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Microsoft word - bd biotech daily sep 22
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECH DOWN: HEARTWARE UP 5%; CATHRX DOWN 18%
* SUNSHINE HEART: ‘MOST IMPROVE’ IN 20-PATIENT CARDIAC TRIAL
* AUSBIOTECH HAILS SENATE GENE PATENT REPORT, LONG WAY TO GO
* MAYNE WINS PRELIMINARY INJUNCTION AGAINST MYLAN
* ANTEO AGM FOR 9.6m DIRECTOR OPTIONS, EMPLOYEE OPTION PLAN
* HELICON EGM ON 155m SHARES, OPTIONS, NAME CHANGE
* BONE EGM ON SHARES, OPTIONS FOR LA JOLLA COVA, PROXIMA FEES
* BAILLIE GIFFORD TAKES 6% OF COCHLEAR
* AUTUS REDUCES 3% IN FERMISCAN
* VIRAX LOSES DIRECTOR TIM COOPER
MARKET REPORTThe Australian stock market tumbled 2.63 percent on Thursday September 22, 2011 withthe S&P ASX200 down 106.9 points to 3,964.9 points.
Five of the Biotech Daily Top 40 stocks were up, 19 fell, eight traded unchanged and eightwere untraded.
Heartware was best, up 16.5 cents or 10.9 percent to $1.675 with 10,500 shares traded.
LBT climbed 3.7 percent; Biota, QRX and Resmed were up more than one percent; withMesoblast up 0.24 percent.
Cathrx led the falls, down 2.5 cents or 17.9 percent to 11.5 cents with 51,000 sharestraded, followed by Benitec down 13 percent to two cents with 9.6 million shares traded.
Impedimed lost 9.1 percent; Prana fell 8.3 percent; Genera, Pharmaxis and Prima shedmore than seven percent; Phosphagenics and Sirtex were down more than six percent;Allied Health and Viralytics fell five percent or more; Cochlear, Optiscan and Starpharmalost more than four percent; Acrux, Circadian and Living Cell were down three percent ormore; Bionomics, Genetic Technologies and Tissue Therapies shed more than twopercent; with CSL down 1.65 percent.
SUNSHINE HEARTSunshine Heart says that most of the 20-patients in its pilot trial of the C-Pulse aorta cuffpump improved heart failure categories.
Sunshine Heart did not provide detailed results, but said that one patient died in aninfection-related operation and two patients improved to the point that they weredisconnected permanently from the heart pump system.
The summarized data was published by the Ohio State University Medical Center and thecompany said the detailed results would be presented at the TranscatheterCardiovascular Therapeutics meeting in San Francisco on November 8, 2011.
Ohio State University Medical Center said that 20 patients, eight women and 12 men withan average age of 56, were enrolled in the trial, of which 18 were classified with New YorkHeart Association (NYHA) class III heart failure and two were class IV, the most severeforms of heart failure.
All patients had cardiac resynchronization therapy, implantable cardiac defibrillators orcombination devices implanted, the Medical Center said.
The Medical Centre said three patients were successfully bridged to transplant with onepatient being supported for 22 months, the longest of any patient participating in the trial.
The Medical Centre said that all but one patient either improved or maintained NYHAheart failure classification.
Sunshine Heart chief executive officer Dave Rosa told Biotech Daily that the results werestill being finalized, with some detail being held back for the San Francisco conference.
“The majority of patients improved, rather than maintained classification, and this is acondition in which patients normally deteriorate,” Mr Rosa said.
Mr Rosa said that two patients improved to the point that they did not require the device,due to the absence of heart failure symptoms, and along with the overall reduction inpatient medication, were positive indicators for the device.
Mr Rosa said that one patient was disconnected after the six month follow-up and thesecond patient after 11 months on therapy.
The Medical Centre said that overall, other improvements were realized as measured byquality of life scores, six-minute walk times, ejection fractions, or the heart’s pumpingability, and reductions in medications.
Mr Rosa said that the patient who died had a non-device-related infection and diedfollowing surgery to treat the infection.
Mr Rosa said there were a number of contributing factors in the death from an aorticdisruption, as a result of a re-sternotomy surgery to treat the procedure-related infection.
The Medical Centre said no neurologic events or heart attacks were reported, while sixsuperficial exit site infections were successfully treated with antibiotics.
The Medical Centre said there was one instance of post-operative, non-device relatedbleeding.
The Medical Centre said that the results warranted a larger pivotal trial.
The Medical Centre’s director of cardiovascular medicine and co-lead principalinvestigator Dr William Abraham said the trial results to date “show positive trends ofefficacy with a strong safety profile as compared to later stage mechanical supportdevices”.
“We believe further investigation is needed as hundreds of thousands of heart failurepatients in this country remain substantially symptomatic despite currently availabletreatments,” Dr Abraham said.
The C-Pulse aorta cuff uses an electrocardiogram-sensing wire to inflate and deflate thecuff to assist the heart, reducing aortic pressure and the heart’s workload.
Sunshine Heart was unchanged at 4.7 cents.
AUSBIOTECH, FEDERAL GOVERNMENTAusbiotech has welcomed a Senate report recommending that the Patent Amendment(Human Genes & Biological Materials) Bill 2010, should not be passed.
Ausbiotech said the Senate Legal and Constitutional Committee Inquiry into the Bill wastabled in the Senate last night.
A Senate officer told Biotech Daily that the Bill was a private members bill sponsored byLiberal Senators Helen Coonan and Bill Heffernan, Greens Senator Rachel Siewert andindependent Senator Nick Xenophon.
The Senate officer said the only opportunities for the Bill to have its Second Reading wereon Thursday mornings when the Senate was sitting and it was unlikely the Bill would beread this year.
The Government dominates the Senate Legal and Constitutional Committee, but theGreens and Coalition could command a majority in the Senate to pass the Bill.
Ausbiotech chief executive officer Dr Anna Lavelle welcomed the Committee’s finding.
“This is the right outcome for patients, researchers and for innovation in this country. I nowcall on the Senate to abandon the Bill, as recommended,” Dr Lavelle said.
Ausbiotech said there had been five Australian inquiries in recent years into patentablesubject matter and each has consistently recommended that excluding specific subjectmatter from patentability was not the right option.
Ausbiotech said the proposed Bill “fails completely to address any of the valid concernsraised by the community about gene patents and should be rejected”.
“The Bill does not serve the interests of patients, researchers or industry and, in fact, theBill threatens the very foundations of scientific research and development of biologicaltherapies and other technologies which are built on patents,” Dr Lavelle said.
The Australian Greens told Biotech Daily they did “not believe it appropriate forpharmaceutical and biotechnology companies to be able to own the intellectual propertyrights and enjoy exclusive use of human genes”.
“Isolated genetic material should be regarded as a discovery, not as an invention,” theGreens said.
“We are particularly concerned by the prospect that such patents could see exorbitantfees charged for medical tests and treatments for many diseases, including cancer,” theGreens said.
MAYNE PHARMA GROUPMayne Pharma says it has been granted a preliminary injunction against Mylan Inc andaffiliate Mylan Pharmaceuticals preventing the launch of a generic Doryx 150mg.
Mayne said the US District Court of New Jersey granted the preliminary injunctionpreventing the launch before the Court rendered a decision in the on-going litigationrelating to US Patent No 6,958,161 covering the tetracycline-class oral antibiotic Doryxproducts, and no trial date had been set.
The company said that in granting the motion, the District Court found that Mayne Pharmaand its US marketing and distribution partner Warner Chilcott demonstrated a reasonablelikelihood of success on the merits of their claim that the ‘161 Patent was valid andinfringed by Mylan’s 150mg generic Doryx product.
Mayne said it manufactured and supplied Doryx to Warner Chilcott in the US under alicence agreement and owned the ‘161 Patent.
The company said the Doryx 150mg product was more than 95 percent of the Doryxfranchise in the US based on total prescriptions.
Mayne fell 2.5 cents or 6.3 percent to 37 cents.
ANTEO DIAGNOSTICSAnteo’s annual general meeting will vote to issue 9,600,000 options to three directors, re-elect those directors and approve an employees and consultants option plan.
The Anteo notice of meeting proposed the issue of 5,000,000 options to chairman MarkBouris, 3,000,000 options to Sandra Andersen and 1,600,000 options to Richard Martin,all exercisable at 12 cents and expiring fours year from the date of issue.
Anteo said shareholders would be asked to approve an option plan for officers, employeesand consultants, along with adoption of a new constitution.
The meeting will be held at the Royal Exchange of Sydney, 1 Gresham Street, Sydney onOctober 24, 2011 at 11am (AEDT).
Anteo was unchanged at 6.6 cents with 3.3 million shares traded.
HELICON GROUPHelicon says shareholders will vote to issue about 154,533,333 shares and 44,900,000options and change its name to Consegna Group.
The Helicon resolutions propose the approval of the prior issue of 29,633,333 shares forpayment to advisors; 44,900,000 shares and options for working capital and theacquisition of the Linguet buccal drug delivery technology; $1,500,000 in shares which attoday’s price of two cents would be 75,000,000 shares for the Aspen Medisys acquisition;and five million shares.
The company has asked shareholders to approve a name change to Consegna Group .
The meeting will be held at Level 31, RBS Tower, Aurora Place, 88 Phillip Street, Sydneyon October 25, 2011 at 10am (AEDT).
Helicon fell 0.1 cents or 4.8 percent to two cents.
BONE MEDICALBone says shareholders will vote to approve the issue of shares and options to La JollaCove, $1,444,343 in lieu of fees to Proxima Concepts and for a placement.
The first seven of 14 resolutions call for the approval of shares to La Jolla Cove forconvertible notes as part of its equity draw down facility.
Resolutions eight to 11 provide for the issue of shares and attaching options to ProximaConcepts for $1,444,343 in “fees owed”.
Proxima’s website says that Bone chairman Dr Roger New is the co-founder and researchand development director of Proxima.
In its most recent substantial shareholder notice the Channel Islands-based Proxima saidit increased and was diluted from 49,028,952 shares (46.82%) to 52,214,829 shares(42.72%) (BD: Jul 11, 2011).
Other resolutions include the issue to chief executive officer Peter Young of 1,000,000options exercisable at five cents each within 36 months, the issue of 1,780,000 shares toGifford Securities and shares with attaching options to Hall Phoenix Inwood and DavidStoup.
The meeting will be held at Ledger Corp, Level 3, 46 Ord Street, West Perth on October20, 2011 at 4pm (AWST).
Bone was untraded at 1.6 cents.
COCHLEARBaillie Gifford & Co and associates have increased their substantial holding in Cochlearfrom 2,903,127 shares (5.11%) to 3,506,482 shares (6.16%).
The Edinburgh-based Baillie Gifford became substantial in Cochlear last month andcontinued acquiring shares between August 18 and September 21 (BD: Aug 19 2011).
Cochlear fell $2.49 or 4.7 percent to $50.01 with 1.2 million shares traded.
FERMISCANAutus Investments has reduced its substantial holding in Fermiscan from 110,000,000shares (16.7%) to 96,428,571 shares (14.66%).
The King Street, Sydney-based Autus said the 13,571,429 shares were sold for $173,923or an average price of 1.28 cents a share.
Fermiscan fell 0.1 cents or 5.9 percent to 1.6 cents with 3.8 million shares traded.
VIRAX HOLDINGSVirax says director Tim Cooper has resigned from the company and its subsidiaries witheffect from September 21, 2011.
Biotech Daily attempted to contact Virax for further details but no one was available tocomment.
Virax was unchanged at 1.7 cents.
Biotech Daily can be contacted at: PO Box 5000, Carlton, Victoria, Australia, 3053
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