Entereg

FDA OKs Adolor's Entereg in first approval

Wed, 21 May 2008 06:59:56 -0400

Exton, PA-based Adolor hit a major milestone with the FDA's approval of Entereg for postoperative ileus, a common condition following surgery that can extend a patient's hospital stay. This is the first approval for Adolor, which partnered with GlaxoSmithKline to get the drug through the approval process. Adolor gained $50 million up front from its pact with GSK and signed on to up to $220 million more in milestones.

The FDA's approval marks "the culmination of a substantial collaborative effort among Adolor, GlaxoSmithKline, and our clinical investigators," Adolor CEO Michael R. Dougherty said in a statement. "Entereg is the first and only product that has demonstrated the ability to address this serious condition, which has negative consequences for patients, and imposes considerable expense on the health-care system."

It wasn't easy. Researchers had to deal with two approvable letters from the FDA, in 2005 and 2006, and a three-month delay at the beginning of the year.

- check out this release
- read the report from the Triangle Business Journal

FDA delays Entereg decision

Fri, 09 May 2008 06:59:58 -0400

GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. The FDA informed the companies that it would not make a decision by Saturday, the drug's PDUFA date. No date was given but the FDA said it would provide further details soon in an action letter.

GSK and Adolor have been attempting to gain FDA approval for Entereg since 2006, when the agency issued an approval letter and asked the companies for additional safety data. If approved, Entereg will be used to treat postoperative ileus in bowel resection.

- here's the release

GSK, Adolor face another Entereg delay

Mon, 11 Feb 2008 06:59:58 -0500

The FDA has told Adolor and GSK that it will take three more months to review Entereg, a anti-constipation drug candidate. The agency is now expected to announce its decision on May 10. Recently, an FDA advisory committee narrowly endorsed the drug, saying that the benefits of the drug outweigh the potential risk of heart attacks that has been associated with Entereg. Adolor also submitted an updated risk management plan for the drug today.

GSK and Adolor have been attempting to gain FDA approval for Entereg since 2006, when the agency issued an approval letter and asked the companies for additional safety data.

- see this release for more

Related Articles:
Entereg wins key FDA advisory committee vote. Report
Adolor shares rise on NDA news. Report
Investors cheer FDA's acceptance of Entereg response. Report
FDA wants more safety data on Entereg. Report
Adolor shelves Entereg studies; shares plunge. Report
FDA needs more data on Adolor drug. Report
Adolor hit by FDA's approvable letter for Entereg. Report

ALSO NOTED: Adolor shares rise on NDA news; Indevus plans Phase III; Exelixis earns milestone; and much more...

Thu, 29 Nov 2007 06:59:50 -0500

> Shares of Adolor surged on the news that the FDA's Gastrointestinal Drugs Advisory Committee will review the new drug application for the pain drug Entereg on Jan. 23. Report

> Backed by a fresh batch of positive, mid-stage data for its experimental therapy to treat a rare hormone condition, Indevus says it will launch Phase III by mid-2008. Release

> Exelixis has earned a $5 million milestone payment from Bristol-Myers Squibb. Report

> Belgium's Galapagos wins up to $2.4 million in upfront fees and research funds in a development deal with Cystic Fibrosis Foundation Therapeutics. Up to $5.7 million in milestones is also on the table. Report

> Protein therapy company Medgenics has raised £3.28 million from a share placing with investors. Report

> AstraZeneca got a bit of a windfall today from the FDA, which granted six extra months of exclusive marketing rights to its Arimidex cancer drug. Report

> New warnings and warning recommendations are flying out of the FDA this week like geese flying south for the winter, partly because of an FDA advisory panel is meeting. Report

> Talk about an outpouring of adverse-event reports. After WFAA-TV in Dallas reported musician Carter Albrecht's violent death--perhaps under the influence of Pfizer's smoking-cessation drug Chantix--more than 5,000 complaints about the med's side effects poured into the FDA. Report

And Finally… Hospital superbugs that can break down antibiotics are so widespread throughout Europe that doctors increasingly have to use the few remaining drugs that they reserve for emergencies. Release

ALSO NOTED: Vernalis reports "striking" weight loss in trial; Genmab shares surge on Phase III; FDA wants more time on Entereg;

Thu, 13 Sep 2007 06:59:50 -0400

> Vernalis is reporting "striking" weight loss results in its Phase I trial of the obesity drug V24343. Release

> Shares of Genmab surged today after the company reported that it's pushing HuMax-EGFr (zalutumumab) into Phase III for head and neck cancer. Report

> Adolor says that the FDA wants more time to review submissions before it decides on whether it will lift a clinical hold on Entereg for postoperative ileus. Report

> A new study of the breast cancer drug tamoxifen demonstrates that it not only works against bipolar disease, it also works faster than many standard therapies. Report

> Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America announced that the first patient has been enrolled in a Phase III study of lubiprostone for opioid-induced bowel dysfunction. Release

> Anesiva has initiated a new Phase II study of Adlea for the relief of post-operative pain in patients undergoing total knee replacement surgery. Release

> Trasylol got something of a reprieve yesterday when an FDA advisory panel recommended that it stay on the market. Report

> When does good news feel almost bad? When a blockbuster drug is deemed the juiciest on the market--but the wolves are circling. If this sounds like Lipitor to you, you're right. Report

And Finally… A U.S. biotech company, Yorktown Technologies, is seeking regulatory permission to import and sell fish that have been genetically modified to glow. Researchers have been developing the fish to identify contaminated waters--though it looks like there could be quite a market among exotic fish lovers. Report

Investors cheer FDA's acceptance of Entereg response

Tue, 28 Aug 2007 06:59:54 -0400

Shares of Adolor took off this morning, climbing 18 percent after the company issued a joint release with GlaxoSmithKline that the FDA had accepted their response to the agency's approvable letter for the constipation drug Entereg (alvimopan). The FDA had placed the trials on clinical hold and asked for more data. The companies are waiting on a request to lift the clinical hold so they can resume trials.

"The FDA informed Adolor that the response is considered a complete class 2 response with a Prescription Drug User Fee Act (PDUFA) goal date of February 10, 2008," according to the release.

- see the release
- read the report from Hemscott

Related Articles:
FDA wants more safety data on Entereg. Report
Adolor shelves Entereg studies; shares plunge. Report
FDA needs more data on Adolor drug. Report
Adolor hit by FDA's approvable letter for Entereg. Report
Adolor shares in meltdown on trial data. Report