Nicetile's Rx has decreased by 40% over the past year

As a result of clinical re-evaluation of ALC, one indication was deleted in July last year

Rx has decreased since the indication was reduced

Sales of 'Acetyl-L-Carnitine (ALC)', a brain function improving agent, fell sharply.

 

As a result of clinical re-evaluation, the market size has decreased by 40% in one year as indications have been reduced.

 

The market for 'Choline alfoscerate', which is predicted for clinical re-evaluation, is also expected to change depending on the results.

 

According to UBIST, a pharmaceutical research institute on the 28th, the outpatient prescription amount of ALC in the first quarter was ₩11.7 billion, a 37.9% decrease from the same period last year.

 

Dong-A ST's ALC, generic for Nicetile, is approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular diseases'.

 

However, as a result of the clinical reevaluation ordered by the MFDS in 2015, the indication was deleted in July as it was unable to prove the efficacy of the 'primary degenerative disease'.

 

Quarterly Rx amounts of ALC (Unit: ₩1 million, Source: UBIST)

Acetyl-L-Carnitine (ALC) formulations have steadily formed a market size of nearly ₩20 billion every quarter.

 

In the first quarter and the second quarter of last year, the prescription results were ₩18.9 billion and ₩17.9 billion respectively.

 

However, the scale of prescriptions has dropped significantly since the reduction of indications.

 

In the third quarter of last year, it fell 26.8% from the previous year to ₩13.5 billion, and in the fourth quarter of last year, it decreased by 38.0% compared to the previous year to ₩12.1 billion.

 

This year, This trend has accelerated.

 

It is analyzed that the prescription avoidance phenomenon has spread due to the reduction in indications according to the reevaluation results.

 

The market for ALC products has been slower since the recent spread of COVID-19.

 

In April and May last year, the prescription amounts of ALC were recorded at ₩6.5 billion and ₩6.4 billion, respectively.

 

The ALC based products had a large reduction in prescription sales amount.

 

Major ALC outpatients prescription amount (Unit: ₩ 1 million, %, Source: UBIST)

Hanmi's 'Carnitil', which is currently in the top position in the market, has a 32.8% decrease in prescription performance in the first quarter to ₩3.7 billion.

 

Dong-A ST's 'Nicetile ' decreased 29.4% from ₩2.7 billion in the first quarter of last year to ₩1.9 billion in the first quarter of this year.

 

Daewoong Bio, Samik, and Myungmoon, all of which have the highest prescriptions, have significantly reduced their prescription amounts from last year.

 

As a result of re-evaluation of the Choline alfoscerate, which has recently been decided on a clinical re-evaluation policy, such as Acetyl-L-Carnitine, it is predicted that prescription reduction will be inevitable if some indications are deleted.

 

Choline alfoscerate is a drug that has three indications: ▲secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal psychological syndrome ▲emotional and behavioral changes ▲senile pseudoplastic depression.

 

It recorded a total of ₩352.5 billion in prescriptions last year, and has established itself as a new source of revenue for pharmaceutical companies.

 

The MFDS approved an item renewal for Choline alfoscerate in 2018, but announced that it would conduct a clinical re-evaluation of Choline alfoscerate on the 23rd as the efficacy controversy continued.

 

The MFDS ordered 255 items from 134 companies to submit domestic clinical trial results.

 

When conducting a clinical trial, it was instructed to submit IND by December 23.