The gigant biopharmaceutical company Pfizer (NYSE: PFE) is obtaining surprising results from its drug Lyrica. This biopharmaceutical company described in an SEC filing that Lyrica (Pregabalin) could be used to treat epilepsy, post-herpetic neuralgia, diabetic peripheral neuropathy and fibromyalgia. Lyrica is considered to have a low potential for abuse, and a limited dependence liability if misused, and is thus classified as a Schedule V drug in the U.S.
Lyrica was invented by medicinal chemist Richard Bruce Silverman at Northwestern University. Silverman headed the team of scientists that discovered novel compounds of vigabatrin (CPP-115 aminotransferase inhibitors and derivatives of vigabatrin) This compound is being developed by Catalyst Pharmaceutical Partners under the patents licensed from Northwestern in August 2009.
Pregabalin (Lyrica, Pfizer) was approved in the European Union in 2004, and received U.S. FDA approval for use in treating epilepsy, diabetic neuropathic pain, and post-herpetic neuralgia in December of that year, first appearing on the U.S. market in fall 2005. In June 2007, the FDA approved Lyrica as a treatment for fibromyalgia. It was the first drug to be approved for this indication and remained the only one until duloxetine (Cymbalta) gained FDA approval for the treatment of fibromyalgia in June 2008. Lyrica's patent will expire in March 2018.
The FDA granted orphan drug designation for Firdapse™ on November 12, 2009. !!
CPP-115 has received orphan drug designation in both the US and the EU for infantile spasms. In 2011 !!
Orphan drugs in the U.S. are granted a seven-year period of marketing exclusivity from the date of drug approval !!
CPRX has about 42 million shares fully weighted and if CPP115 and Firdpase generate the sales recently projected by the analyst at Aegis capital $1.6 billion for CPP115 and $200 million for Firdapse) that translates to gross revenues of $42 per share for CPRX.
CPRX have incredible potential !
A few smart investors who bought Acadia Pharmaceuticals, Inc. (NASDAQ: ACAD) last year are jumping for joy and smiling every step of the way to the bank, while the investors who only thought about it but didn’t pull the trigger, are still kicking themselves pretty hard. Surprisingly, even the most bullish Acadia enthusiasts didn’t foresee shares gaining almost 1,500% in only one year making Acadia one of the best performing stocks in the entire market.
Fortunately, for those who missed the boat with Acadia, there is another strikingly similar, small-cap company named Catalyst Pharmaceutical Partners, Inc. (NASDAQ: CPRX) that appears to be about one year behind Acadia and is all teed up to repeat their stunning performance. One short year ago, Acadia’s market cap was less than $60 million. Today, it is $1.4 billion. Catalyst’s market cap is less than $50 million. A year ago, Acadia was on the ropes because their lead drug Pimavanserin failed its Phase III trial. Last November, Catalyst announced that their drug CPP109 for cocaine addiction failed its Phase II trial. Acadia redesigned their trial and this time Pimavanserin worked.
Catalyst quickly shifted its focus to CPP115 as the next generation of CPP 109 for a large number of indications including epilepsy, infantile spasms, Tourette Syndrome, Post Traumatic Stress Disorder and movement disorders. CPP115
CPP115 is 200 times stronger than CPP109 and it has been shown to be free of the potential adverse side effect of loss of peripheral vision that was associated with CPP109. Acadia’s Pimavanserin addressed an orphan drug market of fewer than 50,000 patients suffering from Parkinson’s Disease Psychosis. Catalysts CPP115 also addresses the lucrative orphan drug markets but is expected to treat more indications than Pimavanserin.
CPP115 was designed by Dr. Richard Silverman, the well-known drug designer who created the blockbusters Lyrica and Neurontin for Pfizer (PFE).