EMCUREPHARMA TO |
one in the United States. Several of these |
INDICATION FOR |
|
RAISE RS. 300 CRORE
FROM IPO
|
facilities have approvals from various regulatory bodies, including the US FDA and the UK-
MHRA. These facilities are capable of producing
|
NOVARTIS ' EYE DRUG
LUCENTIS
|
Mumbai: Emcure Pharmaceuticals Ltd |
APIs and pharmaceutical products encompassing |
Basel: The European Commission has granted a |
( Emcure), a Rs. 1,800 crore Pune based pharma |
a wide range of dosage forms including oral |
new indication for Novartis ' Lucentis |
major, has filed a draft red herring prospectus |
solids, oral liquids, soft gelatin capsules and |
( ranibizumab) to treat patients with visual |
( the DRHP) with the Securities and Exchange |
injectables( both liquid and lyophilized). |
impairment due to choroidal neovascularization |
Board of India( SEBI) for offering of equity shares of face value Rs. 10 each for cash at a price per equity share including a share premium |
IMPAX LABS CONFIRMS
PATENT CHALLENGE
|
( CNV) secondary to pathologic myopia( myopic
CNV). This makes Lucentis, specifically designed for the eye and proven to save sight, the
|
to be determined through the book building |
RELATING TO GENERIC |
first anti-VEGF therapy licensed for four |
process. The Issue comprises a fresh issue of |
TOVIAZ |
indications in the European Union. |
equity shares aggregating up to Rs. 300 crore and |
Hayward, California: Impax Laboratories, |
Pathologic myopia often affects working-age |
an offer for sale of up to 2,513,057 equity shares |
Inc., a technology based specialty |
adults and is a major cause of vision loss |
by certain existing shareholders of the company. |
pharmaceutical company, confirmed that the |
worldwide, with one to three per cent of the |
The equity shares offered in the Issue are |
company has initiated a challenge of patents |
general population. CNV is the most common |
proposed to be listed on BSE and NSE. The book |
listed in the Orange Book in connection with |
vision-threatening complication of high myopia. |
running lead managers to the issue are DSP |
Toviaz( fesoterodinefumarate extended-release |
In patients with untreated myopic CNV the long- |
Merrill Lynch Ltd, IDFC Capital Ltd and |
tablets, 4 mg and 8 mg). |
term prognosis is poor with approximately 90 |
Morgan Stanley India Company Pvt Ltd. |
Impax filed its Abbreviated New Drug |
per cent of affected patients developing severe |
Emcure is a fast growing Indian |
Application( ANDA) containing a paragraph IV |
vision loss after five years. The resulting visual |
pharmaceutical company engaged in developing, |
certification for a generic version of Toviaz with |
loss from myopic CNV which usually affects |
manufacturing and marketing a broad range of |
the US Food & Drug Administration( FDA). |
people younger than 50 years old has a profound |
pharmaceutical products globally. Its core |
Following receipt of the notice from the FDA |
effect on productivity, financial status, career |
strength lies in in-house development and |
that Impax ' s ANDA had been accepted for filing, |
expectations, and quality of life in working-age |
manufacturing of differentiated pharmaceutical |
Impax notified the New Drug Application holder |
individuals. |
products. The company focuses its research and |
and patent owner of its paragraph IV |
According to the European label, |
development efforts on developing a portfolio of |
certification. |
treatment of myopic CNV starts with a single |
differentiated products across several platforms, |
On June 28, 2013, Pfizer Inc. and UCB |
injection. Any further injections are based on an |
including chiral molecules, biosimilars and novel |
Pharma GmbH filed suit for patent infringement |
individualized regimen. Retreatment is based on |
drug delivery systems. It commercializes its |
against Impax in the United States District Court |
vision and anatomical changes, and monitoring |
products through a combination of its own |
for the District of Delaware. This action formally |
is required monthly for the first two months and |
marketing and distribution infrastructure across |
initiated the patent challenge process under the |
then at least quarterly up to one year; in the |
geographies as well as relationships with |
Hatch-Waxman Act. |
second year monitoring is at the discretion of the |
multinational pharmaceutical companies. |
Once the ANDA is approved by the FDA, |
treating physician. |
It has a pan India marketing and |
Global Pharmaceuticals, Impax ' s generic |
RADIANCE, the Novartis-sponsored |
distribution presence with a field force of more |
division, intends to commercialize the product. |
clinical trial in patients with myopic CNV, shows |
than 4,800 personnel, as of March 31, 2013. The |
Toviaz reduces spasms of the bladder |
that Lucentis provides rapid and superior |
company has a well-diversified income base in |
muscles. Toviaz is used to treat overactive |
improvement in visual acuity compared with the |
terms of geographies, therapeutic areas and |
bladder with symptoms of urinary frequency, |
current licensed standard of care, Visudyne |
business segments within the pharmaceutical |
urgency, and incontinence. According to IMS |
( verteporfin PDT). There is an average 14-letter |
industry. The company has its own sales and |
Health( NSP), US sales of Toviaz, 4 mg and 8 |
visual acuity gain in the first year with a median |
marketing infrastructure in the United States |
mg were approximately $ 159 million for the 12 |
of 2 injections and over 60 per cent of patients in |
through its subsidiary, Heritage. |
months ended May 2013. |
RADIANCE did not need any further injections |
The company also sells its portfolio of |
Impax Laboratories, Inc.( Impax) is a technology |
after six months. |
branded generic products to the rest of world. Its |
based specialty pharmaceutical company |
" We are committed to fully understanding |
products are currently shipped to over 65 |
applying its formulation expertise and drug |
medical retina and to serving unmet patient |
countries, where it has established its presence |
delivery technology to the development of |
needs. This fourth indication for our pioneering |
by focusing on important alliances with local and |
controlled-release and specialty generics in |
ophthalmology drug, Lucentis, shows how far |
multinational companies. |
addition to the development of central nervous |
we have come since it was first launched in |
The company has subsidiaries in Brazil, |
system disorder branded products. |
2006," said Tim Wright, global head of |
Dubai, Nigeria, Singapore and South Africa and branch offices in Morocco and Russia, which play an important role in its international |
EUROPEAN
COMMISSION
|
Development, Novartis Pharmaceuticals. " We expect that the use of Lucentis will significantly change the treatment of myopic CNV, as it is the |
operations. It operates nine manufacturing |
APPROVES NEW |
first and only licensed treatment that has been |
facilities, eight of which are located in India and |
proven to restore vision in patients with visual |