Rolontis®to get ₩11.6 billion upon FDA's approval

Spectrum pharmaceuticals filed with SEC & Royalty scale released

Hanmi Pharmaceuticals signed a licensing agreement with Spectrum Pharmaceuticals in 2012 ,not disclosing the total contract size.

The royalty scale of Rolontis® was first revealed.

 

Hanmi Pharmaceuticals will receive rayalty of nearly ₩ 12 billion upon final FDA approval.

 

After the release, Hanmi Pharmaceuticals will also likely receive a certain percentage of revenue annually, depending on sales.

 

Spectrum Pharmaceuticals, Hanmi Pharmaceutical’s partner, recently filed quarterly report SEC.

 

Spectrum Pharmaceuticals noted in its report that it has completed reauthorization application process on Oct 24.

 

The company rescinded its initial BLA for the reason of the FDA’s request for more CMC data in March.

 

The company resubmitted the biologics license applications (BLA) for Rolontis® to the FDA after 7 months.

 

Spectrum pharmaceuticals said with confidence ,“Rolontis® demonstrated safety and efficacy in 643 early breast cancer patients with neutropenia following myelosuppressive chemotherapy.

 

The two phase III clinical trials showed non-inferiority in terms of the duration of neutropenia compared with Pegfilgrastim during the four cycles of chemotherapy.”It expects to enter the Pegfilgrastim market generating $ 4 billion in revenue annually, if approved.

 

According to the report, Spectrum pharmaceuticals agreed to pay $ 10 million milestones to Hanmi Pharmaceuticals upon FDA’s approval.

 

After launch, Spectrum pharmaceuticals will pay a certain percentage of royalties annually based on the net sales.

 

Rolontis® is a biological new drug with long-acting that utilizes Hanmi’s Labscovery platform technoloy.

 

In 2012, Hanmi Pharmaceuticals signed a licensing agreement with Spectrum Pharmaceuticals, giving the global rights for Rolontis® except for Korea, China and Japan.

 

Hanmi Pharmaceuticals and Spectrum Pharmaceuticals did not disclose the total contract size, including the upfront fee and the technology at the time of contract.

 

According to Spectrum Pharmaceuticals, a certain deposit was paid to Hanmi Pharmaceuticals when they signed the contract initially.

 

In September 2014, after confirming the positive phase II clinical results and deciding to proceed with phase III clinical trials, they said the terms of the contract, such as milestones and sales royalties were modified.

 

Spectrum Pharmaceuticals first paid Hanmi Pharmaceuticals $1.9 million milestones when it started the ADVANCE study in the first quarter of 2016.

 

Spectrum pharmaceuticals issued 318,750 common shares for Hanmi pharmaceuticals in April of the same year.

 

Considering the stock price at that time, it was worth $ 2.3 million in cash.

 

, Currently, Hanmi pharmaceuticals owns 0.29 percent of Spectrum pharmaceuticals shares.

 

Joseph W.

 

Turgeon, CEO of Spectrum, who attended the conference call on July 7, said, “Spectrum pharmaceuticals submitted theRolontis®BLA to the FDA last month with a strategic decision considering management priorities.” We plan to introduce the Rolontis® Phase III clinical integration data which was released at the 2019 ASCO conference, at the San Antonio Breast Cancer Symposium (SABCS) in Texas, USA next month“.