Posts for Ticker ‘NOVC’

The 52-Week Low Club

Fremont General (FMT) Mortgage company debt rating cut. Falls to $1.81 from 52-week high of $17.30.

Valeant Pharmaceuticals (VRX) Drops on downgrade. Drops to $10.35 from $18.82.

Nordstrom (JWN) Retailers keep hurting. Drops to $33.71 from 52-week high of $59.70.

Merrill Lynch (MER) CEO gone. Big losses. Drops to $53.86 from 52-week high of $98.68.

Citigroup (C) CEO gone. Bigger loses. Drops to $35 from 52-week high of $57.

Novacea (NOVC) Drug trial blows up. Falls to $2.21 from 52-week high of $17.25.

Vertex Pharmaceuticals (VRTX) Problem with one of its drugs. Downgraded by analyst. Falls to $22.92 from 52-week high of $45.38.

Douglas A. McIntyre

Posted on: November 5, 2007 – 4:41 pm in HI/LOW, , , , , , ,

Biotech Implosion: Novacea (NOVC, SGP)

Novacea, Inc. (NASDAQ:NOVC) has ended its Phase III ASCENT-2 clinical trial of Asentar(TM) (DN-101).  Unfortunately this is Novacea’s lead investigational cancer therapy for the treatment of patients with androgen-independent prostate cancer.

The trial halt is due to an imbalance of deaths between the two treatment arms, as observed by the Data Safety Monitoring Board for the clinical study.  Schering-Plough (NYSE:SGP) is Novacea’s partner on this candidate and both companies plan to fully analyze the clinical data resulting in higher death rates in the Asentar plus Taxotere treatment group.

The study was comparing the benefits of weekly Asentar plus Taxotere to the current standard of care in the treatment of androgen-independent prostate cancer. To date, more than 900 of the planned total of 1,200 patients were enrolled in this study at multiple centers in various countries, including the United States, Canada, Germany, and Central Europe.

 

If you look at Novacea’s pipeline, you’ll see that Asentar is the bulk of the efforts.  It’s going to be a long road ahead for the company.

Shares of Novacea (NOVC) are trading down 65% to $2.50 in pre-market activity.  Friday’s close was $7.19 and the prior 52-week trading range was $5.60 to $17.25.  Before the implosion, Novacea’s market cap was $169.19 million.  Biotechs blowing results are rarely good, but when its a Phase II or Phase III and it is your lead candidate it is as bad as one can imagine.

Jon C. Ogg
November 5, 2007

Posted on: November 5, 2007 – 8:29 am in Biotech, ,

Novacea and Schering-Plough Prostate Cancer Pact; Remind You of Anyone?

Novacea (NOVC-NASDAQ) is seeing its shares up more than 70% after signing a pact with Schering-Plough (SGP-NYSE) over the development and commercialization of Asentar for the treatment of prostate cancer.  Novacea will receive an upfront payment of $60 million, including $35 million as reimbursement for past research and development expenses, a license fee of $25 million, as well as a commitment by Schering-Plough to purchase $12 million of Novacea common stock at a predetermined price within ten days of the closing. Additionally, the agreement provides Novacea with potential pre-commercial milestone payments of up to $380 million, and tiered royalties on worldwide sales of Asentar.

Novacea is currently conducting a large international Phase 3 trial evaluating Asentar in 900 patients with androgen-independent prostate cancer. Asentar is a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor.  Schering-Plough will be responsible for all forward development costs in exploring indications for earlier stages of prostate cancer, such as androgen-dependent prostate cancer and adjuvant therapy and will lead all global commercialization efforts for Asentar. Novacea will provide medical support to Schering-Plough’s commercial operations for Asentar in the United States, including deployment of their Medical Science Liaisons, which will be funded by Schering-Plough.

Based on what happened recently with Dendreon (DNDN-NASDAQ), it looks like Novacea just eliminated much of the future risk from this side of the model.  There is of course a cost for that, but the investment community just gave it the thumbs up approval so far.

Jon C. Ogg
May 30, 2007

Jon Ogg can be reached at jonogg@247wallst.com; he does not own securities in the companies he covers.

Posted on: May 30, 2007 – 9:23 am in Biotech, , ,