FDA regulation

FDA: Embeda could carry abuse risk

Maureen Martino — Thu, 13 Nov 2008 09:17:00 -0500

FDA staffers have expressed concern that Alpharma's powerful painkiller Embeda could be abused even though the company designed the drug not to be. Embeda contains morphine sulfate and Duramorph. Alpharma designed the med to be effective when taken as directed, but to be abuse-resistant if used orally. The FDA, however, says the drug could still be crushed and injected by addicts.

"[I]t is unknown what the potential effects of injecting this product following manipulation," wrote the FDA. "Since [Alpharma] only tested the effects of manipulation orally, we recommend consideration be given during evaluation of the application as to whether these known methods of misuse and abuse are impacted by the abuse deterrents in Embeda."

Embeda will be reviewed by an outside panel of experts Friday. Cowen and Co. analyst Ian Sanderson said he expects the drug to be approved, but that the FDA may be looking for labeling advice and a risk management program.

- see this report for more

Deadline clock running on Lilly's next big blockbuster

John Carroll — Mon, 22 Sep 2008 11:51:16 -0400

One of the biggest moves in biopharma this week will turn on the FDA's decision on prasugrel, a blood-clot drug advanced by Eli Lily and Daiichi Sankyo. Analysts pegged the decision as one of the biggest in quite some time for Lilly, which could push its stock up or down by as much as 10 percent once the agency makes its ruling by the September 26 deadline.

With no advisory guidance to work with, though, the analysts are somewhat mystified whether prasugrel's mixed data--demonstrating efficacy for heart ailments but raising worries about bleeding--will win an approval or not. The agency has been tougher to convince recently, as it grows more wary of potential drug safety fiascos. If prasugrel does get a green light, the drug is a likely blockbuster on the retail drug market.

"It's hard to call this one," Les Funtleyder, a drug analyst with Miller Tabak & Co., told the Star-Tribune. "The FDA is very cautious these days, and rightfully so. It has taken a very strict view of what it will approve."

- read the report from the Indianapolis Star-Tribune

ALSO: GlaxoSmithKline says that the FDA is still reviewing its clotting drug Promacta. Report

FDA delays Roche's blockbuster Actemra

John Carroll — Fri, 19 Sep 2008 10:20:25 -0400

The FDA is delaying approval of Roche's new rheumatoid arthritis drug Actemra, saying that it wants to see more information on the therapy. The news swiftly hit the share price of Chugai, Roche's partner on the drug. The FDA is looking for more information on manufacturing and the final label. But significantly the agency is not looking for more safety or efficacy data and is not asking for any time-consuming clinical trials.

Analysts widely expect Actemra to compete for blockbuster status with more than a billion dollars in annual revenue. The therapy is one of Roche's most promising new drugs. It blocks the IL-6 protein, which plays a role in inflammation. Despite the delay, analysts voiced their confidence of a pending approval.

- here's Roche's release on Actemra
- read the story from the Wall Street Journal

Biotech animals focus of regulatory review

John Carroll — Thu, 18 Sep 2008 11:27:00 -0400

Any biotech company that produces genetically engineered animals for drugs should be prepared to stay in close contact with the FDA. While genetic engineering is common in the food industry, a number of biotechs are also using the science to produce hormones and antibodies that can be used therapeutically. Any snippets of DNA that are introduced into an animal's genetic code will need to be shared with regulators. And the agency wants to know how any genetic changes could affect an animal's health.

BIO counts about a dozen companies that are working in the field. And BIO's Barbara Glenn says the FDA's action should make investors more confident now that the regulatory process has been clarified. "They know that we will reach commercialization of a product," Glenn tells the Washington Post.

- read the story from the Washington Post

Three new therapies approved by the FDA

John Carroll — Mon, 15 Sep 2008 12:01:53 -0400

There was a lot of action on the regulatory side of new drug discovery today. Here's a list of the top hits:

Denmark's Lundbeck has filed an NDA for is schizophrenia drug Serdolect. The drug has had a tremendously controversial history and was withdrawn in 1998--two years after its initial approval--on fears that it could trigger heart problems
The FDA has approved ProStrakan's patch to prevent nausea and vomiting among cancer patients. Sancuso has been in development for the past five years.
The FDA has approved Talecris Biotherapeutics' Gamunex, an immune globulin product for the treatment of chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder.
On Friday Merck's Gardasil was approved for two new gynecological cancers. Report

- here's the release on Serdolect
- read the ProStranka's release on Sancuso
- check out the Gamunex article
- see FiercePharma's Gardasil report

Pfizer's Fablyn may be linked to more deaths

Maureen Martino — Fri, 05 Sep 2008 11:31:13 -0400

The FDA is taking a critical look at Pfizer and Ligand's Fablyn, an osteoporosis drug the companies developed together that has been submitted to the FDA. Ahead of Monday's advisory panel meeting, the agency released data that showed women taking Fablyn had an increased chance of stroke and cancer-related death. Other side effects included blood clots and gynecological problems.

The drug was tested in 8,500 women. The percentage of women on the drug who experienced new fractures was 3.8 percent, compared to 6.4 percent taking placebo. Pfizer said the higher death rate in the Fablyn group is due to an unusually low rate in the control group. We'll have to wait until next week's advisory meeting to see if experts agree.

This isn't Fablyn's first go-around with the FDA. In 2005 the FDA rejected the drug, which at the time was known as Oporia.

- here's the BusinessWeek article

Related Article:
FDA rejects Pfizer's osteoporosis therapy (Sept. 2005)

FDA puts partial clinical hold on MethylGene program

John Carroll — Mon, 18 Aug 2008 12:14:34 -0400

Canada's MethylGene says that as a result of its voluntary decision to halt enrollment in a new drug study, the FDA has put a partial clinical hold on its lead development program in cancer. The agency says it is waiting to see data and a risk mitigation plan to protect volunteers in the study. MGCD0103 is partnered with Celgene as a therapy for solid tumors and hematological malignancies.

"Under the partial clinical hold, patients currently enrolled in MGCD0103 clinical trials who are confirmed to have no signs or symptoms of pericarditis or pericardial effusion may continue in their respective studies," the company stated in a release. "MethylGene and Celgene are working closely together with the FDA to complete this package and communicate it with the FDA to obtain approval to commence enrollment of new patients as soon as possible."

- read the press release
- check out the report on the Canadian Press

Report: FDA lax in clinical trial oversight

Fri, 28 Sep 2007 06:59:58 -0400

A new report has found that the FDA does little to protect the safety of patients who participate in clinical trials. Daniel R. Levinson, inspector general of the Department of Health and Human Services, has released a report slamming the FDA's oversight of the trials. The FDA has 350,000 testing sites but only 200 inspectors, some of whom work part time. The inspectors managed to visit less that 1 percent of testing sites. When problems were found at the sites, they were often overlooked by top FDA officials and the FDA rarely followed up with those that were cited for problems. One expert interviewed by the New York Times noted that animal testing has more stringent oversight than human testing in the U.S.

The OIG concluded that the FDA does not have a mechanism to identify all clinical trials and Institutional Review Boards. It also lacks a comprehensive database for tracking its inspections of clinical trials. "Data limitations hinder the FDA's ability to ensure that participants are protected from unreasonable risks," said Levinson. Janet Woodcock, director of the Center for Drug Evaluation and Research, acknowledged there problems with the inspection process and that the FDA is working to address them.

- see the OIG's release on the FDA
- read this article for more

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Drug safety system 'broken'. Report
IOM slams FDA, calls for major reforms. Report

Alcon faces setback on experimental AMD therapy

Tue, 25 Sep 2007 06:59:57 -0400

Shares of Alcon slipped this morning after the eye care giant announced that the FDA would require another trial of its experimental therapy for wet, age-related macular degeneration. Researchers for the company said there were no plans to mount a new trial of Retaane, due to the difficulty of finding volunteers and the presence of other therapies on the market. But it will wrap another trial of Retaane in three months which is focused on the drug's ability to prevent the disease from progressing from the dry form of age-related macular degeneration to the wet form.

- see Alcon's release for more

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Amgen discusses the future with analysts

Tue, 11 Sep 2007 06:59:58 -0400

Sure, we've got trouble, says Amgen CEO Kevin Sharer. But we can handle it. That's the bottom line from a Monday chat with investors, many of whom are more than a little worried by today's FDA panel meeting on anemia drugs. Amgen is out to counter a Medicare decision to curb the use of Aranesp and other anemia drugs. And the company, which has recently announced a major restructuring, can "hack it," he says reassuringly. Still, the biotech giant notes that it is besieged by some critical problems.

"We're a company that obviously has more than our share of challenges right now," Sharer told analysts. "We have a new reality in the business and it's not a completely predictable dynamic."

- see Amgen's release on the FDA anemia drug meeting
- check out the AP report for more on Amgen's discussion with analysts

ALSO: Throw a bunch of pharma execs into a room with financial analysts, and what do you get? Almost unmitigated hope. Report

Related Articles:
Amgen ups lobbying efforts. Report
New Medicare cap on anemia drugs could hammer Amgen. Report
Amgen makes big workforce, budget cuts. Report
Amgen in crisis? Not us, says CEO Sharer. Report
Amgen stock slips as anemia drug concerns rise. Report

Waiting game continues for biogenerics

Mon, 10 Sep 2007 06:59:59 -0400

The folks at BIO are breathing a sigh of relief over Congressman Henry Waxman's comment that new legislation on biosimilars was unlikely to reach the House floor this week. He chalked the delay up to scheduling issues. Of course, with the Democrats in charge of the House and Senate, one wonders why a piece of legislation like this can't go ahead swiftly. It's more than apparent that lawmakers are willing to create a regulatory pathway for generic versions of biotech drugs. And they'll more than likely follow the FDA's position that each of these biogeneric--or biosimilar--applications should be reviewed on a case-by-case basis. Where regulators see complexity in a biologic, they will raise the bar on data. Where a therapy can be copied without raising serious safety issues, which is now done routinely, it will be approved without a terribly demanding set of trials.

All of that is clear enough. So why the delay? I suspect lawmakers are just finding it tough to get their act together. That's one good reason for the growing level of public frustration at lawmakers of every stripe. PDUFA legislation will go ahead because it has to. The FDA needs the money to operate. Meanwhile, the demand for less expensive biologics will only grow. Does anyone in Washington know how this game is played? - John Carroll

FDA stands firms on need for Thelin trial

Fri, 07 Sep 2007 06:59:56 -0400

The FDA has handed Encysive its fourth--that's right, fourth--dose of bad news for Thelin, a pulmonary arterial hypertension treatment. Encysive received its first approvable letter for the drug back in March of 2006, when the FDA said that another Phase III trial would be necessary to prove the drug met efficacy standards. Encysive chose not to run the costly trial and has spent the last year and a half trying to change the FDA's mind. After the third approvable letter the company asked for formal dispute resolution, which has now been denied. Thelin has already been approved in Europe.

"We continue to believe that the issue raised by the FDA was sufficiently addressed in the NDA and we are reviewing the FDA's response with external experts to determine the next step forward," said George Cole, President and Chief Executive Officer of Encysive. "Simultaneously, our clinical team, together with outside clinical and statistical experts, is developing an additional Phase III study protocol so we can move ahead quickly with a new trial if it is ultimately required for approval in the U.S."

- see Encysive's release on the decision

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

Neurochem hammered on Alzhemed failure

Mon, 27 Aug 2007 06:59:58 -0400

The analysts swiftly began writing off Neurochem's Alzhemed after the company announced last night that its lead drug had failed a late-stage trial for Alzheimer's. The news sent Neurochem's stock into a tailspin, shaving off 30 percent of the company's share value. RBC Capital analyst Philippa Flint told investors that the Canadian company is likely to wait until it gets late stage data from a European trial, but she and others aren't giving the drug much chance of survival. "Alzhemed is dead," sums up Cormark Securities analyst David Dean.

- read the report from the Financial Post

Related Articles:
Investors push up Neurochem stock on data review. Report
Neurochem asked to put up more Kiacta data. Report

IDM shares plunge on FDA's rejection

Mon, 27 Aug 2007 06:59:57 -0400

The FDA has turned thumbs down on IDM Pharma's mifamurtide, which was developed to treat a rare form of bone cancer. The agency is looking for more clinical data, says IDM, adding that company officials anticipated that move last July. Of course, IDM got a strong signal on their chances in May, when an advisory committee voted the drug down, saying the application was light on efficacy data. The company adds they'll be able to respond to the agency's demands by the first quarter of next year. It expects that the supplemental information and an amended NDA will prevent any demands for a new trial.

That wasn't enough to assuage many investors, who saw the value of IDM shares drop 25 percent on the news. The drug, formerly called Junovan, targets the often fatal non-metastatic osteosarcoma, which primarily afflicts children and young adults.

- see this release
- here's the report from RTT News

Related Articles:
IDM shares dive after FDA panel rejects Junovan. Report
IDM Pharma outlines plans for Junovan. Report
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FDA delay forces cutbacks at GPC Biotech

Thu, 23 Aug 2007 06:59:58 -0400

Struggling to overcome FDA hurdles for its cancer drug satraplatin, Germany's GPC Biotech says it will slash its staff by 15 percent and ratchet down research and development costs. An FDA advisory committee opted to delay approval until the company can deliver final data on patient survival, which GPC has estimated would take six months. To survive the delay, the biotech is handing out 46 pink slips among its 316 employees. GPC licensed satraplatin five years ago, agreeing to take on development and regulatory costs. As part of the restructuring, GPC says it will slow down--for a while anyway--its work on its 1D09C3 monoclonal antibody and cell cycle inhibitors.

As part of a planned succession, Dr. Martine George is succeeding Dr. Marcel Rozencweig as senior vice president of drug development and chief medical officer. Dr. Rozencweig will remain with the company in the new role of senior vice president, clinical science and drug evaluation.

- check out the release

Related Articles:
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Shares surge as satraplatin succeeds in Phase III. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

ZymoGenetics deal for rThrombin hits a hurdle

Thu, 23 Aug 2007 06:59:54 -0400

ZymoGenetics' recent deal with Bayer HealthCare to market its new blood-clotting agent rThrombin has hit a snag. The company says that the FDA is considering its request for more manufacturing information as a major amendment to the application, which will push back final approval for the therapy. The FDA review now won't be completed until mid-January, three months later than anticipated. That marketing pact is worth up to $198 million and none of the $40 million in milestones outlined in the deal can now flow this year.

- read the report from The Street

Related Articles:
ZymoGenetics inks $198M deal. Report
Pivotal Thrombin trial a success for ZymoGenetics. Report
ZymoGenetics builds cash reserves as it advances Thrombin. Report

FDA slower to pull trigger on new approvals

Mon, 20 Aug 2007 06:59:56 -0400

Is the FDA getting gun-shy? The agency has rejected so many drugs this year--and slapped warnings on so many others--that industry observers suspect the agency of a self-preserving caution. It's approved only 61 percent of drug applications so far this year, compared with 73 percent during the same period of 2006, according to BioMed Tracker. New molecular entities--drugs based on totally new chemical compounds--have perhaps fared worst. Only seven have been given the FDA go-ahead this year, compared with an average of 12 during the same seven months of every year since 1998.

None of this is news to battle-scarred drug companies, from Big Pharma on down. But the FDA says it hasn't made any systematic changes in its drug review process. Some experts say the jury's still out. Besides, with so many drugs getting pulled offstage after the show's already started, pre-opening night jitters might not be an excess of caution, but an increase in common sense.

- read the article from The Baltimore Sun

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Baraclude given Black Box Warning

Fri, 17 Aug 2007 06:59:55 -0400

The FDA has put a Black Box Warning on Bristol-Myers Squibb's hepatitis B drug Baraclude. A warning letter to doctors said that Baraclude should not be given to HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy because of potential for the development of HIV resistance. BMS recommends that HIV testing should be conducted in all hepatitis B virus patients before starting treatment with Baraclude.

- check out the release on the label change

Related Article:
Baraclude approved for hep B. Report