Guest guest Posted December 14, 2009 Report Share Posted December 14, 2009 Yow. It IS big news! Thank you, . On Sun, Dec 13, 2009 at 8:14 PM, Malseed <rodorbal@...>wrote: > > > > > 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, > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 14, 2009 Report Share Posted December 14, 2009 Dear , Great news about omacetaxine, but I am wondering how it can be new when I was on this drug in 2000. Do they have any explanation for that, other than a change in name? I'm all for new drugs even if they only save a small group of patients with a mutation, but maybe someone can answer this for me. For my information, Lottie Duthu Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.