NEW YORK, Sept. 8, 2010 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease (AD), with an internal diversified pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO:
Dear Shareholder,
With the summer drawing to a close, I would like to update you regarding significant corporate and industry developments since the start of the year, especially after April. These promising new developments reinforce my strong personal conviction that Intellect Neurosciences is a company at the forefront of the fight against Alzheimer's disease and also represents a significant value proposition for investors with a diversified risk profile that is rare among small biopharmaceutical companies. The key value drivers are an internal preclinical and clinical-stage pipeline backed by strong intellectual property; and royalty-bearing licenses with major pharmaceutical companies covering products in late-stage clinical trials (see chart). Our business strategy, namely the licensing of our intellectual property and development of innovative therapeutics through strategic relationships, is on track. Moreover, I believe that attainment of our near-term objectives will add enormously to the enterprise value and reward you for your continued loyalty and support.
Intellect Neurosciences Pipeline:
A chart accompanying this release is available at http://media.globenewswire.com/cache/12707/file/8747.pdf
Some of the recent highlights include:
Strengthened Balance Sheet:
In April, we announced the completion of a restructuring of our balance sheet, eliminating approximately $24 million of aggregate face amount plus accrued interest of debt and preferred stock through the issuance of common stock. This financial restructuring was a tremendous accomplishment, opening up exciting new strategic opportunities to develop our internal drug development pipeline. It was accompanied by a significant infusion of capital to pay for patent costs and other core activities, including our ability to reduce outstanding trade debt through negotiated settlements with several key service providers. The restructuring was an essential step in a process that we hope will assure the longevity and growth potential of Intellect Neurosciences for the benefit of all its shareholders.
Pipeline Developments:
Behind the scenes, we have made important progress with respect to our pipeline with the help of certain external expert consultants who have been prepared to invest their time and efforts wholeheartedly. At least two of these part-time consultants are sufficiently excited about Intellect's promising pipeline to have indicated a strong interest in joining the management on a full-time basis when there are sufficient financial resources to make further progress with regard to our R&D objectives. We look forward to boosting our level of professional management as this occurs.
An important development milestone was reached on August 18 when we locked the database of our Phase 1b clinical trial for our lead drug candidate OX1 ("OXIGON"). OX1, which has broad potential for the treatment of Alzheimer's disease and other indications, was tested for safety and tolerability in 36 healthy elderly volunteers aged 60 or more during 14 days of repeated dosing in a double blind, randomized, placebo-controlled, multiple escalating dose study. The trial was conducted by Kendle, a global clinical research organization, through the Kendle Clinical Pharmacology Unit located in Utrecht, The Netherlands. We anticipate obtaining a draft report in October, to be followed soon thereafter by a final report containing the audited data. The next step will be to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to permit the initiation of Phase 2 trials in patients, which we intend to conduct at a single clinical trial center in the United States, assuming sufficient financial resources. Our Phase 2 plan is to test OX1 in Alzheimer's patients and examine its effects on various relevant biological markers in the brain and blood. In parallel, we plan to test OX1 for its potential utility in the treatment of Wilson's disease, for which we believe OX1 may qualify for Orphan Drug status based on a unique combination of pharmacological properties.
We believe, based on discussions with potential pharma partners and other third parties, that positive data from the short and cost-efficient biomarker trial described above would help secure a strategic partnership to accelerate OX1's development and commercialization. Typically, licensing agreements and/or collaborations with large pharmaceutical companies yield substantial revenues from license fees, development milestone payments and sales based royalties.
Yesterday, we were delighted to announce the engagement of Dr. Giora Feuerstein as a key consultant in advising the Company on its technology programs and pipeline. Until earlier this year, Dr. Feuerstein was Assistant Vice President and Head of Discovery Translational Medicine at Pfizer, having previously held these positions at Wyeth Research. Dr. Feuerstein resigned his position at Pfizer to focus on applying his expertise in assisting smaller biopharmaceutical companies meet their drug development objectives via effective translational medicine strategies. Dr. Feuerstein's breadth and scope of experience in guiding biopharmaceutical research and translational medicine is unparalleled in the industry. He is widely credited in relation to the extraordinary cardiovascular and neuroscience pipeline at Wyeth that drove the acquisition by Pfizer last year. His agreement to provide consulting services to Intellect brings a unique set of skills to help the Company in its endeavors to develop innovative and safe disease-modifying drugs for the treatment of Alzheimer's disease and other serious conditions. The significance of this development was underscored by Dr. Feuerstein himself, who commented: "I am pleased to be able to contribute my knowledge and expertise to help Intellect Neurosciences, which has an exciting pipeline and an abundance of innovative ideas to develop new biopharmaceutical products."
Strategic Collaborations:
We are in preliminary discussions with a leading monoclonal antibody company regarding developing next-generation antibody technology with applications in AD, Parkinson's disease (PD), glaucoma and various neurodegenerative disorders. Assuming we reach an agreement regarding the parameters of the collaboration and its financing, we will use this transforming technology initially to optimize our humanized monoclonal antibody, IN-N01. The restructuring of our balance sheet was a pivotal event that allowed discussions between us to resume after more than two years.
Strengthened Intellectual Property:
We have had several successes across our patent portfolio in recent months, during which time we obtained allowances of four new patents relating to our pipeline. These recent successes were gratifying reward for all our previous efforts, investments and solid patent strategy conducted over many years. Moreover, each new patent allowance increases our potential to successfully partner our programs with major pharmaceutical companies in the future.
The United States Patent and Trademark Office (USPTO) granted a Notice of Allowance with respect to our humanized monoclonal antibody IN-N01 that has potential applications for the treatment of Alzheimer's disease, glaucoma, age-related macular degeneration and traumatic brain injury. Based on our optimization strategy, we envisage that IN-N01 will be useful in treating a potentially broader population of Alzheimer's patients at earlier stages of the disease compared to the monoclonal antibodies now under development by major pharmaceutical companies. The new patent will provide patent coverage for our product well into the third decade of the 21st century.
The USPTO also granted a Notice of Allowance in relation to RECALL-VAX, an active vaccine technology that Intellect is developing with the potential to delay onset or prevent Alzheimer's disease in individuals susceptible by age, genetic or other risk factors. Patents for RECALL-VAX have already been issued in Europe, Australia, New Zealand and South Africa, and patents are pending in Canada and Israel. We believe that the approach will be competitive because of its focus on safety aspects. We have identified two lead candidates, RV01 and RV02, which are awaiting optimization and testing in Alzheimer's models.
Further strengthening our intellectual property portfolio, Intellect received Notices of Allowance for two new patents in Canada and Israel related to the most advanced candidate in our pipeline, OXI (OXIGON™), which has a differentiated mode of action compared to the immunotherapy-based approaches. Jointly owned by New York University and the University of South Alabama and licensed exclusively to Intellect, patents for this invention have issued in the United States, Europe and several other countries and are still pending only in Japan and Mexico, where we expect to obtain patents in the future.
Additionally, I was granted a patent by the European Patent and Trademark Office related to the use of insulin sensitizers for the prevention and treatment of memory loss and dementia. Drugs of this type include Rosiglitazone and Pioglitazone, which have been approved for the treatment of type II diabetes mellitus. The potential utility of such drugs for the treatment of dementia and memory loss continues to garner serious attention from the pharmaceutical industry. I am the co-inventor of the patent with Professor Mike Cawthorne, Director of Metabolic Research, Clore Laboratory at the University of Buckingham and leader of the research team that originally discovered Rosiglitazone as a diabetes treatment. The patent is owned by Mindset BioPharmaceuticals Inc., a privately held company I previously founded. Intellect may exercise an option to acquire the technology.
Meanwhile, we continue to make progress with regard to the ANTISENILIN® patent portfolio, which covers licensed products in late stage clinical development by major pharmaceutical companies that have purchased non-exclusive royalty-bearing licenses from Intellect. During the past several months, we have responded to a number of office actions in the United States and internationally. Patents relating to the ANTISENILIN technology were previously granted in Europe, Japan and several other countries and remain pending in active prosecution in the United States. We believe, based on our prior experience, that we will ultimately have similar positive results at the USPTO as we have had in relation to RECALL-VAX, IN-N01 and other technologies.
We continue to be served by world-class patent attorneys in the United States and other countries who have developed a solid strategy with a clear objective to obtain the broadest possible coverage of our proprietary products and technologies worldwide.
Industry Developments:
I had the pleasure of attending the annual Alzheimer's Association International Conference (ICAD) in Honolulu, Hawaii, in July. I was particularly encouraged by the data presented on Bapineuzumab and Ponezumab (PF-04360365) and by the progress being made by large pharmaceutical companies that are independently developing drugs based on the technology that is the fundamental principle of our ANTISENILIN® technology for the treatment of Alzheimer's disease.
Bapineuzumab, in Phase 3 clinical trials, is being co-developed by Pfizer and Johnson & Johnson, and Ponezumab, in Phase 2 trials, is being developed by Pfizer. Both drug candidates are based on the use of antibodies that uniquely bind unique molecular signatures at either end of the beta amyloid that is formed when the amyloid-beta toxin is generated from the larger amyloid precursor protein. This property is the fundamental principle of Intellect's ANTISENILIN® technology, which is intended to promote the clearance of amyloid protein from sites of damage in the brain while minimizing the potential for adverse effects that may result from less specific binding.
Several scientists presented favorable data on Bapineuzumab and Ponezumab. The Phase 2 Bapineuzumab data presented by Dr. Kaj Blennow from Lund University in Sweden showed that immunotherapy with Bapineuzumab lowers levels of cerebrospinal fluid tau protein (CSF tau), which is considered to be an indicator of neuronal damage in patients with Alzheimer's disease. The Phase 1 Ponezumab data presented by Dr. Qinying Zhao of Pfizer showed favorable pharmacokinetics and pharmacodynamics of Ponezumab following a single-dose intravenous infusion in patients with mild to moderate Alzheimer's disease.
We are increasingly confident that these molecules will prove successful in clinical trials and will herald a new generation of drugs that can slow, arrest and ultimately prevent Alzheimer's disease. The Bapineuzumab data on reducing CSF tau protein levels is especially encouraging when taken with the recent report in Lancet Neurology (Vol. 9, Issue 4, Pages 363-372, April 2010) indicating that Alzheimer's patients receiving Bapineuzumab showed a significant reduction in amyloid plaques.
Competitive Advantage:
Bapineuzumab is increasingly at center stage, with the potential to be the first disease-modifying drug for Alzheimer's disease as competitive drugs fall by the wayside because of poorly devised scientific strategies and/or clinical trials.
While disappointing for the Alzheimer's community at large, the recent failures of drugs in Phase 3 clinical trials by Pfizer and Eli Lilly with respect to Dimebon and Semagacestat, respectively, again indicate the critical importance of Intellect's overriding philosophy and approach to Alzheimer's treatments, the aim of which is to develop efficacious methods to block key steps in the pathogenesis of the disease without compromising safety. In other words, we consider it is essential that mechanism of action, relevant drug targets and drug safety are all considered hand-in-hand. While the results for Dimebon, whose mechanism of action was never properly explained, simply failed to show any improvement in treated patients compared to placebo, the results for Semagacestat are particularly concerning in that treated patients were reported to have fared worse than those on placebo and also experienced a significant tendency to develop skin cancer. In this case, I felt it was important to provide my commentary on the possible reasons for this high-profile failure, which was widely covered by the media during the month of August. In my written commentary, in which I explained the danger of gamma secretase inhibitors, I also clarified how Intellect's approach differs from that of Eli Lilly. My commentary was quoted in full by BioMedReports.com on Aug. 19. Separately, I was interviewed about the Semagacestat failure and quoted in an article in Pharmawire on Aug. 23. In an article I authored to be published later this month in Drug Delivery Technologies, I discuss concerns regarding Solanezumab, a monoclonal antibody being developed by Eli Lilly as a potential competitor to Bapineuzumab. In contrast to Bapineuzumab (and Ponezumab), Solanezumab lacks unique specificity for the amyloid-beta toxin and therefore could potentially unleash a variety of side effects in patients that would not necessarily be detectable in clinical trials.
The continuing Bapineuzumab Phase 3 trials, which involve several thousand patients worldwide, provide us with confidence that the drug is safe at the pharmacological doses being used, despite the fact that it is known to induce vasogenic edema in high doses. We continue to closely monitor announcements by the developers and updates regarding trial status, which are listed at www.clinicaltrials.gov. The site currently indicates that approximately 2,600 Alzheimer's patients are expected to complete Phase 3 in 2012.
Increased Media Coverage:
Since the restructuring event at the end of April, we have seen increased media attention as a direct result of our aggressive, ongoing public and investor relations campaign, which is designed to increase investor awareness.
Notable examples of how Intellect recently had the opportunity to further spread the word about our discoveries include a public radio segment at the ICAD conference in Honolulu during which Dr. William Thies, chief medical and scientific officer of the Alzheimer's Association, and I were interviewed on Southern California Public Radio (89.3 KPCC) by Los Angeles Times op-ed columnist and writer Patt Morrison. The conference focused on the latest research on diagnosing, treating and preventing Alzheimer's disease. Investors interested in hearing the interview can find it at http://www.scpr.org/programs/patt-morrison/2010/07/12/alzheimers-association-convenes-international-conf/
Dana Blakenhorn of ZDNet Healthcare also highlighted Intellect in an article entitled "An Alzheimer's Cure Could Be Closer Than We Think." The article discusses Intellect's proprietary ANTISENILIN® platform technology, which the Company has licensed to several major pharmaceutical companies that are developing drugs in Phase 1, Phase 2 and Phase 3 human clinical trials. The article can be found at http://www.zdnet.com/blog/healthcare/an-alzheimers-cure-could-be-closer-than-we-think/3793.
Intellect was also featured as the topic of an article by Kimberly Ha, Global Editor of Pharmawire, which is a part of the Financial Times group, on July 20.
In addition, a byline I authored was published as the July cover story of Managed Care Outlook, written for hospital and health insurance executives. The publication's coverage ranges from the latest developments within the health insurance industry to legislative issues, management approaches and disease management research. The article links the potential impact of Intellect's pipeline to the overall cost of Alzheimer's care as related to the Alzheimer's Association's recent report, "Changing the Trajectory of Alzheimer's Disease: A National Imperative," which discusses a.) the annual cost of treating people age 65 and older with Alzheimer's (projected to grow from $172 billion this year to $1.08 trillion over the next five years); and b.) the impact that two hypothetical treatment breakthroughs — one to delay onset and one to slow progression of the disease — would have.
Concluding Remarks:
We are continuing discussions with large pharmaceutical companies regarding potential collaborations, as well as with interested bankers to help raise capital. Simultaneously, we are in the process of establishing a new Wall Street-savvy board of independent directors and recruiting additional senior management for research and development and for extending our business development outreach.
We look forward to sharing these and other corporate developments with our shareholders in the coming months, including reporting on progress toward starting Phase 2 trials and establishing proof of concept for OX1 in additional non-Alzheimer's disease indications such as Wilson's disease, and the optimization of IN-N01, pending the increased capitalization that is necessary to allow these activities to proceed.
We continue to be inspired by the progress we are making on all fronts and are always excited by the possibilities we encounter through our close interactions with the leading scientists in the field. We remain grateful that our enthusiasm is matched by that of the collaborators with whom we share our vision to create a world without Alzheimer's disease.
Your continued support bolsters our confidence in our ability to meet the goals of commercialization and growth, while also reminding us daily to never lose sight of our mission to develop innovative approaches to address the large and unmet clinical need for drugs that can slow, arrest and ultimately prevent Alzheimer's disease.
I would like to conclude with the same "take-home" message I am planning to give to investors during my presentation at the upcoming Rodman & Renshaw Global Investor Conference being held in New York Sept. 13 through 15: Intellect Neurosciences offers an unusual diversified risk profile due to potential royalty streams from big pharma with products now in late-stage clinical development as well as products from an internally developed pipeline that is backed by strong intellectual property assets across diversified technologies. It is difficult to identify many other companies in the biopharmaceutical industry that have developed such a promising formula for success.
Sincerely,
Daniel Chain, PhD
Chairman and Chief Executive Officer
About Intellect Neurosciences, Inc.
Intellect Neurosciences Inc. is a Manhattan-based biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease and other disorders. The Company's drug product pipeline includes OX1, which has been tested in Phase 1 clinical trials; IN-N01, a humanized monoclonal antibody designed to promote the clearance of soluble amyloid beta; and RECALL-VAX, a vaccine technology that has the potential to delay or prevent Alzheimer's disease in people who are at risk.
The Company has significant intellectual property assets, which include several patent families underlying the Company's internal programs, and a pivotal patent estate regarding passive AD immunotherapy.
The Company's ANTISENILIN® patent estate claims monoclonal antibodies that bind either end of amyloid beta but do not interact with the amyloid precursor protein from which amyloid beta is produced in the body. This high degree of specificity is an important safety feature, reducing the potential for adverse affects. Examples of monoclonal antibodies exhibiting this property are Bapineuzumab and Ponezumab, which are in Alzheimer's Phase 3 and Phase 2 clinical trials, respectively (http://clinicaltrials.gov/ct2/show/NCT00574132?term=bapineuzumab&rank=1; http://clinicaltrials.gov/ct2/results?term=PF-04360365).
Patents have been granted in Europe, Japan, China and elsewhere and are pending in the United States. Intellect has granted royalty-bearing licenses to its ANTISENILIN® patent estate to several top tier global pharmaceutical companies developing monoclonal antibodies for Alzheimer's disease. For further information, see the Company's filings with the Securities and Exchange Commission, including Forms 8-K filed on:
May 1, 2009
http://www.sec.gov/Archives/edgar/data/1337905/000114420409023426/v147731_8k.htm
January 8, 2009
http://www.sec.gov/Archives/edgar/data/1337905/000114420409000980/0001144204-09-000980-index.htm
October 14, 2008
http://www.sec.gov/Archives/edgar/data/1337905/000114420408057464/0001144204-08-057464-index.htm
May 19, 2008
http://www.sec.gov/Archives/edgar/data/1337905/000114420408030722/v115138_8k.htm
Safe Harbor Statement Regarding Forward-Looking Statements:
The statements in this release and oral statements made by representatives of Intellect relating to matters that are not historical facts (including without limitation those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Intellect's Annual Report on Form 10-K, (file no. 333-128226) filed on October 13, 2009, and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2010, filed on May 17, 2010.