Judith Kulich, Jon Roffman, Cody Powers and Renuka Agarwal co-wrote this blog post with Ben Hohn.
The 2019 BIO International Conference, held June 3-6 in Philadelphia, attracted more than 16,000 attendees from more than 70 countries, with representation from biotechnology and pharmaceutical companies, academic institutions, regulators, investors and other organizations. The conference provided a platform for discovery and discussion, resulting in more than 41,000 partnering meetings.
At the conference, we presented key insights and data on oncology first launches and partnering from 2011 to 2018. Also, we provided a preview of potential future first launches and domestic Chinese emerging pharmaceutical oncology companies.
Notes: (1) MDS: Myelodysplastic Syndrome, GBM: Glioblastoma, GIST: Gastrointestinal Stromal Tumors, AML: Acute Myeloid Leukemia, CML: Chronic Myelomonocytic Leukemia, MM: Multiple Myeloma. (2) Assets include NMEs and NDAs (3) Note that none of these assets had EUR only commercial partners. Source: Evaluate Pharma as accessed on February 25th, 2019, and company press releases. (4) Note that G1 Therapeutics indicated its intent to file trilaciclib in April 2019.
Notes: (1) *Company has trials outside China (2) ^Company has a local China partner for asset (3) Assets include NMEs and NDAs (4) Filed indicates filed in China. Source: PharmCube and Yaozhi, accessed March 2019.
Here are two key takeaways from our research on this “next wave” of oncology launches:
1. Ex-U.S. vs. U.S. partnering: Of the 32 late-stage and pipeline potential oncology first launch assets that we identified from U.S.-based companies, 13 companies (40%) have established commercial partnerships for these assets. Of these 13, 11 have established partnerships for Asia, while only two have out-licensed all global commercial rights to partners (GlycoMimetics to Pfizer for rivipansel, MEI Pharma to Helsinn for pracinostat). This is consistent with ZS findings that companies rarely choose to launch alone in Asia; partnering in Asia enables U.S.-based companies to leverage the regulatory relationships and broader market understanding that their partners have. It’s important to start conversations and establish partnerships early, as these companies have done, to build toward favorable market access and a stronger commercial footprint.
2. China first launches: Of the 19 late-stage and pipeline oncology assets that we identified from China-based companies, seven of these assets would be the first-launched assets for their respective companies if approved. While none of the 19 assets have global commercial partners, two (Hinova’s HC-1119 and Alphamab’s KN035) have local partners, and several of these companies have global partnerships for assets other than their current filed or phase III assets. For example, BeiGene has a partnership with Celgene for tislelizumab (Celgene owns rights in the U.S., EU and Japan); CStone has the China region license for several early stage Blueprint assets and Agios’ TIBSOVO; Akesobio out-licensed worldwide rights to its AK107 assets to Merck; and Hengrui out-licensed global rights, excluding Asia but including Japan, for its BTK inhibitor program to TG Therapeutics. Other Chinese companies are pursuing an in-licensing versus self-development strategy: take Zai Lab, for instance, which has licensed assets from U.S.-based Tesaro, Deciphera and Macrogenics. While none of these 19 assets currently have global commercial partners, their respective owners clearly have an appetite for partnering, and they could enter into partnerships for these assets soon.
At the conference, a panel with Alan Bash (BMS, senior vice president, WW commercial), John Demaree (CCO of G1 Therapeutics), Chris Pierce (former commercial lead, Loxo Oncology) and Mohamed Ladha (vice president and head of commercial at Tocagen) shared their insights on oncology launch strategy. They also covered such innovative launch topics as the specific challenges and nuances of launching with biomarker, cell and gene therapy, I-O indication and rare oncology assets.
If there are any potential first launch oncology assets that you think should be added to our list, please let us know. Perhaps we’ll see you at next year’s event.