taiba Middle East FZ LLC announces a commercialization and distribution agreement with Insmed for ARIKAYCE® in the Countries of GCC (Kingdom of Saudi Arabia, UAE, Kuwait, Oman, Qatar, Bahrain).

taiba Middle East, a leading regional pharmaceutical company specializing in orphan and rare diseases in the region of Middle East/North Africa, announces that Insmed Netherlands BV, a subsidiary of Insmed Incorporated, a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, has granted taiba exclusive rights to market and distribute ARIKAYCE® in the Countries of Gulf Cooperation Council (Saudi Arabia, UAE, Kuwait, Oman, Qatar, Bahrain).

Under the terms of the agreement, taiba will be responsible for the named patient supply program with intent to commercialize ARIKAYCE in the region following receipt of marketing authorization(s) in the territory.

ARIKAYCE has been approved by regulatory authorities in the United States, the European Union, UK, and Japan.* It has also received Orphan Drug Designation in both Europe and the U.S., as well as Breakthrough Therapy Designation and Qualified Infectious Disease Product status in the U.S. ARIKAYCE contains the active substance amikacin.

“We are proud to collaborate with Insmed on the commercialization and distribution of ARIKAYCE for the Gulf countries,” said Saif Al Hasani, CEO of taiba Group. “ARIKAYCE availability in the region addresses, for the first time, the needs of patients with refractory MAC lung disease. Doctors will have a new approach to help manage this difficult-to-treat condition for patients who have suffered with few, or no, treatment options. Taiba focuses on providing innovative therapies to patients in the Middle East region and supporting access to rare disease therapies; our collaboration with Insmed on ARIKAYCE further enhances our orphan and rare disease distinguished portfolio.”

“We are pleased to partner with taiba to provide access to ARIKAYCE for appropriate patients in the Gulf Cooperation Council region,” said Neil Hughes, General Manager, Head of EMEA, for Insmed. “Taiba’s extensive experience in providing access to rare disease therapies in the Middle East makes it an ideal partner for Insmed as we expand our reach globally and serve patients with significant unmet needs.”

About taiba

taiba is a leading specialty marketing, sales and distribution company in the MENA region, providing innovative treatments to patients suffering from orphan and rare diseases. taiba vision is to cover the unmet medical need in its region providing high quality products and high level of service to healthcare organizations and hospitals and commitment to patient treatment. taiba focus is addressing the needs of rare disease patients and providing them access to innovative medicines either through name patients sales or through commercialization.

Over the last fifteen years taiba has earned a reputation as a regional leading company in rare diseases  and currently represents leading multinational companies pioneer in their fields such as Alnylam, Aegerion, Biomarin, Genzyme, Lucane, Veloxis, Vertex etc.

* ARIKAYCE is approved in the U.S. as ARIKAYCE® (amikacin liposome inhalation suspension) in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy; in Europe as ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis; and in Japan as ARIKAYCE® inhalation 590 mg (amikacin sulfate inhalation drug product) for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen.

REFERENCES

1. EMA approval

https://www.ema.europa.eu/en/medicines/human/EPAR/arikayce-liposomal

2. Summary of Product Characteristics - EMA (ARIKAYCE liposomal 590 mg nebuliser dispersion)

https://www.ema.europa.eu/en/documents/product-information/arikayce-liposomal-product-information_en.pdf

3. FDA approval

https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibacterial-drug-treat-serious-lung-disease-using-novel-pathway-spur-innovation#:~:text=The%20U.S.%20Food%20and%20Drug,not%20respond%20to%20conventional%20treatment%20(

4. Japan approval of ARIKAYCE Amikacin liposome inhalation suspension

https://investor.insmed.com/2021-03-23-ARIKAYCE-R-amikacin-liposome-inhalation-suspension-Approved-by-Japans-Ministry-of-Health-Labour-and-Welfare-for-the-Treatment-of-Patients-with-NTM-Lung-Disease-Caused-by-MAC-Who-Did-Not-Sufficiently-Respond-to-Prior-Treatment-with-MDR