safety data

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 buys Sirtris for $720M

Wed, 23 Apr 2008 06:59:58 -0400

GlaxoSmithKline is acquiring Cambridge, MA-based Sirtris Pharmaceuticals for $720 million. GSK will pay $22.50 per share for the company--an 84 percent premium to Sirtris's closing price Tuesday. GSK says that the buyout will boost its metabolic, neurology, immunology and inflammation research efforts by establishing a presence in the field of sirtuins--a class of enzymes that may be involved in the aging process.

Sirtris has grabbed headlines for it work in the field of aging. Earlier this year the company presented positive, early-stage data for its closely-watched therapy based on resveratrol, an ingredient in red wine that has been linked to increased longevity. In a small diabetes trial the drug delivered positive safety data and demonstrated its ability to cut blood glucose levels.

"Modulation of this family of enzymes is a potentially transformative science that could address diseases associated with metabolism and aging such as diabetes, muscle wasting, and neurodegeneration," commented Moncef Slaoui, Chairman GSK R&D. "This acquisition continues GSK's strategy of pursuing the best new science, externally or internally, to bring new medicines to patients and value to the GSK pipeline." Sirtris will remain an autonomous unit. Sirtris was a 2007 Fierce 15 company.

- see GlaxoSmithKline's release
- read this Wall Street Journal report for more

ALSO: GSK is hoping to make a splash at this year's ASCO meeting. GSK release

PLUS: GSK reported its quarterly earnings. Report

Morphotek licenses anti-cancer antibody

Thu, 06 Mar 2008 06:59:57 -0500

Morphotek has inked a deal with Human Monoclonals International to get rights to a human monoclonal IgM antibody that is specific to a cancer cell surface antigen. The company hopes to develop a lead therapeutic MAb and high-titer cell lines suitable for scalable manufacturing. Morphotek, which was acquired by Eisai last year, has a pipeline of antibodies in development for cancer, rheumatoid arthritis, and infectious disease. Financial terms of the deal were not disclosed.

"This agreement provides yet another important addition to our therapeutic antibody portfolio," said Nicholas Nicolaides, Ph.D., Morphotek's president and CEO. "Safety data and positive clinical observations from an exploratory Phase I clinical trial in patients with metastatic melanoma have been reported. Our antibody optimization and development expertise will enable the further development of this promising antibody and clinical proof-of-concept studies in more types of cancer."

- check out the release

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Prana shares soar on IIa Alzheimer's data

Wed, 27 Feb 2008 06:59:57 -0500

Positive efficacy and safety data from a Phase IIa study of an experimental Alzheimer's treatment from Australia's Prana Biotechnology sent its shares soaring more than 50 percent yesterday. The 78-patient study of PBT2 demonstrated a statistically significant response in two of the four "executive function tests" studied in the trial. For tiny Prana, which has been working on its Alzheimer's therapy for years, the data could have big implications. Instead of attempting to reduce the secretion of amyloid proteins associated with plaque, PBT2 attempts to stop the reaction between the proteins and zinc and copper in the brain. As CNBC's Mike Huckman points out, the data significantly boosts Prana's opportunities to strike a rich collaboration deal.

"This is a very exciting and important milestone for the company, particularly because PBT2, a drug known to inhibit the toxic oligomers of Abeta that cause the functional damage in Alzheimer's disease, was able to show such a clear effect in a short trial," said Prana in a statement.

- see the release
- read the report from Hemscott
- and check out the comments from CNBC

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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

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FDA needs more data on Adolor drug. Report
Adolor hit by FDA's approvable letter for Entereg. Report

Entereg wins key FDA advisory committee vote

Thu, 24 Jan 2008 06:59:56 -0500

The FDA's gastrointestinal drug advisory committee narrowly endorsed Entereg, a new drug for postoperative ileus in bowel resection. The vote came down 9 to 6 in Entereg's favor. The FDA is considering an NDA for the drug, which is being developed by Adolor and GlaxoSmithKline. There are currently no drugs approved for this indication.

"A majority of the committee agreed that Entereg produced clinically meaningful acceleration in [gastrointestinal] recovery in bowel resection patients," said Yvonne Greenstreet, senior vice president of the medicine development center at Glaxo, in a statement. "Postoperative ileus can be uncomfortable for the patient, hinder post surgical recovery and delay hospital discharge in bowel resection patients."

- see this release
- check out the report from AFX

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Adolor shares rise on NDA news. Report
Investors cheer FDA's acceptance of Entereg response. Report
FDA wants more safety data on Entereg. Report
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FDA needs more data on Adolor drug. Report
Adolor hit by FDA's approvable letter for Entereg. Report

YM shares hit on clinical trial hold

Thu, 17 Jan 2008 06:59:57 -0500

Canada's YM BioSciences saw its stock take a nasty hit after it announced that the FDA had put a mid-stage trial of its AeroLEF pain therapy on hold as it seeks safety data on volunteers in earlier studies. YM BioSciences says the agency wants data on patients who experienced oxygen desaturation during clinical trials, adding that a subgroup analysis will be conducted. Shares were down 15 percent this morning.

"Data reported in May 2007 from our successful randomized Phase IIb trial demonstrated that patients had a statistical and clinical benefit from AeroLEF," said Dr. Diana Pliura, YM's executive vice president. "We remain strongly committed to the clinical development of this unique product.'

- see this release

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YM gets discouraging preliminary pain data. Report

FDA wants time to ponder Progenics, Wyeth drug

Thu, 10 Jan 2008 06:59:54 -0500

Regulators have tacked on an additional three months of review time for subcutaneous methylnaltrexone--being developed by Wyeth and Progenics--so it can take more time to review safety data on the drug. Regulators want new data on the opioid-induced constipation drug's affect on QT prolongation, where the heart cannot pump blood throughout the entire body. Researchers for the companies say there is no evidence of a QT prolongation effect.

"We, along with our collaborator, Wyeth, are confident in our subcutaneous methylnaltrexone submission," says Paul J. Maddon, M.D., Ph.D, Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "We are enthusiastic about the entire methylnaltrexone program and plan to submit an NDA for the intravenous formulation of methylnaltrexone for the management of post-operative ileus later this year."

- here's the release

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Sirtris causes stir with positive trial data

Tue, 08 Jan 2008 06:59:57 -0500

Sirtris grabbed some headlines at the JP Morgan gathering in San Francisco with its presentation of positive, early-stage data for its closely watched therapy based on resveratrol, an ingredient in red wine that has been linked to increased longevity. In a small diabetes trial the drug delivered positive safety data and demonstrated its ability to cut blood glucose levels. The drug is also in a mid-stage trial in combination with metformin as a therapy for diabetes.

"This is the first time that a small molecule targeting sirtuins, the genes which control the aging process, has shown efficacy in a disease of ageing," said Dr Peter Elliott, senior vice president of development at Sirtris, a 2007 Fierce 15 company. "We are very pleased to see the safety profile observed in preclinical studies translate into a well-tolerated drug molecule in patients, and we are very encouraged by the glucose-lowering effects measured in the oral glucose test."

- check out this release
- read the report on Sirtris in The Telegraph

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Investors fret over Lilly's pipeline, Prasugel data

Wed, 21 Nov 2007 06:59:55 -0500

Barron's concludes that Eli Lilly's anti-clotting drug Prasrugel will probably make it to the market, but recent safety data is likely to prevent it from becoming the kind of blockbuster the drug company badly needs. How badly? A series of upcoming patent expirations will potentially trim up to 60 percent of its revenue. Other big competitor drugs are going to go generic relatively soon. And if physicians are scared away from preferring Prasrugel to Plavix, that's one more big gap to fill on Lilly's financial horizon. Even more worrisome, analysts can't find any other potential blockbusters in the Lilly pipeline. It all spells trouble for the company's stock price, which has shrunk considerably since it issued its latest batch of Prasrugel data.

- read the report on Lilly from Smart Money

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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

ViroPharma, Wyeth halt HCV study

Fri, 10 Aug 2007 06:59:57 -0400

That's not all the bad news for Wyeth today. In yet another blow, the company and its partner ViroPharma have stopped dosing patients with HCV-796, a Phase II hepatitis C drug candidate. The decision follows a review by the joint safety review board of safety data accumulated to date, which shows elevated liver enzyme levels in some patients after eight weeks or more of therapy with HCV-796 with pegylated interferon and ribavirin. Two study subjects experienced serious adverse events and dropped out of the trial. The companies said they will analyze safety data in order to determine the fate of HCV-796.

- see this release

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Acambis' universal vaccine begins human clinical trials

Tue, 17 Jul 2007 06:59:54 -0400

Acambis is putting its universal vaccine approach to influenza to the test as it launches a Phase I trial for ACAM-FLU-A, a universal therapy for all type "A" strains of the influenza virus. Researchers are looking for both efficacy as well as safety data by around the end of the year. The vaccine has potential as a therapy for use against a pandemic flu as well as seasonal flu. Pandemics are typically triggered by an "A" strain flu while seasonal flus are both "A" and "B" strains.

- read the report on Acambis from Hemscott

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Press Release: Bayer HealthCare Discontinues Trasylol Program In Non-CABG Indications

Maureen Martino — Fri, 26 Jan 2007 11:17:29 -0500

Bayer HealthCare Discontinues Trasylol(R) Clinical Trial Program In Non-CABG Indications

LEVERKUSEN, Germany, and WEST HAVEN, Conn., Jan. 25 -- Bayer HealthCare has decided to end three ongoing clinical studies investigating the safety and efficacy of Trasylol® (aprotinin injection) on transfusion requirements and blood loss in adults undergoing: elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer.

The Trasylol labelling that was recently approved in the U.S. and is in the approval process in the European Union and other countries, includes a recommendation that in order to manage possible anaphylactic reactions, Trasylol should be administered only in surgical settings where cardiopulmonary bypass (CPB) can be rapidly initiated. The use of CPB is not practical in non-cardiac surgical settings.

Bayer's decision to discontinue these trials was not made based on any safety findings in these non-CABG studies. On November 18, 2006 an independent Data Monitoring Committee (DMC) reviewed safety data on these three studies, examining data for the first 120 patients randomized. Based on their review of these safety data, the DMC concluded that " ... these three clinical trials could continue as planned without modification."

Trasylol is the only drug approved by the FDA and several other regulatory authorities to reduce blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery in patients who are at an increased risk for blood loss and blood transfusion. Dr. Paul Mac Carthy, Vice President, Medical Affairs Bayer Pharmaceuticals Corporation said, "We believe that Trasylol can continue to provide important benefits for CABG surgery patients and, therefore, fills an important role for their cardiac surgeons."

The current U.S. Prescribing Information for Trasylol is available on http://www.trasylol.com. If you wish to request further information, please contact Bayer Pharmaceuticals Corporation Clinical Communications at 1-800- 288-8371.

About Trasylol

Trasylol® is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. The effects of Trasylol use in CPB involve a reduction in systemic inflammatory response to surgery, which translates into a decreased need for allogeneic (blood donated from another individual) blood transfusions reduced bleeding and decreased mediastinal re-exploration for bleeding.

Trasylol® administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to Trasylol® administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. Trasylol® should be administered only in operative settings where cardio-pulmonary bypass can be rapidly initiated. The benefit of Trasylol® to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin. (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS in the prescribing information.)

Safety Considerations

Trasylol is contraindicated in patients with a known or suspected aprotinin exposure during the last 12 months. Aprotinin may also be a component of some fibrin sealant products.

* In clinical studies, hypersensitivity and anaphylactic reactions were

rare (<0.1%) in patients with no prior exposure to Trasylol.

Trasylol administration increases the risk for renal dysfunction and may increase the need for dialysis in the perioperative period.

* This risk may be increased for patients with pre-existing renal impairment or those who receive aminoglycosides or drugs that alter renal function. * The incidence of serum creatinine elevations >0.5 mg/dL above pre- treatment levels was statistically higher in the high-dose aprotinin group (9.0%) compared with placebo (6.6%).

In clinical trials Trasylol did not increase the risk of the following perioperative events: myocardial infarction, hepatic dysfunction and mortality.

About Bayer HealthCare

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.

Forward-Looking Statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports file with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Press Release: Safety Monitoring Board Recommends Continuation of EntreMed's MKC-1 Phase 2 Breast Cancer Study

Maureen Martino — Tue, 23 Jan 2007 11:12:30 -0500

Safety Monitoring Board Recommends Continuation of EntreMed's MKC-1 Phase 2 Breast Cancer Study

Supply Agreement Also Completed With Roche for MKC-1 Drug Substance

ROCKVILLE, Md., Jan. 23 -- EntreMed, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced a favorable review of MKC-1 safety data by an independent Data Safety Monitoring Board (DSMB). The review was undertaken to assess the safety of MKC-1 in a Phase 2 multi-center clinical trial in patients with advanced or metastatic breast cancer who have failed conventional therapies.

The DSMB concluded that the apparent risk, based on the current safety data review for MKC-1, was appropriate for the population under study. The DSMB also felt that the study did not require any modification, and that the Phase 2 study in patients with metastatic breast cancer should continue as currently designed. The study is being conducted at multiple centers across the United States and is evaluating the safety and efficacy of MKC-1 in metastatic breast cancer patients who have failed therapy with anthracylines and taxanes.

EntreMed also announced that it recently completed the purchase of all remaining bulk quantities of the active pharmaceutical ingredient (API) for MKC-1 from Roche. EntreMed has a worldwide, exclusive license from Roche to develop and commercialize MKC-1. In addition to the clinical trial in metastatic breast cancer, MKC-1 is currently in Phase 1 and 2 clinical studies in patients with non-small cell lung cancer (NSCLC) and hematological (blood) malignancies.

James S. Burns, EntreMed's President and Chief Executive Officer, commented, "Given questions about the toxicity of MKC-1 observed in prior clinical studies using higher doses and shorter schedules, it was important for us to demonstrate MKC-1's safety and tolerability using the 14-day schedule. The DSMB's recommendation that the MKC-1 clinical study in patients with metastatic breast cancer proceed without modification will allow us to continue evaluation of the efficacy of MKC-1 in this patient population. We are continuing to enroll patients in leukemia and non-small cell lung cancer trials, and we expect to report preliminary results from the metastatic breast cancer clinical trial during the first half of this year. Furthermore, the Roche supply agreement provides EntreMed with the means to pursue its clinical development program for MKC-1 with sufficient GMP material at a reasonable cost in anticipation of future pivotal clinical trials."

About MKC-1

MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. In previous studies, MKC-1 demonstrated broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models. MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis. These effects are consistent with mechanisms resulting from MKC-1 binding to multiple intracellular targets, including tubulin and the importin-beta proteins. The importin-beta family of proteins plays a critical role in nuclear transport and cell division.

About EntreMed

EntreMed, Inc. (Nasdaq: ENMD - News) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem® (2-methoxyestradiol or 2ME2), the Company's lead drug candidate, is currently in Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell cycle regulator, is in Phase 2 studies for cancer. ENMD-1198, a novel tubulin binding agent, is also in Phase 1 studies in advanced cancers. EntreMed's goal is to develop and commercialize new compounds based on the Company's expertise in angiogenesis, cell cycle regulation and inflammation -- processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company's website at http://www.entremed.com and in various filings with the Securities and Exchange Commission.

Forward Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance (including the timing of royalty revenues and future R&D expenditures), strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in Securities and Exchange Commission filings under "Risk Factors," including risks relating to the need for additional capital and the uncertainty of additional funding; variations in actual sales of Thalomid®, risks associated with the integration of Miikana and its product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results, uncertainties relating to preclinical and clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).

Northfield shares hammered on late-stage results

Tue, 19 Dec 2006 19:01:38 -0500

Shares of Northfield Labs were halved after the company announced that a higher number of patients receiving its blood substitute died in a late-stage study compared to the number of deaths among patients getting standard care. Altogether, 46 of 349 patients receiving PolyHeme died compared to the deaths of 35 people among 365 receiving standard care. Northfield maintains that part of the data supports PolyHeme and added that mistakes were made in the trial. But investors bailed, sending its shares down 51 percent, which followed a 20 percent dive that occurred Tuesday after the company announced its plans to discuss the data.

Northfield insists that once you exclude the people who were inappropriately enrolled or improperly treated, Polyheme demonstrated that it was not inferior to standard therapy. More safety data will be available in four to six weeks, researchers added, as the company plans to proceed with an application for FDA approval. A number of analysts weren't buying it, though, saying that any application from Northfield would be subject to intense scrutiny.

- check out Northfield's press release on the data
- here's the article from The Chicago Sun-Times

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Adolor hit by FDA's approvable letter for Entereg

Sun, 05 Nov 2006 19:01:36 -0500

Adolor shares took a tumble early this morning after the company announced that the FDA had issued an approvable letter for the postoperative bowel therapy Entereg, a drug it is developing with GlaxoSmithKline. Glaxo shares shed some value in early trading as analysts seemed chiefly concerned that this new delay for Entereg signaled yet another holdup for the big European drug developer. The FDA asked for 12-month safety data including an analysis of cardiovascular risks as well as a risk management plan. An ongoing study of Entereg should wrap in the first quarter of 2007. Data from an Entereg study demonstrated that patients taking the disease who had heart disease were at a high risk of cardiovascular events, an outcome researchers for the companies said was to be expected. Entereg is being developed to treat the nausea, vomiting and other side effects commonly associated with surgery. The ongoing late-stage trial is to determine Entereg's ability to relieve constipation among patients taking opiates for chronic pain.

- here's the AP report on Entereg

Related Articles:
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GSK, Adolor upbeat on Phase IIb Entereg data. Report

Bayer kept Trasylol safety study hidden from FDA

Sun, 01 Oct 2006 20:01:37 -0400

Just days after an FDA advisory committee recommended against adding new warnings on the controversial heart surgery drug Trasylol, the German drug giant Bayer announced that it had not revealed new study data that indicated the drug--designed to prevent bleeding during surgery--was linked to elevated risks of kidney damage, increased risk of stroke, congestive heart failure and death. In a prepared statement, Bayer said that it had "mistakenly" not included data drawn from the evaluation of 67,000 hospital records. It made the announcement after the scientist in charge of the study asked the company to unveil the data. Bayer had contracted with the data mining company Ingenix to look at the records. The drug maker says the data was preliminary and that the study raised serious questions about its methodology, but should have been made available to the FDA. Bayer says it will investigate the incident and take action. The agency is particularly sensitive to safety data following two years of harsh accusations that it has been lax in safeguarding the public from dangerous drugs like Vioxx.

- read the report on the controversy from Forbes

Cardiome upbeat on mid-stage heart drug data

Tue, 12 Sep 2006 20:01:35 -0400

Canada's Cadiome announced that the lower of two doses in a Phase IIa trial of RSD1235 for atrial fibrillation hit its primary endpoint and that the drug demonstrated a good safety profile. A higher dose of the drug "trended" positive but did not achieve a statistically significant improvement in volunteers. Eight percent of patients taking a placebo reported a serious adverse event compared to 10 percent taking the lower dose of the drug and 11 percent taking 600 mg doses.

"This clinical trial has exceeded our expectations, reinforcing the signal we saw in the 300mg interim results and giving us an even greater degree of confidence in the potential for RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation," said Bob Rieder, CEO of Cardiome. "In particular, we are encouraged by the strong safety data we've seen in a target patient population which includes a high proportion of older patients and patients with congestive heart failure."

- see the release on the trial