Celltrion to Launch TemixysTM Double Combination Once-Daily Tablet for HIV Treatment in the U.S.

INCHEON, South Korea

Celltrion (KRX:068270) announced that it is launching Temixys^TM in the U.S. which were approved in November by U.S. Food and Drug Administration (FDA). Celltrion anticipates Temixys to be available in the next coming weeks.

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Celltrion’s Temixys (Photo: Business Wire)

Temixys^TM (lamivudine and tenofovir disoproxil fumarate) 300mg/300mg is a once-daily combination of two nucleoside reverse transcriptase inhibitors, indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg (Temixys^TM USPI 2018).

Celltrion plans to supply Temixys^TM at a significantly discounted and competitive wholesale acquisition cost (WAC) price to any other tenofovir-based double combination product on the U.S. market today. Celltrion’s subsidiary, Celltrion USA, Inc located in New Jersey will focus on the direct distribution and promoting market access to expand HIV treatment options and accessibility for patients. On September 26^th, 2019 – Celltrion USA held its first seminar for HIV physicians in New York to help educate physicians about the treatment guidelines and availability of Temixys^TM. Celltrion USA will continue to expand its marketing efforts and commitment to support the physicians, payors, and patients, in the U.S. where approximately 1.1 million HIV-positive patients^[1] are heavily burdened from medical expenses. Over the next week, Celltrion USA hold additional research conferences, seminars, and bringing awareness to the HIV burdened states across the nation.

To support medication adherence, Celltrion is launching “TuneUpTogether“, a mobile application available both on the Google Play Store and Apple Store, specifically for Temixys^TM to enhance understanding of the tablet to HIV-positive patients and medical related personnel.

Temixys^TM represents Celltrion’s commitment in its pursuit to promote access to complex therapeutic medications. Additional products are currently under development and Celltrion hopes to expand the treatment options to physicians and patients in their quality standard of care.

Forward-looking statement disclaimer

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”, “hope”, “is considering” the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion’s management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

About Celltrion, Inc

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in the research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA^® and Remsima^®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.

[1] 2018.11. EXPRESS SCRIPTS HIV REPORT (https://lab.express-scripts.com/lab/publications/viral-signs-understanding-hiv-medication-use)

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