Diabetes

Novo Nordisk releases more liraglutide data

Maureen Martino — Fri, 17 Oct 2008 10:22:19 -0400

Novo Nordisk has released more data on its much-watched diabetes drug liraglutide. In a head-to-head trial against exenatide (Byetta), liraglutide, a human GLP-1 analog, was more effective at improving blood glucose control than Byetta. "Patients treated with once-daily liraglutide achieved better blood glucose control and also had less minor hypoglycemia than those treated with exenatide," said Lawrence Blonde, MD, Director of the Ochsner Diabetes Clinical Research Unit in the Department of Endocrinology, Diabetes, and Metabolism at the Oxford Center in New Orleans. Fasting plasma glucose was also reduced significantly more with liraglutide. The drug is also in Phase II trials for obesity.

- here's the liraglutide release

Cells coaxed to produce insulin in diabetes breakthrough

John Carroll — Thu, 28 Aug 2008 11:41:45 -0400

A team of scientists at the Harvard Stem Cell Institute have reprogrammed normal pancreas cells into insulin-producing cells in mice. The team injected proteins into the cells to activate genes, flipping a switch on their genetic transformation. After 10 days the cells were able to help regulate blood sugar. And the scientists say the same approach could work across a range of diseases.

"We were able to flip the cell from one state into another," Doug Melton said, adding that the approach should be useful in treating disorders in "any case where there's a cell type missing and there are neighboring cells that are still healthy."

- read the report from the Los Angeles Times

FDA panel backs added risk review on diabetes drugs

John Carroll — Thu, 03 Jul 2008 09:58:10 -0400

A FDA advisory panel has voted 14-2 to recommend that the developers of diabetes drugs specifically demonstrate that their experimental therapies don't increase cardiovascular risks. And if as expected the agency follows the recommendation, developers in the diabetes field are looking at more complex trial demands that are likely to add significant cost to the trials process. The Wall Street Journal nominates AstraZeneca and Bristol-Myers Squibb as the first two biopharma companies to face the new standard. Their diabetes drug saxagliptin is headed to the FDA for a review.

- read the report in the Wall Street Journal

FDA considers new trial standard for diabetes drugs

John Carroll — Tue, 24 Jun 2008 10:26:51 -0400

In a move that could have enormously costly implications for developers of new diabetes therapeutics, Pharmalot reports that the FDA has asked its Endocrinologic and Metabolic Drugs Advisory Committee to consider whether new therapies should undergo a clinical trial to test drugs for potential cardiovascular risks. The move comes after the agency added warnings to Actos and Avandia after researchers determined the drugs raised risks.

"Establishing a hurdle of long-term, costly trials to exclude cardiovascular harm may also affect drug development for type 2 diabetes," says an FDA briefing document, "particularly if this mandate applies to every product, even those that have no suggestion of cardiotoxicity."

- read the report from Pharmalot

Sanofi: Acomplia demonstrates better glucose control

John Carroll — Tue, 10 Jun 2008 11:56:48 -0400

Sanofi-Aventis said that a trial of Acomplia showed a significant improvement in glucose control in comparison to insulin among patients with type 2 diabetes. Glucose control was three times more pronounced among the Acomplia group compared to volunteers who received insulin and lifestyle advice.

The drug has been approved in Europe but faces a lengthy delay in the U.S. as regulators shift through data that the drug may raise the risk of depression. In the trial, 14 percent of the Acomplia drug reported symptoms of anxiety compared to five percent in the control group and 14 percent reported symptoms of depression compared to 7.5 percent in the control arm.

- check out the AFX report

DPP-4 inhibitors get spotlight at ADA meeting

John Carroll — Mon, 09 Jun 2008 11:55:40 -0400

Researchers are unveiling positive data at the American Diabetes Association's meeting for new DPP-4 inhibitors for diabetes. Takeda is the latest, demonstrating that its alogliptin can control blood sugar alone or in combination with other therapies. AstraZeneca has already presented data on saxagliptin. Taken for 26 weeks, says Takeda, alogliptin can cut hemoglobin A1C by 0.6 percent at its strongest dose. DPP-4s have a mixed record. Merck has a therapy on the market--Januvia--while Novartis' Galvus has yet to be approved.

Merck, meanwhile, revealed new data backing Januvia, saying the drug targets key cells in attacking diabetes. And researchers said the DPP-4 inhibitor reduced the risk of hypoglycaemia, a potentially fatal side effect.

- read the AFX report
- read the story from Hemscott

ALSO NOTED: ASCO already churning out news; Lilly, FDA ironing out Zyprexa shot problems; and much more...

Fri, 30 May 2008 06:59:50 -0400

> Today marks the start of the annual ASCO. Here's a round-up of some of the news coming out of the conference. ASCO report

> More from the Web-marketing frontier, where portals and blogs are passé: An Arizona entrepreneur is working up a site where cancer doctors and drugmakers can mix and mingle. Report

> Pharmacy records could soon become an open book in California. Yesterday, the state Senate passed a bill allowing pharmacies to sell patient info to third-party firms working for drugmakers. Report

> Eli Lilly says it's making progress with the FDA on approval of its long-acting, injectable form of Zyprexa. FDA report

And Finally... Solving the mystery of why type 1 diabetes is so prevalent in Finland could be the key to teasing out the causes of the disease. Report

EmergingMed matches patients with clinical trials

Wed, 14 May 2008 06:59:55 -0400

Recruiting the right number of the right patients for any clinical trial can be a tough prospect. Now there are a host of new efforts to match a patient with a clinical trial, including a service offered by the for-profit company EmergingMed. Analysts note that only about a quarter of the 200,000 eligible U.S. patients diagnosed with cancer participate in clinical trials each year. And while there are a number of reasons cited, the primary cause appears to be simple ignorance about what's going on.

The Wall Street Journal notes that there are a number of new outreach efforts that are being launched, but one of the most intriguing is operated by EmergingMed, which helps coordinate a patient's search for the right trial.

"We need to explain to the American public that the drugs we are benefiting from today did not come out of thin air," says Armin Weinberg, director of Baylor College of Medicine's Chronic Disease Prevention and Control Research Center in Houston. "Their participation in trials is the thing that is going to help us advance in all these battles against cancer, asthma, diabetes and hypertension."

- check out this release on the matching service
- read the article from the Wall Street Journal

Pfizer builds plant, creates jobs in Ireland

Fri, 02 May 2008 06:59:58 -0400

Pfizer has finally confirmed earlier reports about its plan to build a biologics manufacturing facility in County Cork, Ireland. The company is investing €190 million ($297 million) in the new facility and anticipates creating 100 jobs. The plant will manufacture small amounts of biologic treatments for use in Phase II and III cancer and diabetes clinical trials. It will be situated next to Pfizer's other Cork facility and is expected to be completed in 2009.

"Our aim is to gain access to the best science inside and outside our walls, and the new Shanbally facility will ensure that we can produce the product for clinical trials which could ultimately impact the lives of millions of patients," said Nat Ricciardi of Pfizer Global Manufacturing.

Pfizer's investment is good news for Ireland. Late last year Amgen said it would "postpone indefinitely" a planned €800 million manufacturing facility in Cork, much to country's disappointment.

- here's the report for more

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

AtheroGenics shares soar on diabetes data

Mon, 14 Apr 2008 06:59:57 -0400

Shares of AtheroGenics shot up this morning on the news that an interim analysis of late-stage data for AGI-1067 showed a statistically significant reduction in Hemoglobin A1c--a standard measure for blood sugar control. Their ANDES study examines the effect of two daily doses of the therapy over a period of six months. The interim analysis covers 806 patients who had completed three months of therapy. Mean changes for patients in the 150 mg, 75 mg, and placebo arms were 0.5 percent, 0.3 percent, and 0.1 percent.

"We are encouraged by these early results, which show a meaningful reduction in blood sugar for patients with diabetes taking AGI-1067," said Alexander Fleming, M.D., Acting Chief Medical Officer. "The interim data also suggest that this three month assessment may not be capturing the full effect of AGI-1067 on A1c reduction."

"These interim results reinforce our belief that AGI-1067 may have the potential to introduce a new therapeutic approach for the treatment of patients with diabetes," said CEO Russell M. Medford, M.D., Ph.D.

- read the press release

Related Articles:
Speculation heats up on fate of AGI-1067. Report
Failed AtheroGenics drug may work as diabetes therapy. AtheroGenics report
AtheroGenics halts high-dose AGI-1067 in trial. AtheroGenics report

Keryx triggers big shakeup to counter trial fiasco

Mon, 07 Apr 2008 06:59:58 -0400

Less than a month after seeing its lead drug candidate go down in flames in a late-stage trial, Keryx Biopharmaceuticals announced plans to restructure, chopping its work force in half as it reduces the company's burn rate. Keryx announced that it will have 25 full- and part-time workers when the restructuring is complete.

Keryx's plans include continuing R&D for Zerenex but cutting 12 of 20 early-stage trials of KRX-0401, delaying a late-stage trial of KRX-0401, terminating a licensing deal and closing offices in San Francisco and Memphis as well as its manufacturing site in Wisconsin. And in pursuit of new capital, Keryx has begun to hunt out new partnerships, strategic alliances and "product-specific financing alternatives." Keryx ended the first quarter of this year with about $50 million.

Keryx's troubles crystallized last month with the late-stage failure of the diabetes drug Sulonex. Sulonex, which Keryx dumped at the end of March, worked no better than a placebo in a pivotal clinical trial.

- check out the press release

Related Articles:
Keryx shares in meltdown after late-stage failure. Report
Keryx inks $100M deal with Japan Tobacco. Report
Keryx sells shares. Report
Keryx drug best at low dose. Report

Developers: Politics behind slow approval process

Wed, 26 Mar 2008 07:59:57 -0400

Woodcock's defense, though, may seem particularly hard to accept at a slate of big pharma companies which have been able to win European approvals only to run straight into a roadblock at the U.S. agency. Galvus, Acomplia and Cervarix have all been OK'd by the European Medicines Agency, but are still languishing at the FDA. And Novartis says it may simply skip the U.S. market for Galvus if the feds raise the bar too high for the diabetes drug. The Wall Street Journal notes that a number of analysts believe the FDA faces a higher degree of public and political pressure during the approval process--precisely the kind of influences that Woodcock rejects as a significant factor.

"The scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill," says James Shannon, Novartis' departing head of drug development. "I think it results in them taking decisions which are conservative."

- read the story in the Wall Street Journal

Related Articles:
FDA getting tougher with refuse-to-file letters. Report
The FDA: Caught between a rock and a hard place. Report
FDA quick to reject drugs as it gets more cautious. Report
Dry spell or parched desert for NME approvals? Report
Blogster sees lessons in FDA approvable letters. report

Emisphere chief sees plenty of new potential for technology

Thu, 20 Mar 2008 07:59:55 -0400

When Michael Novinski took over as CEO of Emisphere Technologies, he was acutely aware of just how unsuccessful the developer had been. For 20 years, he tells the Star-Ledger, Emisphere was never able to get a single mid-stage trial right. Efforts to develop pill versions of insulin and heparin foundered as ithe company struggled. But the former president of Organon BioSciences says the company has a lot of untapped potential. A co-development deal for a pill version of Novartis' osteoarthritis and osteoporosis therapies has been struck and Novinski believes FDA approval could be only a year or two away. Novinski also believes that more such deals involving Emisphere's eli gen technology can be struck. Meanwhile, researchers for Emisphere are on the trail of a pill for diabetes.

- read the article in the Star-Ledger

Related Articles:
Emisphere agrees to $18M settlement. Report
Emisphere fires CEO. Report

Axial Biotech snares $6M tranche of venture funding

Mon, 17 Mar 2008 07:59:54 -0400

Johnson & Johnson Development Corporation along with vSpring Capital and Ohio Biotech Group have stepped in to provide a $6 million tranche for Axial Biotech's second round of venture capital. Axial is advancing new technology in molecular diagnostics and motion preserving to develop a genetic prognostic test for Adolescent Idiopathic Scoliosis. Axial says it has met several scientific milestones in its work on the test.

- see this release for more

ALSO: EnGene, which is developing a treatment for diabetes called GEMS-Insulin, announced today it has raised $6.4 million in a Series A financing. Release

Transition inks $137M diabetes collaboration with Lilly

Fri, 14 Mar 2008 07:59:55 -0400

Eli Lilly has signed on to collaborate with Transition Therapeutics on the development of Transition's diabetes therapies. Transition will pocket a $7 million upfront fee and stands to gain up to $130 million more in milestones. Transition has been advancing gastrin-based therapies. Researchers from both companies will collaborate on a mid-stage trial of Transition's TT-223, after which Lilly takes over development responsibilities. They're following up on research that indicates that gastrin analogues--either alone or in combination with existing therapies--could play a key role in sustained glucose control for type 2 diabetes patients. Some terms of the deal were not disclosed. Shares of the Toronto-based Transition surged about 5 percent this morning.

- check out the AFX report
- here's the press release

Merck inks diabetes deal with fledgling Marcadia

Fri, 07 Mar 2008 06:59:57 -0500

Fledgling developer Marcadia Biotech has lined itself up with the pharmaceutical giant Merck in a licensing deal on the Indianapolis-based developer's work in diabetes. Marcadia has been working with the research of Dr. Richard DiMarchi, who moved to Indiana University's chemistry department after working at Eli Lilly. Merck has gained rights to some of Marcadia's drug candidates and is putting up an unspecified amount of money for collaborative research and milestone payments.

"Marcadia has generated a unique collection of peptide drug candidates with potentially novel therapeutic attributes," said Merck's Senior Vice President Luciano Rossetti M.D. "This latest collaboration underscores our strategy to establish a robust early-stage pipeline that delivers superior diabetes and obesity therapies."

- here's the press release
- read the report from the Indianapolis Business Journal

Related Article:
Fortune scolds Merck for "risky" programs. Report

Analyst sees tighter diabetes drugs standards

Tue, 04 Mar 2008 06:59:54 -0500

Stricter data standards at the FDA could delay an approval of Amylin Pharmaceuticals' new diabetes drug, according to analysts. In a draft of new trial guidelines, the FDA outlined more tests for the macrovascular complications that could be presented by a diabetes drug. Lazard Capital Markets analyst Matthew Osborne signaled that the FDA's stance on large vein diseases particularly threatens Amylin's prospects for exenatide LAR, a long-acting version of Byetta. It could also indicate a general tightening of diabetes standards that could make the discovery process longer and more expensive.

"It appears that now the FDA will start to require of all drugs particularly for diabetes that more safety and efficacy data are generated, and how this will play out with individual agents including exenatide LAR is uncertain," he wrote. His view helped send Amylin shares down four percent.

- read the AP report

Related Articles:
Amylin data doesn't impress Wall Street. Report
Psychogenics, Amylin create new development company. Report
Amylin shares shoot up on Phase II Byetta results. Report
Amylin reports weight-loss success with Symlin. Report
Diabetes market in flux as FDA mandates new warnings. Report

SPOTLIGHT: Takeda NDA triggers milestone

Fri, 29 Feb 2008 06:59:53 -0500

The FDA has accepted Takeda Pharmaceutical's NDA for alogliptin, a DPP-4 inhibitor for type 2 diabetes. The FDA's acceptance of the NDA filing triggers a $15 million milestone payment to PPD. Release

Novocell reports breakthrough in diabetes cure

Thu, 21 Feb 2008 06:59:57 -0500

Researchers at Novocell report a key breakthrough in their program to find a cure for diabetes. The company reports that the researchers were able to turn embryonic stem cells into insulin-producing cells in mice. And after the mice's insulin-producing cells had been destroyed, the new cells kept their blood sugar levels in check.

"For those who say there is not much evidence that embryonic stem cells can cure diabetes, there you go," Dr. Camillo Ricordi, director of the Diabetes Research Institute at the University of Miami told The New York Times. Dr. Ricordi was not involved in the research program. The research did raise red flags, though. Some of the mice in the study developed tumors and there were questions raised whether the cells were characterized well enough for use in humans. Human trials are still several years away.

- read the article in The New York Times

Related Articles:
Novocell garners $25M for stem cell work. Report
Novocell scientists create insulin-producing cells. Report
ESC therapies in race to the clinic. Report