Non-specialty pipeline forecast as of June 2008

[diana.papshev]

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

2-3Q08:

Durezol (difluprednate) Ophthalmic Emulsion, 0.05% by Sirion Therapeutics, Inc.; Approved in 6/08
• 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

• Link to Prescribing Information:

o PI

Sancuso (transdermal granisetron) by ProStrakan/JapanBridge; NDA submitted 2007; expected approval in 7/08
• 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 ProStrakan press release, 6/08
o News article 5/08

• Link to clinicaltrials.gov:

o Phase III safety/efficacy trial

Effient (prasugrel) by Daiichi Sankyo/Lilly; data released in 2007, NDA filed 1/08; FDA response expected 9/08; estimated launch 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:

o News article 6/08
o Lilly press release 1/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

•Link to recent literature:

o TRITON TIMI-38 trial NEJM 11/07

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

• Link to recent literature:

o The UKISS trial…[Lancet Neurol. 2005] – PubMed Result
o A comparative study of vigabatrin vs carbam… [Pharmacol Rep. 2005] – PubMed Result

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 6/08
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; approvable letter issued by the FDA in 3/08; launch expected in 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 Ortho-McNeil press release 3/08
o News article 5/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

• Link to recent literature:

o Results of a double-blind, randomized trial…[Antimicrob Agents Chemother. 2008] – PubMed Result
o A randomized, double-blind trial comparing… [Clin Infect Dis. 2008] – PubMed Result

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

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:

o News release 6/07

• Link to clinicaltrials.gov:

o Phase III trial in ADHD + oppositional symptoms

• Link to recent literature:

o A randomized, double-blind, placebo…[Pediatrics. 2008] – PubMed Results

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:

o Trials registered with NIH

Silenor (doxepin HCl) by Somaxon Pharmaceuticals; NDA submitted 1/08, with estimated approval 12/08
• Class/MOA: TCA
• Use: insomnia
• Dosage form: oral (1, 3, 6 mg)
• Link to press releases:

o Somaxon press release 6/08
o News article 5/08

• Link to recent literature:

o Efficacy and safety of doxepin 1 mg…[Sleep. 2007] PubMed Results

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

o News 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

CIP-tramadol ER by Cipher Pharmaceuticals, approvable letter received in 5/07, NDA resubmitted in 6/08, FDA response expected in 10/08
• Class/MOA: analgesic
• Use: pain
• Dosage form: oral
• Link to press release:

o News article 6/08

PRO-513 (diclofenac potassium powder for oral solution) by ProEthic Pharmaceuticals, Inc; NDA accepted in 12/07
• Class/MOA: NSAID
• Use: migraine
• Dosage form: powder for oral solution
• Link to press releases:

o News article 12/07

Iloperidone by Vanda; NDA submitted 11/07, FDA response expected in 7/08
• Class/MOA: atypical antipsychotic
• Use: schizophrenia
• Dosage form: oral and extended-release injection
• Link to press release:

o Vanda press release 5/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Stavzor (valproic acid delayed-release) by Noven Pharmaceuticals, Inc.; received approvable letter in 10/07, approval expected in 7/08
• Class/MOA: affects GABA levels
• Use: manic episodes in bipolar disorder, seizures, and prophylaxis of migraine headaches
• Dosage form: oral
• Link to press releases:

o News release 10/07

Arbelic (telavancin) by Theravance and Astellas; Approvable letter received in 10/07, response submitted in 3/08, FDA response expected in 7/08
• Class/MOA: antibiotic
• Use: complicated skin and skin structure infections caused by gram-positive bacteria, including resistant pathogens such as MRSA
• Dosage form: IV
• Link to press release:

o Theravance press release 3/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

• Link to recent literature:

o Telavancin versus vancomycin for the…[Clin Infect Dis. 2008] PubMed Results

Gestiva (17-alpha hydroxyprogesterone caproate) by KV Pharmaceutical; FDA approval expected in Q4 of 2008
• Class/MOA: hormonal therapy
• Use: prevention of preterm birth in certain categories of pregnant women
• Dosage form: IM injection
• Link to press release:

o KV Pharmaceutical press release 1/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

BEMA fentanyl by BioDelivery Services International (BDSI) and Meda AB; NDA accepted in 1/08, FDA response expected in 8/08
• Class/MOA: buccal opioid
• Use: breakthrough cancer pain
• Dosage form: buccal application
• Link to press release:

o News article 1/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

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

Iclaprim by Arpida; NDA accepted 5/08, estimated approval 1/09
• Class/MOA: 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 5/08

• 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

Dalbavancin (Zeven) by Pfizer; FDA issued approvable letter in 12/07
• Class/MOA: glycopeptide antibiotic (cell wall synthesis inhibitor)
• Use: complicated skin and skin structure infections, including those caused by MRSA
• Dosage form: IV
• Link to press releases:

o Pfizer press release 12/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

Anti-infectives/Hepatitis:

Viread (tenofivir) by Gilead
• Class/MOA: nucleotide analogue
• Use: Hepatitis B
• Dosage form: oral
• Link to press releases:

o Press release 5/08

• 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:

o Merck press release 3/08

• Link to clinicaltrials.gov:

o 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:

o News article 6/08
o News article 5/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Apixaban by Bristol Myers Squibb; in Phase III
• Class/MOA: factor Xa inhibitor
• Use: venous thromboembolism (VTE), prevention of stroke associated with atrial fibrillation, acute coronary syndrome
• Dosage form: oral
• Link to press release:

o News article 6/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Cardiovascular disease/dyslipidemia:

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:

o News article 6/08
Abbott press release 3/08

• Link to clinicaltrials.gov:

o 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:

o sanofi-aventis press release 9/07

• Link to clinicaltrials.gov:

o 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:

o sanofi-aventis press release 9/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

Gepirone ER by Fabre-Kramer Pharmaceuticals and GSK; amendment to the NDA was filed in 5/07 in response to the FDA’s request in 6/04
• Class/MOA: antidepressant
• Use: major depressive disorder
• Dosage form: oral
• Link to press release:

o Press release 5/07

CNS/Pain management/Epilepsy:

Tapentadol IR by J & J; NDA submitted in 1/08
• Class/MOA: mu-opioid receptor agonist and norepinephrine reuptake inhibitor
• Use: pain
• Dosage form: oral
• Link to press releases:

o Ortho-McNeil press release 1/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

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: oral 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: opioid analgesic
• Use: cancer pain
• Dosage form: nasal spray
• Links to press release:

o Archimedes 2/08

• Link to clinicaltrials.gov:

o 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:

o Endo products in development 2008

• Links to clinicaltrials.gov:

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

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

o NeurogesX press release 6/08
o NeurogesX press release 9/06

• Link to clinicaltrials.gov:

o Trials registered with NIH

Pennsaid (topical diclofenac) by Nuvo Research, Inc.; resubmission to the FDA is expected in first half of 2009
• Class/MOA: topical NSAID
• Use: osteoarthritis
• Dosage form: topical cream
• Link to press releases:

o News release 6/07

Remoxy (oxycodone ) by Pain Therapeutics and King Pharmaceuticals; NDA submitted in 6/08
• Class/MOA: long-acting opioid
• Use: chronic pain
• Dosage form: oral (formulated to prevent abuse)
• Link to press releases:

o Pain Therapeutics press release 6/08

Vimpat (lacosamide) by UCB; NDA filed in 11/07
• Class/MOA: selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target-collapsin-response mediator protein-2
• Use: partial onset seizures in adults with epilepsy, diabetic neuropathic pain
• Dosage form: oral tablets, syrup, IV injection
• Link to press releases:

o News release 11/07
o News release 11/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

Rufinamide by Eisai Corp.; NDA review is pending for safety and efficacy data with the FDA
• Class/MOA: broad-spectrum anticonvulsant
• Use: Epilepsy, Lennox-Gastaut syndrome
• Dosage form: oral
• Link to press releases:

o News release 5/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Zenvia (dextromethorphan and quinidine) by Avanir; approvable letter received in 10/06, Phase III trials are ongoing
• Class/MOA: sigma-1 agonist and NMDA antagonist (low-dose quinidine increases bioavailability of dextromethorphan)
• Use: diabetic neuropathic pain, pseudobulbar affect
• Dosage form: oral
• Link to press releases:

o News release 5/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

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

CNS/antipsychotics:

Asenapine by Schering-Plough; NDA filed in 11/07
• Class/MOA: antipsychotic targeting dopamine and serotonin imbalance
• Use: Schizophrenia, bipolar disorder
• Dosage form: sublingual
• Link to press releases:

o Schering-Plough press release 5/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

CNS/insomnia:

Sublinox (sublingual zolpidem) by Orexo and Meda AB; NDA filed in 5/08
• Class/MOA: interacts with a GABA-BZ receptor complex
• Use: short-term insomnia
• Dosage form: sublingual
• Link to press releases:

o News release 5/08

ZolpiMist (zolpidem spray) by NovaDel; NDA filed in 1/08
• Class/MOA: interacts with a GABA-BZ receptor complex
• Use: short-term insomnia
• Dosage form: oral spray
• Link to press releases:

o News release 1/08

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:

o News release 6/06

• Link to clinicaltrials.gov:

o Trials registered with NIH

• Link to published study:

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

Liraglutide (NN2211) by Novo Nordisk; Phase III results expected 2Q08, w/ NDA filing in 1H08; Phase III trial showed superior blood glucose control than exenatide
• Class/MOA: once-daily dose of human GLP-1 analogue
• Use: Type 2 diabetes
• Dosage form: SQ injection
• Link to press release:

o News article 6/08
o NovoNordisk press release 2008
o NovoNordisk press release 6/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

Onglyza™ (saxagliptin) by BMS/AstraZeneca; currently in Phase III; NDA filing expected in mid 2008
• Class/MOA: dipeptidyl-peptidase-4 (DPP-4) inhibitor
• Use: Type 2 diabetes
• Dosage form: oral
• Link to press release:

o News article 6/08
o AstraZeneca press release 6/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

AGI-1067 (succinobucol) by Atherogenics
• Class/MOA: antiinflammatory, antioxidant agent
• Use: Cardiovascular disease/diabetes
• Dosage form: oral
• Link to press release:

o News article 7/08
o News article 6/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Respiratory disease:

Aclidinium by Forest and Almirall; 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:

o Forest press release 5/08

• Link to clinicaltrials.gov:

o 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:

o Trials registered with NIH

Urologicals/Erectile dysfunction:

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

Alprox-TD (alprostadil) by NexMed and Warner Chilcott; NDA submitted 11/07
• Class/MOA: prostaglandin E1
• Use: erectile dysfunction
• Dosage form: topical cream
• Link to press releases:

o NexMed press release 11/07

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

Fablyn (lasofoxifene) by Pfizer and Ligand; NDA submitted in 1/08
• Class/MOA: selective estrogen receptor modulator (SERM)
• Use: osteoporosis in postmenopausal women
• Dosage form: tablet
• Link to press releases:

o News release 1/08

• 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:

o News article 2/06

TAK-390MR(OTC) by TAP; NDA submitted in 1/08
• Class/MOA: PPI
• Use: heartburn/GERD
• Dosage form: oral
• Link to news article:

o News article 1/08

Oncology:

Hypericin topical phototherapy by Hy BioPharma; FDA has granted orphan drug status for the CTCL indication
• Class/MOA: NK-1 receptor antagonist
• Use: cutaneous T-cell lymphoma (CTCL); also is being developed to treat malignant brain gliomas
• Dosage form: topical
• Link to press releases:

o News article 5/08

Rezonic/Zunrisa (casopitant) by GSK
• Class/MOA: NK-1 receptor antagonist
• Use: chemotherapy-induced nausea and vomiting (CINV)
• Dosage form: oral
• Link to press releases:

o News article 5/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Bonefos (clodronate) by Bayer-Schering; FDA requested additional data in 2005
• Class/MOA: bisphosphonate
• Use: prevention of bone metastases in patients with breast cancer
• Dosage form: oral
• Link to press releases:

o News article 5/05

Ocular conditions:
Prolarcia (diquafosol tetrasodium) by Inspire Pharmaceuticals and Allergan; NDA filed in 2003, additional data being gathered in response to the second approvable letter in 2005
• Class/MOA: dinucleotide which functions as an agonist at the P2Y2receptor
• Use: dry eye disease
• Dosage form: ophthalmic solution
• Link to press releases:

o Inspire press release 1/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

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:

o sanofi-aventis press release 9/07

• Link to clinicaltrials.gov:

o 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:

o Pfizer pipeline report 2/08

• Link to clinicaltrials.gov:

o Safety/Efficacy Phase III 2 year study for weight loss
o 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:

o 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:

o Arena press release 3/08

• Link to clinicaltrials.gov:

o 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:

o Alizyme products in development 2008

• Link to clinicaltrials.gov:

o 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:

o News article 6/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

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

o Orexigen press release 7/07

• Link to clinicaltrials.gov:

o 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:

o AstraZeneca clinical trials 2005

• Link to news article:

o News release 3/06

• Link to clinicaltrials.gov:

o 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:

o Boehringer-Ingelheim press release 1/06

• Link to clinicaltrials.gov:

o 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:

o Schering press release 4/06
o Schering-Plough press release 4/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

Cardiovascular/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); response expected no earlier than 2010
• Class/MOA: extended release niacin/selective flushing pathway inhibitor, DP-1 selective antagonist
• Use: dyslipidemia
• Dosage form: oral
• Link to news article:

o News article 4/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

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

o News article 4/08

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:

o News release 10/07

• Link to clinicaltrials.gov:

o 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:

o Merck press release 10/07

• Link to clinicaltrials.gov:

o 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:

o Roche press release 4/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

CNS/Alzheimer's disease:

Dimebon by Medivation; second pivotal Phase III trial initiated 6/06; anticipated marketing approval 2010
• Class/MOA: inhibit brain cell death in preclinical models relevant to Alzheimer's disease and Huntington's disease
• Use: mild to moderate Alzheimer's disease
• Dosage form: oral
• Link to press releases:

o News article 6/08

• Link to clinicaltrials.gov:

o 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:

o Javelin press release 9/07

• Link to clinicaltrials.gov:

o 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:

o Zars announces Phase III study begins 7/07

• Link to clinicaltrials.gov:

o 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:

o News release 9/07

• Links to clinicaltrials.gov:

o 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:

o Epicept pipeline 2008

• Links to clinicaltrials.gov:

o 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:

o Javelin press release 2/06

• Link to clinicaltrials.gov:

o 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:

o 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:

oNews release 6/07

• Link to clinicaltrials.gov:

o 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:

o News release 6/08

• Link to clinicaltrials.gov:

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

ADL5859 by Adolor and Pfizer; currently in Phase II
• Class/MOA: delta opioid agonist
• Use: pain
• Dosage form: oral
• Link to press release:

o News article 12/07

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:

o Merck press release 4/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

CNS/Epilepsy:

Eslicarbazepine by Sepracor; currently in Phase III trials, NDA filing is expected in 2009
• Class/MOA: voltage-gated sodium channel blocker
• Use: partial seizures
• Dosage form: oral
• Link to press release: [indent]o News release 6/08

CNS/Sleep disorders:

Tasimelteon (VEC-162) by Vanda; currently in Phase III trials
• Class/MOA: melatonin agonist
• Use: insomnia
• Dosage form: oral
• Link to press release: [indent]o Vanda press release 6/08

Huntigton’s Disease:

AMR101 (eicosapentaenoic acid) by Amarin, in Phase III studies
• Class/MOA: semi-synthetic derivative of a long chain highly unsaturated fatty acid
• Use: Huntigton’s disease
• Dosage form: oral
• Link to press releases:

o Amarin pipeline

• Link to clinicaltrials.gov:

o Phase III trial registered with NIH

Diabetes:

Galvus (vildagliptin) by Novartis; FDA requesting additional data in 2007; resubmission is uncertain
• Class/MOA: dipeptidyl peptidase-4 (DPP-4) inhibitor
• Use: Type 2 diabetes
• Dosage form: oral
• Link to press releases:

o News article, 6/08
o News article 11/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

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

o Metabasis diabetes pipeline 2008

• Link to clinicaltrials.gov:

o Phase II safety, efficacy, tolerability study...

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

o Metabasis press release 4/08

• Link to clinicaltrials.gov:

o Phase II safety, efficacy, tolerability study for T2DM
o Phase II study 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:

o sanofi-aventis press release 9/07

• Link to clinicaltrials.gov:

o 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
• Link to press release:

o AstraZeneca press release 6/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

Intranasal insulin by Nastech; Phase II study showed superiority to oral antidiabetic meds and insulin aspart 6/08
• Class/MOA: rapid acting insulin agent
• Use: diabetes
• Dosage form: intranasal spray
• Link to press release:

o News article 6/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Oral-lyn (oral insulin spray) by Generex; Phase III study began patient dosing 6/08
• Class/MOA: insulin
• Use: diabetes
• Dosage form: oral spray
• Link to press release:

o News article 6/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Taspoglutide by Roche and Ispen; decision to move to Phase III 6/08
• Class/MOA: first human once weekly glucagon-like peptide-1 (GLP-1) analogue
• Use: Type 2 diabetes
• Dosage form: SC injection
• Link to press release:

o News article 6/08

Acomplia (rimonabant) by sanofi-aventis; in Phase III
• Class/MOA: CB1 receptor blocker
• Use: Type 2 diabetes
• Dosage form: oral
• Link to press release:

o News article 6/08

• Link to clinicaltrials.gov:

o 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:

o Schering-Plough press release 3/08

Rheumatoid Arthritis:

Lodotra (modified-release prednisone) by Nitec Pharma; currently in Phase III trials
• Class/MOA: circadian cytokine modulator based on night-time release formulation of prednisone
• Use: RA
• Dosage form: oral
• Link to press releases:

o Nitec Pharma Pipeline

• Link to clinicaltrials.gov:

o Trials registered with NIH

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:

Flutiform (formoterol and fluticasone) by SkyePharma and Kos; Phase III; NDA filing in 2009
• Class/MOA: Combination fluticasone furoate (Veramyst) with uLABA
• Use: treatment of asthma
• Dosage form: twice a day inhalation
• Link to news article:

o News release 6/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

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:

o News release 4/07

• Link to clinicaltrials.gov:

o Trials registered with NIH

Mucinex with codeine extended release (Guaifenesin and codeine) by Adams Respiratory Therapeutics; FDA issued approvable letter in 10/2007
• Class/MOA: expectorant and cough suppressant
• Use: cough
• Dosage form: oral
• Link to news article:

o News release 10/07

Antiinfectives:

Omigard (omiganan pentahydrochloride) by Cadence Pharmaceuticals; in phase III
• Class/MOA: topical broad-spectrum antimicrobial (including drug-resistant organisms)
• Use: treatment of device-related, surgical wound-related and burn-related infections
• Dosage form: topical gel
• Link to news article:

o Cadence Pharmaceuticals Pipeline

• Link to clinicaltrials.gov:

o 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:

o News article 4/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

LibiGel (testosterone gel) by BioSante; NDA for expected to be filed in 2010
• Class/MOA: gel formulation of testosterone
• Use: sexual dysfunction in women
• Dosage form: topical gel
• Link to news article:

o BioSante’s Pipeline

Male Hypogonadism:

Nebido (testosterone undecanoate) by Indevus; expected NDA submission 12/09 with anticipated approval 6/10
• Class/MOA: first long-acting testosterone preparation
• Use: treatment of male hypogonadism
• Dosage form: IM injection
• Link to press releases:

o News article 6/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

Note: Dates are estimated based on information provided by the published sources

Sources:

Drugs.com. Accessed at: New Drug Applications

Biotech100.com. Accessed at: Pipeline Drugs -- Biotechnology Drugs in the Pipeline

U.S. Food and Drug Administration. Accessed at: Drugs@FDA

U.S. National Institutes of Health. Accessed at: ClinicalTrials.gov

Walgreens Specialty. Accessed at: Pipeline Report 2Q08