Merck & Co. Inc. (NYSE:MRK) entered a settlement and license agreement with Bristol-Myers Squibb Co. (NYSE:BMY) and partner Ono Pharmaceutical Co. Ltd. (Tokyo:4528) that will end all litigation pertaining to Keytruda pembrolizumab in the U.S., Europe, Australia and Japan. BMS and Ono will receive an initial $625 million payment from Merck, and will receive royalties on Keytruda sales.
Merck markets Keytruda to treat non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). BMS and Ono share rights to Opdivo nivolumab, which is approved to treat NSCLC, melanoma, classical Hodgkin's lymphoma, head and neck cancer, and kidney cancer. Both mAbs target PD-1.
BMS and Ono are to receive 6.5% royalties on global Keytruda sales from Jan. 1, 2017, through Dec. 31, 2023, and 2.5% from Jan. 1, 2024, through Dec. 31, 2026. Ono is to receive 25% of the initial payment and royalties, after legal fees, and BMS will keep 75%.
BMS spokesperson Ken Dominski told BioCentury the ligation involved six patents in Europe, Japan and the U.S., which are owned by Ono and licensed to BMS and which cover use of PD-1 antibodies to treat cancer, as well as a separate group of patents co-owned by BMS and Ono protecting PD-1 antibodies. He said BMS and Ono had filed several lawsuits claiming that Keytruda infringed on patents protecting Opdivo, while Merck had sought invalidation of the BMS and Ono patents.
Dominski added that BMS sought a financial resolution rather than seeking an injunction against Merck "to ensure all patient needs were met."
The companies announced the settlement after market close. BMS shares sank 11% on Friday after the company said late Thursday it will not seek accelerated approval of Opdivo in combination with Yervoy ipilimumab as a first-line treatment for lung cancer (see below).
Bristol-Myers Squibb Co. (NYSE:BMY) sank $6.26 (11%) to $49.23 on Friday, shedding about $10.5 billion in market cap, in the wake of Thursday's annoucement that it will not seek accelerated approval of Opdivo nivolumab plus Yervoy ipilimumab as a first-line treatment for lung cancer based on a review of available data (see BioCentury Extra, Jan. 19).
In intraday trading Friday, BMS shares bottomed at $48.92, their lowest point since October 2014.
The decision represents another major setback for BMS's immuno-oncology franchise in lung cancer. In August, the company said Opdivo monotherapy missed the primary endpoint of a Phase III study in the first-line NSCLC setting. Data released in October from the study showed that Opdivo led to shorter progression-free survival than chemotherapy. BMS has lost $26.09 (35%) since its Aug. 4 close of $75.32, before it announced the NSCLC miss. It has lost about $43.6 billion in market cap over that period (see BioCentury Extra, Aug. 5, 2016 and BioCentury Extra, Oct. 10, 2016).
BMS's decision broadens the market opportunity for competing PD-L1 mAb Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), which is seeking an expanded label in NSCLC. Merck gained $2.20 to $62.53 on Friday, adding about $6.1 billion in market cap (see BioCentury Extra, Jan. 11).
Gilead Sciences Inc. (NASDAQ:GILD) said EMA accepted for review an MAA for pan-genotypic HCV combination therapy sofosbuvir/velpatasvir/voxilaprevir to treat chronic HCV infection. Last month, the company submitted an NDA to FDA for the combo to treat chronic HCV genotypes 1-6 in patients who have failed prior treatment with DAA regimens.
The fixed-dose combo includes Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor; velpatasvir (GS-5816), a pan-genotypic HCV NS5A protein inhibitor; and voxilaprevir (GS-9857), a pan-genotypic HCV NS3/NS4A protease inhibitor.
In October, Gilead reported top-line data from four Phase III trials of the combo (see BioCentury Extra, Oct. 20, 2016).
Gene therapy company Genenta Science s.r.l. (Milan, Italy) named Carlo Russo CMO. Russo was CMO at Adverum Biotechnologies Inc. (NASDAQ:ADVM).
Sosei Group Corp. (Tokyo:4565) named Andrew Oakley CFO, effective Feb. 1. He replaces Hidetoshi Torami, who resigned. Oakley was CFO at Vectura Group plc (LSE:VEC).
Ipsen Group (Euronext:IPN; Pink:IPSEY) named Harout Semerjian president and head of specialty care international region and global franchises, effective Feb. 2. He was SVP and global launch head for ribociclib (LEE011) at Novartis AG (NYSE:NVS; SIX:NOVN).
Stemline Therapeutics Inc. (NASDAQ:STML) raised $45 million through the sale of 4.5 million shares at $10 in a follow-on underwritten by Jefferies, Cowen, Ladenburg Thalmann, H.C. Wainwright, Roth Capital Partners, Joseph Gunnar and Aegis Capital. The price is a 9.1% discount to the company's close of $11 on Thursday, when Stemline proposed the offering after market hours.
Stemline is conducting a Phase II trial of lead candidate SL-401 to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), a form of acute myelogenous leukemia (AML). The company hopes to submit a BLA to FDA next half for the IL-3 receptor targeting agent linked to a truncated diphtheria toxin payload.
The company's SL-701 is in a Phase II trial to treat glioblastoma multiforme (GBM), and its SL-801 is in Phase I to treat solid tumors. SL-701 comprises synthetic short peptides against IL-13RA2, EPHA2 and survivin (BIRC5). SL-801 is a reversible inhibitor of exportin 1 (XPO1; CRM1).
Stemline slipped $0.60 to $10.40 on Friday.
Robert Califf resigned as FDA commissioner Friday, the agency told BioCentury. Stephen Ostroff, the agency's deputy commissioner for foods and veterinary medicine, became acting commissioner. Ostroff served as acting FDA commissioner from April 2015 to late February 2016.
The agency disclosed the timing for Califf's planned resignation earlier this month (see BioCentury Extra, Jan. 9).
Andy Slavitt stepped down as acting CMS administrator. Patrick Conway, the center's deputy administrator for innovation and quality, became acting CMS administrator. Slavitt had been in the role since Marilyn Tavenner stepped down as CMS administrator in 2015.