Microsoft word - bd biotech daily apr 28
Daily news on ASX-listed biotechnology companies
* ASX EVEN, BIOTECH UP: GENETIC TECH UP 55%; ANTISENSE DOWN 8%
* GENETIC TECH UP 119% ON US BREAST CANCER TEST APPROVAL
* $18m FOR AUSTRALIA-CHINA RESEARCH
* US LYMPHEDEMA GROUP BACKS IMPEDIMED TESTING
* GSK PAYS BIOTA $1m RELENZA ROYALTY
* CEPHALON TAKES 43% OF CHEMGENEX, WITH 62% GUARANTEED
* JM FINANCIAL CEASES SUBSTANTIAL IN GENERA
MARKET REPORTThe Australian stock market was virtual y unchanged on Thursday April 28, 2011 with theS&P ASX 200 up 0.1 points to 4873.0 points.
Sixteen of the Biotech Daily Top 40 stocks were up, 14 fel , eight traded unchanged andtwo were untraded. Al three Big Caps were down.
Genetic Technologies was best, up 5.5 cents or 55 percent to 15.5 cents with 10.7 mil ionshares traded, fol owed by Viralytics up 0.3 cents or 6.1 percent to 5.2 cents with 32.5mil ion shares traded.
Impedimed climbed 6.1 percent; Circadian and LBT were up five percent or more; Viraxwas up 3.85 percent; Phylogica and Prana rose more than two percent; with Heartware,Mesoblast, Sirtex, Starpharma and Uscom up more than one percent.
Antisense led the fal s, down 0.1 cents or 7.7 percent to 1.2 cents with 46.9 mil ion sharestraded, fol owed by Patrys down 6.7 percent to 14 cents with 531,559 shares traded.
Prima lost 5.3 percent; Benitec, Bionomics, Compumedics and Psivida fel four percent ormore; Cel mid, Clinuvel and Phosphagenics were down more than three percent; Bioincheshed 2.3 percent; with Biota, CSL and Resmed down one percent or more.
GENETIC TECHNOLOGIESGenetic Technologies climbed 119 percent on the Nasdaq overnight with 25 percent of itsshare register traded on news of final US approval for its Brevagen breast cancer test.
Genetic Technologies chief executive officer Dr Paul MacLeman told Biotech Daily thatthe company peaked at $US6.25 (up 119.2 percent) before closing up 72.25 percent at$US5.46 with 2,878,375 American depository receipts traded.
Dr MacLeman said each ADR was equal to 30 Australian shares implying that equivalentto 25 percent of the issued capital had been traded.
In a media release Genetic Technologies said that the US Centers for Medicare andMedicaid had certified its Australian laboratory under the US Clinical LaboratoriesImprovements Amendments, which was “the culmination of preparations required for theUS launch of the Brevagen breast cancer test”.
Dr MacLeman told Biotech Daily that the approval was the last step in the process tomake Brevagen available in the US and was effectively the green light for 42 US states.
Dr MacLeman said several others states including California, New York, Maryland andFlorida had individual approval regimes, which the company was pursuing.
He said the test was expected to be rol ed out in “the coming weeks” and was targeting a$500 mil ion diagnostic market.
In a media release Genetic Technologies said the Brevagen test informed clinicians abouttheir patients’ individual, non-familial, sporadic risk of breast cancer, thereby fulfil ing anunmet need by better classifying women at moderate risk of breast cancer who wouldpotential y benefit from preventive therapy or more intensive monitoring.
The company said the test combined breast cancer risk from clinical y validated geneticmarkers, with factors from a clinical assessment based on a patient's family and personalhistory (Gail Score) to give a clearer picture of an individual woman's risk of developingbreast cancer.
Genetic Technologies said Brevagen was the first test of its kind to give women a cost-effective personal assessment of their individual risk of breast cancer and fitted therecommendations of the American Cancer Society and American Society of ClinicalOncologists to determine the five year and lifetime risk of getting breast cancer.
“Brevagen is the first in a series of products in [Genetic Technologies’] anticipatedexpansion of its oncology and cancer management test portfolio and the company is alset for commercial rol out,” Dr MacLeman said. “The test wil help many women by betterdetermining their individual breast cancer risk and it wil help health professionals betterdetermine optimum treatment decisions.”Genetic Technologies said the US certification would enable its Australian laboratory tooffer compliant high-complexity medical testing services to US patients through its whol y-owned US subsidiary Phenogen Sciences (BD: Oct 26, 2010).
The company said certification meant it could add further cancer management products indevelopment to its test menu without need for further regulatory applications.
Genetic Technologies said the regulatory scheme established under the US ClinicalLaboratories Improvements Amendments (CLIA) required laboratories to operate underextensive quality systems which included validation and proficiency testing and it was thefirst Australian laboratory to gain such approval.
Genetic Technologies said its Australian laboratory was already NATA, RCPA and ISOaccredited or compliant and was certified to service patients in al its target markets.
The company said Brevagen would be made available to European and Pacific rimmarkets fol owing further regulatory and market development programs.
Genetic Technologies was up 5.5 cents or 55 percent to 15.5 cents with 10.7 mil ionshares traded.
AUSTRALIA-CHINA SCIENCE AND RESEARCH FUNDThe Australian and Chinese governments wil each commit $9 mil ion over three years toan Australia-China Science and Research Fund from 2011-12.
In a media release Science Minister Senator Kim Carr said the Science Ministers ofAustralia and the People’s Republic of China “reaffirmed both countries’ commitment tocontinue to expand col aboration on strategic science and research initiatives of mutualinterest”.
The media release said the fund would build on 30 years of cooperation on science andtechnology between Australia and China.
The Australian Government said China was the “third most important partner forAustralian researchers and Australia is China’s sixth highest partner as reflected inscientific publications”.
The media release said the col aborations contributed to discoveries in medical research,disaster management, biodiversity, water conservation, food security, wirelesscommunications, al oys for manufacturing and clean energy.
The Government said that scientific cooperation created new opportunities for Australianresearchers and firms to work in China.
A Department of Innovation, Industry, Science and Research media officer said the twoGovernments would “work together in the coming months to agree on the arrangementsfor the new fund which will commence in 2011-’12 [and] … further information about thefund wil be made publicly available once these arrangements are agreed”.
IMPEDIMEDImpedimed says the US National Lymphedema Network has backed prospective care forbreast cancer patients, including the pre-treatment baseline measurement of arms.
Impedimed said that a position paper entitled ‘Screening and Measurements for EarlyDetection of Breast Cancer Related Lymphedema’ was written by the NationalLymphedema Network’s medical advisory committee and the posting of medicalguidelines was a “key milestone” for the company.
The company said the position paper specifical y referred to surgeons and oncologists toadopt a prospective care model for breast cancer patients, working closely with therapists.
To obtain an objective measure, “pre-treatment baseline measurement of arms isessential, as this serves as the baseline data to which subsequent measurements can becompared,” Impedimed quoted the paper saying.
“Regular measurements fol owing treatment are indicated for the remainder of thepatient’s life. Surgeons and medical oncologists who treat breast cancer and fol ow breastcancer patients/survivors should conduct these measurements at every patient visit,” thecompany said.
“Such measurements should also be conducted in cases where primary care physiciansor advanced practice nurses provide fol ow up care in lieu of the treating surgeons oroncologists,” Impedimed quoted the paper saying. “The urgency in writing this paper forbreast cancer related lymphoedema is due to evidence indicating that early detection oflatent breast cancer related lymphoedema offers an opportunity to identify and treatlymphedema more successful y at an earlier stage.”Impedimed said the National Accreditation Program for Breast Centers had adopted theguidelines for early detection of breast cancer related lymphoedema and said theguidelines should assist in building coverage by health insurance companies for thetesting of breast cancer patients.
Impedimed was up four cents or 6.1 percent to 70 cents.
BIOTABiota expects to receive a royalty payment of $1.0 mil ion from Glaxosmithkline for $14.1mil ion sales of Relenza in the three months to March 31, 2011.
The payment compares to a royalty of $1.2 mil ion for $17.9 mil ion sales of Relenza in thethree months to December 31, 2010, $2.1 mil ion for $29.6 mil ion in sales for the threemonths to September 30, 2010, a payment of $900,000 for $12.8 mil ion sales in the threemonths to June 30, 2010 and the record royalty payment of $32.6 mil ion fromGlaxosmithkline for $462 mil ion sales of Relenza in the three months to December 31,2009.
Biota fel two cents or 1.65 percent to $1.195.
CHEMGENEXCephalon has filed a substantial shareholder notice saying its Chemgenex holding hasincreased from 86,386,425 shares (27.57%) to 133,438,850 shares (42.58%).
The US-based bidder for al of Chemgenex’s shares has commitments from majorshareholders for 62.61 percent of the company (BD: Apr 31, 2011).
The necessary paperwork for shareholders to commit their shares was posted shortlybefore the Easter holiday break.
Chemgenex fel half a cent or 0.75 percent to 66 cents.
GENERA BIOSYSTEMSJM Financial Group has ceased its substantial holding in Genera with the sale of 336,250shares.
In its previous substantial shareholder notice JM reduced its holding from 4,339,492shares (6.92%) to 4,014,967 (5.76%) (BD Apr 15, 2011).
Genera was untraded at 25 cents.
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