Novacea

Novacea cuts staff after partner dumps collaboration

Tue, 13 May 2008 06:59:54 -0400

A month after Schering-Plough pulled the plug on its collaboration with Novacea for a new prostate cancer therapy--Asentar--the little biotech company announced that it will cut its work force by more than half. Over the next two months Novacea's head count will dwindle from 37 to 15.

"While we believe the company is in a good financial position, the work force reduction was a very difficult decision for the management team, and we extend our sincere gratitude and appreciation to all of the affected employees," said Chairman and Chief Executive John P. Walker.

- see Novacea's release for more on the cuts
- read the AP report

ALSO NOTED: FDA approves Orencia; Delay on Amgen clotting drug decision; Icahn files suit for Biogen Idec papers; and much more

Wed, 09 Apr 2008 06:59:50 -0400

> The FDA has approved Bristol-Myers Squibb's Orencia for juvenile arthritis. Release

> Amgen says that the FDA will delay a decision on its blood clotting drug by three months. A decision had been expected by April 23. Release

> Not satisfied with Biogen Idec's explanation of its failed effort to find a buyer, Carl Icahn has filed suit to get a hold of internal documents on the search. No way, responds Biogen Idec, which says it's just another ploy aimed at forcing a sale. Report

> Antigenics has raised $21 million in a private placement. The money will be used to market Oncophage, a cancer vaccine that just won regulatory approval in Russia. Release

> Potentia Pharmaceuticals has completed a $12 million round of financing. The funds will allow Potentia to complete Phase I and move into Phase II clinical development of Potentia's novel investigational drug candidate, POT-4. Release

> Schering-Plough has officially terminated its partnership with Novacea for its Asentar prostate cancer program. A clinical trial was halted earlier due to an imbalance of deaths between the two treatment arms. Release

> The FDA has rebuked GlaxoSmithKline for failing to regularly report post-marketing Avandia data. Report

> Scientists at Memorial Sloan-Kettering Cancer Center in New York City have identified the molecular process by which breast cancer cells spread to other tissue during metastasis. Report

> The heparin death toll is far worse than we originally thought. The FDA has tripled the number of deaths it's attributing to allergic reactions to the blood thinner since January 2007, to 62 from 19. Report

> Just why would Novartis pay $11 billion for one-fourth of eye-care Alcon company and promise another $28 billion for another big chunk? Report

> Expect the FDA to stay out of the Vytorin fray, at least for now. Report

> In the latter part of the 20th century, the conventional wisdom in the drug industry was simple: bigger is better. But now the Big-Big management model is cracking up. Report

And Finally... It turns out that hundreds of bacteria can actually 'eat' antibiotics, according to researchers at Harvard Medical School. Report

Novacea slows down development program for AQ4N

Thu, 03 Jan 2008 06:59:55 -0500

Novacea, which is burning through $17 million to $19 million this year, says it will scale back on the development of AQ4N, shelving a clinical trial in acute lymphoblastic leukemia and delaying a clinical trial in B-cell lymphoma. The news was included in a strategic review of its plans for 2008. An ongoing Phase Ib/IIa clinical trial of AQ4N in patients with glioblastoma multiforme will continue.

"Since we terminated the ASCENT-2 trial in advanced prostate cancer, managing our capital resources, which totaled approximately $110 million in cash and receivables at the end of the third quarter of 2007, is a top priority as we seek to maximize the strategic options available to the company," says Novacea CEO John Walker.

- see Novacea's release
- read the report from Trading Markets

Related Articles:
Novacea ends Asentar trial, shares plunge. Report
Novacea cheered on decision to expand cancer trial. Report
Novacea stock rockets up on $440M deal. Report
Novacea files $75M IPO. Report

Novacea ends Asentar trial, shares plunge

Mon, 05 Nov 2007 06:59:58 -0500

Novacea has shuttered its Phase III trial of the prostate cancer drug Asentar, citing an "imbalance of death" recorded in the two arms of the study. Novacea and partner Schering-Plough say that they will study the data to try and glean some insight into the higher death rate among Asentar patients. The study--which had enrolled 900 of a planned 1200 patients--dosed patients with a combination of Asentar and Taxotere. Details are scarce this morning, with little more than a tersely worded press release for information. But it was all that investors had to know before deciding to bail out. The company's stock plunged by 65 percent this morning.

Asentar has been one of two leading therapies in development at Novacea. Last July the company collected $60 million from Schering-Plough in exchange for a commercialization pact on the drug. Schering-Plough had also committed up to $380 million in milestones plus royalties for an approved product.

- see the release on the trial failure
- read the AP report on the trial
- and check out the stock report

Related Articles:
Novacea cheered on decision to expand cancer trial. Report
Novacea stock rockets up on $440M deal. Report
Novacea files $75M IPO. Report
Novacea raises $25M in third venture round. Report

ALSO NOTED: EU panel recommends Bayer, GSK drugs; Novacea names new CEO; and much more...

Fri, 21 Sep 2007 06:59:50 -0400

> An EMEA advisory panel has issued six positive opinions on marketing applications for new drugs, paving the way for EU marketing approval. Report

> Chutes & Ladders: Novacea has elected John P. Walker as CEO. He will continue to serve the Chairman of the company. Release

> Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases has won the Lasker Prize. Report

> Millipore is expanding on its reputation as a filtration supplier to scientific labs around the globe. Report

> Generics may be the bane of Big Pharma, but they're inflation-fighting ninjas. Over the last 12 months, prescription drug prices edged up by a measly 1 percent--the lowest rate of inflation in three decades. Report

> Pfizer is looking to set up its Japanese R&D operation, previously slated for shutdown, as an independent company--with the help of a few investors, of course. Report

And Finally... An ancient mechanism for coping with stresses also gives cancer a boost. Release

Novacea cheered on decision to expand cancer trial

Wed, 15 Aug 2007 06:59:56 -0400

Novacea has disclosed that it has asked the FDA to boost enrollment in a late-stage trial of its prostate cancer drug, Asentar. The company, which reported widening second-quarter losses as a result of higher R&D spending, wants to enlist 1200 patients in Phase III rather than the 900 it originally set out to test. Bigger trials produce more reliable results. Novacea shares slid this morning on its numbers, even though the analysts were cheering the company's decision to expand its cancer trial.

- see Novacea's financial results
- read the AP report for more

Related Articles:
Novacea stock rockets up on $440M deal. Report
Novacea files $75M IPO. Report
Novacea raises $25M in third venture round. Report