TaiMed Biologics and AcedrA BioPharmaceuticals Partner to Commercialize Trogarzo® (Ibalizumab-uiyk) in the Middle East and North Africa Region

TAIPEI, Taiwan and RIYADH, Saudi Arabia, March 18, 2024 (GLOBE NEWSWIRE) — Taimed Biologics (“TaiMed”), a publicly held Taiwanese biotechnology company, signed an Exclusive License and Distribution Agreement with AcedrA BioPharmaceuticals (“AcedrA”), a Saudi Arabia–based company operating in Middle East and North Africa region, to satisfy the unmet medical needs, under which AcedrA will register, promote and commercialize Trogarzo® (Ibalizumab–uiyk) in the MENA region.

Trogarzo® has been approved by the United States Food and Drug Administration to treat adults infected with Human Immunodeficiency Virus type 1 (HIV–1), a virus that causes Acquired Immune Deficiency Syndrome (AIDS). Trogarzo® is given with other HIV medicines when none of the standard combinations work to control the infection because the virus is resistant to them (multi–drug resistant HIV).

“We are excited to broaden the reach of Trogarzo® to HIV patients in new countries. AcedrA has a focus on working with rare and orphan drugs, and this agreement gives us a great opportunity to enter the MENA region over a short time frame,” said Dr. Jimmy Chang, Chief Executive Officer of TaiMed. “This is yet another significant step that aims to bring shareholder value through the realization of the full commercial potential of Trogarzo®.”

Under the terms of this agreement, AcedrA will be responsible in providing Trogarzo® in reply to named–patient requests through which physicians can legally and ethically prescribe Trogarzo® for patients prior to commercial availability. AcedrA, then, by a wider array of distribution activities, will be responsible for regulatory, sales, marketing, medical, and distribution in the MENA region.

“AcedrA is responsibly engaged to serve communities where there are significant unmet therapeutic needs in the MENA region; we do believe that a synergy between AcedrA and TaiMed to make affordable the access to Trogarzo® will improve clinical outcomes for HIV patients with limited therapeutic options,” said Dr. Hosni STA, the Chief Executive Officer of AcedrA. “We are committed to be a patient–centric company working closely with healthcare providers in the MENA region, and we will be pleased to partner with TaiMed strategically to improve patients' lives in the region.”

About TaiMed Biologics: TaiMed Biologics was founded in 2007 and has devoted itself as a leading biopharmaceutical developer and manufacturer of innovative biologics drugs. TaiMed has developed a first–in–class anti–HIV antibody drug ibalizumab–uiyk (Trogarzo®) approved by the US FDA in 2018. Leveraging on the experience of developing Trogarzo® and other novel, long–acting anti–HIV monoclonal antibodies in the pipeline, TaiMed has also become a Contract Development and Manufacturing Organization (CDMO), offering manufacturing solutions that will enable partners to discover, develop, and manufacture biologics from the bench to market. For more information, please visit http://www.taimedbiologics.com.

About Trogarzo® (Ibalizumab–uiyk):

Trogarzo®, a registered trademark of TaiMed Biologics Inc., is a CD4–directed post–attachment HIV–1 inhibitor. Trogarzo® is a humanized monoclonal antibody that binds to domain 2 of CD4 on the surface of immune cells. The HIV–1 envelope glycoprotein (gp120) binds to domain 1 of CD4. Through steric hindrance, Trogarzo® blocks the steps required for viral entry without interfering in normal CD4–mediated immune functions. Trogarzo® is the first and only long–acting mAb antiviral agent against HIV–1 approved by the USFDA with a proven safety profile.

Trogarzo®, a CD4–directed post–attachment HIV–1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV–1) infection in heavily treatment–experienced adults with multidrug resistant HIV–1 infection failing their current antiretroviral regimen.

Patients and Healthcare Providers can obtain details about Trogarzo® at: www.trogarzo.com

Healthcare professionals can contact AcedrA BioPharmaceuticals to know more about the Trogarzo® Early/Special Access program by:

Telephone KSA Office: +966 11 400 0036
Telephone UAE Office: +971 4 88 55 083
Telephone Tunisia Office: +216 70 287 207
Email: medical.affairs@acedrarx.com or EAP@acedrarx.com

About AcedrA BioPharmaceuticals:

AcedrA Pharmaceutical Company (also known as AcedrA BioPharmaceuticals) is a specialized company dedicated in operating in unmet medical & commercial needs for contributing to the patient care covering the region of the Middle East & Africa from the Kingdom of Saudi Arabia. AcedrA is a Saudi company based in the capital Al Riyadh with offices in United Arab Emirates, Dubai, and Tunisia, Tunis; focused on Marketing & Distribution of Pharmaceuticals & Biotechnology of Niche Therapeutic Segments Novel Portfolios: Rare Diseases, Orphan Drugs, Haematology, Oncology, Metabolic Diseases, Genetic Disorders, Enzyme Replacement Therapies, Recombinant Technologies, Life Threatening Conditions Medicines, Neurology, Biosimilars, etc.

To know more about AcedrA BioPharmaceuticals: www.acedrarx.com or send your inquiry to: info@acedrarx.com

For Media: media@acedrarx.com

AcedrA Media Contact:

Dr. Ameera Abu Jarour
Quality & Business Support Manager
Tel: +966 11 400 0036
Email: ameera.abj@acedrarx.com
Eng. Layla Wahabi
Chief Compliance Officer
Tel: +966 11 400 0032
Email: layla.wah@acedrarx.com 

TaiMed Media Contact:

Jack Chen
Chief Financial Officer
Email: jchen@taimedbio.com


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