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Makindus Bolsters Management Team with Appointment of Michael Celano as Chief Financial Officer

DOYLESTOWN, Pa., Sept. 15, 2015 /PRNewswire/ -- Makindus, Inc., a specialty pharmaceutical development company focused on late stage therapies for rare ophthalmic indications, today announced that Michael Celano has been appointed Chief Financial Officer.

Mr. Celano is an accomplished finance and accounting executive with nearly 30 years of senior-level experience in both venture-funded and publicly traded pharmaceutical and life science companies. He brings to Makindus sound business acumen and expertise in public company internal and external financial reporting, accounting and controls, and investor relations. Mr. Celano has a solid track record in growing corporate enterprise value and in successful transactional execution including acquisitions, venture investments, and the sale of publicly-traded companies.

"We are pleased to announce the addition of Mr. Celano as our Chief Financial Officer," remarked Manohar Katakam, Ph.D., President and Chief Executive Officer of Makindus. "I believe his seasoned financial and transactional leadership experience will be invaluable as we advance Makindus to the next stage of growth. The Company's lead product candidate, MI-100, has both U.S. and E.U. orphan drug designation and is expected to commence Phase 3 clinical studies for the treatment of Stargardt disease in 2016."

Mr. Celano has served on the Board of Directors and as audit committee chair for Orasure Technologies, Inc. since 2006. He most recently was appointed to the Board of Directors of Performance Health, a privately-held consumer branded health, wellness and self-care company. Prior to joining Makindus, he served as Chief Financial Officer for Drugscan, Inc., a high growth private equity funded clinical laboratory services company, and Kensey Nash Corporation, a medical device company with $90 million in annual revenues acquired by Royal DSM (DSM). Previously, Mr. Celano was Chief Financial Officer at BioRexis Pharmaceutical Corporation, a venture funded life sciences company, where he utilized his expertise to help grow the company from a start-up though to its sale to Pfizer, Inc.

"I am very excited to join the Makindus team as we move to the next stage of bringing meaningful therapies to address rare ophthalmic diseases," commented Mr. Celano. "I look forward to working with the team as we advance MI-100, an important therapy for Stargardt disease, into a Phase 3 clinical program."

Mr. Celano was a partner at Arthur Andersen and KPMG during his 24 years in public accounting, and led the U.S Life Sciences Practice. During his public accounting career, he served more than 40 life science clients and was lead audit partner for 17 public life science companies and multiple IPOs. Mr. Celano was the first non-venture capital/investment banker to serve as a Chairman of the Mid-Atlantic Venture Conference and is the Co-Founder of the Association of BioScience Financial Officers. He earned his Bachelor of Science in Accounting from St. Joseph's University.

Makindus Appoints World Renowned Experts on Stargardt Disease to Newly Formed Scientific Advisory Board

- Preparations underway to commence Phase 3 program of MI-100 for the treatment of Stargardt disease-

DOYLESTOWN, Pennsylvania, June 24, 2015 -- Makindus, Inc., a specialty pharmaceutical development company focused on ophthalmology, announced today the formation of its Scientific Advisory Board (SAB) with four key appointments: Marco A. Zarbin, M.D., Ph.D., FACS, Adrian Koh Hoch Chuan, M.D., Urlich Kellner, M.D., and Paul S. Bernstein, M.D., Ph.D. This prestigious Board will provide scientific oversight, strategic guidance and work closely with the Makindus management team as it prepares to advance its lead product candidate MI-100 for Stargardt disease into Phase 3 clinical development this year.

Stargardt disease, also known as juvenile macular degeneration, is a genetic disorder that causes progressive vision loss. The estimated prevalence in the U.S. and Europe is approximately 1 in 10,000 individuals. There is currently no cure or treatment. Makindus has received orphan drug designation for MI-100 in both the United States and Europe.

Makindus has assembled a preeminent group of retinal specialists renowned worldwide for their research and experience with Stargardt disease.

MARCO A. ZARBIN, MD, PhD, FACS, Professor and Chair, Institute of Ophthalmology and Visual Science, Professor of Neurosciences, Rutgers New Jersey Medical School; Chief, Department of Ophthalmology, University Hospital, Newark, New Jersey.

ADRIAN KOH HOCK CHUAN MD, Director, Retinal Centre International, Vice-President of the International Retinal Foundation; Founding Partner, Senior Consultant, Eye & Retina Surgeons, Camden Medical Centre; Visiting Consultant to the Vitreoretinal Service, Singapore National Eye Centre (SNEC) and Visiting Consultant to the Eye Institute, Tan Tock Seng Hospital.

ULRICH KELLNER, MD, AugenZentrum Siegburg Professor, Medical Head MVZ ADTC Siegburg GmbH, (Germany). Specializes in rare retinal disorders with over 155 publications as author or co-author in peer-reviewed journals (primarily on the diagnosis and treatment of retinal diseases) and 9 books about retinal diseases and adverse drug reactions.

PAUL S. BERNSTEIN, MD, PhD, Professor of Ophthalmology and Visual Sciences, Moran Eye Center of the University of Utah; Adjunct Professor, University of Utah Department of Pharmacology and Toxicology. Focuses on both basic science retina research and clinical practice devoted to diseases of the retina and vitreous with special emphasis on macular and retinal degenerations.

"We are thrilled to have attracted some of the world’s leading experts in Stargardt diseases to our newly formed Scientific Advisory Board as we prepare to advance MI-100 into a Phase 3 registration program this year," said Manohar Katakam, Ph.D., President and Chief Executive Officer of Makindus. “Their background and experience with retinal diseases will be invaluable to Makindus. Importantly, the formation of our SAB serves as an endorsement of scientific and clinical enthusiasm for MI-100 and more broadly our ophthalmology pipeline."

"The Makindus Scientific Advisory Board will also serve as a Clinical Steering Committee which underscores our commitment to gaining the insights, direction and expertise of the world’s leading retinal specialists as we advance MI-100. We expect the upcoming clinical trial of MI-100 will be the largest study ever done for Stargardt disease and are excited about the possibility of providing a solution for these patients where no viable therapy currently exists," said David Eveleth, Ph.D., Clinical Head of Makindus and former Head of Ophthalmology at Pfizer. "The core and heart of our clinical program for MI-100 is to improve vision and quality of life for individuals living with Stargardt disease.”

MI-100 is a novel formulation of a legacy compound that has shown promising results in improving visual acuity for Stargardt patients in an investigator-initiated clinical trial. Makindus has developed MI-100 in a new proprietary sterile and more convenient ophthalmic dosage form that allows for a ready-to-use multi-dose eye dropper for easy administration.

Makindus has reviewed the clinical development program for MI-100 with the U.S. Food & Drug Administration (FDA) and plans to file a New Drug Application (NDA) utilizing a streamlined 505(b)(2) regulatory pathway. The Company is in the process of finalizing clinical supplies and preparing for the initiation of the Phase 3 program for MI-100. Makindus in discussions to secure additional funding and collaboration support for the development of MI-100 for Stargardt disease.

European Medicines Agency (EMA) Grants Orphan Designation for Makindus' MI-100 for Stargardt's Disease

DOYLESTOWN, Pa., May 4, 2015 /PRNewswire/ -- Makindus, Inc. a specialty pharmaceutical development company focused on ophthalmology announced today that the European Medicines Agency (EMA) has granted orphan drug designation for their lead candidate, MI-100, for the treatment of Stargardt's Disease.

"We are extremely pleased to now have orphan drug designation for MI-100 to treat Stargardt's disease in place for Europe. This complements and reinforces our development program in the United States for which orphan designation has already been granted," stated Manohar Katakam, President and CEO of Makindus.

MI-100 is a novel formulation of a legacy compound that has been shown to have a clinical effect in improving visual acuity for Stargardt's patients in an investigator-initiated clinical trial. Makindus has developed MI-100 in a new sterile and more convenient ophthalmic dosage form. The proprietary packaging for MI-100 is a single bottle closed container mixing system that allows for a ready-to-use multi-dose eye dropper for easy administration.

Stargardt's disease, also known as juvenile macular degeneration, is a genetic disorder that causes progressive vision loss. The disorder affects a small area near the center of the retina called the macula which is responsible for sharp central vision needed for detailed tasks such as reading, driving, and recognizing faces. The signs and symptoms of Stargardt's disease typically appear in late childhood to early adulthood and worsen over time. The estimated prevalence in the U.S. and Europe is approximately 1 in 10,000 individuals. There is currently no cure or treatments.

Makindus recently met with the Food & Drug Administration (FDA) to review a clinical development program to evaluate MI-100 in a Phase 3 program. "We had a very productive meeting with the FDA and plan to start our Phase 3 trials by the end of this year," stated David Eveleth, PhD and Clinical Head for Makindus. "Stargardt's patients present a unique challenge for retinal specialists and we are looking forward to conducting the largest clinical trial that has ever been done in this orphan indication."

In obtaining orphan designation from the European Medicines Agency's Committee for Orphan Medicinal Products (COMP), Makindus will benefit from a number of incentives, including protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity for ten years once the medicine is on the market.

Makindus is in the process of completing the clinical trial design and contracting for clinical supplies in order to enroll Stargardt's patients into a clinical trial by the end of the year. The company is currently in discussions with corporate partners to help fund and collaborate on the development of MI-100 for Stargardt's disease.

Makindus Receives Orphan Designation For MI-100 For Stargardt's Disease ... June 10, 2014.

DOYLESTOWN, PA., June 10, 2014. On June 2, 2014 Makindus, Inc. a specialty pharmaceutical company, received orphan drug designation for their lead product MI-100 from the U.S.Food and Drug Administration Office of Orphan Products Development for the treatment of Stargardt's Disease. "The FDA's approval of our orphan drug designation application for MI-100 to treat Stargardt's disease is a key milestone for the company and we look forward to initiating our Phase 3 confirmatory trial early next year," stated Manohar Katakam, President and CEO of Makindus. Makindus acquired all intellectual property and associated clinical data supporting multiple ocular indications through a licensing deal that was closed in 2013.

"Stargardt's is a progressive, debilitating disease with no currently approved treatments or methods to halt progression. We are thrilled with the approved orphan designation request and are looking forward to sharing details about the program with potential strategic partners at BIO 2014 in San Diego, June 23-27. We believe our product is an excellent fit for companies focusing on rare/ specialty /orphan /ophthalmic diseases."

Orphan drug designation provides certain exclusivity benefits, tax credits for certain research and a waiver of the New Drug Application (NDA) user fee. Approximately 1:9,000 individuals suffer from Stargardt's disease in the U.S. where there is no currently approved treatment.