Dr. Reddy's Laboratories enters into a licensing agreement with Slayba...
`
`https://www.businesswire.com/news/home/20220729005454/en/Dr.-Re...
`
`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 01:24 PM Eastern Daylight Time
`
`HYDERABAD, India & PRINCETON, N.J.--(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
`
`1 of 3
`
`8/22/2022, 3:17 PM
`
`Eye Therapies Exhibit 2085, 1 of 3
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Dr. Reddy's Laboratories enters into a licensing agreement with Slayba...
`https://www.businesswire.com/news/home/20220729005454/en/Dr.-Re...
`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 the management’s current views and assumptions and involve known or unknown risks and uncertainties
`that could cause actual results, performance or events to differ materially from those expressed or implied in such
`statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”,
`“expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar
`expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in
`such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit
`defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii)
`mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes
`in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or
`reorganization, 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, epidemics,
`pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties
`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.
`
`Contacts
`INVESTOR RELATIONS
`AMIT AGARWAL
`AMITA@DRREDDYS.COM
`
`MEDIA RELATIONS
`USHA IYER
`USHAIYER@DRREDDYS.COM
`
`Tweets by @drreddys
`
`#Hashtags
`
`#medicines
`
`#SlaybackPharma
`
`#licensingagreement
`
`#DrReddys
`
`#Alcon
`
`#DrReddysLaboratories
`
`#overthecounter
`
`#Pataday
`
`#pharmaceutical
`
`#eyedrop
`
`#MarcKikuchi
`
`#SlaybackPharmaLLC
`
`#PharmaceuticalServices
`
`#Lumify
`
`$Cashtags
`
`$RDY
`
`Social Media Profiles
`
`2 of 3
`
`8/22/2022, 3:17 PM
`
`Eye Therapies Exhibit 2085, 2 of 3
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`Dr. Reddy's Laboratories enters into a licensing agreement with Slayba...
`Dr. Reddy's Laboratories Ltd.
`
`https://www.businesswire.com/news/home/20220729005454/en/Dr.-Re...
`
`Dr. Reddy’s Laboratories Ltd
`
`Dr. Reddy's Laboratories
`
`Dr.Reddy's Laboratories
`
`Dr. Reddy's Laboratories
`
`3 of 3
`
`8/22/2022, 3:17 PM
`
`Eye Therapies Exhibit 2085, 3 of 3
`Slayback v. Eye Therapies - IPR2022-00142
`
`