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

• FDA Approved Temixys^TM, a two-drug single-tablet antiretroviral (ARV) for HIV Treatment, will be Celltrion’s first branded product to be commercialized in 4Q 2019 through its direct-customer partnerships
• Celltrion will launch Temixys^TM at a significant discount to the price of competing products to bring cost savings to patients and payors, and affirms its commitment to provide complex therapeutics and promote better access to patients

INCHEON, South Korea–(BUSINESS WIRE)–#ARV—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.

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.

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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)

Contacts

Celltrion, Inc.

Kyungchul Park, +82 32 850 5320

kyungchul.park@celltrion.com
Or

Tae-Gyun Kim, +82 32 850 5136

Taegyun.kim@celltrion.com