SOURCE: Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc.

May 17, 2010 16:30 ET

Adeona Announces First Quarter 2010 Results and Achievements

Investor Call Scheduled for Tuesday, May 18, at 9:00 AM EDT

ANN ARBOR, MI--(Marketwire - May 17, 2010) -  Adeona Pharmaceuticals, Inc. (AMEX: AEN) announced today its first quarter 2010 financial results and recent achievements.

Adeona will hold an investor conference call on Tuesday, May 18, at 9:00 a.m. EDT to discuss these results and achievements. Adeona's Chief Executive Officer, James S. Kuo, M.D., M.B.A., will host the call. In order to participate, please call toll free: 888-211-7451 (US); international dial-in: 913-312-0688, conference ID. 4904128. The audio recording will be available for replay at http://www.adeonapharma.com for a period of at least 15 days after the call.

For the three months ended March 31, 2010, Adeona's research and development expenses were $419,213 as compared to $495,994 for the three months ended March 31, 2009. The decrease of approximately 15% is due to numerous factors including decreases in payroll expenses, stock based compensation charges and drug related expenses, offset slightly by an increase in consulting expenses.

For the three months ended March 31, 2010, general and administrative expenses were $735,447 as compared to $593,444 for the three months ended March 31, 2009. The increase of approximately 24% is primarily due to increases in payroll expenses, stock based compensation charges and overhead expenses, offset by a decrease in G&A expenses.

Net loss for the three months ended March 31, 2010 as compared to the three months ended March 31, 2009 decreased by 2% from $1,113,275 in 2009 to $1,087,522 in 2010. As of March 31, 2010, Adeona reported $1,979,059 of cash, which cash amount does not include the additional $2,150,000 in net cash received by Adeona from Meda on May 7th of this month. 

Adeona's recent achievements include the following:

  • Completion of a landmark corporate partnership with Meda AB for the development and commercialization of flupirtine for fibromyalgia with potential milestone payments of up to $17.5 million dollars.

  • Positive results from Part 1 of the CopperProof-2 clinical trial of Zinthionein ZC, the first controlled clinical trial of zinc therapy in Alzheimer's disease or mild cognitive impairment.

On May 7, Adeona announced that it had entered into a corporate partnership with Sweden-based Meda AB to develop flupirtine for the treatment of fibromyalgia syndrome. Adeona may receive up to $17.5 million in upfront and milestone payments, plus royalties.

Under the terms of the agreement, Adeona has granted Meda an exclusive sublicense to all of Adeona's rights to patents covering the use of flupirtine for fibromyalgia. These patents have issued in the U.S. and are pending in Canada and Japan. Meda will assume all future development costs for the commercialization of flupirtine for fibromyalgia. Adeona received an up-front payment of $2.5 million and may receive an additional $15 million in milestone payments if certain milestones are achieved.

Flupirtine is a potential first-in-class, centrally-acting, selective neuronal potassium channel opener for fibromyalgia that also has NMDA receptor antagonist properties. Flupirtine is currently approved and marketed by Meda for the treatment of pain in various countries outside of the U.S. Meda estimates the U.S. market for fibromyalgia to be near $1 billion at the time of potential launch of flupirtine.

On April 14, Adeona announced positive results from Part 1 of the CopperProof-2 clinical study of Zinthionein ZC. Part 1 demonstrated that Zinthionein ZC (containing 150 mg of zinc acetate and 100 mg of cysteine) had a substantially lower incidence of adverse effects in Alzheimer's disease and mild cognitive impairment subjects compared to Galzin® (containing either 50 mg or 100 mg of zinc acetate). Zinthionein ZC also demonstrated superior serum zinc bioavailability in these subjects compared to both the 50 mg and 100 mg dose levels of Galzin®.

Part 2 of the CopperProof-2 clinical study is intended to enroll 60 Alzheimer's disease and mild cognitive impairment subjects and is currently ongoing. Part 2 subjects are randomized on a 50:50 basis to either Zinthionein ZC or matching placebo. Subjects will be assessed at 3 and 6 months for serum parameters of zinc and copper as well as changes in cognitive function using standard clinical tests used in Alzheimer's disease and mild cognitive impairment. Adeona recently added two additional clinical sites in Florida to further expedite enrollment and complete Part 2 of the study.

"There have been several major transformative changes at Adeona during the past few months," stated James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer. "We recently completed a major corporate partnership with Meda AB to develop flupirtine for fibromyalgia, a potential billion dollar market opportunity. That transaction is evidence that the management team here is executing on our stated corporate strategy of developing each of our programs to an inflection point in valuation. We continue to move our Trimesta, Zinthionein ZC, dnaJP1, and ZincMonoCysteine clinical programs forward while conserving our financial resources." 

About Adeona Pharmaceuticals, Inc.

Adeona (AMEX: AEN) is a pharmaceutical company developing new medicines for serious central nervous systems diseases. Adeona's primary strategy is to in-license clinical-stage drug candidates that have already demonstrated a certain level of clinical efficacy and develop them to an inflection point in valuation resulting in a significant development and marketing collaboration. Trimesta (estriol) is an investigational oral drug for the treatment of relapsing remitting multiple sclerosis. A 150-patient, 16-center, randomized, double-blind, placebo-controlled clinical trial is currently underway. Effirma (flupirtine) is a centrally-acting investigational oral drug for the treatment of fibromyalgia syndrome. Adeona has entered into a potential $17.5 million corporate partnership with Meda AB. As part of the agreement, Meda will assume all future development costs while Adeona is entitled to receive milestone payments and royalties. Zinthionein ZC (zinc cysteine) is an oral, gastro-retentive, sustained-release medical food candidate being developed for the dietary management of Alzheimer's disease and mild cognitive impairment. A 60-patient randomized double-blind, placebo-controlled clinical study is currently underway. dnaJP1 (hsp peptide) is an investigational oral drug for the treatment of rheumatoid arthritis. It has completed a 160-patient, multi-center, randomized, double-blind, placebo-controlled clinical trial.

This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the success of our clinical trials and our ability to capture a significant percent of the market. The forward-looking statements include statements regarding the potential market for flupirtine and timing of the commercialization of flupirtine for the treatment of fibromyalgia and are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure Meda to commercialize flupirtine and to make any other payments under the sublicense agreement, a failure to obtain regulatory approval for flupirtine or Zinthionein ZC or to comply with ongoing regulatory requirements, regulatory limitations relating to the company's ability to promote or commercialize flupirtine or Zinthionein ZC, a lack of acceptance of flupirtine or Zinthionein ZC in the marketplace and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2009 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contact Information

  • For further information, please contact:

    James S. Kuo, M.D., M.B.A
    Chief Executive Officer
    734-332-7800