Selected products with Phase III or regulatory milestones expected in 4Q12. (A) Assumes priority review; (B) Assumes 10-month review; Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

Event

Milestone

Abbott Laboratories (NYSE:ABT)

Duodopa levodopa/ carbidopa

Advanced Parkinson's disease (PD)

Submit NDA

YE12

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)

Pimavanserin

PD psychosis

Top-line Ph III data

November

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

Sufentanil NanoTab PCA System

Post-operative pain in patients undergoing major surgery

Ph III data

4Q12

Actelion Ltd. (SIX:ATLN)

Macitentan

Pulmonary arterial hypertension (PAH)

Submit NDA; submit MAA

4Q12

Active Biotech AB (SSE:ACTI)

Anyara naptumomab estafenatox

Renal cell cancer (RCC)

Ph II/III data

YE12

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Lomitapide

Homozygous familial hypercholesterolemia (hoFH)

FDA panel; PDUFA date

10/17/12; 12/29/12

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)

Adasuve Staccato loxapine

Acute agitation in patients with schizophrenia or bipolar disorder

PDUFA date

12/21/12

Algeta ASA (OSE:ALGETA)/ Bayer AG (Xetra:BAYN)

Alpharadin radium-223

Bone metastases in patients with castration-resistant prostate cancer (CRPC)

Submit NDA; submit MAA

4Q12

Allon Therapeutics Inc. (TSX:NPC)

Davunetide

Progressive supranuclear palsy

Ph II/III data

YE12

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG)

Feraheme ferumoxytol

Iron deficiency anemia

Submit sNDA

4Q12

Amicus Therapeutics Inc. (NASDAQ:FOLD)/ GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Amigal migalastat (AT1001)

Fabry's disease

Ph III data

4Q12

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)/Merck & Co. Inc. (NYSE:MRK)

Taltorvic ridaforolimus (MK-8669)

Soft tissue and bone sarcoma

Additional Ph III SUCCEED data

4Q12

ArQule Inc. (NASDAQ:ARQL)/ Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568)

Tivantinib

Non-small cell lung cancer (NSCLC)

Interim Ph III MARQUEE data

4Q12

AspenBio Pharma Inc. (NASDAQ:APPY)

AppyScore test

Identify patients with abdominal pain who are at low-risk for acute appendicitis

CE Mark approval

4Q12

Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL)/BioSpecifics Technologies Corp. (NASDAQ:BSTC)/Asahi Kasei Pharma Corp.

Xiaflex collagenase clostridium histolyticum

Peyronie's disease

Submit sBLA

YE12

Bayer AG (Xetra:BAYN)

Riociguat

Pulmonary hypertension

Ph III data

4Q12

Bayer AG (Xetra:BAYN)/ Johnson & Johnson (NYSE:JNJ)

Xarelto rivaroxaban

Treat deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevent recurrent DVT and PE

PDUFA date

November (A)

Biogen Idec Inc. (NASDAQ:BIIB)

BG-12

Relapsing forms of multiple sclerosis (MS)

PDUFA date

YE12 (B)

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

Long-lasting rFACTOR VIII (rFVIIIFc)

Hemophilia A

Ph III data

4Q12