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APRIL-MAY-JUNE 2009
Visit our website www.iris-pharma.com
 
 IN THIS ISSUE
» Retrospective Iris Pharma
   - Iris Pharma in 20 figures
   - Testimonials: Inspire & Fovea
   - Iris Pharma clients worldwide
   - Zoom on preclinical services
» News
   CIR acccreditation
   - Upcoming events
» Miscellaneous

Happy reading, enjoy your vacation and see you soon!

 RETROSPECTIVE

Iris Pharma in 20 figures

• 20 as in 20 years of expertise: Iris Pharma is a pioneering CRO in the field of ophthalmology and is considered a reference in its own sector.
 
• +14,8%: the rise in revenue reported by Iris Pharma in 2008. Our growth has been consistent since the company’s earliest days and reflects the confidence shown by our clients.
 
154: the number of clients that Iris Pharma has served to date. Iris Pharma partners pharmaceutical, biotechnology and academic organizations around the world to provide appropriate products and services at every stage of ocular drug and medical device development. Although the goal is always the same, each development program is unique. Our team of specialists is able to help you and guide you on the best way to market, whether you are experts or novices in ophthalmology, whether you have a specific project well underway or just wish to test your compounds in this promising high-growth market, like many of our new clients do.
 
• 
50: the number of highly qualified staff members at your service. A figure that is constantly on the rise. In 2008, 6 new people joined our team of experts, thereby boosting still further our product development understanding capacity. 
 
• 
7,69%: a low turnover rate in 2007. Iris Pharma has chosen to invest in its employees. By enabling our people to develop and progress on a constant basis, we have banked on motivation and the building of a long-term relationship which guarantees input from each person to the best of his or her ability.
 
• 
152: Iris Pharma has published more than 150 posters and papers in international ophthalmology meetings and journals. This reflects our commitment to and role in ophthalmologic research.
 
• 
2.5 million euros ($US 3.5 million): this is the amount invested in high technology devices now utilized by the company (RRLC-MS/MS, ApoTome, Laser Flare Meter, HRT II, HRA I, Fluorotron Master…)
 
• 
41: Iris Pharma has helped bring more than 40 ophthalmologic drugs and medical devices to market – such as Azyter® and Nyogel® – for glaucoma, dry eye, inflammation, infection and allergies.
 
• 
790: the number of audits undergone by Iris Pharma
        - 754 internal audits performed on GLP studies
        - 17 audits from clients
        - 19 audits from legal organizations: the last audit was performed by AFSSAPS (French Drug Agency) in September 2008 and Iris scored A for its capacity to manage your GLP studies
 
• 
500 femtograms: the best in class sensitivity for qualitative analyses of your compounds.
 
• 
43 animal models validated and customizable in the following therapeutic fields: angiogenesis, neurodegeneration, hypertension, allergy, inflammation, infection, corneal wound healing, diabetic retinopathy, dry eye, edema and pain. Our research department is currently working on the development and validation of additional models in the fields of hypertension, diabetic retinopathy and retinal edema.
 
• 
1,600: the number of preclinical studies performed at Iris Pharma.
 
• 
495: the number of pre-clinical efficacy studies performed at Iris Pharma
 
• 
1,400: the number of intravitreal injections performed on average each year for our customers.
 
• 
2.13 mg: the average weight of samples taken by our technicians on the retina of young mice.
For some, these figures are highly impressive, for our technicians they are a part of their everyday activity, their profession and their know-how.

 
• 
15 years of concrete expertise in ocular product clinical development. 
 
• 
84 clinical trials from Phase I to Phase IV and surveys
 
• 
13,444 patients recruited
 
• 
2,142 clinical sites
 
• 
A network of 1,100 international investigators specializing in ophthalmology.
For each type of study and each pathology, our network of experts means we can provide you with the very best specialists, a geographically very diverse choice of site, access to a huge population of volunteers and efficient, quick recruitment.


Testimonials


Logo InspireIris Pharma was instrumental in our entry into ophthalmology more than 10 years ago.  We had new compounds with novel pharmacology, but no internal experience in ophthalmology.  The responsiveness, flexibility and preclinical study advice we received from Iris Pharma helped us to reach proof of concept very quickly and their nonclinical safety work supported our first ophthalmic IND filing.  We have now worked with them on front, middle and back of the eye projects. Iris Pharma’s expertise and depth in ophthalmology makes them a perfect choice for outsourcing any ophthalmology project.
 
Ben Yerxa, PhD, Executive Vice President R&D, Inspire Pharmaceuticals, Inc.




Logo FoveaFovea Pharmaceuticals and Paris-team of Iris Pharma are now both located within the recently built Vision Institute at the 15-20 Eye Hospital. Between our two companies it is not only a matter of smooth neighborhood, we are in close collaborative relationship for the clinical development of a promising new drug for the treatment of retinal vein occlusion, a severe and blinding retinal disease.
Scientific and clinical teams have started to work together almost four years ago for the benefit of Fovea’s products developments.This long standing relationship between Fovea and Iris will hopefully translate into more drugs available for low vision patients in the near future.”
 
Pierre Belichard, COO, Fovea Pharmaceuticals, Vision Institute, Paris, France





Iris Pharma clients worldwide

Iris Pharma clients in the world

More and more of you prefer to work with Iris Pharma:
154 clients in 2009, i.e. a 15% increase in client numbers compared with 2008.

Since 1989 we have been offering ophthalmologic drug and device development services to pharmaceutical and biotechnology companies worldwide:
In 2008 we conducted 76% of our business in Europe, 20% in America, 6% with our clients based in Australasia and 1% with our Asian clients. 

Whether you are leaders, mid-size or start-up companies, experts or novices in ophthalmology, we deliver the solution and the expertise to help you develop your ocular drugs or devices:
In 2008, 59% of our clients were biotechnology firms and 41% were pharmaceutical companies. 

Iris Pharma services

Our company offers individual services and solutions or as part of an integrated program (one-stop shop solution):


Focus on Iris Pharma preclinical services

Preclinical services at Iris PharmaIn our previous newsletter, we presented our strategic consulting services and the ways in which Iris Pharma, buoyed by over 20 years of experience and one-of-a-kind expertise in ophthalmology, can guide you and effectively, intelligently and successfully help you set up and realize preclinical and clinical development programs for your ocular drugs and devices. 

Bringing new products to market is a long, difficult and costly process. It is even complex in today’s environment of capped budgets, increased refocusing on priority projects and financing that is harder to come by than ever before. Your product must be innovative, original and above all highly promising.

Meaning that the preclinical development stage is key. An obligatory phase to lay the foundations of successful development with people. Your compounds must be extensively tested and the choice of the right partner is paramount.


Cutting-edge pre-clinical studies in ophthalmology services
At Iris Pharma we know all about the importance of each stage and of each study for your project. We have already conducted over 1,600 ophthalmologic preclinical studies and we have helped bring more than 50 ophthalmologic drugs and medical devices such as Azyter® and Nyogel® to the market for glaucoma, dry eye, inflammation, infection and allergy.

We supply the necessary resources, expertise and range of services to guide and speed-up your new ocular drug discovery through the preclinical drug development process.

Our laboratories and animal husbandries are totally dedicated to ophthalmology and designed according to Iris Pharma's values and the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes; animal welfare and respect for the environment are paramount.
We own state-of-the-art apparatus such as Heidelberg Retina Tonograph 2 (HRT2), and digital slit lamps to provide high-quality, reliable and accurate data.
Our research department develops new animal models to address your specific needs and continuously lead the way.
Our highly qualified staff performs individual studies or full customized preclinical testing programs with the same objective: to ensure as effectively as possible the safety and efficacy of your products and comply with the regulatory requirements to move your drugs or devices into the clinical stage of development.

We can provide :
                        » Pilot and proof of concept studies
                        » Regulatory studies:
                                           - Ocular safety
                                           - Ocular pharmacokinetics
                        » Ocular efficacy studies


The unparalleled expertise of our histology department
The eye forms a complex organic system. Performing histological sections on such an organ is a delicate business and very different to sections made from other tissue. The difference in density from one ocular structure to another may cause acute difficulty for any person who has little experience in ocular histology. Our team has been working for 20 years on each and every structure of the eyeball – from the cornea to the optic nerve – even going so far as to observe pathological inflammatory cells in the vitreous body and aqueous humor. The reading and analysis of sections are carried out by our histopathologists specializing in animal ocular histopathology with respect for GLPs if need be.

Our histology-related activity sits very comfortably alongside the preclinical and clinical studies conducted by Iris Pharma’s various departments in order to ascertain the efficacy, toxicity or tolerability of a new therapeutic agent in keeping with statutory standards.


Endothelial cells* Biopsies
* Histological sections
* Ophthalmic Specimen Slide Preparation along with the cornea and optic nerve
* Microscopic examination of tissues
* Staining by Immunohistochemistry (IHC), Immunofluorescence and biochemistry (e.g. radioactive)
* Examination and analysis of histological slides
* Evaluation and reporting



Rat endothelial cells staining on
flatmount choroid lectine CNV model.

For more information on how we can help you, please visit our website or contact our team at info@iris-pharma.com
 NEWS

CIR accreditation
Credit impot recherche
Attractive tax measures with Iris Pharma

For almost 6 years now, Iris Pharma has worked as an organization accredited by the French Ministry of Higher Education and Research for Research Tax Credits (CIR). Our recognition procures a significant financial benefit – up to $10 million p.a. – for firms wishing to pursue their R & D work in ophthalmology with Iris Pharma.
CIR is a tax measure designed to support the R & D expenditures of firms located in France. It is calculated on the base of R & D expenditures – including those subcontracted to approved outside service providers.
The Ministry of Higher Education and Research delivers the accreditation based on the adequacy of an organization’s R & D potential. Iris Pharma can proudly point to the fact that we have been accredited this way since 2004, a token of the lasting performance of our activity.


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Visit us or meet with us at the following upcoming events:

September 12-16, 2009 : XXVII Congress of the ESCRS, Barcelona, Spain

September 30-October 3, 2009 : EVER 2009 Congress, Portoroz, Slovenia

 
November 2-4, 2009: BIO-EUROPE 2009, Vienna, Austria

 
December  3-6, 2009: 8th International Symposium on Ocular Pharmacology and Therapeutics (ISOPT), Rome, Italy

 
December 11-12, 2009: Ateliers d'Ophtalmologie Pratique (AOP), Paris, France

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  MISCELLANEOUS

Easymetros, a tool designed to help blind and visually impaired persons who travel on subway systems.
 

EasymetrosThe 108th edition of the “Concours Lépine International de Paris”, a competition founded back in 1901 with the aim of rewarding an original inventor, this year gave their award to a woman, Florence Daumas, for her invention of “Easymetros”, a tool designed to help blind and visually impaired persons who travel on subway systems.
“Easymetros” is a device that gives subway travelers vocal information. The size of a cellphone, the unit is equipped with alphabetic keys. The user enters the names of the departure and arrival stations and a voice then indicates the itinerary, the number of stations, connections and length of journey. The idea for this invention came to Florence Daumas when she was accompanying a blind friend of hers in the Paris metro: “Above all else I wanted to deliver a service. I have been working with vocal technology for almost 20 years. I focused on my knowledge in this area to come up with a technical solution.”

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For more information on Iris Pharma activities, visit www.iris-pharma.com or contact us by email at info@iris-pharma.com

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