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Fovea Pharmaceuticals Receives Orphan Drug Designation from EC
for RdCVF for the Treatment of Retinitis Pigmentosa
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Paris, France January 7, 2008
Fovea Pharmaceuticals SA, which, last December 2007, raised $44M in a Series B financing, today announced that its product, Recombinant human rod-derived cone viability factor (rh-RdCVF), has received designation as Orphan Medicinal Product from the European Commission, following the positive opinion from the European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Orphan Medicinal Product (COMP) for the treatment of retinitis pigmentosa, a genetic disease leading to progressive loss of vision. Fovea is currently conducting pre-clinical studies of RdCVF and has demonstrated efficacy in animal model of the disease.
Orphan drug designation would entitle Fovea to exclusive marketing rights in the European countries for ten years should Fovea be the first company to receive marketing approval for this type of therapeutic drug product. In addition, the designation would allow Fovea to apply for research funding, tax credits for certain research expenses, and protocol assistance. Similar orphan drug designation is currently being assessed in the USA by the Food and Drug Administration (FDA).
"We are pleased to have received this orphan drug designation for RdCVF in the treatment of retinitis pigmentosa," said Bernard Gilly, Chairman and Chief Executive Officer of Fovea. "This designation is a recognition of the quality of our work and will also provide us with financial and regulatory benefits in addition to market exclusivity."
In a study on animal model of the disease performed at INSERM U592 in Paris (Pr. Jose Sahel s team) RdCVF was shown to improve the survival and the functionality of retinal cone cells that are responsible for central vision and that are degenerating in patients suffering from this disease. Fovea is conducting further studies to produce RdCVF and plans to start clinical trials in 2009.
About Retinitis Pigmentosa
RP is a long lasting disease that slowly evolves towards irreversible blindness. Classically in affected people, the retinal rod photoreceptors responsible for night vision and side vision slowly degenerate, first leading to night blindness. As the disorder progresses, the cone photoreceptors degenerate also and their loss is responsible of a narrowing of the peripheral field of vision which progressively worsens to become "tunnel-like". During the last phase of the disease, the central vision can decrease until the patient becomes blind.
RP usually appears in teenagers and young adults but may sometimes be present from early childhood and generally progresses over several decades. However, in extreme cases the disease may evolve rapidly over two decades. In the European Community, 150 000 patients are affected by this disorder.
RP is a genetic disorder. The inheritance pattern is variable and can be either autosomal dominant, autosomal recessive or X-linked recessive. Most genes for RP cause only a small proportion of cases, exceptions being the rhodopsin gene, which leads to about 25% of dominant RP. Overall, approximately 40% of cases of RP are due to genes that are as yet undiscovered.
About RdCVF
RdCVF (Rod derived Cone Viability Factor) is a protein that is produced by the rods and is necessary for the functionality and the survival of the cones. RdCVF was first identified by Pr. José Sahel's team at INSERM U592. The original work was published in Nature Genetics in 2004.
In RP, preventing cone cell death is a very promising therapeutic approach as vision can remain substantial in patients with 95% cone loss. This offers greater hope for a positive outcome from a strategy aimed at preserving the remaining cones in RP patients and simultaneously broadens the window for therapeutic intervention.
About FOVEA Pharmaceuticals
Fovea Pharmaceuticals SA (Fovea) is a privately-held biopharmaceutical company specialized in development and commercialization of drugs for the treatment of ocular diseases, with a special focus on retinal pathologies. Created in May 2005, Fovea has a highly experienced board and management team. Last December 2007, it raised EUR30M ($44M) in a Series B financing from a strong, international syndicate of new and existing investors led by Forbion Capital Partners (Naarden, The Netherlands). All existing institutional investors participated in the round including Sofinnova Partners, Abingworth, GIMV, The Wellcome Trust and Crédit Agricole Private Equity (CAPE).
Fovea has built a project portfolio including internal research programs on dry AMD, glaucoma (neuroprotection) and retinal dystrophies as well as clinical programs underway for such indications as macular edema, allergic conjunctivitis, and retinitis pigmentosa.
To advance the development and commercialization of its programs, FOVEA is working both independently and through collaborators including industrial partners like Novartis, Genzyme, and CombinatoRx, as well as with academic teams, like the Inserm unit U592, the Rothschild Ophthalmological Foundation, or the Johns Hopkins University.
For additional information about FOVEA and its programs, please visit
 www.fovea-pharma.com
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Fovea Pharmaceuticals Completes EUR30M Series B Financing
Top venture syndicate invests to advance expanding pipeline of products to treat ophthalmic diseases.
Paris, France December 12, 2007
Fovea Pharmaceuticals SA., a biopharmaceutical company developing novel therapeutics for the treatment of ophthalmic diseases announced today that it raised EUR30M ($44M) in a Series B financing from a strong, international syndicate of new and existing investors led by Forbion Capital Partners (Naarden, The Netherlands). All existing institutional investors participated in the round including Sofinnova Partners, Abingworth, GIMV, The Wellcome Trust and CAPE.
Fovea plans to use the proceeds from this financing to advance its clinical and preclinical pipeline and further develop its technology platform. In 2008, Fovea expects to advance its FOV1101 program for chronic allergic conjunctivitis into phase 2 clinical trials and to initiate phase 2 studies of its FOV2302 and FOV2301 programs for the treatment of respectively acute and diabetic macular edema. The company expects to bring its fourth drug candidate, FOV2501, a protein discovered by Pr Jose-Alain Sahel's team (Inserm-UPMC U 592), into clinical trials in the first half of 2009.
"We are pleased that these leading investment firms recognize the value of Fovea's well balanced pipeline and unparalleled expertise in developing these novel therapies" said Bernard GILLY, Ph.D., Chairman and Chief Executive Officer of Fovea Pharmaceuticals. "The company has made enormous progress and this financing will enable us to continue to advance our lead programs through later-stage clinical studies."
"Forbion Capital Partners invests in biopharmaceutical companies pursuing first or best in class drugs. In particular, we focus on companies with strong domain expertise and experienced management. Fovea in our view is well positioned to become a leader in the ophthalmology field. We are impressed by how quickly they have built a highly promising pipeline of products, which will be validated in the clinic using the proceeds of this financing round," said Sander Slootweg, managing partner at Forbion Capital Partners. "We are delighted to invest in Fovea Pharmaceuticals and join an experienced and proven management team along with a very strong and committed group of investors."
In connection with the financing, Sander Slootweg will join the Board of Directors which is comprised of Antoine Papiernik (Sofinnova Partners), Tim Haines (Abingworth), Anthony Wild (Bows Pharmaceuticals) and Bernard Gilly. Bernard Gilly has been elected as Chairman of the Board.
"Fovea's unique product platform has led to the generation of a robust pipeline of promising therapeutic candidates for the treatment of front and back of the eye disorders. Clinical candidates are already in development and at least three new products are expected to progress into the clinic in 2008," commented Pr. Jose-Alain Sahel, Founder of Fovea Pharmaceuticals and Chairman of the Scientific Advisory Board. "It has been a pleasure to work with the talented and productive team at Fovea, and we all look forward to continued progress in exploiting the potential of these novel dedicated therapies."
In parallel to these clinical developments, a strong discovery platform has been implemented, leading to the identification of novel targets. Fovea Pharmaceuticals has recently signed a Research Partnership Agreement with Genzyme to develop gene related therapies on the basis of one of these programs, using Fovea selected targets to treat major retinal dystrophies.
About FOVEA Pharmaceuticals
Fovea Pharmaceuticals SA (Fovea) is a privately-held biopharmaceutical company specialized in development and commercialization of drugs for the treatment of ocular diseases, with a special focus on retinal pathologies. Created in May 2005, Fovea has a highly experienced board and management team. Fovea has been funded by six leading European investors including Forbion Capital Partners, Sofinnova Partners, Abingworth Management, The Wellcome Trust, GIMV and Crédit Agricole Private Equity.
FOVEA has built a project portfolio including internal research programs on dry AMD, glaucoma (neuroprotection), retinal dystrophies as well as clinical programs underway for such indications as macular edema, allergic conjunctivitis, or retinitis pigmentosa. To advance the development and commercialization of its programs, FOVEA is working both independently and through collaborators including industrial partners like Novartis, Genzyme, CombinatoRx, as well as with academic teams, like the Inserm unit U592, the Rothschild Ophthalmological Foundation, or the Johns Hopkins University.
For additional information about FOVEA and its programs, please visit
www.fovea-pharma.com
About Forbion Capital Partners
Forbion Capital Partners invests in EU and US Life Sciences companies, developing worldclass products and technologies. The Forbion team has invested in 38 drug development and med tech companies since 2000, initially as ABN AMRO Capital Life Sciences, the venture arm of ABN AMRO Bank NV. In December of 2006 the group became independent by broadening its investor base and changing its name to Forbion Capital Partners. In recent years, the Forbion team has successfully divested from 13 portfolio companies leaving an active portfolio of 25 companies. Assets under management currently exceed €200 M.
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FOVEA Pharmaceuticals Enter into a Research Collaboration in Ophthalmology with GENZYME Corporation
Paris, France November 27, 2007
FOVEA Pharmaceuticals SA. announced today that they have entered into a Collaborative Research Agreement with GENZYME Corporation (NASDAQ: GENZ). The alliance is anchored around Fovea's proprietary high content technology platform that allows the identification of new targets involved in photoreceptor degeneration in retinal dystrophies. The companies will collaborate to develop gene related therapies using Fovea selected targets and Genzyme gene delivery technologies.
The ultimate cause of irreversible blindness in major retinal diseases is photoreceptor degeneration. According to the Foundation Fighting Blindness, rare inherited retinal dystrophies like Stargardt's Disease or Retinitis Pigmentosa are recognized as one of the most common inherited causes of blindness in people below the age of 50, affecting approximately 1.5 million people worldwide. In addition, in more common retinal disorders like the dry form of Age related Macular Degeneration, sight loss also results ultimately from photoreceptor degeneration.
In this complementary partnership, Fovea's scientific, clinical and pharmaceutical expertise in retinal diseases and Genzyme's extensive know-how in protein production and gene delivery will offer customized solutions for the understanding of the disease mechanisms, with the goal to develop new therapeutic strategies to prevent or reduce the severity of blindness.
"This first Research Partnership signed with Genzyme demonstrates the interest of our proprietary discovery platform," said Bernard Gilly, Chairman and Chief Executive Officer of FOVEA. "This collaboration underscores the substantial opportunity that our expertise in retinal diseases and unique platform provide to increase the efficiency and probability of success in ophthalmology drug discovery and development."
Pr José-Alain Sahel, Professor of Ophthalmology, co-founder of FOVEA and Chairman of the SAB, said: 'Retinal dystrophies are a major cause of vision loss. This collaborative agreement with GENZYME will allow FOVEA's discovery team to leverage its resources to develop new targets that have been identified using the technology platform and will hopefully give the opportunity to translate these discoveries into care for patients affected with blinding orphan diseases.'
About FOVEA:
Fovea Pharmaceuticals SA (Fovea) is a privately-held biopharmaceutical company specialized in development and commercialization of drugs for the treatment of ocular diseases (dry eye, age-related macular degeneration, retinitis pigmentosa, diabetic retinopathy), with a special focus on retinal pathologies. Created in May 2005, Fovea has a highly experienced board and management team. Fovea has been funded by five leading European investors led by Sofinnova Partners and including Abingworth Management, The Wellcome Trust, GIMV and Crédit Agricole Private Equity.
FOVEA has built a project portfolio including internal research programs on dry AMD, glaucoma (neuroprotection), retinal dystrophies as well as clinical programs underway for such indications as macular edema, allergic conjunctivitis, or retinitis pigmentosa.
To advance the development and commercialization of its programs, FOVEA is working both independently and through collaborators including industrial partners like Novartis, Genzyme, CombinatoRx, as well as with academic teams, like the Inserm unit U592, the Rothschild Ophthalmological Foundation, and the Johns Hopkins University.
For additional information about FOVEA and its programs, please visit
www.fovea-pharma.com
Contact at Fovea Pharmaceuticals SA
Bernard Davitian
Chief Financial Officer
+33 1 44 16 42 61
info@fovea-pharma.com
About GENZYME:
One of the world's leading biotechnology companies, GENZYME is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more 9 800 employees in locations spanning the globe and with 2006 revenues of $3.2 billion. GENZYME has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.
With many established products and services helping patients in nearly 90 countries, GENZYME is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. GENZYME's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
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FOVEA Pharmaceuticals SA Obtains Exclusive Worldwide Rights on RdCVF Protein Therapy
 English version PDF
Paris, France - January 15, 2007. – Fovea Pharmaceuticals SA (Fovea), a biopharmaceutical company developing innovative therapeutics in the field of Ophthalmology (www.fovea-pharma.com) announced today that they have signed an exclusive development and commercialization agreement with Novartis Pharma AG (Novartis) on RdCVF (“Rod derived Cone Viability Factor”), for the treatment of retinal degenerations.
RdCVF is one of the most promising new protein factors recognized for potential therapy of retinal degeneration. This factor was first identified under a research collaboration between INSERM (Paris-France) and Novartis. The RdCVF research team at Paris-based INSERM-ULP was led by Fovea co-founders, Pr José-Alain Sahel and Dr Thierry Léveillard. Through its license agreement with Novartis, Fovea will fund and conduct pre-clinical and clinical development of RdCVF up to its commercialization.
In exchange for its development efforts, Fovea received exclusive worldwide commercial rights to RdCVF protein therapy. Novartis can exercise a pre-negotiated one-time call back option, which includes an upfront payment and royalties to Fovea. Should Fovea successfully bring RdCVF to market, Novartis is eligible for development and regulatory milestone payments, as well as royalties on their sales. Additional financial terms are not released.
Pr José-Alain Sahel, Professor of Ophthalmology and co-founder of Fovea said: “This Licensing agreement with Novartis provides the team that has discovered RdCVF the opportunity to pursue work in translating its use into clinical care and patients. RdCVF has the potential to prevent cone cell death not only in Retinitis Pigmentosa, but potentially in other retinal degenerative conditions where no existing palliative or curative treatments exist”.
Retinal degenerations comprise a genetically heterogeneous group of retinal diseases very often leading to profound visual impairment or blindness, with more than one hundred causal genes identified so far. The potential of treatments employing RdCVF has applicability to different pathophysiological conditions where rod photoreceptors are initially affected and cones secondarily involved independent of the specific nature of causative mutation.
“Our mission is to develop and provide innovative products to treat ocular diseases and in particular those that affect the retina” said Bernard Gilly, President and CEO of Fovea. “This major in-licensing partnership with Novartis provides Fovea with a novel first-in-class drug that nicely complements our pipeline and contributes to further enhance the value to our shareholders. It also acknowledges Novartis’ recognition of Fovea’s Research and Development capabilities”.
RdCVF will first be developed in Retinitis Pigmentosa (RP). RP is recognized as one of the most common inherited causes of blindness in people below the age of 50, affecting 100,000 Americans, 100,000 Europeans and approximately 1.5 million people, worldwide. There is no known cure for RP. RP qualifies as an orphan disease, and represents a significant market opportunity. The development of RdCVF could also be extended to wider markets, including the highly prevalent atrophic form of Age Related Macular Degeneration (AMD).
About RdCVF and Retinal Degenerative Diseases
Based upon a clinical hypothesis, cell biology studies and using a systematic functional genomic approach Pr José-Alain Sahel, Dr Léveillard and Dr Mohand-Said and their team identified the protein RdCVF. This discovery was published in Nature Genetics (2004) and led to Pr. Sahel receiving the Foundation Fighting Blindness Trustee Award (2005) with Thierry Léveillard. Pr Sahel also was the recipient of two major awards from the French National Academy of Sciences (2005 and 2006) for his research on retinal diseases.
Loss of cones causes disabling visual loss, as cone photoreceptor cells are responsible for central vision and central acuity, as well as color vision. In RP, as in other retinal degenerations, preventing cone cell death is a meaningful and promising therapeutic approach as useful vision can be preserved, even in patients with 95% cone photoreceptor loss. Such an approach offers hope for preserving vision by protecting remaining cones in patients suffering rod damage, while simultaneously broadening the window for successful therapeutic intervention.
About Fovea Pharmaceuticals SA
Fovea Pharmaceuticals SA (Fovea) is a Paris-based biopharmaceutical company specialized in development and commercialization of drugs for the treatment of ocular diseases with a special focus on retinal pathologies. Created in May 2005, Fovea has a highly experienced board and management team, including Bernard Gilly, Chairman and CEO, Professor José-Alain Sahel, Chief Scientific Advisor, Bernard Davitian, CFO, Pierre Bélichard, COO and Barrett Katz, CMO. Fovea has been funded by five leading European investors led by Sofinnova Partners and including Abingworth Management, The Wellcome Trust, GIMV and Crédit Agricole Private Equity. Fovea raised a Series A financing round of $25 million (€20.5million) in November 2005 and has initiated last January 31st a collaboration with CombinatoRx to develop novel ophthalmic therapeutics built from synergistic drug combinations.
For further information, please visit the Fovea website at:
www.fovea-pharma.com
Contact at Fovea Pharmaceuticals SA
Bernard Davitian
Chief Financial Officer
+33 1 44 16 42 61
info@fovea-pharma.com
Press contact : EuroRSCG C&O
Marie Carole de Groc
+33 1 58 47 95 07
marie-carole.de-groc@eurorscg.fr
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Bernard Davitian, MBA, Appointed EVP & CFO of Fovea Pharmaceuticals
English version PDF
Paris, France - October 17, 2006. – Fovea Pharmaceuticals SA, a biopharmaceutical
company specializing in the discovery, development and commercialization of innovative
drugs for the treatment of ocular diseases, with special focus on retinal pathologies,
announced today it has appointed Bernard Davitian as Executive Vice-President and Chief
Financial Officer. Bernard Davitian reports to Bernard Gilly, Fovea’s Chief Executive Officer.
Bernard Davitian is the former CEO of Neurotech SA, a biopharmaceutical company that he
refocused on ophthalmology. While with Neurotech, he led the company’s Series C round
and drove the flip of the entire company from France to the USA where it is now established
near Boston. Prior to Neurotech, Bernard was SVP and CFO of Transgene SA, a French
biopharmaceutical company specialized in gene therapy and immunotherapy. At Transgene,
he was a key member of the team that developed the company and conducted its IPO in
1998 both on the NASDAQ and the French Nouveau Marché in Paris. Bernard Davitian was
earlier with Pasteur Mérieux (now Sanofi Pasteur) for almost 10 years, where he served as
Corporate CFO and was involved in a number of global strategic operations, including a key
role in the acquisition of Connaught Laboratories in 1989.
“Bernard’s extensive operational and international management experience in biotech and
finance environments makes him an excellent addition to the Fovea management team," said
Bernard Gilly, Chairman and CEO of Fovea. "His thorough understanding of the critical
strategic, tactical and compliance issues within all areas of business operations will help us
scale our business as we see our projects moving into clinical development and as we
expand beyond the pure discovery and development field."
Bernard Davitian added: “I am delighted to join Bernard Gilly and the team at Fovea
Pharmaceuticals. Strongly supported by top-tier European investors and under the scientific
leadership of Pr José-Alain Sahel, the Company is moving aggressively into development
and represents a unique opportunity to build a new major player in the ophthalmology
space.”
A Certified Public Accountant, Bernard Davitian holds a MBA from EM Lyon (France) and an
Executive MBA from Wharton. He is a Board member of DNA Therapeutics, a si DNA start
up company fighting cancer, recently spun-off from Institut Curie, CNRS, INSERM and MNHN
in Paris. |
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Gary J. Sternberg, MD, MBA, Appointed Chief Business Officer of Fovea Pharmaceuticals
English version PDF
Paris, France - September 28, 2006. – Fovea Pharmaceuticals SA, an integrated
biopharmaceutical company specialized in the discovery, development and
commercialization of novel drugs for the treatment of ocular diseases, with a special focus on
retinal pathologies, announced today the appointment of Dr Gary Jay Sternberg, MD, MBA
as Senior Vice-President and Chief Business Officer.
Gary J. Sternberg joins Dr. Barrett Katz, Executive Vice President and Chief Medical Officer,
at the New York branch of Fovea Pharmaceuticals. He will focus on Fovea’s licensing and
product acquisition strategy and will also assist Fovea to develop and market therapies
directed at diseases in the ophthalmic space.
Dr. Sternberg has accumulated over 12 years of experience in licensing, business
development, clinical research and medical practice. He held the position of Vice President,
Alliance Management and Business Development at Eyetech Pharmaceuticals (recently
acquired by OSI) prior to joining Fovea. As such, he was lead negotiator at Eyetech on all
key licensing deals over the last 3 years. Prior to this, he worked for Bristol-Myers Squibb
(BMS) and DuPont Pharmaceuticals Company in significant business development roles. He
started his career as an ophthalmologist and trained at New York’s Mount Sinai Medical
Center. Dr. Sternberg subsequently worked in private clinical practice, where he
concentrated on the treatment of general ophthalmology, cornea and external ocular
diseases.
Bernard Gilly, Chairman and CEO of Fovea, stated: “We are very happy to welcome Gary
onto our team today. His in-depth knowledge of licensing and acquisitions in ophthalmology,
combined with his ophthalmic medical experience, will effectively complement the clinical
network and expertise developed by Pr. Jose Sahel, co-founder of Fovea, and by Dr. Barrett
Katz, who recently joined Fovea and with whom Gary has already worked in close
cooperation. Gary’s skills and competence will be key for adding to Fovea’s product pipeline
and in helping advance these products from clinical trials to market.”
Gary Sternberg added: “I am very pleased to join the Fovea Pharmaceuticals team, with
whom I already had many connections. I am also excited to play an active part in helping
Fovea build a successful drug development and commercial company, with the chance to
bring novel eye drugs to patients in need.” |
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Barrett Katz, MD, MBA, Appointed EVP & CMO of Fovea Pharmaceuticals
English version PDF
Paris, France - May 2, 2006. – Fovea Pharmaceuticals SA, a biopharmaceutical company specializing in the discovery, development and commercialization of innovative drugs for the treatment of ocular diseases, with special focus on retinal pathologies, announced today it has appointed Dr. Barrett Katz, MD, MBA as Executive Vice-President and Chief Medical Officer.
Barrett Katz is a renowned Ophthalmologist, with over 25 years of experience in medical practice and academics, clinical trials and medical strategy, drug development and regulatory issues. He brings a distinguished career in neurosciences and academic Ophthalmology and Neurosciences as well as business and finance expertise to Fovea, complementing the company’s commitment to and expertise in the development and commercialization of therapies directed at diseases of the eye.
In his new role, Barrett Katz will support Fovea’s efforts to develop a diversified pipeline of products through clinical trials. His recruitment coincides with Fovea’s recently culminated collaboration with CombinatoRx (Nasdaq : CRXX) to develop novel ophthalmic therapeutics from synergistic drug combinations. This unique platform will complement Fovea’s ongoing internal discovery programs in ocular therapeutics.
Bernard Gilly, Chairman and CEO of Fovea, said: “We are very proud and excited to welcome Barrett to our team. His presence will efficiently complement the clinical network developed by Pr. Jose Sahel, co-founder and Chairman of the Scientific Advisory Board of Fovea. His outstanding reputation in the global ophthalmologic community and his experience and expertise in the field of clinical development, drug approval and product launch will be key for taking Fovea’s product candidates from clinical trials to market under the best possible conditions.”
Barrett Katz added: “I am honored and delighted to join Fovea Pharmaceuticals at this inflection point in its history, as it moves into active drug development and bringing unique products for the eye into the clinical arena.”
Dr. Barrett Katz has spent the last years as Vice President of Medical Affairs and Medical Strategy at Eyetech Pharmaceuticals, and has been integral to the team that developed Macugen™ and brought it to market. He shared in their senior leadership team, and helped manage their phase III/IV clinical protocols and trials, their publications strategic working group, and the Macugen™ steering committee alliance, as well as serving in a senior liaison position with Pfizer. Before that, he served as Professor of Ophthalmology, Neurology and Neurosurgery, and as the Chairman of the Department of Ophthalmology at The George Washington University School of Medicine, in Washington, D.C. While there he formulated and sponsored a joint fellowship in ophthalmic drug development, clinical trials, and regulatory affairs with the U.S. Food and Drug Administration.
Dr. Barrett Katz has previously held faculty and leadership positions at several prestigious medical centres, including the University of Rochester and the University of California at San Diego. He has been on the executive committee of the Optic Neuritis Treatment Trial, and has been an active participant and organizer of many multi-centre clinical trials.
A magna cum laude graduate of Colgate University, and an honors graduate of Case Western Reserve University School of Medicine, Dr. Katz first trained in Internal Medicine at Parkland Hospital in Dallas, Texas. He is fully trained as both an Ophthalmologist and a Neurologist, with a background in medical retina and neuroprotection of the central nervous system. After serving as a fellow and staff associate at the National Institutes of Health, he completed residencies in both Neurology, at Harvard Medical School, and Ophthalmology, at Tufts-New England Medical Center. He has served as a fellow at Harvard University in Boston, The National Hospital at Queen’s Square in London, and the University of California at San Francisco. He holds an M.B.A in Health Care and Finance from the University of Rochester’s Simon School of Business, is the author of over 200 publications, and the recipient of over two dozen major research grants. |
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CombinatoRx and Fovea Pharmaceuticals enter into collaboration to develop novel ophthalmic therapeutics built from synergistic drug combinations
English version PDF
January 31, 2006. – Collaboration To Leverage CombinatoRx Approach And Fovea Expertise To Provide New
Product Candidates And Commercial Territories To Both Companies
BOSTON, MA and PARIS, FRANCE – January 31, 2006 – CombinatoRx, Incorporated
(NASDAQ: CRXX) and Fovea Pharmaceuticals SA today announced a collaboration for the
potential development and commercialization of combination drugs to treat ophthalmic diseases.
The agreement unites CombinatoRx’s leadership in the systematic discovery of novel
combination drug candidates with Fovea’s drug development resources and expertise in the field
of ophthalmic therapeutics.
“Fovea is dedicated to creating the next generation of drugs to treat disorders of the eye and we
look forward to working with their development team to advance CombinatoRx’s product
candidates into the ophthalmic space,” said Alexis Borisy, President and CEO of CombinatoRx.
“This deal exemplifies the continued execution of our strategy to capture the value created by
CombinatoRx’s portfolio of product candidates and provides an innovative and financially
compelling way to mobilize into a new specialty business. In this deal we access specialty
development expertise, non-dilutive capital and retain significant product rights.”
“This exciting relationship allows us to immediately leverage our preclinical and clinical team and
scientific capabilities by seeking to create novel ophthalmic drugs built from CombinatoRx
synergistic combinations,” said Bernard Gilly, Co-Founder CEO and Chairman of Fovea. “In
addition, this deal is consistent with our strategy of building a fully integrated ophthalmology
franchise. This collaboration will result in Fovea receiving important marketing rights to anchor
our future commercial business in exchange for our development investment.”
Under the terms of the agreement, Fovea has agreed to fund and conduct pre-clinical and clinical
development of combination drug candidates it selects from the CombinatoRx portfolio, including
creating ophthalmic formulations. Fovea has agreed to develop promising combination
candidates up to the start of Phase III clinical trials. In exchange for Fovea’s development
investment, CombinatoRx will grant to Fovea exclusive commercial rights to selected products in
Europe and certain additional countries.
CombinatoRx will jointly own new intellectual property and data generated by Fovea up to Phase
III trials and retains the rights to develop and commercialize the ophthalmic products in North
America and certain other countries. The parties will have co-exclusive rights in Japan and
Taiwan. CombinatoRx and Fovea may choose to jointly pursue Phase III trials and regulatory
approval of the product candidates in preparation for launch in their respective territories.
Under the agreement, CombinatoRx will also grant to Fovea an exclusive worldwide license to
certain preclinical drug combinations to treat allergic and inflammatory diseases of the front of the
eye. For these licensed compounds, CombinatoRx is eligible to receive up to approximately $20
million in upfront and development and regulatory milestone payments for the first product
candidate successfully developed, and an additional milestone payment for the approval of a
product in an additional indication. CombinatoRx is also eligible to receive royalties for each
licensed product commercialized by Fovea.
About CombinatoRx
CombinatoRx, Incorporated is a biopharmaceutical company focused on developing new
medicines built from synergistic combinations of approved drugs, designed to attack disease on
multiple fronts. CombinatoRx applies its proprietary combination drug discovery technology to
identify new combination product candidates in a number of disease areas, including immunoinflammatory
disease, oncology, metabolic disease, neurodegenerative disease, and infectious
disease. By applying our proprietary screening technology, we have discovered and advanced
into clinical trials a portfolio of seven product candidates targeting multiple diseases. For further
information, please visit the CombinatoRx website at www.combinatorx.com
About Fovea Pharmaceuticals SA
Fovea Pharmaceuticals SA (Fovea) is a Paris-based biopharmaceutical company specialized in
development and commercialization of drugs for the treatment of ocular diseases (dry eye, agerelated
macular degeneration, retinitis pigmentosa, diabetic retinopathy), with a special focus on
retinal pathologies. Created in May 2005, Fovea has a highly experienced board and
management team, including Bernard Gilly, Chairman and CEO, Professor José-Alain Sahel,
Chief Scientific Advisor, and Pierre Bélichard, COO. Fovea has been funded by five leading
European investors led by Sofinnova Partners and including Abingworth Management, The
Wellcome Trust, GIMV and Crédit Agricole Private Equity. Fovea raised a Series A financing
round of $25 million (€20.5million) in November 2005. For further information.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 concerning CombinatoRx, its and Fovea’s plans for
research and development, the performance of CombinatoRx and fovea under the research and
license agreement, its drug discovery technology, and its collaboration strategy. These forwardlooking
statements about future expectations, plans and prospects of CombinatoRx involve
significant risks, uncertainties and assumptions, including risks related to the unproven nature of
the Company’s drug discovery technology, the Company’s and Fovea’s ability to initiate and
successfully complete clinical trials of product candidates, potential difficulty and delays in
obtaining regulatory approval for the sale and marketing of its product candidates, the Company’s
ability to obtain additional funding for its research and development, the ability of CombinatoRx
and Fovea to successfully perform under the research and license agreement and those other
risks that can be found in the "Risk Factors" section of CombinatoRx's Registration Statement on
Form S-1 on file with the Securities and Exchange Commission. No forward-looking statement
can be guaranteed and actual results may differ materially from those CombinatoRx projects. |
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Fovea Pharmaceuticals completes a €20.5 million ($25 million) Series A financing to develop new drugs for retinal diseases.
Paris, France, November 7, 2005. – Fovea Pharmaceuticals SA (Fovea), a biopharmaceutical company created in May 2005 by a team of experienced scientists and managers, announced today the closing of a €20.5 million ($ 25 million) equity financing round. The international syndicate was led by Sofinnova Partners (France) and includes Abingworth Management (UK), The Wellcome Trust (UK), GIMV (Belgium) and Crédit Agricole Private Equity (France).
Fovea is aiming at discovering, developing and commercializing innovative breakthrough drugs for the treatment of retinal diseases such as age-related macular degeneration, retinitis pigmentosa, diabetic retinopathy or macular edema. These “back-of-the-eye diseases” affect large populations of patients (over 50 million people in North America and Europe). Despite their growing incidence, mainly due to ageing populations and to the increasing incidence of diabetes, there is still no satisfactory treatment and in most cases no treatment at all for these diseases. According to recent surveys, these pathologies lead to very high levels of morbidity and account for over 50% of all cases of legal blindness in Europe and North America.
Located in Paris (France), Fovea plans to build a world-class organization bringing together experts from around the world focused on breakthrough treatments of retinal diseases. Fovea benefits from an extensive network of internationally renowned scientists and clinicians. Using its proprietary technology platform, Fovea will use the proceeds to develop a diversified pipeline of products through both (1) internal research and, (2) therapeutic switching in Ophthalmology of molecules currently developed in other indications. Its development strategy leverages the combination of world class science and a privileged access to well-designed cohorts of patients.
The Company has a strong board and management team, including Bernard Gilly, co-founder of Fovea and partner at Sofinnova Partners since 2000 who has decided to join Fovea as Chairman of the Board and Chief Executive Officer, Professor José-Alain Sahel, co-founder of Fovea and Chief Scientific Advisor, and Pierre Bélichard, co-founder and Chief Operating Officer.
Other co-founders are Serge Picaud and Thierry Léveillard, group leaders at Inserm Unit 592. In addition, Dr Elisabeth Latour, former Director of preclinical development at Novartis Ophtha Research has joined Fovea’s team.
“I am delighted to see that we have already been able to provide Fovea with the necessary means to achieve its short term objectives in terms of management, finance and science” said Bernard Gilly, Chairman and CEO. “The support of INSERM, of the National Eye Hospital des XV-XX and of The Institut de la Vision are key differentiating factors which should hopefully allow Fovea to be rapidly successful. We are very grateful to have received such a strong financial support from top-tier European investors at this early stage of development of Fovea”.
Professor Jose Sahel added: “We have a window of opportunity to create and develop Fovea. Science has evolved to a point allowing the development of innovative molecules to treat these millions of people affected with retinal degenerative disorders. We intend to attract and associate first class scientists and renowned clinicians to better serve patients expectations”.
“Fovea was seeded by Sofinnova as a result of our permanent effort towards sourcing new breakthrough technology and scientific teams” commented Antoine Papiernik, Managing Partner at Sofinnova Partners, and we are extremely pleased to lead this international syndicate of investors in order to support the future growth of Fovea”.
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Bernard Gilly, PhD, was previously VP R&D at Pasteur-Mérieux Connaught and then President and CEO of Transgene and has been involved in the management of a substantial number of start-up companies including CareX and Faust Pharmaceuticals. At Transgene, he managed the initial financing rounds as well as the dual listing of the company on the Nasdaq and the Nouveau Marché in 1998. Bernard Gilly will also bring his experience of the private equity sector, as he spent the last 5 years as Partner in the Life Sciences team at Sofinnova Partners in Paris.
Professor Sahel has been conducting pioneering research into the understanding of the pathological mechanisms involved in retinal cell degeneration. He is currently Chairman of one department of Ophthalmology at the National Eye Hospital of XV-XX and at the Rothschild Ophthalmology Foundation. He is also the director of INSERM Unit 592 and coordinates the Paris-based Clinical Investigation Centre of the National Eye Hospital of XV-XX. He is Professor at both the Pierre and Marie Curie University (Paris VI) and the University College of London. Professor Sahel recently received Awards from the US Foundation Fighting Blindness and the French Académie des Sciences, for his work on retinitis pigmentosa.
Pierre Bélichard, PhD, also co-founder of Fovea, joined the Company since inception as Chief Operating Officer. Pierre Bélichard has an extensive experience in the pharmaceutical and biotech industries both as a scientist and in business development. He was previously Licensing Director at Laboratoires Fournier, director of Business Development for Europe at Ethypharm, and more recently VP Business Development at UroGene.
About Sofinnova Partners
Founded in Paris in 1972, Sofinnova Partners is one of Europe's leading independent venture capital firms. With EUR900 million under management, Sofinnova Partners invests in start-ups and early-stage companies in information technology and life sciences. Its investment strategy consists of investing early in teams and projects with high potential, most often acting as lead or co-lead investor. Sofinnova Partners also benefits from a long-established relationship with its sister company in San Francisco, Sofinnova Ventures. Sofinnova Partners’ team consists of 10 professionals who bring valuable market insight and technical expertise to portfolio companies.
www.sofinnova.fr
About Abingworth Management
Abingworth is a long-established venture capital firm specialising in investment in life science biomedical companies. With offices in London, Cambridge (UK), Menlo Park and Boston, Abingworth is active on both sides of the Atlantic and has backed more than 90 developing life science/medical businesses. The majority of these have gone on to public offerings or have merged or been acquired. Abingworth has funds under management of over $750 million. www.abingworth.com
About The Wellcome Trust
The Wellcome Trust is the second-largest medical research charity in the world, with assets over 11 billion GBP managed by the Investments Division. The Direct Investment Fund is part of The Wellcome Trust's Investments Division and provides equity financing to early-stage companies in the life sciences industry. The Wellcome Trust is an active investor, using its broad scientific and financial network to help build its portfolio companies in the US and Europe. Direct Investments has participated in the success of numerous life sciences companies since 1993.
www.wellcome.ac.uk
About GIMV
Since its incorporation in 1980, GIMV has grown into Belgium's most important venture capital provider and company-builder. GIMV has now become a major European and international market player. Both in Belgium and abroad, GIMV invests in information and communication technology, life sciences as well as in growth financing and management buy-outs (MBOs) of companies in more traditional sectors. With its own portfolio and third party fund activities together, GIMV managed more than EUR1.2 billion at the end of 2004. Today, the net asset value of GIMV's portfolio amounts to about 1 billion euros. GIMV has been listed on Euronext Brussels since 1997.
www.gimv.com
About Crédit Agricole Private Equity
Crédit Agricole Private Equity is the asset management company of Crédit Agricole SA, dedicated to private equity investments in unlisted companies. 30 professionals specialising in four activity segments (Expansion, Capital & LBO, Venture Capital, Secondary Market Mezzanine) manage €1.3 billion under French private equity mutual funds (FCPR and FCPI) and private equity companies (SCR). Crédit Agricole Private Equity advises business managers in their growth plans.
www.ca-privateequity.fr
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