Egetis and taiba rare Sign Exclusive Distribution and Early Access Agreement to Enable Named Patient Sales of Emcitate® in the Gulf Region
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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Stockholm, Sweden, October 15, 2025. Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (NASDAQ Stockholm: EGTX), today announced that the Company, through its wholly-owned subsidiary Rare Thyroid Therapeutics International AB, has entered into an exclusive distribution and early access agreement with Taiba Middle East FZ LLC (“taiba rare”) to supply Emcitate® (tiratricol), for the treatment of MCT8 deficiency, in Saudi Arabia, United Arab Emirates, Qatar, Oman, and Bahrain with the ambition to extend to other countries in the Middle East.
Nicklas Westerholm, CEO of Egetis, commented: “We are delighted to enter into this partnership with taiba rare, an ideal partner for expanding the access to Emcitate® for patients with MCT8 deficiency, with their strong track record of bringing rare and innovative medicines to patients in the Middle East. This partnership marks another important step in our commitment to ensuring patients worldwide can access Emcitate®.
“We have launched Emcitate® in the first market, Germany, on May 1, 2025, and aim to commercialize Emcitate® ourselves in EU and the US. In Japan, we have signed an exclusive license agreement for the development and commercialization of Emcitate® with Fujimoto Pharmaceuticals and recently a distribution agreement with Er-Kim for Emcitate® in Türkiye. This second distribution agreement highlights our continued focus on reaching patients with urgent unmet needs, wherever they are.”
Saif Al Hasani, CEO of taiba rare, commented: “We are proud to join forces with Egetis to introduce Emcitate® to patients affected by MCT8 deficiency throughout the Gulf Region. This strategic alliance reflects our shared dedication to advancing care for rare diseases and delivering meaningful solutions where they are needed most. Emcitate® strengthens our portfolio of transformative therapies aimed at underserved patient populations.”
For further information, please contact:
Nicklas Westerholm, CEO
+46 (0) 733 542 062
nicklas.westerholm@egetis.com
Karl Hård, Head of Investor Relations & Business Development
+46 (0) 733 011 944
karl.hard@egetis.com
About Egetis Therapeutics
Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.
The Company’s lead drug candidate Emcitate® (tiratricol) is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In February 2025 the European Commission approved Emcitate® as the first and only treatment for MCT8 deficiency in EU. Egetis initiated the launch of Emcitate® in Germany on May 1, 2025.
After a dialogue with the FDA, Egetis is conducting a randomized, placebo-controlled withdrawal study to provide evidence of T3 normalization with a correlation to a clinically meaningful outcome. The Company plans to initiate the submission of the NDA application for tiratricol in 2025.
Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation (RPDD) by the FDA, which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.
The drug candidate Aladote® (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The development program for Aladote® has been parked until Emcitate® marketing authorization submissions for MCT8 deficiency have been completed. Aladote® has been granted ODD in the US and in the EU.
Egetis Therapeutics is listed on the Nasdaq Stockholm main market (Nasdaq Stockholm: EGTX).
For more information, see www.egetis.com
About taiba rare
taiba rare is a regional leader in the marketing, distribution, and commercialization of orphan and rare disease therapies across the Middle East and North Africa (MENA). With two decades of trusted collaboration with clinicians, hospitals, and global partners.
taiba rare combines deep regional expertise with robust commercial execution—from regulatory approvals and patient access programs to strategic partnerships and long-term brand lifecycle management, the company connects healthcare systems with breakthrough treatments through early access and commercialization initiatives. Driven by a mission to close the treatment gap.
taiba rare empowers medical institutions with cutting-edge solutions and exceptional service, ensuring patients with unmet medical needs gain timely and sustainable access to life-changing therapies.
Please visit http://www.taibarare.com/