Oncobiologics: New Strategic Partnership, Late-Stage Adalimumab Biosimilar Trials

Biosimilar developer Oncobiologics has announced a new strategic partnership with Singapore-based GMS Tenshi Holdings. The agreement provides for the private placement of up to $25 million in Oncobiologics’ series A convertible preferred stock as well as 16,750,000 shares of common stock (with an aggregate price of approximately $15 million).

The agreement also includes a joint development and license agreement that provides GMS Tenshi the rights to ONS-3010, an adalimumab (Humira) biosimilar, and ONS-1045, a bevacizumab (Avastin) biosimilar in emerging markets exclusive of China, India, and Mexico. This new agreement replaces a previous arrangement between the companies that licensed only the bevacizumab biosimilar to GMS Tenshi, and resulted in payments to Oncobiologics of $2.5 million.

New Jersey-based Oncobiologics intends to use the proceeds of the private placement to initiate phase 3 clinical trials for its adalimumab biosimilar in 2018. The company says that it intends to pursue a designation of interchangeability with its product and the reference Humira.

“This investment by GMS Tenshi represents the culmination of our efforts to align with a strategic financial partner with a global strategy to accelerate commercialization of our biosimilar candidates and enhance our partnering and licensing capabilities,” said Oncobiologics CEO, Pankaj Mohan, PhD. “We believe that we now have a partner with the necessary financial and global commercial pharmaceutical expertise that…will allow us to realize our vision to bring affordable biologic drugs to patients in need around the world.”

Shares of Oncobiologics rose on news of the new partnership, ending last week at $2.04 per share (an increase of 126%). The company will need to secure stockholder approval of its agreement at its annual meeting, and will file a proxy statement with the US Securities and Exchange Commission in the interim.

In addition to the 2 drugs covered by its new agreement with GMS Tenshi, the biosimilar developer also reports 2 additional products in its pipeline: ONS-1050, a trastuzumab (Herceptin) biosimilar, and ONS-4010, a denosumab (Prolia, Xgeva) biosimilar. The company expects to initiate phase 1 trials for both products in 2018.