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MedicaSafe Announces Partnership with Amneal Pharmaceuticals

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-- MedicaSafe will combine the generic version of Suboxone® (buprenorphine and naloxone) with its smart medication systems to treat opioid dependence--

MedicaSafe, Inc. today announced a partnership with Amneal Pharmaceuticals, Inc. (NYSE:AMRX) to provide Amneal's generic version of Suboxone® (buprenorphine and naloxone) as part of MedicaSafe's data-generating medication system. This partnership provides a system aimed to deliver real-time information about the patient's medication access pattern, producing actionable information for clinicians treating opioid use disorder (OUD).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191003005211/en/

MedicaSafe Announces Partnership with Amneal Pharmaceuticals (Photo: Business Wire)

MedicaSafe Announces Partnership with Amneal Pharmaceuticals (Photo: Business Wire)

More than 2.5 million Americans suffer from OUD according to the National Institute on Drug Abuse (NIDA). Buprenorphine, the active opioid ingredient in Suboxone, is the only opioid substitute approved by the FDA for office-based treatment of OUD. However, studies have shown patients are often non-compliant with buprenorphine medications such as Suboxone and reports of illicit diversion are widespread.1 Poor compliance, whether unintentional or intentional, can reduce treatment success rates. Relapse is harmful to patients and ultimately proves costly to insurance companies and government programs.

"The MedicaSafe system enables dose-by-dose tracking of medication access," said Matt Ervin, Chief Executive Officer at MedicaSafe. "Our research with generic Suboxone indicates that providing clinicians with detailed data on medication access can allow them to adjust treatments in a targeted and timely manner."

Amneal's generic Suboxone will come pre-packaged in disposable, secure and tamper-evident MedicaSafe cartridges. A separate companion device, the MedicaSafe SmartKey, will be required to dispense an authorized dose from a cartridge. The SmartKey will then authenticate the user and consider factors such as the prescribed regimen and recent medication access before dispensing. Prescribers will be able to specify the dose access algorithm via a standard written prescription, while specialty pharmacies will handle setup and distribution.

The MedicaSafe SmartKey records each dispensation and transfers data to a cloud portal for prescriber review. Reports aim to highlight aberrant patterns for a single individual and across a patient population.

Prescribers can rule out tampering by asking patients to bring cartridges to each office visit. Dose dispensation data can be further corroborated by labs tests to confirm that doses were ingested. These approaches are consistent with current standard of care.

"We are happy to partner with the MedicaSafe team as they bring data-generating medication systems to market," said Chirag Patel, Co-CEO at Amneal Pharmaceuticals. "Clinicians dealing with opioid misuse desire new treatment approaches, and we hope a complete system like this can help prescribers treat OUD and promote successful compliance."

SAFETY INFORMATION, INCLUDING ALL WARNINGS AND PRECAUTIONS, CAN BE FOUND IN THE FULL PRESCRIBING INFORMATION ACCESSIBLE FROM THE LINK BELOW.

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=17b63f10-c9df-44be-80fa-6f1c305583b8&audience=consumer

About MedicaSafe Inc.

MedicaSafe is at the forefront of smart medication systems designed to improve clinical insight and promote patient compliance, by providing information about medication access in real-time. The company's first product, funded by the National Institutes of Health, combines buprenorphine and naloxone with novel technology to target the treatment management of opioid use disorder. As poor compliance to this medication is associated with relapse, MedicaSafe's approach aims to facilitate earlier, potentially life-saving interventions when necessary. Learn more at www.medicasafe.com.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE:AMRX), headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has an extensive portfolio of more than 300 generic medicines and is expanding its portfolio to include complex dosage forms in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding Amneal management's intentions, plans, beliefs, expectations or forecasts for the future. Words such as "may," "will," "could," "expect," "plan," "anticipate," "intend," "believe," "estimate," "assume," "continue," and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal. Such risks and uncertainties include, but are not limited to: Amneal's ability to successfully develop and commercialize new products; Amneal's ability to obtain exclusive marketing rights for Amneal's products and to introduce products on a timely basis; the competition Amneal faces in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition as well as consolidation of institutional buyers and payers on Amneal's ability to set prices; Amneal's ability to manage its growth; Amneal's dependence on the sales of a limited number of products for a substantial portion of its total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including United States federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; Amneal's reliance on certain licenses to proprietary technologies from time to time; Amneal's dependence on third party suppliers and distributors for raw materials for its products and certain finished goods; the impact of global economic conditions; Amneal's dependence on third party agreements for a portion of Amneal's product offerings; Amneal's ability to make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by Amneal's brand competitors to deter competition from Amneal's generic alternatives; and the significant amount of resources Amneal expends on research and development. A further list and descriptions of these risks, uncertainties and other factors can be found in Amneal's most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from Amneal.

Forward-looking statements included herein speak only as of the date hereof and Amneal undertakes no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Trademarks referenced herein are the property of their respective owner.

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4177012/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2453114/

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