Replies to post #97245 on Biotech Values

[scriznik]

BIOD is also on watch.

[DewDiligence]

Pharming’s Rhucin gets European approval for acute HAE:

http://finance.yahoo.com/news/Pharming-receives-positive-iw-2559771255.html?x=0&.v=1

Formal approval for marketing will follow in 2-3 months upon rubber stamping by the EU Commission, which always follows the recommendation of the CHMP.

[DewDiligence]

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: Updated status of Pharming’s Rhucin; deleted
entry for DYAX because DX-88 now has an ex-US partner.

  
 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 
 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      apprvd  HAE (approved in Europe; US status unclear)      
 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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