NEW YORK, Oct. 13, 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 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,
I would like to take this opportunity to initiate quarterly updates contemporaneous with the filing of our financial statements with the SEC to inform you of pertinent corporate and industry developments.
I remain excited about Intellect and am encouraged daily by the support we obtain from collaborators and industry experts who recognize the value of our diversified portfolio. In contrast to the majority of biopharmaceutical companies, which promote single products or technologies, Intellect was founded on the premise that multiple shots on goal are necessary to achieve success in the face of the high attrition rate in drug development, which is nowhere more evident than in the Alzheimer's field.
A principal component of our overriding philosophy and approach to Alzheimer's treatments is to develop efficacious methods to block key steps in the pathogenesis of the disease without compromising safety. We consider it to be essential that mechanism of action, relevant drug targets, pharmacokinetics and drug safety are all considered hand-in-hand. Numerous other drugs have failed because of poor scientific rationale, faulty drug development and/or clinical trial design.
There remains an enormous and unmet need in the treatment of Alzheimer's and Intellect is uniquely positioned for success. Clinical trials for drugs we have licensed to major pharmaceutical companies are ongoing and our internal pipeline of innovative technologies will keep us far ahead of the competition and result in lucrative collaborations as our drug development programs mature. I ask for your continued patience and support as we strive toward these important goals.
New Milestone Patent:
We recently announced the issuance of a new patent related to our internal monoclonal antibody programs. The significance of this milestone event was noted by Dr. Giora Feuerstein, M.D., who recently joined us as a consultant. Dr. Feuerstein was formerly Head of Discovery Translational Medicine at Wyeth Research and Pfizer, both of which are developing antibodies based on Intellect's underlying platform. Dr. Feuerstein commented: "We are assisting Intellect in its innovation-driven, strategic development plan to produce drugs that will be highly competitive in the market place. The goal in this case is to develop a completely new class of improved antibodies with better safety and efficacy to treat the broadest possible population of Alzheimer's patients at the earliest stages of the disease, possibly even before it becomes symptomatic. These novel antibodies will substantially expand the repertoire of neutralizing antibodies and enable us to better define and optimize drug efficacy based on pharmacokinetic and safety profiles. Whereas drugs currently in development will require frequent office visits and expensive monitoring for adverse side effects, we envision developing drugs with an improved therapeutic index avoiding the incidence of vasogenic edema and microhemorrhage in the brain. Attainment of our objective would reduce the need for costly office visits and broaden patient access to disease-modifying treatments."
If successful in Phase 3 clinical trials, Bapineuzumab will likely be the first disease-modifying drug for Alzheimer's with the potential to slow down or stop disease progression. With this exciting prospect in mind, and as noted by Dr. Feuerstein, we are currently focused on the next generation of antibodies for the treatment of Alzheimer's disease. These antibodies hold the promise for even better efficacy and safety than current drugs in development such that we could expect to partner with major pharmaceutical companies hungry for drugs to fill their pipeline because of the impending "patent cliff" when patents expire on lucrative products. As we embark on our quest to develop better drugs, I am reminded of a remark two years ago from Professor Donald Price, Emeritus Professor of Pathology, Neurology and Neuroscience and Founding Director of the Alzheimer's Disease Research Center at The Johns Hopkins School of Medicine and a member of Intellect's Scientific Advisory Board: "Dr. Chain's idea of using antibodies in this way to reduce amyloid toxicity in the brain has gained considerable momentum over the past few years and we are currently optimistic that drugs of this type herald an exciting new era of drug development for safe and efficacious disease-modifying treatments for this devastating disease."
Financial results:
Intellect operates on a fiscal year basis and as such, today we filed with the SEC our Annual Report on Form 10-K for the fiscal year ended June 30, 2010. Our net loss for the year ended June 30, 2010 was $33,047,726 compared to net income of $1,846,763 for the year ended June 30, 2009. The decrease in net income of $34,894,489 primarily was due to the absence of any license fee revenue in 2010 plus incremental expense that we recorded in connection with the financing transaction that occurred in April, 2010. As more fully described in our Form 10-K, this incremental expense, which is a non –cash expense, arises primarily from the issuance of warrants and other "derivative liabilities", which are "marked to market" on the balance sheet date, with changes in value charged to gain or loss. Accordingly, our accounting loss for the year is largely a "non-cash" loss and is not representative of the amount of our cash outlays for research and development and general and administrative expenses.
Increased public awareness:
We have continued in our efforts to promote public and investor awareness of Intellect Neurosciences through media outreach and other activities, such as the launch of a new website www.intellectns.com which incorporates several features to enhance browsing efficiency for our current and potential partners and investors. The percentage of global internet users who visit our site has increased 110% over the past month and 350% over the past three months according to the web information company, ALEXA.
Intellect Neurosciences was featured in an article by PharmaVoice (www.pharmavoice.com) in its September 2010 issue based on an interview in which I discussed the development of monoclonal antibodies as Alzheimer's therapeutics. Also in September, an article I authored entitled, "ANTISENILIN® monoclonal antibody platform to prevent accumulation and neurotoxicity of amyloid beta in Alzheimer's brain," was published by Drug Delivery Technologies (www.drugdeliverytech.com).
I am regularly interviewed by the press, including both radio and print media, most recently by the Wall Street Journal, Bloomberg News and La Opinion. These interviews provide ample opportunity to underscore Intellect's important role and activities in developing innovative approaches for the treatment of Alzheimer's disease.
Another component of our public awareness campaign involves speaking at conferences in the United States and abroad. My presentation at the Rodman & Renshaw Global Healthcare Conference in New York on September 14 was well attended, and more recently, I gave a keynote speech at a medical conference in Ireland. I am invited as a Distinguished Speaker to participate in the upcoming 4th Annual Alzheimer's Drug Development Summit sponsored by The Center for Business Intelligence (CBI) December 14-15, 2010 in Washington D.C. www.cbinet.com/alzheimers). My speech on "Unique Molecular Signatures of Beta Amyloid as Targets for Therapy" is followed by a presentation from Pfizer discussing the Phase 2 clinical development of Ponezumab (PF-04360365), a highly specific monoclonal antibody against amyloid beta that is based on Intellect's ANTISENILIN® platform.
Conclusion:
The foregoing summary indicates several positive developments that have occurred in the short intervening period since my letter to you dated September 8, 2010. I hope that this letter helps you to understand the significant potential for growth of our revitalized company following the restructuring of our balance sheet in April. With the licensing of our intellectual property behind us, it is time to focus on the second value driver, our internal pipeline that is backed by strong intellectual property assets across diversified technologies.
Continued investment in these programs is an essential component in our strategy to produce innovative new drug products that will be highly sought after by major pharmaceutical companies from whom we would anticipate substantial revenues from license fees, development milestone payments and sales based royalties -- based on similar types of deals currently taking place in the industry. Moreover, our success in developing such drugs would alleviate the suffering of millions of people who are either afflicted by or who live in fear of this devastating fatal condition for which no disease-modifying treatment exists. Your continued support of is essential to realize our mission and vision to create a world without Alzheimer's.
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 Alzheimer's immunotherapy.
The Company's ANTISENILIN(R) 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(R) 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
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October 14, 2008
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May 19, 2008
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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, 2010.