Monday, December 27, 2010

King Pharma Re-submits NDA for Remoxy

King Pharma (NYSE: KG) is resubmitting its NDA for Remoxy to the FDA.  The NDA was submitted berfore, but the FDA wanted more information about the deterrence technology used in Remoxy and its effectiveness.  If Remoxy is approved, it's main competitor will by OxyContin manufactured by Purdue Pharma.  Because the high abuse of Oxycontin, it may be given that a drug with abuse deterrence will trump the use of one without such technology.  King Pharma has taken a leading role in developing drug deterrence technology and may get a large market share in narcotic medications.

Remoxy is a novel formulation of the pain killer oxycodone, which has high addictive and abuse potential.  Purdue's OxyContin is a delay-release formulation, which means that the drug is slowly release and the patient does not get the "high" feeling.  However, drug abusers have found ways to extract the oxycodone from the formulation for recreational use.  Remoxy is a high viscosity (think thick) liquid in a hard gelatin capsule (physical barrier).  Freezing, dissolving in ethanol, and manipulation are made difficult.  The fraction of oxycodone released is a fraction compared to OxyContin.    

There are two other formulations that fall in the same cateogry as Remoxy: Embeda by Alpharma which was bought by King Pharma and Acurox by Acura Pharma and King Pharma.  Embeda has been approved by the FDA while Acurox was rejected in April.

Both technologies are great in fighting against abuse of narcotics.  Personally, I believe Embeda's drug deterrence technology is better than Remoxy.  Embeda is a combination of morphine and naltrexone, which opposes the effects of morphine.  When swallowed, naltrexone is digested by the stomach and has no counter-effect.  When injected, naltrexone is active and prevents effects of morphine.  Separating naltrexone from the formulation is difficult without degrading morphine.  Remoxy's deterrence technology may be easier to "hack."  There might be higher prescribing of Embeda than Remoxy but  it may be too early to tell.

Since both formulations are under license of King Pharma, it is a win-win situation potentially (not to mention Acurox is also developed by King Pharma).  It will be interesting to see if KG stock price increases in response to submission of the Remoxy NDA.  The price may simply increase because of FDA approval.  The sales figures from the two drugs are difficult to predict and the fact that they may compete against each other may cancel any great benefit for investors.  Both drugs are used for moderate-to-severe pain.  Think of GM when it had numerous brands and each brand had models that competed against each other.  Embeda is restricted to use in opioid-tolerant patients; those who no longer respond to lower potency drugs.  KG may decide to try to market them in different ways to increase prescribing.  It would be wise of King Pharma to promote Remoxy and if the patient becomes tolerant (unresponsive) to it, the patient could be placed on Embeda.  

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