Replies to post #76056 on Biotech Values

[ghmm]

I was curious how the list has progressed and here is a very brief summary:

Partnered
AUXL (partnered with Pfizer ex-US and no plans to partner US)
AEZS (Sanofi-Aventis deal 3/09)
EPIX (sold Vasovist)

Failed
INFI (trial halted)
NTII (trial failed at interim)


Partnered and Failed
LJPC


PS sorry genisi I hadn't seen you had already posted INFI in your edits a while back.

[DewDiligence]

Pharming resubmits Rhucin MAA to EMEA:

http://finance.yahoo.com/news/Pharming-submits-marketing-iw-2113854232.html?x=0&.v=1

There is still no firm guidance as to when Pharming will submit a Rhucin BLA to the FDA; all Pharming is promising is a pre-BLA meeting with the FDA by the end of 2009.

[DewDiligence]

Pharming, the Dutch company that once seemed like a bright
star in transgenics, is attempting to get the EMEA to approve
Rhucin as a treatment for acute HAE—for the third time!
Still no firm guidance as to when Pharming will submit a Rhucin
BLA to the FDA; all Pharming is promising is a pre-BLA meeting
with the FDA by the end of 2009.

http://www.reuters.com/article/marketsNews/idCNLO8493320090924

›Pharming's Rhucin Evaluation to Start

Thu Sep 24, 2009 4:06am EDT

AMSTERDAM, Sept 24 (Reuters) - Dutch biotech firm Pharming (PHAR.AS) said late on Wednesday that the European Medicines Agency (EMEA) has begun the scientific evaluation of its lead product Rhucin in its third attempt to win marketing approval.

The regulator has twice rejected Pharming's application to market Rhucin, which treats hereditary angioedema, characterised by acute attacks of painful swelling of the skin, intestine, mouth and throat.

But the company has said it has followed up on and addressed concerns raised by the EMEA during the former evaluation procedure in 2007, adding that the size of the clinical database has been significantly expanded.

Pharming said the EMEA informed it on Wednesday it had completed the validation of its application dossier, allowing the start of the scientific evaluation.

"The start of the procedure is positive news for Pharming. If there are no unforeseen circumstances, a decision on the approval of Rhucin can be expected before year end 2010," SNS Securities analyst Ilja Zaanen said in a note.

Pharming shares were up 9.2 percent at 0.48 euros by 0749 GMT and were the biggest winner on the Amsterdam stock exchange.

The next step in the process is the drafting of a list of questions by the agency's Committee for Medicinal Products for Human Use which could take 120 days, Pharming said.

It added that it may expect the adoption of the final opinion from the committee within a total of 210 days of review, excluding any clock-stops triggered by questions the company has to answer.

Pharming, which produces therapeutic proteins in milk of genetically modified animals, had lodged its request for marketing approval of Rhucin with the EMEA at the start of September.

The company had previously said that its next focus would be the admission of a Biologic License Application (BLA) for Rhucin in the United States and that it would request a pre-BLA meeting by the end of 2009.‹

[genisi]

Late-Stage Products Looking for a Home

Criteria for inclusion:
a) Program is in phase-3 or beyond and is non-partnered.
b) Company does not have enough cash to bring the product to market.

Edits: Removed – MDVN (MDV-3100 partnered with Astellas)

  
  
  Stock    Product          Stage                   Comments        
 -----    ---------------  ---------------------   -----------------------------        
 ARNA     Lorcaserin       Phase 3                 Obesity  
 BPAX     Libigel          Phase 3 ~2010 Submit    Adequate Safety      
 CHTP     Droxidopa        Pivotal Phase III       Orthostatic hypotension.  Results expected 02/09.  
 CRGB     Abiraterone      Phase 3                 Prostate cancer  
 DYAX     DX-88 for HAE    BLA filed 9/24/08       (CABG indication partnered w CBST)     
 GNVC     TNFerade         Pivotal Phase III       Pancreatic cancer  
 JAV      Dyloject         Phase III               Approved in UK.  Post operative Pain (injectable)      
 JAV      Ketamine         Phase III               Acute moderate-to-severe pain (intranasal) 
 OREX     Contrave         Phase 3                 Obesity  
 OXGN     Zybrestat        Phase 3                 Anaplastic thyroid cancer     
 Pharming Rhucin           Pre-BLA                 Rejected in EU   
 Protalix prGCD            Phase III               Gaucher's disease. Not enough cash for a commercial infrastructure    
 RPRX     Proellex         Phase 3                 Uterine fibroids  
 SVNT     Puricase         BLA filed               Treatment refratory gout 
 

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