Non-specialty pipeline forecast 2Q08

[chantell.reagan]

NOTE: This forecast is updated on a monthly basis, please check Non-Specialty Drug Pipeline by Month for the latest forecast post.

3Q08:
Effient (prasugrel) by Daiichi Sankyo/Lilly; data released in 2007, NDA filed 1/08; expected launch 2-3Q08
•Class/MOA: antiplatelet agent
•Use: treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI), including coronary stenting
•Dosage form: oral
•Link to press release:

1. Lilly press release 1/08

•Link to clinicaltrials.gov:

1. Trials registered with NIH

4Q08:
Viviant (bazedoxifene) by Wyeth/Ligand; expected FDA advisory committee to review the pending NDAs for both the treatment and prevention for postmenopausal osteoporosis in 4Q08; received approvable letter 5/08
•Class/MOA: selective estrogen receptor modulator (SERM)
•Use: prevention/treatment of postmenopausal osteoporosis
•Dosage form: oral
•Link to press release:

o Ligand Pharmaceuticals press release 5/08

oNews article 5/08

•Link to clinicaltrials.gov:

o Phase III trial evaluating use in osteoporosis
o Phase III trial evaluating prevention of PMO in women

Intuniv (guanfacine) by Shire; approvable letter received from the FDA in 6/07, requiring additional information; launch is expected in 2008
•Class/MOA: targeting alpha-2A-receptors in the prefrontal cortex (non-stimulant)
•Use: monotherapy for the treatment of ADHD symptoms throughout the day in children aged 6 to 17 years
•Dosage form: oral extended release tablet
•Link to news article:

1. News release 6/07

•Link to clinicaltrials.gov:

1. Phase III trial in ADHD + oppositional symptoms

Milnacipran by Forest; Phase III trials; NDA filing 2/08, expected decision 10/08
•Class/MOA:SNRI (dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin)
•Use:fibromyalgia syndrome
•Dosage form: oral
•Link to press release:

1. Forest press release 2/08

•Link to clinicaltrials.gov:

1. Trials registered with NIH

2009:

Aclidinium by Forest; currently in Phase III trials with expected NDA submission 2008
•Class/MOA: anticholinergic bronchodilator
•Use: COPD
•Dosage form: dry powder inhalation for once a day use
•Link to press release:

1. Forest press release 9/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Amibegron (SR58611A) by sanofi-aventis; Phase III; 2008 filing based on MDD trial outcome
•Class/MOA: beta3-adrenoceptor agonist
•Use: anxiety and depressive disorders
•Dosage form: oral
•Link to press release:

1. sanofi-aventis press release 9/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Byetta LAR (exenatide) by Amylin; Phase III; NDA filing in 2008; expected to hit the market in 2009
•Class/MOA: incretin mimetic
•Use: diabetes
•Dosage form: SQ once weekly injection
•Link to press release:

1. Amylin pipeline 2006

•Link to published study:

1. Diabetes Care.2007;30:1487-93.

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Cordaptive (MK-0524A) (combination of niacin + laropiprant) by Merck; NDA filed 8/07; received non-approvable letter from the FDA in 4/08 (rejected name of Cordaptive, will pursue Tredaptive)
•Class/MOA: extended release niacin/selective flushing pathway inhibitor, DP-1 selective antagonist
•Use: dyslipidemia
•Dosage form: oral
•Link to news article:

1. News article 4/08

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Indacaterol by Novartis; NDA filing in 2008; Schering-Plough and Novartis collaborate on combination with mometasone
•Class/MOA: 24 hour ultra-long acting bega agonist (uLABA)
•Uses: COPD and asthma
•Dosage form: inhaler
•Link to press release:

o Novartis press release 9/05
o Novartis press release 8/06

•Link to clinicaltrials.gov:

oTrials registered with NIH

Liraglutide (NN2211) by Novo Nordisk; Phase III results expected 2Q08, w/ NDA filing in 1H08
Once daily dosing similar to byetta
•Class/MOA: once-daily dose of human GLP-1 analogue
•Use: Type 2 diabetes
•Dosage form: SQ injection
•Link to press release:

1. NovoNordisk press release 2008
2. NovoNordisk press release 6/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

NasalFent (fentanyl nasal spray) by Archimedes; currently in Phase III; expected launch in 2009
•Class/MOA: opiod analgesic
•Use: cancer pain
•Dosage form: nasal spray
•Links to press release:

1. Archimedes 2/08

•Link to clinicaltrials.gov:

1. Phase III treatment of breakthrough cancer pain in patients taking regular opioids

Prevacid (OTC) by TAP/Novartis; expected launch in 2009
•Class/MOA: PPI
•Use: heartburn
•Dosage form: oral
•Link to news article:

1. News article 2/06

Rivaroxaban by J&J/Bayer; in progress with Phase III trials being compared to enoxaparin; NDA filing in 2008 for prevention of VTE in orthopedic surgery
•Class/MOA:direct Factor Xa inhibitor
•Use: prevention and treatment of blood clots; prevention of VTE in orthopedic surgery
•Dosage form: oral tablet
•Link to press release:

1. Bayer press release 8/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Saredutant by sanofi-aventis; 4 Phase III trials with mixed results; expected NDA submission for major depressive disorder in 2008
•Class/MOA: NK2 receptor antagonist
•Use: major depressive disorders and general anxiety disorders
•Dosage form: oral
•Link to press release:

1. sanofi-aventis press release 9/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Saxagliptin by BMS/AstraZeneca; currently in Phase III; NDA filing expected in 1H08
•Class/MOA: dipeptidyl-peptidase-4 (DPP-4) inhibitor
•Use: Type 2 diabetes
•Dosage form: oral
•Link to press release:

1. AstraZeneca press release 6/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Singulair/Claritin by Schering-Plough/Merck; NDA filed in 8/07; received non-approvable letter from FDA in 4/08
•Class/MOA: leukotriene antagonist/Non-sedating antihistamine combination
•Use: Treatment of asthma and allergy symptoms
•Dosage form: oral
•Link to news article:

1. News article 4/08

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Sufentanil (EN 3720) by Endo; in Phase II; filing 2008
•Class/MOA: opioid analgesic
•Use: Moderate-to-severe chronic pain for up to seven days
•Dosage form: transdermal patch
•Links to press release:

1. Endo products in development 2008

•Links to clinicaltrials.gov:

1. Phase II open label, safety study in severe non-malignant chronic pain

Taranabant (MK-0364) by Merck; NDA in 2008
•Class/MOA: cannabinoid-1 receptor (CB1R) blocker
•Use: Obesity
•Dosage form: oral
•Link to press release:

1. Merck press release 3/08

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Transacin (synthetic capsaicin) by NeurogesX; currently in Phase III trials; filing 2H08
•Use: pain, HIV neuropathy
•Dosage form: dermal patch
•Link to press release:

1. NeurogesX press release 9/06

•Link to clinicaltrials.gov:

1. Phase III trial for treatment of painful HIV neuropathy

TriLipix (ABT-335) by Abbott; Phase III, NDA filing submitted
•Class/MOA: fenofibric acid molecule
•Use: treating LDL, HDL cholesterol, and triglycerides as monotherapy and in combination
•Dosage form: oral
•Link to press release:

1. Abbott press release 3/08

•Link to clinicaltrials.gov:

1. Trials registered with NIH

LONG-TERM PIPELINE:

Women's Health:
Aprela (bazedoxifene/conjugated estrogen) by Wyeth/Ligand; 4Q07 meeting with FDA to review the Phase III clinical trial results with expectation for NDA filing 1H09
•Class/MOA: First SERM/conjugated estrogen combination
•Use: treatment of vasomotor symptoms, vaginal atrophy and prevention of osteoporosis
•Dosage form: oral
•Link to news article:

o Ligand Pharmaceuticals press release 5/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Arzoxifene by Lilly; NDA for breast cancer prevention expected to be filed in 4Q09
•Class/MOA: Next generation SERM
•Use: Breast cancer and osteoporosis
•Dosage form: oral
•Link to news article:

1.News article 4/08

•Link to clinicaltrials.gov:

1.Trials registered with NIH

Gastrointestinal:

Zegerid (omeprazole/sodium bicarbonate) OTC by Santarus/Schering-Plough; NDA filed 3/08; possible launch 2010
•Class/MOA: PPI / bicarbonate
•Use: heartburn
•Dosage form: oral
•Link to press release:

1. Schering-Plough press release 3/08

Anti-obesity

AVE1625 by sanofi-aventis, Phase II
•Class/MOA: cannabinoid (CB-1) antagonist
•Use: schizophrenia/obesity
•Dosage form: oral
•Link to press release:

1. sanofi-aventis press release 9/07

•Link to clinicaltrials.gov:

1. Phase II Dose ranging study in obese patients with dyslipidemia

CP-945598 by Pfizer; Phase III
•Class/MOA: cannabinoid (CB-1) antagonist
•Use: Obesity
•Dosage form: oral
•Link to pipeline report:

1. Pfizer pipeline report 2/08

•Link to clinicaltrials.gov:

1. Safety/Efficacy Phase III 2 year study for weight loss
2. Long-term Phase III study on weight loss and safety

Surinabant by sanofi-aventis; Phase II
•Class/MOA: cannabinoid (CB-1) antagonist
•Use: Obesity, smoking cessation
•Dosage form: oral
•Link to press release:

1. sanofi-aventis press release 9/07

•Link to clinicaltrials.gov:

1. Phase II trial evaluating safety and efficacy as an aid to smoking cessation

Lorcaserin by Arena Pharmaceuticals; Phase III
•Class/MOA: 5-HT2c agonist
•Use: Obesity
•Dosage form: oral
•Link to press release:

1. Arena press release 3/08

•Link to clinicaltrials.gov:

1.Trials registered with NIH

Cetilistat by Alizyme and Takeda; 1st Phase III study outline plan approved by FDA
•Class/MOA: lipase inhibitor
•Use: obesity
•Dosage form: oral
•Link to press release:

1. Alizyme products in development 2008

•Link to clinicaltrials.gov:

1. Phase II safety and efficacy study in obese patients

Contrave (bupropion SR/naltrexone SR) by Orexigen; planned FDA submission in 2009
•Use: obesity
•Dosage form: oral
•Link to press release:

1. Orexigen press release 10/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Empatic (bupropion + zonisamide) by Orexigen, Phase II
•Use: obesity
•Dosage form: oral
•Link to press release:

1. Orexigen press release 7/07

•Link to clinicaltrials.gov:

1. Phase II trial evaluating safety and efficacy of different combinations to treat obesity

Qnexa (phentermine + topiramate) by Vivus; currently in Phase III
•Use: obesity
•Dosage form: oral
•Link to press release:

1. Vivus press release 10/06

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Pain Management
PMI-150 (ketamine) nasal spray by Javelin; Phase III
•Class/MOA: N-methyl-D-aspartate (NMDA) receptor antagonist (non-opiate)
•Use: emergency analgesic intended for military and civilian use; moderate to severe pain
•Dosage form: nasal spray
•Links to news article:

1. Javelin press release 9/07

•Link to clinicaltrials.gov:

1. Phase III study for treatment of breakthrough pain in cancer

Thermoprofen (ketoprofen) patch by Zars; currently in Phase III trials
•Class/MOA: topical NSAID
•Use: pain associated with osteoarthritis (OA)
•Dosage form: transdermal patch
•Link to news article:

1. Zars announces Phase III study begins 7/07

•Link to clinicaltrials.gov:

1. Phase III study to evaluate the use in OA of knee

Diractin gel (ketoprofen) by Alpharma; filing 2H09
•Class/MOA: topical NSAID
•Use: pain associated with osteoarthritis (OA)
•Dosage form: ketoprofen in Transfersome gel
•Links to news articles:

1. News release 9/07

•Links to clinicaltrials.gov:

1. Phase II trial vs. celecoxib in treatment of OA of knee

LidoPAIN BP (lidocaine 5%) by Epicept; currently in Phase IIb trials; potential filing 2009
•Class/MOA: anesthetic
•Use: acute or recurrent muscular skeletal lower back pain of moderate severity of less than three months duration
•Dosage form: patch
•Links to press release:

1.Epicept pipeline 2008

•Links to clinicaltrials.gov:

1.Safety and efficacy study for use of OA of knee

Rylomine (morphine) nasal spray by Javelin; Phase II
•Class/MOA: opiod analgesic
•Use: moderate to severe pain
•Dosage form: nasal spray
•Links to press release:

1. Javelin press release 2/06

•Link to clinicaltrials.gov:

1.[url=http://www.clinicaltrials.gov/ct2/show/NCT00388011?term=morphine+nasal+spray+javelin&rank =1] Efficacy/Safety Phase II study for pain after bunion surgery

TAIFUN (fentanyl) nasal spray by Akela; in Phase II; 2/08 received letter from FDA that toxicology studies invalid
•Class/MOA: opiod analgesic
•Use: breakthrough cancer pain
•Dosage form: nasal spray
•Links to news article:

1. News release 2/08

Fentanyl spray by Nycomed; currently in Phase III
•Class/MOA: opiod analgesic
•Use: breakthrough cancer pain
•Dosage form: nasal spray
•Links to news article:

1.News release 6/07

•Link to clinicaltrials.gov:

1. Phase III trial compared with oral transmucosal fentanyl in cancer breakthrough pain

AeroLEF (fentanyl) nasal spray by YM Biosciences; Phase II
•Class/MOA: opiod analgesic
•Use: pain managment
•Dosage form: nasal spray
•Link to news release:

1. News release 7/07

•Link to clinicaltrials.gov:

1. Phase II efficacy/safety study for Acute Post-op Pain

MK-0974 by Merck; currently in Phase III w/ projected NDA submission in 2008 and launch in 2010
•Class/MOA: calcitonin gene-related peptide (CGRP) antagonist
•Use: acute treatment of migraine pain
•Dosage form: oral
•Link to press release:

Merck press release 4/07

•Link to clinicaltrials.gov:

Trials registered with NIH

Dyslipidemia:
Lapaquistat (TAK-457) by Takeda; Phase III
•Class/MOA: Oral squalene synthase inhibitor
•Use: cholesterol lowering agent
•Dosage form: oral
•Link to press release:
•Link to news article:

1. News release 10/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

MK-0524B/simvastatin (Cordaptive + simvastatin) by Merck; currently in Phase III
•Class/MOA: extended release niacin + DP-1 selective antagnonist + simvastatin
•Use: dyslipidemia
•Dosage form: oral
•Link to news article:

1. News release 10/06

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Anacetrapib (MK-0859) by Merck; Phase IIb
•Class/MOA: selective cholesteryl ester transfer protein (CETP) inhibitor
•Use: hypercholesterolemia
•Dosage form: oral
•Link to press release:

1. Merck press release 10/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

R1658 (also known as RO4607381/JTT-705) by Roche; currently in Phase III
•Class/MOA: cholesterol ester transfer protein (CETP) inhibitor
•Use: dyslipidemia
•Dosage form: oral
•Link to press release:

1. Roche press release 4/08

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Antithrombotics:
AZD6140 by AstraZeneca; Phase III (CV event trial compares to Plavix)
•Class/MOA: antiplatelet drug; reversible oral adenosine diphosphate (ADP) receptor antagonist
•Use: acute coronary syndromes (ACS)
•Dosage form: oral
•Link to press release:

1. AstraZeneca clinical trials 2005

•Link to news article:

1.News release 3/06

•Link to clinicaltrials.gov:

1.Trials registered with NIH

Rendix (dabigatran) by Boehringer Ingelheim; Phase III (RE_VOLUTION trials: 27,000 patients, will compare to enoxaparin)
•Class/MOA: oral direct thrombin inhibitor
•Use: prevention and treatment of thromboembolic disease
•Dosage form: oral tablet
•Link to press release:

1. Boehringer-Ingelheim press release 1/06

•Link to clinicaltrials.gov:

1. Trials registered with NIH

SCH 530348 by Schering-Plough; currently in Phase III trials
•Class/MOA: thrombin receptor antagonist
•Use: prevention of arterial thrombosis in patients with acute coronary syndrome and those with prior myocardial infarction or stroke, as well as in patients with existing peripheral arterial disease
•Dosage form: oral tablet
•Link to press release:

1. Schering press release 4/06
2. Schering-Plough press release 4/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Diabetes:

CS-917 by Metabasis; Phase II
•Class/MOA: gluconeogenesis inhibitor
•Use: Tyle 2 diabetes
•Dosage form: [ORAL??]
•Link to news article:

1. News article 6/07

•Link to clinicaltrials.gov:

1. Phase II safety, efficacy, tolerability study evaluating glucose lowering effect of CS-917

MB07803 by Metabasis; Phase II
•Class/MOA: Fructose 1,6 biphosphonate inhibitors
•Use: Type 2 diabetes
•Dosage form: oral
•Link to press release:

1. Metabasis press release 4/08

•Link to clinicaltrials.gov:

1. Phase II safety, efficacy, tolerability study for T2DM
2. Phase II tudy evaluating glucose lowering effect

AVE 2268 by sanofi-aventis; Phase IIb results due in the first half of 2008, followed by rapid start of phase III
•Class/MOA: Sodium glucose co-transporter-2 (SGLT-2) inhibitor
•Use: diabetes
•Dosage form: oral
•Link to press release:

1. sanofi-aventis press release 9/07

•Link to clinicaltrials.gov:

1. Phase II dose ranging study in T2DM not adequately controlled by metformin

Dapagliflozin by AstraZeneca; currently in Phase III in combination with metformin
•Class/MOA: sodium glucose contransporter 2 (SGLT2) inhibitor
•Use: diabetes
•Dosage form: oral tablet
•Link to press release:

1. AstraZeneca press release 6/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH

Respiratory conditions:
Fluticasone furoate (Veramyst) (GSK642444 ('444) with uLABA GSK159797 ('797), aka “Beyond Advair” by GSK/Theravance; Phase IIb; NDA filing in 2010
•Class/MOA: Combination fluticasone furoate (Veramyst) with uLABA
•Use: treatment of asthma and COPD
•Dosage form: once a day inhalation
•Link to news article:

1. News release 4/07

•Link to clinicaltrials.gov:

1. Trials registered with NIH