PDUFA Decision for Talon Therapeutics Due Soon Print E-mail
By Brian Wilson, Contributor   
Thursday, 26 April 2012 02:30
Shares of Talon Therapeutics (TLON), a drug-development company that specializes in the creation of cancer therapies, rose 9% after we reminded our subscribers that the company is anticipating a key upcoming binary event.

Talon’s flagship product, Marqibo (vincristine sulfate liposomes injection, OPTISOME), is an optisome-coated targeted compound with vincristine that is being developed for the treatment of Acute Lymphoblastic Leukemia (ALL) in patients that test negative for the Philadelphia Chromosome (Ph-).

Acute Lymphoblastic Leukemia is highly dangerous and rare type of cancer affects about 4,000 new patients a year, with two thirds of the cases being in younger children. Due to the rarity of the disease, Marquibo has been granted orphan drug status, which allows a waiver of the PDUFA fees that Talon would have had to pay under normal circumstances and guarantees seven years of patent exclusivity for the compound given an FDA approval, among other stellar benefits.

The current NDA submitted by Talon specifies that Marquibo is being developed exclusively as a treatment for relapsed cases of Acute Lymphoblastic Leukemia in adults, although clinical trials are being conducted for its use as a front-line treatment in a variety of demographics as well. The proprietary compound is also undergoing clinical trials for the front-line treatment of aggressive Non-Hodgkin’s Lymphoma.

The BioMedReports FDA Calendar shows that the NDA that was submitted for the treatment of relapsed cases of ALL in adults has a designed PDUFA date of May 13, 2012, and is being evaluated under FDA Subpart H (Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses) which increases the likelihood of approval given that the drug offers meaningful improvements over current therapies for the targeted disease.

There are two major drugs that are used as targeted therapies for ALL patients: Gleevec, marketed by Novartis (NVS), and Sprycel which is sold by Bristol-Myers Squibb (BMY). These drugs are only approved for patients who test positive for the Philadelphia Chromosome (Ph+), so Marquibo could be a useful option for oncologists treating Ph- ALL patients.

To give some insight into the probability of approval, we can look at the voting results from the latest Oncologic Drugs Advisory Committee (ODAC) in March, where the drug received a vote of 7-4.

“"We are very pleased the majority of the ODAC members agree that Marqibo offers a meaningful benefit/risk ratio for a very rare patient population that has a grave prognosis and no current standard of treatment," stated Steven R. Deitcher, M.D., President, Chief Executive Officer and Board Member of Talon Therapeutics in late March.

While the vote did reflect that the majority of the panel favored approval, the final decision on the New Drug Application does not have to follow suit. Since an approval of Marquibo for the treatment of relapsed ALL would make way for supplemental NDAs targeting front-line drug status, expect Talon investors to react dramatically to the FDA’s decision on May 13th. Shares of the company are currently trading at nearly half the value of their 52 Week High ($1.65).

Marqibo is a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner.


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