"Recruiting a company to co-develop pitavastatin+ezetimibe"

Seung Hee Baek, Shinil Pharmaceutical's Executive Director

"We are searching for a partnering company to co-develop combination drug for treating hyperlipidemia…will make a technology transfer as well"

"Through generics co-development, we will improve profitability and share technology know-how …aim to launch the product by 2027"

Seung Hee Baek, Shinil Pharmaceutical

Shinil Pharmaceutical will collaborate with other biopharmaceutical company to co-develop a generic 'pitavastatin+ezetimibe' combination drug for treating hyperlipidemia.

 

Through joint-collaboration, Shinil Pharmaceutical plans to improve not only the contract manufacturing of medicines but also cost savings and productivity.

 

In the meantime, the company plans to teach its construction technology for active ingredients and production know-how to companies participating in joint development in addition to out-licensing.

 

"The pitavastatin+ezetimibe combination drug is set to enter the generics market in 2027," Seung Hee Baek (52), Shinil Pharmaceutical's Executive Director who is directing the co-development·out licensing project, said.

 

"We started to prepare for the current project amid searching for a new sales approach following the implementation of 1+3 bioequivalence regulation." 'pitavastatin+ezetimibe' combination drug sales are skyrocketing…Sinil has completed the bioequivalence test for its generic drug, set to enter the market The company's pitavastatin+ezetimibe combination drug for treating hyperlipidemia received approval under the name Livalozet (JW Pharmaceutical).

 

Livalozet sales are skyrocketing in the prescription market.

 

According to the pharmaceutical market research firm UBIST, Livalozet generated sales of KRW 70.4 billion in prescription sales, more than twice the previous year's growth.

 

Up to September 2024, it generated KRW 66.8 billion in sales.

 

It is expected to surpass last year's prescription record.

 

It seems that Korean pharmaceutical companies have started to show interest in these generics, as Livalozet has shown strong sales in the prescription market.

 

During 2020-2021, many generics containing pitavastatin+ezetimibe received approvals.

 

Livalozet generics are currently subjected to reconsideration.

 

When the reconsideration period ends after 2027, product launch is possible.

 

Sinil Pharmaceutical focused on pitavastatin's low statin side effects and significant treatment effects.

 

The company has already completed a bioequivalence test and is set to enter the market.

 

"The advantage of pitavastatin is that it lowers the risk of diabetes than other statin agents," Baek said.

 

"Sinil Pharmaceutical had selected the pitavastatin+ezetimibe combination as an in-house project.

 

In April 2024, the company demonstrated the bioequivalence of the drug to the control drug through a bioequivalence test." "Searching for a company to co-develop…we will make a technology transfer, including active agent designing·production know-how" Sinil Pharmaceutical will begin technology marketing based on its completed bioequivalence demonstration.

 

The company plans to secure a co-development company and make a technology transfer to the partner, including active agent designing·production know-how·how-to prepare documents for approval.

 

Baek anticipated that such a co-development·technology transfer strategy would be a win-win for both Sinil Pharmaceutical and its partnering company.

 

Baek explained that Sinil Pharmaceutical could benefit from improving its profitability by sharing the development cost.

 

A co-development company can learn various know-how during the technology transfer process.

 

In addition, a co-development company can appoint a CMO company.

 

"Sinil Pharmaceutical conducts the process of product development·approval·production in-house.

 

We can make a technology transfer of necessary technology for each stage up to launching a product," Baek emphasized.

 

"Partnering company can secure various know-how, including the production technology needed in a plant and CTD documentation for applying for approval, in addition to active ingredient designing that made Sinil Pharmaceutical successfully complete the bioequivalence test." Baek emphasized that 'timing is a key to generics development.' Baek explained that the timely development of drugs secures high drug pricing and establishment in the market.

 

Additionally, a company has to consider the cost-effectiveness of the development for an agent that is difficult to demonstrate bioequivalence.

 

"Sinil Pharmaceutical has already demonstrated a bioequivalence of its pitavastatin+ezetimibe combination," Baek emphasized.

 

"Considering cost-effectiveness, joining one of the three co-development companies will provide benefits." Changes occurred following the 1+3 bioequivalence regulatory policy…"It's our new sales strategy" Sinil Pharmaceutical strategized this approach following the 1+3 bioequivalence regulatory policy, which the government implemented in July 2021.

 

The policy requires that a bioequivalence document can be used up to three times when a manufacturing plant produces a pharmaceutical that is equivalent to one for which a pharmaceutical company conducted a bioequivalence test.

 

Only four generics can receive approval based on a single bioequivalence test.

 

After the implementation of the policy, CMO companies faced significant changes, Sinil Pharmaceutical likewise.

 

Concerns have risen in the company that profitability could be lowered because the company can appoint only three CMOs companies.

 

"Sinil Pharmaceutical has been actively developing first-generics," Baek said.

 

"After the implementation of the 1+3 policy, the company had to find a different sales approach for its CMO business." Baek explained, "Recruiting only three CMO companies can hinder development, but on the bright side, expanding to technology sales can be a win-win strategy for both CMO and consignment companies." Sinil Pharmaceutical plans to expand its business field based on the current joint development·technology transfer experience.

 

"We have tried technology transfer of previously manufactured products after the implementation of the 1+3 policy.

 

However, we had difficulty starting a business because too much information had already been shared," Baek said.

 

"For a new product, it is different.

 

We plan to pursue technology transfer sales for a new product actively."