Boston-based Verastem signed a definitive deal to sell its global commercial and development rights to Copiktra (duvelisib) to Henderson, Nevada and San Diego-based Secura Bio. Copiktra is an oral inhibitor of phosphoinositide 3-kinase (PI3K) approved for treatment of adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two previous therapies and relapsed/refractory follicular lymphoma (FL) after at least two previous systemic therapies.
Under the terms of the deal, Secura is paying Verastem $70 million upfront and up to $241 million in milestone payments. A total of $45 million of the milestones are two separate payments for U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals of Copiktra for peripheral T-cell lymphoma. There is another $50 million for cumulative worldwide net sales of Copiktra starting at $100 million of cumulative net sales. Verastem will receive low double-digit royalties over $100 million in the U.S., Europe and the UK. Verastem is also eligible for 50% of licensing milestones up to $146 million and royalties outside of the U.S., Europe and UK.
Secura picks up an exclusive worldwide license for R&D, commercialization and manufacture of Copiktra in all oncology indications. Secura will take over all operational and financial activities that were previously part of Verastem’s Copiktra program, including commercialization in the US and Europe, ongoing clinical trials, Verastem’s partnerships with Yakult, CSPC and Sanofi, as well as existing royalty obligations.
The two companies are continuing negotiations on whether to transfer Verastem’s field sales and medical professionals.
Verastem is making the deal to essentially raise funds to focus on its other oncology programs.
“By focusing our expertise and efforts on rapidly advancing the RAF/MEK/FAK development program, we believe we will be providing the best path forward for patients, customers, our shareholders and our company,” said Brian Stuglik, Verastem’s chief executive officer. “These strategic decisions will enable us to best deliver on our mission to advance new medicines on behalf of cancer patients. The agreement with Secura Bio will ensure Copiktra continues to help more patients, leveraging the established commercial structure, support of ongoing clinical study and potential expansion into new indications.”
To that end, Verastem indicated that the company met with the FDA in July to discuss registration-directed study design for the VS-6766/defactinib combination in patients with low-grade serious ovarian carcinoma (LGSOC).
Copiktra has a somewhat troubled history. In 2016, AbbVie abandoned a partnership with Infinity for the drug after seeing the approval-worthy but not dazzling data in a competitive area of oncology. Verastem picked it up and got it approved by the FDA, but the drug only brought in $12 million in 2019. Verastem has plenty of other problems, including a loss of about $149 million last year and its burn rate is approaching $500 million. It really wants the KRAS programs to make headway.
Verastem also indicated that is non-small cell lung cancer study will have an adaptive design and focus on patients with KRAS-G12V mutant tumors. It expects to have meetings with the FDA after it completes the initial cohort of the lung cancer trial and then initiate registration-directed clinical trials for possible accelerated approval in LGSOC and KRASmt NSCLC by the end of this year.
The company also expects to continue its clinical collaboration with the Drug Development Unit at ICR/Royal Marsden Hospital. They have a Phase I/II FRAME trial of VS-6766 with defactinib in LGSOC, KRASmt NSCLC and colorectal cancer ongoing, which was put on hold during the COVID-19 pandemic. The FRAME trial is also expanding to include new cohorts in pancreatic cancer, KRASmt endometrial cancer and KRAS-G12V NSCLC. It expects additional data from the LGSOC cohort in September.
As a result of this deal, Verastem expects decreased annual expenses of about $50 million, and will have enough cash to continue operations until at least 2024.