Many companies apply for a patent challenge for Otezla

Daewoong, Donga & Chong Kun Dang, etc.

As a blockbuster drug with about ₩2 trillion in overseas sales, its marketability is sufficient

Korean pharmaceutical companies' patent challenges are continuing on new psoriasis treatments that are not released in Korea due to the failure to apply insurance benefits.

 

Otezla (Apremilast), which was approved in 2017 as a treatment for psoriasis and psoriatic arthritis in Korea, has recently received a patent challenge from domestic companies such as Daewoong.

 

In particular, Otezla is not released in Korea, but is recognized for its marketability overseas.

 

According to the industry on the 9th, Dongkoo Bio & Pharma filed a trial for a passive confirmation of the scope of rights for the patents of Otezla's use (expired on March 20, 2023) on the 8th and formulation (December 26, 2032) registered on the MFDS patent list.

 

It started a procedure to evade a patent for generic drugs.

 

Since Daewoong requested the first patent trial on the 29th of last month, four companies, including Dong-A ST, Chong Kun Dang, and Dongkoo Bio & Pharma, began to challenge the patent.

 

Otezla is a drug that Celgene was approved in Korea in November 2017.

 

As Amgen acquired the drug for $13.4 billion in August last year, it also acquired domestic copyright.

 

Otezla is a prescription medicine approved for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate and for the treatment of adult patients with active psoriatic arthritis.

 

In Korea, after approval, they tried to raise benefits, but the agreement failed due to differences of opinion between the company and the insurance authorities.

 

Insurance authorities judged that Otezla was not cost-effective due to its high price compared to other drugs in psoriasis, and suggested less than the amount converted to the average price of alternative drugs, but importers and sellers did not accept this.

 

It was not officially released in Korea after the reimbursement failure.

 

However, in the global market, it is active as a blockbuster with annual sales of about ₩2 trillion.

 

According to ESTEEM 1 and 2 studies in plate-shaped psoriasis patients (about 1250 patients), Otezla, a new family that specifically acts on intracellular cyclic AMP (cAMP) concentration, 33.1% of patients 16 weeks after taking the drug PASI 75 (75% decrease in PASI score) was reached, showing a significant improvement compared to the placebo group (5.3%).

 

Moreover, it is evaluated as a drug that improves the life and quality of patients by improving symptoms of itchy nails, scalp, and itching, which are difficult to treat.

 

Psoriasis treatments that were compared before insurance benefits as Enbrel records annual sales of over ₩10 billion (based on IQVIA), it is expected to guarantee high performance if reimbursement is carried out in Korea.

 

Moreover, it is an oral medication unlike Enbrel.

 

However, even if generic drugs have surpassed their patents, it is difficult to launch a product within a short period of time as new drugs still have reexamination.

 

This is because Otezla's PMS remains on November 19, 2023, with about three more years left.

 

It is expected that more domestic pharmaceutical companies will participate in the drug market.