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AstraZeneca (AZN) and Merck (MRK) announced that the companies have received marketing authorization from China's National Medical Products Administration for LYNPARZA as a first-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA-mutated epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. LYNPARZA is the first PARP inhibitor approved in China for first-line maintenance in BRCAm advanced ovarian cancer.

AstraZeneca (AZN) and Merck & Co (MRK) announced that the companies have received marketing authorisation from China's National Medical Products Administration for Lynparza as a 1st-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy. The approval in China is based on the results from the Phase III SOLO-1 trial, which were published in The New England Journal of Medicine. Results showed that Lynparza significantly reduced the risk of disease progression or death by 70% vs. placebo in women with BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. Of those women receiving Lynparza, 60% remained progression-free at three years vs. 27% of women receiving placebo. Lynparza is the first PARP inhibitor approved in China for 1st-line maintenance in BRCAm advanced ovarian cancer. AstraZeneca and MSD are exploring additional trials in ovarian cancer and recently announced positive results from the Phase III PAOLA-1 trial, which tested Lynparza in combination with bevacizumab as a 1st-line maintenance treatment for women with newly-diagnosed advanced ovarian cancer, regardless of their biomarker status or surgical outcome.

AstraZeneca has agreed to sell the commercial rights to Seroquel and Seroquel XR in the U.S. and Canada to Cheplapharm Arzneimittel GmbH. Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in the US and Canada. Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: "This divestment supports our strategy of reducing the number of mature medicines to enable reinvestment in our main therapy areas. Cheplapharm recently agreed to acquire the commercial rights to Seroquel and Seroquel XR in most European markets and Russia from AstraZeneca and this new agreement will help ensure continued patient access to this important established medicine in North America as well." AstraZeneca will continue to manufacture and supply Seroquel and Seroquel XR to Cheplapharm during a transition period. Cheplapharm will make an upfront payment of $35M to AstraZeneca and may also make future sales-contingent payments of up to $6M. Income arising from the upfront and future payments will be reported in AstraZeneca's financial statements within Other Operating Income & Expense. In 2018, Seroquel generated sales of $36M in the markets covered by this agreement, while Seroquel XR generated $79M. The agreement does not impact the company's financial guidance for 2019. As there were no closing conditions to the divestment, the agreement became effective upon signing. The consideration will be paid in cash and the proceeds used for general corporate purposes.