The mazda pharma Guide 15th Julu - 21st july 2013 | Page 64

�PH AR M AC EU TIC AL N EW S
impairment due to myopic CNV."
Novartis provides innovative healthcare
customers and product lines with Neogen, who
Rapid visual acuity gains were achieved
solutions that address the evolving needs of
would continue the strong product development
after only a single Lucentis injection and more
patients and societies. The company also offers a
and customer service that built our business.”
than 70 per cent of patients treated with Lucentis
diversified portfolio to best meet these needs:
A Neogen spokesman indicated the
in RADIANCE experienced a reduction in CNV
innovative medicines, eye care, cost-saving
company would continue to operate from the
leakage and intraretinal edema, with central
generic pharmaceuticals, preventive vaccines
SyrVet location in Iowa through a transition
retinal thickness being significantly reduced
and diagnostic tools, over-the-counter and
period, but ultimately product engineering,
from as early as month one.
animal health products
manufacturing, and distribution would be
Lucentis has a well-established safety
NEOGEN BUYS IOWAprofile
relocated to Neogen facilities in Lansing,
and its safety profile in RADIANCE was consistent with that observed in other studies, as well as in real-world experience, and no new ocular / non-ocular safety risks were identified.
Lucentis is a humanized therapeutic antibody fragment designed to block all
BASED VETERINARY
INSTRUMENT SUPPLIER
SYRVET
Lansing, Michigan: Neogen Corporation, a company develops and markets products
Michigan, and Lexington, Kentucky. Terms of the acquisition were not disclosed.
BRECKENRIDGE
PHARMA LAUNCHES
RIZATRIPTAN BENZOATE
biologically active forms of vascular endothelial
dedicated to food and animal safety, has acquired
ORALLY
cell growth factor-A( VEGF-A). Increased levels
the assets of Iowa-based, SyrVet Incorporated, a
DISINTEGRATING
of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema
( DME) and retinal vein occlusion( RVO).
Lucentis was specifically designed for the eye, minimizing systemic exposure.
Lucentis is licensed for the treatment of wet AMD in more than 100 countries, in more than 90 countries for the treatment of visual impairment due to DME and in 90 countries for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. In many countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.
Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there
is more than 1.7 million patient-treatment years of exposure since its launch in the United States in 2006.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world.
Lucentis is a registered trademark of Genentech
Inc.
Novartis sponsors the eXcellence in
Ophthalmology Vision Award( XOVA). XOVA is an annual award launched in 2010 that provides funding to non-profit initiatives and projects that will have a positive impact on improving the quality of eye care and make a significant impact in addressing unmet needs in the fields of ophthalmology and optometry.
veterinary instrument business which has become an important supplier to farmers, ranchers, and veterinarians in more than 30 countries worldwide.
SyrVet ' s product line ranges from animal handling products to sophisticated supplies for artificial insemination, and has earned the company significant shelf space in major farm store suppliers throughout the US. The majority of the company ' s products are used in the production of food animals; however, the company ' s Horse Sense product line provides a wide array of tack products to the professional equine market.
“ The SyrVet acquisition can be viewed as a ' bolt-on ' opportunity for Neogen. The SyrVet product line will join Neogen ' s Ideal Instruments division that has supplied animal health products to the industry for over 82 years,” said Dr Jason
Lilly, Neogen ' s vice president of corporate development.“ As the trend toward larger, but fewer, food animal producers has continued, it is important for suppliers to those industries to strengthen their operations.”
Though many of SyrVet ' s products are similar to those offered by Ideal Instruments,
SyrVet has developed its own distribution system to reach dairy, pork, beef, and sheep producers.
Also, the addition of the SyrVet product line to
Neogen ' s existing veterinary instrument business broadens its product offering. Approximately 30 per cent of SyrVet ' s sales come from international markets, primarily in Mexico and
Latin America.
“ During the 27 years we were building our business, we have always had a great respect for Neogen,” said Daniel Klein, SyrVet ' s president.“ When we made the decision to exit our business it was our desire to place our
TABLETS
Boca Raton, Florida: Breckenridge
Pharmaceutical, Inc., a privately-held pharmaceutical marketing, research and development company, has launched Rizatriptan
Benzoate orally disintegrating tablets.
The US Food and Drug Administration has granted final approval for the Abbreviated New
Drug Application( ANDA) for this product on
July 1, 2013, approximately nine months prior to expiration of the paediatric-exclusivity period for the challenged Orange Book patent( April 1,
2014). Breckenridge ' s ANDA to Maxalt-MLT contained a Paragraph IV certification patent challenge, permitting launch after the 180-day exclusivity period of the first filer.
Breckenridge ' s Rizatriptan Benzoate
ODT is manufactured and supplied by
NatcoPharma Limited, the ANDA holder, and will be supplied in both 5mg and 10mg strengths. Rizatriptan Benzoate Orally
Disintegrating Tablets are AB rated to Maxalt-
MLT, a $ 200 million dollar brand drug marketed by Merck & Co., Inc. Maxalt-MLT is a prescription medicine indicated for the acute treatment of migraines. Breckenridge and Natco also launched Rizatriptan Benzoate Tablets on
December 31, 2012.
Breckenridge ' s patent challenge regarding Rizatriptan Benzoate Orally
Disintegrating Tablets is a continuing part of its larger aggressive Paragraph IV strategy commenced a few years ago. Since the beginning of 2011, Breckenridge has filed twelve
( 12) Paragraph IV patent challenges and intends to continue that trend in the next several years, focusing on niche Paragraph IV opportunities with certain barriers to entry.
64 THE MAZADA PHARMA GUIDE ●15 July- 21 July 2013