Infinity Pharmaceuticals, Inc. INFI announced that AbbVie Inc. ABBV has exercised its right to terminate the collaboration with the company for the development and commercialization of duvelisib. Both companies had entered into discussions related to the restructuring of the partnership, which failed to arrive at a mutually attractive financial structure for the continuation of the collaboration.
With the termination of this agreement, Infinity has regained worldwide rights to duvelisib. Neither Infinity nor AbbVie will owe future financial obligations to each other. The termination of the agreement will be effective from Sep 23, 2016.
We note that Infinity had entered into a collaboration and license agreement with AbbVie to jointly develop and commercialize duvelisib for oncology indications in Sep 2014.
Currently, Infinity is exploring strategic options for the duvelisib program that will support the submission of global regulatory applications and commercialization of duvelisib. Infinity will continue to focus its efforts on filing a new drug application for duvelisib with the FDA in the fourth quarter of 2016.
The company's filing strategy includes the incorporation of data from both DUO and DYNAMO studies. While DUO is a randomized phase III monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), DYNAMO is a single-arm, phase II monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).
Infinity plans to seek feedback from the FDA regarding the DYNAMO data, which was announced earlier this month. In addition, the company expects to report top-line data from the DUO study, based on the results of an interim analysis, in the third quarter of 2016.
Additionally, the company plans to focus on SYNCHRONY – a combination study on duvelisib plus Gazyva in CLL or small lymphocytic lymphoma patients who were previously treated with a Bruton's tyrosine kinase inhibitor and FRESCO – a combination study in patients with relapsed/refractory follicular lymphoma planned to evaluate the potential of duvelisib to replace chemotherapy.
The company intends to discuss with the FDA the potential for FRESCO to serve as a confirmatory study for full approval in follicular lymphoma if duvelisib receives an accelerated approval based on the DYNAMO study.
Announces Restructuring Plan
Infinity announced that it also plans to eliminate 100 positions across the organization, representing approximately 58% of the company’s workforce. Earlier this month, the company had said that it will close down its discovery research organization impacting 21% of the company’s workforce or 46 positions.
The company’s restructuring plans also include closing BRAVURA, a phase III study on duvelisib in patients with relapsed iNHL and CONTEMPO, a phase Ib/II study on duvelisib in treatment-naïve patients with follicular lymphoma. Moreover, Infinity will not proceed with the phase Ib/II study on duvelisib in combination with Venclexta.
The company currently expects to incur severance, benefit and related costs of approximately $8 million, with future cash outlays of $5 million expected to be paid at end 2016 and up to approximately $3 million expected to be paid at end 2017. The company currently expects clinical trial and related development close down costs between $5 million and $7 million, and expects the related cash outlays to be paid during the end of this year.
The company expects this restructuring to be substantially completed by Jul 15, 2016, and to be fully completed by Dec 31, 2016.
Considering that Infinity is highly dependent on successful development of duvelisib for growth, the termination of the duvelisib agreement with AbbVie is a huge setback for Infinity. The company is now solely responsible for the development of the candidate and has to bear all related costs.
Infinity currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Bristol-Myers Squibb Company BMY and Pfizer Inc. PFE, both sporting a Zacks Rank #1 (Strong Buy).
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