The London-based EMA declined to speculate Friday about the implications of the U.K.'s decision to leave the EU, but national pharmaceutical industry trade associations have already begun lobbying for the right to host to the organization's headquarters.
EMA's relocation is likely. The EU will also certainly reconsider its decision to locate in London the pharmaceuticals division of its Unified Patent Court, which has yet to open.
"No country has ever decided to leave the EU, so there is no precedent for this situation," EMA said in a statement. "It is too early to foresee the implications of this decision and we will be in close contact with the EU institutions. When we have concrete information, we will share it with our stakeholders." EMA has 890 employees in London, spokesperson Sophie Labbe told BioCentury.
The German Federation of Pharmaceutical Manufacturers called Friday for relocation of EMA headquarters to Bonn. Prior to Thursday's vote, pharmaceutical trade associations in Italy, Denmark and Sweden made cases for hosting the agency in their countries in case of a Brexit.
In a statement, Association of the British Pharmaceutical Industry (ABPI) CEO Mike Thompson said the British vote "creates immediate challenges for future investment, research and jobs in our industry in the U.K. With that being the case, we are committed to working closely with the government to agree what steps need to be taken to send a strong signal that the U.K. is open for business."
In an open letter published Wednesday, ABPI and senior management of 15 global biopharmaceutical companies had urged a Remain vote. They warned that a Brexit "would mean uncertainty for our firms, less trade with Europe and fewer jobs."
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said it returned its Japanese rights to fulranumab (AMG 403) and trebananib (AMG 386) to Amgen Inc. (NASDAQ:AMGN).
In April, Johnson & Johnson (NYSE:JNJ) said it discontinued Phase III development of fulranumab to treat osteoarthritis pain, and returned the candidate's rights to Amgen. J&J had held exclusive ex-Japan rights to the IgG2 mAb against nerve growth factor (NGF) (see BioCentury Extra, April 1).
In April 2015, Amgen said it terminated Phase III development of trebananib to treat ovarian cancer. Takeda had exclusive Japanese rights to the recombinant Fc-peptide fusion protein (peptibody) targeting angiopoietins.
FDA is asking an advisory committee to vote on whether data from a cardiovascular outcomes trial (CVOT) show diabetes drug Jardiance empagliflozin does not result in an unacceptable increase in CV risk, and that the data demonstrate "substantial efficacy" in reducing CV mortality. The agency's Endocrinology and Metabolic Drug Advisory Committee is to meet on Tuesday to discuss the addition of data from the EMPA-REG OUTCOME study and an efficacy claim on Jardiance's label.
Last September, Boehringer Ingelheim GmbH (Ingelheim, Germany) and partner Eli Lilly and Co. (NYSE:LLY) said EMPA-REG OUTCOME showed Jardiance plus standard of care was superior to placebo plus SOC in reducing CV risk. The sodium-glucose cotransporter 2 (SGLT2) inhibitor reduced risk by 14% vs. placebo on the combined primary endpoint of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke (see BioCentury Extra, Sept. 17, 2015).
In briefing documents released ahead of Tuesday's meeting, FDA reviewers wrote that there is no precedent for using a CV safety study to support an efficacy claim. "It does remain an issue on whether the results from a single study initially designed for safety will be sufficient to obtain efficacy claims," they wrote.
The reviewers said the primary endpoint for EMPA-REG OUTCOME did not include asymptomatic "silent MIs," and said Jardiance would no longer show superiority to placebo if silent MIs were included. Silent MIs were evaluated as part of a secondary analyses based on criteria including ECG parameters.
The reviewers also noted that CV death was the primary driver of statistical significance on EMPA-REG OUTCOME's primary endpoint. The Jardiance group had a 38% lower risk risk of CV death than the placebo group. The data did not show Jardiance's superiority to placebo at reducing non-fatal stroke or MI.
EMA's CHMP recommended approval of PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) for non-small cell lung cancer, as well as asthma treatment Cinqaero reslizumab from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and cell therapy Zalmoxis from MolMed S.p.A. (Milan:MLM).
The committee recommended Keytruda's approval to treat locally advanced or metastatic NSCLC in adults whose tumors express PD-L1 and who have received at least one prior therapy. The drug is already approved in the EU and U.S. for advanced melanoma, and in the U.S. for NSCLC that expresses PD-L1 and that has progressed on or after platinum-based chemotherapy.
CHMP backed approval of Cinqaero as an add-on maintenance treatment for adults whose severe eosinophilic asthma is inadequately controlled by high-dose inhaled corticosteroids plus another maintenance therapy. FDA approved the humanized mAb against IL-5 as Cinqair in March (see BioCentury Extra, March 23).
The committee recommended conditional approval of Zalmoxis as an adjunctive treatment to aid immune reconstitution and reduce the risk of graft-versus-host disease (GvHD) in adults with high-risk hematological malignancies who are receiving a hematopoietic stem cell transplantation (HSCT). Zalmoxis comprises donor lymphocytes engineered to express human herpes simplex thymidine kinase suicide gene.
CHMP also said Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) requested that the committee re-examine last month's negative recommendation for Ninlaro ixazomib to treat relapsed or refractory multiple myeloma. CHMP had said the oral proteasome inhibitor's possible benefit was insufficient to outweigh its risks (see BioCentury Extra, May 27).
Biotech stocks sank Friday amid a worldwide sell-off on news that U.K. voters approved a referendum to leave the EU. The BioCentury 100 Index fell 246.47 (5.1%) to 4,552.30, with decliners outnumbering gainers 97-3.
The NASDAQ Biotechnology Index (NBI) and the iShares NASDAQ Biotechnology ETF (IBB) each dipped 5% on Friday and ended the week down 2.9%. The NYSE Arca Biotechnology Index (BTK) lost 5.1% on Friday, and ended the week off 2.5%.
The BC London Index, which includes 14 stocks that trade on the London Stock Exchange, lost 1.1% on Friday and 5.8% during the week. The BC Europe Index, which has 19 components traded on other European exchanges, sank 3% on the day but gained 1% for the week.
London's FTSE 100 lost 3.1% on Friday, but rose 2% for the week. The Euro Stoxx 50 fell 8.6% on Friday, and ended the week down 2.6%.
The NASDAQ Composite sank 4.1% on Friday, and the Dow Jones Industrial Average was down 3.4%.
Gene editing company CRISPR Therapeutics AG (Basel, Switzerland) raised $38 million in the final close of its series B round, bringing the round's total to about $140 million. Participating were new institutional investors and specialized healthcare funds including Franklin Templeton Investments, New Leaf Venture Partners, funds advised by Clough Capital Partners and Wellington Capital Management.
In April 2015, CRISPR Therapeutics raised $29 million for the round's first close. Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) invested $30 million as part of a four-year research collaboration, and Bayer AG (Xetra:BAYN) added $35 million as part of a deal to create a JV focused on blood disorders, blindness and congenital heart disease. Both deals were announced in 4Q15 (see BioCentury, Jan. 4).
Undisclosed insiders invested $11 million in the round. New Enterprise Associates, Abingworth, Versant Ventures, SR One and Celgene Corp. (NASDAQ:CELG) are among CRISPR Therapeutics' investors.
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