Non-specialty pipeline forecast as of May 2008

[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; estimated 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:

• Lilly press release 1/08

•Link to recent literature:

• TRITON TIMI-38 trial NEJM 11/07

•Link to clinicaltrials.gov:

• Trials registered with NIH

Sabril (vigabatrin) by Ovation Pharmaceuticals, Inc.; received Fast Track designation from the FDA
•Class/MOA: oral irreversible GABA-transaminase inhibitor
•Use: antiepileptic (infantile spasms, refractory complex partial seizures); also being developed as a treatment for cocaine and methamphetamine dependence
•Dosage form: oral
•Link to press releases:

o News release 2/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

4Q08:
Alogliptin by PPD and Takeda Pharmaceutical Company Limited; NDA accepted 2/08, estimated approval 4Q08
•Class/MOA: highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor
•Use: Type 2 diabetes
•Dosage form: oral
•Link to press releases:

o News article 2/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Ceftobiprole by Basilea Pharmaceutica International Ltd., Johnson & Johnson; NDA submitted 7/07, estimated approval 2008
•Class/MOA: first-in-class anti-MRSA broad-spectrum cephalosporin antibiotic
•Use: treatment of complicated skin and skin structure infections (cSSSI) including diabetic foot infections
•Dosage form: oral
•Link to press releases:

o News article 5/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

CloniBID (clonidine hydrochloride) by Addrenex Pharmaceuticals, Inc; approval estimated 12/08 with launch in early 2009
•Class/MOA: centrally acting alpha-2 agonist
•Use: hypertension
•Dosage form: 12-hour, sustained-release formulation of clonidine hydrochloride
•Link to press releases:

o News article 4/08

Durezol (difluprednate) Ophthalmic Emulsion, 0.05% by Sirion Therapeutics, Inc.; NDA accepted 2/08 with priority review
•Class/MOA: ophthalmic steroid
•Use: postoperative ocular inflammation
•Dosage form: ophthalmic emulsion
•Link to press releases:

o News article 2/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

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

Sancuso (transdermal granisetron) by ProStrakan/JapanBridge; NDA submitted 2007; expected launch 2008
•Class/MOA: serotonin 5-HT3 receptor antagonist
•Use: prevention of chemotherapy-induced nausea
•Dosage form: transdermal patch formulation containing 34.3 mg of granisetron
•Link to press releases:

o News article 5/08

•Link to clinicaltrials.gov:

o Phase III safety/efficacy trial

Silenor (doxepin HCl) by Somaxon Pharmaceuticals; NDA submitted 1/08, with estimated approval 4Q08
•Class/MOA: TCA
•Use: insomnia
•Dosage form: oral
•Link to press releases:

o News article 5/08

Silodosin by Watson; NDA accepted 2/08; estimated approval 4Q08
•Class/MOA: α1-adrenoceptor antagonist with high uroselectivity
•Use: BPH
•Dosage form: oral
•Link to press releases:

o News article 2/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Summers’ Lice Asphyxiator by Sciele Pharma; PDUFA date extended to 7/08
•Class/MOA: contains a naturally occurring monohydric aralkyl alcohol
•Use: Lice treatment
•Dosage form: topical gel
•Link to press releases:

o News article 2/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

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

2009:
Anti-infectives:
Cethromycin by Advanced Life Sciences Holdings, Inc.; NDA expected to be filed 3Q08, with estimated approval 2009
•Class/MOA: ketolide antibiotic
•Use: mild-to-moderate community acquired pneumonia (CAP)
•Dosage form: once-daily oral
•Link to press releases:

o News article 4/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Oritavancin by Targanta Therapeutics Corporation; NDA accepted 4/08, estimated approval 2009
•Class/MOA: semi-synthetic lipoglycopeptide antibiotic
•Use: treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA
•Dosage form: IV
•Link to press releases:

o News article 4/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

ST-246 by SIGA Technologies, Inc.; expected to have NDA batches completed by 2H08
•Class/MOA: smallpox antiviral
•Use: treatment for exposure to Smallpox Virus
•Dosage form: oral
•Link to press releases:

o News article 4/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Anti-obesity drugs:
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

Cardiovascular disease:
Multaq (dronedarone) by sanofi-aventis; NDA submission planned 3Q08, with expected approval 2009
•Class/MOA: multi-channel blocker that affects calcium, potassium and sodium channels and has anti-adrenergic properties
•Use: prevention and treatment of patients with atrial fibrillation or atrial flutter
•Dosage form: oral
•Link to press releases:

o sanofi-aventis press release 5/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

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

Cardiovascular disease/dyslipidemia:
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

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

CNS/depression:
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

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

CNS/Pain management:

Embeda (morphine extended-release with sequestered naltrexone hydrochloride) by Alpharma Inc; NDA withdrawn with plans to resubmit (data presentation issues) by end of 2008
•Class/MOA: opiod analgesic/opiod antantagonist
•Use: pain
•Dosage form: capsule
•Link to press releases:

o News article 4/08

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

Sufentanil (EN 3720) by Endo; in Phase II; NDA filing expected in 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

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

CNS/Parkinson's disease:
KW-6002 (istradefylline) by Kyowa Pharmaceutical, Inc.; received not-approvable letter from FDA in 2/08
•Class/MOA: adenosine A2A receptor antagonist
•Use: Parkinson’s Disease
•Dosage form: oral
•Link to press releases:

o News release 2/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Diabetes:
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

Galvus (vildagliptin) by Novartis; approvable letter received 2/07 (FDA requesting additional data, re-submitted 11/07)
•Class/MOA: dipeptidyl peptidase-4 (DPP-4) inhibitor
•Use: Type 2 diabetes
•Dosage form: oral
•Link to press releases:

o News article 11/07

•Link to clinicaltrials.gov:

o Trials 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

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

Respiratory disease:
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

AllerNase (triamcinolone acetonide) Nasal Spray by Collegium Pharmaceutical, Inc.; NDA submitted 4/08, with estimated approval 1Q09
•Class/MOA: intranasal steroid
•Use: treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children twelve years of age and older
•Dosage form: nasal spray
•Link to press releases:

o News article 4/08

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

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

Urologicals:
Oxybutynin chloride topical gel (OTG) by Watson; NDA accepted 5/08; estimated approval 1Q09
•Class/MOA: anticholinergic
•Use: treatment of overactive bladder (OAB)
•Dosage form: topical gel
•Link to press releases:

o News article 5/08

•Link to clinicaltrials.gov:

o Phase III placebo-controlled trial in overactive bladder

Women's Health:
Ophena (ospemifene) by QuatRx Pharmaceuticals; in Phase III; estimated approval 2009
•Class/MOA: selective estrogen receptor modulator (SERM)
•Use: vulvovaginal atrophy
•Dosage form: tablet
•Link to press releases:

o QuatRx press release 5/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Gastroenterology:
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

LONG-TERM PIPELINE (2010 and beyond):
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

Cardiovascular disease:
VIA-2291 by Via Pharmaceuticals; Phase II data to be reported in 3Q08
•Class/MOA: elective and reversible inhibitor of 5-LO, which is a key enzyme in the biosynthesis of leukotrienes
•Use: cardiovascular disease, including ACS
•Dosage form: oral
•Link to press releases:

o Via Pharmaceuticals press release 5/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

Cardiovascular/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

Cardiovascular/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

CNS/Alzheimer's disease:
Flurizan by Myriad; in Phase III
•Class/MOA: first in a new class of drug candidates known as Selective Amyloid beta-42 Lowering Agents (SALAs)
•Use: Alzheimer’s disease, dementia
•Dosage form: oral
•Link to press release:

• News article 6/07

•Link to clinicaltrials.gov:

• Trials registered with NIH

CNS/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. 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

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

Gastroenterology:
Pumosetrag (DDP733) by Dynogen Pharmaceuticals; in Phase IIa
•Class/MOA: prokinetic
•Use: for irritable bowel syndrome with constipation (IBS-C)
•Dosage form: oral
•Link to press releases:

o Dynogen press release 5/08

•Link to clinicaltrials.gov:

o Trials registered with NIH

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

Osteoporosis:
Odanacatib by Merck; in Phase II
•Class/MOA: inhibits cathepsin K enzyme
•Use: osteoporosis
•Dosage form:
•Link to press releases:

o News article 5/08

•Link to clinicaltrials.gov:

o 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

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