AZ and SK's Sidapvia is approved, first collab in 10 yrs

first collaboration made between a domestic pharmaceutical company and a multinational pharmaceutical company in 10 years

‘Sidapvia,’ which was jointly developed by AZ and SK Chemicals, is approved

Combined the original Forxiga and No.1 DPP-4 inhibitor ingredient...increases line-up

Past Hanmi-Sanofi collaborated ‘Rovelito’ a success... posts sales of KRW 78 billion

The first collaboration between a domestic company and big pharma has come to fruition.

 

This is the first collaboration made in almost a decade since the development of Rovelito.

 

Whether AstraZeneca, which is trying to increase the use of its diabetes treatment 'Forxiga' in clinics in Korea, and SK Chemicals, which is trying to increase production through global expansion with AstraZeneca, will create a synergistic effect is gaining attention.

 

According to industry sources on the 19th, AstraZeneca and SK Chemicals succeeded in codeveloping a combination treatment for Type 2 diabetes.

 

The drug, Sidapvia, is a combination of the SGLT-2 inhibitor dapagliflozin and DPP-4 inhibitor sitagliptin.

 

Under the collaboration agreement, AstraZeneca will be in charge of the commercialization strategy and execution of Sidapvia.

 

The company also holds the global commercialization rights to Sidapvia as its licensor.

 

SK Chemicals will be in charge of its manufacture and supply.

 

The executives of both compnaies are celebrating the first production of the diabetes combo drug in June at SK Eco Hub in Pangyo, Korea.

 

(from the left)Yoon-Ho Kim (CEO, Pharma at SK Chemicals) Jae-Hyun Ahn (President and CEO, SK Chemicals) Choi Chang-won (Vice chairman, Discovery), Leon Wang (Executive Vice President, International and China President AstraZeneca), Sylvia Varela(Vice Presdient, Asia AstraZeneca), Ankush Nandra (Vice President, Finance and Chief Financial Officer International AstraZeneca), Sangpyo Kim ( Country President, AstraZeneca Korea)

Both companies are looking forward to the synergistic effect that the collaboration will bring, accentuating their strengths and supplementing their weakness.

 

AstraZeneca owns Forxiga, the original dapagliflozin drug.

 

Also, as a global company with branches around the world, the company owns the infrastructure that can easily facilitate Sidapvia’s global entry.

 

SK Chemicals will be supporting AstraZeneca, which does not own a domestic manufacturing facility, by manufacturing the dapagliflozin+sitagliptin combination in Korea.

 

The collaboration between the two companies began in early 2020 when they signed an agreement for the development, manufacture, and global commercialization of a combination therapy for diabetes.

 

To develop the combination, AstraZeneca supplied the API and invested R&D expenses to SK Chemicals.

 

Based on such support, SK Chemicals conducted the R&D and domestic clinical trials for the combination drug.

 

Building on Sidapvia’s approval in Korea, AstraZeneca plans to start the approval process for Sidapvia in 12 countries and plans to further expand the countries in the future.

 

First combo drug collaboration made in 10 years It is rare for a global pharmaceutical company and a domestic pharmaceutical company to jointly develop and commercialize a drug.

 

Combination drug for hypertension and hyperlipidemia produced through collaboration between Hanmi Pharm and Sanofi in 2013

One similar case was ‘Rovelito,’ a treatment for hypertension and hyperlipidemia.

 

The drug was jointly developed by the global pharmaceutical company Sanofi-Aventis and domestic company Hanmi Pharm.

 

The drug is a two-drug fixed-dose combination of the ARB class irbesartan and atorvastatin.

 

Hanmi Pharm manufactured Rovelito and for the two companies to sell together.

 

Unlike now, at the time of the companies' collaboration in 2013, combination drugs were an unfamiliar concept for hypertension and hyperlipidemia.

 

Hanmi Pharm received attention for releasing an incrementally modified two-drug combination.

 

One of Rovelito’s APIs, Avapro, was the original irbesartan drug owned by Sanofi.

 

This was why the collaboration brought a synergistic effect.

 

In fact, Rovelito posted annual sales of KRW 20 billion and was recorded as a commercialization success case.

 

The drug also served a major role in establishing Hanmi Pharm as a strong player in the field of incrementally modified drugs.

 

No other collaboration between a global company and a Korean company has risen since then.

 

One reason was that Hanmi Pharm’s success prompted many Korean companies to jump into the combination drug market, making it difficult for such collaboration to lead the competition.

 

Also, the change in the business strategy of global pharmaceutical companies played a role.

 

The global pharmaceutical companies spun off their chronic disease businesses that lost profitability and started focusing on high value-added areas such as anticancer drugs and rare diseases, removing the areas for collaboration.

 

Therefore, AstraZeneca and SK Chemicals agreement was the first collaboration made for a combination drug in 10 years in the field of chronic diseases.

 

As Sidapvia’s licensor is AstraZeneca, the industry believes the collaboration reflects AstraZeneca’s strong will for the development of a combination drug.

 

With the collaboration, AstraZeneca now owns a line-up of 4 products in Type 2 diabetes - ▲single dapagliflozin, ▲dapagliflozin+metformin combination, ▲ dapagliflozin+saxagliptin(DPP-4i) combination, and a ▲dapagliflozin+sitagliptin combination.

 

AstraZeneca already owns the original DPP-4 inhibitor class saxagliptin drug ‘Onglyza,’ and also ‘Qtern,’ which is a combination of Onglyza and Forxiga.

 

Also, Qtern posted the most monthly prescription sales in May, when sales of SGLT-2i+DPP-4i combos started.

 

Despite such success, AstraZeneca is thought to have added Sidapvia to its lineup because sitagliptin holds the largest share of the DPP-4 inhibitor market.

 

Sitagliptin accounts for over 25% of the DPP-4 inhibitor market and is the leading ingredient in the area.

 

The Januvia family that contains sitagliptin had posted outpatient prescription sales of KRW 150 billion last year.

 

Unlike DPP-4 inhibitors, which are widely used in private clinics around the nation, only half are using SGLT-2 inhibitors.

 

This means that the combination drugs that contain DPP-4 inhibitors can benefit from the established DPP-4 inhibitor market and quickly broaden prescriptions for the combined SGLT-2 inhibitors as well.

 

Owning a combination drug that contains sitagliptin, the most commonly used DPP-4 inhibitor, would facilitate the company in expanding the use of its SGLT-2 inhibitor as well.

 

Il Shim, Director of the CVRM (Cardiovascular, Renal, and Metabolism) Business Unit at AstraZeneca Korea, said, “Sidapvia is a very special product we developed in collaboration with SK Chemicals.

 

We hope our combination drug Sidapvia, which is based on Korea’s only SGLT-2 inhibitor that owns indications for Type 2 diabetes, chronic kidney disease, and chronic heart failure, will help patients to more easily and effectively manage their Type 2 diabetes.”