1. Image CopyrIght: REUTERS/ERIC THAYER
THE ONES TO WATCH
A PHARMA MATTERS REPORT.
JAnUARY-MARCH 2010
Expert review from Thomson Reuters of the most promising
drugs changing clinical phase, receiving approval and launched
this quarter, based on the strategic data and insight of
Thomson Pharma®, the world’s leading pharmaceutical
competitive intelligence solution.
AWARDED TO THOMSON SCIENT FIC LIMITED
(THE SCIENTIFIC BUS NESS OF THOMSON REUTERS)

2. As the dust settles after the passing of the new healthcare
bill in the United States, the consensus seems to be that the
pharmaceutical industry has emerged relatively unscathed. For
example, legislation allowing Medicare to negotiate with the
pharmaceutical industry on the price of drugs was eliminated,
protecting future revenues, and the estimated additional 32
million Americans receiving insurance over the next decade
should boost drug sales significantly. Policy analysts are
suggesting drug industry revenues could increase by US$30
billion in that time.
Similarly, producers of biologic drugs will be relieved that
biologics will have patent exclusivity for 12 years – rather than
the 5-7 that generics companies were lobbying for. Biologic
drugs represent only a small portion of industry sales, but
they are a fast-growing area and the new legislation could
inject optimism – vital in a field that requires much larger R&D
investment than other types of drugs.
But the drug industry will pay out US$85 billion in new fees, rebates
and discounts under the new legislation, which could mean a rocky
road for drug development in the short term if companies tighten
belts and wait for the promised revenue growth.
Will the industry optimistically pour money into drug
development in the hope of capturing this new market or divert
funds into ensuring it can survive in this new environment?
Only time will tell. But this quarter’s The Ones to Watch sees a
diverse range of products moving through the pipeline.
Many could make drug administration easier for patients.
Merck & Co’s Elonva® will slash the number of injections
required by women undergoing follicle stimulation for assisted
reproduction, while Zelos Therapeutics’ ZT-034, entering
phase I trials this quarter, could potentially make nasal
treatment for osteoporosis a reality.
Small patient populations and those who suffer from serious
diseases with few treatment options are also set to benefit.
BioMarin is hoping that its BMN-195 candidate, also beginning
phase I trials, will be the first treatment to reach the market
specifically for Duchenne muscular dystrophy, while the same
company’s Zenas® has been launched for the rare Lambert-
Eaton myasthenic syndrome.
Let’s take a closer look at the five most promising drugs
launched or receiving approval, and moving through each of
the clinical phases, between January and March 2010.
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PHARMA MATTERS | THE OnES TO WATCH

3. THE FIvE MOST PROMISIng dRUgS lAUnCHEd OR
RECEIvIng APPROvAl
dRUg dISEASE COMPAnY
Resolor® Constipation Movetis
Ampyra™ Multiple sclerosis Acorda
Elonva® Assisted Merck & Co
reproduction
Zenas® Lambert-Eaton BioMarin
myasthenic
syndrome
Menveo® Meningitis Novartis Vaccines
& Diagnostics
First in this edition of The Ones to Watch we have an oral
treatment that could benefit women suffering from chronic
constipation. Women make up the majority of the estimated
35-50% of the patient population who have constipation
associated with impaired gut motility and do not respond to
dietary and lifestyle changes in combination with laxatives.
Resolor™ (prucalopride) was launched in Germany in January
2010 and in the UK in March 2010 after European approval
in October 2009. Developed by Movetis, under license from
Janssen (a subsidiary of Johnson & Johnson), Resolor offers
a new treatment option for these women. Resolor is the first
in a new class of selective, high-affinity agonists for serotonin
5-HT4 receptors, which trigger peristalsis, and is also under
investigation for the treatment of chronic constipation in men
and children, and for opioid-induced constipation.
Next up is Ampyra™ (dalfampridine), the first ever oral
therapy available to improve walking ability in multiple
sclerosis (MS) patients. Ampyra™, a tablet formulation of
fampridine, the potassium channel blocker, is the only drug to
have been shown in phase III trials to improve walking ability
– demonstrated by an increase in walking speed – in MS
patients, most of whom experience a decline in their mobility
as their disease progresses.
Developed by Acorda, under license from Elan, Ampyra™
was launched in the United States in March 2010. Crucially,
Ampyra™ can be taken by patients with acute and chronic MS
and alongside other drugs, including disease-modifying agents.
Rather than reducing the inflammation that damages the
central nervous system, as other MS treatments do, Ampyra™,
which is an extended-release formulation of fampridine, was
found in preclinical studies to increase signal transmission in
the nerves with damaged myelin sheaths that characterize MS.
Thomson Pharma forecasts sales of US$411.5 million in 2013
and analysts at Merriman Curhan Ford & Co expect sales to rise
to US$1 billion by 2015 or 2016.
PHARMA MATTERS | THE OnES TO WATCH

4. Turning to assisted reproduction, a new drug from Merck &
Co, gained from its November 2009 acqusition of Schering-
Plough, could reduce the number of injections received by
women undergoing fertility treatment. Elonva® (corifollitropin
alfa) is the first drug to sustain multiple follicular stimulation
in the ovaries for a whole week, potentially doing away with the
need for the first seven daily injections of recombinant follicle
stimulating hormone (FSH) given to women during a controlled
ovarian stimulation cycle. The subcutaneous injection, an
agonist of FSH, is used in combination with a gonadotropin-
releasing hormone (GnRH) antagonist.
Elonva® was approved in the EU in January 2010 after a set of
phase III trials, including the ENGAGE trial of over 1,500 women
in which the Elonva® regimen resulted in a similar amount of
pregnancies as the standard follicle-stimulating treatment.
Returning to potassium channel blockers, BioMarin
Pharmaceutical announced in January 2010 the approval
of the oral treatment Zenas® (amifampridine phosphate) for
Lambert-Eaton myasthenic syndrome (LEMS). As this issue of
The Ones to Watch was going to press, this drug was launched
in the UK and Germany. Developed by the pharmaceutical
unit (AGEPS) of the Paris Public Hospital Authority, Zenas®
is the first approved treatment for LEMS so has Orphan drug
protection and a decade of marketing exclusivity in Europe, and
Orphan drug designation in the United States.
LEMS is a rare autoimmune disease in which auto-antibodies
reduce the amount of acetylcholine released by nerve endings,
resulting in muscle weakness, particularly in the legs and trunk.
About 4-10 people per million have LEMS. Most treatment
options focus on treating small-cell lung cancer, which half of
LEMS patients also have, but treatment options are limited for
this type of cancer. While immunosuppressive drugs to treat
LEMS itself have been tested, issues with toxicity, and the
difficulty of administering the necessary regimens, has limited
their use.
Amifampridine phosphate has been central to treating
LEMS, but as an unapproved drug was available only on a
compassionate basis. The approval of Zenas® will open up
this treatment option to many more patients. BioMarin is also
investigating Zenas® for the potential treatment of MS.
We finish our review of newly approved or launched drugs with
Menveo®, a quadrivalent meningitis vaccine approved by the
FDA in February 2010 and in Europe in March 2010. Developed
by Novartis Vaccines & Diagnostics, following the merger of
Novartis and Chiron, it is the first quadrivalent vaccine against
Neisseria meningitidis to be approved in Europe.
PHARMA MATTERS | THE OnES TO WATCH

5. Menveo® targets the A, C, Y and W-135 serogroups
of N. meningitidis and has been approved for the treatment
of people 11-55 years of age after success in a non-inferiority
phase III trial comparing it with an existing commercially
available quadrivalent vaccine.
The vaccine targets four of the five major bacterial groups
that cause meningococcal diseases and can lead to bacterial
meningitis and sepsis. This ability to target four subgroups is
important because the dominant forms of N. meningitidis in a
region can change over time and people travelling to new regions
may encounter new varieties of subgroups – meaning protection
from as many subcategories as possible is highly desirable.
Meningococcal disease progresses rapidly and patients can
die within 24-48 hours of the first symptoms. Up to one fifth of
survivors suffer life-long complications such as brain damage,
learning disabilities, hearing loss and limb loss.
The vaccine is being investigated for use in infants and toddlers,
another group at serious risk from bacterial meningitis.
THE FIvE MOST PROMISIng dRUgS EnTERIng
PHASE III TRIAlS
dRUg dISEASE COMPAnY
custirsen Solid tumors OncoGenex
Pharmaceuticals/
Teva Pharmaceutical
Industries
otamixaban Thrombosis/ sanofi-aventis
cardiovascular
events
aleglitazar Type 2 diabetes Roche
ethynylestradiol Contraception Population Council
and Nestorone®
vaginal ring
Seprehvir Glioblastoma Crusade Laboratories
multiforme
We kick off our roundup of promising drugs entering
phase III trials with custirsen (OGX-011), an intravenous
infusion formulation of an antisense oligonucleotide that inibits
clusterin, a protein overproduced by cancer cells.
In January 2010 licensee Teva Pharmaceutical Industries, which
is developing the drug along with OncoGenex Pharmaceuticals,
announced that custirsen was in phase III trials for solid tumors.
Phase III studies of the drug for first- and second-line therapy
of castration-resistant prostate cancer are due to begin later in
2010, and a phase III trial as a first-line therapy for advanced,
unresectable non-small cell lung cancer is planned for early 2011.
PHARMA MATTERS | THE OnES TO WATCH

6. Encouraging phase II trials saw patients given custirsen in
combination with docetaxel and prednisone experience better
survival rates, less pain and a reduction in prostate-specific
antigen compared with those on docetaxel and prednisone alone.
Clusterin has been shown in preclinical testing to enhance
cancer cell survival and is linked with faster disease progression
and treatment resistance in patients. The protein is also
produced in response to a range of cancer therapies, including
hormone ablation therapy, chemotherapy and radiation
therapy, and increased clusterin levels have been observed in
a range of cancers, including prostate, non-small cell lung,
breast, ovarian, bladder, renal, pancreatic and colon cancers,
anaplastic large cell lymphoma, and melanoma. This suggests
custirsen has the potential to treat many different cancers,
including those that are treatment-resistant.
Second in the group entering phase III trials is otamixaban from
sanofi-aventis, a potential intravenous treatment for thrombosis
and the prevention of cardiovascular events. Otamixaban is an
antagonist of Factor Xa, preventing the formation of thrombin
which is key to the formation of blood clots.
Phase I/II trials in healthy patients and those with coronary
artery disease showed otamixaban to be fast-acting – being
rapidly distributed throughout the blood plasma – and with
a shorter half-life, at just 30 minutes, than other synthetic
Factor Xa inhibitors. It entered phase III trials for acute
coronary syndrome, an umbrella term for signs and symptoms
associated with heart attack, in February 2010. Such patients
represent an unmet clinical need as almost one in ten die or
suffer a second myocardial infarction in the week after an initial
cardiovascular event.
Cardiovascular complications are also the largest cause
of death in type 2 diabetes patients. Roche is hoping that
aleglitazar, for which enrollment for a phase III trial began in
March 2010, will reduce the impact of cardiovascular events
such as myocardial infarction and stroke in type 2 diabetes
patients with recent acute coronary syndrome.
Aleglitazar is an oral dual PPAR alpha and gamma agonist,
designed to balance PPAR alpha/gamma activation. More
specificially, PPAR gamma activation should result in increased
peripheral insulin sensitivity – therefore improving glucose
control – and PPAR alpha activation is associated with control
of blood lipids. The phase II SYNCHRONY trial showed this to
be the case, along with good safety and tolerability in type 2
diabetes patients. While type 2 diabetics are encouraged to
reduce their risk of high glucose and lipid levels, many fail to,
leaving them vulnerable to cardiovascular events.
PHARMA MATTERS | THE OnES TO WATCH

7. The Population Council, along with North American marketing
partner Watson Pharmaceuticals, is developing a hormone-
releasing vaginal ring that could provide women with a unique
long-term, user-controlled method of contraception. The device
entered phase III trials in March 2010.
The one-year ring formulation releases Nestorone®, a novel
syntheic progestin, and the estrogen ethynylestradiol to inhibit
ovulation and maintain menstrual bleeding. It is designed
to simultaneously release both hormones for 13 cycles (one
year), with three continuous weeks in the vagina and one week
ring-free. Women should be able to insert and remove the
ring themselves, without the need for help from a healthcare
professional. Another advantage is that the overall exposure to
hormones is lower than the dose delivered by the daily self-
administration of a pill, for example.
Crusade Laboratories is exploiting the ability of the cold sore
virus, herpes simplex (HSV), to target the brain and cause
encephalitis by using an oncolytic gene-deleted variant to
kill brain tumor cells. Phase III trials of Seprehvir (HSV-1716)
were underway by March 2010 in patients with glioblastoma
multiforme, for which there is no treatment.
A single gene called ICP34.5, which is responsible for virus
replication and virulence, has been removed from HSV type
1, rendering it lethal only to replicating tumor cells, which it
enters and replicates in until it causes cell lysis. The therapy
which has shown no toxicity in early trials is also being
investigated for head and neck cancers, and melanoma.
THE FIvE MOST PROMISIng dRUgS EnTERIng
PHASE II TRIAlS
dRUg dISEASE COMPAnY
ACU-4429 Dry age- Acucela/Otsuka
related macular
degeneration
CK-2017357 Amyotrophic lateral Cytokinetics
sclerosis
ErepoXen® Anemia Lipoxen/Serum
Institute of India
CMX-2043 Reperfusion injury Ischemix
VB-201 Psoriasis VBL
The first of our agents beginning phase II trials mentioned in this
edition is a treatment for dry age-related macular degeneration
(dry AMD) from Acucela and licensee, Otsuka Pharmaceutical.
Dry AMD accounts for 90% of AMD cases – around 26 million
worldwide – and is a leading cause of sight loss in the over
50s, yet has no approved treatment. As light is converted into
electrical signals in the retina as part of the normal visual cycle
of the eye, toxic by-products build up over time, gradually
PHARMA MATTERS | THE OnES TO WATCH

8. breaking down cells in the center of the retina (the macula),
affecting visual acuity and color vision. Cases of the disease
are expected to double worldwide in the next 20 years as the
population ages.
The ENVISION phase II trial began in January 2010 of an oral
formulation of ACU-4429, a non-retinoid visual cycle modulator.
By slowing the eye’s processing of light, ACU-4429 should
decrease the build up of by-products and if given in the early
stages of the disease, stop it progressing to blindness. The drug,
which is easier to administer due to its oral formulation than
laser surgery, photodynamic therapy and injections that are
the mainstay of early wet AMD treatment, was developed using
Acucela’s proprietery visual cycle modulation (VCM) technology.
It received Fast Track status from the FDA in March 2010.
Next up is a potential treatment of amyotrophic lateral sclerosis
(ALS), a progressive neurodegenerative disease associated with
muscle wasting. ALS sufferers rarely survive more than 3-5
years, and death is usually caused by weakness in the skeletal
muscles associated with breathing. Few treatment options
exist. Cytokinetics is developing CK-2017357, the lead from
a series of small-molecule, troponin complex activators that
increase muscle cell sensitivity to calcium and increase skeletal
muscle contractility.
Phase I trials showed that CK-2017357 was well-tolerated and
dose-dependently increased strength in the tibialis anterior
muscle. A phase II trial began in March 2010.
Patients with renal failure often experience anemia as the
kidneys no longer produce enough erythropoietin (EPO),
the hormone responsible for maintaining red blood cell
production. Patients are treated with one to three injections
of erythropoietin per week to prevent anemia. Lipoxen is
hoping that its injectable ErepoXen® (polysialic erythropoietin)
formulation of EPO can improve patient experience by reducing
the frequency of doses to just once a month. Phase II trials of
ErepoXen® began with partner Serum Institute of India under
European regulations in March 2010.
The EPO in ErepoXen® is a polysialylated form. Polysialic acid
(PSA) is a biodegradable polymer of sialic acid which is found
naturally in the human body, suggesting that ErepoXen® may
prove to be less immunogenic and toxic that standard EPO. In
phase I trials, it caused a sustained rise in hemoglobin levels for
28 days after dosing.
Reperfusion injury, caused by damaging inflammation to
tissues upon re-entry of blood after ischemia during surgery, is a
common side effect for which there is no prevention. Ischemix is
hoping that its candidate CMX-2043, which began phase II trials
in March 2010, could meet some of this clinical need. CMX-2043
has two pharmacophores and works by both reducing calcium
entry to the ischemic tissue and preventing oxidative stress. It
PHARMA MATTERS | THE OnES TO WATCH

9. acts through the PI3 kinase pathway to activate Akt.
Preclinical tests in rodents showed reductions in reperfusion
arrhythmia and other markers of reperfusion injury in CMX-
2043-treated animals.
Moving on to auto-inflammatory diseases, VBL Therapeutics
is developing VB-201 (CI-201), a small-molecule oxidized
phospholipid for the oral treatment of a range of inflammatory
diseases. A phase II trial for mild to moderate psoriasis, along
with a sub-group of atherosclerosis patients, began in January
2010. VB-201 is the first in a new class of drugs and is believed
to act by inhibiting the production of the pro-inflammatory
cytokines IL-12/23p40 by dendritic cells and macrophages,
counterbalancing pro-inflammatory immune system activity
without affecting system-wide immune factors.
Psoriasis is a chronic, immune-mediated disease for which there
is no treatment. Current therapies focus on minimizing the
symptoms of the disease, which include raised, dry skin lesions. A
significant number of psoriasis patients also have atherosclerosis
caused by chronic inflammation. VB-201 has shown a strong
anti-atherosclerosis effect in preclinical studies.
VB-201 is also being investigated for the treatment of
rheumatoid arthritis, MS and inflammatory bowel disease.
THE FIvE MOST PROMISIng dRUgS EnTERIng
PHASE I TRIAlS
dRUg dISEASE COMPAnY
BMN-195 Duchenne muscular BioMarin
dystrophy
ZT-034 (nasal spray) Osteoporosis Zelos
IMO-3100 Autoimmune Idera
diseases
DPX-0907 Cancer Immunovaccine
MyoCell SDF-1 Cardiovascular Bioheart
disease
Our first candidate making the leap from the laboratory to
the clinic in this quarter is BMN-195, a potential treatment
for Duchenne muscular dystrophy (DMD), a muscle-wasting
disease for which there is no approved treatment. Around
40,000 people suffer from DMD in the developed world, most
of whom will die by their early 20s from respiratory and cardiac
function failure due to muscle wastage.
BioMarin Pharmaceutical, under license from Summit, began a
phase I safety trial in healthy volunteers of BMN-195 in January
2010. The candidate has been shown to upregulate expression
of the utrophin gene – a homolog of the missing or damaged
dystrophin gene that characterizes DMD – in human muscle
cells in the laboratory, and in mouse models of DMD where
PHARMA MATTERS | THE OnES TO WATCH

10. animals given BMN-195 have become stronger. Utrophin is
present only in fetal muscle cells, and it is hoped its presence in
the muscles of DMD patients will ameriolate the disease. BMN-
195 is the first candidate drug to work via utrophin stimulation
to enter development.
Elli Lilly’s teriparatide (Forteo™) is a synthetic human parathyroid
hormone (hPTH) for the treatment of severe osteoporosis. An
injectable formulation, Forteo acts by increasing bone formation
by regulating calcium and phosphate levels in bones, and in
combination with calcium and vitamin supplements increases
bone growth and reduces the risk of fractures in people with
severe osteoporosis. But the drug must be injected daily
and Zelos Therapeutics is hoping that its nasal formulation
of teriparatide, ZT-034, will provide simple, convenient
administration for patients. ZT-034 is being compared with
Forteo in a phase I trial that began in January 2010. ZT-034
uses Aegis Therapeutics’ Intravail technology, which has been
successful in the intranasal delivery of other peptides.
Sales of Forteo reached US$816.7 million in 2009. Zelos
believes the nasal spray formulation could expand the
market to US$1 billion annually. Zelos is also investigating a
subcutaneous formulation of teriparatide.
Idera is hoping to use a completely novel mode of action
to treat autoimmune and inflammatory conditions such as
lupus, rheumatoid arthritis, multiple sclerosis, psoriasis,
colitis and hyperlipidemia. In January 2010, a phase I safety
trial of subcutaneously administered IMO-3100, a DNA-based
antagonist of toll-like receptors 7 and 9, began in healthy
volunteers. TLR-7 and TLR-9 are found in cells of the innate
immune system and play a key role in autoimmune disorders.
IMO-3100 has shown strong ability to suppress immune responses
mediated via TLR-7 and TLR-9 in preclinical studies, and has
been effective against a range of autoimmune and inflammatory
diseases in mouse and non-human primate models. Idera will
select an autoimmune indication for further clinical development
of the drug after completing two phase I trials.
Our penultimate drug in this edition of the The Ones to Watch is
a therapeutic anticancer vaccine delivered by a novel method.
DPX-0907, the first Immunovaccine product to enter clinical trials,
is made up of seven proprietary peptide cancer antigens licensed
from Immunotope that are believed to be found on the surface
of breast, ovarian and prostate cancer cells. These antigens are
delivered, along with an adjuvant, by Immmunovaccine’s novel
sustained-release technology, DepoVax.
PHARMA MATTERS | THE OnES TO WATCH

11. A phase I study for ovarian, breast and prostate cancer began in
March 2010 as Immunovaccine announced plans to outlicense
the vaccine after phase I or II trials. Preclinical data have shown
DPX-0907 to effectively eliminate tumors.
The seven antigens are encapsulated in liposomes within an
oil carrier which is then freeze dried. Upon preparation for
injection, these active components remain in the oil phase,
creating a depot effect, or store of vaccine in the subcutaneous
tissue, presenting the antigens and adjuvant to the immune
system for a long period and producing a significant immune
response against the cancer cells, but not healthy cells.
And finally, Bioheart, under license from the Cleveland Clinic,
is developing an improved formulation of its MyoCell therapy,
MyoCell SDF-1. MyoCell involves the injection of autologous
skeletal myoblasts into the scar tissue of the heart and has
been shown in clinical trials to induce the expression of
markers important for muscle contraction and so could improve
contractile function of the heart.
MyoCell SDF-1 differs in that the myoblasts are genetically
modified to express the growth protein SDF-1 before injection.
It is hoped that higher levels of SDF-1 will stimulate the
recruitment of the patient’s existing stem cells to the cell
transplanted area, aiding in tissue repair and blood vessel
formation. In preclinical animal studies MyoCell SDF-1
improved heart function by 54%, compared with 27% with the
original MyoCell formulation and 10% with placebo.
A phase I trial began in February 2010 in congestive heart
failure (CHF) patients in Jordan and is the first FDA approved
trial of a combined gene/cell therapy for CHF.
PHARMA MATTERS | THE OnES TO WATCH

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Focuses on the latest phase changes in the pharmaceutical pipeline.
MOvERS And SHAKERS
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