epitanman posted this on the sla thread this morning:
Sydney - Tuesday - June 5: (RWE Aust Business News) - These were some of the developments in the biotech sector over the past week - from ABN AMRO Morgans:
News & Research ***************
Ventracor (VCR) - Buy, Price Target: $1.20, Share Price: 81c; Market Cap: $234m. Ventracor expects to report total revenue for FY07 of approximately $5m. Sales revenue for May exceeded $1m, following eleven implants. This is ahead of our expectations. We had been forecasting revenue for FY07 of $3m. There have now been 119 patients implanted with the VentrAssist world wide who have collectively enjoyed approximately 55 patient years of support, with the longest duration of support two years and eight months. In the United States, the company has received FDA approval to start the Bridge To Transplant (BTT) and Destination Therapy (DT) clinical trials, and expects the Institutional Review Board (Ethics Committees) requirements to be finalised shortly, allowing the first patients to be enrolled.
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Alchemia (ACL) - Buy. Price Target: $2.10, Share Price: $1.07; Market Cap: $145m. ACL has released the final data from its Phase 2 clinical trial in 80 patients for its HyCamp compound to treat metastatic colorectal cancer. In this trial, HyCamp (a combination of irinotecan with Hyaluronic Acid) was compared with irinotecan alone. Irinotecan (brand name Camptosar) is an existing treatment for metastatic colorectal cancer marketed by Pfizer. Like most cytotoxic drugs, its use is limited by its side effects, like diarrhea. If these side effects can be reduced, more of the drug can be given to patients, potentially improving the treatment outcome. Sales for Camptosar of $US903m were recorded in CY06 and patent exclusivity expires in 2008 in the US and 2009 in the EU. The key conclusions were a significantly longer period (+116pc) of 'progression-free survival' for patients receiving HyCamp and patients on HyCamp were able to receive therapy for a median of three times longer than those receiving Camptosar. Given the high quality of the results, it is possible that the FDA will support the use of the data as part of a filing for a Phase 3 pivotal trial.
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SDI Limited (SDI) - Share Price: 57c; Market Cap: $68m. Dental product company SDI has released a profit downgrade. The key drivers of the downgrade include lower than anticipated sales of new product range Riva, devaluation of the USD versus the AUD, and SDI's strategy of smoothing sales to reduce seasonal factors, particularly in the May and June months. SDI now expects that Riva product range to take 3-5 years to have a substantial impact on forecasts. This is clearly disappointing news. While we had identified the acceptance of the new Riva product range as a risk to our forecasts, we had not anticipated acceptance of the product to be so slow.
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Avexa (AVX) - Buy. Price Target: $1.42, Share Price: 61c; Market Cap: $249m. AVX has been awarded a Commercial Ready Grant worth $4.3m to develop a new generation of HIV antiviral drugs using fragment based drug design, a non traditional research methodology. The grant provides funding for up to 50pc of early R&D expenditure. This is positive news for AVX and provides support for the company's early stage R&D program.
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Pharmaxis (PXS) - Share Price: $3.48; Market Cap: $605m; Not formally covered. Following Sweden's acceptance of Aridol late last year, the European Mutual Recognition Procedure has successfully completed evaluating PXS's lung function test Aridol, allowing the 13 European countries involved to issue a marketing authorisation. Distribution partners have been established for most major markets, with further distributors pending. Pharmaxis distributes Aridol directly to physicians in the UK and Australia. A simple-to-use airways inflammation test, Aridol is administered as a dry powder in a hand-held inhaler. Doctors can use the results of this test to identify airway hyper-responsiveness - a hallmark of asthma. Countries where Aridol is now approved: Germany, France, the United Kingdom, Italy, the Netherlands, Belgium, Denmark, Greece, Spain, Finland, Ireland, Norway, Portugal, Sweden and Australia.
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Bionomics (BNO) - Share Price: 32c; Market Cap: $59m; Not formally covered. BNC105 is a new type of drug called a Vascular Disruption Agent (VDA) that acts to rapidly shut down the blood supply within a tumour. It thereby starves the tumour of the oxygen and nutrients it needs to survive. Animal model data has shown BNC105 to be effective in shutting down the blood vessels within human prostate tumours. BNC105 is now expected to enter clinical trials in late 2007, following submission of an Investigational New Drug (IND) application to the US FDA in September. The BNC105 program is supported by a Commercial Ready grant from the Federal Government, which provides some of the funding for the program up to and including the Phase I/IIa clinical trial. BNO has $5.3m in cash at end March 07.
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CSL Limited (CSL) - Hold. Price Target: $91.00, Share Price: $89.93; Market Cap: $16.254b According to a Bloomberg report, GlaxoSmithKline (GSK) has not received a 'priority review' from the US FDA for its HPV vaccine, Cervarix. Instead, it has received a 'standard review' starting from now. Essentially, the purpose of a review is to make sure that the vaccine is safe, and the manufacturing processes are satisfactory. A 'priority review' by the US FDA is granted when there are no other alternatives to the proposed therapy. Note there is an alternative - namely Merck's HPV vaccine, which is already on the market in the US. A 'priority review' takes six months, as opposed to a 'standard review' which takes 10-12 months. This means that instead of Glaxo's HPV vaccine entering the US market at end-CY07 it is more likely to enter the US market in 1QCY08. Hence, Merck's HPV vaccine will have the US market to itself for longer. [Source: Dr David Stanton ABN AMRO Analyst]
Near-term milestones to watch *****************************
Genepharm Australasia (GAA) 3QCY07: FY07 result expected to show modest profit.
Avexa (AVX) 2HCY07: Commence Phase 3 trial for HIV compound AVX754.
Cytopia (CYT) 2QCY07: CYT997 - Complete toxicity study in preparation for Phase 2 (was 1QCY07).
Ventracor (VCR) 2QCY07: Commence further clinical trials in the US (bridge and destination).
Chemgenex (CXS) 2QCY07: Ongoing results from Quinamed Phase 2 trial; Mid 07: Interim results of Ceflatonin registration directed clinical trial.
Metabolic Pharmaceuticals (MBP) Mid 07: Result for Phase 2a in sciatic nduropathic pain for ACV1.
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Source: ABN AMRO Morgans (Note that Biotech & Healthcare Weekly Snippets provides a summary of views only. Full reports can be found at www.abnamromorgans.com.au).
ACL Price at posting:
0.0¢ Sentiment: Buy Disclosure: Not Held
(20min delay)