omacetaxine

[Guest guest]

Hi Everyone,

This was big news here today in Australia.

CHEMGENEX yesterday became the first Australian company to submit a cancer

drug to the stringent US regulator for approval -- the last hurdle before

the drug can be sold.

The Geelong-based developer of a cure for a rare leukemia mutation is also

the first Australian biotech to approach the powerful Food and Drug

Administration (FDA) without help from a large pharmaceutical company to

gain new drug approval status for a small molecule therapy.

Led by chief executive Greg Collier, Chemgenex took less than five years and

$40 million to develop omacetaxine as a drug trademarked as Omapro to treat

chronic myeloid leukemia.

If it convinces the FDA to review the application as a matter of priority,

the drug will be on the shelves in the first half of next year.

Speaking to BusinessDaily from New York, Mr Collier said he was pleased to

have the good news to take into a round of investor meetings at the Rodman &

Renshaw healthcare conference.

Mr Collier will present Chemgenex's story at the conference, which begins

tomorrow and is the largest gathering of biotech investors in the US.

He refused to comment on the possibility that a bidder for the company may

emerge on the back of the company's announcement.

" If someone wanted to buy Chemgenex, they would have to go to the board . .

.. it is not something for a manager to contemplate, " Mr Collier told

BusinessDaily.

" I'm not skirting around the issue of a sale, but my job is to build a

successful company with a product in the market and try to achieve more

liquidity in the stock. "

Mr Collier, who has been with the company from the outset, said he was

particularly excited to have a drug that went one step further than existing

leukemia treatments because it can kill cancer stem cells.

Omacetaxine has also been shown by medical researchers to destroy the stem

cells of other cancers, providing the drug with even greater commercial

potential.

Yesterday's achievement is being hailed by sector analysts as proof that the

nation's life sciences industry is maturing.

" Increasing investor interest in biotechs, demonstrated by the takeover bid

for Peplin last week, coupled with Chemgenex's announcement shows that there

is a real biotechnology industry here that can deliver commercial outcomes, "

ABN AMRO s analyst Power said.

The FDA approves only about 20 new drugs a year, after applying the most

stringent tests of any health body in the world.

" This is set to be the first time one of our companies has put a new drug,

not a device, not a diagnostic, not an old drug wrapped in a new delivery

system, but a brand new drug before the regulator of the largest healthcare

market in the world, " said Blake, editor of weekly online magazine

BioShares.

" The FDA is not known for churning out new drugs, so if they give Omapro

their blessing, it will be one of the select few that make the grade each

year and that in itself is a big achievement, " Mr Blake said.

Mr Power said the stock softened yesterday after some profit taking but he

expected it to strengthen once Wall Street opened for business today.

Chemgenex closed down 3c at 66c.

BIRTH OF A DRUG

2004 AGT BioSciences merges with California's ChemGenex to develop leukemia

drug

2006 US regulator FDA grants fast track status to the drug

2008 ChemGenex acquires full control of the drug

Jan 2009 FDA assigns " orphan drug " status

Sept 2009 ChemGenex files final application with FDA

LEUKEMIA drug researcher ChemGenex is confident a breakthrough treatment

will be sold in the US market before next March, following test results

presented at a prestigious medical convention in Florida overnight.

Clinical trials showed the drug led to remission for 85 per cent of 66

enrolled patients resistant to the standard treatment for chronic myeloid

leukemia.

Some of the patients being studied in 36 medical centres around the world

were still alive three years after starting treatment with the drug, known

as Omacetaxine.

Developed by the Geelong-based company, the drug is expected to have sales

of $US250 million by 2012, according to estimates by biotech analyst Shane

Storey, of HTM.

" The response rates for this drug are truly remarkable, " Mr Storey said.

The findings were presented to the American Society of Clinical Oncology

(ASCO) in Florida, which Mr Storey said was an " important milestone for this

asset " .

Related Coverage

* Local <http://news.com.au/heraldsun/story/0,,26482719-664,00.html>

leukemia treatment goes global Herald Sun, 2 hours ago

* Biotechs

<http://www.theaustralian.news.com.au/business/story/0,,26455078-20142,00.ht

ml> respond well to treatment The Australian, 6 days ago

* ChemGenex

<http://www.theaustralian.news.com.au/business/story/0,,26451274-23634,00.ht

ml> trial boost The Australian, 7 days ago

* Investors

<http://www.theaustralian.news.com.au/business/story/0,,26334090-23634,00.ht

ml> unmoved by drug breakthrough The Australian, 10 Nov 2009

" The key point for investors to grasp is the independence and intellectual

rigour of the ASCO event -- we are now talking about objectively measured,

clinical facts about Omacetaxine. "

ChemGenex chief executive Greg Collier told BusinessDaily yesterday he had

already begun interviewing candidates for the position of chief commercial

officer as the likelihood of speedy commercialisation firmed.

" We are now writing the final submission to the FDA (US Food and Drug

Administration) and should be ready to file for approval around August, " Dr

Collier said.

" This should line us up for potential approval and launch in the US in the

first quarter of calendar 2010 and in the third quarter in Europe. "

Dr Collier said ChemGenex would commercialise the drug in the US

independently, in what would be the first time in years that an Australian

company had taken a medicine all the way to market without a licensed

partner.

Mr Storey said ChemGenex's business model was " pretty smart and it tells you

what could be the future for biotechs " .

" Rather than focusing on the next blockbuster drug, small biotechs that

concentrate on niche patient groups and own 100 per cent of their IP, like

ChemGenex, may have better luck discovering a nice lucrative little market

for themselves. "

After a strong early rally yesterday, shares in ChemGenex closed nearly 1

per cent, or 0.5c, up at 0.56c.

Regards,