Ophthotech Raises $30 Million in Series B Financing
December 15, 2009–Company Plans to Initiate Phase 2 Combination Study with E10030 in Wet Age-related Macular Degeneration, Advance Two Additional Clinical State Programs in Macular Degeneration–
NEW YORK, December 15, 2009 — Ophthotech Corp., a biopharmaceutical company focused on developing novel ophthalmic therapies for both wet and dry age-related macular degeneration (AMD), announced today that it has closed a $30 million Series B financing round.
The financing round was led by Clarus Ventures, which will be represented on Ophthotech’s board of directors by Nicholas Galakatos, Ph.D., managing director of Clarus. Clarus is joined in the current round by existing investors SV Life Sciences, Novo A/S and HBM BioVentures. Proceeds from the financing will be used to fund a Phase 2 combination trial of Ophthotech’s lead product candidate for treatment of wet AMD, E10030, and development activities for the company’s other targeted therapies for wet and dry AMD.
"In its Phase 1 combination therapy trial, E10030, which targets PDGF, has demonstrated unprecedented visual gain in patients with wet AMD. This remarkable visual outcome was accompanied for the first time by robust neovascular regression, reflecting the disruption of underlying pathology. E10030 has the potential of becoming a new standard for wet AMD treatment," said Samir Patel, M.D., president and chief executive officer of Ophthotech. "We welcome Nick Galakatos and Clarus Ventures to Ophthotech at an important time, as we look to move E10030 into a larger, randomized Phase 2 wet AMD study. Their deep experience in drug development and business strategy will be invaluable as we move all of our potentially breakthrough programs forward."
Galakatos added, "Ophthotech has an innovative pipeline of best-in-class products for the treatment of AMD. Our investment decision was driven by the quality of the pipeline and the experience of the management team, who successfully developed Macugen® into the first marketed anti-VEGF therapy for the eye. We are excited to be working with this team again."
E10030, an aptamer targeting PDGF, has demonstrated potency when combined with anti-VEGF agents such as Lucentis. In this Phase 1 combination study, 59 percent of patients treated with a combination of E10030 and Lucentis gained significant vision (3-line gain) 12 weeks after therapy. All patients demonstrated neovascular regression, a first in wet AMD therapy, with no evidence of drug-related adverse events.
In addition to E10030, Ophthotech is pursuing multiple therapeutic targets to develop next-generation treatments for wet AMD and potentially the first approved treatment for dry AMD.
About AMD
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. The role of abnormal neovascularization, or angiogenesis, in the pathogenesis of neovascular AMD has been well established. There are two forms of the disease, "dry" and "wet" AMD. The wet form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for wet AMD. Dry AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for dry AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in dry AMD is typically not as severe as wet AMD, however, over time, dry AMD can progress to the wet form of the disease.
About Ophthotech
Ophthotech Corp. is a privately held biopharmaceutical company focused on developing and commercializing therapies for back-of-the-eye diseases. Ophthotech plans to develop a pipeline of compounds with strong scientific foundations for the treatment of AMD and bring them to market in an accelerated manner. In August of 2007, Ophthotech announced a Series A venture financing and two separate in-licensing deals with Archemix Corp. and (OSI) Eyetech. A third in-license from Biogen Idec and PDL BioPharma was announced in January of 2008. Ophthotech’s venture investors include SV Life Sciences, HBM BioVentures and Novo A/S. For more information, please visit http://www.ophthotech.com.
Positive Results for Ophthotech's Novel Therapy for Wet AMD
May 4, 200959% of patients showed 3-line gain (significant visual gain) and 100% neovascular regression
Fort Lauderdale, Fla, May 4, 2009 – Ophthotech Corp. today announced positive results of a phase 1 clinical study evaluating E10030, its novel anti-platelet derived growth factor (anti-PDGF) in conjunction with an anti-vascular endothelial growth factor (anti-VEGF), to treat wet age-related macular degeneration (wet AMD). Anti-PDGF therapy resulted in enhanced visual outcome and was associated with significant neovascular regression. The results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting in Fort Lauderdale.
59% percent of patients treated with anti-PDGF and anti-VEGF gained significant vision (3-line gain) at week 12 after therapy. 100% of treated patients demonstrated neovascular regression. E10030 was well tolerated with no evidence of drug-related adverse events. Current standard of care treatment utilizing monotherapy anti-VEGF results in 3-line visual gain in approximately one third of patients and without significant neovascular regression.
“Marked neovascular regression, a first in any study, with an outstanding level of visual gain, is very promising for our patients. My clinical experience with current monotherapy anti-VEGF regimen in wet AMD is consistent with published studies, which show that on average neovascular regression does not occur,” said Dr. Lawrence J. Singerman, Clinical Professor at Case Western Reserve University and a principal investigator in over 50 macular clinical trials.
E10030 is an aptamer targeting PDGF, a key molecule involved in the recruitment and maturation of pericytes. Pericytes in neovascular tissue have been shown to be protective and play a major role in anti-VEGF treatment resistance. E10030 strips the pericytes from the neovascular tissue rendering it highly sensitive to an anti-VEGF attack.
“The objective and robust response of neovascular regression is consistent with the biologic activity of E10030. I look forward to a randomized trial design to confirm the strong proof of concept data of this study,” said Dr. Donald J. D’Amico, Professor and Chairman, Department of Ophthalmology, Weill Cornell Medical College, New York-Presbyterian Hospital.
“It is exciting to see our clinical trial confirm the strong preclinical data from oncology and ophthalmic studies targeting the molecules regulating pericyte and endothelial cell survival. Ophthotech will continue to devote its resources towards an accelerated development of our anti-PDGF compound,” said Dr. Samir C. Patel, President and CEO of Ophthotech Corp.
Wet AMD is characterized by the abnormal growth of blood vessels (neovascularization) beneath the retina, which leak blood and fluid and can cause permanent damage to cells in the center of the retina (the macula). This form of AMD is the most severe form of the disease, and often leads to permanent vision loss.
E10030 is one of three compounds that Ophthotech is developing to treat wet and dry AMD. Additional molecular entities include an anti-C5 aptamer and volociximab, an anti-angiogenic monoclonal antibody targeting the α5β1 integrin, both currently in a Phase I study.
About anti-PDGF E10030
E10030 is an aptamer-based compound directed against PDGF-B. Pharmacology studies indicate that E10030 binds to PDGF-B with high specificity and affinity and inhibits the functions of PDGF-B both in vitro and in vivo. In preclinical studies, E10030 demonstrated the potential to regress neovascularization when used in combination with a VEGF-A inhibitor. In experiments involving models of ocular vascularization, concurrent inhibition of PDGF-B and VEGF-A signaling was superior to inhibition of the VEGF-A pathway alone.
About AMD
Age-related macular degeneration (AMD) is the leading cause of blindness for people over the age of 50 in the United States and Europe. The role of abnormal neovascularization, or angiogenesis, in the pathogenesis of neovascular AMD has been well established. There are two forms of the disease, namely "dry" and "wet" AMD. The “wet” form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for “wet” AMD. “Dry” AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for “dry” AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in “dry” AMD is typically not as severe as “wet” AMD, however, over time, “dry” AMD can progress to the wet form of the disease.
About Ophthotech
Ophthotech Corp. is a privately held biopharmaceutical company based in Princeton, NJ and New York, NY focused on developing and commercializing therapies for back-of-the-eye diseases. Ophthotech plans to develop a pipeline of compounds with strong scientific foundations for the treatment of AMD and bring them to market in an accelerated manner.
Ophthotech Treats First Patient in a Phase I Trial of Monoclonal Antibody, Volociximab, for Age-Related Macular Degeneration
November 10, 2008Princeton, NJ and New York, NY- November 10, 2008 - Ophthotech Corp., announced today the treatment of its first patient with Volociximab, a monoclonal antibody targeting α5β1 integrin, in a Phase I trial for the treatment of wet age-related macular degeneration (AMD). Ophthotech is a privately held biopharmaceutical company focused on developing ophthalmic therapies for both wet and dry AMD. Volociximab represents Ophthotech’s third compound in clinical development. This Phase I trial will assess the safety, tolerability and pharmacokinetic profile of Volociximab.
"There is strong scientific rationale for α5β1 integrin antagonism to interrupt the cell survival signals in neovascular tissue and associated inflammation in eyes afflicted with AMD. Ophthotech’s monoclonal antibody, Volociximab, holds great promise as a potential breakthrough therapy for the wet and dry forms of AMD," said Scott W. Cousins, MD, the Robert Machemer, MD, Professor of Ophthalmology at Duke University, and the director of the Duke Center for Macular Diseases at the Duke Eye Center.
"Initiating clinical development of Volociximab, our third compound, is an important milestone, as it demonstrates our commitment to developing and commercializing therapies for both wet and dry AMD in an accelerated manner," said Samir Patel, MD, President and Chief Executive Officer of Ophthotech.
This trial involves the company’s third compound in clinical development to date. Recently, Ophthotech enrolled its first patient in a Phase I complement inhibition trial for age-related macular degeneration with its anti-C5 complement factor aptamer, ARC1905, in combination with an anti-VEGF agent. In February 2008, the company initiated a Phase I trial with E10030, an anti-PDGF aptamer, also in combination with an anti-VEGF agent, for the treatment of agerelated macular degeneration. A dry AMD trial with ARC1905 is scheduled to commence in 2009.
About Volociximab (M200)
Volociximab is a monoclonal antibody targeting α5β1 integrin, a key protein involved in the formation of new blood vessels (angiogenesis). α5β1 integrin is a critical survival factor for proliferating endothelial cells involved in angiogenesis. Volociximab blocks the binding of α5β1 to fibronectin, thereby disrupting a variety of processes involved in neovascularization. Inhibition of α5β1 integrin has demonstrated potent anti-angiogenic effects in multiple preclinical models of angiogenesis. Unlike current therapies such as ranibizumab and bevacizumab, Volociximab inhibits endothelial cell proliferation downstream of growth factor stimulation, irrespective of the upstream proangiogenic stimulating factors. In January 2008, Ophthotech licensed worldwide development and commercial rights to all ophthalmic uses of Volociximab from Biogen Idec and PDL.
About AMD
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. The role of abnormal neovascularization, or angiogenesis, in the pathogenesis of neovascular AMD has been well established. There are two forms of the disease, namely "dry" and "wet" AMD. The "wet" form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for "wet" AMD. "Dry" AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for "dry" AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in "dry" AMD is typically not as severe as "wet" AMD, however, over time, "dry" AMD can progress to the wet form of the disease.
About Ophthotech
Ophthotech Corp. is a privately held biopharmaceutical company focused on developing and commercializing therapies for back-of-the-eye diseases. Ophthotech plans to develop a pipeline of compounds with strong scientific foundations for the treatment of AMD and bring them to market in an accelerated manner. In August of 2007, Ophthotech announced a Series A venture financing and two separate in-licensing deals with Archemix Corp. and (OSI) Eyetech. A third inlicense from Biogen Idec and PDL BioPharma was announced in January of 2008. Ophthotech’s venture investors include SV Life Sciences, HBM BioVentures and Novo A/S.
Ophthotech Enrolls First Patient in a Phase I Complement (Anti-C5) Inhibitor Trial for Macular Degeneration
October 27, 2008ARC1905 Represents Second Compound in Clinical Development
Princeton, NJ and New York, NY- October 27, 2008 - Ophthotech Corp. ("Ophthotech"), a privately held biopharmaceutical company focused on developing ophthalmic therapies for back-of-the-eye diseases, announced today the enrollment of its first patient in a complement inhibition trial for the treatment of age-related macular degeneration (AMD). This Phase I trial will assess the safety and tolerability of ARC1905, an anti-C5 complement factor aptamer, in combination with an anti-VEGF agent.
Dr. Donald J. D’Amico, Professor and Chairman, Department of Ophthalmology, Weill Cornell Medical College, New York-Presbyterian Hospital, and a member of Ophthotech’s Scientific Advisory Board, said, "Multiple lines of evidence now point to a fundamental problem with inflammation and complement activation in patients with high susceptibility to develop AMD. Intervention in the complement pathway is the single most promising target for new therapeutic and preventive strategies for AMD."
"Preclinical and human genetic linkage studies strongly support the significant role of complement-mediated inflammation in both dry and wet AMD," said Samir Patel, M.D., President and Chief Executive Officer of Ophthotech. "We believe that anti-C5 aptamer blockade represents a potential breakthrough therapy for both wet and dry forms of AMD."
Published studies in Science, the New England Journal of Medicine and other leading journals suggest that abnormalities involving the complement pathway may be responsible for the majority of cases of dry and wet forms of AMD in the western world.
ARC1905 represents one of three compounds that Ophthotech is developing to treat AMD. Additional molecular entities include E10030, an anti-PDGF aptamer currently in a Phase I study, and volociximab, an anti-angiogenic monoclonal antibody targeting the α5β1 integrin, which is on track to commence clinical trials in the near future.
About ARC1905
Anti-C5 aptamer ARC1905 inhibits C5, a central component of the complement cascade, which plays multiple roles in innate immunity and inflammatory diseases. Inhibition of this key step in the complement cascade at the level of C5 prevents the formation of key terminal fragments (C5a and C5b-9) regardless of which pathway (alternate, classical or lectin) induced their generation. The C5a fragment is an important inflammatory activator inducing vascular permeability, recruitment and activation of phagocytes. C5b-9 is involved in the formation of membrane attack complex (MAC: C5b-9), which initiates cell lysis. By inhibiting these C5- mediated inflammatory and MAC activities, therapeutic benefit may be achieved in both dry and wet AMD. In August 2007, Ophthotech licensed worldwide rights to all ophthalmic uses of Archemix’s proprietary aptamers (ARC186 and ARC1905) targeting the C5 component of the complement cascade.
About E10030
E10030, currently being investigated in a Phase I trial, is an aptamer-based compound directed against PDGF-B. Pharmacology studies indicate that E10030 binds to PDGF-B with high specificity and affinity and inhibits the functions of PDGF-B both in vitro and in vivo. In preclinical studies, E10030 demonstrated the potential to regress neovascularization when used in combination with a VEGF-A inhibitor. In experiments involving models of ocular vascularization, concurrent inhibition of PDGF-B and VEGF-A signaling was superior to inhibition of the VEGF-A pathway alone.
About Volociximab (M200)
Volociximab is a monoclonal antibody targeting α5β1 integrin, a key protein involved in the formation of new blood vessels, a process known as angiogenesis. α5β1 integrin is a critical survival factor for proliferating endothelial cells involved in angiogenesis. Inhibition of α5β1 integrin has demonstrated potent anti-angiogenic effects in multiple pre-clinical models of angiogenesis.
About AMD
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely "dry" and "wet" AMD. The "wet" form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for "wet" AMD. "Dry" AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for "dry" AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in "dry" AMD is typically not as severe as "wet" AMD, however, over time, "dry" AMD can progress to the wet form of the disease.
About Ophthotech
Ophthotech Corp. is a privately held biopharmaceutical company focused on developing and commercializing therapies for back-of-the-eye diseases. Ophthotech plans to develop a pipeline of compounds with strong scientific foundations for the treatment of AMD and bring them to market in an accelerated manner. In August of 2007, Ophthotech announced a Series A venture financing and two separate in-licensing deals with Archemix Corp. and Eyetech, Inc., which recently spun out of (OSI) Eyetech. A third in-license from Biogen Idec and PDL BioPharma was announced in January of 2008. Ophthotech’s venture investors include SV Life Sciences, HBM BioVentures and Novo A/S.
Ophthotech Enrolls Its First Patient in a Phase I Anti-PDGF Macular Degeneration Trial
February 12, 2008Princeton, NJ - February 12, 2008 - Ophthotech Corp. ("Ophthotech"), a privately held biopharmaceutical company focused on developing ophthalmic therapies for back-of-the-eye diseases, today announced that the first patient has been enrolled in its Phase I clinical trial for the treatment of wet age-related macular degeneration (AMD). The Phase I trial will assess the safety and tolerability of E10030, an anti-PDGF aptamer, in combination with an anti-VEGF agent. This trial will enroll up to a maximum of 36 patients.
"The current treatment regimen for angiogenesis in AMD does not result in neovascular regression. The combination of anti-PDGF and anti-VEGF agents has been shown to cause neovascular regression, in both ocular and tumor angiogenesis preclinical models. We believe E10030 holds great promise for enhancing the visual outcome for patients with AMD," said Samir Patel, M.D., President and CEO of Ophthotech Corp.
E10030 is the first of three compounds that Ophthotech Corp. is developing to treat AMD. Additional molecular entities include ARC1905, a complement (anti-C5) inhibitor, and volociximab, an anti-angiogenesis monoclonal antibody targeting α5β1 integrin.
About E10030
E10030, is an aptamer-based compound directed against PDGF-B. Pharmacology studies indicate that E10030 binds to PDGF-B with high specificity and affinity and inhibits the functions of PDGF-B both in vitro and in vivo. In preclinical studies, E10030 demonstrated the potential to regress neovascularization when used in combination with a VEGF-A inhibitor. In experiments involving models of ocular vascularization, concurrent inhibition of PDGF-B and VEGF-A signaling was superior to inhibition of the VEGF-A pathway alone.
About ARC1905
Anti-C5 aptamer ARC1905 inhibits C5, a central component of the complement cascade, which plays multiple roles in innate immunity and inflammatory diseases. Inhibition of this key step in the complement cascade at the level of C5 prevents the formation of key terminal fragments (C5a and C5b-9) regardless of which pathway (alternate, classical or lectin) induced their generation. The C5a fragment is an important inflammatory activator inducing vascular permeability, recruitment and activation of phagocytes. C5b-9 is involved in the formation of membrane attack complex (MAC: C5b-9) which initiates cells lysis. By inhibiting these C5-mediated inflammatory and MAC activities, therapeutic benefit may be achieved in both dry and wet AMD.
About Volociximab(M200)
Volociximab is a monoclonal antibody targeting α5β1 integrin, a key protein involved in the formation of new blood vessels, a process known as angiogenesis. α5β1 integrin is a critical survival factor for proliferating endothelial cells involved in angiogenesis. Inhibition of α5β1 integrin has demonstrated potent anti-angiogenic effects in multiple pre-clinical models of angiogenesis.
About AMD
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely "dry" and "wet" AMD. The "wet" form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for "wet" AMD. "Dry" AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for "dry" AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in "dry" AMD is typically not as severe as "wet" AMD, however, over time, dry AMD can progress to the wet form of the disease.
About Ophthotech
Ophthotech Corp. is a privately held biopharmaceutical company focused on developing and commercializing therapies for back-of-the-eye diseases. Ophthotech plans to develop a pipeline of compounds with strong scientific foundations for the treatment of AMD and bring them to market in an accelerated manner. In August of 2007, Ophthotech announced a $36 million Series A venture financing and two separate in-licensing deals with Archemix Corp and (OSI) Eyetech, Inc. A third in-license from Biogen Idec and PDL BioPharma was announced in January of 2008. Ophthotech’s venture investors include SV Life Sciences, HBM BioVentures and Novo A/S.
Biogen Idec and PDL BioPharma License the Rights to Develop Volociximab in Ophthalmic Indications to Ophthotech
January 8, 2008—Ophthotech to develop anti-angiogenesis antibody for Age-Related Macular Degeneration—
—Biogen Idec and PDL to receive future milestones and royalties—
Princeton, NJ, Cambridge, Mass., and Redwood City, Calif., January 8, 2008 – Ophthotech Corp. (“Ophthotech”), a privately held biopharmaceutical company focused on developing ophthalmic therapies for back-of-the-eye diseases, Biogen Idec Inc. (NASDAQ: BIIB) and PDL BioPharma, Inc. (NASDAQ: PDLI) today announced that they have entered into an exclusive worldwide licensing agreement for an anti-angiogenesis antibody to treat Age-Related Macular Degeneration (AMD). Under the terms of the agreement, Biogen Idec and PDL have granted Ophthotech worldwide development and commercial rights to all ophthalmic uses of volociximab (M200). Volociximab is an investigational monoclonal antibody targeting α5β1 integrin, a key protein involved in the formation of blood vessels, a process known as angiogenesis. Biogen Idec and PDL will each receive an equity position in Ophthotech as well as a combination of development milestone payments and royalties on future product sales. Other terms, including financial terms, related to the agreement have not been disclosed.
“α5β1 integrin is a critical survival factor for proliferating endothelial cells involved in angiogenesis,” said Samir Patel, MD, president and CEO of Ophthotech. "The preclinical studies to date provide very strong support for developing volociximab for ophthalmic indications. It represents a potential breakthrough for the treatment of AMD.”
"There remains a significant unmet need in treating AMD, and we’re pleased that Ophthotech, founded by leaders in the development of new therapeutics for this disease, has chosen to explore the potential of volociximab in AMD," said Faheem Hasnain, executive vice president, oncology and rheumatology strategic business unit, Biogen Idec.
"We believe the anti-angiogenesis properties of volociximab, coupled with Ophthotech’s expertise in developing ophthalmic therapies, provide an excellent opportunity to maximize volociximab’s value," said L. Patrick Gage, PhD, PDL’s interim CEO. Separately, Biogen Idec and PDL are co-developing volociximab in solid tumor cancers and the companies retain rights in all other indications pursuant to their September 2005 collaboration agreement.
About Age-Related Macular Degeneration (AMD)
AMD is the leading cause of blindness for people over the age of 55 in the United States and Europe. There are two forms of AMD, namely "dry" and "wet" AMD. The "wet" form is characterized by the growth of new blood vessels into the central region of the retina. These new vessels cause severe visual loss due to retinal damage caused by subsequent leakage and scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for “wet” AMD. “Dry” AMD accounts for up to 90 percent of all cases of AMD. There is no approved therapy for "dry" AMD, which afflicts 8 million patients in the United States and an additional 8 million in Europe. Visual loss in "dry" AMD is typically not as severe as "wet" AMD, however, over time, dry AMD can progress to the wet form of the disease.
About Ophthotech
Ophthotech Corp. is a biotechnology company focused on developing and commercializing therapies for back-of-the-eye diseases. Ophthotech plans to develop a pipeline of compounds with strong scientific foundations for the treatment of AMD and bring them to market in an accelerated manner. In August of 2007, Ophthotech announced a $36 million Series A venture financing and two separate in-licensing deals with Archemix Corp and (OSI) Eyetech, Inc. Ophthotech’s venture investors include SV Life Sciences, HBM BioVentures and Novo A/S. For more information, please visit www.ophthotech.com.
About Biogen Idec Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
About PDL BioPharma PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for severe or life-threatening illnesses. For more information, please visit www.pdl.com.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.
Forward-looking Statement
This press contains forward-looking statements regarding the development of volociximab for ophthalmic indications. These statements are based on the companies’ current beliefs and expectations. Drug development and commercialization involves a high degree of uncertainty and risk.
For more detailed information on the risks and uncertainties associated with the drug development and other activities of Biogen Idec and PDL BioPharma, see Item 1A "Risk Factors" in each company’s most recent 10-Q or 10-K filing with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Ophthotech Quickly Snares $36M And 2 AMD Licenses
August 14, 2007The core management team that hit a home run with the first vascular endothelial growth factor (VEGF) inhibitor for the eye, which resulted in a $900 million merger and acquisition deal, is taking another swing at bringing new molecular entities to the marketplace with a newly formed company.
Former Eyetech co-founders David R. Guyer and Samir Patel have formed Ophthotech, which announced Series A financing of $36 million and two in-licensing deals for compounds for age-related macular degeneration (AMD).
SV Life Sciences led the round with HBM BioVentures and Novo A/S participating.
Guyer, former chief executive officer for Eyetech, is serving as Opthotech’s chairman of the board, and Patel is president and CEO.
The entrepreneurs found success with the anti-VEGF product Macugen (pegaptanib sodium), approved by the FDA in 2004 for the treatment of neovascular (wet) AMD.
Wet AMD, the leading cause of blindness in the U.S., occurs when abnormal blood vessels start to grow under the macula, the central portion of the retina that is responsible for focusing central vision and aids with the ability to read, recognize faces and colors and see objects in fine detail.
Macugen binds to the VEGF protein that triggers the abnormal blood vessel growth, ultimately slowing vision loss.
Betting on Macugen’s potential for success, Melville, N.Y.-based OSI Pharmaceuticals acquired Eyetech in November 2005 for $935 million in cash and stock.
Many investors were baffled that OSI would take such a risk on a one-drug firm like Eyetech, especially after results of a Phase III study examining Genentech’s Lucentis (ranibizumab), a humanized monoclonal antibody fragment, showed that drug to be highly effective in treating wet AMD, which set the stage for Lucentis to be an aggressive rival to Macugen. (See BioWorld Today, Nov. 4, 2005.)
Indeed, after Lucentis entered the U.S. market in June 2006, sales of Macugen tumbled.
But Patel does not view Lucentis’ success as a failure for Macugen.
The attention both drugs have received, he said, makes it clear that there is still a "very large market space" available for further opportunities in development and commercialization of newer and better AMD therapies.
As part of its strategy to move from "infancy to adolescence" in product development, Patel said, Ophthotech, based in Princeton, N.J., entered into a licensing agreement with Archemix, of Cambridge, Mass.
Archemix has granted Ophthotech worldwide rights to all ophthalmic uses of the firm’s proprietary aptamers, short oligonucleotides that form three-dimensional structures that bind with high specificity and affinity to protein and nonprotein targets, targeting the C5 component of the complement cascade.
Ophthotech’s anti-C5 aptamer, Patel said, will be the first breakthrough drug for dry age-related macular degeneration, which occurs when the light-sensitive cells in the macula slowly break down, gradually blurring central vision in the affected eye.
Dry AMD is more common than wet AMD. There are currently no treatments on the market for dry AMD.
"Dry AMD is an enormous market with major unmet medical needs," Patel said, noting that about 8 million Americans and an additional 8 million Europeans have the condition.
The other licensing agreement Ophthotech announced involves a deal with OSI, the firm that acquired Eyetech.
OSI is transferring to Ophthotech all rights to Eyetech’s anti-platelet derived growth factor (PDGF) aptamer program, including rights to its preclinical compound E10030, in exchange for an up-front cash payment, an equity interest in Ophthotech and potential future milestones and royalties. Financial details of the in-licensing agreements were not disclosed.
In preclinical studies, E10030 demonstrated the potential to regress neovascularization when used in combination with a VEGF inhibitor, Ophthotech said.
"Wet age-related macular degeneration is a huge opportunity for combination therapy," Patel said.
Anti-VEGF therapy, he said, "is still in its infancy."
"Wet AMD is very similar to cancer therapeutics where combination therapies have resulted in efficacy," Patel said. "Preclinical studies in both oncology and ophthalmology have shown that when you have a therapeutic regimen that combines and targets anti-VEGF agent with anti-PDGF agent, you get regression of the neovascularization."
Patel said that Ophthotech has recruited a stellar team of ex-Eyetech executives "who have tremendous expertise and experience in developing these molecules in a very accelerated fashion and bringing them to the marketplace for patients with these very unfortunate diseases."
In addition to Patel and Guyer, Ophthotech’s board includes former Eyetech chairman of the board Henry Simon of SV Life Sciences, Axel Bolte of HBM BioVentures, and Thomas Dyrberg of Novo A/S.
©2007. Reprinted With Permission From BioWorld® Today, Atlanta, Georgia.
Ophthotech Raises $36 Million; In-Licenses two compounds for macular degeneration
August 13, 2007Princeton, NJ - Ophthotech Corporation ("Ophthotech") today announced its Series A financing of $36 million and two in-licensing deals for compounds for macular degeneration. Ophthotech and Archemix Corp. ("Archemix") announced an exclusive, worldwide license agreement for the treatment of the wet and dry forms of Age-Related Macular Degeneration (AMD). Under the terms of the agreement, Archemix has granted Ophthotech worldwide rights to all ophthalmic uses of Archemix’s proprietary aptamers targeting the C5 component of the complement cascade. Specific terms related to the agreement have not been disclosed.
"Preclinical and human genetic linkage studies have demonstrated the significant role of complement mediated inflammation in both forms of AMD," said Samir Patel, M.D., President and Chief Executive Officer of Ophthotech. "We are excited to have the opportunity to develop and commercialize anti-C5 aptamers, derived through Archemix’s proven leadership in therapeutic aptamers. We believe that the anti-C5 aptamer blockade represents a potential breakthrough therapy for dry and wet AMD."
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) recently announced that its subsidiary, (OSI) Eyetech, Inc., has entered into an agreement with Ophthotech to divest its anti-platelet derived growth factor (PDGF) aptamer program. Under the terms of the agreement, OSI will transfer to Ophthotech all rights in the PDGF aptamer program, including rights to its pre-clinical compound E10030, in exchange for an up-front cash payment, an equity interest in Ophthotech and potential future milestones and royalties. Financial terms of the agreement have not been disclosed.
In pre-clinical studies, E10030 demonstrated the potential to regress neovascularization when used in combination with a vascular endothelial growth factor (VEGF) inhibitor. Anti-VEGF agents alone have shown the ability to slow or halt, but do not regress choroidal neovascularization. OSI elected to suspend further research on this compound in connection with its decision to divest its eye disease business. "We are pleased to transfer the development of this highly promising agent to an Ophthotech team that has the commitment to move this program forward aggressively," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals, Inc.
Dr. Patel continued, "We are excited to develop this Phase I ready anti-PDGF aptamer for AMD. Studies suggest that this compound, in combination with anti-VEGF agents, may cause regression of abnormal blood vessels in AMD. This is not observed with anti- VEGF therapy alone."
With the $36 million of financing raised in the initial round of funding, Ophthotech expects to have sufficient resources to execute its strategy. Participants in the private round include SV Life Sciences, HBM BioVentures and Novo A/S.
The lead investor, Lutz Giebel, Ph.D. of SV Life Sciences stated, "We are thrilled to invest in this all-star, ex-senior Eyetech management team that has a proven, stellar track record in accelerated drug development and commercialization of therapeutics for the back-of-the-eye."