|
R&D Pipeline News -
Therapeutic Edition Sample September 2005
Return to introduction ~
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3 week FREE trial ~
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Part A
Part B
|
Product
Type:
Pharmaceutical |
TA:
Cardiovascular & blood
|
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|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
B
051 |
TAXUS® Express2™ |
Tubulin |
Paclitaxel- eluting coronary stent |
Boston Scientific |
Medical device with active ingredient |
Coronary artery lesions |
Mar-ket |
Study shows signifant reduction of 9-mth re-narrowing vs. bare-metal stents
in a population with complex lesions
read more |
|
B 054 |
Xact®
carotid stent |
- |
Carotid artery stent |
Abbott |
Medical device |
Carotid artery disease |
Approved
CE |
Received FDA approval of the minimally invasive carotid artery stent to
treat pts at risk of stroke; already launched in EU
read more |
|
B
057 |
Flextome™ Cutting Balloon® dilatation device |
- |
Balloon device with surgical blades (ath-erotomes) |
Boston Scientific |
Medical device |
Coronary artery blockages resistant to PTCA |
Approved |
Received clearance from the FDA to market the device and plans to launch the
product immediately which is already approved 01/2005 in EU
read more |
|
S
104 |
Thelin™
Sitaxsentan sodium |
Endothelin type A receptor antagonism |
Small molecule |
Encysive Pharma-ceuticals |
Small molecule |
Pulmonary arterial hypertension |
MAA
NDA |
Announced interim data of ongoing extension trial after 1 yr of treatment in
support of submission
read more |
|
142 |
ATryn®
Rhu
antithrombin |
Thrombin |
Rhu
antithrombin |
GTC
Bio-therapeutics |
Protein |
Hereditary antithrombin deficiency |
MAA |
EMEA
needs more time for completion of the required site inspection process which
delays the overall review process
read more |
|
S
321 |
MC-4232 |
ACE
inhibition + purinergic receptor antagonism |
Combination of MC-1 and lisinopril |
Medicur |
Small molecule |
Diabetic hypertension |
II |
Announced that combination product MC-4232 met primary hypertension and
metabolic endpoints
read more |
|
S
294 |
Trans NV-04 |
Antioxidant |
Oral
metabolite of isoflavone |
Novogen |
Small molecule |
Patients at risk of cardiovascular events |
Ib |
Study results show significant improvement in blood pressure and arterial
stiffness
read more |
|
Product
Type:
Pharmaceutical |
TA:
Dermatology
|
|
|
|
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ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
N
010 |
Oligopeptide-10 |
Antimicrobial and woundhealing properties |
HB64
peptide |
Levlad &
Helix BioMedix |
Cosme-ceuticals |
Acne
|
Mar-ket |
Levlad acquired from Helix BioMedix rights to use its HB64 peptide in
natural and organic cosmetics for use in acne OTC treatment, a US $ 350 mln
market
read more |
|
S
046 |
ISA247 |
immunosuppressive |
Trans-isomer of cyclosporine analogue |
Isotechnika |
Small molecule |
Stable moderate to severe psoriasis |
III |
Announced that 90 % of pts in the phase III trial wish to extend treatment
with study drug
read more |
|
448 |
PRTX-100 |
? |
Protein A (by bacterial fer-mentation) |
Protalex |
Protein |
Pemphigus |
IND |
FDA
released clinical hold on IND; company may start phase I study in healthy
volunteers
read more |
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Product
Type:
Pharmaceutical |
TA:
Gastrointestinal
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|
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ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
458 |
Remicade® infliximab |
TNF-alpha |
Rec
chimeric IgG1 mab |
Centocor (J&J) & Schering-Plough & Tanabe Seiyaku |
Antibody |
Moderately to severely active ulcerative colitis |
sBLA |
FDA
approved use of Remicade in ulcerative colitis, the 5th approved
indication
read more |
|
S
324 |
Entereg®
alvimopan |
Peripherally acting mu-opioid receptor antagonism |
Small molecule |
GSK
& Adolor |
Small molecule |
Opioid-induced constipation & related symptoms |
III |
Announced initiation of phase III clinical program which consists of three
studies globally and n=1700 pts
read more |
|
S
300 |
STA-5326 |
IL-12/IL-23 |
Oral
small molecule |
Synta Pharma-ceuticals |
Small molecule |
Active Crohn’s disease |
IIb |
Initiated a rx, pc study evaluating once-daily, oral STA-5326
read more |
|
S
286 |
KOS-2187 |
Motilin agonism |
Erythromycin-based small molecule |
Kosan Biosciences |
Small molecule |
Gastrointestinal motility disorders |
Precl |
Selected KOS-2187 for develop-ment as it is potent, but lacks known side
effects
read more |
|
Product
Type:
Pharmaceutical |
TA:
Infectious & toxicology
|
|
|
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ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
B
050 |
GelSite® |
Polymer drug delivery technology |
|
DelSite Bio-technologies |
Biomaterial |
Flu
vaccination |
DMF |
Submitted Drug Master File for manufacturing and use in nasal and other
mucosal applications
read more |
|
S
322 |
Cetraxal otic; cipro-floxacin otic |
antibiotic |
Small mole-cule 0.2 % solution |
Salvat |
Small molecule |
External otitis |
NDA |
FDA
accepted Salvat’s NDA for review
read more |
|
087 |
TNX-355 |
CD4 |
Rec
humanized mab |
Tanox |
Antibody |
HIV |
II |
DSMB
interim safety review concluded to continue study
read more |
|
451 |
V3526
Venezuelan
equine encephalitis vaccine |
Subtype 1A/B + related subtype VEE virus strains |
Attenuated live vaccine |
Dynport Vaccine Company (DVC) (a CSC company) |
Vaccine |
Venezuelan equine encephalitis |
I |
Received Fast Track designation status from the FDA
read more
And
entered phase I evaluation
read more |
|
452 |
Botulinum neurotoxin A and B vaccine |
Botulinum neurotoxin A and B |
Recombinant bivalent botulinm vaccine |
Dynport Vac-cine Company (DVC)
www.csc.com/dvc |
Vaccine |
Botulinum intoxication (botulism) |
I |
Received Fast Track designation status from the FDA
read more
And
entered phase I evaluation
read more |
|
453 |
rF1V;
Plague vaccine |
F1
capsular protein fused to V virulence protein |
Recombinant vaccine (E.coli) |
Dynport Vaccine Company (DVC) (a CSC company) |
Vaccine |
Plague from Yersinia pestis |
I |
Received Fast Track designation status from the FDA
read more
and
entered phase I evaluation
read more |
|
|
Pandemic avian flu vaccine |
Variable sur-face proteins + unchanging core proteins |
DNA
vaccine |
Vical |
Vaccine |
Avian influenza |
Res
|
Received US$ 2.9 mln grant from US NIAID to develop a DNA vaccine against
human pandemic avian flu
read more |
|
444 |
siRNA SCV (SARS coronavirus)
SC2
and SC5 |
SCV (SARS
corona virus) |
siRNA, intranasally delivered |
Intradigm Corp |
RNA |
SARS
respiratory infection |
Res
|
Showed effectiveness to prevent and treat SARS in Rhesus monkeys with siRNA
against SARS corona-virus (published in Nature Medicine)
read more |
|
Product
Type:
Pharmaceutical |
TA:
Metabolism & endocrine
|
|
|
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
S
288 |
Actos®
Pioglitazone HCl |
Insulin-sensitizer
(PPARγ
agonism) |
Oral
small molecule thiazolidine-dione |
Takeda Phar-maceuticals & Eli Lilly |
Small molecule |
Type
2 diabetes |
Mar-ket |
Landmark study showed to reduce heart attacks, strokes and deaths by Actos
read more |
|
S
304 |
MD-0727 |
Cholesterol absorption inhibition |
|
Microbia |
Small molecule |
hypercholesterolemia |
I |
Initiated phase I study in healthy human volunteers to evaluate safety,
tolerability, PK and PD |
|
S
317 |
Bonviva® ibandronic acid |
|
Oral, once monthly small molecule bis-phosponate |
Roche & GSK |
Small molecule |
Postmenopausal osteoporosis |
Approved |
Swiss authorities approved Bonviva which is already approved, but not yet
marketed in the US and received a positive opinion from the CHMP of the EMEA
read more |
|
S
318 |
Oporia;
lasofoxifene |
Selective estrogen receptor modulator |
Small molecule estrogen-like |
Pfizer & Ligand Pharma-ceuticals |
Small molecule |
Osteoporosis |
NDA |
Received non-approvable letter from FDA
read more |
|
Product
Type:
Pharmaceutical |
TA:
Neurology
& psychiatry
|
|
|
|
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
S
315 |
Inovelon;
rufinamide; CGP 33101 |
Anti-epileptic by membrane-stabilizing effects |
Triazole derivative |
Eisai |
Small molecule |
Adjunctive: Lennox-Gastout syndrome in children;
Partial-onset seizures in adults |
NDA
MAA |
Eisai submitted a NDA to the FDA for the anti-epileptic drug licensed in
from Novartis in 2004; MAA was submitted to EMEA in March 2005
read more |
|
S
325 |
Adartrel®
ropinirole |
Dopamine D2 and D3 receptor agonism |
Small molecule |
GSK |
Small molecule |
Moderate to severe idiopathic restless leg syndrome |
MAA |
CHMP
of the EMEA issued positive opinion on the MAA of GSK which is already
marketed in the US and Australia and approved for Parkinson’s disease
read more |
|
263 |
Myozyme®
Alglucosi-dase alpha |
Alglucosidase replacement |
Rec
hu enzyme |
Genzyme |
Protein |
Late
onset Pompe disease |
BLA
MAA |
Initiated clinical trial in pts with late onset of disease to provide
additio-nal support for Myozyme’s use
read more |
|
122 |
Naglazyme® galsulfase |
Arylsulfatase B replacement |
Rec
hu enzyme |
Biomarin Pharmaceutical |
Protein |
Mucopolysaccharidosis VI (Maroteaux-Lamy syndrome) |
MAA |
Received positive opinion on the MAA from the CHMP of the EMEA; already
received approval from FDA
read more |
|
457 |
NovoLog® (insulin aspart) |
Insulin receptor |
Rhu
rapid-acting insulin analog |
Novo
Nordisk |
Protein |
Treatment of diabetes in children |
sNDA |
FDA
approved the drug to be used in children, originally approved for use in
adults in 2000
read more |
|
S
312 |
Alzhemed™; 3APS |
Soluble amy-loid B protein binding |
3-amino-1-propanesulfonic (3APS) oral NCE |
Neurochem |
Small molecule |
Mild-to-moderate Alzheimer’s disease |
III |
Launched its European phase III study with an Investigators meeting; the US
phase III study completed enrollment
read more |
|
N 009 |
Diachrome® |
|
Chromium picolinate and biotin containing formula |
Nutrition 21 |
Nutraceutical |
Type
2 diabetes with antidiabetic treatment |
Clin
GRAS* |
A rx,
db, pc 12-wk study showed an average 0.7-1.9% point reduction in HbA1c
levels by Diachrome
read more |
|
B
049 |
Precision™ spinal cord stimulation system |
|
Neurostimulation system medical device |
Boston Scientific |
Medical device |
Chronic pain |
CE
mar-ked |
Received European approval as medical device and plans to start launch of
the product in Europe in 2005
read more |
|
S
050 |
Bicifadine |
Serotonin- + norepinephr-ine reuptake inhibitor |
Small molecule |
DOV
Pharma-ceutical |
Small molecule |
Chronic lower back pain |
III |
Initiated additional phase III study in chronic lower back pain
read more |
|
S
050 |
Bicifadine |
Serotonin- + norepinephr-ine reuptake inhibitor |
Non-narcotic small molecule |
DOV
Pharma-ceuticals |
Small molecule |
Moderate to sev-ere pain follow-ing bunionec-tomy surgery |
III |
Produced significant analgesic effect comparable to tramadol in first of
four phase III trials
read more |
|
S
308 |
Keppra® levetira-cetam |
Unknown (anti-epileptic) |
Oral
small molecule |
UCB
|
Small molecule |
Epilepsy with partial or generalized tonic-clonic seizures |
III |
Phase III study with monotherapy met its non-inferiority, primary endpoint
in comparison with carbamazepine, drug approved for partial onset seizures
in adults and children
read more |
|
207 |
Miraxion®;
LAX-101 |
Phospholipase A2 and caspases |
Semi-syn-thetic highly purified eico-sapentaenoic acid (EPA) |
Amarin |
Natural |
Huntington’s disease
Depressive disorder |
III
II |
Reached agreement with the FDA under SPA procedure for the design of two
pivotal clinical trials of Miraxion to be conducted in 540 pts in the US and
Europe
read more |
|
455 |
Campath®;
MabCampath
alemtuzu-mab |
CD52 |
Rec
humanized IgG1 mab |
Genzyme & Schering |
Antibody |
Active relapsing-remitting multiple sclerosis |
II |
Interim results of phase II study comparing alemtuzumab once a year with
interferon beta-1 show a large treatment effect in favor of alemtuzumab
after 1 yr; prepare phase III study; 3 cases of ITP occurred
read more |
|
232 |
NicVAx™
Nicotine conjugate vaccine |
Active immunization to nicotined |
Nicotine derivative + carrier protein |
Nabi
Biopharma-ceuticals |
Vaccine |
Nicotine addiction and smoking relapse |
II |
Received a US$ 4.1 mln grant to fund development
read more |
|
S
289 |
NRP290 |
Opioid receptor |
Hydrocodone conditionally bioreversible derivative |
New
River Pharma-ceuticals |
Small molecule |
Pain
|
I |
Presented phase I healthy volun-teers PK data after single doses showing
bioavailability comparable to hydrocodone
read more |
|
Product
Type:
Pharmaceutical |
TA:
Oncology
|
|
|
|
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class
of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
S
314 |
Photofrin PDT |
Photodynamic therapy with 630 nm laser light activa-tion (reactive radicals) |
Photofrin / Photobarr; porfimer sodium |
Axcan Pharma |
Medical device |
Prevention of esophageal cancer in high risk pts |
Mar-ket |
Photofrin PDT + omeprazole reduced occurrence of esophageal cancer in pts
with high grade dysplasia associated with Barrett’s esophagus in 5-yr
observation period
read more |
|
450 |
Herceptin® trastuzumab |
HER2 |
Rec
humanized IgG1 mab |
Genentech |
Antibody |
Women with Her2+ metastatic breast cancer |
Mar-ket
|
Interim results of 4th phase III study with herceptin plus
chemotherapy show improved disease-free survival in early stage Her2+ breast
cancer
read more |
|
S
293 |
Aromasin® exemestane |
Hormonal treatment |
Small molecule |
Pfizer |
Small molecule |
Adjuvant treat-ment of estro-gen-positive invasive early breast cancer after
2-3 yrs of tamoxifen |
Approved |
Received European approval by the MRP procedure for further indication
read more |
|
459 |
Neulasta®
pegfilgrastim |
G-CSF
receptor |
Pegylated rec methionyl human G-CSF |
Amgen |
Protein |
Pts
receiving myelosuppressive chemotherapy with at least a 17 % risk of feb-rile
neutropenia |
Mar-ket |
FDA
accepted update on prescribing information including now data from landmark
phase III study showing efficacy also in cancer pts undergoing moderately
myelosup-pressive chemotherapy
read more |
|
S
295 |
Revlimid® lenalidomide |
Immunomodu-latory drug |
Thalidomide analogue |
Celgene |
Small molecule |
Transfusion-dep. anemia due to low- or inter-mediate-1-risk myelodysplastic
syndrome + deletion 5q cytogenetic abnormality |
NDA |
read briefing docs
FDA
advisory Committee recommended Revlimid for approval, studies in other
oncology indications (MM, MDS, CLL, solid tumors) are ongoing
read more |
|
S
296 |
Xinlay™ atrasentan |
Selective endothelin A receptor antagonism |
Oral
small molecule |
Abbott |
Small molecule |
Hormone-refractory prostate cancer with bone metastases |
NDA |
read briefing docs
FDA
Advisory Committee did not recommend the drug for approval, phase III study
with earlier stage HRPC is ongoing
read more |
|
S
285 |
Sorafenib; BAY43-9006 |
Multi-kinase: RAF, VEGF-R2, VEGF-R3, KIT, FLT-3, RET |
Oral
small molecule inhibitor |
Bayer & Onyx |
Small molecule |
Advanced renal cell carcinoma |
MAA;
NDA |
Bayer submitted to the EMEA a MAA for sorafenib in kidney cancer
read more
FDA
accepted submission and granted priority review
read more |
|
S
309 |
Arranon® nelarabine
injection |
DNA
synthesis inhibition (cytotoxic) |
Small mole-cule chemo-therapeutic, a prodrug of ara-G (arabinosid) |
GSK |
Small molecule |
Refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma |
NDA |
FDA
Oncology Advisory Committee recommended accelerated approval of Arranon
pediatric pts
read more |
|
S 61 |
Tarceva;
erlotinib |
EGF-R1 tyrosine kinase |
Oral
small molecule |
OSI
Pharma-ceuticals |
Small molecule |
Treatment naive advanced pancreatic cancer + gemcitabine |
sNDA |
briefing docs were published; FDA staff question new use of Tarceva
read more; FDA Oncology Drug Advisory Committee recommended approval of
pancreatic cancer label
read more |
|
S
116 |
Taxotere®
docetaxel |
Tubulin |
Semisyn-thetic small molecule |
Sanofi-Aventis |
Small molecule |
Various cancers
Early stage Her2+ breast cancer |
Mar-ket
III |
Interim results of phase III study of taxotere-including chemotherapy plus
trastuzumab show significantly improved disease free survival
read more |
|
65 |
Provenge; APC8015 |
Prostatic acid phosphatase (rec PAP used to stimulate) |
Activated autologous dendritic cell therapy |
Dendreon |
Cells |
Advanced prostate cancer
Early stage PC |
Pre-BLA
III |
Decided to submit BLA after meeting with FDA which concluded that clinical
data were sufficient for BLA submission
read more |
|
S
252 |
Acapodene® toremifene citrate |
Slective estrogen receptor modulation |
Small molecule |
GTx |
Small molecule |
High
grade prostatic intraepithelial neoplasia (PIN) |
III |
Received FDA response under SPA protocol on design of phase III trials
read more |
|
079 |
L-BLP25 |
MUC-1 |
Liposomal synthetic peptide vaccine |
Biomira & Merck KGaA |
Vaccine |
Advanced non-small cell lung cancer |
IIb |
Engaged clinical CRO for conduct of planned phase III study scheduled to
commence by end of 2005
read more |
|
079 |
L-BLP25 |
MUC-1 |
Liposomal synthetic peptide vaccine |
Biomira & Merck KGaA |
Vaccine |
Advanced non-small cell lung cancer |
IIb |
Completed enrollment of a 20-pts phase II safety study to assess the
formulation to be used in phase III
read more |
|
446 |
INGN
225;
Ad-p53 |
P53
tumor suppression |
Autologous dendritic cells + adenovector p53 gene |
Introgen Therapeutics |
Vaccine |
Advanced small cell lung cancer |
II |
Interim results from ongoing phase II study show good tolerability and
appears to sensitize for chemotherapy
read more |
|
S
259 |
Xcytrin®;
Motexafin gadolinium; PCI-0120 |
Thioredoxin reductase inhibition |
Small mole-cule + para-magnetic gadolinium |
Pharmacyclics |
Small molecule |
Brain meta-stases from solid tumors + radio-surgery |
II |
Started patient enrollment of phase II study with planned n=45 pts in North
America
read more |
|
339 |
HuMax-CD20 |
CD20 |
Rec
fully human mab |
Genmab |
Antibody |
Relapsed CLL |
I/II |
Announced positive interim results after 11 wk, the MTD not yet reached
read more |
|
S
291 |
PXD101 |
Histone deacetylase (HDAC) |
Small molecule |
CuraGen & Topotarget |
Small molecule |
Advanced solid tumors incl. ovarian cancer |
Ib |
Initiated phase Ib clinical trials in combination with carboplatin and/or
paclitaxel
read more |
|
S
313 |
Sodium stibu-gluconate;
VQD001 |
Target newly discovered: specific protein tyrosine phosphatase |
Small molecule used for leishmaniasis treatment |
Cleveland Clinic Taussig Cancer Center & VioQuest Pharma-ceuticals |
Small molecule |
Solid, lymph node or bone marrow tumors |
I |
Initiated enrolling patients in the phase I study to evaluate MTD in
combination with IFN-2b
read more |
|
S
297 |
TPI
287 |
Tubulin |
Taxane derivative |
Tapestry Phar-maceuticals |
Small molecule |
Cancer |
I |
Will
give update on compound in a webcast
read more |
|
429 |
GTO-2040 |
R2
component of ribonucleotide reductase |
antisense |
Lorus Thera-peutics & NCI |
RNA |
Various cancers |
Clin |
Ongoing Steering Committee assessment on six active clinical studies |
|
445 |
ICS-283 |
VEGF |
siRNA |
Intradigm |
RNA |
Colorectal cancer |
Precl |
Expect to enter the clinic in mid 2005
read more |
|
S
303 |
ENMD-1198 |
HIF-1alpha inhibition |
2nd
genera-tion analog of 2-meth-oxyestradiol |
EntreMed |
Small molecule |
Cancer |
Precl |
Is
conducting IND enabling studies to submit IND by end of 2005
read more |
|
449 |
INGN
007 |
ADP
gene ov-erexpression |
Oncolytic virus |
Introgen |
DNA |
Cancer |
Precl |
Animal studies show the safety of the improved oncolytic virus
read more |
R&D Pipeline News -
Therapeutic Edition Sample September 2005
Return to introduction ~
Request a
3 week FREE trial ~
Purchase
|
Product
Type:
Pharmaceutical |
Category:
Ophthalmology
|
|
|
|
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class of Compound |
Company |
Product
Category |
Indication |
R&D Stage |
Message |
|
456 |
Macugen®
Pegaptanib sodium |
VEGF |
Pegylated oligonucleotide (aptamer) |
Eyetech Pharmaceutical & Pfizer |
RNA |
Neovascular (wet) age-related macular degeneration |
Mar-ket
MAA |
The
CHMP of the EMEA issued a positive opinion on Macugen which is already
approved in the US
read more |
|
447 |
ZFP
TV™ |
VEGF-
turn off;
PEDF:
turn on |
Plasmid DNA encoding DNA-binding protein transcription factors |
Sangamo Biosciences |
DNA |
Age-related “wet” macular degeneration |
Res
|
Reported animal study results showing effectiveness of combined therapy
red more |
|
Product
Type:
Pharmaceutical |
TA:
Orthopedics, dental & surgery
|
|
|
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class of Compound |
Company |
Product Category |
Indication |
R&D Stage |
Message |
|
B
053 |
TruTunnel™ BGS Plug |
|
PolyGraft® polymeric scaffold (polylactide-co-glycolide copolymer + calcium
sulfate) |
OsteoBiologics |
Medical device |
Ligament reconstruction procedures |
Mar-ket |
Announced launch of its bone graft substitute material for ligament
reconstruction procedures
read more |
|
B
055 |
DuraSeal® Sealant |
|
Synthetic absorbable hydrogel with dual syringe applicator |
Confluent Surgical |
Medical device |
Elective pulmonary resection |
CE
mark |
Received CE mark for its Sealant in pulmonary surgery, already approved in
neurosurgery
read more |
|
B
056 |
BioBlanket™ soft tissue repair patch |
|
Resorbable collagen sheet |
Kensey Nash |
Medical device |
Repair of hernias; rotator cuff repair surgery |
Approved |
FDA
approved indications for its surgical mesh, first approval in 2004
read more |
|
B 048 |
Xpanse™ bone insert device |
|
Demineralized bone fiber + cancellous bone chips |
Osteotech |
Medical device |
Orthopedic and reconstructive bone graft procedures |
Approved |
Osteoinductive, -conductive and –conforming device tissue graft to be
introduced
read more |
|
B
048 |
GraftCage™ TLX verte-bral body replacement device |
|
Polymer device |
Osteotech |
Medical device |
Transverse spinal interbody procedures |
510
(k) pending |
To
be introduced at forthcoming meeting
read more |
|
B
052 |
Periowave® photo-dynamic disinfection system |
Laser handpiece |
Photo-sensitive compound |
Ondine Biopharma |
Medical device |
Chronic periodontitis |
Clin
|
Pilot clinical study showed that photodynamic disinfection in addition to
scaling and root planing was superior to scaling and root planing alone
read more |
|
Product
Type:
Pharmaceutical |
Category:
Drug Delivery
|
|
|
|
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class of Compound |
Delivery System |
Company |
Indication |
R&D Stage |
Message |
|
S
298 |
Alvesco®
Ciclesonide inhaled |
Anti-inflammatory |
Inhaled cor-ticosteroide |
Inhaler system |
Sanofi-Aventis & Altana & Tejin |
Moderate to se-vere persistent asthma |
Appr
letter
Mar-ket |
Long
term use of inhaled ciclesonide does not affect the HPA-axis of the
neuroendocrine system
read more |
|
S
290 |
Actiq®
sugar free |
Opioid receptor |
Fentanyl small molecule – sugar-free formulation |
Oral
transmucosal lozenge with handle |
Cephalon |
Breakthrough cancer pain |
Approved |
FDA
approved the sugar-free formulation of Actiq for the same indication
read more |
|
S
292 |
SPD476 |
Anti-inflammatory |
Mesalamine (salicylic acid derivative) |
Multi-Matrix System™ high strength |
Shire Phar-maceuticals |
Mildly to mode-aely active ulcerative colitis |
III |
Once-a-day high-dose formulation of mesalamine was active in induc-ing
remission
read more |
|
S
301 |
Amoxicillin PULSYS |
Antibiotic |
Once-daily amoxillin antibiotic |
Pulsatile delivery technology PULSYS |
Advancis Pharma |
Pharyngitis & tonsilitis in adults and adolescents |
III |
Decided to conduct another phase III trial with 10-d treatment (instead of 7
d) of its frontloaded regimen
read more |
|
136 |
Oral-lyn™
oralin |
Insulin receptor |
Rec
insulin |
Buccal drug delivery with RapidMist spray |
Generex Bio-technology |
Type
1 and 2 diabetes |
II |
Study found similar glucodynamic responses between Oral-lyn and sc Humulin
read more
Approved in Ecuador |
|
S
302 |
Sterile lidocaine patch |
Analgesic |
Lidocaine |
Patch with sustained-release |
Adolor Corp |
Post-surgical incisional pain |
II |
Initiated a phase II study in hernia repair surgery with its sterile
lidocaine patch
read more |
|
S
156 |
Davanat® / 5-FU |
Lectin (protein receptor for Carbosome) |
Poly-saccharide |
Carbosome™ |
Pro-Pharma-ceuticals |
Cholangio-carcinoma 1st line treatment |
I |
Submitted a clinical protocol of a phase II study protocol in
cholan-giocarcinoma; a phase II colorectal cancer study is ongoing
read more |
|
S
287 |
TerbiFoam™ 2 % foam |
Antifungal |
Terbinafine antifungal |
Emollient Foam base |
Foamix |
Tinea pedis (athlete’s foot) |
I |
Announced plan to initiate phase II clinical study after study approval by
EC
read more |
|
Product
Type:
Pharmaceutical |
Category:
Generic
|
|
|
|
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class of Compound |
Company |
Product Category |
Indication |
R&D Stage |
Message |
|
S
299 |
Leflunomide Tbls. |
Dihydro-orotate dehydrogen-ase inhibition |
Generic equivalent to Sanofi-Aventis’ Arava® |
Barr
Therapeutics |
Rheumatoid & immune |
Active rheumatoid arthritis in adults |
ANDAapproved |
Received approval from FDA and plan to launch immediately; US sales of
leflunomide products total US$ 238 mln
read more |
|
S
311 |
Leflunomide Tbls. (Par) |
Dihydro-orotate dehydrogen-ase inhibition |
Generic equivalent to Sanofi-Aventis’ Arava® |
Par Pharma-ceuticals
& Kali Laboratories |
Rheumatoid & immune |
Active rheumatoid arthritis |
ANDAapproved |
Received final approval from FDA; US sales of Arava exceed US$ 200 mln (IMS)
read more |
|
S
305 |
Gabapentin (Ranbaxy) |
|
Generic equivalent to Pfizer’s Neurontin® |
Ranbaxy Pharma-ceuticals |
Neurology & psychiatry |
Postherpetic neuralgia & partial seizures |
ANDA
approved |
Received final approval from
FDA to market gabapentin
read more |
|
S
306 |
Tolterodine tartrate (Ranbaxy) |
Competitive muscarinic receptor antagonism |
Generic equivalent to Pfizer’s Detrol |
Ranbaxy Pharma-ceuticals |
Genito-urinary |
Overactive bladder |
ANDA |
Recived tentative approval from FDA
read more |
|
S
307 |
Metronida-zole
Topical Gel USP 0.75 % (Fougera) |
Antifungal |
Generic equivalent to Galderma’s MetroGel® |
Fougera |
Infectious |
Rosacea |
ANDA |
Received tentative approval from the FDA
read more |
|
S
310 |
Metformin
hydro-chloride ER Tbls.
(Mylan) |
Improves glucose tolerance |
Generic equivalent to BMS’s Gluco-phage® |
Mylan |
Metabolism & endocrine |
Type
2 diabetes |
ANDA |
Received final approval from the FDA; Glucophage sales: US$ 173 mln (IMS)
read more |
|
S
320 |
Metformin hydrochlo-ride XR Tbls. (Impax) |
Improves glucose tolerance |
Generic equivalent to BMS’s Gluco-phage® |
Impax Laboratories |
Metabolism & endocrine |
Type
2 diabetes |
ANDA |
Received final approval from the FDA; Glucophage XR US sales: US$ 23 mln (IMS)
read more |
|
S
316 |
Fexofenadine hydro-chloride (Prasco) |
Histamine H1-receptor antagonism |
Generic equivalent to Sanofi-Aventis Allegra® |
Prasco Laboratories & Sanofi-Aventis |
Pulmonary & respiratory |
Seasonal allergic rhinitis |
ANDA |
Sanof-Aventis signed a distribution and supply agreement with Prasco for its
Allegra as authorized generic fexofenadine
read more |
|
S
319 |
Famotidine Tbls. (Perrigo) |
Histamine H2-receptor antagonism |
Generic equivalent of Merck’s Pepcid® |
The
Perrigo Company |
Gastro-intestinal |
Active duodenal ulcer, benign gastric ulcer and gastroesophage-al reflux
disease |
ANDA |
Received tentative approval from FDA; final approval upon patent expiration
on Sept. 23, 2006
read more |
|
S
323 |
Ribavirin tbls. |
Unclear (nucleoside analog) |
Generic equivalent of Roche’s Copegus® |
Teva
Pharma-ceuticals |
Infectious |
Hepatitis C virus infection in combination with peg-IFN alfa-2a |
ANDA |
FDA
granted tentative approval; copegus has annual sales of approx. US$ 206 mln
read more |
Product
Type: Positive recommendations for Orphan Drug Designations by the COMP* of
the EMEA in September 2005
|
|
ID No. |
Product Name |
Target / Mechanism of
Action |
Class of Compound |
Company / Represen-tative |
Product Category |
Indication |
R&D Stage |
Message |
|
|
Rec
modified vaccinia virus Ankara expressing TB antigen 85A |
Tuberculosis antigen 85A |
Rec
viral vector with TBC antigen 85A plasmid (DNA vaccine) |
University of
Oxford, UK |
Vaccine
|
Prevention of tuberculosis in BCG vaccinated individuals |
|
Based on “insufficient return on investment” criterion |
|
|
|
|
|
Orphix Consulting GmbH |
Small molecule |
Primary malignant bone tumors |
|
Based on “prevalence” criterion |
|
|
|
|
|
The
Mathews Consultancy Ltd. |
Small molecule |
Peripheral T-cell lymphoma |
|
|
|
|
alfimeprase |
|
|
Quadramed |
|
Acute peripheral arterial occlusion |
|
|
|
|
Bacterial lipase |
|
|
Nordmark Arzneimittel GmbH u. Co. KG |
|
Malabsorption due to exocrine pancreatic enzyme insufficieny |
|
|
|
|
Levamisol hydro-chloride |
|
|
ACE
Pharma-ceuticals BV |
|
Nephrotic syndrome |
|
|
|
|
Mannitolum |
|
|
Stricent AB |
|
Cystic fibrosis |
|
|
|
|
Oligonucleo-tide phos-phorothioate |
|
|
Oligovax |
|
Glioma |
|
|
|
|
Peptide 144 |
TGF-beta-1 inhibitor |
Peptide |
Digna Biotech
S.L. |
Peptide
|
Systemic sclerosis |
|
|
|
|
Peptide 144 |
TGF-beta-1 inhibitor |
Peptide |
Digna Biotech
S.L. |
Peptide
|
Localised scleroderma |
|
|
|
|
rec
microbial lipase |
|
Rec
protein |
Solvay Phar-maceuticals |
Protein |
Malabsorption due to exocrine pancreatic enzyme insufficiency |
|
|
|
|
Human
Sta-phylococcus aureus Imm-unoglobulin |
Passive
immunization |
Human plasma
derived Ig |
Nabi
Biophar-maceuticals Europe Ltd. |
Antibody
|
Staphylococcus
aureus bacteremia |
|
|
|
|
Tilarginine
acetate |
|
