chances of
gaining approval look high given an FDA panel voted unanimously
(14-0) in favor of approving Sivextro for the treatment of acute
bacterial skin and skin structure infections (ABSSSI). The FDA
action date is Jun 20.
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