Many scientists never get to taste the success of developing a successful compound. With over 1,000 biotechnology companies in North America presently, there are thousands of researchers that are working every day to develop drugs with one goal in mind: FDA approval. There are more than 2,000 drugs in development at this time. Estimates vary, but only 5 to 10 percent of compounds ever make it to this final goal. How rare is FDA approval for a new drug? In the last three years, 65 new drugs have been granted final FDA clearance (25 in 2009, 22 in 2008 and 18 in 2007).
Dr. Krishna Menon, Chief Scientific Officer of Cellceutix Corporation has been involved in the development of a successful compound not once, but twice. While a lead researcher at Eli Lilly and Company (NYSE:LLY), Dr. Menon was integral to the initial research on cancer drugs Pemetrexed (marketed as “Alimta”) and Gemcitabine (marketed as “Gemzar”).
Granted its first FDA approval in August of 2004, Alimta is a chemotherapy drug used to treat non-small cell lung cancers and mesothelioma, a form of lung cancer associated with the exposure to asbestos. Alimta has received 4 different FDA approvals as a therapy for cancers with the most recent coming in July of last year.
Gemzar received FDA approval in July of 2006 as a therapy to be used in combination with carboplatin for patients with advanced ovarian cancer that have suffered a relapse after receiving treatments of platinum-based therapies. Presently, it is also used to treat cancers of the pancreas, lung and breast.
These two drugs combined are responsible for billions of dollars annually for Eli Lilly. Gemzar has revenues totaled $1.59 billion in 2007, $1.71 billion in 2008 and $1.36 billion in 2009. Total revenues from Alimta were $854 million in 2007, $1.52 billion in 2008 and $1.71 billion in 2009. That’s nearly $9 billion in combined revenues of the last three years.
As CSO at Cellceutix, Dr. Menon is presently working on developing another novel compound for the treatment of cancer. Kevetrin™, the Company’s flagship compound, is approaching Phase I clinical trials as a therapy for specific strains of multi-drug resistant cancers of the lungs, colon and breast. Pre-clinical research is nearly completed as Cellceutix is only awaiting final data from toxicology studies which is anticipated within the next two weeks. Cellceutix is making preparations for an Investigational New Drug (IND) filing with the FDA and human trials will follow (tentatively scheduled for late fourth quarter 2010 or early first quarter 2011).
The pre-clinical data collected has been very promising for Kevetrin as detailed by Cellceutix throughout via press releases and website (www.cellceutix.com). In a recent press release, Dr. Menon stated, “I have been closely involved in the development of several successful compounds in my 30 years in the industry and am extremely encouraged by the data that Kevetrin has produced.” If Dr. Menon is encouraged by the data collected thus far, it leads to the question “Is he going to do it again?”
More information on Cellceutix Corporation, Kevetrin for multi-drug resistant cancers and the investment opportunity presented can be found on the Company’s website at www.cellceutix.com.
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