Tous Actualités
Suivre
Abonner Novagali Pharma

Novagali Pharma

Novagali Pharma Announces FDA Clearance of IND for US Clinical Trial of Nova63035 in Patients With Diabetic Macular Edema

Evry, France (ots/PRNewswire)

- Not for Distribution in the United States, Canada or Japan
Novagali Pharma, an emerging ophthalmic pharmaceutical company
announced  today that the Company's Investigational New Drug
Application (IND) to  conduct a Phase I clinical trial of its
Nova63035, an ophthalmic injectable  emulsion based on EYEJECT(R)
technology containing a corticosteroid prodrug  for the treatment of
Diabetic Macular Edema (DME), has been granted by the  U.S. Food and
Drug Administration (FDA).
DME is a severe form of diabetic retinopathy, a common
complication of diabetes. In diabetic retinopathy, the blood vessels
in the retina are damaged and can become blocked causing
oxygen-deprivation in the retina; serious complications, such as
retinal detachment and neovascular glaucoma may then occur. The
modification of vessels can also lead to accumulation of fluid
(edema) in the central area of the retina (macula) and can damage
central vision leading to severe vision loss and even blindness.
It is forecasted that the number of patients with diabetes
worldwide will reach 215 million by 2010(1). Nearly 50% of patients
with diabetes develop some degree of diabetic retinopathy and the
risk increases with age. The only approved method for treating DME
involves laser photocoagulation therapy, which can leave irreversible
blind spots in the retina. Due to such significant limitations, there
is a need for more effective treatments. While there are no drugs yet
approved by the FDA for DME, there is clinical evidence that
corticosteroids reduce edema associated with DME (off-label ITV
injection of triamcinolone, a molecule normally used in other
indications).
Nova63035 is a unique injectable emulsion allowing the sustained
release of the prodrug over six to nine months thanks to EYEJECT(R)
technology features. The prodrug is converted into the drug by the
presence of enzymes which are present in the targeted tissues, in the
present case, retina and choroid. These enzymes are not present in
the vitreous or in the aqueous humor. This specific distribution of
the enzymes could allow for avoidance of the common corticosteroid
side effects such as the increase of the intraocular pressure
(glaucoma) and the opacification of the lens (cataract).
The FDA has agreed that Novagali may proceed with Phase I clinical
trials in the United States in patients with DME aiming to evaluate
the safety and to observe the efficacy trend of the injection of
Nova63035. The patients will be monitored for a period of twelve
months following injection.
"It is the first FDA clearance for a clinical trial with a
Novagali product addressing a retinal pathology," said Jerome
Martinez, president and CEO of Novagali Pharma. "This step is very
encouraging for the research teams that have developed this first
product candidate based on our innovative proprietary EYEJECT(R)
technology designed to allow the administration of drugs to the back
of the eye."
(1) Source: Amos A., McCarty D., and Zimmet P. "The Rising Global
Burden of Diabetes and its complications: Estimates and Projections
to the Year 2010" Diabete Med 1997, 14 S7 - 85.
The registration document (document de base) of Novagali Pharma,
registered with the French market authority (Autorité des marchés
financiers (AMF)) on July 18, 2007 under number I.07-132 and its
update (actualisation), filed with the AMF on September 12, 2007, are
available free of charge from Novagali Pharma, 1 rue Pierre Fontaine,
Bâtiment Genavenir IV, 91000 Evry, France, as well as on the AMF
website (http://www.amf-france.org)  and on the Novagali Pharma
website (http://www.novagali.com).
The public attention is drawn to the chapter 4 of the registration
document (document de base), entitled << Risk Factors >>.
This press release, the information contained herein, the
registration document (document de base) and its update
(actualisation) which is referred to, do not constitute an offer to
sell or a solicitation of an offer to buy or subscribe for shares in
Novagali Pharma in any country. No offer to sell shares in Novagali
Pharma has been made, nor will be made, prior to the official
approval by AMF of a prospectus comprising the registration document
(document de base), its update (actualisation) and an offering
prospectus (note d'opération) which will be submitted to the AMF at a
future date.
Shares of Novagali Pharma may not be sold in the United States of
America (as defined under Regulation S of the U.S. Securities Act of
1933, as amended) without registration or an exemption from
registration under the U.S. Securities Act of 1933, as amended. There
will be no registration of any public offering of Novagali Pharma
securities in the United States. This press release may not be
distributed, either directly or indirectly, in the United States and
does not constitute an offer to sell securities in the United States.
There is no offer in the United Kingdom. In the United Kingdom,
this information is directed only at investment professionals within
the meaning of Article 19(1) of the Financial Services and Markets
Act 2000 (Financial Promotion) Order 2005 of the United Kingdom (the
Order) or persons who fall within Article 49(1) of the Order, or any
other person to whom Novagali Pharma may legally transmit an
invitation or solicitation to invest under the Order.
About Novagali Pharma: http://www.novagali.com
Novagali Pharma is an emerging ophthalmic pharmaceutical company
based in the Génopôle biocluster in Evry (France), that develops
innovative products for all segments of the eye. Thanks to its
proprietary technology platforms Novasorb(R) and Eyeject(R), the
company has developed a broad pipeline of 8 innovative products
addressing main ocular conditions as well as orphan diseases. Most
advanced products include Vekacia(R), an orphan product for treatment
of vernal keratoconjunctivitis, Cationorm(R), a CE mark product for
dry eye relief, and Nova22007, a product for the treatment of
moderate-to-severe dry eye syndrome. Founded in 2000, Novagali Pharma
has 50 employees.

Contact:

Press contacts: Novagali Pharma, VP RH & Communication, Geneviève
Garrigos, +33-6-65-54-60-19, genevieve.garrigos@novagali.com; Euro
RSCG C&O Emilie Dhélens, +33-1-58-47-95-62,
emilie.dhelens@eurorscg.fr

Plus de actualités: Novagali Pharma
Plus de actualités: Novagali Pharma