Biosimilar developer Oncobiologics has announced a new strategic partnership with Singapore-based GMS Tenshi Holdings.
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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Switching Patterns Highlight Nocebo Effect in European Patients Using Amgevita
July 23rd 2024About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Eye on Pharma: EU Biosimilar Approval, Launches and Product Returns, Denosumab Switching Data
July 10th 2024The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.