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R&D Pipeline News - Technology Edition Sample September 2005

Return to introduction ~ Request a 3 week FREE trial ~ Purchase
 

Part A                                                                                            

Product Type

Category

No. of news

Page

 

Frequent abbreviations

Pharmaceuticals

Small molecule

36

3

 

Ol

Open-label

 

Antibody

5

9

 

Rx

Randomized

 

Protein

6

10

 

Db

Double-blind

 

Peptide

5

11

 

Pc

Placebo-controlled

 

RNA

5

12

 

Pts

Patients

 

DNA

2

13

 

PK

Pharmacokinetic

 

Cells

5

14

 

PD

Pharmacodynamic

 

Vaccine

5

15

 

PoC

Proof-of-concept

 

Natural Source

3

16

 

NCE

New chemical entity

 

Generics

5

17

 

Co

Cross-over

 

Drug Delivery 

8

18

 

GRAS

Generally recognized as safe

Radiotherapy & Radiopharmaceuticals 

2

19

 

NDI

New dietary ingredient

NutraCeuticals, Dietary Supplements & Cosmeceuticals 

-

-

 

ANDA

Abbreviated new drug application

Biomaterials, Medical Devices, Combination & NanoTechnology Products 

7

20

 

BLA

Biologics License Application

 Part B

Company Profiles 

-

 

 

IDE

Investigational device exemption

Technology & BioManufacturing Sites 

6

21

 

NDA

New drug application

R&D Collaborations

6

22

 

MAA

Marketing authorization application

R&D Licensing Agreements 

7

23

 

SPA

Special protocol assessment

 

Product Type:  Pharmaceutical

Category:  Small molecule

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

S 333

Aliskiren;

SPP100

Renin inhibition

Oral small molecule

Novartis & Speedel

Cardio-vascular & renal

Hypertension: monotherapy;

combination

 

III

II

Released positive phase III results from monotherapy and HCTZ-combination studies and plan filing in 2006 HTUread moreUTH

S 346

MC-1

Purinergic receptor agonist

Naturally occurring small molecule

Medicure

Cardio-vascular

Prevention of cardio- + cerebrovascular events after PCI, CABG and ACS

II/III

FDA granted Fast Track Designation HTUread moreUTH

S 046

ISA247

Immuno-suppressive

Trans-isomer of cyclospo-rine analog

Isotechnika

Dermatology

Stable moderate to severe psoriasis

III

Announced that phase III study met all primary and secondary endpoints HTUread moreUTH

S 348

Aplaviroc;

GW873140; ONO-4128

CCR5 chemokine antagonism

Oral small molecule

GSK

Infectious

Treatment naive HIV

 

Treatment experienced HIV

II

 

 

III

GSK halted all clinical trials with the CCR5 inhibitor after two pts developed severe liver toxicity in the phase II study HTUread moreUTH

S 343

Vildagliptin

LAF237

DPP-IV inhibition

Oral small molecule

Novartis

Metabolism & endocrine

Type 2 diabetes

III

New study results show sustained efficacy (after 12 wks) in lowering HbA1c and excellent tolerability without weight gain; plans to file in 2006 HTUread moreUTH

S 331

Parecoxib

COX-2 selective antagonism

Non-narcotic injectable small molecule

Pfizer

Neurology & psychiatry & pain

Acute pain in post-surgical setting

NDA

Received non-approvable letter from FDA for parecoxib which is approved in many countries and marketed in the EU as Dynastat HTUread moreUTH

S 191

Neurodex;

AVP 923

NMDA R antagonism + sigma-1 agonism

Combination of dextro-methorphan + quinidine sulfate

Avanir

Neurology & psychiatry

Pseudobulbar affect

NDA

FDA requested more analyses to better support the electronic data submission guideline HTUread moreUTH

S 010

Phenserine tartrate

Acetycholin-esterase synthesis of beta-amyloid

Small molecule

Axonyx

Neurology & psychiatry

Mild to moderate Alzheimer’s disease

III

12-wk treatment did not achieve significant improvement over placebo as measured by scales HTUread moreUTH

S 335

Silenor™

Doxepin hydro-chloride

Presumably via influence on adrenergic activity

Oral small molecule (tricyclic compound)

Somaxon Pharma-ceuticals

Neurology & psychiatry

Sleep maintenance insomnia

III

Announced that enrollment has begun in the second phase III trial with 3-mth dosing HTUread moreUTH

S 351

ACP-104

Partial ago-nism of D2 + D3 dopamine R, muscarinic M1 agonism, 5-HT2A inver-se agoninsm

Small molecule (major metabolite of clozapine)

Acadia Pharma-ceuticals

Neurology & psychiatry

Schizophrenia

II

Published results of preclinical investigation in the JPET about molecular mechanisms of new schizophrenia drug candidate HTUread moreUTH

S 080

arimoclomol

Induces heat shock protein expression

Oral small molecule: L-hydroxylamine derivative

CytRx

Neurology & psychiatry

Amyotrophic lateral sclerosis (Lou-Gehrig’s diseaes)

II

Initiated phase II study which plans to enroll n=80 pts in the db, pc study in the US to evaluate safety and tolerability HTUread moreUTH

S 352

NG2-73

GABA-A receptor modulation

Oral small molecule

Neurogen

Neurology & psychiatry

Insomnia

I

Induction of deep sleep was “dose-limiting” effect in phase I trial with healthy volunteers, single doess of drug were well tolerated HTUread moreUTH

S 034

Flurizan; MCP-7869

Selective amyloid beta lowering (Abeta42 inhibition)

Oral small molecule (R-enantiomer of flurbiprofen)

Myriad Genetics

Neurology & psychiatry

Mild Alzheimer’s disease

III

Follow-on study results suggest that pts appear to stabilize from months 12 to 15 with continued medication HTUread moreUTH

S 116

Taxotere®

docetaxel

Tubulin

Semisyn-thetic small molecule

Sanofi-Aventis

Oncology

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 HTUread moreUTH

S 296

Xinlay™ atrasentan

Selective endothelin A receptor antagonism

Oral small molecule

Abbott

Oncology

Hormone-refractory prostate cancer with bone metastases

NDA

HTUread briefing docsUTH

FDA Advisory Committee did not recommend the drug for approval, phase III study with earlier stage HRPC is ongoing HTUread moreUTH

S 285

Sorafenib; BAY43-9006

Multi-kinase: RAF, VEGF-R2, VEGF-R3, KIT, FLT-3, RET

Oral small molecule inhibitor

Bayer & Onyx

Oncology

Advanced renal cell carcinoma

MAA;

 

 

NDA

Bayer submitted to the EMEA a MAA for sorafenib in kidney cancer HTUread moreUTH

FDA accepted submission and granted priority review HTUread moreUTH

S 309

Arranon® nelarabine

injection

DNA synthesis inhibition (cytotoxic)

Small mole-cule chemo-therapeutic, a prodrug of ara-G (arabinosid)

GSK

Oncology

Refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma

NDA

FDA Oncology Advisory Committee recommended accelerated approval of Arranon pediatric pts HTUread moreUTH

S 61

Tarceva;

erlotinib

EGF-R1 tyrosine kinase

Oral small molecule

OSI Pharma-ceuticals

Oncology

Treatment naive advanced pancreatic cancer + gemcitabine

sNDA

HTUbriefing docsUTH were published; FDA staff question new use of Tarceva  HTUread moreUTH; FDA Oncology Drug Advisory Committee recommended approval of pancreatic cancer label HTUread moreUTH 

S 61

Tarceva;

erlotinib

EGF-R1 tyrosine kinase

Oral small molecule

OSI Pharma-ceuticals & Roche

Oncology

Advanced non-small cell lung cancer (NSCLC)

Approved

Roche received approval from the European Commission to market the drug in the EU HTUread moreUTH

S 334

Arimidex®

anastrozole

Aromatase inhibition

Small molecule

AstraZeneca

Oncology

Adjuvant treat-ment of hormo-ne-receptor positive early breast cancer in postmenopausal women

Approved

Gained full approval from FDA for its aromatase inhibitor, the only with 5-yr full data set and superior disease free survival over tamoxifen, holds accelerated approval since September 2002 HTUread moreUTH

S 252

Acapodene® toremifene citrate

Selective estrogen receptor modulation

Small molecule

GTx

Oncology

High grade prostatic intraepithelial neoplasia (PIN)

III

Received FDA response under SPA protocol on design of phase III trials HTUread moreUTH

S 61

Tarceva;

erlotinib

EGF-R1 tyrosine kinase

Oral small molecule

OSI Pharma-ceuticals & Roche

Oncology

First line treatment of advanced NSCLC

II

Uncontrolled phase II study in elderly pts reveiled benefits of Tarceva as first line treatment in NSCLC pts > 70 yrs HTUread moreUTH

S 128

Combre-statin A4 phoshate, CA4P

Microtubules

Synthetic drug derived from root bark of Combretum caffrum tree

Oxigene

Oncology

Advanced, relapsed, platinum-resistant ovarian cancer in triple combination

II

Initiated phase II triple combination therapy with carboplatin and paclitaxel HTUread moreUTH

S 347

Teverelix LA (long acting)

Gonadotropin-releasing hormone antagonism

Small molecule

Ardana

Oncology

Prostate cancer and benign prostate hyperplasia

II

Reported acceleration of clinical development by 2 yrs after pre-IND meeting with FDA; launch now planned for 2010 HTUread moreUTH

S 332

cloretazine® 

DNA-alkylation

Small molecule

Vion Pharma-ceuticals

Oncology

Advanced small cell lung cancer

II

Initiated phase II clinical study to determine the response rate and toxicity in up to n=90 pts HTUread moreUTH

353

Perifosine

Signal trans-duction (AKT, MAPK, JNK) inhibition

Oral small molecule

Aeterna Zentaris & Keryx Biophar-maceuticals

Oncology

NSCLC in combination with radiotherapy

II

Initiated an European exploratory phase II study in n=160 pts with once daily dosing HTUread moreUTH

S 015

Cloretazine;

VNP40101M

DNA alkylation; AGT + GST inhibition

Sulfonyl hydrazine prodrug

Vion Pharma-ceuticals

Oncology

Relapsed SCLC

II

Started phase II trial in up to n=90 pts HTUread moreUTH

S 354

RP101; INOC001;

 

STAT3 and APEX down-regulation

“well known antiviral drug for herpes zoster”

Avantogen & Innovate (from RESprotect)

Oncology

Pancreatic cancer in combination with standard chemotherapy

II

Reported survival results from extended observation of pts from clinical study: median survival of 447 d which is higher than historical controls HTUread moreUTH

S 340

XL844

Chk1 and 2 protein kinases

Oral small molecule

Exelixis

Oncology

CLL

I

Initiated phase I clinical trial to study safety, tolerability and PK profile HTUread moreUTH

S 341

XL184

Hepatocyte growth factor receptor (Met) + VEGF-R2 + other RTKs

Oral small molecule

Exelixis

Oncology

Solid tumors

I

Initiated phase I clinical trial to study safety, tolerability and PK profile HTUread moreUTH

S 338

Trp-p8 agonists

Trp-p8 trans-membrane ion channel

Oral small molecules

Dendreon & Genentech

Oncology

Tumors

Leads

Identified several lead candidates which were effective in animal models HTUread moreUTH

344

Visudyne®

verteporfin

Oxygen radicals generated after laser light activation

Small molecule in photo-dynamic therapy setting

QLT Inc & Novartis Ophthtalmics

Ophthal-mology

Wet AMD with predominantly occult neo-vascularization

Mar-ket

Primary endpoint not achieved after 2 yr follow up in clinical study HTUread moreUTH

S 339

Lomucin™

talniflumate

hCLCA1 chloride channel blocking

Small molecule

Genaera

Pulmonary

Cystic fibrosis

II

Started phase II trial with support of the CF Foundation Therapeutics in n=200 pts over 1 yr HTUread moreUTH

S 342

Indacaterol

QAB149

Beta2-receptor agonism

Oral small molecule

Novartis

Pulmonary

Asthma and chronic obstructive pulmonary disease

II

Study results show that once-daily indacaterol is effective over 24 h and well tolerated HTUread moreUTH

S 350

Altace®

ramipril

Angiotensin converting enzyme inhibition

Oral small molecule

King Pharmaceutical & Wyeth

Renal

Delay of progreesion of chronic kidney disease in hypertensive, non-diabetic pts

sNDA

FDA accepted a supplemental NDA filing for new indication of the ACE inhibitor HTUread moreUTH

S 098

XL784

ADAM-10 matrixmetalloproteinase

Oral small molecule

Exelixis

Renal

Renal failure

I

A repeat dose phase I study has been initiated in healthy volunteers HTUread moreUTH

 

R&D Pipeline News - Technology Edition Sample September 2005

Return to introduction ~ Request a 3 week FREE trial ~ Purchase

 

Product Type:  Pharmaceutical

Category:  Antibody

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

318

Tysabri / antegren;

natalizumab

Alpha4 / beta1/7 integrin

Rec humanized mab

Elan & Biogen Idec

Neurology / gastro-intestinal

Multiple sclerosis

 

Crohn’s disease

Off mar-ket

Expect to complete the safety evaulation in a few weeks and to file a sBLA for Tysabri in multiple sclerosis HTUread moreUTH

071

Eculizumab ;

H5G1.1

Complement C5

Rec humanized full mab

Alexion Pharma-ceuticals

Cardio-vascular & blood

Paroxysmal nocturnal hemoglobinuria

III

Completed enrollment of the phase III trial with n=95 in the orphan drug indication HTUread moreUTH

460

Avastin®

Bevacizumab

R435

VEGF

Rec humanized mab

Genentech & Roche

Oncology

Platinum-refractory ovarian cancer

II

Discontinued enrollment of a phase II study due to occurrence of 5 cases of gastrointestinal perforation in the first 44 pts HTUread moreUTH

117

Altastaph™

Capsular polysaccharides from S. Aureus types 5+8

Purified immunoglobulin from humans immunized with StaphVAX®

Nabi Biopharma-ceuticals

Infectious

S aureus infections in very low birth weight infants & hospitalized adults

II

Received a favorable opinion from the COMP of the EMEA for desi-gnation as orphan drug in treatment of Staphylococcus aureus bacteremia HTUread moreUTH

467

Proxinium™

VB-845

EpCAM

immunotoxinscFv + pseu-domonas exotoxin

Viventia Biotech

Oncology

Recurrent, refractory head & neck cancer

Pre II

Received FDA clearance to start phase II trial HTUread moreUTH

 

Product Type:  Pharmaceutical

Category:  Protein

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

009

Increlex rhIGF1

IGF1 receptor

Rec human insulin growth factor 1

Tercica

Metabolism & endocrine

Severe primary
IGF1 deficiency

Mar-ket

Presented results of 6 children treated until they have received adult height (gaining 16 cm); and further biochemical and PK data  HTUread moreUTH

330

Procrit®

Epoetin alfa

Erythropoietin receptor

Rec hu ery-thropoietin

Ortho Biotech

Oncology

Chemotherapy-induced anemia

Mar-ket

Procrit® was superior to Aranesp® in increasing hemoglobin after 4 wks of treatment with standard doses HTUread moreUTH

474

MM-093

AFP receptor

Rec hu alpha fetoprotein produced in transgenic goats

Merrimack Pharmaceuticals

Rheumatoid

Rheumatoid arthritis

II

Contracted out further manufacturing to GTC Biotherapeutics, ongoing pilot phase II study HTUread moreUTH

481

rEV131

Immuno-suppressive via histamine receptor

Recombinant tick protein

Evolutec

Pulmonary & respiratory

Allergic rhinitis (hay fever)

II

The intranasally administered protein achieved its primary endpoint of symptoms scores in a n=112 pts study HTUread moreUTH

483

V10153

Thrombin

Modified rec human plasminogen

Vernalis

Neurology & psychiatry

Acute ischemic stroke

II

Currently being studied in stroke pts; signed process development and manufacturing agreement for phase III material with Diosynth Biotechnology HTUread moreUTH

476

sPHEX Metallo peptidase

Enzyme substitution

Rec enzyme

Enobia

Metabolism & endocrine

X-linked hypophosphatemia

Precl

Contracted out process development and cGMP batch manufacturing for phase I study scheduled for Q3/06 HTUread moreUTH

 

Product Type:  Pharmaceutical

Category:  Peptide

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

048

Chrysalin®

TP508

High-affinity thrombin receptor

23-aa synthetic peptide

OrthoLogic

Metabolism & endocrine

Bone fracture repair

III

Preclinical study showed neovas-cularization effects in support of bone repair and growth HTUread moreUTH

150

Xerecept®;

Corticorelin acetate

Corticotropin release

Synthetic human CRF peptide

Neurobiological Technologies & Celtic Pharma

Oncology

Peritumoral brain edema

III

Celtic Pharma acquired ww licen-sing rights for Xerecept HTUread moreUTH

008

Hematide™

Erythropoietin receptor

Synthetic pegylated peptide

Affymax

Renal

Chronic kidney disease with pts not on dialysis

II

Initiated third phase II study in  Europe with sc injection to evaluate safety, PD and PK HTUread moreUTH

469

PCK3145

Survival mechanism: signal transduction inhibition

Synthetic 15-mer peptide from PSP94

Procyon Biopharma

Oncology

Advanced prostate cancer

IIa

Filed IND to start clinical phase II development in USA following prior clinical experience abroad and published various preclinical papers on mechanism of action HTUread moreUTH

206

LAB CGRP

CGRP receptor

37 aa neuro-peptide (calcitonin gene related peptide)

LAB International

Pulmonary

Asthma

I

Completed phase I trial in healthy volunteers with inhalation of siingle ascending doses; showed safety and tolerability HTUread moreUTH

   

Product Type:  Pharmaceutical

Category:  RNA

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

029

Genasense®

Oblimersen sodium

Bcl-2

Antisense oligo-nucleotide

Genta

Oncology

Relapsed/refrac-tory CLL + chemotherapy

NDA

Announced results from extended follow-up of phase III pts showing longer remission duration and less relapse HTUread moreUTH

303

Isis 301012

apoB-100

2PndP generation antisense

Isis Pharma-ceuticals

Metabolism

High cholesterol

II

Initiated phase II development and plans to start with optimization of dose and frequency of dosing HTUread moreUTH

475

ARC183

Direct thrombin inhibition

Aptamer

Archemix & Nuvelo

Cardio-vascular

Acute cardiovascular settings

I

Clinical results showed sub-optimal dosing profiles due to amounts needed; project terminated in favor of 2PndP generation molecule HTUread moreUTH

135

AEG35156

Inhibition of X-linked inhibitor of apoptosis protein (XIAP)

2PndP generation antisense

Aegera Therapeutics

Oncology

Solid tumors in combination with docetaxel

I

Announced start of second phase I trial of XIAP antisense in combination with docetaxel HTUread moreUTH

473

ALN-RSV01

RSV

RNAi intranasal

Alnylam Phar-maceuticals

Infectious

RSV infection

Precl

Expects to file IND by end of 2005; dropped its ALN-VEG01 project in AMD due to competitive reasons HTUread moreUTH

  

Product Type:  Pharmaceutical

Category:  DNA

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

477

CERE-120

Neurturin (NTN)

NTN gene via AAV type 2 vector

Ceregene

Neurology

Parkinson’s disease

I

Initiated patient treatment in the phase I study with NTN gene therapy to maintain survival of dopamine producing nerve cells HTUread moreUTH

478

CERE-100; AAV-NGF

NGF

NGF gene via AAV vector

Ceregene

Neurology

Alzheimer’s disease

I

Recently completed enrollment in phase I study in Chicago HTUread moreUTH

  

Product Type:  Pharmaceutical

Category:  Cells

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

325

CB001

Transplantation of stem cells

Cord blood stem cells

ViaCell

Oncology

Hematopoietic stem cell transplantation in cancer

I

Suspended enrollment into clinical study due to acute graft-versus-host disease grade IV in 2/8 pts HTUread moreUTH and HTUeven moreUTH

472

CVA 21 virus

Oncolytic action of virus

Oncolytic Coxsackie-virus produced in rec cell line

Psiron

Oncology

Melanoma stage IV

I

Announced delay in clinical study completion due to supply problems and changes in the production cell line of the virus; material from the new cell line will be used for further phase I studies HTUread moreUTH

470

HuCNS-SC

Regeneration

Human fetal neural stem cells

StemCells

Neurology & psychiatry

Batten disease (neuronal ceroid lipofuscinosis)

IND

Phase I trial on hold since Feb 2005; company filed an amendment of its initial IND HTUread moreUTH

406

Adult mes-enchymal precursor cells

Tissue regeneration

Adult mes-enchymal precursor cells (aMPC)

Mesoblast Ltd

Orthopedic

Non-union or long bone fractures

Ethics comm approval

Received approval from Ethics Committee to study stem cell treatment in up to 10 pts HTUread moreUTH

482

ReN001

Tissue repair and regeneration

c-mycER technology based genetically stable neural stem cells

ReNeuron

Neurology & psychiatry

Chronic disability after stroke

Pre-IND

Held pre-IND meeeting and based upon agreed preclinical develop-ment program expects to file IND by mid 2006 HTUread moreUTH 

  

Product Type:  Pharmaceutical

Category:  Vaccine

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

471

Hexavac

Active immunization

Combination of 6 existing vaccines

Sanofi-Aventis

Infectious

Prevention of diphtheria, teta-nus, whooping cough, hepatitis B, polio and haemophilus influenzae  B

Mar-ket

EMEA suspended sales of Hexavac due to concerns on efficacy of the vaccine ragarding hepatitis B immunogenicity possibly related to manufacturing changes performed at Merck HTUread moreUTH and HTUread FaQsUTH

047

FluMist® CAIV-T; influenza vaccine live, intranasal

Active immunization with influenza virus

Cold adapted live influenza vaccine, trivalent

MedImmune

Infectious

Prevention of influenza in healthy individuals 5-49 yrs of age

sBLA

Submitted sBLA for its refrigerator-stable formulation HTUread moreUTH

480

Proquad

 

Combination of vaccines

Sanofi-Pasteur

Infectious

Measle, mumps, rubella, varicella

MAA

The CHMP of the EMEA adopted a positive opinion on Proquad HTUread moreUTH

190

StaphVax®

Outer coating polysaccharide of Staph aureus types 5+8

S. aureus polysaccharide linked to large carrier molecule

Nabi Biopharma-ceuticals

Infectious

Pts at high chronic risk for Staph. Aureus infection, e.g. ESRD

III

Initiated repeat dose clinicl study in high chronic risk pts HTUread moreUTH

079

L-BLP25

MUC1

Liposomal synthetic peptide vaccine

Biomira & Merck KGaA

Oncology

Advanced NSCLC

IIb

Paper on phase IIb study was published in J Clin Oncol HTUread moreUTH; announced delay in start of phase III study due to accelerated stability problems HTUread moreUTH

  

R&D Pipeline News - Technology Edition Sample September 2005

Return to introduction ~ Request a 3 week FREE trial ~ Purchase

 

Product Type:  Pharmaceutical

Category:  Natural Source

 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

468

Hyalgan®

hyaluronate

Substitution of hyaluronic acid/hyaluronate

HMW fraction of purified hyaluronate form rooster combs

Sanofi-Aventis

Metabolism

Pain due to osetoerthritis (knee)

sPMA

FDA accepted filing of supplemental Pre-Market Approval application to include shoulder pain due to osteoarthritis HTUread moreUTH

207

Miraxion®;

LAX-101

Phospholipase A2 and caspases

Semi-syn-thetic highly purified eico-sapentaenoic acid (EPA)

Amarin

Neurology & psychiatry

Huntington’s disease

III

Announced patient enrollment and fist patient dosing in the US phase III trial conducted under SPA by the FDA HTUread moreUTH

485

Betulinol derivative

Cell division

Derivative from outer layer of the bark of the white birch tree

Marc Pharma-ceuticals

Oncology

Prostate cancer

Res-earch

Water soluble drug candidate slowed prostate tumor progression in mice by influencing tumor cell division HTUread moreUTH

  

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 355

SMT

Sulfameth-oxazole + trimetoprim

antibiotic

Generic equivalent of Bactrim®

Interpharm Holdings

Small molecule

Urinary tract infections, bronchitis, otitis, traveler’s diarrhea et al.

Mar-ket

Announced the launch of the generic antibiotic HTUread moreUTH

S 326

Tretinoin cream USP, 0.05 %

Unclear (retinoid irritation)

Generic equivalent of J&J’s Renova®

Spear Pharma-ceuticals

Small molecule

Mitigation of fine wrinkles, mottl-ed hyperpigmen-tation, tactile roughness of facial skin

ANDA

Received approval on Sept 15, is looking for strategic alternatives in commercializing the cosmetic product HTUread moreUTH

S 330

Ziduvidine Tbls. USP 300 mg

HIV reverse transcriptase inhibition

Generic equivalent to GSK’s Retrovir®

Ranbaxy Laboratories

Small molecule

Treatment of HIV infection

ANDA

Received approval from FDA to market the generic antiretroviral AZT agent with a total oral zidovudine market of US$ 34 mln. HTUread moreUTH

S 336

Ziduvidine Tbls. and oral solution

HIV reverse transcriptase inhibition

Generic equivalent to GSK’s Retrovir®

Aurobindo Pharma (India)

Small molecule

Treatment of HIV infection

ANDA

Received approval from FDA to market the generic antiretroviral HTUread moreUTH

S 337

Ziduvidine Tbls.

HIV reverse transcriptase inhibition

Generic equivalent to GSK’s Retrovir®

Roxane Laboratories

Small molecule

Treatment of HIV infection

ANDA

Received approval from FDA to market the generic antiretroviral HTUread moreUTH

  

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 345

Vivitrex® naltrexone long-acting injection

Opioid receptor

Small molecule

ER Medisorb technology with polylacti-de co-glycolide microspheres

Cephalon & Alkermes

Alcohol dependence

NDA

FDA notifed about extension of action date by 90 days HTUread moreUTH

S 349

Symbicort®

budesonide + formoterol

Corticosteroid receptor + beta 2 recep-tor agonism

Combination of inhaled budesonide + formoterol

Dry powder inhaler device Turbuhaler®

AstraZeneca

Maintenance treatment of asthma

NDA

Submitted an NDA to the FDA based on 27 clinical trials HTUread moreUTH

354

Junovan™ L-MTP-PE;

MEPACT

Macrophage targeting and activation

Synthetic tripeptide derived from muramyl dipeptide

Liposomal formulation

IDM Pharma

High-grade, non-metastatic osteosarcoma

III

Produced first lot of commercial production process via CMOs which appears to be comparable with previous phase III material HTUread moreUTH

S 328

SABER™-Bupivacaine

Blocks gener-ation and con-duction of ne- rve impulses

Amino amid class of local anesthetics

SABER™-depot injectable DD technology

Durect Corp

Post-operative pain relief

II

Completed dosing in last cohort of phase II study in hernia pts with local administration HTUread moreUTH

352

PYY 3-36

Appetite regulation

Hormone peptide

Intranasal with spray

Nastech Pharmaceutical

Obesity

II

Announced publication in J Obesity about preclinical study results showing PoC in weight reduction HTUread moreUTH

484

IFN-alpha-XL

IFN-alpha 2b receptor

Rec interferon alpha 2b

Medusa® nanoparticle technology

Flamel Bio-technologies

Chronic hepatitis C virus infection

I/II

Phase I/II results show safety, tolerability and long-acting activity HTUread moreUTH

S 329

Zolmitriptan +

Actyve™

Selective 5-hydroxytryptamine 1B/1D receptor agonism

Zolmitriptan (NCE)

Actyve™ transdermal iontophoretic delivery

Vyteris

Migraine

I

Showed clinical PoC of its transdermal iontophoretic delivery in comparison with oral zolmitriptan HTUread moreUTH

S 327

Oral heparin capsule

Indirect thrombin inhibition

Heparin

Eligen® oral DD technology with carriers

Emisphere Technologies

Anticoagulation

Clin

Completed dosing in a trial comparing oral heparin with iv and sc heparin HTUread moreUTH

 


Product Type:  Radiotherapy & Radiopharmaceuticals 

 

 

 

 

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company

Therapeutic Area

Indication

R&D Stage

Message

X 005

Y-90

Yttrium 90 sterile solution

radiation

Isotope

MDS Nordion

Oncology

NHL

Mar-ket

MDS Nordion will supply Berlex Canada with sterile Yttrium 90 to be used for its radioimmunotherapy with Zevalin

479

P131PI-labeled Labetuzu-mab

CEA

P131PI-radio-labeled rec humanized mab

Immuno-medics

Oncology

Colorectal cancer

II

Results of a 5-yr follow up study with n=23 pts were published in the J Clin Oncol showing twice as long survival as historical and con-temporaneous controls HTUread moreUTH

  

Product Type:  Biomaterials, Medical Devices, Combination & NanoTechnology Products