Selected products with Phase III or regulatory milestones expected in 2Q13. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Sufentanil NanoTab PCA System

Post-operative pain in patients undergoing major abdominal surgery

Ph III data

2Q13

Actelion Ltd. (SIX:ALTN)/Nippon Shinyaku Co. Ltd. (Tokyo:4516; Osaka:4516)

Selexipag

Pulmonary arterial hypertension PAH)

Interim Ph III GRIPHON data

Mid-2013

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Juxtapid lomitapide

Homozygous familial hypercholesterolemia (hoFH)

MAA action

Mid-2013

Allergan Inc. (NYSE:AGN)/Nektar Therapeutics (NASDAQ:NKTR)

Levadex dihydroergotamine

Acute migraine

PDUFA date

4/15/13

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC)

Tavaborole

Onychomycosis

Submit NDA

Mid-2013

Astellas Pharma Inc. (Tokyo:4503)/Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)

Tarceva erlotinib

First-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with EGFR-activating mutations

PDUFA date

2Q13

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO)/Astellas Pharma Inc. (Tokyo:4503)/Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)

Tivopath tivozanib

Advanced renal cell carcinoma (RCC)

FDA panel

5/2/13

Baxter International Inc. (NYSE:BAX)

Gammagard Liquid 10%

Mild to moderate Alzheimer's disease (AD)

Ph III data

2Q13

BioDelivery Sciences International Inc. (NASDAQ:BDSI)

Bunavail (formerly BEMA buprenorphine/naloxone)

Opioid dependence

Submit NDA

Mid-2013

Biogen Idec Inc. (NASDAQ:BIIB)

Plegridy peginterferon beta-1a

Relapsing-remitting multiple sclerosis (RRMS)

Submit BLA and MAA

Mid-2013

Biogen Idec Inc. (NASDAQ:BIIB)

Tecfidera dimethyl fumarate (BG-12)

RRMS

MAA action

2Q13

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)

Vimizim elosulfase alfa (formerly GALNS)

Mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome)

Submit BLA and MAA

2Q13

Celgene Corp. (NASDAQ:CELG)

Revlimid lenalidomide

Relapsed or refractory mantle cell lymphoma

PDUFA date

6/5/13

Celgene Corp. (NASDAQ:CELG)

Pomalyst pomalidomide

Myelofibrosis

Ph III data

2Q13

Celgene Corp. (NASDAQ:CELG)

Abraxane nab-paclitaxel

Pancreatic cancer

Submit sNDA and MAA

2Q13

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP)/Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506)

Northera droxidopa

Symptomatic neurogenic orthostatic hypotension

Resubmit NDA

2Q13

Clinuvel Pharmaceuticals Ltd. (ASX:CUV; Xetra:UR9)

Scenesse afamelanotide

Erythropoietic protoporphyria

MAA action

2Q13

Curis Inc. (NASDAQ:CRIS)/Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)

Erivedge vismodegib

Advanced basal cell carcinoma

MAA action

2Q13

Delcath Systems Inc. (NASDAQ:DCTH)

Chemostat melphalan

Unresectable melanoma that is metastatic to the liver

FDA panel; PDUFA date

5/02/13;

Depomed Inc. (NASDAQ:DEPO)

Sefelsa gabapentin

Menopausal hot flashes

PDUFA date

5/31/13

DiaGenic ASA (OSE:DIAG)

Adtect

Early detection of AD

CE Mark approval

Mid-2013

DiaGenic ASA (OSE:DIAG)

MCItect

Diagnose AD at mild cognitive impairment stage

CE Mark approval

Mid-2013

Durata Therapeutics Inc. (NASDAQ:DRTX)

Dalbavancin

Acute bacterial skin and skin structure infcction (ABSSSI)

Submit NDA

Mid-2013

Endo Health Solutions Inc. (NASDAQ:ENDP)/Bayer AG (Xetra:BAYN)

Aveed testosterone undecanoate

Male hypogonadism

FDA panel; PDUFA date

4/18/13; May

Genmab A/S (CSE:GEN)/GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Arzerra ofatumumab

First-line treatment of chronic lymphocytic leukemia (CLL)

Ph III data

Mid-2013

Gilead Sciences Inc. (NASDAQ:GILD)

Cobicistat

Boosting agent for HIV treatment with protease inhibitors

PDUFA date

4/28/13

Gilead Sciences Inc. (NASDAQ:GILD)

Sofosbuvir

HCV

Submit NDA and MAA

2Q13

Halozyme Therapeutics Inc. (NASDAQ:HALO)/Baxter International Inc. (NYSE:BAX)

HyQvia formulation of IV Gammagard /recombinant human PH20 hyaluronidase (rHuPH20)

Primary immunodeficiency disorder

MAA action

2Q13

Hisamitsu Pharmaceutical Co. Inc. (Tokyo:4530; Osaka:4530)

Paroxetine mesylate

Vasomotor symptoms associated with menopause

PDUFA date

6/28/13

InSite Vision Inc. (OTCBB:INSV)

DexaSite dexamethasone

Blepharitis

Ph III data

2Q13

InSite Vision Inc. (OTCBB:INSV)

AzaSite Plus azithromycin/dexamethasone

Blepharitis

Ph III data

2Q13

Insmed Inc. (NASDAQ:INSM)

Arikace amikacin

Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients

Ph III data

Mid-2013

Japan Tobacco Inc. (Tokyo:2914; Osaka:2914)/Gilead Sciences Inc. (NASDAQ:GILD)

Elvitegravir

HIV-1 infection in treatment-experienced adults

PDUFA date

4/27/13

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX)/Panion & BF Biotech Inc.

Zerenex ferric citrate

End-stage renal disease (ESRD) patients on hemodialysis or peritoneal dialysis

Submit NDA; submit MAA

2Q13; mid-2013

Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH)/Bayer AG (Xetra:BAYN)

ATX-101 synthetic sodium deoxycholate

Reduce submental (under chin) fat

Ph III data

Mid-2013

Medivir AB (SSE:MVIR B)/Johnson & Johnson (NYSE:JNJ)

Simeprevir

HCV genotype 1 infection

Submit MAA

2Q13

Nektar Therapeutics (NASDAQ:NKTR)/AstraZeneca plc (LSE:AZN; NYSE:AZN)

Naloxegol

Opioid-induced constipation

Ph III KODIAC-04 and KODIAC-05 data

May

NewLink Genetics Corp. (NASDAQ:NLNK)

HyperAcute Pancreas algenpantucel-L

Pancreatic cancer

Ph III IMPRESS data

Mid-2013

Newron Pharmaceuticals S.p.A. (SIX:NWRN)/Zambon Co. S.p.A./Meiji Seika Pharma Co. Ltd.

Safinamide

Parkinson's disease (PD)

Additional Ph III SETTLE data and additional Ph III MOTION DATA

June

Novo Nordisk A/S (CSE:NVO; NYSE:NVO)

Victoza liraglutide

Obesity and pre-diabetes

Additional Ph IIIa SCALE data

2Q13

Novo Nordisk A/S (CSE:NVO; NYSE:NVO)

IDegLira liraglutide/insulin degludec

Type II diabetes

Submit MAA

Mid-2013

Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY)

Bronchitol mannitol

Bronchiectasis

Ph III data

2Q13

Pharming Group N.V. (Euronext: PHARM)

Rhucin conestat alfa

Acute attacks of hereditary angioedema (HAE)

Submit BLA

2Q13

Raptor Pharmaceutical Corp. (NASDAQ:RPTP)

Procysbi cysteamine bitartrate

Nephropathic cystinosis

PDUFA date

4/30/13

Rigel Pharmaceuticals Inc. (NASDAQ:RIGL) AstraZeneca plc (LSE:AZN; NYSE:AZN)

Fostamatinib

Rheumatoid arthritis (RA)

Ph III OSKIRA data

2Q13

Sanofi (Euronext:SAN: NYSE:SNY)

Iniparib

First-line squamous NSCLC

Ph III data

2Q13

Sanofi (Euronext:SAN: NYSE:SNY)

SAR302503

Myelofibrosis

Ph III JAKARTA data

2Q13

Sanofi (Euronext:SAN: NYSE:SNY)

New insulin glargine formulation

Diabetes mellitus

Ph III data

2Q13

Sanofi (Euronext:SAN: NYSE:SNY)

Otamixaban

Acute coronary syndrome (ACS)

Ph III data

2Q13

Sanofi (Euronext:SAN: NYSE:SNY)

Lemtrada alemtuzumab

RRMS

CHMP opinion

2Q13

Shire plc (LSE:SHP; NASDAQ:SHPG)/Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507)

Vyvanse lisdexamfetamine dimesylate

ADHD in pediatric patients ages 6-17 years

PDUFA date

4/29/13

Synta Pharmaceuticals Corp. (NASDAQ:SNTA)

Ganetespib

Advanced, metastatic NSCLC

Ph IIb/III data

2Q13

The Medicines Co. (NASDAQ:MDCO)/AstraZeneca plc (LSE:AZN; NYSE:AZN)

Cangrelor

Prevent platelet activation and aggregation in patients under-going percutaneous coronary intervention (PCI)

Submit NDA

2Q13

Theravance Inc. (NASDAQ:THRX)/GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Breo fluticasone furoate/vilanterol

Chronic obstructive pulmonary disease (COPD)

FDA panel; PDUFA date

4/17/13; 5/12/13

Titan Pharmaceuticals Inc. (OTCBB:TTNP)/Braeburn Pharmaceuticals S.p.r.l.

Probuphine buprenorphine

Opioid dependence

PDUFA date

4/30/13

Topotarget A/S (CSE:TOPO)/Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI)

Belinostat

Relapsed or refractory peripheral T cell lymphoma (PTCL)

Submit NDA

Mid-2013

Trius Therapeutics Inc. (NASDAQ:TSRX)/Dong-A Pharmaceutical Co. Ltd. (KSE:000640)/Bayer AG (Xetra:BAYN)

Tedizolid phosphate

ABSSSI

Additional Ph III ESTABLISH 2 data

April

Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX)/Kaken Pharmaceutical Co. Ltd.

Efinaconazole

Mild to moderate onychomycosis

PDUFA date

5/24/13

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA)/Bristol-Myers Squibb Co. (NYSE:BMY)

Tasimelteon

Non-24-hour sleep wake disorder

Submit NDA

Mid-2013

Veloxis Pharmaceuticals A/S (CSE:VELO)/Chiesi Farmaceutici S.p.A.

LCP-Tacro tacrolimus

Prevent organ transplant rejection in de novo kidney transplant recipients

Ph III data

Mid-2013

Vical Inc. (NASDAQ:VICL)/AnGes MG Inc. (Tokyo:4563)

Allovectin velimogene aliplasmid

Recurrent stage III or IV metastatic melanoma

Ph III AIMM data

Mid-2013

Wilex AG (Xetra:WL6)/Nestle S.A. (SIX:NESN)/Esteve S.A.

Rencarex girentuximab

Clear cell RCC

Additional Ph III subgroup data

2Q13