A class action has been filed against Noven Pharmaceuticals, Inc. (Nasdaq: NOVN) and certain of its officers and directors by stockholders who purchased the company's common stock between October 29, 2001, and April 28, 2003. The action claims that the defendants violated federal securities laws by issuing a series of material misrepresentations to the market over this time period, thereby artificially inflating the price of the company's securities. The stockholders seek to recover compensatory damages for the loss of value of their stock.
Noven is currently developing a methylphenidate transdermal drug delivery system for attention-deficit/hyperactivity disorder (ADHD) called MethyPatch. During the time period involved, Noven was engaged in the development and testing of MethyPatch. Noven began screening and enrollment for a repetition of a Phase III clinical study of the drug on October 29, 2001.
The action alleges that the defendants' false and misleading statements regarding the rationale and marketing strategies for approval of MethyPatch permitted Noven to artificially inflate the value of its technology to shareholders and thereby minimize the impact of financial uncertainties relating to serious marketed product issues during this time period. Moreover, this conduct allegedly allowed the defendants to reap bonuses and insider trading proceeds.
The true facts, the stockholders claim, were as follows:
1. MethyPatch did not possess the safety and efficacy of immediate-release oral methylphenidate products.
2. The utility and advantages for MethyPatch had been misrepresented by pointing to unmet needs and product advantages that did not and would not exist by the time Noven expected New Drug Application (NDA) approval.
3. The Food and Drug Administration was aware of the reasons why MethyPatch would not be considered as safe or efficacious as Noven had claimed.
4. Transdermal drug delivery systems have been the source of serious medication errors that would complicate the product's contemplated use.
5. For one or more reasons related to the safety or efficacy of the product, the MethyPatch NDA submitted on June 27, 2002, would not be "approvable" as submitted.
As a result of the defendants' allegedly false and misleading statements, Noven's stock traded at inflated prices during the time period, increasing to as high as $27.45 on June 17, 2002, whereby the company's top officers and directors reaped bonuses and insider trading proceeds, selling more than $500,000 worth of their own shares.