Drug Trials

Acadia shares plunge on mid-stage trial failure

John Carroll — Mon, 16 Jun 2008 09:26:07 -0400

Shares of Acadia Pharmaceuticals went into free fall this morning after the company announced that one of its schizophrenia drug candidates failed a mid-stage trial. Researchers said that ACP-104 was no better than a placebo in relieving symptoms of schizophrenia. And the company said that they would probably shutter the development program as a result of the data.

That news sent Acadia's stock into a nose dive, with shares losing 56 percent of their value this morning. Acadia does have another schizophrenia drug--pimavanserin--in mid-stage development.

"We clearly are disappointed in the results of this study," said Uli Hacksell, Ph.D., the CEO of Acadia. "While we will thoroughly analyze the data to understand the outcome, we currently do not anticipate conducting further studies with ACP-104."

- check out the press release
- read the AP report

Symphogen inks $330M collaboration pact with Genentech

John Carroll — Wed, 11 Jun 2008 11:15:13 -0400

Denmark's Symphogen has inked a $330 million collaboration deal with Genentech to discover new antibodies for three infectious disease targets. Symphogen gets an undisclosed equity investment as well as an undisclosed upfront payment, which will be used to fund a lead program in a mid-stage trial. Genentech gets a worldwide license on the developed candidates and will fund related R&D costs. The pact is a coup for Symphogen, which has smaller deals in place with Sweden's Biovitrum AB and Japan's Meiji Seika Kaisha.

According to a report in BioWorld, Symphogen has developed a rapid process for cloning antibodies as well as a more efficient manufacturing process.

"This deal underscores our belief that Symphogen's technologies offer a valuable approach to create next-generation therapeutics that address critical unmet medical needs in the treatment of serious infections," said Kirsten Drejer, Ph.D., CEO of Symphogen.

- check out the press release
- read the story from BioWorld

Novo Nordisk discontinues Phase III on disappointing results

John Carroll — Wed, 11 Jun 2008 11:14:01 -0400

Concluding that a late-stage trial of its experimental therapy to prevent bleeding in trauma patients was headed to a likely failure, Novo Nordisk discontinued the study of NovoSeven. "Due to an observed lower mortality than anticipated in the overall study group (around 10 percent in the Phase III trial in total compared to more than 25 percent in the Phase II trial), a futility analysis was conducted to assess the likelihood of reaching a successful outcome on the primary endpoint. The analysis predicted a low likelihood of obtaining a positive trial outcome with the planned study population, and as a consequence, Novo Nordisk has decided to discontinue the trial," the company announced.

"It is regrettable that this trial is coming to an end," said Mads Krogsgaard Thomsen, executive vice president and CSO. "It has, however, already now provided a lot of important data on the treatment of severely injured patients. We will share these findings with the medical community as soon as the full clinical analysis has been completed."

- check out Novo's release

BioSante Pharma exploring its strategic alternatives

John Carroll — Tue, 10 Jun 2008 11:54:01 -0400

BioSante Pharmaceuticals has brought in Deutsche Bank to advise the company on its "strategic alternatives." The developer has advanced LibiGel, a topical therapy for female sexual dysfunction, into a late stage trial. BioSante has told investors that it hopes to gain an FDA approval on the treatment by 2010.

News of the Deutsche Bank move helped buoy shares of BioSante. The company announced in March that it had begun a Phase III trial on LibiGel.

- read the AP report

Vertex shares rise on positive data for telaprevir

John Carroll — Mon, 09 Jun 2008 11:52:41 -0400

Vertex Pharmaceuticals saw a significant bump in its share price this morning after researchers released new, mid-stage interim data backing telaprevir for hepatitis C. The company is now penciling in the start of a new late-stage trial for the closely watched drug--enrolling patients who had failed standard therapy--in the third quarter. The new data is from a Phase IIb involving patients who had failed a standard therapy.

In the study, patients received telaprevir in combination with interferon/ribavirin for 12 weeks, then the combination therapy for the next 12 weeks followed by 12 weeks of neither therapy. The control arm received the combination therapy for 36 weeks. Slightly more than half of the telaprevir group had undetectable levels of the virus after 36 weeks compared to 30 percent in the control group. A late stage trial for the hep C drug began in spring with patients who had received no prior therapy.

- check out the press release
- read the AP report

Inspire Pharma shares soar 75% on CF data

Fri, 06 Jun 2008 06:59:58 -0400

Shares of Durham, NC-based Inspire Pharmaceuticals took off this morning after researchers announced that a late-stage trial of its cystic fibrosis therapy produced promising results. Patients taking the drug experienced an improvement in lung function during the 24-week study. After hearing the news on denufosol, investors pushed up Inspire's shares by more than 75 percent.

"The data from this Phase 3 trial with denufosol are encouraging for the cystic fibrosis community because it brings us one step closer to a novel treatment that addresses the basic cystic fibrosis defect," Robert J. Beall, CEO of the Cystic Fibrosis Foundation.

- read the report in the Triangle Business Journal

IRX Therapeutics raises $25M Series A

Tue, 03 Jun 2008 06:59:55 -0400

New York-based IRX Therapeutics announced that it has raised $25 million in a Series A. The new money will be used to further develop IRX's cancer and viral disease product platform, including IRX-2 (citoplurikin), its lead candidate for cancer treatment. IRX researchers are developing a therapy that stimulates a coordinated cellular immune response that can enable a patient's own immune system to fight disease. IRX has reported positive mid-stage data and say they plan to launch a late-stage trial.

- check out IRX's release

ALSO: Canada's Inimex Pharmaceuticals has rounded up $22 million in venture funds to conduct the first clinical trials of its IDR drugs. Report

Amgen's D-mab beats Fosamax in trial

Wed, 28 May 2008 06:59:55 -0400

In a head-to-head trial, Amgen's twice-yearly osteoporosis drug denosumab outperformed weekly oral doses of Merck's Fosamax. D-mab, as it's known, showed greater improvement in bone mineral density in the hip and spine compared to Fosamax. "The novel means by which denosumab inhibits osteoclast-mediated bone breakdown shows the promise of RANK Ligand inhibition," said Javier San Martin, Global Development Lead for the denosumab osteoporosis program.

- see Amgen's release
- read the report for more

ALSO NOTED: FDA, Medicare team up on drug surveillance; Early stage prostate vaccine shows promise; and much more...

Fri, 23 May 2008 06:59:50 -0400

> FDA is teaming up with the Center for Medicare and Medicaid Services on data-mining. FDA will be able to probe CMS's patient databases, actively looking for potential safety problems. Next, the data-mining will move into the private arena via deals with insurance companies. Report

> An early-stage trial of an experimental prostate cancer vaccine demonstrated that it was safe and also generated an immune response among a large percentage of the volunteers in the study. Report

> Certain segments of the biopharmaceutical manufacturing industry are set to make big leaps in capacity over the next five years. Report

> An experimental vaccine developed at the University of Rochester Medical Center prevented the build-up of amyloid plaques in the brains of mice engineered to develop an aggressive form of Alzheimer's disease. Report

> The antiviral Relenza has won a battle over Tamiflu in the competition for government contracts from governments anxious about a possible bird flu epidemic. Report

> There's another corruption scandal brewing in Italy--this time involving a pay-to-play scheme at AIFA, the pharma regulatory agency. Report

And Finally... Drugmakers are climbing on the disclosure bandwagon. AstraZeneca and Merck have come out in favor of a bill requiring pharma and device-makers to report their payments to doctors, joining Eli Lilly, which gave the legislation a thumbs-up last week. Report

Myriad Genetics pencils in $350M deal for Flurizan

Thu, 22 May 2008 06:59:57 -0400

Myriad Genetics has landed a key partnership for its late-stage Alzheimer's therapy. H. Lundbeck has agreed to pay $100 million in an upfront fee along with $250 million in milestones for the European rights to Flurizan. The pact includes escalating royalties on sales. Myriad will hand a sublicense royalty check to Encore Pharmaceuticals.

Myriad is still looking for a co-promotion deal in the U.S. for Flurizan, planning to tackle the specialty market itself while a major pharma company markets the drug to the primary care crowd. The developer is also seeking a deal for Japan and the Pacific Rim that's more in line with the pact now forged for Europe.

One Phase III trial for Flurizan has already been completed with data expected in June. A second late-stage trial is underway and should be wrapped at the end of this year.

- check out the press release
- read the story in MarketWatch