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Post# of 252293
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Re: DewDiligence post# 96299

Monday, 06/14/2010 8:15:33 PM

Monday, June 14, 2010 8:15:33 PM

Post# of 252293
Late-Stage Products Looking for a Home

Criteria for inclusion:
a) Program has completed phase-2b or later and is non-partnered; AND
b) Company lacks the financial resources to commercialize the product on its own.

Edits: Added ONCY who have now started a Phase 3 in refractory SCC Head & Neck Cancer with a FDA SPA in hand. ONCY is also more than midway through a closely watched Phase 2 trial for first line kras+ NSCLC lung cancer. Preliminary data in this Phase 2 trial is due in Q3-2010. ONCY may partner or raise funds after this data is released as the company is currently only funded to complete and analyze the first-look portion of the Phase 3 at this time.


Company Product Phase Indication (notes)
======= ======= ===== ==================
ARNA Lorcaserin NDA Obesity
ARYX Budiodarone 2B Atrial Fibrillation
ARYX Tecarfarin 3 VTE prevention (failed initial ph-3)
BPAX Libigel 3 Female Sexual Desire Disorder
DYAX Kalbitor US app acute HAE (seeking ex-US partner)
HNAB Marqibo 2B ALL (ENZN failed acc. approval in NHL)
JAV Dyloject NDA Post-op pain (approved in UK)
JAV Ketamine 3 Acute pain
ONCY Reolysin 3 SCC Head & Neck cancer (ph-3 SPA)
OREX Contrave NDA Obesity
OXGN Zybrestat 3 Anaplastic thyroid cancer
MNKD Afrezza BLA Diabetes (CRL rec’d 3/15/10)
Pharming Rhucin BLA HAE (CHMP decision expctd Jun 2010)
SOMX Silenor apprvd Insomnia (low dose of generic doxepin)
SVNT Krystexxa BLA Gout (response to CRL submtd 3/30/10)
VVUS Qnexa NDA Obesity



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