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| EDITO
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The
Iris Pharma Team are proud to bring you our first e-newsletter. This
quarterly bulletin will provide you with the latest news and
information on our thriving services company and will also give you
information on the ophthalmic world and market.
For
more information on our services and how we can assist you in
your activities,
please visit www.iris-pharma.com
or contact us (email: info@iris-pharma.com, phone: +33 493 594 959).
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| EVENTS |
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A new website for Iris Pharma
We are
pleased to announce the launch of our new website www.iris-pharma.com
More
concise, more user-friendly, and with a fresh and dynamic new look, the
new website offers visitors access to useful information on the
company, our services, activities, news and publications. Along
with enhanced navigation and usability, the new website also offers a
focus in ophthalmology and is a key portal for us to communicate Iris
Pharma's unique expertise and experience.
The website
will be regularly updated with new information and upcoming
events so make sure to visit often!
Take
a look around at http://www.iris-pharma.com now.
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Animal husbandry expansion
On
October 26, 2007, Iris Pharma announced a planned expansion of animal
housing facilities to support the steady increase in demand for our
services.
As planned, the expansion at the main facility in La Gaude, France,
began in January 2008 and was completed in October, increasing the size
of the existing facility by nearly 30% and increasing the animal
housing capacity by 46%. The new animal rooms will allow us to meet the
increasing demand for ocular preclinical studies. This is essential for
Iris Pharma to continue to guarantee, and even to improve, the high
level of flexibility, responsiveness and service quality we offer to
our clients.
Pierre-Paul Elena, President and Chief Executive Officer for Iris Pharma, said: “We
are extremely excited about the expansion of our animal housing
facility. This is the result of continuous growth over recent years and
is proof of the confidence that our sponsors have in Iris
Pharma‘s services and expertise. The decision to expand was in
keeping with our general objective: to provide our clients with the
best quality services to ensure the greatest satisfaction. With this
expansion we will ensure room availability and fast study starts to
meet our customers’ needs in the short term and into the
future.”
Like the existing animal housing facility, the new rooms will only
house small animals and are 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. As an example, the latest
generation air-conditioning system will maintain a constant temperature
and hygrometry and will ensure permanent ventilation at all
times.
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Iris
Pharma opens its new Paris premises at the Institut de la Vision, one
of Europe's major research centers dedicated to eye diseases
Sure you heard of it in the news?
This collaboration will facilitate the accelerated development of new
therapies to benefit patients with impaired vision and suffering from
ocular ailments.
Iris Pharma, the global specialist in preclinical and clinical
ophthalmic research, is cementing its partnership with the "Institut de
la Vision", with which it joined forces over a year ago. With the
official opening of this international center that occured on December
11, an R&D team from Iris Pharma is now on board, helping to
underpin the joint collaborative efforts of the academic and the
industrial teams.
These close ties constitute a first-rate acknowledgment of Iris
Pharma’s contribution, and crown almost 20 years of experience in
the field of vision-related diseases. In the words of Prof.
José-Alain Sahel, Director of the Institut de la Vision: “Our
European research center exclusively dedicated to eye diseases today
houses several academic and industrial teams specialized in the field
of vision, who wish to develop and validate their innovations relating
to therapeutic molecules, diagnostic tools and devices to improve the
daily lives of the partially sighted. This collaboration with Iris
Pharma is a major boon for the Institut de la Vision. Integrated within
an academic environment that is uncompromising where the scientific
issues are concerned, it provides us with comprehensive oversight of
the entire industry, from the major corporations to the innovative
startups, that will be so valuable for us. It is our guarantee of
maintaining a strategic approach when striking appropriate industrial
partnership deals. These kinds of partnerships are vital to the
culmination of our research when it comes to making available
treatments to patients."
Read the press release
Have a look the Vision Institute's website at http://www.fondave.org/Home-page.html?lang=en.
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| NEWS |
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Iris Pharma validates new in-vivo model
The
Iris Pharma Research Team has developed a new rat Experimental
Autoimmune Uveitis (EAU) model to add to its catalogue of animal models
of ocular inflammation for preclinical testing in the field of
ophthalmology. Experimental Autoimmune Uveitis (EAU) is an
organ-specific autoimmune disease and serves as a model of certain
ocular inflammatory pathologies in human. In this model rats develop
EAU in up to 75% of induced eyes. Treatment with oral cyclosporine A
administration totally reduced the inflammation in this model with 100%
of eyes protected; rat eyes treated with oral cyclosporine A
administration do not show any incidence of EAU.
Uveitis specifically refers to inflammation of the middle layer of the
eye, called the "uvea". This vascular layer includes the iris, the
ciliary body, and the choroid. The most common form of uveitis is
anterior uveitis, which involves inflammation in the front part of the
eye. Pars planitis is inflammation of the pars plana, a narrow area
between the iris and the choroid. Posterior uveitis affects the back
portion of the uveal tract, and involves primarily the choroid. The
inflammation causes spotty areas of scarring on the choroid and retina
that result in areas of permanent vision loss.
Destructive inflammatory diseases of the eye such as uveitis are the third leading cause of blindness worldwide.
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New
French organization gathers local experts, industries,
researchers and patients to better promote ophthalmology
Ophta
Biotech is a non-profit organization with headquarters near Nice in
France which was established in February 2008 by four co-founders: Pr
Pierre Gastaud, ophthalmologist at the Nice University Hospital and
active member of many ophthalmology organisations (including the French
Ophthalmology Society -SFO- and Retina France), Dr Loïc Lozivit,
ophthalmologist in Nice, Claude Claret, General Manager at Horus
Pharma, and Dr Pierre-Paul Elena, CEO at Iris Pharma.
Ophta
Biotech aims to unite experts in ophthalmology based in the French
Riviera, Monaco and Corsica, including doctors, industries,
researchers, patients organizations and others who have an interest in
the field. Its first mission statement is the global promotion of the
local expertise and know-how in this field. "The
French Riviera, Monaco and Corsica areas have the chance to host
everyone involved in ophthalmology, from academics and researchers to
patient associations, pharmaceutical and drug manufacturing companies,
biotechnology companies and services providers. With Ophta Biotech we
would like to combine this experience and knowledge to create and
reinforce cooperation and relationships between the companies involved
in ophthalmology", stated Pierre-Paul Elena.
Other main objectives of the organization are to formalize and
structure projects to improve development, to engage in discussions
with institutional and economic partners on a local (department,
region), national and European level and to represent associations of
patients suffering from eye diseases.
Best wishes to Ophta Biotech!
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Tox
studies: Iris
Pharma well prepared to help clients to respond to the
new regulatory frameworks
In
April 2008, Iris Pharma received accreditation from the
Interministerial Group of Chemical Products (GIPC) for the conduct of
toxicity studies according to OECD’s Principles of Good
Laboratory Practice (GLP). This award was based on the results of the
inspection carried out by the French Committee of accreditation
(COFRAC).
Iris Pharma proposes Local Lymph Node Assay LLNA in compliance with GLP
guidelines and allows you to respond to the scientific and regulatory
requirements of the REACH European regulation concerning chemicals and
their safe use which came into force on 1 June 2007.
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Agilent 6410 triple
quadrupole
LC-MS/MS: greater speed, greater sensitivity, and greater productivity to
quantify drug metabolites
Mass
spectrometry is used for the structural characterization and
pharmaceutical profiling of drug compounds. The RRLC-MS/MS (triple
quadrupole liquid chromatography/mass spectrometer) system dramatically
increases speed of analysis, sample throughput and sensitivity, all of
which are key factors in todays modern analytical labs. Indeed labs are
under greater pressure from regulatory agencies for lower detection
limits whilst at the same time facing demands to increase sample
workload and work faster.
To help solve these modern lab issues, Iris Pharma have acquired a
sophisticated new RRLC-MS/MS system: the Agilent 6410 triple quadrupole
LC-MS/MS. This purchase is in keeping with Iris Pharma’s general
objective: to strive to always offer the best in-class services to our
contractors and partners by employing experienced and well-trained
staff and using state-of-the-art apparatus. We were confident in our
purchase as the Agilent 6410 had been in use at the bioanalysis
department for one year before its acquisition.
Coupled with the Agilent 1200 series of LC modules and ZORBAX LC
columns, the RRLC enables up to 20x faster separations through the use
of high inlet pressures (up to 600 bar) in combination with short
analytical columns packed with small 1.8 µm particles. It also
provides a 500 femtogram sensitivity specification and the most
sensitive analyte detection.
To conclude, this "ultimate quantitative tool" brings the highest level
of performance and reliability to Iris Pharma labs that will provide
you with clearly superior results in bioanalysis.
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Publication
Immunochemistry
and in-situ zymography to assess matrix metalloproteinases expression
and activation by latanoprost in rat uveoscleral pathway (P.P. Elena, A. Freton, A. Spadafora (Iris Pharma, La Gaude, France); M. Lazdunski (CNRS, Sophia-Antipolis, France)).
This poster has been published at ARVO 2008 in Fort Lauderdale by the
Research Team of Iris Pharma and Pr Lazdunski from the CNRS of
Sophia-Antipolis.
Glaucoma is a wide spread disease frequently associated with
intraocular hypertension. Intraocular pressure (IOP) is regulated by
the balance between aqueous humor production and outflow. Aqueous humor
outflow routes are the trabecular pathway and the uvoscleral pathway,
where the fluid flows through intercellular spaces among ciliary muscle
fibers to the supraciliary and suprachoroidal vessels. Prostaglandin
analogues upregulate the uveoscleral pathway and are widely used to
reduce IOP. Previous studies, mainly on primates, have shown that
prostaglandin analogues induce remodeling of the extracellular matrix
of the ciliary muscle. The matrix metalloproteinases (MMP) 1, 2, 3 and
9 are involved in this process.
The purpose of the study was to evaluate the topography of expression
and activation of MMP-2 and MMP-9, the main matrix metalloproteinases
implicated in uveoscleral pathway regulation, in rat ciliary muscle
following latanoprost treatment.
The two methods used were immunohistochemistry and in situ zymography.
The results showed that latanoprost instillation increased expression
of MMP-2 and MMP-9, in rat cliliary muscle. Proteolytic activity was
also upregulated in this area after latanoprost treatment. These data
suggest that ciliary muscle could play a major role in uveoscleral
pathway in rodents as in humans and primates.
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| BACK
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Iris Pharma and
Clirophtha merger: a success
On the
11th of December 2007, Iris Pharma, a specialist Contract Research
Organisation (CRO) for pre-clinical research in ophthalmology,
announced the completion of its merger with Clirophtha, a unique CRO in
Europe and North America completely dedicated to ophthalmology clinical
trials. This merger established the first global drug-development
service provider to be totally dedicated to ophthalmology, offering a
complete range of services to biotechnology and pharmaceutical
companies worldwide.
Less than one year later, we can say the merger has been a success.
Internally, the amalgamation was just a formalization of an existing
relationship between the two CROs - they were both established within
five years of each other by Pierre-Paul Elena, who has also served as
President for the two companies and the headquarters of both companies
were in the same building. Dr Mustapha Benchaboune, ophthalmologist and
medical director at Iris Pharma, stated: "A
merger is a big step for a company in both financial and human terms.
The integration of the clinical teams went very well because the
objectives of the merger had been well understood on both sides. The
desire for integration was real and conflicts in working cultures were
non-existent."
From an external point of view, the impact of the merger for Iris
Pharma’s clients and partners was very positive and was welcomed
with enthusiasm. Indeed the complementary nature of the expertise and
services offered by both companies was immediately recognized; the
first proposal for a complete drug development process, including
preclinical and clinical research has already been received. "The role of Iris Pharma goes much further than the role of a classic CRO” says Yann Quentric, business development director for the clinical department. “We
do not simply perform preclinical studies or clinical trials. Our
global expertise and ability to see further reassures our clients.
Thanks to our background of 33-years combined experience in
ophthalmology, we have an in depth knowledge of each step in the
development of ocular drugs and medical devices. For each of our
collaborators we design a logical and customized pathway adapted to
their projects, whilst always keeping in mind the next steps and any
future constraints that could show up on the way to market."
This fully-integrated solution offered by Iris Pharma provides a smooth
transition from preclinical to clinical research and guarantees a more
efficient program and faster access to the market.
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| FOCUS |
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Azithromycin eye drop solution shows efficacy in the treatment of bacterial conjunctivitis
Various ocular studies have been performed at Iris Pharma to evaluate
the potential of azithromycin ophthalmic solution in non-clinical
disease model for the treatment of bacterial conjunctivitis.
In February 2008, Thierry Amar study director, Thierry Caillaud
business development director and Pierre-Paul Elena, CEO at Iris Pharma
published a paper in Current Eye Research (2008 Feb; 33(2):149-58)
showing good ocular pharmacokinetic results of topical administrations
of 1.50% azythromycin dihydrate solution in pigmented rabbits. These
results were promising for the expected therapeutic indication in man
(bacterial conjunctivitis).
ABSTRACT
Ocular pharmacokinetic study following single and multiple azithromycin administrations in pigmented rabbits.
PURPOSE:
The aim of this study was to investigate whether the ocular
pharmacokinetic parameters observed following systemic administration
are also seen following topical administration. METHODS:
Azithromycin concentrations were measured by HPLC-MS in pigmented
rabbits' tears, cornea, bulbar conjunctiva, and aqueous humor following
single instillation and twice-daily instillations of topical 1.50%
azithromycin dihydrate solution for three consecutive days.
RESULTS:
Following a single administration, azithromycin levels were higher than
the MIC 4 µg/g breakpoint for susceptible germs for at least 4
hrs after instillation in tears, 1 hr in conjunctiva, and 1 hr in
cornea. Following multiple administrations, azithromycin levels were
higher than the MIC 4 µg/g for at least 16 hrs after the last
instillation in tears, 24 hrs in conjunctivae, and 1 week in cornea.
CONCLUSIONS:
Both dosage regimens resulted in adequate and long-lasting azithromycin
levels in the conjunctiva, which is the ocular target tissue relative
to the expected therapeutic indication in man (bacterial
conjunctivitis), and also in the cornea and tears.
Speech of Dr Pierre-Paul Elena at ARVO 2008
Dr Pierre-Paul Elena had the pleasure of giving a speech at ARVO 2008
in Fort Lauderdale at the reception organized by Laboratoires Thea. In
this presentation he outlined the positive results obtained with an
azythromycin-based solution in pharmacokinetic studies performed at
Iris Pharma. Dr. Pierre-Paul Elena introduced the pharmacokinetic
particularities of azithromycin which were revealed during those
studies to the audience, which was composed mostly of ophthalmologists.
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Thea fights against trachoma
in Cameroon
To enable them to participate in eliminating the most prevalent
preventable infectious blinding disease, Laboratoires Thea has
developed a stable ophthalmic solution of azythromycin. These eye
drops, administered at a dose of two drops daily for 3 days, received
marketing authorization in Europe in 2007 having proven clinical
efficacy in the treatment of bacterial conjunctivitis and trachoma
during clinical trials.
Laboratoires Thea is now assessing the use of topical azythromycin in
mass treatment in an endemic area in Africa. In addition to the
provision of free treatment for more than 110,000 people over three
years, Laboratoires Thea also supports training of health workers and
development of community-based health education.
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