Boryeong’s copyright of anti-cancer drug,commercial value↑

Spain's PharmaMar signs US license agreement with Jazz’s Zepsyre for up to ₩640 billion

Boryeong, domestic contracts for two new anti-cancer drugs including Zepsyre

Strengthen partnership with PharmaMar

The anti-cancer drug 'Zepsyre', which is owned by Boryeong in Korea, has entered the early stage of commercialization.

 

PharmaMar, the original developer, is expected to secure the first FDA indication for small cell lung cancer by August next year.

 

The company also won a large contract worth up to ₩640 billion to surpass the US copyright, which is expected to be released the fastest.

 

Boryeong signed a domestic exclusive promotional license agreement for Zepsyre from PharmaMar in November 2017.

 

In 2016, the company signed a monopoly on sales and development of a myeloma treatment drug, Aplidin, to build a strong partnership.

 

According to the industry on the 26th, Borm Pharmaceutical's partner, Spanish PharmaMar, recently signed a monopoly license agreement with jazz pharmaceuticals’ Lurbinectedin.

 

Lurbinectedin is the ingredient name of 'Zepsyre', an ovarian cancer drug introduced by Boryung in November 2017.

 

It selectively exhibits anticancer activity by inhibiting the cause of cancer.

 

It is a mechanism that selectively inhibits the oncogenic transcriptional processes activated in cancer cells and tumor-associated macrophages (TAM) and causes cell death by cutting DNA double strands.

 

With the deal, PharmaMar secured a $200 million deposit (approximately ₩232.2 billion) from Jazz with no obligation to return.

 

When Zepsyre is licensed to sell the US Food and Drug Administration (FDA), it will receive up to $250 million in additional technology charges (milestones).

 

In the future, commercial milestones were guaranteed up to $550 million in technology fees and sales royalties ranging from late 10% to 30%.

 

Jazz is a well-known company that is a partner of 'Sonosi (Solriamfetol)', a sleep disorder new drug exported by SK Biopharm.

 

In the industry, Jazz has secured a huge short-term milestone from Zepsyre's US market potential.

 

PharmaMar submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) on the 17th, based on the results of the second phase clinical trial of Zepsyre.

 

According to PharmaMar's announcement of the American Society for Clinical Oncology (ASCO 2019) in June, patients with small cell lung cancer who received Zepsyre had a significant improvement in tumor response rate (ORR) of 35.2% compared to currently available Topotecan (16.9%).

 

In addition to small cell lung cancer, various cancers including ovarian cancer, head and neck cancer, and BRCA mutation breast cancer are being actively researched.

 

In recognition of this potential, the company signed a licensing agreement with Luye pharmaceutical of China (including Hong Kong and Macao) in April of this year.

 

PharmaMar's executives are confident in the FDA's rapid approval.

 

Small cell lung cancer monotherapy, a rare disease with high unmet demand, has secured positive clinical results.

 

Zepsyre was designated by the FDA in August last year as a rare drug for small cell lung cancer.

 

PharmaMar expects to receive the FDA's final approval in mid-August when the document is completed early next year and undergoes a six-month quick review process.

 

Since then, the aim is to expand the indications to various carcinomas including ovarian cancer, head and neck cancer, and breast cancer.

 

Bruce Cozadd, Chief Executive Officer of Jazz Pharmamaticals, said, “The treatment is limited in patients with advanced small cell lung cancer.

 

The agreement is significant because it expands the jazz anticancer pipeline and later stage assets”.