Global orphan drug Lamzede receives GIFT designation

in Korea…a global orphan drug sold exclusively by Kwang Dong Pharmaceutical

Company signed an exclusive domestic sales and distribution contract with an Italian pharmaceutical company in July

MFDS has designated 23 GIFT drugs since the system launch

'Lamzede Inj (velmanase)’ received the Global Innovative Products on Fast Track (GIFT) designation and will receive an expedited review in Korea.

 

Lamzede is an orphan drug for which Kwang Dong Pharmaceutical signed an exclusive sales and distribution agreement with Italy's Chiesi Farmaceutical in July this year.

 

As the GIFT program seeks to shorten the review period by at least 25%, the drug could be granted within 90 working days if Kwang Dong Pharmaceutical thoroughly submits the required supplementary materials.

 

The Ministry of Food and Drug Safety recently announced that it had designated Lamzede, an enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis (AM) to receive review through the GIFT program.

 

The MFDS grants the GIFT designation and the expedited review to ▲ drugs aimed at treating serious life-threatening diseases such as cancer or rare diseases ▲ drugs aimed at preventing or treating infectious diseases that may cause serious harm to public health, such as bioterrorism infectious diseases or pandemics, ▲ new drugs developed by Korea Innovative Pharmaceutical Companies designated by the Ministry of Health and Welfare, ▲ drugs used in combination with medical devices subject to expedited review, ▲ drugs that showed clinically significant improvements in effect over existing treatments or for which no existing treatment exists.

 

Lamzede is a global orphan drug for which there are no existing therapies and was granted Priority Review (PR) by the US FDA on February 16, and was granted approval under the Marketing Authorisation Under Exceptional Circumstances (MAEC) program by the European Medicines Agency (EMA) in March 2018.

 

Kwang Dong Pharmaceutical signed an exclusive domestic sales and distribution contract with the Italy-based global pharmaceutical company Chiesi Farmaceutical in July this year.

 

Under the agreement, Kwangdong Pharmaceutical partnered with Chiesi Farmaceutici, for the exclusive sales distribution of Chiesi’s three rare disease drugs – Lamzede, Leber's neuropathy drug Raxone, and Fabry disease treatment Elfabrio – in Korea.

 

The company plans to introduce Chiesi’s diverse lineup to the Korean market through the partnership agreement.

 

In March, before partnering with Chiesi, the company had also signed an agreement with a Hong Kong opathamology drug company Zhaoke Ophthalmology to introduce the latter’s new drug candidate for pediatric myopia, 'NVK002,’ to Korea.

 

Since the commencement of the program in September last year, a total of 23 products have been designated as GIFT products until now.

 

Meanwhile, the first GIFT drug, Lunsumio (mosunetuzumab)’ has been approved in November this year.

 

Drug subject to GIFT receives various support for the rapid commercialization of its product including at least a 25% reduction in the review period (ex: 120 working days → 90 working days), support for preparing approval data, rolling review support, and opportunities for close communication between the reviewer and developer and expert consulting on regulatory affairs, etc.