Dr. Reddy's Laboratories enters into a licensing agreement with Slayback Pharma to obtain exclusive rights in the first-to-file ANDA for the private label version of Lumify® in the U.S.
July 29 2022 - 1:24PM
Business Wire
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY, along with its subsidiaries together
referred to as “Dr. Reddy’s”) today announced that it has entered
into a licensing agreement with Princeton, New Jersey based
Slayback Pharma LLC (“Slayback”), to acquire rights in Slayback’s
Brimonidine Tartrate Ophthalmic Solution 0.025%, the private label
equivalent of Lumify® in U.S. Lumify® is an over-the-counter (OTC)
eyedrop that can be used to relieve redness of the eye due to minor
eye irritations. The agreement also provides Dr. Reddy’s exclusive
rights to the product outside the U.S.
Slayback Pharma is the first company to file an ANDA for the
private label equivalent for Lumify® with the USFDA under Paragraph
IV certification. The ANDA is currently under USFDA review and
covers Brimonidine Tartrate Ophthalmic Solution 0.025% in 2.5 ml
and 7.5 ml fill volumes.
“We are pleased to license this important OTC ophthalmic product
for the U.S. market,” says Marc Kikuchi, Chief Executive Officer,
North America Generics, Dr. Reddy’s. “This product complements Dr.
Reddy’s growing OTC product portfolio in the eyecare category that
includes the private label versions of Pataday® Once Daily Relief
and Pataday® Twice Daily Relief.”
“Slayback is proud to develop this first-to-file ANDA for
Lumify®, a significant OTC product in the eye redness reliever
category, that continues to highlight the R&D capability of the
company,” said Ajay Singh, CEO and Founder of Slayback.
The value of total addressable market for this product in the
U.S. is approximately $130 million for the 52 weeks period ending
June 12, 2022.*
*IRI Data June 2022
Pataday® Once Daily Relief and Pataday® Twice Daily Relief are
trademarks of Alcon
RDY-0722-BD-OTC
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated
pharmaceutical company, committed to providing affordable and
innovative medicines for healthier lives. Dr. Reddy’s offers a
portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain
management and dermatology. Dr. Reddy’s operates in markets across
the globe. Our major markets include – USA, India, Russia & CIS
countries, and Europe. For more information, log on to:
www.drreddys.com
About Slayback: Slayback Pharma is a Princeton, NJ
headquartered, specialty pharmaceutical company focused on the
development and commercialization of complex, high-value ANDAs and
patent-protected NDAs that address meaningful unmet needs. Slayback
has 116 employees, including over 75 in R&D who are located in
its office and state-of-the-art R&D laboratory in Hyderabad,
India. In Slayback’s short history, the company has built a
differentiated, robust pipeline, while achieving consistent success
in PIV-related patent litigations and earning nine exclusivities
(seven sole first-to-files and two competitive generic
therapies).
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
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unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
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and regulations and in the policies of central banks and/or
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including related integration issues, and (vi) the susceptibility of our industry
and the markets addressed by our, and our customers’, products and
services to economic downturns as a result of natural disasters,
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identified in our public filings with the Securities and Exchange
Commission, including those listed under the “Risk Factors” and
"Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2022. The company assumes no
obligation to update any information contained herein.
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com
MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM
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