Amgen submits BLA for XGEVA

Image via WikipediaTHOUSAND OAKS, Calif., June 27, 2011 /PRNewswire/ --

Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating XGEVA versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrate that XGEVA significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.

 Bone metastasis-free survival is a composite measure of the development of bone metastases or death.
"The successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK Ligand pathway to penetrate bone," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.  "XGEVA has the potential to become a significant advance for patients with castrate-resistant prostate cancer who currently have no treatment options to help prevent the spread of cancer to their bones."

Continued

This Week's Watchlist Oct 25 2010 With the FDA

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A, B and Z DNA Structures, the building blocks of Proteins and Amino Acids

Today's Theme For Pictures Today

 On tap for this week we have three FDA decisions:

ARNA - Arena received an expected CRL on Saturday for its weightloss drug Lorcaserin. (Subscribers to BioRunUp were immediately notified via SMS and email alerts) The CRL was as expected with no real surprises. It will be interesting to see how the market reacts to the FDA's requests on Monday morning. ARNA closed at $1.63 on Friday after surging nearly 22% at one point during the day. These prices are much below its run-up high of $8 in late July.  Arena Receives CRL

BIOD - Biodel is up for an FDA decision on 10/30/10, and trader consensus is clearly leaning towards a CRL from the FDA. Traders became even more jittery last week as the FDA delivered some heavy handed CRLs to AMLN/ALKS, on a drug that was widely expected to receive approval. The market seemed to react as if saying 'If AMLN/ALKS was 'in the bag' and the FDA required more trials, there is NO way that the FDA will approve Linjeta with that botch India data.' Trading at under a 100M market cap, BIOD has incredible potential on approval. However FDA uncertainty seems to have limited the run-up.

AVNR - Out of this week's watchlist stocks, AVNR seems to have the best odds of approval. Despite this, AVNR still took a hit from the AMLN/ALKS CRL. This was because that CRL was based largely because the FDA was concerned about prolongation of QT interval, a concern that was also expressed by the FDA in Avanir’s first CRL for AVP-923. Will this continue to haunt AVNR? We will soon find out.

EXAS - Its catalyst time for one of our best picks of the year. We recommended EXAS in the high $3 range and were thrilled to watch it climb to over $9. Study results are going to be presented this Friday, 10/29 at the AACR conference.  
 
BioPharma Investor's Decisions:
 
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FDA approve's Dendreon's Provenge

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Here's Dendreon's newswire on it's approval of Provenge. Stock hit an all time high of 57.55 and has tapered off a bit around the 53 point range. This is a quality stock and it's profits should help the bottom line with this big news on April 29th, 2010.

SEATTLE, April 29, 2010 /PRNewswire via COMTEX/ --Dendreon Corporation (Nasdaq: DNDN ) today announced that the U.S. Food and Drug Administration (FDA) has approved PROVENGE(R)
(sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies.