The public-private partnership Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) launched on Thursday with $70 million in committed first-year R&D funding. The five-year program intends to support early preclinical development of new antibiotics, diagnostics and vaccines for drug-resistant bacterial infections. CARB-X said it will begin reviewing funding applications in September.
In its first year, CARB-X aims to focus primarily on therapeutics for Gram-negative bacteria included on the CDC's serious or urgent threat list, as well as "non-traditional approaches." HHS's Biomedical Advanced Research and Development Authority (BARDA) will provide $30 million and the U.K. Centre for Antimicrobial Resistance (AMR Centre) will provide $14 million for the first year.
Over five years, BARDA is to provide up to $250 million in R&D funding for CARB-X projects, and the AMR Centre is to provide up to $100 million. The AMR Centre is a new private-public initiative that aims to provide translational R&D services for development of new antibiotics and diagnostics.
The Wellcome Trust will also contribute funding and oversight, and NIH's National Institute of Allergy and Infectious Disease (NIAID) will provide in-kind services and technical support.
The Broad Institute of MIT and Harvard will host the new Collaborative Hub for Early Antibiotic Discovery (CHEAD), which aims to partner with academic laboratories to develop early stage small molecules.
CARB-X's executive director and principal investigator is Kevin Outterson, a professor at Boston University School of Law. Its executive team will include John Rex, SVP and chief strategy officer of the infection business unit at AstraZeneca plc (LSE:AZN; NYSE:AZN), and Barry Eisenstein, who is retiring from Merck & Co. Inc. (NYSE:MRK). He was SVP of scientific affairs at Cubist Pharmaceuticals Inc., which Merck acquired.
CARB-X emerged from President Obama's 2015 Combating Antibiotic Resistant Bacteria initiative (see BioCentury Extra, March 27, 2015).
In the company's 2Q16 financial presentation on Thursday, AstraZeneca plc (NYSE:AZN; LSE:AZN) CEO Pascal Soriot stressed pipeline progress and growth from new product launches as the company rebuilds from the loss of key products' patent protection. AZ gained $2.75 to $34.29 in New York and 337p to 5,027p in London on Thursday.
Soriot emphasized upcoming data readouts including the Phase III MYSTIC and ARCTIC trials of durvalumab (MEDI4736) plus tremelimumab (CP-675) to treat non-small cell lung cancer (NSCLC), both expected in 1H17.
Sales of NSCLC drug Tagrisso osimertinib were $92 million in 2Q16, up sequentially from $51 million in 1Q16 and beating a consensus estimate of $75 million. FDA granted accelerated approval for the EGFR inhibitor in November 2015. Brilinta ticagrelor sales were $214 million, up from $144 million in 2Q15 and topping the $199 million consensus. Soriot has identified Brilinta, an anticoagulant, as a major growth driver for AZ (see BioCentury, April 8, 2013).
AZ reported $5.6 billion in 2Q16 revenue, down from $6.3 billion in 2Q15 but beating the $5.5 billion consensus. The company said the decline was driven largely by patent expirations, including generic competition for cholesterol-lowering drug Crestor rosuvastatin (see BioCentury Extra, July 20).
On a conference call Thursday, Soriot said that as the company adds value to its pipeline, "at some point our pipeline becomes attractive." Media reports on Thursday suggested the company may be an M&A target.
The company reiterated 2016 guidance of a low- to mid-single-digit decline in total revenue and core EPS, and said it reduced core SG&A expenses by 5%. In April, it pledged to reduce core SG&A expenses to support continued investment in oncology (see BioCentury Extra, April 29).
In its 2Q16 financial results, Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) raised its full-year guidance for its metabolic programs after sales of hypophosphatasia drug Strensiq asfotase alfa exceeded expectations.
Strensiq sales were $45.1 million in 2Q16, up sequentially from $33.2 million in 1Q16 and beating the $40 million consensus estimate. The company now expects its metabolic franchise to deliver $200-$220 million in 2016 revenues, up from previous guidance of $180-$200 million.
The metabolic franchise also includes Kanuma sebelipase alfa, a recombinant human lysosomal acid lipase (LAL) enzyme replacement therapy for LAL deficiency. Sales of that drug were $6.4 million in 1Q16, topping the $5 million consensus.
FDA approved Kanuma and Strensiq in 4Q15. Alexion has said it expects a slow launch trajectory for Strensiq, a fusion protein incorporating the catalytic domain of human tissue non-specific alkaline phosphatase (TNSALP; ALPL) and a bone-targeting peptide (see Biocentury Extra, Oct. 26, 2015).
Sales of Soliris eculizumab were $701 million in 2Q15, up from $636 million in 2Q15 and beating the $697 million consensus.
Alexion's overall product sales were $752.5 million in 2Q16, up 18% from 2Q15 and exceeding the $743 million consensus.
On a conference call Thursday, CCO Carsten Thiel said 2Q16 Strensiq sales included revenue from the U.S., Germany and Japan, and the company expects greater sales momentum by 2017 as it continues reimbursement negotiations in various territories. The European Commission approved Strensiq in September 2015.
Non-GAAP EPS was $1.13 in 2Q15, down from $1.30 in 2Q15. Alexion said it lowered its non-GAAP EPS 2016 guidance to $4.50-$4.65 from $5-$5.20 due to changes in SEC accounting rules.
Alexion gained $0.62 to $130.40 on Thursday.
Bristol-Myers Squibb Co. (NYSE:BMY) reported 2Q16 financial results that beat estimates, and raised its EPS guidance for the year. Revenues in the quarter were $4.87 billion, up from $4.16 billion in 2Q15 and topping the $4.65 billion consensus estimate. Non-GAAP EPS in the quarter were $0.69, up from $0.53 in 2Q15 and edging out the $0.67 consensus.
BMS boosted its full-year 2016 non-GAAP EPS guidance to $2.55-$2.65 from $2.50-$2.60.
Worldwide 2Q16 sales of PD-1 inhibitor Opdivo nivolumab were $840 million, up sequentially from $704 million in 1Q16 and beating the $811.2 million consensus. The drug gained FDA approval during the quarter to treat classical Hodgkin's lymphoma, as well as approval from the European Commission in combination with BMS's Yervoy ipilimumab to treat melanoma. Opdivo is also approved to treat melanoma as monotherapy, and to treat non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC).
Sales of Yervoy were $241 million during 2Q16, down from $296 million in 2Q15. The melanoma drug's sales missed the $261.4 million consensus in 2Q16.
Sales of multiple myeloma (MM) drug Empliciti elotuzumab were $34 million, up from $28 million in 1Q16. BMS shares rights to Empliciti with AbbVie Inc. (NYSE:ABBV). FDA approved the humanized mAb targeting SLAM family member 7 (SLAMF7; CS1) in November, and the European Commission approved it in May.
BMS dipped $1.81 to $74.66 on Thursday.
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said FDA accepted and granted Priority Review to a BLA for Brineura cerliponase alfa (BMN 190) to treat children with neuronal ceroid lipofuscinosis type 2 (CLN2) disease, a form of Batten disease. Its PDUFA date is Jan. 27, 2017.
The company has also submitted an MAA to EMA for Brineura, a recombinant human tripeptidyl peptidase-1 (TPP1) enzyme replacement therapy. Brineura has Orphan Drug and breakthrough therapy designations from FDA in the indication.
In March, BioMarin said Brineura significantly improved CLN2 disease rating scale scores vs. natural history data in a Phase I/II trial to treat CLN2 (see BioCentury Extra, March 3).
BioMarin gained $0.11 to $98.20 on Thursday.
FDA approved Adlyxin lixisenatide from Sanofi (Euronext:SAN: NYSE:SNY) as an adjunct to diet and exercise to treat Type II diabetes. The once-daily glucagon-like peptide-1 receptor (GLP-1R; GLP1R) agonist is marketed as Lyxumia in over 40 countries, including most EU countries and Japan. Sanofi spokesperson Susan Brooks said the pharma expects to disclose Adlyxin's U.S. price when it decides on a launch date.
Sanofi expects a decision in August from FDA on another Type II diabetes therapy, iGlarLixi lixisenatide/insulin glargine, a fixed ratio combination of lixisenatide and Sanofi's Lantus insulin glargine. In May, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-2 to recommend approval of iGlarLixi (see BioCentury Extra, May 25).
Sanofi has exclusive, worldwide rights to develop and commercialize lixisenatide from Zealand Pharma A/S (CSE:ZEAL), which added DKK12 (10%) to DKK131 on Thursday.
Yuhan Corp. (KSE:000100) granted Shandong Luoxin Pharmaceutical Group Stock Co. Ltd. (HKSE:8058) exclusive rights to EGFR-mutation positive non-small cell lung cancer candidate YH25448 in Greater China, including mainland China, Hong Kong and Macau.
The partners said they will develop YH25448 simultaneously in Asian territories, and aim for concurrent NDA submissions. Yuhan is to conduct clinical development in South Korea and Taiwan, while Luoxin will develop the candidate in Greater China. Yuhan said it is eligible for $120 million in total milestones, plus double-digit royalties. Director and Head of R&D Strategy and Partnering Han-Joo Kim told BioCentury that Yuhan received $6 million up front.
Kim said the partners expect to begin clinical trials by YE16, and plan to find a global partner for the candidate eventually.
YH25448 is a third generation tyrosine kinase inhibitor (TKI) targeting both the initial EGFR-activating mutation and the T790M EGFR resistance mutation.
Gene editing company Editas Medicine Inc. (NASDAQ:EDIT) partnered with Fondazione Telethon (Milan, Italy) and Ospedale San Raffaele (Milan, Italy) to focus on R&D of genome-edited hematopoietic stem cell and T cell therapies. The Italian groups operate the joint venture San Raffaele-Telethon Institute for Gene Therapy (SR-TIGET), which is focused on gene and cell therapies.
In their three-year collaboration, the partners will aim to develop gene correction strategies to treat rare diseases, including two specified but undisclosed indications in the blood and bone marrow. Financial terms are undisclosed, as are details on IP ownership.
Editas slipped $0.92 to $27.28 on Thursday.
Exact Sciences Corp. (NASDAQ:EXAS) raised $131.8 million through the sale of 8.5 million shares at $15.50 in a bumped-up follow-on underwritten by Jefferies, Baird and Canaccord Genuity. The company had proposed after market close Wednesday to sell 7 million shares. It gained $0.50 to $17.32 on Thursday.
Exact Sciences' shares rose 30% on Tuesday after it reported 2Q16 earnings showing strong sales of colorectal cancer test Cologuard. The company said it would use the new funds to expand commercialization of the diagnostic (see BioCentury Extra, July 26).
NIH named psychiatrist and neuroscientist Joshua Gordon as director of its National Institute of Mental Health. Gordon is an associate professor of psychiatry at Columbia University Medical Center and a research psychiatrist at the New York State Psychiatric Institute. He is expected to join NIH in September, and will replace acting director Bruce Cuthbert.
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