Drug Industry Daily - Jan. 10, 2011 Issue

Vol. 10 No. 6

Dendreon Could File Provenge in Europe Later This Year

Dendreon plans to file an EU application for its prostate-cancer treatment Provenge late this year or early next year and expects a regulatory decision in the first half of 2013.

Dendreon plans to use the clinical data from its U.S. BLA to file its marketing authorization application and will not need to conduct new trials, the company said Friday.

Initially, Provenge (sipuleucel-T) would be manufactured by a contract manufacturing organization while Dendreon builds an immunotherapy manufacturing facility in Europe.

The company will also start trials in Europe in earlier-stage disease while it awaits marketing authorization.

If approved, the drug will likely be priced comparably to the U.S., Dendreon Chief Financial Officer Gregory Schiffman said during a conference call Friday. Provenge is one of the most expensive drugs on the market, with a price tag of $93,000 for three injections given two to three weeks apart.

Provenge had revenues of about $48 million last year, and the company has increased its sales force to about 100 reps.

In development news, Dendreon last month filed an IND for its next active cellular immunotherapy candidate, Neuvenge (lapuleucel-T), for bladder cancer.

A randomized, Phase II study will evaluate the safety and efficacy of Neuvenge in patients with invasive, HER2-positive transitional cell carcinoma, the most common type of the disease in the U.S. and Europe, following the cystectomy, Dendreon CEO Mitchell Gold said. The trial will evaluate overall survival and recurrence-free survival in about 180 patients. — April Hollis


FDA Delays Decision on AstraZeneca’s Thyroid Cancer Drug Zictifa

The FDA has extended by three months its review of AstraZeneca’s NDA for Zictifa, a treatment for thyroid cancer.

The user fee action goal date is now set for April 7.

The extension will allow the FDA further time to review AstraZeneca’s Risk Evaluation and Mitigation Strategy (REMS), which the company submitted as part of the review process.

The REMS was submitted recently by the company, after the FDA requested it, following the initial NDA submission, AstraZeneca spokeswoman Laura Woodin told DID.

AstraZeneca is seeking approval for Zictifa (vandetanib) as a treatment for patients with unresectable (nonoperable) medullary thyroid cancer.

The drug received support from the FDA’s Oncologic Drugs Advisory Committee, which last month agreed that although the drug comes with a “substantial toxicity profile,” it was not worrisome enough to limit the drug’s indication (DID, Dec. 3, 2010).

However, committee members agreed that if the FDA approved the drug, additional doses should be explored by AstraZeneca in postmarket trials to determine the optimal dosage. — Molly Cohen


Appeals Court Denies Patient Group’s Request for FDA Docs on Provenge

A federal appeals court has denied a patient advocacy group’s request to conduct discovery on the FDA to find information on the agency’s initial denial of Dendreon’s application for the prostate cancer treatment Provenge.

In a ruling issued Thursday, the U.S. Court of Appeals for the Sixth Circuit said that a lower court was correct to deny the request from CareToLive because the FDA had given the group all of the information it had asked for.

CareToLive had originally made a Freedom of Information Act (FOIA) request with the FDA in 2007 seeking internal emails and other documents following the agency’s decision not to approve Provenge (sipuleucel-T) at that time despite an advisory committee recommendation to the contrary.

Though the drug has now been approved, CareToLive continued its suit saying the FDA failed to live up to the request because it took over two years to respond and then did not provide enough documentation (DID, April 30, 2010).

The appeals court disagreed, however, saying that the delay was due to a backlog of FOIA requests at the agency and that CareToLive did not provide any evidence that the FDA was withholding information.

“Although agencies must respond to requests under the [FOIA], they are not required to open their doors and invite the public in to peruse their records,” the court says. “CareToLive does not identify any additional offices or departments where the FDA should have searched for documents.”

Meanwhile, the Centers for Medicare & Medicaid Services (CMS) is continuing its national coverage analysis of Provenge and the agency has also been hit with lawsuits from government watchdog groups suspicious that CMS is reviewing the drug because of its high cost.

The latest suit was filed last month by the group Judicial Watch, who accused HHS of failing to respond to a FOIA request filed in November (DID, Jan. 7). — David Belian


FDA Gives Makers of Unapproved Drugs Last Chance to Appeal

The FDA is seeking to determine whether manufacturers of prescription cough, cold and allergy medications that were cited as unapproved drugs decades ago would still like to appeal the agency’s decision.

The products in question were sold for decades and benefited from entering the market before 1962, when Congress mandated that all new drugs be proven safe and effective before being approved, the FDA says in a Federal Register notice published Friday.

Prior to 1962, drugs that were deemed “identical, related or similar” to an approved product could be marketed without independent approval from the FDA, the agency says.

In the late 1960s and early 1970s, the FDA attempted to backtrack and review the thousands of products that had entered the market without an agency review in a process known as the Drug Efficacy Study Implementation (DESI).

Most of the products reviewed were either granted approval or ordered removed from the market, but some companies requested a hearing with the FDA appealing a decision and, according to the agency’s records, a number of those hearing requests are still pending.

While many of the drugs involved have since been removed from the market anyway, the FDA is notifying the manufacturers of the products that they now have until Feb. 6 to inform the agency whether they still want a hearing; otherwise, their request will be withdrawn.

The Federal Register notice containing the full list of products involved can be found at www.ofr.gov/OFRUpload/OFRData/2011-00104_PI.pdf. — David Belian


Teva Recalls One Lot of Antibiotic as Some Tablets May Be Underweight

Teva Pharmaceutical is recalling one lot of its antibiotic metronidazole as some tablets may be underweight and may not contain the full amount of active ingredient.

The company’s investigation into the issue is ongoing, company spokeswoman Denise Bradley told DID Friday. Teva has identified about 75 bottles that would be affected by the recall and has already received more than 55 of the 250-count bottles.

Tablets with a lower than prescribed dose of active ingredient could cause patients’ infections to worsen or recur and could be life-threatening when treating severe infections, though Teva has received no reports of adverse events associated with use of the product lot so far, the FDA said Thursday.

Metronidazole is indicated to treat amebiasis, asymptomatic consorts, symptomatic and asymptomatic trichomoniasis, and a variety of anaerobic bacterial infections.

Separately, the company is also recalling four lots of its ProAir HFA (albuterol sulfate) inhalers, manufactured in Ireland, that failed U.S. Pharmacopeia content uniformity requirements. That recall, announced Wednesday by the FDA, began in late November and affects 792,603 inhalers. It is still under active investigation, Bradley said. — April Hollis

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Reporters: David Belian, April Hollis, Virgil Dickson, Wilson Peden, Molly Cohen

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