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| Issue: 7 |
January/February 2009 |
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Greetings!
Welcome to MacuCLEAR's first View Company update for 2009!
This new year has already started off with several positive developments that are detailed in this issue. We are proud of our progress. We greatly appreciate our many stakeholders who are helping us achieve our goal of bringing a treatment for Dry Age Related Macular Degeneration to the millions who suffer from this terrible disease. We are highly motivated to do our best because of the many emails and letters we get from individuals who have found us and want to participate in our clinical development and hope for anything that will prevent the progression of their affliction.
We are improving our communication tools so that we can be more efficient in keeping you apprised of our progress. We hope you like our new newsletter format. We encourage you to visit our updated website. Soon we will have a vivid animation of our topically administered drug MC-1101's ability to get to the back of the eye, and how its mechanism of action helps to restore blood flow and prevent the progression of Dry AMD to Wet AMD.
Thank you for your interest and continued support! As always we welcome your comments and suggestions!
Best,
Phil |
| FDA Confirms Fast Track Status |
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On January 23 MacuCLEAR received confirmation of its Fast Track Designation for it first drug candidate MC-1101. MC-1101 is being investigated for the treatment and prevention of the progression of Age Related Macular Degeneration (AMD). The fast track designation is intended to facilitate development and expedite review for drugs that treat serious diseases and fill unmet medical needs.
The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously,
and the option of requesting evaluation of studies using surrogate endpoints. More information about the FDA's Fast Track program can be found at Food and Drug Administration Modernization Act of 1997 (FDAMA).
MacuCLEAR's lead compound, MC-1101 is a novel, topically delivered solution to treat and prevent the progression of Dry (early stage) AMD. MC-1101 has recently entered clinical development.
"This is a very important milestone for us as we prepare to initiate clinical trials with MC-1101 this year," said Philip G. Ralston, CEO of MacuCLEAR. "If successful, MC-1101 has the potential to make a very positive difference in the lives of patients who suffer from AMD."
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| MacuCLEAR/Mystic Pharmaceuticals Announce Collaboration for Phase I Clinical Trial |
MacuCLEAR has entered into a collaborative business relationship with Mystic Pharmaceuticals Inc. for its upcoming Phase I/II Human Clinical Trials. Mystic Pharmaceuticals, Inc. ('Mystic") has developed a novel unit dose drug delivery platform that includes a device capable of dispensing a calibrated and "counted" drop directly and precisely on the eye.  "We believe Mystic's novel delivery system will help overcome many of the challenges of topical delivery of ophthalmic drugs to the eye.", said Philip G. Ralston, Jr., President and CEO of MacuCLEAR. "Standard eyedroppers typically deliver a large drop that "floods" the eye, causing an instinctive blinking response that wipes away much of the drug. Mystic's individually packaged drops can be precisely sized and accurately delivered with its unique "eyecup" design." Ralston added, "It also counts the drops delivered, which will be helpful in accounting for the usage of a reimbursed product." Mystic Pharmaceuticals' President and CEO, Tim Sullivan, stated, "We are pleased we are able to work with MacuCLEAR in their clinical program. Their drug has shown promise throughout its preclinical program, and it addresses a huge market. AMD is a growing healthcare problem for our aging population. Our device is uniquely designed to safely and effectively deliver drugs to low vision and elderly people. MacuCLEAR's and Mystic's collaboration offers great potential for delivering a solution for this terrible disease." |
| Governor's Office Approves $1.7 Million ETF Allocation |
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On January 12, 2009, MacuCLEAR was notified the State of Texas has approved the allocation of $1.7 Million from the Emerging Technology Fund. The Company is now in the contract phase and expects its first tranche or at least half of this allocation by March 15, 2009. This allocation is not as ominous as early rounds of the ETF. The State now takes its stake in MacuCLEAR at the same terms as the next round of major funding if it occurs within the next 18 months. This timing is consistent with our strategy to secure a strategic partner. This ETF funding will complement our current Series A Preferred Shares fund raising efforts, and assure completion of our Phase I. This major milestone confirmation letter is enclosed here in its entirety.
January 12, 2009
Mr. Phil Ralston
Macuclear, Inc.
2300 McDermott Road, 4200-147 Plano, Texas 75205
Dear Mr. Ralston:
The State of Texas is honored that Macuclear, Inc. is dedicated to commercialization of topically administered treatment for dry age-related macular degeneration, which will lead to an increase in high-quality jobs in our state. We are confident that you will find Texas to have an ideal environment for expediting your emerging technology to the market.
During the 791h Texas Legislative Session, the Texas Emerging Technology Fund was created as a tool to develop and diversify the Texas economy by expediting innovation and commercialization of research. Allocations from the fund will support the creation of high-quality jobs, address priorities in emerging technology fields and leverage private investment for activities that will strengthen the economic future of the state.
We value your commercial drive and commitment to advance technology in our state, and are prepared to allocate $1,700,000 contingent upon execution of a formal Texas Emerging Technology Fund Agreement to be negotiated. This offer may be rescinded if a finalized agreement is not executed by all applicable parties within three months of the date of this letter.
Texas is pleased to provide this incentive for economic development purposes, and we look forward to working with you to help you achieve your objectives for this project.
Sincerely,
Rick Perry, Governor
David Dewhurst,Lieutenant Governor
Tom Craddick Speaker of the House
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| Macular Degeneration Foundation features MacuCLEAR |
 The MD Foundation is dedicated to those who have and will develop macular degeneration. They offer this growing community the latest information, news, hope and encouragement.
In addition, the Foundation gives financial support to researchers investigating treatments and others helping those coping with the challenges of living with the loss of their central vision.
MacuCLEAR is featured in MD Foundation's online newsletter "The Magnifier". The article states "MC1101, a compound patented by MacuCLEAR, is a novel, topically delivered solution for the treatment and prevention of the progression of the Dry or early stage of AMD. MC1101 was invented at Texas A&M University by George C.Y. Chiou, PhD, who previously led the discovery of Timolol, the pioneering treatment for glaucoma. How can a topical eyedrop affect the progression of AMD? MC1101 is designed to increase choroidal blood flow, decrease inflammation, and prevent oxidative damage. This compound along with a new eye drop delivery system from Mystic Pharmaceuticals will provide a double bonus for elderly patients in the phase I/II clinical trial. Stay tuned for more information."
MacuCLEAR and MD Foundation agree on a number of issues regarding diseases of the retina. You can get a free subscription to MD Foundation's newsletter at www.eyesight.org |
| Recent Happenings/Upcoming Events |
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MacuCLEAR and Mystic Pharmaceuticals CEO's Phil Ralston and Tim Sullivan, participated at the OneMedPlace Emerging Healthcare Technologies Finance Forum, on January 13, 2009, where they collaborated as panel members during a lunchtime presentation on the Texas Emerging Technology Fund. Hosted by Susan Davenport of the Central Texas Regional Center for Innovation and Commercialization, these gentlemen,addressed how this state government funding is positively helping their respective companies' growth. More than 200 conference attendees participated.
MacuCLEAR has been selected to present at the WBT Showcase to held March 24 and 25 in Arlington, Texas. Leveraging a national screening panel of active venture capitalists and corporate licensees, over 100 of the most promising seed stage companies and cutting edge technologies have been selected to present at the 2009 WBTshowcase.
This year's selected presenters - each seeking investment capital and/or licensing partners - have been drawn from the United States, Canada, Chile, Israel, Netherlands, Sweden, Singapore, Ireland, Australia, and more. Each representing investment and licensing opportunities from top universities (e.g. Johns Hopkins University, University of Waterloo, Florida International University, Université Laval, Auburn University, Tel Aviv Univ, McGill University and Universidad Austral de Chile), federal labs (e.g. U.S. Army Research Lab, Air Force Research Lab, Oak Ridge National Lab, Institute of Surgical Research), federal agencies (e.g. DoD, NIH, DOE, NSERC) and numerous research institutions (e.g. National Institutes of Health, National Science Foundation, American Alzheimer Association, Swedish Cancer Foundation). MacuCLEAR will be representing Texas A&M University.
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Final Word...Update on sale of Series A Preferred Shares
We appreciate the current and new Series A Preferred Shareholders who have increased their investment or have become investors in the past few months. This investment has allowed us to proceed toward our critical Phase I trial later this spring. As of now, we have commitments for all but approximately 65,000 of the original 192,678 shares.
These shares were priced at a board meeting last March (2008) while at our Pre IND status. Since that value was set we had a successful Pre-IND meeting with FDA; successfully completed a critical ocular tissue toxicity test which showed MC-1101 had no deleterious effects on ocular tissue; received a German patent; received IND clearance allowing MC-1101 to be used in human clinical trials; and successfully navigated the rigorous ETF process resulting in a recommendation to receive $1.7M.
As noted in this newsletter, we have 1)received formal notice from FDA granting us Fast Track Status; 2) Announced a collaboration with Mystic Pharmaceuticals, Inc. which has a novel drug delivery system that several big Pharma companies are evaluating; and 3) we have received final sign off from the Governor's office and have entered the contracting stage for the ETF money. With all of this progress, we expect our board will agree to a share price increase.
We will be able to sell the remaining shares at the current price until the board approves a price increase. We will continue to use this money to timely support our novel clinical program and our efforts to secure a strategic partner.
If you would like to know more about availability of these Series A Preferred Shares...or anything else in this issue of the View, please contact me at your convenience.
Sincerely,
Phil Ralston
MacuCLEAR, Inc |
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