Pharmaxis Completes Long-Term Safety Study Of Bronchitol

Sydney-based Pharmaxis has completed the 12-month Phase III clinical trial evaluating the safety of Bronchitol (mannitol) in 100 subjects with bronchiectasis, the company announced June 12.

The 12-month study was an open-label extension to a three-month efficacy trial, which demonstrated that Bronchitol improved quality of life and mucus clearance. The purpose of the safety study was to determine the adverse event profile of Bronchitol following prolonged use.

Pharmaxis CEO Alan Robertson said the company would be filing its marketing authorization in Australia next quarter.

The company submitted a clinical trial application to China's State FDA in March to conduct clinical trials for approval there (Also see "Aussie Pharma Pharmaxis Submits Bronchitol Application to China’s State FDA" - Scrip, 10 March, 2008.).

Meanwhile, Pharmaxis announced June 17 that it would appoint IDIS to manage and provide eligible patients with access to Bronchitol though a Named Patient Program, which will allow patients who are unable to participate in clinical trials but whose physicians believe would benefit from Bronchitol treatment.

TGA Approves CSL's Panvax

Australia's biggest biopharmaceutical firm CSL announced approval June 17 from the Therapeutic Goods Administration for Panvax , the firm's avian influenza vaccine.

The vaccine was developed in collaboration with the Australian government to prevent influenza caused by a pandemic strain of avian influenza virus.

"In the event of a pandemic, CSL will rapidly gear up to manufacturing levels that will ensure all Australians will have access to safe, effective coverage against avian flu," CSL General Manager Mary Sontrop said.

CSL is the only vaccine supplier that manufactures influenza vaccines in Australia.

PHARMAC Herceptin Consultation Ends

New Zealand's Pharmaceutical Management Agency announced that the consultation on the agency's proposal to decline funding for 12 months treatment with breast cancer drug Herceptin (trastuzumab) ended June 9 with more than 300 comments received.

CEO Matthew Brougham said the agency would seek further input from advisory committees and make a decision by July.

The agency earlier announced a decision would be reached in June (Also see "PharmAsia News Australia/New Zealand Roundup: Medicines Australia, PHARMAC, Helicon, Pharmaxis" - Scrip, 19 May, 2008.).

"We need to consider all the information we have received very thoroughly and where appropriate seek further input from our advisory committees," Brougham said.

To that end, PHARMAC will seek input from a committee of cancer specialists that will then advise PHARMAC's main clinical committee, the Pharmacology and Therapeutics Advisory Committee.

The PTAC will meet to consider the outcome of the Cancer Treatment subcommittee in June and the Consumer Advisory Committee will meet July 4, with a board decision expected in late July.

PHARMAC Reviews Application Guidelines

PHARMAC also announced it is reviewing application guidelines for new chemical entities, new indications and formulations, combination products and generic drugs. PHARMAC said it would consult on a revised version of the guidelines in 2009.

In the meantime, minor amendments have been made to the application guidelines to align them with the revised version of the Prescription for Pharmacoeconomic Analysis, which was updated in 2007.

Those amendments include: clarifying that the form of analysis required is cost-utility analysis; discount rate amended from 8 percent to 3.5 percent; request for information on disability-adjusted life years omitted; and applications for generics where the chemical entity has been considered by PTAC requires one copy of synopsis, but further copies may be required later.

- Tamra Sami (t.sami@elsevier.com)

Australia, New Zealand Roundup: Pharmaxis, CSL, PHARMAC

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