Selected products with Phase III or regulatory milestones expected in 2013. (A) Merging with Vivalis S.A. (Euronext:VLS); Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Accentia Biopharmaceuticals Inc. (OTCQB:ABPI)

BiovaxID vaccine

Follicular non-Hodgkin's B cell lymphoma (NHL)

Submit MAA; NDS

1Q13

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Sufentanil NanoTab PCA System (ARX-01)

Post-operative pain

Ph III data; submit NDA

1Q13; 3Q13

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

Selexipag

Pulmonary arterial hypertension (PAH)

Interim Ph III data

Mid-2013

Active Biotech AB (SSE:ACTI)

Anyara naptumomab estafenatox

Renal cell carcinoma (RCC)

Ph III data

1Q13

Active Biotech AB (SSE:ACTI)/Ipsen Group (Euronext:IPN; Pink:IPSEY)

Tasquinimod

Metastatic castration-resistant prostate cancer (CRPC)

Ph III data

YE13

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS)

AEZS-130 (Formerly Solorel macimorelin)

Diagnose adult growth hormone deficiency

Submit NDA

1Q13

Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS)/Handok Pharmaceutical Co. Ltd. (KSE:002390)/Yakult Honsha Co. Ltd. (Tokyo:2267)

Perifosine

Multiple myeloma (MM)

Interim DSMB analysis of Ph III

1Q13

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Soliris eculizumab

Shiga-toxin producing Escherichia coli hemolytic uremic syndrome

Ph III data

Mid-2013

Alimera Sciences Inc. (NASDAQ:ALIM)/pSivida Corp. (NASDAQ:PSDV; ASX:PVA)

Iluvien fluocinolone acetonide

Diabetic macular edema (DME)

Resubmit NDA

1Q13

Alkermes plc (NASDAQ:ALKS)

ALKS 9070 extended-release aripiprazole

Schizophrenia

Ph III data

YE13

Amarin Corp. plc (NASDAQ:AMRN)

Vascepa icosapent ethyl

Hypertriglyceridemia

Submit sNDA

February

Amgen Inc. (NASDAQ:AMGN)

Talimogene laherparepvec

Metastatic melanoma

Ph III data

2013

Amgen Inc. (NASDAQ:AMGN)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

AMG 386

Ovarian cancer

Ph III data

2013

Anacor Pharmaceuticals Inc. (NASDAQ:ANAC)

Tavaborole

Onychomycosis

Submit NDA

Mid-2013

Antares Pharma Inc. (NASDAQ:ATRS)/Uman Pharma Inc.

Vibex MTX methotrexate

Rheumatoid arthritis (RA)

Submit NDA

Early 2013

Apricus Biosciences Inc. (NASDAQ:APRI)

MycoVa terbinafine

Onychomycosis

Submit NDS

4Q13

AstraZeneca plc (LSE:AZN; NYSE:AZN)/Bristol-Myers Squibb Co. (NYSE:BMY)

Dapagliflozin

Type II diabetes

Resubmit NDA

Mid-2013

Basilea Pharmaceutica AG (SIX:BSLN)/Astellas Pharma Inc. (Tokyo:4503)

Isavuconazole

Aspergillus infections in patients with renal impairment and rare fungal infections

Ph III data

2H13

Baxter International Inc. (NYSE:BAX)

BAX 326 recombinant Factor IX (rFIX)

Hemophilia B

Submit MAA

2013

Baxter International Inc. (NYSE:BAX)

Gammagard Liquid 10%

Mild to moderate Alzheimer's disease

Ph III data

1H13

Bayer AG (Xetra:BAYN)

Riociguat

Chronic thromboembolic pulmonary hypertension and PAH

Ph III CHEST-2 & PATIENT-2 data; submit regulatory application

1H13; 2013

BioDelivery Sciences International Inc. (NASDAQ:BDSI)

BEMA buprenorphine/naloxone

Opioid dependence

Submit NDA

2Q13

BioDelivery Sciences International Inc. (NASDAQ:BDSI)/Endo Health Solutions Inc. (NASDAQ:ENDP)

BEMA buprenorphine

Chronic pain

Ph III data

4Q13

Biogen Idec Inc. (NASDAQ:BIIB)

PEGylated interferon beta-1a

Relapsing multiple sclerosis (MS)

Ph III data

1H13

Biogen Idec Inc. (NASDAQ:BIIB)/Swedish Orphan Biovitrum AB (SSE:SOBI)

rFVIIIFc

Hemophilia A

Submit BLA

1H13

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)

Vimizim elosulfase alfa (formerly GALNS)

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

Submit BLA and MAA

1Q13

Boehringer Ingelheim GmbH/Eli Lilly and Co. (NYSE:LLY)

Empagliflozin

Type II diabetes

Submit regulatory application

2013

Celgene Corp. (NASDAQ:CELG)

Apremilast

Psoriasis

Submit MAA; sNDA

2H13

Celgene Corp. (NASDAQ:CELG)

Revlimid lenalidomide

Newly diagnosed MM

Submit MAA

Mid-2013

Celgene Corp. (NASDAQ:CELG)

Apremilast

Psoriatic arthritis

Submit NDA

1H13

Celgene Corp. (NASDAQ:CELG)/Otsuka Pharmaceutical Co. Ltd.

Abraxane nab-paclitaxel

Advanced pancreatic cancer

Additional Ph III data

January

Chembio Diagnostics Inc. (NASDAQ:CEMI)

DPP Syphilis Screen & Confirm

Detect syphilis

Submit 501(k)

Mid-2013

Clavis Pharma ASA (OSE:CLAVIS)

Elacytarabine

Late-stage acute myelogenous leukemia (AML)

Ph III CLAVELA data

1Q13

Cubist Pharmaceuticals Inc. (NASDAQ:CBST)

CXA-201 (CXA-101 cephalosporin/tazobactam)

Complicated intra-abdominal infection (cIAI); complicated urinary tract infection (cUTI)

Submit NDA

YE13

Durata Therapeutics Inc. (NASDAQ:DRTX)

IV dalbavancin

Acute bacterial skin and skin structure infection (ABSSSI)

Ph III DISCOVER 2 data; submit NDA; submit MAA

1Q13; 1 H13; 2H13

Durect Corp. (NASDAQ:DRRX)

Bupivacaine

Post-operative pain

Submit NDA

1Q13

Eli Lilly and Co. (NYSE:LLY)

Dulaglutide

Type II diabetes

Ph III data; submit regulatory applications

2013

Genentech Inc./Chugai Pharmaceutical Co. Ltd. (Tokyo:4519)/Roche (SIX:ROG; OTCQX:RHHBY)

Avastin bevacizumab

Adjuvant treatment for HER2-positive breast cancer

Ph III BETH data

2013

Genentech Inc./Chugai Pharmaceutical Co. Ltd. (Tokyo:4519)/Roche (SIX:ROG; OTCQX:RHHBY)

Avastin bevacizumab

Ovarian cancer

Additional Ph III data

2013

Gentium S.p.A. (NASDAQ:GENT)/Sigma-Tau Group/Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX)

Defibrotide

Hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem cell transplantation

CHMP recommendation; resubmit NDA

1Q13; 1H13

Gilead Sciences Inc. (NASDAQ:GILD)

Sofosbuvir

Chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection

Submit MAA; NDA

Mid-2013

Gilead Sciences Inc. (NASDAQ:GILD)

Sofosbuvir

HCV

Ph III FISSION, FUSION and NEUTRINO data

1Q13

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

MAGE-A3

Metastatic MAGE-A3-positive melanoma; non-small cell lung cancer (NSCLC)

Ph III data

2013

GTx Inc. (NASDAQ:GTXI)

Ostarine enobosarm

Prevent and treat muscle wasting in patients with NSCLC

Ph III data

2Q13

InSite Vision Inc. (OTCBB:INSV)

DexaSite dexamethasone

Blepharitis

Ph III data

Early 2013

InSite Vision Inc. (OTCBB:INSV)

BromSite bromfenac

Ocular inflammation and pain after cataract surgery

Ph III data; submit NDA

Early 2013; 2013

Insmed Inc. (NASDAQ:INSM)

Arikace amikacin

Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients

Ph III data

Mid-2013

Inspiration Biopharmaceuticals Inc./Ipsen Group (Euronext:IPN; Pink:IPSEY)

OBI-1 porcine rFVIII

Hemophilia A in patients who have developed inhibitory antibodies to human Factor VIII

Submit BLA

1H13

IntelGenx Corp. (TSX-V:IGX; OTCBB:IGXT)/RedHill Biopharma Ltd. (Tel Aviv:RDHL)

RHB-103 fast-dissolving thin-film formulation of rizatriptan

Migraine

Submit NDA

1Q13

Intercell AG (VSE:ICLL; OTCQX:INRLY) (A)

IC43 vaccine

P. aeruginosa bacterial infection

Interim Ph II/III data

2H13

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

ATX-101 synthetic sodium deoxycholate

Reduce submental (under chin) fat

Ph III data

Mid-2013

Ligand Pharmaceuticals Inc. (NASDAQ:LGND)/The Medicines Co. (NASDAQ:MDCO)

Captisol-enabled clopidogrel IV

Acute coronary syndrome (ACS)

Submit NDA

YE13

MannKind Corp. (NASDAQ:MNKD)

Afrezza inhaled insulin

Type I and Type II diabetes

Resubmit NDA

3Q13

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

Simeprevir

Chronic HCV genotype 1 infection

Submit regulatory applications in U.S., EU and Japan; additional Ph III QUEST-1, QUEST-2 and PROMISE data

1H13

Merck & Co. Inc. (NYSE:MRK)

V503 vaccine

HPV infection

Submit BLA

2013

MolMed S.p.A. (Milan:MLM)

NGR-hTNF

Malignant pleural mesothelioma

Ph III data

3Q13

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

Naloxegol

Opioid-induced constipation

Submit MAA and NDA

3Q13

NewLink Genetics Corp. (NASDAQ:NLNK)

HyperAcute Pancreas algenpantucel-L

Pancreatic cancer

Interim Ph III data

1H13

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

Safinamide

Mid- to late-stage Parkinson's disease (PD)

Submit regulatory application

2013

Novartis AG (NYSE:NVS; SIX:NOVN)

Secukinumab

Moderate to severe plaque psoriasis

Ph III data; submit regulatory applications worldwide

2013

Novartis AG (NYSE:NVS; SIX:NOVN)

Panobinostat

Relapsed or refractory MM

Submit MAA and NDA

2013

NPS Pharmaceuticals Inc. (NASDAQ:NPSP)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Natpara recombinant human parathyroid hormone

Hypoparathyroidism

Submit BLA

Mid-2013

Nymox Pharmaceutical Corp. (NASDAQ:NYMX)/Recordati S.p.A. (Milan:REC)

NX-1207

Benign prostatic hyperplasia (BPH)

Prelim Ph III data

YE13

Omeros Corp. (NASDAQ:OMER)

OMS302 (ketorolac/phenylephrine)

Maintain pupil dilation during cataract and other lens replacement surgery and reduce post-operative pain and irritation

Submit NDA; submit MAA

1Q13; mid-2013

OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI)/Isis Pharmaceuticals Inc. (NASDAQ:ISIS)/Teva Pharmaceutical Industries Ltd. (NYSE:TEVA)

Custirsen sodium

Metastatic CRPC

Ph III data

YE13

Onconova Therapeutics Inc./Baxter International Inc. (NYSE:BAX)/SymBio Pharmaceuticals Ltd. (JASDAQ:4582)

IV Estybon rigosertib

Myelodysplastic syndromes (MDS)

Ph III data

2H13

Opko Health Inc. (NYSE-A:OPK)/Tesaro Inc.

Rolapitant

Prevent chemotherapy-induced nausea and vomiting (CINV)

Ph III data

2H13

Orexigen Therapeutics Inc. (NASDAQ:OREX)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Contrave naltrexone/bupropion

Obesity

Interim Ph III LIGHT data; resubmit NDA

2013

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

Bronchitol mannitol

Bronchiectasis

Ph III data

1H13

Pharming Group N.V. (Euronext:PHARM)/Hyupjin Corp./MegaPharm Ltd./Santarus Inc. (NASDAQ:SNTS)/Swedish Orphan Biovitrum AB (SSE:SOBI)/Transmedic Pte. Ltd.

Ruconest conestat alfa

Acute attacks of hereditary angioedema (HAE)

Additional Ph III Study 1310 data; submit BLA

2013; 1H13

Pozen Inc. (NASDAQ:POZN)

PA32540 (325 mg aspirin/40 mg omeprazole)

Secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers

Submit NDA

1H13

Pozen Inc. (NASDAQ:POZN)

PA8140 (81 mg aspirin/40 mg omeprazole)

Secondary prevention of cardiovascular disease in patients at risk for gastric ulcers

Submit NDA

April

Protein Sciences Corp./UMN Pharma Inc. (Tokyo:4585)/Astellas Pharma Inc. (Tokyo:4503)/Ildong Pharmaceutical Co. Ltd. (KSE:000230)

FluBLok

Prevent seasonal flu

Ph III data

YE13

QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY)/Paladin Labs Inc. (TSX:PLB)

MoxDuo IR oxycodone/morphine

Moderate to severe acute pain

Resubmit NDA; submit MAA

Early 2013; 1H13

Repros Therapeutics Inc. (NASDAQ:RPRX)

Androxal enclomiphene

Secondary hypogonadism

Ph III AZ-301 data

2Q13

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

Fostamatinib

RA

Ph III OSKIRA data; submit NDA; submit MAA

1H13; 2H13; 2H13

Rockwell Medical Technologies Inc. (NASDAQ:RMTI)

Soluble ferric pyrophosphate

Iron deficiency anemia in chronic kidney disease (CKD) patients

Submit NDA

2H13

S.L.A. Pharma AG/Ventrus Biosciences Inc. (NASDAQ:VTUS)

VEN 307

Anal fissures

Ph III data; submit NDA

4Q13

Sanofi (Euronext:SAN; NYSE:SNY)

SAR302503

Myelofibrosis

Ph III data

2013

Sanofi (Euronext:SAN; NYSE:SNY)

Iniparib

First-line treatment of NSCLC

Ph III data

2Q13

Sanofi (Euronext:SAN; NYSE:SNY)

Eliglustat tartrate

Type I Gaucher's disease

Ph III data

1Q13

Seaside Therapeutics Inc./Roche (SIX:ROG: OTCQX:RHHBY)

Arbaclofen

Fragile X syndrome

Ph III data

2013

Shire plc (LSE:SHP; NASDAQ:SHPG)

Vyvanse lisdexamfetamine dimesylate

Major depressive disorder (MDD)

Ph III data

2H13

Synta Pharmaceuticals Corp. (NASDAQ:SNTA)

Ganetespib

Advanced, metastatic NSCLC

Ph IIb data from Ph IIb/III

2H13

The Medicines Co. (NASDAQ:MDCO)

IV oritavancin

ABSSSI

Ph III SOLO-2 data; submit MAA, NDA

Mid-2013; 2013

Tioga Pharmaceuticals Inc./Ono Pharmaceutical Co. Ltd. (Tokyo:4528; Osaka:4528)

Asimadoline

Diarrhea-predominant irritable bowel syndrome (IBS-D)

Ph III data

Mid-2013

Trimel Pharmaceuticals Corp. (TSX:TRL)

CompleoTRT testosterone

Hypogonadism

Submit NDA

Early 2013

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

Tedizolid phosphate

ABSSSI

Ph III data; submit NDA; submit MAA

Early 2013; 1H13; 2H13

UCB Group (Euronext:UCB)

Brivaracetam

Partial-onset seizures in patients with epilepsy

Ph III data

1H13

Unigene Laboratories Inc. (OTCBB:UGNE)/ Tarsa Therapeutics Inc.

Oral calcitonin

Postmenopausal osteoporosis

Submit NDA

1H13

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

Tasimelteon

MDD

Ph IIb/III data

1Q13

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

Tasimelteon

Non-24-hour sleep wake disorder

Top-line Ph III RESET data; submit NDA

1Q13; mid-2013

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

LCP-Tacro tacrolimus

Prevent organ rejection in kidney transplant patients

Submit NDA; submit MAA

2H13; 2013

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

Allovectin velimogene aliplasmid

Recurrent stage III or IV metastatic melanoma

Ph III data

Mid-2013

Vivus Inc. (NASDAQ:VVUS)

Qsiva phentermine/topiramate

Obesity

CHMP appeal outcome

1H13

XenoPort Inc. (NASDAQ:XNPT)

Arbaclofen placarbil

Spasticity in MS patients

Ph III data

2Q13

Ziopharm Oncology Inc. (NASDAQ:ZIOP)

Zymafos palifosfamide

Metastatic soft tissue sarcoma

Ph III data

1Q13