TPTX » Topics » (9) Subsequent Events

These excerpts taken from the TPTX 10-K filed Mar 31, 2008.

Subsequent Events

        On February 29, 2008 our discovery-phase GSM collaboration with Eisai concluded. In connection with conclusion of this agreement we implemented a reduction of our work force. In addition, Neil Kurtz, M.D., our President and Chief Executive Officer, will assume oversight of all clinical development programs. Michael Murphy, M.D., Ph.D., who has served as our Chief Medical Officer, left the company effective February 29, 2008 to pursue other interests.

Subsequent Events



        On February 29, 2008 our discovery-phase GSM collaboration with Eisai concluded. In connection with conclusion of this agreement we implemented a reduction
of our work force. In addition, Neil Kurtz, M.D., our President and Chief Executive Officer, will assume oversight of all clinical development programs. Michael Murphy, M.D., Ph.D., who has served as
our Chief Medical Officer, left the company effective February 29, 2008 to pursue other interests.



This excerpt taken from the TPTX 10-K filed Mar 16, 2006.

NOTE K – SUBSEQUENT EVENTS

 

 

 

In January 2006 the Company announced that it had granted to Daewoong Pharmaceutical Company Ltd. (Daewoong) an exclusive license for the use of Phenserine in the South Korean market. Under the terms of the agreement Daewoong, at its own costs, undertakes to pursue the product development and regulatory work necessary for a New Drug Application (NDA) (or its equivalent) in South Korea with respect to Phenserine for the treatment of AD. The financial terms of the deal include royalty payments to Axonyx based on sales of Phenserine by Daewoong in the South Korean market.

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AXONYX INC.

Exhibits filed with Annual Report on Form 10-K
for the fiscal year ended December 31, 2005

 

 

14

Code of Business Conduct and Ethics

 

 

23.1

Consent of Eisner LLP

 

 

31.1

Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer

 

 

31.2

Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer

 

 

32

Section 1350 Certification of Chief Executive Officer and Chief Financial Officer

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This excerpt taken from the TPTX 10-Q filed Aug 8, 2005.

(9) Subsequent Events

          The Company announced a second interim analysis of the Phase IIb trial on July 26, 2005 with respect to its lead drug, Phenserine. Overall, the results from each trial to date did not show statistically significant improvements over placebo for the protocol’s primary endpoints following 26 weeks of treatment. While the second interim analysis appeared to again to confirm that Phenserine may have an impact on the levels of beta amyloid, there is still insufficient evidence due to the variability of the data to draw definitive conclusions. Further detailed analysis as well as additional laboratory bio assay activities are being undertaken by the Company, its scientific advisors and bio-statisticians to investigate the variability of the data.

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Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

          This Form 10-Q contains “forward-looking” statements, as defined in the Private Securities Litigation Reform Act of 1995 that are based on current expectations, estimates and projections. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. These statements involve potential risks and uncertainties; therefore, actual results may differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. We do not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

          Specifically, with respect to our drug candidate Phenserine, Axonyx cannot assure that the Phase IIb and/or the other ongoing Phase III clinical trials, amendments thereto or others, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the previous small Phase II and Phase III trials will remain the same, be better or worse in future clinical trials, if any, that the pre-clinical results related to the regulation of beta-APP will be substantiated by the Phenserine Phase IIb clinical trial and that Phenserine will be able to slow the progression of Alzheimer’s disease, that the Phase IIb clinical trial data will differentiate Phenserine from the currently marketed drugs, that any efficacy and safety results of the Phase III trial program if pursued, will prove pivotal, that Axonyx will obtain the necessary financing to complete the Phenserine and/or other development programs, that the Company’s development work on Phenserine will support an NDA filing, that the results of the Phase III trials will allow Phenserine to be approved by the FDA, that the FDA will grant marketing approval for Phenserine, that if Phenserine is approved by the FDA, it will prove competitive in the market, and that Axonyx will obtain licensing or corporate partnership agreements that will enable acceleration of the development of and optimize marketing opportunities for, Phenserine, or that Axonyx will be able to advance Posiphen, BisNorCymcerine and any of its other potential memory enhancing compounds toward and beyond IND status. Axonyx undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

          We refer you to our report on form 10-K for the year ended December 31, 2004 filed with the SEC, where these risks and others are more fully described.

          We do not undertake to discuss matters relating to our ongoing clinical trials or our regulatory strategies beyond those which have already been made public or discussed herein.

          We are a biopharmaceutical company, specializing in central nervous system (CNS) neurodegenerative diseases, engaged in the business of acquiring the patent rights to clinical stage compounds, compounds with strong proof of concept data and compounds ready for proof of concept validation with convincing scientific rationale. We further develop and add value to these compounds and then seek to out-license or partner them when we believe it business prudent. We have acquired worldwide exclusive patent rights to three main classes of therapeutic compounds designed for the treatment of Alzheimer’s disease (AD), Mild Cognitive Impairment, and related diseases.  We have acquired patent rights to a class of potential therapeutic compounds designed for the treatment of prion related diseases, which are degenerative diseases of the brain that are thought to be caused by an infectious form of a protein called a prion.  Prions, unlike viruses, bacteria and fungi, have no DNA and consist only of protein.  Such diseases include Creutzfeldt Jakob Disease, new variant in humans, Bovine Spongiform Encephalopathy (BSE or Mad Cow Disease) in cows, and Scrapies disease in sheep.  We have licensed these patent rights separately from New York University and from the National Institutes of Health/National Institute on Aging (via a sublicense).  We also have co-inventorship rights to a patent application regarding a therapeutic compound named Posiphen designed for the treatment of Alzheimer’s disease progression.

          Our mission continues to be the leading biopharmaceutical company that develops products and technologies to treat AD and other central nervous system disorders. Our current business strategy is to

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concentrate our financial resources primarily on three compounds in development for Alzheimer’s disease.
These are:

 

 

 

 

Phenserine – A symptomatic and disease progression treatment of mild to moderate AD.

 

 

 

 

Posiphen™ – A disease progression treatment for AD

 

 

 

 

BisNorCymcerine (BNC) – A symptomatic treatment of severe AD.

          Phenserine is an inhibitor of acetylcholinesterase, and is our lead drug candidate for the treatment of AD.  Acetylcholinesterase is an enzyme in the synapse that degrades the neurotransmitter acetylcholine in the brain and other tissues of the body. Acetylcholinesterase inhibitors are drugs designed to selectively inhibit acetylcholinesterase. Acetylcholine is a chemical substance that sends signals between nerve cells, called neurotransmission, and is therefore called a neurotransmitter.  Neurotransmitters are secreted by neurons, or nerve cells, into the space between neurons called the synapse.  Acetylcholine is a primary neurotransmitter in the brain, and is associated with memory and cognition.

          Posiphen is a compound that appears to decrease the formation of the beta amyloid precursor protein (beta-APP) with potential applications in the treatment of AD. Posiphen is the positive isomer of Phenserine. As such, it appears to affect the messenger RNA of beta-APP as well as inhibit beta secretase whereby beta amyloid levels, in preclinical animal models, are reduced.

          BisNorCymcerine is one of our butyrylcholinesterase inhibitors. Butyrylcholinesterase is found in high concentration in the plaques taken from individuals who have died from AD. Butyrylcholinesterase is an enzyme that is normally found widely in the body and butyrylcholine appears to play a relatively increasingly important role in advancing AD. Therefore inhibition of the enzyme may prove valuable in the treatment of severe AD. 

          The Company’s lead drug, Phenserine, is a third generation acetylcholinesterase inhibitor, which has progressed to late stage clinical trials. The results of the 1st Phase III trial were announced on February 7, 2005 and the interim results from the Phase IIb beta amyloid trial were announced on March 11, 2005. The Company announced a second interim analysis of the Phase IIb trial on July 26, 2005.

          Overall, the results from each trial did not show statistically significant improvements over placebo for the protocol’s primary endpoints following 26 weeks of treatment. We have evaluated the results, and following recommendations from our Scientific Advisory Board and Safety Steering Committee, we have modified the planned Phenserine clinical program going forward. The Phenserine results to date demonstrate a consistent positive trend on all primary and secondary domains in the symptomatic management of Alzheimer’s disease. However, there was no statistically significant efficacy in cognition, global function and activities of daily living, that may in part have been caused by the fact that there was minimal decline over the 26 weeks in the placebo group. Our conclusion from analyzing the data is that we need to investigate the reformulation of Phenserine to a sustained or extended release formulation rather than the immediate release formulation used in the recently completed trials. The reformulation should reduce the pharmacokinetic peak experienced with the immediate release formulation and enable more drug to work longer over the dosing interval in the patients. Therefore, we have halted additional patient recruitment to our second and third Phase III clinical trials that were commenced in June 2004 and September 2004 respectively. Those patients already enrolled in the trial will receive 12 weeks of treatment.

          The March 11, 2005 interim statistical analysis of the results from our Phase IIb beta amyloid trial, while not meant to show significance, showed a consistent trend towards beta amyloid reduction with the 15mg doses. While the second interim analysis announced on July 26, 2005 appeared again to confirm that Phenserine may have an impact on the levels of beta amyloid, there is still insufficient evidence due to the variability of the data to draw definitive conclusions.  Further detailed analysis as well as additional laboratory bio assay activities are being undertaken by the Company, its scientific advisors and bio- statisticians to investigate the variability in the data.  Mean while, the enrollment in the phase IIb trial will continue at the 15mg dose level and placebo with a target of 150 patients.   

          Posiphen has been shown to lower beta-amyloid precursor protein (beta-APP) levels in pre-clinical studies. The primary mechanism of action results in a dose dependent reduction of beta amyloid, which may

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result in slowing AD progression. The initial pre-clinical side effect rates potentially allow for higher clinical doses. On August 1, 2005 the Company announced that the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) application allowing phase I clinical testing of Posiphen.  The first Phase I clinical study is expected to begin shortly and will primarily evaluate the safety of Posiphen in healthy volunteers. 

          BisNorCymcerine (BNC) is a highly selective butyrylcholinesterase inhibiter. Butyrylcholinesterase is found in high concentration in the plaques taken from individuals who have died from AD. Butyrylcholinesterase appears to have an increasing role with advancing Alzheimer’s disease and its primary mechanism of action results in a dose dependent reduction of Acetylcholine. The initial pre-clinical side effect rate potentially allows higher clinical doses. A secondary mechanism of action is associated with dose dependent reductions of beta APP and amyloid beta. BNC, the lead compound from our butyrylcholinesterase family, is currently in full pre-IND development and we plan an IND submission in fourth quarter 2005 followed by the initiation of Phase I clinical studies in first quarter 2006.

          In December 2000, the Company incorporated Axonyx Europe BV, a wholly owned subsidiary, in the Netherlands.  Gosse Bruinsma, M.D., currently the President and Chief Executive Officer of Axonyx Inc., is also the President of Axonyx Europe BV. The majority of our clinical development activities and a significant amount of our pre-clinical development activities are carried out in Europe. The Axonyx Europe BV office manages, directs, and controls these activities. Axonyx Europe BV explores and pursues in-licensing and out-licensing opportunities for the Company’s licensed technologies and facilitates communication with the Company’s European shareholders and Serono.

          In June 2005, the Company appointed Paul Feuerman as its General Counsel.  Mr. Feuerman is a founding member of Pharm Advisors LLC, a consulting firm serving pharmaceutical and biopharmaceutical companies. Formerly, he was Executive Vice President and General Counsel of Schein Pharmaceutical Inc., a New York Stock Exchange listed specialty pharma/generics company.

          We have incurred negative cash flows from operations since the inception of the Company in 1997.  Our net losses for the three fiscal years ended 2002, 2003 and 2004 were $6,256,000, $8,106,000 and $28,780,000 respectively, and our net loss for the six months ended June 30, 2005 was $18,612,000.  We have no products available for sale and we do not expect to have any products commercially available for several years, if at all.

          Axonyx Inc. was incorporated in Nevada on July 29, 1997.  Our principal executive offices are located at 500 Seventh Avenue, 10th Floor, New York, New York 10018, and our telephone number is (212) 645-7704.

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