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CSL's HPV Vaccine Data Out Soon - ABN

 

Tuesday, September 20, 2005 11:01:54 PM ET

Dow Jones Newswires

 

 

 

1301 [Dow Jones] STOCK CALL: ABN Amro issues bullish note on CSL (CSL.AU), noting that much-anticipated HPV phase 3 data may be released sooner than expected; citing industry contracts, broker says data likely to be presented in October, and likely to be positive. Adds there is strong chance of royalty revenues for CSL from product by end of March 2006. Broker values HPV at A$6.38/share for CSL. Valuation, target price for CSL unchanged at A$40.28 vs latest shares A$36.22, up 1.5%.

 

from:

 

http://www.newratings.com/analyst_news/article_1023221.html

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CSL ready to battle bird flu

AAP

September 24, 2005

 

BLOOD products and vaccines developer CSL hopes to have a bird flu vaccine ready by August next year - or earlier, if there is an emergency.

 

CSL director of public affairs Rachel David said the company had been working for years to develop a vaccine.

 

"The federal Government has recently given us a grant of $4.93 million to accelerate our program ... we are currently in a clinical (human phase one) trial of a prototype product that we've already made," she said.

 

"What we're trying to determine from the trials is the optimum dose to use and whether or not we need to add an adjuvant (a chemical that makes the product more potent) to the products."

 

The results from the current trial should be available in December.

 

 

 

 

 

 

"We're aiming to be completely finished by August 2006," Ms David said.

 

"However, we have an emergency dossier which we'll put together much, much earlier in case we have a problem that arises sooner.

 

"So if worse comes to worst, early next year we will be able to manufacture product for this circulating (bird flu) strain, if we need to."

 

Ms David said CSL was using identical technology for an existing seasonal flu vaccine.

 

The company could move quickly to production of a bird flu vaccine once trials were completed.

 

CSL will manufacture the vaccine at its factory in Parkville, Victoria, where it makes its human flu vaccine.

 

"If the strain that causes a flu pandemic is a strain that we know about, and the dose (of the vaccine) is what we expect, we can start getting vaccine out within six weeks and have a complete order filled by three months," Ms David said.

 

"So that means we can vaccinate everyone in the country within three months."

 

The company would expect to produce 40 million doses of the vaccine in case it needed to give each person two doses.

 

CSL shares rose $1.24 or 3.3 per cent to $38.90.

 

from:

 

http://www.theaustralian.news.com.au/commo...255E643,00.html

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CSL Limited

Geoffrey Hill | September 28 2005 | The Sydney Morning Herald & The Age (subscribe)

 

GRAPH: CSL Share price SOURCE: IRESS

 

Profile Commonwealth Serum Laboratories was established in 1916 and began plasma fractionation in 1952. It was floated by the Federal Government in 1994 as CSL. It is the largest company in the Australian biotechnology-pharmaceutical sector. Its main business and revenue earners are blood fractionalising and vaccine development.

 

CSL's four main divisions are animal health, bioplasma, biosciences and pharmaceutical. It continues to be Australia's biggest investor in pharmaceutical research and development. This R&D expenditure is aimed at new products for the global markets.

 

Current details CSL announced a financial year net profit of $297 million, up from $145 million last year. Its Australian businesses underperformed but an excellent result from ZLB Behring (formerly Aventis Behring, taken over in March last year) contributed to the results.

 

Analyst expectations for the June 2006 financial year are a drop in net profit to $285 million, but then increasing significantly to $350 million in 2007. ZLB Behring is expected to generate almost 82 per cent of total group revenues and more than 90 per cent of profits this year.

 

Sector Industry rationalisation has been good for CSL and it will extract more economies of scale and synergies from its Aventis Behring acquisition. It is now No.2 in the world market for plasma therapeutics, behind Baxter International (US). However, the importance of ZLB Behring to group profits is a big risk to its share price, should management under-deliver on cost recoveries and profits.

 

Worth buying?

 

With an already high price-to-earnings ratio of 22 and low dividend, CSL is priced for growth which will not occur this financial year. The risk is that low dividends and high expectations could cause the share price to quickly lose $3 or $4. Value investors who do not own the stock could buy in on such weakness. Existing investors could contemplate taking some profits if they feel nervous about the price at these levels as short-term gains may be limited over the next six months. Hold.

 

from:

 

http://moneymanager.smh.com.au/articles/20...7586791116.html

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Bird flu vaccine trials to begin

From:

By Adam Cresswell

 

October 04, 2005

 

 

THE first of 400 Australian volunteers are expected to start receiving shots of a prototype bird flu vaccine this week as the guinea pigs in a scientific race to plug gaps in the world's defences against a pandemic.

Approval for the clinical trial of the vaccine, to be held in Melbourne and Adelaide, was granted on Friday and gives the green light for 200 volunteers to be recruited in each city.

 

Australian vaccine manufacturer CSL has begun incubating hundreds of eggs with the H5N1 strain of bird flu under tight security at its facility in Melbourne. The volunteers are all healthy adults and will receive two doses of the vaccine several weeks apart. They will then be tested to see whether their immune systems have recognised the presence of the viral fragments and responded by making antibodies.

 

Terry Nolan, head of the vaccine and immunisation research group at the Murdoch Childrens Research Institute in Melbourne, said results were due in December and, if positive, would clear the way for a second-phase trial looking at ideal formulations and what dosages worked best in children and the elderly.

 

However, he said, a true test of the vaccine would only be "in the real situation".

 

"These indicators (of immune response) are only proxies," he said. "You can't inoculate someone with the (live) virus and see if the vaccine protects them. It's unethical and completely unacceptable."

 

Advertisement:

The strain of the H5N1 bird flu virus being used in the vaccine is derived from a human who was infected in Vietnam. The same viral sample is being used for research and vaccine development around the world.

 

The virus is killed after being incubated in the eggs and there is no live virus in the vaccine, which means it is impossible to develop bird flu as a result of being vaccinated.

 

from:

 

http://www.news.com.au/story/0,10117,16803939-2,00.html

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Impressive!!!!!!!!

MEDIA RELEASE

INVESTIGATIONAL VACCINE PREVENTED 100% HIGH GRADE

CERVICAL PRE-CANCERS, AND NON-INVASIVE CERVICAL CANCERS IN

PHASE III STUDY

MELBOURNE Oct. 7 2005 ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“ CSL Limited announced today that GARDASILÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢, an

investigational vaccine developed by Merck & Co., Inc., based on technology licensed from

CSL, prevented 100 percent of high-grade cervical pre-cancers and non-invasive cervical

cancers (CIN 2/3 and AIS) associated with human papillomavirus (HPV) types 16 and 18

which account for 70 percent of all cervical cancers.

The Company advised that the trial compared GARDASILï›› to placebo in women who

were not infected with HPV 16 and 18 at enrolment and who remained free of infection

through the completion of the vaccination regimen.

A secondary analysis of the trial data demonstrated that even trial women who may have

become infected with HPV16 or 18 during the vaccination period or who violated the

protocol in significant ways were at a reduced risk of developing high grade pre-cancer and

non-invasive cervical cancer.

The Company noted that Merck remained on track to submit a Biologics Licence

Application for GARDASILÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ to the Food and Drug Administration (FDA) in the fourth

quarter of 2005, with the Australian regulatory file being submitted to the Therapeutic

Goods Administration (TGA) soon thereafter.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¹Ãƒƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“These results could not be betterÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢, Dr Brian McNamee Managing Director of CSL

Limited said today.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¹Ãƒƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“They show that prophylactic vaccination with GARDASILÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ comprehensively eliminates

HPV 16 and 18 related cervical pre-cancer and non-invasive cervical cancer.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¹Ãƒƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“CSL is proud of the development of this investigational vaccine from discovery of the

fundamental technology by Professor Ian Frazer of the University of Queensland in 1991

to its potential filing for approval for international marketing by Merck & Co., Inc.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¹Ãƒƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“The success of this phase III trial validates CSLÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s commitment to realizing the potential of

AustraliaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s first class scientific base, and represents a further step in recognising the value

of our R&D portfolioÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢, Dr McNamee said.

The Company advised that more than 12,000 women from 13 countries worldwide

participated in the trial. Women received three doses of either the investigational vaccine or

placebo over a six month period, and were subsequently tested for signs of cervical cancer

or pre-cancerous lesions over a two year period.

The Company commented that the technology licensed by CSL to Merck in 1995 had been

developed as a result of a collaboration in the early 90s between CSL and Professor Ian

Frazer of the University of Queensland, following Dr Ian FrazerÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s discovery of HPV

recombinant virus-like particles (VLPs) circumventing the need to grow HPV in the

laboratory.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“Before Professor FrazerÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s achievement, a vaccine for cervical cancer had been

inconceivable because of the very significant challenges of being able to grow this particular

virusÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ÂÂ, Dr Andrew Cuthbertson Chief Scientific Officer at CSL said today.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“This breakthrough has far-reaching implications for both vaccine and cancer research, and

is a triumph for Australian scienceÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ÂÂ, he said.

The Company advised that GARDASILÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ will be marketed in Australia and New Zealand

by CSL, pending assessment by the TGA and Medsafe.

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Underwhelmed by the response on SS. Certainly made the press. Disclosure CSL represent largest individual stock in my Superfund

Cheers Dave

 

http://news.bbc.co.uk/2/hi/health/4317972.stm

Cervical cancer jab 'in a year'

 

A vaccine shown to be 100% effective against two virus strains that cause most cervical cancer could be available within a year, say manufacturers.

 

http://www.smh.com.au/news/science/cervica...8562981827.html

 

Cervical cancer vaccine breakthrough

By Julie Robotham Medical Editor

October 7, 2005 - 1:57PM

 

A vaccine against the virus that causes cervical cancer could be available as early next year, after the first large-scale human trial showed it was completely effective in preventing infection in more than 6000 young women.

 

http://www.theage.com.au/news/science/canc...8562975109.html

 

Cancer vaccine breakthrough hailed

October 7, 2005 - 3:57PM

 

A cervical cancer vaccine should be available by next year following an Australian breakthrough hailed as one of the biggest advances in women's health since the contraceptive pill.

 

But the dreaded pap smear won't be consigned to history just yet.

Final trials of the vaccine, known as Gardasil, show it to be

100 per cent effective against the most common strains of human papilloma virus (HPV) which cause an estimated 70 per cent of cervical cancers.

 

http://www.theage.com.au/news/business/csl...8562975035.html

 

CSL shares jump on cervical cancer results

October 7, 2005 - 11:26AM

 

Shares in blood products and vaccine developer CSL Ltd jumped in early trading today after global pharmaceutical giant Merck & Co Inc and CSL announced that a new vaccine under development eliminated types of cervical cancer.

 

http://www.abc.net.au/news/newsitems/200510/s1476578.htm

Australian-developed vaccine prevents cervical cancer

By Sophie Scott and wires

 

A major international trial has confirmed the effectiveness of a cervical cancer vaccine developed in Australia.

 

 

 

 

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In reply to: davesss on Friday 07/10/05 07:47pm

awesome stuff!! what a huge breakthrough- it deserves the nobel prize!

 

CSL Vaccine Could Be Fast Tracked - ABN Amro

 

Friday, October 07, 2005 10:17:12 PM ET

Dow Jones Newswires

 

1214 [Dow Jones] STOCK CALL: ABN Amro expects CSL and Merck's cervical cancer vaccine could be fast-tracked for approval by the FDA, believes Biologics License Application process likely to take 4 months, rather than usual 6-12 months. Broker, which issued note last month predicting early release of trial data, values vaccine at A$6.38 a share for CSL. CSL latest up 3.8% at A$37.91. (LMF)

 

from:

http://www.newratings.com/analyst_news/article_1051973.html

 

also:

http://www.news.com.au/story/0,10117,16851827-39555,00.html

 

http://www.smh.com.au/text/articles/2005/1...8562999590.html

 

http://www.theadvertiser.news.com.au/commo...255E911,00.html

 

http://www.theaustralian.news.com.au/commo...255E643,00.html

 

http://www.theage.com.au/text/articles/200...8562997913.html

 

http://www.theage.com.au/text/articles/200...8562999768.html

 

 

 

 

 

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Transcript

 

Cervical cancer vaccine has huge potential: CSL chief

 

Date : 09/10/2005

 

Reporter: Alan Kohler

 

Print Email

 

 

ALAN KOHLER: It's been an extraordinary week for Australian medical science. On Monday there was the Nobel Prize for the researchers who'd discovered a cure for stomach ulcers and on Friday the global pharmaceutical market was abuzz with news of the extraordinary trial results for a vaccine to prevent most cervical cancers, developed by the plasma group, CSL. It's been a busy time for the Melbourne-based CSL, which is also working on a vaccine for the bird flu virus. I spoke to CSL's chief, Brian McNamee, just after results for that cervical cancer drug, or, more correctly, the human papilloma virus vaccine, called Gardasil, were released.

 

Well, Brian McNamee, can you give us some sense of the importance of Gardasil to CSL, and, I guess, to the Australian biotech business?

 

BRIAN MCNAMEE: I think it is the first real commercial product that's going to come out of Australian science for which Australia gets a significant commercial benefit.

 

ALAN KOHLER: The first?

 

BRIAN MCNAMEE: I think it's the first. We've had many important scientific discoveries here from Australia, but frequently they went into the public domain, commercialised by others. So, arguably, this is the first major time that we've not only been involved in a scientific breakthrough, but actually made a contribution, and therefore benefiting in the long-term commercialisation of this product. That's a significant step forward for the industry. Clearly, we are delighted with the efficacy of the vaccine. We are delighted for what it's going to do for human health with the second-most common cause of cancer, cervical cancer. So there's lots of medical and people positives, as well as positives for Australian science, biotechnology and, of course, CSL.

 

ALAN KOHLER: The Phase III trials came up with 100 per cent efficacy. That seems hard to believe?

 

BRIAN MCNAMEE: The data is fantastic. It's a great vaccine. Merck have done a wonderful job. Ian Frazer did a great discovery. We've been involved the whole way through. We couldn't have anticipated this data would be this good, but it's real. The Phase II data also gave us a hint it was going to be 100 per cent effective but this is a big Phase III study.

 

ALAN KOHLER: Is anything else 100 per cent effective?

 

BRIAN MCNAMEE: This is as good as it gets. No, I mean many vaccines are pretty good, but I don't know of many others that that have ever shown 100 per cent. It doesn't get any better than this.

 

ALAN KOHLER: What is the potential revenue from it?

 

BRIAN MCNAMEE: Thankfully I've got a whole lot of analysts who follow CSL and Merck and it is their job to try and protect the market long-term, but clearly we see it, and Merck see it, as a blockbuster drug. Really, the question is just how broadly it will be taken up. The vaccine trial, this trial was in women 16 to 26. That's a big part of the population. There are other studies going on with older women. There are studies going on with males. This vaccine, I think, is very important because HPV is a very nasty virus and it infects a lot of people and causes a lot of disease. So, yes, we think it's going to be, clearly, a blockbuster drug.

 

ALAN KOHLER: I have seen some estimates of $2 billion. If that was true, what proportion, what percentage is CSL's share of that?

 

BRIAN MCNAMEE: We get a royalty stream from Merck and we also have, very importantly, the Australian and New Zealand marketing rights and we think they are very valuable and we think they are very important product here for Australia. So, if the market is as big as some are projecting, $3 billion, $3.5 billion, then, sure, it's very valuable to us. Could it be worth $100 or $200 million royalty a year, income a year? It's possible.

 

ALAN KOHLER: Is it also a potential universal childhood vaccine?

 

BRIAN MCNAMEE: I don't think it needs to be a childhood vaccine, but I certainly think it's a universal adolescent vaccine as part of its application. That won't be its only application, but certainly that's an important part of it.

 

ALAN KOHLER: Obviously CSL's main business is blood plasma products and you've built a pretty strong global position in that. To what extent does Gardasil represent a whole new direction for CSL?

 

BRIAN MCNAMEE: What we have tried to create with CSL is a global biopharmaceutical company. How you make the product, whether you make it from plasma, whether you make it using vaccine technology, recombinant DNA technology, so-called biotech, that doesn't really matter. So what I've got now is a global capability of selling specialised medicines. So our strategy is to move up the value chain. We used to do innovation and then we'd partner with big companies. We now want to take products a lot further, even right through to the marketplace, so the infrastructure I now have globally provides me with the opportunity and the R&D investment capability to develop new important medicines. That's the future of the company.

 

ALAN KOHLER: So it is not just plasma anymore? You'll be going into new drugs, whatever can be distributed through your infrastructure?

 

BRIAN MCNAMEE: Certainly protein-based, certainly involving the areas of immunology and protein is where we have a specialist focus and a great capability, so what we see is that even some of the so-called plasma products will be replaced by biotech subsequently, so we'll work on those substitutes. We are working on new products. It's this capability of understanding what you are really good at, which academic groups that you can collaborate with to create great science, and then taking it as far as you can and as fast as you can.

 

ALAN KOHLER: But It's a risky business. In a sense you are in a commodities business with plasma. The drugs business is much riskier. Is it likely to increase CSL's risk profile?

 

BRIAN MCNAMEE: We don't see it that way. We see it that we've demonstrated our ability to create intellectual property assets of great value. Gardasil is the first and the best. We have other assets as well. So my belief is that we have demonstrated capability on the innovation side, we have demonstrated capability on the commercial side and we now need to marry those two for great success. I wouldn't say the risk profile has changed. I think the opportunity, the scale of the opportunity and what we are trying to create is a different paradigm to where we've been before.

 

ALAN KOHLER: Do you have any other interesting drugs in the pipeline now?

 

BRIAN MCNAMEE: Yes, we do, but they are at an earlier stage than Gardasil. Some of them are based on biotechnology, some of them are based on our insights into human papilloma viruses, a treatment rather than a vaccine again for certain subgroups of patients. So we have three or four very interesting things. Now, unfortunately I am a realist. I know that not everything will work.

 

ALAN KOHLER: Just on Gardasil, are you convinced it will get to market? What are the chances of it falling over from here?

 

BRIAN MCNAMEE: None, in my view. Now, that's a strong statement, but with a vaccine that's 100 per cent effective, I mean a very, very trivial side-effect profile. Merck have done a superb job on the project. I think it is all systems go.

 

ALAN KOHLER: There have been a lot of scare stories lately about bird flu. Do you think the concerns are justified or overdone?

 

BRIAN MCNAMEE: I think that it is very appropriate that the Commonwealth and the states and, in one sense, the nation, plans in a very detailed way for the contingency of a pandemic flu. Whether that planning has been assisted by all the background noise in the media, I could debate that, but the issue is real, the need for planning --

 

ALAN KOHLER: It hasn't just been in the media. We've had government ministers, the Health Minister has frequently talked about it and warned people about it --

 

BRIAN MCNAMEE: I think the minister has done a very good job because, fundamentally, all roads lead to him. It's his call. He needs to plan for this and so I think that that's quite appropriate, what he has done. I think that, clearly, we are very involved in the vaccine prevention side, which I think is a key part of our defence, long-term.

 

ALAN KOHLER: Do you have a product, a vaccine, that is available, or would be available?

 

BRIAN MCNAMEE: Our involvement to date is that we are now doing an initial trial of a prototype vaccine. So we're doing a trial here in Melbourne and Adelaide, where we test both just how much vaccine you need to stimulate the body's immune response, what the dosing schedule should look like, and whether or not you need an adjuvant, which is something to help it stimulate a stronger response. We are testing those things. Now, as we learn from that study, that study, hopefully, will be completed by the end of this year, we will have data probably by February, now, next year, that will give us a very clear insight as to whether we could do a further study and then move to registration rapidly. That's our game plan.

 

ALAN KOHLER: That's still a long way off, isn't it?

 

BRIAN MCNAMEE: It's certainly many, many months off, but clearly we would like, within 12 months, to have completed the program. Now, that relies on this initial study being somewhat positive. We may have to do further work.

 

ALAN KOHLER: Does all this mean that if there was a bird flu pandemic CSL would make an absolute fortune?

 

BRIAN MCNAMEE: No, we have already agreed with the Commonwealth that this isn't the issue for us. We know that, given the flu vaccine for the pandemic is manufactured with the same methodologies as the existing flu vaccine, our cost structure is relatively well known by the Government. Of course we will sell a lot more doses, but it's not going to be a windfall gain that some are wrongly anticipating. We have a responsibility to the Australian public and our regional partners and others to actually get the vaccine out there.

 

ALAN KOHLER: You lived in the US for a few years and then moved back to Australia. Can you successfully run a global pharmaceuticals, or life sciences, business from Australia?

 

BRIAN MCNAMEE: Well, I guess the experiment is continuing, isn't it? But, in essence, I think we've done a good job so far. I think that we've got a very clear understanding of what Melbourne does; we do the innovative R&D, we do the intellectual property management, we do finance, treasury, legal, very clear views of what we do, and we have very important manufacturing here for flu and plasma at Broadmeadows. We know what we do. Then in the US and Europe weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve got very strong commercial organisations. So I think as long as we have the technology and the ability of our staff to do it, yes, our clear objective is to remain this somewhat unique company in the Australian model because we think that the disadvantage of being away from our markets is actually turned to an advantage because this is a preferred place for our scientific staff to live, and I think the Australian scientific community is a wonderful resource for whom we look to collaborate. So they are the advantages we work to.

 

ALAN KOHLER: You've been running the company for a long time, about 15 years I think, quite a while before it was privatised. Any thought of moving on and giving someone else a go?

 

BRIAN MCNAMEE: I guess one's time always turns up, but the job is great, it's interesting. I'm not sure it's the same job I signed up for as well. So the company's changed so much, the challenges are very real, we've got lots of opportunity to grow. I can't imagine a better job, to some degree. I think we do great things. We try to develop new medicines for people. We try to look after our patients, so it's a wonderfully interesting job. I love living here in Melbourne, it's great fun. So I think at the moment I'm here, Alan, until someone tells me it's time to leave, and if that happens, that's fine.

 

ALAN KOHLER: We'll leave it there. Thanks very much.

 

BRIAN MCNAMEE: Thanks, Alan.

 

from:

 

http://www.abc.net.au/insidebusiness/conte...05/s1477874.htm

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