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Xencor (XNCR) announced it has entered into a research and license agreement with Genentech, a member of the Roche Group (RHHBY), to develop and commercialize novel IL-15 cytokine therapeutics, including XmAb24306. XmAb24306 is an IL-15/IL-15Ralpha cytokine complex engineered with Xencor's bispecific Fc domain and Xtend Fc technology and is Xencor's most advanced preclinical cytokine program. Under the terms of the agreement, the companies will co-develop XmAb24306 and other potential IL-15 programs, in which the companies will share development costs and profits. Genentech will commercialize medicines worldwide, and Xencor has the option to co-promote in the United States. Additionally, the companies will engage in a two-year research program to discover new IL-15 drug candidates, including ones targeted to specific immune cell populations. Genentech will pay Xencor $120M upfront, and Xencor will be eligible to receive up to $160M in development milestones for the XmAb24306 program and up to $180 million in development milestones for each new IL-15 drug candidate. The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closing is expected to occur in the first half of 2019.

Genentech, a member of the Roche Group, announced completing the submission of a supplemental Biologics License Application, or sBLA, to the FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer, or EBC, with residual disease after neoadjuvant treatment. The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.

Senseonics (SENS) announced an extension of its distribution agreement with Roche Diabetes Care (RHHBY). As extended, the agreement now runs through January 31, 2021. Under terms of the extended agreement, Roche will continue its role as Senseonics exclusive distributor in Europe, the Middle East and Africa, excluding Scandinavia and Israel. In addition, the agreement has been expanded to provide Roche with exclusive distribution rights in 17 additional countries, including Brazil, Russia, India and China, as well as select markets in the Asia Pacific and Latin American regions.

Roche announced that the EU Committee for Medicinal Products for Human Use has adopted a positive opinion for Hemlibra for routine prophylaxis of bleeding episodes in adults and children with severe haemophilia A without factor VIII inhibitors. The CHMP has also recommended that Hemlibra can be used at multiple dosing options for all indicated people with haemophilia A, including those with factor VIII inhibitors. The positive CHMP opinion is based on results from the pivotal HAVEN 3 and HAVEN 4 studies. In the HAVEN 3 study in people with haemophilia A without factor VIII inhibitors, Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis, and compared to prior treatment with factor VIII prophylaxis in a prospective intra-patient comparison. In the HAVEN 4 study in people with haemophilia A with and without factor VIII inhibitors, Hemlibra showed a clinically meaningful control of bleeding when dosed every four weeks. Based on this opinion, a final decision regarding the approval of Hemlibra for people without factor VIII inhibitors is expected from the European Commission in the near future.

Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Tecentriq, in combination with Avastin, paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer. In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. Based on the positive CHMP recommendation, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future. The CHMP recommendation is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin, paclitaxel and carboplatin helped people live significantly longer, compared with Avastin and chemotherapy in the intention-to-treat population. The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

The Roche board a dividend increase to CHF 8.70 per share and non-voting equity security. Subject to approval by the Annual General Meeting of Shareholders on March 5, 2019.