NEW YORK, Oct. 16, 2012 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for proteinopathies, today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO.
Dear Shareholder,
I am encouraged by several recent developments that reinforce my confidence in our corporate strategy. Intellect's origins are rooted in my pioneering work from the late 90's that stimulated development of the monoclonal antibodies, which several global pharmaceutical companies have tested as treatments for Alzheimer's disease. While the recently reported Phase 3 clinical trial results for bapineuzumab fell short of expectations, the Alzheimer's community is encouraged by the demonstration using biomarkers that the drug had engaged the target, reduced the amount of plaque and slowed neurodegeneration based upon the decrease in the amount of tau protein measured in the cerebral spinal fluid (CSF). Similarly, Phase 3 data from Lilly's solanezumab appeared to show some clinical benefit in a pooled analysis of early Alzheimer's patients. Lilly is anticipated to present biomarker data at a conference later this month.
As I wrote in my recent blog, the presenters and expert panelists at the American Neurological Association (ANA) annual meeting in Boston last week conveyed a strong sense that Intellect is correct in its belief beta amyloid (Aβ) plays a central and causative role in the pathogenesis of Alzheimer's disease and that immunotherapy represents a realistic path forward. The next-generation drugs will have an improved probability of success because of the lessons we have learned, especially the need for earlier intervention and careful criteria for the selection of patients to improve homogeneity in clinical trials.
Importantly, these data support our investment in IN-N01, a next-generation antibody drug candidate that recently completed the humanization process. As explained in our joint announcement with MRC Technology on September 19, we anticipate IN-N01 will have an improved safety profile, which means that it can be used at higher, more frequent doses than the other amyloid-beta antibodies in development. The enhanced dosing likely will result in stronger clinical efficacy, particularly if administered to early stage or presymptomatic patients. We believe IN-N01 could be developed rapidly by using biomarker signals during Phase 2 trials in patients with mild disease, similar to Lilly's approach for solanezumab. This approach should offset the increased costs associated with lengthy trials anticipated to be required in presymptomatic patients. IN-N01 is patent protected until at least the mid-2020s in the United States, Europe and Japan.
With several license agreements to date and products in clinical development for Alzheimer's disease and Friedreich's Ataxia, Intellect has established an impressive track record of being at the forefront of tomorrow's therapeutic candidates for neurodegeneration. Moreover, based upon conversations with several pharmaceutical companies, we anticipate further transactions for a number of our preclinical assets, which have the potential to generate significant revenues for Intellect, long before any of our products reach the market.
Pipeline activities:
Our antibody-drug conjugate platform, CONJUMAB, provides potential development of two independent antibody-based products from the same starting material, our compound, IN-N01. Our recent agreement with Lonza, with whom we signed a letter of intent, was an important step in the development of our first ADC, CONJUMAB-A. We are excited to have reached a point at which Lonza is now manufacturing the preclinical materials for the drug optimization and drug selection program, and look forward to testing these compounds in the near future. With sufficient financial resources, we could reasonably expect to file two INDs within two years, one for CONJUMAB-A initially focused on age-related macular degeneration and a second for IN-N01 for a second indication such as familial Alzheimer's disease or traumatic brain injury, both of which could qualify as orphan diseases.
Patent news:
We remain determined to secure our ANTISENILIN patents still under review by the USPTO and hopeful that this can be accomplished over the next few months. The demonstration using biomarkers that bapineuzumab reduces amyloid plaque and neurodegeneration in the brain of Alzheimer's patients provides compelling new evidence in support of the ANTISENILIN platform technology. Similarly, we plan to continue with the appeal process that we initiated in February to overcome the challenge to our patents in Europe.
We were disappointed by the failure of one of our global pharmaceutical licensees to pay the $2 million milestone payment triggered by the issuance of our patent by the USPTO on May 8, 2012 eventually leaving us no option except to pursue our claim in the courts. The action of our licensee in this regard is unconscionable and, in my opinion at least, an affront to the pharmaceutical industry that desperately needs to foster rather than thwart innovation at a time that global pharmaceutical companies are substantially reducing their internal R&D and relying more and more on companies such as Intellect Neurosciences to provide the next generations of high value therapeutics. The community at large should be aghast that a small company such as ours needs to divert attention and limited resources from its critically important mission of developing disease modifying therapies for Alzheimer's and other serious neurological diseases.
Business Development:
We are engaged in discussions regarding potential collaborations with several global pharmaceutical companies. Our recent acquisition of two monoclonal antibodies against neurotoxic forms of tau protein prompted inquiries from several pharmaceutical companies, two of which have signed confidentiality agreements, and indicated a high level of interest in seeing additional data. Additionally, we have obtained significant interest in our CONJUMAB-A program. Such statements should be useful to our fund raising efforts as we seek to advance candidate selection and preclinical development on an accelerated path and underscore the need to focus on our internal programs.
Increased Public Awareness:
We continue our efforts to increase public and investor awareness of Intellect through media outreach and other activities, including my participation as presenter at several international industry and investor conferences.
I was pleased to accept an invitation to participate as Distinguished Speaker at CBI's 6th Annual Alzheimer's Drug Development Summit, December 11-12, 2012, in Philadelphia, PA (http://www.cbinet.com/conference/pc12188). The title of my presentation is Recent Advancements in Vaccine Development for AD Prophylaxis and Management that will give me an excellent opportunity to discuss Intellect's dual target amyloid beta/tau vaccine in the context of other developments in the field.
We recently introduced a blog page to our website (www.intellectns.com/blog) in which I plan to share my thoughts and perspectives on industry-related developments and invite you to visit the site regularly for news and blog updates.
Conclusion:
We are pleased with the recent progress, which speaks volumes about a company the size of Intellect Neurosciences. Our ability to move forward is the result of a carefully planned strategy as we continue to develop distinctive platform technologies that are generating drug candidates for a variety of neurodegenerative diseases. These platforms and the resulting candidates continue to attract interest from pharmaceutical companies, which indicate their desire to engage in more substantive partnering discussions as our next milestones are met. Intellect remains ahead of the curve with respect to next-generation therapies, and the company is dedicated to retaining its position by capitalizing on its experience in biopharmaceutical development, network of world-renowned academic and clinical consultants, and specialized contract research organizations.
Thank you for your continued support of Intellect Neurosciences and our important mission to create a world without Alzheimer's disease and other debilitating neurodegenerative diseases.
Sincerely,
Daniel Chain, PhD
Chairman and Chief Executive Officer
Safe Harbor Statement Regarding Forward-Looking Statements:
The statements in this release and oral statements made by representatives of Intellect Neurosciences 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 15, 2012, and in our Quarterly Report for the quarterly period ended March 31, 2012, which was filed on May 14, 2012.