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YOUR WEEKLY SOURCE FOR MARKET AND FINANCIAL NEWS
BIoTeCH'S MoST ReSPeCTeD NeWS SoURCe FoR MoRe THaN 20 yeaRS
VolUMe 22, No. 20
two chinas emerging as biopharmas Money Raised By Biotech: 2014 vs. 2013shift toward innovative drugs
Jan. 1 – May15, 2014: $15,199.04M Jan. 1 – May16, 2013: $7,124.49M
By Marie Powers, Staff Writeralthough innovation is the topic of much conversation in
China's biopharma industry, Western companies are likely to
observe that the notion of innovative drug development in
China is more hype than reality. however, participants at the
Chinabio partnering forum, held in Suzhou earlier this month, offered compelling evidence that Chinese biotechs are, indeed,
transforming cutting-edge discoveries into drug pipelines, with
partnering opportunities very much welcomed.
no one disputes that the opportunities for drugmakers in China
are enormous. Characterizing the country as a BrIC nation,
along with Brazil, russia and India, is a misnomer at this point, according to ray Stevens, co-founder of ruiyi Inc. and
professor in the departments of molecular biology and
chemistry at the Scripps research Institute. Stevens contended
that China "is ahead of every other BrIC national by 10 years."
that assessment isn't far off. a recent thomson reuters white
paper, "overcoming Clinical Challenges in BrIC markets,"
citing feb. 18 data from Cortellis Clinical trials Intelligence, indicated that more than 4,200 clinical trials were started in
* Includes financings of public biotech firms with the exceptions of public offerings and certain investments from corporate partners.
China over the past five years, compared to approximately 1,200 in Brazil, 2,600 in russia and 2,300 in India over the same period. In fact, China is the only BrIC nation seeing an increase in the number of clinical trials initiated each year, according to the white paper. forecasts suggest that China will
become the second largest pharmaceutical market in the world
CompanIeS jumpIng on potentIal
in 2017, overtaking japan.
SgC modulatorS payoff
China's potential is attracting droves of returnees – Western-
BIoteCh SeCtor ContInueS to Stall
educated Chinese nationals – including tens of thousands of
aS general marketS alSo tumBle
scientists with advanced degrees. many also have work experience at big pharmas or biotechs and are eager to apply
money raISed By BIoteCh In 2014
their knowhow to the Chinese market.
Word on the Street
Chinese bioteChs in hunt for partners
Consider Shenogen pharma group. after eight years of effort,
Week In WaShIngton
the Beijing-based company advanced its lead compound, Sng-
phaSe I, II & III ClInICal trIalS update
162 (lcaritin), into a phase II study in China. Shenogen was co-founded by two lab mates: kun meng, chairman and Ceo,
amerICan aSSoCIatIon for CanCer
who completed his postdoctoral training at harvard university
reSearCh; pharma data
and the Washington university School of medicine, and Charlie Wang, chief science officer, who completed postdoctoral
non-u.S. ClInICal trIalS update;
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monday, may 19, 2014
BIoWorld™ InSIght
companies jumping on potential regulating cgmp, Ironwood's chief scientific officer, mark
Currie, told BioWorld Insight. "In our mind, there are very
sGc modulators payoff
few regulators that have this kind of utility," he said.
By Michael Fitzhugh, Staff Writer
Currie and his team now are advancing preclinical molecules that target sgC in a bid to address indications
merck & Co. Inc.'s new billion-dollar collaboration with
beyond the gastrointestinal space. they expect to initiate
Bayer ag threw a spotlight on drugs capable of amping up
their first sgC clinical study in the first half of 2015,
concentrations of the messenger molecule cyclic guanosine
prioritizing evaluation of application in pah and other
monophosphate (cgmp) to impact cardiovascular and
gastrointestinal diseases. now Bayer, Ironwood pharmaceuticals Inc. and others are leveraging expertise
By looking at ways to optimize the half-life and volume of
built on the way to gaining fda approval for drugs in the
distribution of molecules targeting sgC, Currie's team is on
space to expand their use.
the path to finding ways to deliver a controlled day-long
lowering of blood pressure and, in other cases, diminish
the only two fda-approved drugs capable of modulating
fibroblast proliferation in the treatment of pulmonary, liver
cgmp, Bayer's adempas (riociguat) and Ironwood's linzess
and kidney fibroses. they're also looking at ways to cross
(linaclotide), do so in different ways. Both impact targets in
the blood-brain barrier to impact alzheimer's disease and
the guanylate cyclase family and both are showing potential improve memory, he said.
for interesting new applications.
adempas targets soluble guanylate cyclase (sgC), the only
sharing risks and rewards
known nitric oxide receptor in the human body. nitric oxide
despite the promise of sgC modulators, major development
activates soluble guanylate cyclase, which in turn kicks off
efforts and clinical programs will be required to realize their
production of cgmp, relaxing arteries and thereby increasing potential. that's where the Bayer-merck deal comes in. Both blood flow and decreasing blood pressure. the fda
companies have been working on sgCs for years.
approved adempas to treat two forms of pulmonary
underscoring Bayer's desire to defray the major costs it will
hypertension in october 2013, making it the first drug in its
face developing adempas and other sgCs for new
class to be approved to treat pulmonary arterial
indications, this month it struck a deal giving merck full
hypertension (pah) and the first drug of any class to be
commercialization rights for adempas outside the americas,
shown to be effective for patients with chronic
half the profits for its phase II sgC, vericiguat, and
thromboembolic pulmonary hypertension.
optionally half of any profit from several other sgCs the
Ironwood's linzess (linaclotide), on the other hand,
companies plan to co-develop. In exchange, merck will
selectively activates guanylate cyclase C (gC-C), a receptor
shoulder half the development costs for those new drugs.
found almost exclusively in the membrane of cells lining the for the potential rewards adempas and the other sgCs inner surface of intestinal tissue. In august 2012, it became
offer, merck agreed to pay Bayer $1 billion up front and up
the first and only gC-C activator approved by the fda to
to an additional $1.1 billion if adempas and the other sgCs
treat chronic idiopathic constipation (CIC) and irritable
hit certain sales milestones. In addition to contributing its
bowel syndrome with constipation (IBS-C), easing
cash and one phase I compound, the Whitehouse Station,
abdominal pain in the latter, and netting 2013 sales of
n.j.-based company also brings serious credibility in the
about $119 million. now Ironwood is pursuing an expanded
cardiovascular market to the table. (See BioWorld Today,
indication for linzess in opioid-induced constipation (oIC).
the company is also developing another gC-C activator,
Importantly for both, Bayer's vericiguat, an investigational
IW-9179, to treat functional dyspepsia and gastroparesis.
But there's much more opportunity to be realized in
bioworld insight pRacticaL infoRMation
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monday, may 19, 2014
BIoWorld™ InSIght
Biotech sector continues to stall
little over 0.5 percent in may. however, companies in the group have seen their share values go on a wild ride during
as general markets also tumble
this period of uncertainty for the sector.
By Peter Winter, Editor
leading rnai therapeutics company alnylam
pharmaceuticals Inc., for example, saw its share value drop
With the general markets sliding last week over concerns
15 percent in april only to regain most of it back so far this
about an uncertain economy, biotech companies followed
month on the strength of reporting positive top-line results
suit and by close of market thursday, the BioWorld Blue
from its ongoing phase I trial of aln-at3, a subcutaneously
Chip Biotech Index had dropped almost 1 percent since the
administered rnai therapeutic targeting antithrombin in
start of the month. this was, however, slightly better than
development for the treatment of hemophilia and rare
the 1.5 percent decline in the nasdaq Composite Index over
bleeding disorders.
the same period, while the dow jones Industrial average has so far held its own and remained unchanged.
among the leading decliners in the group was aegerion
pharmaceuticals Inc., of Cambridge, mass., whose shares
leading the decliners so far in may has been Seattle
have tumbled 25 percent after posting a wider loss than
genetics Inc., whose shares have fallen 8.7 percent despite
analysts were expecting in its first quarter financials. the
reporting solid revenue growth in its first quarter results
company did post $27 million in net product sales for its
with net product sales of its adcetris (brentuximab vedotin)
juxtapid (lomitapide) capsules, approved to treat patients
antibody-drug conjugate for treating hodgkin's lymphoma
with homozygous familial hypercholesterolemia (hofh), a
and anaplastic large-cell lymphoma coming in at $38.7
genetic disorder that causes extremely high cholesterol
million compared to $33.9 million for the same period in
levels. the amount represented a growth of 24 percent over
2013. despite the fact that most analysts believe the
net product sales from the u.S. business in the prior quarter.
company's prospects are very good going forward investors are still looking for more. It is a story that has been reflected news of acorda therapeutics Inc.'s complete response letter across the whole spectrum of the sector – despite a
for the new drug application (nda) related to plumiaz
generally positive first quarter for public biotech companies, (diazepam) for epileptic cluster seizures was enough to send the reports have failed to bring investors back to the fold.
its shares down about 14 percent so far this month. the
(See BioWorld Blue Chip Index, below.)
company also said the nasal spray version of the benzodiazepine therapy is unlikely to win approval this year.
the BioWorld growth Index, which includes companies with
(See BioWorld Today, may 5, 2014.)
market caps in the range of $1 billion to $3 billion and a résumé that typically includes a strong drug pipeline and
the dive in share prices permeated across the board for all
partnered products in late-stage clinical trials, has seen its
biotech companies. the BioWorld emerging Biotech Index,
value drop almost 8 percent since the end of the first
which tracks selected small-cap companies that have
quarter, but similar to the Blue Chip Index has only fallen a
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monday, may 19, 2014
BIoWorld™ InSIght
Money Raised By Biotech: Jan 1 - May 15, 2014
we've observed in the clinic, not just in animal studies, that every time we saw activity, we saw it first at metastasized sites. We're thinking that, if you combine our drug with some chemotherapy,
it can wipe out metastasized sites as well as the primary tumor
site, which would be a nice combination. But we can only do one
or two trials at a time with our resources. a partner can do
multiple trials."
‘the quality of the sCienCe is outstanding'
Suzhou alphamab Co. ltd. is another model of innovative drug discovery. founded in 2008, the company has 90 employees, including more than 65 scientists in its r&d operation. alphamab is advancing biosimilars as its bread and butter but also building a pipeline of novel oncology drugs. for example,
Public Offerings
kn-014 is a genetically engineered therapeutic protein that
inhibits various isotopes of vegf, pIgf and pdgf, with the goal
Private biOtechs
of treating lung, bladder, colorectal and other metastatic cancers, as well as wet age-related macular degeneration.
kn-010 is a bispecific antibody that binds different epitopes on cancer cells to prohibit cancer cell growth and proliferation
through a variety of mechanisms. designed for improved efficacy against tumors while preventing resistance, the drug is being
training at princeton university and served as an associate
developed to treat breast cancer and other solid tumors.
professor at harvard medical School. Wang also is a professor of pathology at Creighton university.
founded last year, mabspace Biosciences Co. also is focusing on antibodies for therapeutic and diagnostic applications. using
jun Bao, the company's senior vice president, chief business
immune tolerance breaking technology, the company has
officer and acting chief financial officer, holds a phd from the
identified three therapeutic antibodies, mSB-001, mSB-002 and
university of kansas. Bao's resume includes tenure at
mSB-003, and one diagnostic application, mSB-004, that it is
glaxosmithkline plc in China and at u.S. firms onyx
seeking to partner. mSB-001 is designed as a best-in-class
pharmaceuticals Inc., Icos Corp. – acquired in 2006 by Cialis
antibody that targets the tumor microenvironment for treating
(tadalafil) joint venture partner eli lilly and Co. – and Cell
gastric and lung cancers. mSB-002 is a first-in-class antibody
therapeutics Inc. (See BioWorld Today, oct. 18, 2006.)
with the potential to treat tissue fibrosis and cancer, and mSB-
Shenogen is targeting first-in-class drug development. Its Sng-
003 is an antibody-targeted immunotherapy for lung cancer,
162 is a naturally derived traditional Chinese medicine known as
renal cancer and melanoma.
yingyang huo, a perennial grass whose name translates as
and ruiyi has a bi-coastal strategy in its effort to develop novel
"horny goat weed." the small molecule, which targets the
drugs for the Chinese market. the company is headquartered in
estrogen receptor er-alpha 36, is in a phase II study in China,
la jolla, Calif., but has its discovery efforts and research facility
with applications in liver and breast cancer as well as leukemia.
in the Zhangjiang hi-tech park in Shanghai. earlier this year,
Shenogen was started with just $100,000 in seed money,
ruiyi netted a $15 million series B round from its existing
according to Bao, and now has 80 employees. the company's
investors, which include 5am ventures, versant ventures,
business acumen and scientific prowess last year helped
apposite Capital, Sr one, merck Serono ventures and aravis Sa.
Shenogen attract a $20 million series C from a syndicate that
(See BioWorld Asia, april 2, 2014.)
included Qiming venture partners llC, of Shanghai, and legend ruiyi is using its intermembranous Conformation antigen
Capital, of Beijing, an affiliate of tech company lenovo, along
presenting System, or iCapS, technology to leverage therapeutic
with China Investment Wealth venture fund and Shenzhen
specificity across a set of targets from the large g protein-
venture, a venture arm of the municipal government. lead
coupled receptor (gpCr) family. although nearly one-third of
investors from Shenogen's series B, including Idg venture and
approved drugs modulate gpCrs, traditional drug discovery
lapham group Inc., also joined. (See BioWorld Asia, nov. 6,
methods have been stymied in exploring many of the selective
targeting gpCrs – especially those with small extracellular
Bao attended Chinabio seeking partners.
domains. ruiyi's iCaps changed that equation, enabling the
"We'd like to find one or two partners for the market outside
purified, isolated, conformationally correct presentation of
China," he told BioWorld Insight, "and in China we are also open
functional gpCrs, optimized to identify selective antibody
for collaborations." the fact that Sng-162 has shown activity in
inhibitors or activators with greater specificity, resulting in the
solid tumors as well as leukemia is intriguing, Bao said, "and
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monday, may 19, 2014
BIoWorld™ InSIght
riemser pharma gmbh acquired keocyt, which markets
pharmaceutical products to treat rare diseases.
Zalicus inc. said horizon discovery group will acquire its
aeterna Zentaris inc. entered an at-market issuance sales
combination high-throughput screening platform and related
agreement with mlv & Co. llC.
assets for $8 million.
agile therapeutics inc. filed to raise up to $65 million in an Ipo. . . and More
Celator pharmaceuticals inc. entered a $15 million loan
abeona therapeutics has been granted fda orphan drug
agreement with hercules technology growth Capital Inc.
designations for its lead investigational therapies for treatment
Chase pharmaceuticals Corp. raised $21 million in a series B
of Sanfilippo syndromes a and B.
financing round.
alk-abello a/s said partner Merck & Co. inc. launched
imaginab inc. completed a $21 million series B financing round.
ragweed allergy immunotherapy tablet ragwitek in Canada.
invivo therapeutics holdings Corp. closed a public offering for
beryllium has finalized its consolidation of assets from
gross proceeds of approximately $16.1 million.
emerald Bio and decode genetics and emerged as a drug
gemmus pharma inc. said it closed a $3.3 million series B
discovery company.
financing round.
daiichi sankyo Co. ltd. discontinued a phase III trial for
Marinus pharmaceuticals inc. filed to raise up to $63 million in
nimotuzumab after four treatment-related deaths were
observed, all in the nimotuzumab arm.
radius health inc. postponed its Ipo citing poor market
health Canada has suspended the establishment license of
biolyse pharma Corp.'s facility in St. Catharines, ontario,
because of concerns with the manufacturing process.
sorrento therapeutics inc. expects to generate $25 million in
gross proceeds from a public offering.
Merck & Co. inc. said the fda approved Zontivity (vorapaxar)
to reduce thrombotic cardiovascular events in patients with a
sorbent therapeutics inc. said it closed a $6.5 million tranche
history of heart attack or with peripheral arterial disease.
of a $15 million series d financing.
provectus biopharmaceuticals inc. said its shares have been
Zs pharma inc. is seeking to raise up to $86 million from an
approved for listing on the nySe mkt.
woRd on the stReet
allergan inc. has rejected the unsolicited april 22 acquisition
proposal from Valeant pharmaceuticals international inc.
"I think [cancer immunotherapy] is very exciting and ultimately will be beneficial to patients, but I do think it's blocked out a
aslan pharmaceuticals pte ltd. signed an agreement with Csl little bit of the sun at aSCo again."
ltd. to develop an anti-Il-13 receptor monoclonal antibody,
CSl334, for severe to moderate asthma.
ron squarer, Ceo, array Biopharma Inc.
bristol-Myers squibb Co. is testing pd-1 checkpoint inhibitor
"this study characterizes the extent to which our genetic
nivolumab in non-small-cell lung cancer with Celldex
makeup influences biomarkers in our blood, and it helps to
therapeutics inc.'s Cd27-targeting varlilumab.
define their general characteristics. With its help, we can begin to understand very comprehensively to what extent our
Jubilant biosys ltd. and orion Corp. are collaborating to
physiological status is controlled by genetics and by
discover small-molecule inhibitors in the neuroscience
nongenetic factors."
therapeutic area.
nicole soranzo, group leader at the Wellcome
Mabvax therapeutics inc., a privately held cancer immuno-
trust Sanger Institute in hinxton, Cambridgeshire,
therapy company, is merging with publicly traded telik inc.
on a massive study exploring the ways in which
Medimmune is testing its anti-pdl-1 immune checkpoint
common genetic variants influence the levels of
inhibitor, medI4736, in combination with incyte inc.'s oral
various metabolites in human blood
indoleamine dioxygenase-1 inhibitor.
"the decision to divest our ophthalmic business is part of our
Merck & Co. inc. signed a deal to sell nine of its ophthalmic
ongoing strategy to sharpen our commercial focus and improve
products to japan-based santen pharmaceutical Co. ltd.
our operational effectiveness."
prometic life sciences inc. increased its ownership in nantpro
Jay galeota, president of hospital and specialty
care at merck & Co. Inc., on its decision to sell
shire plc is acquiring lumena pharmaceuticals inc. for $260
nine of its ophthalmic products to japan-based
million up front plus undisclosed milestones.
Santen pharmaceutical Co. ltd.
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monday, may 19, 2014
BIoWorld™ InSIght
week in washinGton
residual uncertainty and assumptions about analytical quality and similarity – as especially relevant to the development of
the ema and the fda released a draft joint proposal to
facilitate multi-arm, multicompany clinical trials for pediatric
the federal trade Commission (ftC) is once again proposing a
treatments of gaucher disease. the proposed approach would
study of patent assertion entities, also known as patent trolls,
determine the safety and efficacy of several new medicines at
and their impact on innovation and competition. the ftC first
the same time, reducing the total number of children enrolled
proposed the study last year. after reviewing 70 comments on
since all the therapies would be evaluated against one control
the study plan, the commission revised the study to sharpen its
group. If successful, this concept could be used to develop
focus and reduce the burden on participants.
multiple drugs for other rare diseases in a reduced time frame
the ema issued an update on joint u.S.-european efforts to
and with limited enrollment.
tackle the rising tide of antimicrobial resistance, detailing
the fda released the latest installment in its series of draft
progress in converging the ema and fda regulatory
biosimilar guidances. It discusses the design and use of clinical requirements in the development of new antibacterial drugs. pharmacology studies. pharmacokinetic and
the move to merge regulation in that area sits under the
pharmacodynamic data are required as part of the fda's
umbrella of the transatlantic taskforce on antimicrobial
stepwise approach to demonstrating biosimilarity to the
resistance, established between the european Commission
reference drug. the draft guidance identifies three key
and the u.S. department of health and human Services, to act
concepts – exposure and response assessment, evaluation of
together in fighting drug-resistant pathogens. //
cakewalk. locals cite challenges with importing cells, gaining
access to radioactivity and interfacing with the China food and
drug administration (Cfda), along with mundane tasks such
potential development of more effective antibodies and other
as making bank deposits, which can require a half-day of
standing in line. the perception of drug development also is
the company's lead candidate, ryI-008, is an anti-Il-6
different in China, where biosimilars remain the standard and
monoclonal antibody with potential uses in autoimmune
domestic investors view phase II as early stage.
diseases and cancer, with rheumatoid arthritis as a proposed
for that reason, ruiyi's lead compound uses well-established
initial indication. (See BioWorld Today, may 17, 2013.)
biology that is sufficiently innovative to help the Cfda gain
ruiyi's Stevens was lured to China by the energy and
experience working with the company's technology. "once we
entrepreneurship in the nation's science community. after
have that one going, we can follow suit with our gpCr
teaching students from China for more than a decade and
antibodies, which are innovative," Stevens said.
hearing the hype about their home country, he wanted to
pursuing innovative drug discovery and development in China
answer three questions: Is the science real? Is it high quality?
requires commitment, he added.
and how would it lead to innovative drug development?
"everything is changing rapidly, so if you want to do drug
"I've been coming to China for 20 years, and I used to see a lot
development here, you can't do it part-time," he maintained.
of empty buildings," Stevens told BioWorld Insight. after three
"you commit or you don't. If you care about quality, you have to
years on the ground in Shanghai, he's convinced the science "is
be fully invested."
very real." his students at the ihuman Institute at Shanghaitech In some ways, however, China reminds Stevens of California,
university – a research university modeled after the
which was the "wild, wild West" in the early days of biotech.
massachusetts Institute of technology and developed from the ground up by the Shanghai municipal government and Chinese
"no one has really hit it big yet in China" in terms of innovative
academy of Sciences – already are publishing papers in Nature
drug development, he said, "but our investors know this is
and Science.
where they need to be. We know a breakthrough drug is going to happen."
"the quality of the science is outstanding," Stevens said, adding
that the opportunity to conduct drug development is better in
until it does, patience is the key.
China than almost anywhere else in the world, including the
"don't come to China because you think that's where the
u.S. "putting ruiyi in China was exactly the right thing to do," he money is," Stevens advised. "Instead, come to China if you
have a really good business model. there's double-digit growth potential and a large population of treatment-naïve patients
‘you haVe to be fully inVested'
with unmet medical needs. But you need long-term thinking,
that's not to say innovative drug development in China is a
not just one or two years." //
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monday, may 19, 2014
BIoWorld™ InSIght
and marketing partner in japan, also is working on sgCs and
has built an extensive patent position in the space, but with
very different chemistry than Ironwood's, Currie said.
sgC it's developing in two phase IIb studies in an indication
"I think it's a natural progression as you see advances in
it's calling "worsening chronic heart failure," is included in
these area that once you're able to bring clear benefit to
the deal. merck's lengthy experience selling cardiovascular
patients," he said, "there will continue to be innovations." //
treatments in the u.S. market could be a boon for Bayer, noted Bayer Ceo marijn dekkers, during a conference call discussing the deal. "the significant expertise that merck has built as a top five
global player in the cardiovascular area, and its strong
presence in the large u.S. market, make merck a partner of choice for our current and future sgC program," he said.
market caps averaging about $500 million, has seen its
Without doubt, having a partner to foot the cost of what
value drop about 1 percent in may.
dekkers called "a significant and comprehensive" phase III
despite a rocky start to the month, the overall declines for
trial of vericiguat next year will help, too.
biotech companies have not been as dramatic as predicted.
for vericiguat and other potential investigational sgC
there will still be some turbulence going forward but with
modulators, Bayer will lead the commercialization outside
investors squarely focused on the upcoming 50th meeting of
the americas while merck will lead commercialization in the the american Society of Clinical oncology later this month
americas. Both companies will have the option to
this could be enough to smooth the ride for biotech stocks
co-promote adempas and the follow-on sgC modulators in
given the number of promising results from important cancer
each others' territories.
therapies that drug developers are scheduled to report. //
meanwhile, leverkusen, germany-based Bayer already is looking for ways to expand riociguat's use. It's preparing to run phase II trials studying the drug's impact in pulmonary
hypertension (ph) associated with interstitial idiopathic
NEGOTIATE LUCRATIVE BIOPHARMA LICENSING DEALS
pneumonia, diffuse systemic sclerosis, cystic fibrosis and the
BIOPHARMACEUTICAL ROYALTY
rare raynaud's disease.
the partners also are testing two more compounds in phase I, an unnamed Bayer sgC stimulator in development as a
ESSENTIAL BENCHMARKS FOR DEALMAKING
treatment for resistant hypertension and merck's mk 8892
New data from BioWorld reveal that biotechnology companies are now
for ph and heart failure. a second Bayer compound is part
garnering higher royalty rates from pharmaceutical partners, higher
of the deal, but is still preclinical.
than other biotech partners.
BioWorld Data's new resource, Biopharmaceutical Royalty
More in play
Rates Analysis: Essential Benchmarks for Dealmaking,
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adempas already has competition from actelion
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pharmaceuticals ltd.'s opsumit (macitentan), an oral
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new york-based Synergy pharmaceuticals Inc. is developing
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plecanatide, a drug targeting gC-C to treat the same indications as linzess. the company intends to initiate
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pivotal phase III trials with IBS-C patients in the second half
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of 2014. It's additionally developing a gC-C agonist it calls Sp-333 for the treatment of oIC and ulcerative colitis. (See
2013 Thomson Reuters
BioWorld Today, nov. 13, 2013.)tokyo-based astellas pharma Inc., Ironwood's development
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monday, may 19, 2014
BIoWorld™ InSIght
fda approvals in april
Company
alk-abello a/S (Copenhagen) and merck & Co. Inc.
ragweed allergic rhinitis
(Whitehouse Station, n.j.)Biogen Idec Inc. (Cambridge, mass.)
dyax Corp. (Cambridge, mass.)
acute hereditary angioedema
genmab a/S (Copenhagen) and glaxosmithkline plc arzerra
Chronic lymphocytic leukemia
(london)greer laboratories Inc. (lenoir, n.C.)
allergic rhinitis
kaleo Inc. (richmond, va.)
phase i clinical trials update april 2014
results from a pilot study of 20
polymer treatment
patients showed statistically
inc. (new york)
significant improvement in ulcerations and pain
phase I data confirmed safety in
therapeutics ag
a compound aimed relapsed
dosing started in its phase I/II trial 4/17/14
at restoring normal platinum-
of apr-246; it will enroll about
function to tumor
180 patients in a two-part design
suppressor protein
arno therapeutics
enrolled the first patient in a
inc. (flemington,
progestin hormone castration-
phase I/II trial
resistant prostate cancer
vaccine consisting
final phase I data demonstrated
therapeutics inc.
of a fully human
robust antibody and t-cell
responses and evidence of clinical
benefit in patients with very
specificity for the
advanced cancers and suggest
that CdX-1401 may predispose
receptor deC-205
patients to better outcomes on
subsequent therapy with
checkpoint inhibitors
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
Cleveland biolabs
phase I trial characterized the
inc. (Buffalo, n.y.)
orally administered cancers
drug's safety, profiled its
pharmacokinetics, and assessed it for preliminary evidence of antitumor activity in the liver
deciphera
pan-raf inhibitor
Started a phase I trial
pharmaceuticals
llC (lawrence,
kan.)
development
received approval from the fda
Center for
and the tfda to begin phase I
a synthetic double- Solid tumors,
Started a phase I trial
stranded rna in a
inc. (Watertown,
stable lipid particle myeloma or
helix biopharma
a targeted antibody Stage Iv
received fda approval to start a
Corp. (aurora,
naturally occurring metastatic plant enzyme
non-small-cell lung cancer
immatics
a phase I trial met its primary
endpoints of safety and
gmbh (tuebingen,
germany)
innate pharma sa
Began the cohort expansion
(marseille, france)
checkpoint inhibitor
portion of an open label phase I trial
karyopharm
Started a phase I trial of selinexor 4/22/14
therapeutics inc.
in children with high-risk
malignancies resistant to standard chemotherapy
peregrine
opened enrollment of a trial of
bavituximab in combination with
inc. (tustin, Calif.)
yervoy (ipilimumab, Bristol-myers Squibb Co.)
precision biologics neo-102
a reformulation of
phase I/IIa data showed
preliminary signs of activity based
on stabilization of disease
colorectal cancer
sorrento
phase I/II data from six patients
therapeutics inc.
showed clinically meaningful
improvement in quality of life, achieving, on average, a 20% reduction in their pain intensity
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
tocagen inc. (San
Interim data of patients treated
amiretrorepvec and grade glioma
with the combination showed it to
flucytosine; gene
be safe and well tolerated with
therapy candidate
minimal treatment-related toxicity
Xbiotech inc.
advanced cancer results from a phase I/II study
showed an excellent safety profile,
antitumor therapy
while overall, patients' constitutional symptoms improved
phase I/II data showed it met its
therapeutics inc.
primary endpoint of safety
Capstone
dosing was started in the phase Ia 4/9/14
therapeutics inc.
lipoprotein/non- trial
high-density lipoprotein cholesterol reduction
Cytori therapeutics Cytori Cell
Chronic ischemic data from the preCISe trial phase 4/15/14
inc. (San diego)
I/IIa feasibility trial demonstrated
statistically significant differences
regenerative cells
in cardiac functional capacity
extracted from a
between treated and placebo
patient's own fat
tissue using Cytori's Celution system
CENTRAL NERVOUS SYSTEM
Cynapsus
Interim data from its pilot study
therapeutics inc.
sublingual strip
indicated that a higher load of
drug on the strip does result in a
higher amount of drug entering the bloodstream
glenmark
Is entering human trials
pharmaceuticals sa
ltd.)
prothena Corp. plc
Started a phase I trial
antibody targeting
Vernalis plc
an a2a antagonist
results from a phase Ib/II proof-
of-concept study showed it
attention deficit achieved a statistically significant hyperactivity
improvement in the number of
correct scores in permp-p
measure (p = 0.019) compared to placebo
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final phase Ib data demonstrated 4/23/14
that while octreotide significantly
ltd. (tel aviv, Israel)
inhibited the secretion of insulin and glucagon in humans and showed a significant and sustained increase of plasma glucose levels, the company's dg3173 had much less of an effect on insulin and glucagon release
halozyme
recombinant and a type 1 diabetes
the primary endpoint of non-
therapeutics inc.
inferiority of a1C levels at six
months was met for the ConSIStent 1 trial
sernova Corp.
Contains insulin-
Interim results from a phase I/II
(london, ontario)
study demonstrated that in the first group of patients the implanted Cell pouch is showing
longer-term safety and biocompatibility
targets galectin-3
the first patient in cohort 2 of its
therapeutics inc.
phase I trial was successfully
dosed with 4 mg/kg, which is
double the dose given in cohort 1; all eight patients have received their first infusion in cohort 2
hepatera ltd.
Inhibits the entry
Chronic hepatitis Initiated a trial investigating it for
mechanism of hBv B virus and
the effects of myrcludex in
combination with pegylated
interferon and the use of the entry inhibitor as pre-treatment before
interferon therapy is initiated
INFLAMMATORY
ablynx nV (ghent,
Started dosing in healthy
volunteers in a phase I trial evaluating a subcutaneous formulation
a small molecule
Started a phase I trial
inc. (Cambridge,
mass.)
allena
phase I data demonstrated a
statistically significant difference
inc. (newton, mass.)
in the reduction of urinary oxalate
oxalate degrading
levels in 30 healthy subjects when
the treatment was compared with placebo (p = 0.0002)
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Started a phase I trial in healthy
postmenopausal women
ltd. (nottingham,
teriparatide product
galectin inhibitor
the first phase I cohort showed a
therapeutics inc.
therapeutic effect on fibrosis,
inflammation and cellular injury
kamada ltd. (ness
Company is starting a small phase 4/4/14
alpha-1 antitrypsin
I/II proof-of-concept study
lpath inc. (San
Started a study of brain injury
lysophosphatidic
induced by blast overpressure
nitto denko Corp.
dosing of healthy volunteers in a
sirna that inhibits liver and other
phase I study has completed
the cause of fibrosis, organsas well as a targeted lipid nanoparticle delivery system
oxford biomedica
a lentiviral vector-
neovascular wet Completed the planned
plc (oxford, uk)
recruitment of 21 patients into its
prothena Corp. plc
Interim data from an ongoing
phase I study showed that
neod001 administered
intravenously once per month was generally safe and well tolerated at the doses studied
questcor
h.p. acthar gel repository
Clinical results showed it could be 4/22/14
a potentially useful therapy for
inc. (anaheim hills,
inducing remission of proteinuria
phase I/II data showed that the
therapeutics inc.
severe glabellar trial met its primary efficacy and
stemcells inc.
human neural stem Spinal cord
Completed enrollment of the
a modified form of
positive results from its phase I
inc. (lexington,
recombinant human
trial in russia showed that two
doses of 2,500 Iu and 5,000 Iu were found to be safe and well tolerated
notespublic biotech company stock symbols can be found in the stock report located on the last two pages of this issue.
the date indicated refers to the BioWorld Today issue in which the news item can be found.
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monday, may 19, 2014
BIoWorld™ InSIght
phase ii clinical trials update april 2014
therapeutic vaccine allergic asthma
failed in a phase IIb trial
ag (Schlieren,
Switzerland)
galapagos nV
a selective jak1
gSk2586184 met the primary
(mechelen, Belgium)
endpoint in phase IIa psoriasis
and glaxosmithkline
study, with patients given the drug
achieving a 75% or greater improvement from baseline in their psoriasis area Severity Index
scores at week 12
gene signal
a phase IIa study demonstrated
international sa
that topical application of gS-101
reduced the size of psoriatic
lesions and inflammation compared to placebo
geneuro sa
multiple sclerosis the one-year open-label extension 4/18/14
of its phase IIa study in 10 patients
targets the mSrv-
was completed, with results
showing that the treatment was well tolerated over the long term and that pharmacodynamic
responses could be observed
phosphagenics ltd. tretinoin
Completed enrollment in a phase
transdermal delivery technology tpm
synthetic biologics trimesta
oral estriol; oral,
topline data from the phase II trial 4/30/14
inc. (rockville, md.)
demonstrated that trimesta given
multiple sclerosis with first-line rrmS therapy
Copaxone (glatiramer acetate injection) resulted in reduced annualized relapse rate and improved cognitive function at 12 months of treatment as compared to placebo plus Copaxone
CANCER
ambit biosciences
flt3-Itd positive Started a phase II cohort of a
Corp. (San diego)
phase I/II study of quizartinib in
combination with either 5-azacitidine or low-dose cytarabine
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
dendreon Corp.
phase II Stand data suggested
recurrent prostate tumor-specific t-cell responses cancer
appear to be enhanced and sustained when provenge is given following androgen deprivation therapy
halozyme
pancreatic cancer halted its phase II trial following
therapeutics inc.
an unexpected imbalance in
thromboembolic event rate
between treatment and control groups; fda placed a clinical hold on patient enrollment and dosing
oncosec Medical
Cutaneous t-cell Company is relaunching a phase II 4/8/14
inc. (San diego)
progenics
Comprises a fully
Completed enrollment in the
human monoclonal
chemotherapy-naïve cohort in its
inc. (tarrytown, n.y.)
antibody selectively
phase II trial of pSma adC; that
targeting prostate-
cohort of 36 patients, all of whom
specific membrane
progressed on hormonal therapies,
antigen linked to a
was added to the phase II study
chemotherapeutic
following positive response to
pSma adC in patients in the chemotherapy-experienced setting
neratinib; a pan-
metastatic breast phase II data showed that the
biotechnology inc.
her tyrosine kinase cancer
neratinib-containing regimen
graduated, based on a high probability of success in phase III with a signature of her2-positive/
hr-negative; neratinib achieved an estimated pCr rate of 55.6% compared to the control arm, which had an estimated pCr rate
spectrum
Captisol-enabled
met the primary endpoints in a
propylene glycol-
pivotal phase II trial
inc. (henderson,
a small molecule
Completed enrollment in gog-
that targets toll-
3003 (nCt01666444), a
epithelial ovarian, randomized, placebo-controlled fallopian tube or phase II trial of vtX-2337 in primary
combination with pegylated
peritoneal cancer liposomal doxorubicin
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monday, may 19, 2014
BIoWorld™ InSIght
to prevent atrial
genetically screened the first
inc. (Westminster,
patient in its phase IIb/III trial
patients with heart failure or left ventricular dysfunction
glycomimetics inc. gmI-1070
phase II data showed it improved
(gaithersburg, md.)
crisis in people
efficacy outcomes independent of
with sickle cell
ISIS-apoCIIIrx an antisense drug
high triglycerides phase II data showed patients
treated achieved average
inc. (Carlsbad, Calif.)
reductions of as much as 71% in apolipoprotein C-III a component of very low density lipoprotein, up to 64% in triglycerides, and
average increases of up to 52% in high-density lipoprotein cholesterol
CENTRAL NERVOUS SYSTEM
alder
a randomized, double-blind,
inc. (Bothell, Wash.)
concept trial showed it met the
primary endpoint of the study by
targets calcitonin
significantly reducing mean
migraine days per month vs.
placebo during weeks five to eight
In a subgroup of patients with
articular injection
associated pain in moderate to severe oak, there
inc. (greenwood
were statistically significant
osteoarthritis of
improvements in WomaC pain (p
= 0.005) and function scores (p = 0.04) over 20 weeks
brainstorm Cell
fda approved commencement of 4/29/14
therapeutics inc.
mesenchymal stem lateral sclerosis
its phase II trial
Civitas therapeutics Cvt-301
reported positive results from a
inc. (Chelsea, mass.)
phase IIb trial of Cvt-301 showing
the study met its primary endpoint
Cytokinetics inc.
failed in a phase IIb trial
lateral sclerosis
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BIoWorld™ InSIght
phase IIa data showed that at 10
lateral sclerosis
weeks following completion of
llC (pasadena,
dosing clinical measurements of
alS progression remained the same in two of eight patients, while the rates of degradation of those clinical measurements had slowed in five of the remaining six treated patients
early data from a phase II study
therapies inc. (new
reveal that low doses of the drug
show it acts as a potent 5-ht2a receptor antagonist, and that, as the dose is increased, it gradually engages other key brain receptors with regional selectivity
the phase II Imaging trial,
biotechnology ltd.
ImagIne, did not meet its primary
endpoint of a statistically
significant reduction in the levels of beta-amyloid plaques
DIABETES
adocia sas (lyon,
phase IIa data showed that in
comparison to humalog (eli lilly
and Co.) commercial insulin, it met the primary endpoint and showed a significant increase in Biochaperone lispro bioavailability in the first half-hour compared to humalog
missed the primary endpoint in a
selective inhibitor of disease
phase II trial of Ctp-499 in
inc. (lexington,
patients with diabetic kidney
disease, but the 48-week results showed some promise in a longer treatment duration
islet sciences inc.
remogliflozin a selective Sglt2
two 12-week phase IIb studies
(raleigh, n.C.) and
and nonalcoholic showed that at week 12, twice-
bhV pharma inc.
daily dosing of remogliflozin
(research triangle
etabonate produced a statistically
significant trend in dose response for change from baseline with changes in hba1c ranging from -1.0 to -1.4%; once-daily dosing demonstrated a trend in dose response for change from baseline in hba1c above the lowest dose with changes in hba1c ranging from -0.5 to -0.8%
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BIoWorld™ InSIght
phase II data showed it met the
primary endpoint of reducing
inc. (the
mealtime insulin use as well as
Woodlands, texas)
several secondary endpoints
noxxon pharma ag noX-e36
phase IIa proof-of-concept data
showed statistically significant reductions in urinary albumin excretion and improved glycemic control
an orally ingestible type 2 diabetes
phase IIa data showed that the
oral insulin appeared to be safe
and well tolerated for the dosing regimen tested
dosed the first subject in a phase II 4/28/14
study designed to treat
inc. (austin, texas)
omnipod infusion pump
GASTROINTESTINAL
athersys inc.
Stem cell product
product failed to moderate the
severity of disease in a phase II
ulcerative colitis
study of 128 patients; it did not show statistically significant improvement compared to placebo
Chronic hepatitis the first cohort of eight patients
research Corp.
was fully enrolled and dosed in a
(pasadena, Calif.)
gilead sciences inc. Sovaldi
hepatitis C virus
phase II data of 400 mg of Sovaldi 4/11/14
(foster City, Calif.)
with the nS5a inhibitor ledipasvir
90 mg, with and without ribavirin
twice-daily, showed 100% of
treatment-naïve genotype 3 patients who got 12 weeks of the combo plus ribavirin, and 64% of the same patients without ribavirin
achieved Svr 12 weeks after treatment
Medivir ab
protease inhibitor
phase II data from cohort 2 in the
hepatitis C virus
interferon-free CoSmoS study
showed that 93% of prior null responder and treatment-naïve patients achieved sustained
virologic responses 12 weeks after the end of treatment with simeprevir and Sovaldi (sofosbuvir, gilead Sciences Inc.)
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monday, may 19, 2014
BIoWorld™ InSIght
a hypoxia-inducible anemia
Completed enrollment in its
therapeutics inc.
ongoing 200-patient phase IIb
(Cambridge, mass.)
auris Medical ag
phase IIb data demonstrated it
(Basel, Switzerland)
aspartate (nmda)
was well tolerated and safe and
receptor antagonist
established proof of concept
Celgene Corp. and
formerly known as anemia in end-
Interim phase IIa data showed
acceleron pharma
aCe-011; targets
dose-dependent increases in
inc. (Cambridge,
hemoglobin in patients on
an antisense drug
phase II data showed that of seven 4/30/14
infants, five are alive without the
inc. (Carlsbad, Calif.)
need for permanent ventilation; in another phase II study in children with Sma encouraging preliminary results were also observed in two additional functional tests: the six-minute walk test and the upper limb module test
ohr pharmaceutical Squalamine
an anti-angiogenic Wet form age-
Completed enrollment of its phase 4/30/14
inc. (new york)
small molecule that related macular
II trial with 142 patients
multiple growth factors
abnormal dermal the first patient has enrolled in a
Corp. (marlborough,
targets connective
tissue growth factor
scioderm inc.
a topical therapy
Completed enrollment in a phase
lesions in patients IIb study (Sd-003) to evaluate the
safety and efficacy of Sd-101; the
study enrolled a total of 48
subjects, ages 6 months and older
RESPIRATORY
anergis sa
Birch pollen allergy Birch pollen
the long-term efficacy trial is fully 4/24/14
enrolled, including 196 patients
enrolled that participated in the 2013 field-based phase IIb trial of allert
dbV technologies
a patient enrolled in the phase II
sa (Bagneux,
araChIld study who received
18-month epicutaneous immunotherapy with viaskin remained desensitized to peanut allergy after one year off-
treatment, with a strict peanut diet
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
novavax inc.
phase II data in 720 healthy
(gaithersburg, md.)
women of childbearing age
vaccine candidate
showed it was well tolerated with no serious adverse events; it also demonstrated significant increases in rSv-f antibody levels across all doses and formulations, as well as clear increases in rSv neutralizing antibodies
theravance inc.
Started a dose-ranging phase IIb
obstructive pulmonary disease
notespublic biotech company stock symbols can be found in the stock report located on the last two pages of this issue.
the date indicated refers to the BioWorld Today issue in which the news item can be found.
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monday, may 19, 2014
BIoWorld™ InSIght
phase iii clinical trials update april 2014
atopic dermatitis enrolled the first patient in a pair
of pivotal phase III trials
inc. (palo alto,
biogen idec inc.
peginterferon beta- relapsing
two-year phase III data from the
(Cambridge, mass.)
multiple sclerosis advanCe trial demonstrated
favorable results on relapse rates, magnetic resonance imaging findings and disease progression when dosed every two weeks
Catalyst
reached patient enrollment target 4/2/14
for its pivotal phase III
partners inc. (Coral
gables, fla.)
CANCER
agenus inc.
Companies are terminating the
(lexington, mass.)
therapeutic that
phase III magrIti study after it
missed both the first and second
glaxosmithkline plc
Stimulon adjuvant
co-primary endpoints
(london)
ambit biosciences
an oral, once-daily relapsed/
Initiated the phase III
inc. (San diego)
selective inhibitor
refractory acute
Quantum-r study comparing
myeloid leukemia quizartinib as a monotherapy to
chemotherapy regimens in patients with the fmS-like tyrosine kinase-3 (flIt3)-Itd mutation
amgen inc.
phase III secondary endpoint data 4/7/14
on overall survival showed a
"strong trend" despite a statistical
miss; the trend in favor of t-vec achieved a "p" value of 0.051
Celsion Corp.
final trial results from a
(lawrenceville, n.j.)
701-patient trial suggest that it
may significantly improve overall
survival, compared to a control, in patients whose lesions undergo
the radiofrequency ablation treatment for 45 minutes or more
heron therapeutics Sustol
formerly apf530; to prevent
Started a phase III label expansion 4/1/14
inc. (redwood City,
induced nausea and vomiting
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monday, may 19, 2014
BIoWorld™ InSIght
a drug designed to metastatic
failed to perform better than
block production of castrate-resistant standard chemotherapy in the
inc. (Bothell, Wash.)
pivotal Synergy trial; adding
custirsen to docetaxel and
prednisone did not significantly
industries ltd.
improve overall survival for the
oncolytics biotech
the phase III reo 018 study
inc. (Calgary,
testing reolysin in combination
with carboplatin and paclitaxel
showed a statistically significant
improvement (p = 0.0072); an
analysis of overall survival also demonstrated a statistically significant improvement in the
reolysin arm vs. control arm (p = 0.0146)
oncothyreon inc.
Started a phase III trial
(Seattle) and Merck
locally advanced
kgaa (darmstadt,
small-cell lung cancer
Sorafenib tablets
locally recurrent results from the phase III
deCISIon trial demonstrated that
inc. (South San
nexavar tablets significantly
extended the time patients lived
bayer healthcare
thyroid carcinoma without their disease worsening
inc. (Whippany, n.j.)
sorrento
metastatic breast the first patient was dosed in the
therapeutics inc.
polymeric micelle
pivotal trial, trIBeCa (trIal
designed to evaluate
bioequivalence between Cynviloq and abraxane)
CARDIOVASCULAR
amgen inc.
protein convertase Cholesterol
phase III data confirmed phase II
subtilisin/kexin
results showing evolocumab
brought down low-density lipoprotein cholesterol by 50-60%
armetheon inc.
oral anticoagulant prosthetic heart
reached an agreement with the
(Sunnyvale, Calif.)
fda on an Spa for the final pivotal trial of tecarfarin
biogen idec inc.
positive top-line results of the kids 4/11/14
(Cambridge, mass.)
factor vIII fc fusion
a-long phase III trial showed it
and swedish
was generally well tolerated and
orphan biovitrum
no neutralizing antibodies that
might interfere with its activity were detected
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BIoWorld™ InSIght
once-daily factor
launched a global, pivotal phase
Xa anticocagulant
III trial to determine whether
inc. (South San
extended preventive treatment
can prevent blood clots in the leg and lung that can occur in hospitalized cardiovascular disease patients
regado biosciences reg1
Company is expanding enrollment 4/4/14
inc. (Basking ridge,
in the phase III trial comparing
reg1 to angiomax (bivalirudin,
the medicines Co.) after achieving
intervention, or
its 1,000-patient enrollment
CENTRAL NERVOUS SYSTEM
alkermes plc
favorable phase III data
demonstrated statistically
significant reductions from baseline in positive and negative Syndrome Scale total scores at week 12, compared to placebo
dextromethorphan pseudobulbar
phase III data showed that 19% of 4/29/14
hBr and quinidine affect
treated patients achieved
inc. (aliso viejo,
remission from symptoms after
one week; 50% of patients achieved remission by the end of
the 12-week trial
a breath-powered Severe migraine
migraine relief for some patients
began as early as 15 minutes
inc. (aliso viejo,
following treatment, and a
statistically significant greater
number of treated patients experienced headache relief
compared to placebo at all time points from 30 minutes through two hours
Cytokinetics inc.
a novel skeletal
results from BenefIt-alS
lateral sclerosis
showed that of the 711 patients
enrolled in the trial, 605 were randomized to double-blind
treatment with either tirasemtiv or placebo for 12 weeks; the trial did not achieve its primary efficacy endpoint,, but did result in a statistically significant and potentially clinically meaningful reduction in the decline of slow vital capacity
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BIoWorld™ InSIght
formulation of the attention-deficit
Began enrollment in a phase III
pharmaceuticals &
development inc.
(subsidiary of
highland
therapeutics Inc.;
toronto)
navidea
technetium tc 99m pain
navidea is testing lymphoseek
injection in a head-to-head study
inc. (dublin, ohio)
with radiolabeled sulfur colloid to see which drug causes patients less pain
enrolled the first patient in a
sciences
international inc.
(raleigh, n.C.)
evoke pharma inc.
enrolled the first patient in the
recurrent diabetic phase III trial
INFECTION
abbvie inc.
ritonavir; fixed-
hepatitis C virus
phase III data showed patients
dose combination
achieved sustained virologic
response rates of 91.8% and
95.9% in the 12-week and
co-formulated with
24-week treatment arms,
267) 25 mg, dosed once daily, and dasabuvir (aBt-333) 250 mg with or without rBv, dosed twice daily
durata began enrollment of a
therapeutics inc.
phase IIIb trial to evaluate the
efficacy and safety of dalvance for
infections caused injection, in a single 1,500-mg by susceptible
dose infused over 30 minutes
hepatitis B virus
Started a phase III trial
technologies Corp.
combines hepatitis
(Berkeley, Calif.)
B surface antigen with a toll-like receptor 9 agonist
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monday, may 19, 2014
BIoWorld™ InSIght
Completed the last licensure-
biosolutions inc.
enabling study in its Biothrax
post-exposure prophylaxis
program; it met both its primary and secondary endpoints
aBt-450, aBt- three direct-acting Chronic genotype pivotal phase III SapphIre-I and
antiviral regimen,
1 hepatitis C virus II study data showed patients
inc. (Watertown,
boosted protease
achieved sustained virologic
mass.) and abbvie
inhibitor aBt-450/
response rates 12 weeks post-
treatment of 96.2% (n = 455/473)
inhibitor aBt-267
and 96.3% (n = 286/297),
nucleoside polymerase inhibitor aBt-333
gilead sciences inc. Sovaldi
positive top-line results from a
(foster City, Calif.)
chronic hepatitis phase III trial of Sovaldi with C virus infection
ribavirin showed it met its primary efficacy endpoint of superiority compared to a predefined historical control sustained
virologic response rate
Medivir ab
Chronic genotype two phase III trials are recruiting
1 hepatitis C virus patients to study simeprevir in
combination with sofosbuvir in
treatment-naïve and treatment-experienced patients with and without cirrhosis
Initiated separate multinational,
placebo-controlled trials to
inc. (Cheshire,
evaluate the safety and efficacy of
eculizumab in patients
generalized myasthenia gravis
phase III data showed that
therapeutics inc.
subjects who switched from
placebo to migalastat after month
six turned up a statistically
significant reduction in kidney interstitial capillary gl-3 at month 12 (p = 0.013), and those who stayed on migalastat for 12 months showed a durable reduction
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BIoWorld™ InSIght
additional phase III data showed
improved clinical outcomes;
inc. (Chesterbrook,
histolyticum (CCh)
adverse events were mostly
pa.) and swedish
localized to the penis, non-serious
orphan biovitrum
and resolved without intervention
before the next injection
biomarin
phase IIIb Spark data showed it
pharmaceutical inc.
met its primary endpoint
(San rafael, Calif.)
and Merck kgaa
(darmstadt,
germany)
intercept
phase III poISe trial data showed 4/15/14
it met its primary endpoint (p <
inc. (new york)
lipocine inc. (Salt
oral testosterone
Completed enrollment of its Soar 4/30/14
(Study of oral androgen
replacement) pivotal phase III study
phase III data supported the safety 4/8/14
liposome injectable arthroplasty
and efficacy to achieve a femoral
inc. (parsippany,
nerve block in patients; there was
a 24% reduction in total opioid use
reached its enrollment goal of
therapeutics inc.
120 subjects in the first of two
head-to-head studies comparing
androxal to the leading u.S.
testosterone replacement therapy
revo biologics inc. atryn
Started a phase III program in
pregnant women during the 24th
to 28th week of pregnancy
Xoma Corp.
Based on its meeting with the
(Berkeley, Calif.)
fda, plans are being finalized for a gevokizumab phase III program expected to include two double-blind, placebo-controlled clinical studies
RESPIRATORY
theravance inc.
Started a phase III study testing
the combination treatment, ff/vI
100/25 mcg once daily, compared
glaxosmithkline plc
fluticasone furoate disease
to vI 25 mcg once daily,
administered via the ellipta
notesSpa = Special protocol assessment.
public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.
the date indicated refers to the BioWorld Today issue in which the news item can be found.
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monday, may 19, 2014
BIoWorld™ InSIght
american association for cancer Research april 2014
phase I data showed complete
remissions in three of seven
inc. (Cambridge,
targeting candidate
evaluable patients
mass.)
bergenbio a/s
a small-molecule
phase Ia data showed the drug to 4/10/14
inhibitor of the axl
be safe and well tolerated in doses
receptor tyrosine
up to 1.5 g daily with a predictable
pharmacokinetics profile and long plasma half-life, allowing for different dosing options
bind therapeutics
phase I data demonstrated a
inc. (Cambridge,
greater dose intensity by about
50% at once weekly for three
containing cytotoxic
weeks dosing (Q1W), as compared
to once every week dosing described in a previous study
Calithera
phase I data showed that a 100-
biosciences inc.
mg dose resulted in peak plasma
levels of drug at or above 300 nm
and generated a greater than 80% inhibition of glutaminase in
platelets four hours after dosing
deciphera
pan-raf inhibitor; Cancer
Started a phase I trial
a small-molecule
llC (lawrence,
kan.) and eli lilly
and Co.
(Indianapolis)
delmar
data from its ongoing phase I/II
trial showed that the drug is well
inc. (vancouver,
tolerated, with no drug-related
British Columbia)
serious adverse events detected in 26 patients treated to date
immunogen inc.
a targeted antibody Cancer
Clinical activity was seen starting
at doses of 3.3 mg/kg, and its dose-limiting toxicity was the reversible ocular side effects (blurred vision and keratitis) reported with antibody-drug conjugates (adCs)
immunomedics inc. Immu-130
phase I data showed it was
colorectal cancer
therapeutically active in all three
conjugated to the
trials, but a more frequent dosing
schedule was more active in
metabolite, Sn-38
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BIoWorld™ InSIght
phase I data showed that ISa101
pharmaceuticals bV
produced strong immune
responses in almost all of the
advanced cervical carcinoma patients treated
tumor infiltrating
data showed evidence of clinical
biotechnologies inc.
efficacy from a phase II trial
Merck & Co. inc.
responses were observed in
(Whitehouse Station,
patients with pd-l1 negative
tumors; although the preliminary
findings for both tumor types
suggest that higher pd-l1 expression was associated with higher overall response rates
Merrimack
phase I data demonstrated that
feraheme was well tolerated
inc. (Cambridge,
mass.)
Mirna therapeutics mrX34
Interim safety data from an open-
inc. (austin, texas)
microrna mimic of primary liver
label phase I study showed that
naturally occurring cancer
the drug has a manageable safety
tumor suppressor
noxxon pharma ag noX-h94
lexaptepid pegol; a anemic cancer
data from a pilot phase IIa study
showed significant increases in
designed to bind
hemoglobin levels (greater than 1
g/dl) in five of 12 patients (42%)
in response to monotherapy
oncoethix sa
Interim results from an ongoing
molecule inhibitor
phase I trial showed linear
pharmacokinetics and excellent
pfizer inc. (new
phase II paloma-1 data showed it 4/8/14
doubled progression-free survival
receptor-positive in an open-label phase II trialbreast cancer
provectus
a 10% solution of
data showed significant decrease 4/8/14
in melanoma cells in patients'
inc. (knoxville,
injected tumors 7-14 days after
intralesional pv-10 treatment that
was accompanied by similar decrease in uninjected bystander tumors
phase II data showed an
biotechnology inc.
estimated pCr rate of 55.6%
compared to the control arm, which had an estimated pCr rate
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monday, may 19, 2014
BIoWorld™ InSIght
an ongoing phase Ib/II university
of texas md anderson Cancer
inc. (South San
Center-sponsored trial of vosaroxin
in combination with decitabine in
older patients showed that the combination has been found to be effective and well tolerated
a cyclin-dependent Chronic
In 62 patients, patient response
was correlated with mitochondrial
inc. (Salt lake City)
response from pre-treatment specimens to peptides known to interact with proteins that promote cell survival: Bim, noxa, Bad, Bmf and hrk
Viralytics ltd.
Interim results from the ongoing
phase II Calm trial showed antitumor activity in non-injected metastatic tumors in patients participating in the trial, and investigators reported partial or complete reduction of non-
injected tumors in multiple patients who had been on treatment at least eight weeks
notespublic biotech company stock symbols can be found in the stock report located on the last two pages of this issue. the date indicated refers to the BioWorld Today issue in which the news item can be found.
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monday, may 19, 2014
BIoWorld™ InSIght
pharma clinical and fda action update april 2014
(location)
abbvie Inc. (north
locally advanced Started a global phase III trial
or metastatic squamous non-small-cell lung cancer
new results showed that those
peptide 1 receptor
who previously had been exposed
agonist exenatide
to exenatide had an advantage of 5.6 points over their controlled-tested counterparts when using the blinding mdS-updrS motor subscale
12 drugs targeted
opened a phase II trial testing 12
(london) and pfizer
drugs in a single study
fda granted orphan drug
Bayer healthcare
Began enrollment in a phase III
trial studying Xofigo injection in
combination with abiraterone
acetate and prednisone/
resistant prostate prednisolonecancer
a polo-like kinase 1 acute myeloid
fda and european Commission
granted orphan designation
germany)Boehringer
the Chmp of the ema issued a
positive opinion recommending
approval of pradaxa Â; fda
approved it in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent
dvt and pe in patients who have been previously treated
Combination tablet; type 2 diabetes
fda accepted for filing an nda
co-transporter-2
germany) and eli
peptidase-4 inhibitor
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
Bristol-myers Squibb daclatasvir
Submitted an nda; phase III data 4/8/14;
replication complex hepatitis C virus
showed that dCv plus aSv given
inhibitor and a nS3
in a 24-week regimen gained
protease inhibitor
Svr12 among treatment-naïve patients (90%), peg-interferon/ribavirin non-responders (82%) and peg-interferon/ribavirin ineligible or intolerant (82%)
Bristol-myers Squibb atazanavir
a protease inhibitor hIv
Co. (new york) and
gilead Sciences Inc. cobicistat
(foster City, Calif.)
daiichi Sankyo Co.
oral, once-daily
to prevent stroke Began enrolling patients into the
direct factor Xa
phase III enSure-af study
Started a phase Ib/II study to
assess the safety and potential
growth factor eye
efficacy of the eye drops in two
doses vs. placebo
eisai Co. ltd. (tokyo) Zonegran
phase III data showed it was well
tolerated and efficacious
eli lilly and Co.
fda approved Cyramza as a
metastatic gastric single-agent treatment
endothelial growth cancer or factor receptor 2
gastroesophageal
junction adenocarcinoma
forest laboratories
phase IIb data showed
Inc. (new york) and
statistically significant
gedeon richter plc
bipolar I disorder
improvements were observed in
(Budapest, hungary)
the 1.5 mg/day group relative to placebo at six weeks for the primary endpoint, the
montgomery-asberg depression rating Scale total score, and the key secondary endpoint, the Clinical global Impressions – Severity score
glaxosmithkline plc tanzeum
subcutaneous injection
glaxosmithkline plc ellipta
received marketing authorization 4/18/14
pulmonary disease, including chronic bronchitis and emphysema
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
Ipsen Sa (paris)
an injectable form
phase III data demonstrated a
of botulinum toxin
statistically significantly higher
proportion of responders in muscle tone improvement vs. placebo
janssen Biotech Inc. Sylvant
janssen research & prezista
once-daily, fixed-
dose antiretroviral
(raritan, n.j.; part of
combination tablet
johnson & johnson)
containing protease inhibitor prezista (darunavir) and cobicistat
european Commission approved
therapy combining mellitus
(Beerse, Belgium)
canagliflozin and immediate-release metformin hydrochloride in a
topical botulinum
Clinical data showed significant
pharmaceuticals Inc.
reductions in both urinary urgency
(pittsburgh, pa.)
and urinary frequency
merck & Co. Inc.
hepatitis C virus phase II data showed sustained
(Whitehouse Station, mk-8742
protease inhibitor
viral responses with 12-week
dosing in genotype 1 treatment-
replication complex
naïve patients reached 94% to
98%, even without ribavirin
merck & Co. Inc.
(Whitehouse Station,
n.j.)novartis ag (Basel,
the data monitoring committee
receptor neprilysin failure with
unanimously recommended early
reduced ejection
closure of the paradIgm-hf
phase III study, indicating patients with chronic heart failure with reduced ejection fraction (hf-ref)
who received lCZ696 lived longer without hospitalization than those who received standard care
novartis ag (Basel,
lymphoma kinase-positive metastatic non-small-cell lung cancer
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
pfizer Inc. (new
top-line phase III data showed
that tofacitinb, as a 5-mg or
10-mg dose taken as a pill twice daily, met the primary endpoints of statistically significant superiority over placebo
roche ag (Basel,
received a positive opinion from
rheumatoid arthritis
phase III data showed a reduction 4/29/14
(vaccines division of
of 56% of dengue disease cases
Sanofi Sa; paris)Sanofi pasteur mSd gardasil
european Commission granted
marketing authorization for a
2-dose schedule at 0 and six
months in children ages 9 to 13
Sanofi Sa (paris)
fda expanded the approved age
reduced diphtheria tetanus,
indication of adacel for active
toxoid and acellular diphtheria and
booster immunization for the
pertussis vaccine
prevention of tetanus, diphtheria
and pertussis as a single dose in subjects, ages 10 through 64
teva pharmaceutical generic lovaza omega-3-acid ethyl hypertri-
approved in the u.S.
(jerusalem)teva pharmaceutical pridopidine
enrolled the first patient in the
pride-hd study, a phase II trial
(jerusalem)teva pharmaceutical duoresp
a new dry-powder
the european Commission has
inhaler containing a chronic
granted marketing authorization
fumarate dehydrate disease
twi pharmaceuticals generic
extended-release
phase I data demonstrated it was 4/30/14
laboratories Inc.
rapidly absorbed and exhibited a
(maple grove, minn.)
notesBla = Biologics license application; Cma = Continuous marketing application; fda = food and drug administration; Ind = Investigational
new drug application; nda = new drug application; pdufa = prescription drug user fee act; Spa = Special protocol assessment.
public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.
the date indicated refers to the BioWorld Today issue in which the news item can be found.
To subscribe, call (770) 810-3144 or (800) 477-6307 if calling from the U.S. and Canada or email [email protected].
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monday, may 19, 2014
BIoWorld™ InSIght
non-u.s. clinical trials and regulatory actions april 2014
european independent board of
sa (paris)
experts in charge of the safety
profile of the relive phase III trial unanimously recommended continuing the study without modification
Cytrx Corp. (los
received orphan medicinal
doxorubicin with a
product designation from the
european Commission
that binds specifically to albumin
erytech pharma sa graspa/ery-
Was granted orphan drug
designation by the fda
e-therapeutics plc
the uk phase Ia trial showed it
was well tolerated at all six dose escalations with no serious diverse events
adjunct treatment
patient enrollment was initiated in 4/10/14
japan in a phase III trial
inc. (Cambridge,
regeneron
the first phase II study in japanese 4/2/14
antibody targeting
patients met its primary endpoint
inc. (tarrytown, n.y.)
and sanofi sa
(paris)
CENTRAL NERVOUS SYSTEM
Coronado
trichuris suis ova
autism spectrum launched in jerusalem a
biosciences inc.
randomized, double-blind,
(Burlington, mass.)
placebo-controlled, study of 60 patients ages 6 to 17
intelgenx Corp. (St. versafilm
Initiated a comparative
laurent, Quebec)
bioavailability clinical study
and redhill
comparing versafilm to the
biopharma ltd. (tel-
european reference drug
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monday, may 19, 2014
BIoWorld™ InSIght
methylnaltrexone
Submission to the ema has been
accepted for review
ltd. (raleigh, n.C.)
and progenics
pharmaceuticals
inc. (tarrytown, n.y.)
INFECTION
Chongqing Zhifei
aC-hib vaccine vaccine against
the Cfda gave the green light to
biological products
Chongqing to launch its joint
Co. ltd. (hong
meningococcus and
vaccine against group a and C
meningococcus and haemophilus
influenzae type B
influenzae type B
targets microsomal Chronic
plans to begin phase I testing in
ltd. (mumbai, India)
diseases and pain management
to prevent graft
european Commission has
granted an orphan drug
inc. (Cheshire,
organ transplantation
ema's Committee for orphan
medicinal products adopted a
inc. (Cambridge,
positive opinion
topical version of
approved in luxembourg;
inc. (San diego)
approved in Spain
hospira inc. (lake
european data showed it appeared 4/29/14
to be as safe as other epoetin alfa products
ema determined that the firm's
inc. (new york)
chronic kidney disease
thrombogenics nV jetrea
Was approved in malaysia
(leuven, Belgium)
notesBla = Biologics license application; Chmp = european Committee for medicinal products for human use; Cma = Continuous marketing
application; ema = european medicines agency; fda = food and drug administration; Ind = Investigational new drug application; maa =
marketing authorization application; nda = new drug application; pdufa = prescription drug user fee act; Spa = Special protocol
public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.
the date indicated refers to the BioWorld Today issue in which the news item can be found.
To subscribe, call (770) 810-3144 or (800) 477-6307 if calling from the U.S. and Canada or email [email protected].
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monday, may 19, 2014
BIoWorld™ InSIght
fda submissions, approvals & other actions april 2014
fda said its complete response
pharmaceutical inc.
submission to the november 2013
(lexington, mass.)
partial clinical hold showed it is safe to proceed; it was placed on partial clinical hold following the death of a patient who progressed to liver failure approximately one month following discontinuation of CudC-427 dosing
genmab a/s
fda approved a supplemental
(Copenhagen) and
Bla for the use of arzerra in
glaxosmithkline plc
combination with chlorambucil for
the treatment of previously untreated patients with Cll for whom fludarabine-based therapy is considered inappropriate
kite pharma inc.
fda granted orphan drug
engineered t-cell
product designed to target Cd19 expression
pharmacyclics inc.
Submitted a supplemental nda,
(Sunnyvale, Calif.)
based on data from the phase III
leukemia or small reSonate study, pyC-1112, a lymphocytic
head-to-head comparison of
Imbruvica vs. arzerra (ofatumumab, genmab a/S and
glaxosmithkline plc) in 391 patients
fda granted orphan drug
inc. (Salt lake City)
CARDIOVASCULAR
biogen idec inc.
Coagulation factor hemophilia B
fda approved it for the control
(Cambridge, mass.)
IX, fc fusion protein
and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B
dyax Corp.
ecallantide; peptide acute hereditary Won fda approval to treat
(Cambridge, mass.)
inhibitor of plasma angioedema
patients older than 12 years
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monday, may 19, 2014
BIoWorld™ InSIght
(location)
the Medicines Co.
to control mild or fda accepted the filing of a Bla
(parsippany, n.j.)
for hemostatic agent fibrocabs
CENTRAL NERVOUS SYSTEM
impax
resubmitted an nda with
updated safety and stability
(division of Impax
laboratories Inc.;
intelgenx Corp.
fda acknowledged receipt of the
companies' response to the
Quebec) and redhill
complete response letter and has
biopharma ltd. (tel
requested further clarifications
aviv, Israel)
kaleo inc.
pozen inc. (Chapel
fda issued a complete response
friendly aspirin
qrxpharma ltd.
fda's anesthetic and analgesic
release dual opioid severe acute pain drug products advisory (oxycodone and
Committee voted to recommend
DIABETES
Mannkind Corp.
fda's endocrinologic and
(valencia, Calif.)
metabolic drugs advisory
Committee recommended approval
psivida Corp.
diabetic macular the fda set a pdufa date of
(Watertown, mass.)
Sept. 26 for Iluvien following
and alimera
intravitreal insert
resubmission of the nda
sciences inc.
(atlanta)
INFECTION
Cubist
fda committee recommended
pharmaceutical inc.
approval, and a study specifically
(lexington, mass.)
in adolescents and teens before
the label is extended for pediatric use
inc. (lexington,
complicated intra-abdominal infections
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monday, may 19, 2014
BIoWorld™ InSIght
fda committee recommended
therapeutics inc.
second-generation, skin and skin
edmond pharma srl erdosteine
a small-molecule
fda granted orphan drug
emergent
fda has granted orphan drug
biosolutions inc.
(rockville, md.)
enanta
oral, interferon-free Chronic genotype Submitted an nda
inc. (Watertown,
mass.) and abbvie
inc. (Chicago)
gilead sciences inc. Cobicistat
fda accepted the company's
(foster City, Calif.)
refiling of two ndas
boosting, agent that increases blood levels of the protease inhibitors atazanavir and
darunavir, and the integrase inhibitor elvitegravir
fda said the nda "should be
therapeutics inc.
fileable" with existing data
(Cambridge, mass.)
RESPIRATORY
alk-abello a/s
an allergen extract
ragweed allergic fda approved the Bla for
(Copenhagen) and
ragwitek as an immunotherapy
Merck & Co. inc.
for short ragweed pollen-induced
(Whitehouse Station,
allergic rhinitis, with or without
conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific Ige antibodies for short ragweed pollen
greer laboratories
under-the-tongue
allergic rhinitis
fda approved oralair to treat
inc. (lenoir, n.C.)
allergic rhinitis with or without conjunctivitis
notesBla = Biologics license application; Cma = Continuous marketing application; fda = food and drug administration; Ind = Investigational
new drug application; nda = new drug application; pdufa = prescription drug user fee act; Spa = Special protocol assessment.
public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.
the date indicated refers to the BioWorld Today issue in which the news item can be found.
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monday, may 19, 2014
BIoWorld™ InSIght
10 BiGGest u.s. winneRs foR the week
10 BiGGest u.s. LoseRs foR the week
by percent
by dollars
by percent
by dollars
regeneron pharma 16.02
-32.34 puma Biotech
-25.00 portola pharma
-24.46 ani pharma
accentia Biopharma -22.45 agios pharma
THE EMERGING BIOSIMILARS DRUG DEVELOPMENT MARKET…
OPPORTUNITY OR THREAT?THE BIOSIMILARS GAME:
AVAILABLE IN PRINT AND PDF
A scorecard for opportunities, threats and
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(31 countries covered)
• Includes market regulatory strategies• Profiles 139 key players developing biosimilars• More than 75 major biosimilar deals are profiled• Data on 276 biosimilars now in the pipeline• And much more…
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monday, may 19, 2014
BIoWorld™ InSIght
BiowoRLd stock RepoRt foR puBLic BiotechnoLoGy coMpanies
syMBoL cLose cLose
syMBoL cLose cLose
acceleron pharma
accentia Biopharma aBpI
0.0049 0.0038 -22.45
Crmd 1.74 1.55 -10.92 25.00 612
-4.30 -19.58 5446
-6.47 -33.33 2128
-2.64 -55.24 4859
dara Biosciences
9.28 -29.10 12694
depo 10.57 10.93
aeterna Zentaris
-8.33 -14.44 1119
-2.88 -21.97 1482
albany molecular
-2.82 -17.77 4835
adhd 15.85 16.82
-5.07 -33.16 8282
eglt 11.75 11.35 -3.40 -5.42 172
alimera Sciences
alSe 0.04 0.03 -25.00 50.00 25
-3.12 -38.95 6223
-9.27 -30.46 13082
ambit Biosciences
-3.48 -45.68 9240
five prime thera
applied genetic tech agtC
-9.43 -29.26 2470
galena Biopharma gale
-6.87 -56.25 9028
aryX 0.0105 0.01
3.89 -60.55 13626
6.48 -29.03 -28.08 549
-4.24 -38.25 3085
4.07 -48.83 22688
4.86 -44.06 10214
Bio-path holdings
-4.72 -22.97 3488
CpXX 2.65 2.47 -6.79 -18.21 47
-4.22 -18.53 2900
-27.02 -38.39 11880
Cell therapeutics
Intercept pharma
19.07 310.46 1935
-4.88 132.93 10167
4.22 -44.94 22001
5.47 -38.00 17653
-32.34 -38.94 1930
karyopharm thera
kythera Biopharma kyth
Cleveland Biolabs
-0.70 -21.67 5463
mgnX 19.01 19.09
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monday, may 19, 2014
BIoWorld™ InSIght
BiowoRLd stock RepoRt foR puBLic BiotechnoLoGy coMpanies
syMBoL cLose cLose
syMBoL cLose cLose
tetralogic pharma
tetraphase pharma ttph
-4.75 -34.69 1058
myrX 0.18 0.17 -5.56 -5.56 99
the medicines Co.
-3.47 -22.48 2110
neurocrine Biosci
ngSX 0.008 0.0093 16.25 132.50 30
transcept pharma
newlink genetics
0.86 -15.69 -30.08 1417
rare 36.55 34.48 -5.66 -18.39 822
ugneQ 0.0008 0.0005 -37.50 -16.67 43
-14.56 -10.10 2354
oncogenex pharma ogXI
-5.30 -56.45 1090
vrml 3.04 2.95 -2.96 25.00 103
vSar 28.02 27.53
-7.65 -46.81 9351
oxis International
14.02 -34.96 1903
-0.27 -46.06 8256
pacific Biosciences paCB
-7.42 -38.37 5220
pain therapeutics
peregrine pharma
London stock exchanGe
5/9 5/16 %Wk %ytd volume
305 289.25 -5.16 -6.69
horizon discovery hZd 179.925 169.975 -5.53 -20.76
oxford Biomedica
progenics pharma
33.37 -21.01 -28.85
protalix Biothera
237 -1.25 106.90
note: prices are denoted in pence.
toRonto stock exchanGe
-16.02 -10.66 1227
5/9 5/16 %Wk %ytd volume
regado Biosciences rgdo
regeneron pharma regn
Bioniche life Sci
0.18 -10.00 -43.75
0.57 0.00 -25.00
oncolytics Biotech onC
rvX 0.66 0.66 0.00 37.50
theratechnologies
note: prices are denoted in Canadian dollars.
trading volumes for nasdaq, amex and nySe are recorded as the total
Seattle genetics
number of shares traded (in thousands) on a weekly basis (cumulative
monday through friday); the weekly and ytd % changes are from Ipo
completion, where applicable.
average percent Change week: -0.27%
range: -37.50% to +38.05%; number of Companies: 288
(does not include lSe or tSX; not market weighted)
average percent change ytd: -2.34%
range: -72.25% to +310.46%; number of Companies: 288
(does not include lSe or tSX; not market weighted)
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Source: http://ihuman.shanghaitech.edu.cn/wp-content/uploads/2014/06/BWIS05192014.pdf
Comparison of the efficacy and safety of 10 mg amlodipine versus 12.5 mg captopril and combination 5 mg amlodipine with 6.25 mg captopril in treating hypertensive urgency Praew Kotruchin MD Cardiovascular unit, Department of Internal Medicine Faculty of Medicine, KhonKaen University Corresponding author
MATERIAL SAFETY DATA SHEET SECTION: 1.1 PRODUCT IDENTIFICATION Product Name: Melt & Pour Soap Base Suspending Product Use: CAS #: n/a Country of Origin: SECTION: 1.2 COMPANY IDENTIFICATION Company Name: Saffire Blue Inc. Address: 1444 Bell Mill Road, Tillsonburg, ON N4G4G9 Canada