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R&D Pipeline News - Therapeutic Edition Sample September 2005

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Part A       

Product Type

Category (click to view)

No. of news

Page

 

Frequent abbreviations

Pharmaceuticals

Cardiovascular & blood

7

3

 

Ol

Open-label

 

Dermatology

3

4

 

Rx

Randomized

 

Gastrointestinal

4

5

 

Db

Double-blind

 

Infectious & toxicology

8

6

 

Pc

Placebo-controlled

 

Metabolism & endocrine

4

7

 

Co

Cross-over

 

Neurology & psychiatry

15

7

 

Pts

Patients

 

Oncology

24

10

 

PK

Pharmacokinetic

 

Opthalmology

2

13

 

PD

Pharmacodynamic

 

Orthopedics, dental & surgery

6

14

 

PoC

Proof-of-concept

 

 

 

 

 

BLA

Biologics License Agreement

 

Drug Delivery

8

15

 

NCE

New chemical entity

 

Generics

 

10

16

 

GRAS

Generally recognized as safe

 Part B

Orphan Drug Recommendations & Designations in Europe

 

26

18

 

HDE

Humanitarian device exemption

Antibody Pipeline Chugai / Genentech / Roche

23

22

 

IDE

Investigational device exemption

Technology & BioManufacturing Sites

 

5

28

 

NDA

New drug application

R&D Collaborations

8

29

 

MAA

Marketing authorization application

R&D Licensing Agreements

 

3

30

 

SPA

Special protocol assessment

 

Product Type:  Pharmaceutical

TA: Cardiovascular & blood

 

 

 

 

 

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

 

 

 

 

 

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

 

Product Type:  Pharmaceutical

TA: Gastrointestinal

 

 

 

 

 

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

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action