POLARTECHNICS DEMAND DOUBLES; RESULTS IMPROVE; US INTEREST
August 17th 2008 05:29
Thursday August 14, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS UP: ACRUX, NEUREN UP 6%, LIVING CELL DOWN 12%
* POLARTECHNICS DEMAND DOUBLES; RESULTS IMPROVE; US INTEREST
* ACRUX MANUFACTURING ALLIANCE WITH ORION
* BIOTRON EXPANDS HEPATITIS C PHASE II TRIAL
* PROGEN RENEWS PHASE I PG11047 ANTI-CANCER TRIALS
* PEPLIN COMPLETES PHASE II ACTINIC KERATOSIS ENROLMENT
* CSL RAISES $1.75b TO BUY TALECRIS
* SOLAGRAN TO RETAIN RUSSIANS; DIRECTORS LOSE 21m SHARES
* CIRCADIAN TAKES VEGENICS; DR JONATHAN SKIPPER ON BOARD
* SAFETY MEDICAL SELLS 285k SYRINGES TO DIABETES SCHEME
* FMR, FIDELITY INCREASES TO 8% OF HEARTWARE
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POLARTECHNICS
Polartechnics says China’s demand for its Truscreen cervical cancer test has outstripped supply, the test is more accurate than previously stated and there is increased interest in the US for the product.
In a quarterly shareholder update the company said there had been a three month delay to the production ramp-up of the Truscreen test’s single use sensors.
Chinese production of the sensors began in March 2008, with production increasing according to plan until quality issues arose.
“We have now identified the causes of the quality issues, which included unacceptable variations in the lens component during plastic injection moulding in China and dust contamination of the lens during transport and handling to and from the US for specialized coatings,” Polartechnics said.
“We have revised our processing procedures accordingly. We anticipate that production will slowly ramp up and we are only three months behind our original plan,” the company said.
“This process is not unusual when taking a product from test manufacturing to full commercial production,” Polartechnics said.
Polartechnics managing director Ben Dillon told Biotech Daily that the company had backorders to fill but there had been “a doubling of the market opportunity in China”, following the acquisition of the distributor by an unnamed “major Chinese technology conglomerate”.
Mr Dillon said a total of 160 Truscreen console sets had been sold, of which 90 were in China.
Typically each hospital would have one console originally expected to run an average of 2,000 tests a year.
“The average in China is 5,000 tests per annum per machine,” Mr Dillon said.
Due to the increase in expected demand the company was considering the commissioning of a second manufacturing plant outside China.
The Polartechnics shareholder update said sales were 94 percent of forecast units in the six months to June 30, 2008.
“Once we have achieved a user base of 600 to 800 Truscreen consoles the associated SUS sales will take us to breakeven cash flow,” Polartechnics said. “This should be achieved within the near term dependent of course, on our SUS production build-up.”
Mr Dillon said the Chinese commitment to 200 consoles had doubled.
He said the additional results coming from experienced operators of the system showed sensitivity had increased from 70 percent to 80 percent compared to the PAP smear test’s average of 54 percent sensitivity.
“Recent published abstracts from trials of Truscreen in Poland and China have confirmed the superior performance of Truscreen at, or better than the initial [Conformitée Européenne] CE product registration trials,” Polartechnics said.
“This continues to reinforce Truscreen as the only proven real-time point-of-care screening test for cervical cancer,” the company said.
Mr Dillon said he had been travelling extensively and there was significant interest in the test from “key opinion leaders and medical practitioners in the US”.
“Consequently we are involved in discussions regarding the entry of Truscreen into the US market.
“Support has been offered from a number of parties to assist with the US Food and Drug Administration product registration process, which is expected to take up to two years to complete,” Mr Dillon said.
Polartechnics fell one cent or eight percent to 11.5 cents.
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