May 8, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Israeli company NeuroDerm Ltd. announced today that the U.S. Food and Drug Administration (FDA) had freed up the company to continue with its clinical studies of a Parkinson’s treatment.
The FDA had placed a clinical hold on the company’s development program in the U.S. of ND0612H and ND0612L while the company supplied more data on accuracy, safety and compatibility of the drug delivery devices used. NeuroDerm performed a compatibility study and provided the requested data to the FDA, which lifted the hold.
The company plans to restart the clinical programs in the second half of 2015.
The most common treatment of Parkinson’s disease using Levodopa/Carbidopa (LD/CD) is orally. However, levodopa is not absorbed well when taken orally and consistent dosage is a problem. In order to provide steady delivery, an invasive surgical procedure may be performed with a tube permanently implanted into the upper part of the intestine.
NeuroDerm’s application is a continuous, subcutaneous delivery of LD/CD through a pump worn on the belt. Positive results from a clinical trial in 2014 showed the pump system could deliver a higher, more reliable dose of the drugs. When those results were announced, company stock more than doubled in one day.
“Maintaining consistent levodopa concentrations has been the most significant hurdle in Parkinson’s disease therapy,” said Sheila Oren, NeuroDerm’s vice president of Clinical and Regulatory Affairs in a statement. “The results from this study (in December 2014) demonstrate that ND0612H can reach high LD plasma levels that, to date, could only be reached and maintained by products that require surgical intervention. ND0612H is designed to be delivered continuously, thus we believe it should offer a simple and effective treatment option that will minimize the need for surgical intervention in advanced Parkinson’s patients.”
Other companies working on alternate levodopa formulations include IMPAX Laboratories, Inc. ’ Rytary and AbbVie ’s Duodopa.
NeuroDerm stock jumped from $6.06 per share on Dec. 26, 2014 to $18.14 on Dec. 30, 2014. It moderated for a while to a lower value on Jan. 23, 2015 to $13.47, hitting a 2015 high of $15.22 on April 14. It is currently selling for $13.47.
The company’s recent 2014 annual report indicates it had total assets in 2014 of $43.2 million, up from a 2013 total of $3.05 million. According to the annual statement, “The company reported a net loss of $29.9 million in the twelve months ended December 31, 2014 compared to $86.9 million for the same period in 2013.”
In analyzing the market for new Parkinson’s treatments, Thomas Wei, an analyst with Jefferies and Co. indicated that NeuroDerm’s Parkinson’s drugs and delivery system were probably more effective and safe compared to Impax Laboratories’ Rytary, and was likely more convenient and safer than AbbVie’s Duodopa.
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