New Drugs

J&J psoriasis drug may carry cancer risk

Maureen Martino — Fri, 13 Jun 2008 11:19:19 -0400

Outside experts are preparing to review ustekinumab, Centocor's injectable treatment for severe psoriasis. Two Phase III studies demonstrated positive results, but staffers will have to consider possible increased risk of cancer associated with the drug. Animal studies indicated that the drug may encourage tumor growth. "Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients," FDA reviewers noted. Centoror, a division of Johnson & Johnson, is expecting an FDA decision by September.

Though ustekinumab may have produced impressive results in trials, J&J may have an uphill battle convincing insurers to cover the expensive drug for patients with severe forms of psoriasis. Insurers would prefer members to stick with older, cheaper psoriasis drugs rather than allow them to switch to one of the newer biologics that have hit the market.

- see this report for details

GSK outlines plans to become more ‘biotech-like’

John Carroll — Tue, 10 Jun 2008 11:53:09 -0400

Biotech is in. At least, that's the message from GlaxoSmithKline's Patrick Vallance, the pharma giant's head of drug discovery. In a speech in London on Monday Vallance made clear that Glaxo intends to become more "biotech-like" in advancing new therapies. That calls for smaller discovery teams which would be incentivized for creating value and ‘disincentivized' for value destruction.

Glaxo has been one of the most aggressive pharma companies in the industry when it comes to in-licensing new biotech therapies in development. The company has been setting up Centres of Excellence in Drug Discovery and is funding outside research through the Centre of Excellence in External Drug Discovery. But Glaxo has been talking up an entrepreneurial atmosphere for eight years even as pressure has built to advance new drugs to take the place of blockbusters losing patent protection.

That trend, no doubt, will make those ‘disincentives' ever more painful.

- read the report from the Financial Times

Genetic mutation will narrow target cancer groups

Mon, 02 Jun 2008 06:59:55 -0400

The K-ras gene is coming in for some star treatment at the ASCO meeting in Chicago. The gene plays a key role in several cancers, and new research indicates that the common genetic mutation makes Erbitux useless for slightly more than a third of all patients who may currently qualify for the drug.

The Wall Street Journal notes that the genetic signpost is helping R&D teams design clinical trials for new cancer drugs, using the genetic information to help them identify patients most likely to respond. The developers will benefit by increasing their shot at producing statistically significant data but will likely have to scale back the potential size of their market--a trade-off that payers in the U.S. will be glad to see.

- read the article in the Wall Street Journal

Eli Lilly shakes up R&D ops in restructuring

Thu, 22 May 2008 06:59:58 -0400

Eli Lilly has shaken up the management structure of its R&D and international operations as it looks for a more efficient way to speed new drugs through the approval process. Its worldwide regulatory, medical and patient safety divisions at the R&D division will be placed under Dr. Tim Garnett, who's been appointed chief medical officer. Current CMO Dr. Alan Breier is leaving for a job in academia and regulatory affairs chief Dr. Tim Franson is retiring.

Other changes: Dr. Jen Stotka has been appointed vice president of global regulatory affairs; Dr. Don Therasse will become vice president of global patient safety; Enrique Conterno becomes vice president for health care professional markets; Jack Bailey has been named vice president for account-based markets; Karim Bitar has been named president of European operations. Abbas Hussain leaves for GSK.

It's all a result of the housecleaning ordered by new CEO John Lechleiter (photo), who's looking to create a nimbler, more effective organization at a time the pharma giant is under tremendous pressure to perform better.

- here's the release
- read the AP report
- read the story from the Chicago Tribune

GSK's Garnier: FDA raised the bar for new drugs

Fri, 16 May 2008 06:59:55 -0400

In an interview with the Financial Times, outgoing GSK CEO Jean-Pierre Garnier shares his thought on the new, tougher FDA approval environment. While many drug developers hope the FDA's reticence to approve new drugs in the wake of recent safety scandals will fade over time, Garnier think the regulatory environment is irrevocably changed.

"The hurdle rate has gone up. It is not going to come down. This is not a pendulum. Society wants to avoid risk. We have to tease out rare side-effects earlier," Garnier observed. Blockbusters as we know them are a dying breed. Instead, he predicted that there will be more "progressive blockbusters," drugs approved for one indication that gain other approvals over time. This approach minimizes the risk that a marketed drug could cause serious side effects that were not observed during clinical trials.

- for more on Garnier's thoughts, see this article

1,300 new hires planned for FDA expansion

Thu, 01 May 2008 06:59:57 -0400

The FDA is hiring some 1,300 badly-needed workers to help with drug reviews and post-approval monitoring activities. Flush with fatter fees from drug developers, the agency says it will recruit biologists, chemists, pharmacologists and more to fill more than 700 new positions as well as 547 recruits for current vacancies. The FDA has been under increasing pressure to beef up its ranks to do a better job at providing timely regulatory oversight for new drugs as well as the safety of therapies already on the market.

The agency is betting that its strategic position at the crossroads of science, regulatory supervision and drug safety--to say nothing of a hefty package of federal benefits--will make it a competitive player in the job market. The FDA will go head to head with drug developers to fill many of these jobs, and that could have a buoyant effect on salaries in the industry.

"Each month, there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission," John Dyer, the agency's deputy commissioner for operations and COO, said in a release.

- see the FDA's release
- read the report in USA Today

SPOTLIGHT: Biocon establishing R&D sub

Mon, 28 Apr 2008 06:59:53 -0400

India's Biocon says it will transfer four molecules to a new R&D subsidiary, resisting a trend in the subcontinent of spinning off R&D into a new company. Its researchers are working on new drugs for diabetes, cardiovascular, inflammation, oncology and endocrinology. Report

FDA approves Wyeth, Progenics drug

Fri, 25 Apr 2008 06:59:57 -0400

There's a big sigh of relief coming from Wyeth and Progenics today as the FDA approved Relistor, a subcutaneous injection for opioid-induced constipation in patients with advanced illness who are receiving palliative care. Back in January the FDA added an additional three months of review time so that it could study the drug's side effects. Though European regulators gave a thumbs up to the drug on Thursday, some U.S. analysts doubted Relistor would gain FDA approval. The FDA came through though, and Progenics' stock shot up on the news. The approval triggers a $15 million milestone payment from Wyeth.

"The approval of Relistor is a transformative event for Progenics Pharmaceuticals," says Paul J. Maddon, CEO of Progenics. "This is our first U.S. product approval.

- see the release on Relistor
- read TheStreet report

SPOTLIGHT: Colorado passes $26.5M biotech incentive bill

Fri, 25 Apr 2008 06:59:53 -0400

Like so many other regions, Colorado is hoping to get its own slice of the biotech industry pie with the passage of a $26.5 million incentive bill. The bill "provides grants for five years to Colorado startup companies and research institutions seeking to commercialize new biotech drugs, biofuels, medical devices and nanotechnology," reports the Colorado Business Journal. Thirty percent of the funds will go to university and research institution technology transfer offices, thirty percent will go to start-up bioscience companies, and forty percent will be used to support the development of public-private infrastructure that will help commercialize Colorado's bioscience research. Release | Report

Wyeth, Elan suspend Alzheimer's vaccine study

Fri, 18 Apr 2008 06:59:54 -0400

Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Studies of ACC-001 that have been mounted outside of the U.S. have also been suspended. Researchers, though, quickly sought to reassure investors that another late-stage program for AAB-001 wasn't affected by the unexplained case of lesions. AAB-001, or bapineuzumab, has demonstrated an improvement in cognitive function in Alzheimer's patients in a small study and is being closely followed by the investment community.

- read the story in the Wall Street Journal
- read the story in TheStreet.com

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