Hana says it will advance Marqibo while awaiting approval of Zensana, reports $20.7 million Q2 net loss

By Jennifer Lanning Drey

Eugene, Ore., Aug. 14 - Hana Biosciences Inc. plans to begin pivotal clinical trials of Marqibo (vincristine sulfate) by the end of the year, while also preparing for an expected April 2007 launch of its lead product, Zensana (ondansetron HCl) oral spray, said Mark Ahn, chief executive officer of Hana, during a company conference call Monday.

Interim data from a multi-center, phase 1 clinical trial of Marqibo in relapsed refractory acute lymphocyctic leukemia (ALL) has given the company confidence to move forward with testing the drug in ALL, said Greg Berk, Hana's chief medical officer, during Monday's call.

The data showed a 27% complete response rate, he said.

"This level of activity in a setting that is traditionally very difficult to treat supports taking this drug into a registrational trial in this setting," Berk said.

Hana has plans to begin an open-label, multi-center phase 2 clinical trial in the relapsed refractory setting in the next few weeks. That trial is expected to support a phase 3 registration trial, Berk said.

In addition, the company is preparing to launch a phase 3 clinical trial before the end of the year comparing dexamethasone plus Marqibo to dexamethasone alone in second or greater relapse patients, as well as first relapse elderly patients, Berk said. The trial's primary endpoint will be complete response at six weeks.

Hana is scheduled to meet with the Food and Drug Administration to discuss the trial in the fall, Berk said.

In the meantime, the company is also preparing for the commercial launch of Zensana, which it expects to begin in April.

Hana submitted a New Drug Application to the FDA for Zensana on June 30 and expects the agency's standard 10-month review process to lead to approval.

The company's application compares Zensana spray to GlaxoSmithKline's Zofran tablets and looks to establish bioequivalence, according to Fred Vitale, chief business officer of Hana.

"We ran four clinical trials for Zensana and clearly demonstrated statistically significant bioequivalence to Zofran," Vitale said during the call.

Upon FDA clearance, Hana is required to certify to GlaxoSmithKline that Zensana does not infringe on the Orange Book patents for Zensana.

"We are absolutely convinced that there's no basis for GSK to bring viable claim which will impede our progress. Our energy, therefore, are directed toward the Zensana commercial launch," he said.

Hana will initially focus Zensana on breast cancer patients.

Net loss, cash increase

Hana reported a second-quarter GAAP net loss of $20.7 million, or $0.81 per basic and diluted share, compared with a $2.1 million GAAP net loss, or $0.13 per share, in the second quarter of 2005, according to a company news release.

The company's quarterly results reflect its continued pipeline progression, which was a primary cause of the increased GAAP net loss, Hana chief financial officer John Iparraguirre said.

In addition, the 2006 GAAP net loss reflects an $11.9 million one-time charge related to the acquisition of three products from Inex, and a $2.5 million charge related to FAS 123R employee stock-based compensation expense, Iparraguirre said.

In May, the company completed a $40 million financing that Iparraguiree said Monday will allow Hana to maintain the momentum of its clinical progress and ensure that it will be able to move forward aggressively.

The company's cash, cash equivalents and short-term investments increased to $46.6 million at June 30 from $17.6 million at Dec. 31, 2005, according to the release.

"With our NDA for Zensana filed and the potential product launch slated for the first half of 2007, we believe Hana is uniquely positioned to move into the next phase of corporate growth," Iparraguirre said.

Additional advancements

During the quarter, Hana also began a multi-center phase 2 clinical trial of Talvesta (talotrexin) in relapsed or refractory non-small cell lung cancer patients.

In addition, the company plans to move forward with Talvesta in ALL patients and is close to identifying an appropriate phase 2 dose, Berk said Monday.

Hana is exploring other opportunities for Talvesta in the clinic, he added.

Hana is a South San Francisco, Calif.-based biopharmaceutical company.

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