News

Potentia Pharmaceuticals Enters into Licensing and Purchase Option Agreements with Alcon (October 2009)

-- Alcon takes over development of POT-4 as a treatment for patients with age-related macular degeneration

-- Deal provides path for Alcon to acquire Potentia

LOUISVILLE, Ky., Oct. 23 /PRNewswire/ -- Potentia Pharmaceuticals, a privately-held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD), announced today that it has entered into licensing and purchase option agreements with Alcon Research, Ltd., a wholly-owned subsidiary of Alcon, Inc. (NYSE: ACL). The agreements provide Alcon with a license to develop Potentia's leading drug candidate, POT-4, for the treatment of AMD. The agreements also provide for Alcon to acquire the shares of Potentia if specified development milestones are achieved and if Alcon elects to continue development of POT-4.

Alcon will make upfront payments to Potentia for the initial license and option rights. The agreements also provide for potential future payments to Potentia's shareholders based on the achievement of multiple clinical and global regulatory approval milestones for several therapeutic indications and on Alcon's decision to proceed with development. They also provide for sales-based royalty payments to Potentia's shareholders on any products that are ultimately approved and commercialized. Financial terms were not disclosed.

"Alcon is the proven leader in the clinical development and marketing of eye care products and compounds. We could not wish for a better company to develop POT-4 into a new treatment option for the millions of patients with macular degeneration," said Cedric Francois, President and CEO of Potentia Pharmaceuticals.

POT-4 was the first complement inhibitor to enter the clinic for ophthalmological use and is being developed as a potential treatment for both dry and wet AMD. Potentia has completed a Phase I trial for POT-4 in patients with wet AMD. The trial was designed to determine the safety and tolerability of an intravitreal injection of POT-4, as well as its stability and depot-forming properties. In the study investigators observed only minimal and mild local adverse events related to the injection with no serious adverse events related the drug itself. The study also found that POT-4 deposits form at doses of 450 microgram and greater and that the higher the concentration was the longer the deposits lasted.

"There is a body of science supporting the potential for complement inhibitors in the treatment of retinal disease," said Sabri Markabi, MD, Alcon's senior vice president of research and development and chief medical officer. "Although at a very early stage, Potentia has developed the first complement inhibitor for age-related macular degeneration and positioned it for Phase II trials and we look forward to carrying development forward with the goal of treating patients with AMD."

About POT-4
POT-4 is a complement inhibitor discovered by Dr. John Lambris of the University of Pennsylvania, a leading researcher in the field of complement. POT-4 inhibits complement factor C3 and interrupts the complement activation cascade. Complement activation can lead to local inflammation in the eye that is believed to play a pivotal role in the development of AMD. Potentia has completed a Phase I trial of POT-4 in patients with wet AMD. The rights to the technology underlying POT-4 for application outside of ophthalmology are held by Swiss-based Apellis, AG.

About Alcon
Alcon, Inc. is the world's leading eye care company, with sales of approximately $6.3 billion in 2008. Alcon, which has been dedicated to the ophthalmic industry for 65 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contacts lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon operates in 75 countries and sells products in 180 markets. Alcon's majority shareholder is Nestle, S.A., the world's largest food company. For more information on Alcon, Inc., visit the Company's web site at www.alcon.com.

About Potentia
Potentia Pharmaceuticals, Inc. is a biotechnology company focused on developing novel therapeutics to address ophthalmological diseases. HealthCare Ventures and MASA Life Science Ventures are lead institutional investors in Potentia in conjunction with a number of long-term individual investors and the Kentucky Science and Technology Corporation. Potentia is among several companies housed under the umbrella of Nucleus, Kentucky's Life Sciences & Innovation Center, established in 2008 by the University of Louisville. WilmerHale and Frost Brown Todd acted as legal advisors to Potentia.

View full press release here.

Potentia Pharmaceuticals’ Drug Candidate for Age-Related Macular Degeneration Shows Positive Safety Profile in Phase I Clinical Trial (November 2008)

ATLANTA, GA – November 10, 2008 – Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD), presented Phase I data last week during the Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) Annual Meeting in Atlanta, GA. The data was from the ASaP (Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration) clinical trial for the company’s leading drug candidate, POT-4, which is being developed for the treatment of AMD.

The ASaP trial is a first-in-man, multi-center, single escalating dose study. The interim results of this trial revealed no drug-related toxicity based on clinical signs, ophthalmic examinations, or laboratory results at any time point monitored in patients treated with up to 150 ug/dose of POT-4. Additionally, no serious adverse events and no identifiable intraocular inflammation were reported.

Preliminary results indicate that intravitreal POT-4 is safe, and the data accumulated so far support the continued investigation of POT-4 for the treatment of both dry and wet AMD with larger randomized clinical trials to further define its efficacy profile.

“These safety data strongly support the further development of POT-4 as a potential treatment for patients with AMD,” said Cedric Francois, President and CEO of Potentia Pharmaceuticals. “We believe that the product has significant promise based on these early-stage findings and look forward to further testing of the compound in higher doses as we continue this trial.”

View full press release here.

Potentia Pharmaceuticals to present ASaP clinical trial data during the the AAO annual meeting on November 7, 2008 (October 2008)

LOUISVILLE, Ky., Oct. 27 /PRNewswire/ -- Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD), announced today that the Company will be presenting its ASaP Phase I clinical data for its leading drug candidate, POT-4, during the Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) Annual Meeting in Atlanta, GA, on November 7, 2008.

Cedric Francois, President and CEO of Potentia Pharmaceuticals, said, "POT-4 is the first of several complement inhibitors that will ultimately be tested in macular degeneration. The role of complement in this disease was established in 2005 as the first breakthrough discovery resulting directly from the human genome project. If complement inhibition is successful at treating macular degeneration, it would be the first of hopefully many new drugs born out of the human genome project, and usher in an era of improved healthcare for millions of patients."

Dr. Philip J. Rosenfeld, M.D., Ph.D., Professor of Ophthalmology at the Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine in Miami, FL, and a clinical investigator in the study, will present the data on Potentia's behalf.

POT-4 is a complement inhibitor, which shuts down the complement activation cascade that could otherwise lead to local inflammation, tissue damage and upregulation of angiogenic factors such as vascular endothelial growth factor (VEGF) in the eye. Based on this mechanism of action, POT-4 holds the potential to be effective against both dry and wet AMD. POT-4 has shown early positive safety results in its Phase I study.

For more information on the presentation at AAO:

Title: Complement C3 Inhibitor POT-4 for AMD
When: Friday, November 7 at 9:01 AM EST
Location: Hall A-3 Session Room
Session: Retina 2008: Vistas and Viewpoints
Section II: AMD, Part II

View full press release here.

Potentia Pharmaceuticals Announces Positive Safety Data and Study Expansion in Phase I Trial for Lead Drug Candidate POT-4 (September 2008)

September 29, 2008—Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD) announced today that the Company's leading drug candidate, POT-4, has shown early positive safety results in its Phase I study. POT-4 is a complement inhibitor, which shuts down the complement activation cascade that could otherwise lead to local inflammation, tissue damage and upregulation of angiogenic factors such as vascular endothelial growth factor (VEGF). Based on this mechanism of action, POT-4 holds the potential to be effective against both dry and wet AMD.

"POT-4 has generated encouraging safety and tolerability data in this Phase I study and holds significant promise as a novel agent for treating AMD; a debilitating condition for which there is no cure," said Cedric Francois, President and CEO of Potentia. "As a result of the favorable early data, it was decided to expand the trial to permit further dose escalation, with the goal of prolonging the pharmacological benefit from POT-4. Potentia looks forward to the presentation of the Phase I data at a future medical conference and, with additional information gained from the extension of the study, to the initiation of Phase II trials in the future."

View full press release here.

Potentia featured in BioCentury article "The eye have it" (BioCentury, September 2008)

View BioCentury article here.

Potentia Poises for Validation in Complement Inhibition in AMD (BioWorld Today, September 2008)

View BioWorld article here.

Potentia gets awarded Phase II STTR grant from the National Eye Institute (September 2008)

Potentia Pharmaceuticals, together with academic collaborators, received a Phase II STTR grant from the National Eye Institute to push forward their development of a new, less invasive delivery technology for ocular therapeutics. This grant, involving a collaboration with the Lions Eye Center of the University of Louisville, revolves around the use of disease-targeted drug-eluting polymeric nanoparticles that are administered intravenously.

Company raises $12 million to help fund study of vision drug(Courier Journal, April 2008)

View Courier Journal article here.

Potentia Pharmaceuticals Secures Additional $12 Million in Funding (April 2008)

April 9, 2008—Potentia Pharmaceuticals, Inc., a private development-stage biotechnology company, announced today that it has completed a $12 million round of financing. The funds will allow Potentia to complete Phase I and move into Phase II clinical development of Potentia's novel investigational drug candidate, POT-4. POT-4 is a peptide that specifically inhibits complement activation and is initially being developed for the treatment of age-related macular degeneration (AMD).

The financing was led by HealthCare Ventures, a leading venture capital firm specializing in the life science industry, and MASA Life Science Ventures, LP, one of Potentia's previous investors. In connection with the financing, Douglas E. Onsi of HealthCare Ventures will join Potentia's board of directors.

"Millions of patients are eager for an effective treatment for dry AMD. Complement inhibition, using therapies such as POT-4, is the most promising approach being developed for these people," said Cedric Francois, co-founder and CEO of Potentia Pharmaceuticals. "This additional funding will allow us to complete Phase I and move into Phase II clinical trials of POT-4 which is a first-in-class complement therapy that we believe will revolutionize the treatment for AMD. We are very grateful for the continued support by our original investors and are extremely pleased to have a venture capital group with the stature of HealthCare Ventures on board as our newest investor."

Douglas E. Onsi of HealthCare Ventures commented, "We were very impressed by Potentia's experienced management team and the company's unique approach to the treatment of AMD. HealthCare Ventures invests in companies, like Potentia, that open new avenues of research and develop novel products that will change the practice of medicine."

AMD is the leading cause of blindness in the elderly of the western world. An estimated 10 million patients in the USA are affected with the disease, of which approximately 3 million are afflicted with an advanced form of the disease, moreover this number is expected to double over the next ten to fifteen years. Dry AMD is the most common form of the disease, accounting for about 85% of all cases. AMD represents a multi-billion dollar market for which only a limited number of treatment options are available.

View full press release here.

9 area technology companies get state grants (Courier Journal, July 2007)

View Courier Journal article here.

Potentia Pharmaceuticals announces initiation of Phase I clinical trials to evaluate its lead compound for age-related macular degeneration (March 2007)

March 20, 2007—Potentia Pharmaceuticals, Inc. announced today that it is entering the clinical phase of development for POT-4, its lead drug candidate for the treatment of age-related macular degeneration (AMD). POT-4 is a complement inhibitor, which shuts down the complement activation system that could lead to local inflammation, tissue damage and upregulation of angiogenic factors such as vascular endothelial growth factor (VEGF).

Four landmark studies published in April 2005 demonstrated a genetic link between the complement system and AMD, providing evidence that complement activation plays a significant role in the cause of the disease. Less than two years after the publication of the studies, POT-4 will be the first complement inhibitor tested in patients with AMD.

“These recent data have sparked hope that AMD can be treated with complement inhibitors, which help treat the early stages of the disease. We are hopeful that POT-4 may represent a new therapeutic option for patients with dry and wet forms of the disease,“ said Cedric Francois, M.D., Ph.D., Potentia’s President and CEO.

AMD is the leading cause of blindness in the elderly of the western world and affects more than 10 million patients in the United States alone. The current standard of care for AMD relies primarily on angiogenesis inhibitors, an approach geared towards the approximately 10-15% of AMD patients with complications resulting from ocular angiogenesis (growth of new blood vessels and bleeding in the back of the eye). No drug currently on the market has been approved for the treatment of the remaining patients, who suffer from the so-called “dry” form of the disease.

View full press release here.

Potentia Pharmaceuticals Raises $5 Million from Private Investors (March 2007)

March 6, 2007—Potentia Pharmaceuticals, Inc. announced today that it closed a $5 million round of financing. The funds will be used in part to support the pre-clinical and clinical development of Potentia’s main drug candidate, POT-4. POT-4 is a derivative of Compstatin, a peptide that inhibits complement activation. POT-4 is initially being developed for the treatment of age-related macular degeneration (AMD)

View full press release here.

Potentia Pharmaceuticals Appoints Armen H. Tashjian to its Scientific Advisory Board (December 2006)

December 5, 2006—Potentia Pharmaceuticals, Inc. announced today the appointment of Armen H. Tashjian, Jr., M.D. to its Scientific Advisory Board. Dr. Tashjian is Professor of Biological Chemistry and Molecular Pharmacology, emeritus at Harvard Medical School where his research focuses on the biochemical and molecular mechanisms of signal transduction with an emphasis on neuropeptides and their receptors. A second long-term interest has been on intracellular and extracellular calcium metabolism and skeletal biology and pharmacology. He founded the Department of Molecular and Cellular Toxicology at the Harvard School of Public Health where he is Professor of Toxicology, emeritus. Under his guidance, this department was at the forefront of discovering mechanisms of toxicity of environmental chemicals and therapeutic agents.

Dr. Tashjian has been an officer in numerous scientific societies, serving on NIH study sections and government advisory panels, and on the editorial boards of over 15 scientific journals including the New England Journal of Medicine. He is a senior advisor to a number of pharmaceutical and biotechnology companies, and venture capital funds. He is an elected member of the Norwegian Academy for Science and Letters and is Deputy Editor of the recently published textbook entitled Principles of Pharmacology: The Pathophysiologic Basis of Drug Therapy.

"We are excited that Dr. Tashjian has agreed to join Potentia's Scientific Advisory Board," said Cedric Francois, M.D., Ph.D., Chief Executive Officer for Potentia. "He has a stellar record of accomplishment and brings years of scientific leadership to Potentia."

View full press release here.

Potentia Pharmaceuticals licences complement inhibitor Compstatin from the University of Pennsylvania (July 2006)

July 27, 2006—Potentia Pharmaceuticals, Inc. announced today that it has entered into an exclusive, worldwide licensing agreement with the University of Pennsylvania that provides broad rights to develop and commercialize University of Pennsylvania’s Compstatin class of complement-inhibiting peptides for the treatment of ocular diseases.  While the terms of the license have not been disclosed, this agreement will allow Potentia to move forward with the preclinical development of the first complement-inhibiting drug product aimed at treating both the “wet” and “dry” forms of age-related macular degeneration (AMD).  

“We are excited to work with the University of Pennsylvania in developing the first treatment for macular degeneration based on the important genetic findings of the last year” said Cedric Francois, M.D., Ph.D., Chief Executive Officer for Potentia.  “Genetic analysis of patients with macular degeneration has now clearly established that excessive complement activation is involved in the development of macular degeneration.  Compstatin is one of the best complement-inhibiting drugs available and we look forward to evaluate its potential and to help patients suffering from this devastating disease.”

View full press release here.

Potentia Pharmaceuticals awarded Phase I STTR grants from the National Eye Institute (June 2006)

Potentia Pharmaceuticals, together with academic collaborators, received two Phase I STTR grants from the National Eye Institute to develop new, less invasive delivery technologies for ocular therapeutics. The first grant, involving a collaboration with the Lions Eye Center of the University of Louisville, investigates the use of disease-targeted polymeric nanoparticles that could be administered intravenously. The second program will explore the use of a local controlled-release transscleral delivery vehicle in collaboration with the University of Arkansas for Medical Sciences. These two programs address the important aspect of delivery of drugs to the back of the eye, one of the major obstacles currently facing many promising therapies for ocular diseases.

Potentia Pharmaceuticals hosts reception at the 2006 ARVO annual meeting in Fort Lauderdale (April 2006)

Potentia hosted a reception in Fort Lauderdale during the Association for Research in Vision and Ophthalmology (ARVO) annual meeting. The event brought together the entire Potentia team and Scientific Advisory Board, along with collaborators and potential partners and introduced them to Potentia and its focused developmental timetable. The reception was a frank success and approximately 35 people attended.

Potentia gets $2.6 million from East Coast investors (Courier Journal, April 2005)

View Courier Journal article here.

Biotech company attracts funding from investors in northeast (Business First, April 2005)

View Business First article here.

Potentia Pharmaceuticals closes fourth round of funding (April 2005)

Potentia raised a fourth round of Angel funding of $2,600,000.

Louisville's life sciences 'import' strategy scores (Courier Journal, March 2005)

View Courier Journal article here.

Potentia Pharmaceuticals' third round of funding (April 2004)

Potentia raised a third round of Angel funding of $400,000.

Potentia Pharmaceuticals raises a second round of funding (October 2003)

Potentia raised a second round of Angel funding of $315,000.

Potentia Pharmaceuticals awarded 4 grants (June - August 2003)

Potentia was awarded two NIH SBIR Phase I grants and two Kentucky state grants for a total of $1 million. These funds will be used to launch Potentia's first two research programs.

Potentia Pharmaceuticals begins its operations (April 2003)

The core scientific founders relocated to Louisville, KY after raising a seed fund of $300,000 from a group of Angel investors. Potentia is currently setting up its first laboratory and will be incubated within the confine of the University of Louisville.

Winner of the Harvard Business School Business Plan Competition (May 2001)

View the Harvard Business School news release here.

Winner of the GSAS Harvard Biotech Club Business Plan Competition (April 2001)

View the GSAS Harvard Biotech Club website here.