Biotech Intelligence: L2D is the first independent company offering "non-clinical development management services"; can you explain what is meant by the term "non-clinical development"?
Jonathan Kearsey, Director of Pharmacology & Business Development, L2D Services: Non-clinical development covers all preclinical development activities, but also the aspects of clinical development that do not directly relate to the treatment of patients. Once preclinical development is completed and clinical studies commence there are parallel non-clinical tasks that must be performed, these include CMC activities, but also stability studies, pharmacokinetics and completion of the toxicology profile. So, non-clinical development refers to all development activities that are not treatment related and not just to the pharmacology and toxicology package that has to be performed prior to the initiation of a first-in-man study.
Biotech Intelligence: Over the last few years there has been a significant increase in the outsourcing of R&D activities, particularly by the pharmaceutical industry, how do you see the future of non-clinical development?
Jonathan Kearsey: I think that non-clinical development activities will be out-sourced more and more by pharmaceutical companies, but also by biotechnology or biopharmaceutical companies. The need for innovative medicines is greater than ever before, but, the pharmaceutical industry and investors are looking to minimise their investment risk. One strategy is to use independent companies to perform both non-clinical and clinical activities. This allows projects to be initiated and, if required, terminated rapidly. When you take into account the attrition rate of therapeutic leads during preclinical and phase I clinical studies it becomes clear that out-sourcing these activities is a better financial option compared to the cost of using internal resources.
Twenty-five years ago clinical trial management was rarely out-sourced, yet today, no one would envisage launching a clinical study without using a clinical research organisation. This evolution, or revolution, will continue over the coming years with more companies starting to out-source their non-clinical, as well as clinical activities.
Biotech Intelligence: Companies will therefore out-source at an earlier stage, how do you see L2D Service's role in this "revolution"?
Jonathan Kearsey: I see the role of companies like L2D Services as pivotal in this process. Organisations will be looking for highly experienced and flexible development teams that can operate in this regulated international market meeting the standards defined by worldwide regulatory authorities.
As the first independent company offering such services L2D's role will be that of a pioneer, opening a new avenue towards more efficient and flexible drug development. Our proposition is to either manage the entire non-clinical development programme for the client, or provide à la carte services. We offer expertise that covers all aspects of non-clinical development management, from the design of the preclinical development plan through to the submission of regulatory dossiers to the relevant authorities. The client remains very close to the project but relies on L2D for all the operational aspects.
Biotech Intelligence: That is very interesting; however, opening a new avenue is not always easy even though I can see that this effort can be valuable to the pharmaceutical community. What type of companies do you envisage will use L2D's services?
Jonathan Kearsey: L2D's clients will include virtual companies, university spin-outs, start-up companies and small biotechnology companies who need to carry out non-clinical development, but whose number of leads is not sufficient to justify the formation of an internal development team, or whose financing runway creates difficulties in attracting experienced development staff. We also envisage that mature companies, including pharmaceutical companies, will use our services, which will provide them with additional resources and flexibility. We are also working closely with financiers who have invested in companies that are planning to start non-clinical development. We can also provide services at an earlier stage when the financier is considering an investment and requires independent evaluation of a novel therapeutic platform or product.
L2D Services is primarily aimed at the European market and we have therefore chosen to be located in Paris, for its strategic central position. However, we already have a number of American clients, who have found our services to be particularly valuable for their business transactions or development activities in Europe.
Biotech Intelligence: You are contemplating a particularly wide range of potential customers, but what do you believe are the main advantages of out-sourcing non-clinical development to L2D services, which will attract them?
Jonathan Kearsey: Out-sourcing these activities to L2D allows an immediate start since an experienced team is already in place. We provide total flexibility for the client who avoids the fixed charges of an internal team. Their financial, as well as human resources can therefore stay focused on innovation. Out-sourcing of non-clinical activities to L2D Services allows a more rapid project valorisation at lower cost and lower risk.
To the investors and shareholders a major advantage is that if a project can be initiated immediately, perhaps more importantly it can also be stopped rapidly when needed, for scientific or strategic reasons, with an overall cost that is far lower.
We offer an efficient approach to the management of non-clinical product development, by providing non-clinical development services for organisations wishing to out-source these highly specialised aspects of drug development. We allow project timelines, costs and risks to be minimised, whilst optimising pipeline progression.
Biotech Intelligence: You say that L2D is the first independent company of its kind. How are L2D's services distinct from the preclinical development services that are offered by some of the major CROs or consultants?
Jonathan Kearsey: A number of large CROs are indeed able to offer preclinical development services. However, the major disadvantage of their approach is that all the required service contracts (including pharmacology, toxicology and CMC activities) will be given to their own departments without negotiation with any competitors to identify the optimal service based on cost, quality and timing for the client. We will negotiate the best contracts for our clients, and ensure contract synchronisation and satisfactory completion. When tasks are completed we will review all documentation provided to ensure that it meets the requirements of the regulatory bodies and use these documents to complete the regulatory submission. Other CROs are able to carry out certain aspects of non-clinical development but without offering the synchronisation required between all of the service providers. Unlike us, their mission is not proactive operational management of the development programme.
Finally, there are numerous consultants with a very high level of expertise, but often in just one or two aspects of development, and they do not constitute a "development team". They provide opinions and advice but not operational project management.
Biotech Intelligence: Do you provide additional services to non-clinical development management?
Jonathan Kearsey: Yes, our experience also allows us to provide strategic and business support covering a range of key areas, such as strategic planning, drug positioning, strategic advice, in/out-licensing technical evaluations, due diligence and technical support for financing rounds and for merger-and-acquisition operations. For this as well we provide a highly flexible service and immediate access to practical expertise.
Biotech Intelligence: So you really seem to be trying to maximize the output from your accumulated experience. Who are the company founders?
Jonathan Kearsey: L2D Services has been launched by an international team of developers (British, French and Belgian) who have a proven track record of working together to advance a range of therapeutic leads into clinical development.
The company founders are myself, Jonathan Kearsey Ph.D. (Director of Pharmacology & Business Development), Vincent Dubois Ph.D. (Director of Product Development) and Jerome Quinonero Ph.D. (Director of Toxicology & Safety Pharmacology). We have a cumulated experience of more than 35 years in the biopharmaceutical industry, covering a diverse range of product types and therapeutic areas.
About L2D Services
L2D Services is headquartered in Paris (France). L2D Services is the first independent specialist of its kind in the management of the non-clinical development of therapeutics.
Website: www.L2Dservices.com
www.biotech-intelligence.com
10/01/09
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Robert Lutjens, Head of Core Biology, about Addex Pharmaceuticals' allosteric approach to non-GPCR targets
Biotech Intelligence: At Addex's recent R&D day, the company disclosed a broadening of its target discovery efforts. Could you explain the significance of this?
Robert Lütjens, Head of Core Biology, Addex Pharmaceuticals: At our R&D day in July we announced the extension of our proprietary allosteric modulation platform beyond G-protein coupled receptors (GPCRs) to a different class of receptors called Type 1 transmembrane proteins, which includes cytokine receptors like the TNF-receptor family that are implicated in rheumatoid arthritis. This is a significant advance because small molecules have not yet been developed to target these types of receptors.
Biotech Intelligence: Which other new target receptors are you addressing?
Robert Lütjens: The other new targets disclosed at our R&D day include Orexin 2 receptor, a GPCR associated with sleep disorders; adenosine A2A and interleukin-1 receptors, both involved in inflammatory disorders; and gastric inhibitor polypeptide (GIP) implicated in Type II diabetes.
Biotech Intelligence: How did the company identify its allosteric modulators and how does their unique binding mechansim make them attractive as drug candidates?
Robert Lütjens: Allosteric modulators are an emerging class of orally available small molecule therapeutic agents that we believe will have a competitive advantage over other types of drugs. This potential stems from their ability to offer greater selectivity and better modulatory control at disease mediating receptors.
Most marketed drugs bind receptors where the body's own natural molecular activators (i.e. endogenous ligands) bind, specifically to a key part of each receptor called the "active site". Allosteric modulators bind at a different (allos is Greek for "other") site than the endogenous ligand and are non-competitive because they bind receptors and modify their function even if the endogenous ligand is also binding.
Because of this mode of action, allosteric modulators aren't limited to simply turning a receptor on or off as most drugs do. Instead, they act more like a dimmer switch, offering control over the degree of receptor activation or deactivation, while allowing the body to retain its natural control over initiating receptor activation.
To identify allosteric modulator candidates, we found that typical drug screening assays were not appropriate. To target the GPCRs we were interested in, we had to develop totally new tools, as for example an assay that responds instantly and dynamically to changes in the levels of cAMP. In-house development of novel biological assays has enabled us to expand our discovery efforts beyond GPCRs.
Biotech Intelligence: Can you describe your company's approach to drug discovery from a technology point of view?
Robert Lütjens: Since 2002, we have built and integrated a unique allosteric modulator discovery and development platform. There are multiple components, including proprietary assays like our "accessory protein relocalization assay" (APRA); the ADX tags series 1 assays, measuring activation-dependent association or dissociation of binding partners, applicable to both GPCR and to non-GPCR targets; and ADX tags series 2 assays, which allow activation-dependent measurement of conformational or multimerization changes of the receptor. These assays are applicable to non-GPCR targets, like cytokine receptors, including TNF-R1.
Biotech Intelligence: Describe the therapeutic areas the company is working in and some of the products it is developing.
Robert Lütjens: Addex has chosen to focus on discovering and developing drugs for three core therapeutic areas: CNS, metabolic disorders and inflammation. However, the allosteric approach is very broadly applicable to a much wider range of therapy areas.
Our lead product ADX10059, a negative allosteric modulator (NAM) of metabotropic glutamate receptor 5 (mGluR5), is currently being investigated in phase IIb trials for gastroesophageal reflux disease (GERD) and migraine prevention.
ADX48621 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM), which may have potential in multiple indications. The lead indication for the product is Parkinson's disease levodopa induced dyskinesia, or PD-LID, for which ADX48621 has completed Phase I testing. ADX48621 is also a backup for ADX10059.
ADX71149 is a selective positive allosteric modulator (PAM) of mGluR2. The product has potential for anxiety and schizophrenia. Our partner, Ortho-McNeil-Janssen, a Johnson & Johnson company, started Phase I testing of ADX71149 in June 2009.
ADX71943 is a selective positive allosteric modulator of gamma-aminobutyric acid subtype B (GABAB) receptors. We believe this selective GABAB PAM has potential for a variety of indications, including urinary incontinence and GERD. ADX71943 is in preclinical testing and scheduled to start Phase I testing in 2010.
ADX68692 is a series of follicle stimulating hormone receptor (FSHR) negative allosteric modulators (NAM) in lead optimization. Early preclinical evidence points to potential for FSHR NAM in hormone resistant prostate cancer.
Our pipeline is completed with two programs licensed to Merck & Co in schizophrenia and Parkinson's disease.
Biotech Intelligence: What is the company's business strategy with respect to partnering and how does this complement its in-house research and development programmes?
Robert Lütjens: Ultimately, Addex aims to develop and market breakthrough products for important therapeutic indications. However, for the foreseeable future, most of the company's products will be partenered. This is because Addex believes it is best to realize the commercial opportunity for its products through partnerships with large companies that have the necessary infrastructures to develop and sell drugs for large therapeutics indications. We are open to discussions on partnering on several different levels, whether that is for multiple indications, a specific therapy area as wells as for geographical markets.
Addex has established three deals that demonstrate the value of its drug discovery capabilities.
In December 2004, we entered into a collaboration and licence agreement with Ortho-McNeil-Janssen, a Johnson & Johnson company, to discover and develop positive allosteric modulators (PAM) of metabotropic glutamate receptor 2 (mGluR2). The mGluR2 PAM approach is a clinically validated strategy in both anxiety and schizophrenia. Several series of mGluR2 PAMs have been discovered and the lead program, ADX71149, entered the clinic in mid-2009. Addex received €3 million up-front, €4.2 million in research funding and a €1 million milestone payment when ADX71149 started clinical testing.
In December 2007, Addex entered into an exclusive license and collaboration agreement with Merck & Co., Inc. affiliate Merck Sharp & Dohme to discover and develop mGluR4 PAM for Parkinson's disease. The partnership includes a number of mGluR4 PAM discovered at Addex. Merck is responsible for preclinical and clinical development. Addex received $3 million up-front and has received $750,000 after reaching the first two preclinical milestones.
In January 2008, we entered an exclusive worldwide license agreement with Merck & Co., Inc. to develop ADX63365, an orally available mGluR5 PAM with potential for treatment of schizophrenia and other undisclosed indications. The product is in late preclinical development and Merck is responsible for all future development of ADX63365 or its backups. Addex received $22 million upfront.
Biotech Intelligence: Are there any other companies working in the allosteric modulators area, and are there any competitive issues that the company faces?
Robert Lütjens: We believe we are the world leaders in allosteric modulation. Some pharma and biotech, including Novartis, AstraZeneca and GlaxoSmithKline do have individual compounds that act via this mechanism.
About Robert Lütjens, Head of Core Biology, Addex Pharmaceuticals
Dr. Lütjens joined Addex in 2002 to head up assay development for discovery and high throughput screening. Prior to that he completed a postdoctoral fellowship in the Department of Neuropharmacology at the Scripps Research Institute, in La Jolla, CA. His research focused on the cellular and molecular mechanisms of memory, and more particularly, in the mechanisms responsible for addiction to drugs of abuse. Dr Lütjens obtained his master’s degree in Biology at the Swiss Institute for Experimental Cancer Research and went on to do complete a Biology Ph.D. thesis at the Glaxo Institute for Molecular Biology in Geneva and the Institute for Cellular Biology and Morphology in Lausanne. He has an undergraduate degree in Biology from the University of Geneva, Dr. Lütjens is co-author of more than 10 research publications and co-inventor on several patents.
About Addex Pharmaceuticals
Addex Pharmaceuticals discovers and develops allosteric modulators for human health. Allosteric modulators are a different kind of orally available small molecule therapeutic agent, which is believed to offer a competitive advantage over classical drugs. Addex Pharmaceuticals' lead allosteric modulator product, ADX10059, has achieved clinical proof of concept and is in Phase IIb testing for the treatment of GERD and, separately, migraine headache. ADX10059 is a first-in-class mGluR5 inhibitor, a therapeutic strategy that also is being pursued in multiple indications by large pharma competitors.
Addex Pharmaceuticals' products and technology already have proven their value through their relationships with four of the top 10 pharmaceutical companies in the world. Specifically, under an agreement with Ortho-McNeil-Janssen Inc., a Johnson & Johnson company, ADX71149, a positive allosteric modulator (PAM) of mGluR2, is undergoing Phase I clinical testing and has potential for treatment of schizophrenia and anxiety. Under two separate agreements with Merck & Co., Inc., Addex is developing PAMs of mGluR4 and mGluR5 as drugs to treat Parkinson's disease and schizophrenia, respectively. In addition, GlaxoSmithKline and Roche have made equity investments in Addex.
Website: www.addexpharma.com
www.biotech-intelligence.com
09/16/09
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Eric Viaud, CEO, Gene Signal, on GS-101 for Corneal Graft Rejection
Biotech Intelligence
Gene Signal recently published Phase I data in the British Journal of Pharmacology (BJCP). Describe the results of the paper and why they are so important.
Eric Viaud, CEO, Gene Signal
The Phase I study published in the BJCP shows that Gene Signal's GS-101 is safe, with no signs of intolerability following administration to healthy volunteers.
New options are urgently required for the thousands of corneal graft recipients whose current treatment with immunosuppressants is not ideal due to side effects. This often leads to corneal graft rejection. These data support the continued development of GS-101 as a treatment to prevent neovascularisation (new blood growth) in the cornea, a risk factor strongly associated with corneal transplant rejection.
Biotech Intelligence
Have you disclosed any Phase II data yet?
Eric Viaud, CEO, Gene Signal
We have not yet published the Phase II data but anticipate publication in a major international journal in the near future.
Biotech Intelligence
How is GS-101 administered?
Eric Viaud, CEO, Gene Signal
GS-101 is administered topically in the form of eye drops.
Biotech Intelligence
How does GS-101 work?
Eric Viaud, CEO, Gene Signal
GS-101 is an antisense oligonucleotide that acts by blocking the production of IRS-1, a protein required for the formation and growth of new blood vessels. GS-101 is a single strand fragment of DNA that binds IRS-1 mRNA to form a duplex. The formation of this duplex, or two-stranded molecule, prevents the RNA from functioning normally and from producing the IRS-1 protein.
By blocking the expression of IRS-1 in pro-angiogenic conditions, GS-101 inhibits and regresses corneal neovascularisation. It is well documented that the risk of a corneal graft rejection rises by two-thirds from an avascular eye to a highly neovascularised one.
Biotech Intelligence
GS-101 is currently in Phase III trials. When do you anticipate data? When do you anticipate a launch?
Eric Viaud, CEO, Gene Signal
We anticipate reporting data from the Phase III trials in late 2010. If successful, GS-101 could be launched in mid 2011.
Biotech Intelligence
Why is there a need for Corneal Grafts?
Eric Viaud, CEO, Gene Signal
Corneal Transplantation is widely used to ameliorate the blinding consequences of corneal disease, which, according to the WHO, is the fourth cause of visual impairment after cataracts, age-related macular degeneration (AMD) and glaucoma in industrial countries.
Biotech Intelligence
How many cornea transplants occur each year?
Eric Viaud, CEO, Gene Signal
Over 40,000 corneal grafts are performed every year worldwide.
Biotech Intelligence
How many people suffer from corneal graft rejection?
Eric Viaud, CEO, Gene Signal
The risk of corneal graft rejection is particularly high in the presence of inflammation and corneal neovascularization. 50% of corneal graft rejections occur during the first 6 months after the operation and 65% occur less than one year after the operation. The risk of rejection is higher in the case of pre-existing neovascularization of the graft bed, which reduces the relative immune protection of the cornea .The 5 year rejection rate is currently estimated at 35%.
Biotech Intelligence
What is standard treatment to avoid graft rejection?
Eric Viaud, CEO, Gene Signal
Topical steroids are the mainstay of graft rejection management. In the high-risk situations however, systemic steroids, and other immunosuppressive drugs such as cyclosporin are of proven benefit, both for treatment and prevention of rejection. Steroid treatment does come with the risk of severe side effects in many cases.
Biotech Intelligence
What are the main side effects of current treatments?
Eric Viaud, CEO, Gene Signal
For corneal graft recipients, to avoid rejection, immunosuppressants are commonly administered. However, immunosuppressants are associated with a broad range of side effect which limits their use. Since the advent of anti-VEGF therapies for macular degeneration, their use in other eye disorders is increasing.
Studies suggest that GS-101 provides an upstream, specific blockade of pathological angiogenesis, whereas anti-VEGF based therapies such as Lucentis act more downstream and via a more complete suppression of VEGF. As VEGF is a nerve growth factor essential for survival, blocking it completely may result in some other detrimental effects, including red eye, eye pain, small speck in vision, feeling that something is in the eye and increased tears. Common non-eye side effects include nose and throat infections, headache, and respiratory and urinary tract infections.
Since VEGF is a vital growth factor therefore, achieving control of unwanted ophthalmic angiogenesis without its complete suppression may be desirable.
Biotech Intelligence
What do you estimate the market size to be for the corneal graft indication?
Eric Viaud, CEO, Gene Signal
The population of patients eligible for treatment of threatened corneal graft rejection is estimated to be approximately 46,000 patients in the European Union.
Biotech Intelligence
Could GS-101 be applicable for other indications where angiogenesis occurs?
Eric Viaud, CEO, Gene Signal
Yes, in fact we are conducting trials for other indications encompassing both orphan and non orphan indications.
Orphan Indications - Phase II trials for Neovascular Glaucoma and Retinopathy of Prematurity will start by Q4 2009 once back of the eye trials have been initiated in Q2 2009.
Non-Orphan Indications - A phase II trial is planned in 2009 in Switzerland, Germany, France, UK and Spain in indications covering the Back of the Eye - either Diabetic Retinopathy (DR) or Age Related Macular Degeneration (AMD).
Biotech Intelligence
What is the difference between neovascularization and angiogenesis?
Eric Viaud, CEO, Gene Signal
Angiogenesis is the formation of new blood vessels in the body, while neovascularisation is angiogenesis "gone wrong". Neovascularisation is abnormal growth of new blood vessels, such as in an excessive amount, or in tissue that normally does not contain them (i.e. the cornea), or of a different kind than is usual in that tissue.
Biotech Intelligence
What is your strategy for product development? Are you looking for partners?
Eric Viaud, CEO, Gene Signal
Our strategy calls for the development of orphan indications in Europe ourselves. For non orphan and/or American and Asian markets, we will be seeking partners for development and commercialization.
Biotech Intelligence
Are you concentrating on eye diseases only?
Eric Viaud, CEO, Gene Signal
No, we focus on diseases and disorders caused by pathogenic angiogenesis. This includes dermatology, vascular and oncology indications.
About Gene Signal
Gene Signal is a research and development based biotechnology company focused on discovering genes involved in the regulation of angiogenesis. Gene Signal is currently developing therapeutic solutions based on a family of antisense oligonucleotides (short DNA fragments) to conquer disease associated with significant unmet medical needs despite the advent of VEGF (Vascular Endothelial Growth Factor) based therapies.
Gene Signal is currently closing Phase II study for GS-101, its most advanced therapeutic ophthalmic solution. Gene Signal is also evaluating three other drugs in ophthalmology and in dermatology and is in the discovery phase with four more molecules addressing indications in the field of vascular disease and oncology. Seven more R&D products are in the pipeline.
Gene Signal’s discovery program leverages a patented gene discovery platform named GENE-MAAP (GENE Signal Angiogeneis, Angiostatic Platform). GENE-MAAP streamlines the identification process of genes exclusively involved in the regulation of angiogenesis and has allowed Gene Signal to identify and patent more than 94 genes involved in the angiogenic process.
Website: www.genesignal.com
www.biotech-intelligence.com
08/12/09
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Concert Pharmaceuticals CEO on GlaxoSmithKline Alliance to Develop Novel Deuterium Modified Drugs
Biotech Intelligence
Concert Pharmaceuticals recently announced a collaboration to develop and commercialize deuterium-containing medicines with GlaxoSmithKline (NYSE: GSK). What will the two companies be pursuing together through the collaboration?
President and CEO Roger Tung, Ph.D.
The deal includes three of Concert's research and development programs; namely, CTP-518, a protease inhibitor for the treatment of HIV expected to enter Phase I clinical trials in the second half of 2009, a preclinical compound with a novel mechanism of action for the treatment of chronic renal disease, and a third research product in Concert's pipeline. Concert will also provide GSK with deuterium-modified versions of three GSK pipeline compounds for GSK to develop.
Biotech Intelligence
Can you provide an overview of the financial terms?
President and CEO Roger Tung, Ph.D.
Under the terms of the agreement, Concert received $35 million in upfront payments, including a $16.7 million equity investment by GSK. Concert is eligible to receive milestones and tiered, double-digit royalties based on deuterium-containing products arising from the Concert pipeline programs. In addition, Concert is eligible to receive milestones as well as royalties on the sales of deuterium-containing products arising from the GSK pipeline compounds. Overall, Concert has the potential to receive in excess of $1 billion in total milestone and upfront payments from GSK spread across all programs. The large majority of milestone payments are associated with the Concert compounds and are mostly pre-commercial.
Biotech Intelligence
What role will each company play as you research and develop drug targets, and what will be the disposition of candidates identified through the collaboration?
President and CEO Roger Tung, Ph.D.
In addition to the two named programs, Concert and GSK will mutually agree on a third program from Concert's pipeline. For each Concert pipeline program, Concert will have responsibility for research and development activities through completion of pre-agreed proof of concept clinical trials. After the completion of such clinical trials for each program, or earlier if it chooses, GSK may elect to obtain an exclusive, worldwide license to product candidates within the program. At such time, GSK will assume responsibility for development and commercialization. Concert will retain full rights to further develop and commercialize its product candidates in any program GSK chooses not to license.
Biotech Intelligence
Why is this collaboration a good fit for Concert?
President and CEO Roger Tung, Ph.D.
GSK understands the value of our technology and we believe they are an excellent development and commercialization partner for these promising programs. For example, CTP-518 for the treatment of HIV is our lead drug candidate and will benefit from GSK's strong leadership and long-term commitment to the treatment of HIV, as evidenced by its formation of an HIV dedicated joint venture with Pfizer.
This is a transformative partnership for Concert. Not only does it add to our financial strength, but it also allows us to independently advance additional programs and recognizes the early value created in our programs. It also validates our deuterium chemistry platform and our drug discovery/ development capabilities.
Biotech Intelligence
What can we expect in the near term from the Concert-GSK collaboration?
President and CEO Roger Tung, Ph.D.
We anticipate exciting developments from the Concert-GSK collaboration. The near-term focus will be on CTP-518 which we expect to advance into clinical trials later this year. Concert and GSK are also excited about the potential of other promising compounds in the collaboration. We look forward to advancing these deuterium-modified drugs to the market and ultimately having a positive impact in treating important diseases.
Thank you
About Concert Pharmaceuticals
Founded in April 2006, Concert Pharmaceuticals is a clinical stage biotechnology company dedicated to creating new medicines through a novel scientific approach utilizing the naturally-occurring element deuterium.
Concert applies its innovative precision deuterium chemistry platform to modify specific properties of validated drug molecules, yielding a rich pipeline of new chemical entities (NCEs). Concert leverages decades of pharmaceutical experience to create novel drug candidates with potential for best-in-class efficacy and safety, while greatly reducing R&D risk, time and expense.
The Company has over 100 patent applications for new drug candidates addressing a broad range of therapeutic areas, including HIV/AIDS, renal disease, cardiovascular disease, among others. In 2009, Concert's first patents were granted by the USPTO.
In June 2009, Concert announced a strategic partnership with GlaxoSmithKline to develop and commercialize deuterium-containing drugs, including CTP-518, a protease inhibitor for the treatment of HIV.
Concert is a rapidly growing company based in Lexington, Massachusetts. The Company is led by an experienced management team and Board of Directors, and is supported by top-tier venture capitalists and leading institutional investors. Concert has raised $110 million since its inception. Concert was co-founded by Richard Aldrich, Roger Tung and Christoph Westphal.
Website: www.concertpharma.com
www.biotech-intelligence.com
07/29/09