Amgen Inc., of Thousand Oaks, Calif., said it completed its acquisition of global rights to the plaque psoriasis and psoriatic arthritis drug Otezla (apremilast) from Celgene Corp., of Summit, N.J., in connection with Celgene’s merger with Bristol-Myers Squibb Co., of New York, which was completed Wednesday. Otezla, along with related assets and liabilities, was acquired for $13.4 billion in cash, or approximately $11.2 billion net of present value of $2.2 billion in anticipated future cash tax benefits. With the acquisition’s closing, Amgen updated its 2019 guidance, projecting full-year revenues ranging from $23.1 billion to $23.3 billion, up from the previous range of $22.8 billion to $23 billion. On a GAAP basis, Amgen expects earnings per share in a range of $12.50 to $12.75 compared with the previous range of $12.50 to $12.80. Amgen shares (NASDAQ:AMGN) hit a one-year high of $228.52 Thursday before closing at $227.82 for a gain of $2.31. Shares have increased nearly 8% in November.
Appili Therapeutics Inc., of Halifax, Nova Scotia, said it inked an agreement with Fujifilm Toyama Chemical Co. Ltd., of Tokyo, for exclusive global rights outside Japan to develop and commercialize antifungal candidate T-2307, renamed ATI-2307. Fujifilm Toyama Chemical is eligible for undisclosed regulatory and commercial milestone payments and a royalty on net sales. The arylamidine, which was evaluated in multiple preclinical studies and three phase I trials, exhibited broad-spectrum antifungal activity in vitro and in vivo against multiple high priority fungi, including Cryptococcus and the multidrug resistant Candida species.
Boundless Bio Inc., of San Diego, said research by company scientists describing mechanisms by which extrachromosomal DNA (ecDNA) drive growth, resistance and recurrence in aggressive cancers was published in Nature. The paper describes how ecDNA encode information not only in their sequence but also in their shape, which differs from human chromosomal DNA in ways not previously well characterized. The team’s analysis of ecDNA in cancer revealed a circular structure organized around protein cores in a way that permits greater access to the transcriptional machinery than occurs on chromosomes. As a result of that architecture, along with the high number of ecDNA particles inside a tumor cell, oncogenes amplified on ecDNA are among the most highly transcribed genes in a tumor, according to the researchers, who also showed that the circular architecture of ecDNA permits regulatory interactions that might be important to control gene expression in cancer.
Bristol-Myers Squibb Co., of New York, said it completed its acquisition of Celgene Corp., of Summit, N.J., which began operating as a wholly owned subsidiary. For each share, Celgene shareholders received one common share of BMS (NYSE:BMY), $50 in cash without interest and one tradeable contingent value right (CVR) to a payment of $9 in cash on the achievement of predetermined regulatory milestones. Celgene common shares (NASDAQ:CELG) ceased trading at Wednesday’s market close. On Thursday, newly issued BMS shares and CVRs were set to begin trading on the NYSE, with the CVRs listed under the symbol BMYRT. Celgene also said the merged companies plan to transfer the listing of Celgene CVRs (NASDAQ:CELGZ) related to Abraxane (paclitaxel) from Nasdaq to the NYSE, where they’re expected to begin trading as CELGRT following their official Nasdaq delisting, expected Dec. 2. Separately, BMS said its board authorized the repurchase of $7 billion of its common stock through accelerated share repurchase (ASR) agreements with Morgan Stanley & Co. LLC and Barclays Bank. BMS plans to fund the repurchase with cash on hand and expects to receive approximately 80% of the repurchased shares on Nov. 27 and to complete the ASR agreement by mid-2020. On Thursday, BMY gained 44 cents to close at $56.85.
Cellectis SA, of Paris, said European Patent EP3004337, which claims a method of preparing T cells for immunotherapy using the CRISPR/Cas9 system, initially granted on Aug. 2, 2017, was upheld by the European Patent Office following an opposition procedure initiated in May 2018. The inventors include André Choulika, Philippe Duchateau and Laurent Poirot, all senior officials at the company. Cellectis said the patent has a validity period to 2034.
Cytodyn Inc., of Vancouver, Washington, reported that the CCR5 antagonist leronlimab inhibited a common precursor to nonalcoholic steatohepatitis (NASH) in a humanized mouse model. Immunodeficient, NOD-scid gamma mice were fed a high-fat, NASH-inducing diet, transplanted with human stem cells to repopulate the deficient immune system and then treated with leronlimab, which inhibited fatty liver development.
Cyxone AB, of Stockholm, said it inked an agreement with an undisclosed U.K. contract research organization to conduct six-month toxicology studies with rabeximod ahead of a planned phase IIb study in participants with moderate to severe rheumatoid arthritis. The toxicology studies are planned to begin by year-end.
Daré Bioscience Inc., of San Diego, said it closed the acquisition by merger of privately held Microchips Biotech Inc., of Lexington, Mass., which began operation as a wholly owned subsidiary. Microchips’ cash and equivalents at the merger’s close, less estimated transaction-related expenses, were approximately $5.7 million. Daré expected to issue approximately 3 million common shares in exchange for the cash, less any liabilities, at closing. Consequently, former stockholders of Microchips, including Polaris Venture Partners, MS Pace, Intersouth Partners and Jerusalem-based Teva Pharmaceutical Industries Ltd., were to become Daré stockholders.
Entera Bio Ltd., of Jerusalem, said it established a U.S. headquarters in metropolitan Boston and hired Jonathan Lieber as its U.S.-based chief financial officer.
Enzychem Lifesciences Corp., of Seoul, South Korea, said nonclinical data from three animal models of its nonalcoholic steatohepatitis (NASH) candidate, EC-18 (mosedipimod), were presented at The Liver Meeting 2019 in Boston. In an STZ-induced acute hepatosteatosis model, a STAM NASH and fibrosis model and a high-fat high-fructose hepatosteatosis model, results confirmed nonclinical activity of the CCL26 gene inhibitor by facilitating the resolution of hepatic inflammation caused by lipotoxicity and consequent oxidative stress through removal of damage-associated molecular patterns and an early termination of the necroptosis signal and by increasing lipid uptake in peripheral tissues such as muscle tissue, thereby protecting beta-cell damage and subsequently restoring the function of lipoprotein lipase, which in turn reduced delivery of free fatty acids into the liver.
Excision Biotherapeutics Inc., of Oakland, Calif., presented preclinical data at the Personalized Nanomedicine Symposium in Miami demonstrating the ability to remove HIV genomes from cell lines as well as transgenic mice using CRISPR gene editing technology. Researchers combined multiple guide RNAs to cut multiple locations to deactivate the viral genomes. The team used AAV9-, AAV6- and AAV2-mediated delivery of CRISPR/Cas9, which led to viral suppression. Excision is developing CRISPR-based gene therapies delivered by a single intravenous infusion, with an aim to cure viral infectious diseases. Lead compound EBT-101, a treatment for HIV, will enter human clinical trials in 2020.
Preclinical data from Edison, N.J.-based Hepion Pharmaceuticals Inc. show that CRV-431, an antifibrotic agent, prevented development of liver cirrhosis in a preclinical model. In the study, rats were administered a hepatotoxic compound, thioacetamide, for nine weeks to induce liver injury and fibrosis, in combination with either CRV-431 or vehicle control. Blinded, histopathological analysis of the livers was conducted at the end of the study. In the vehicle control group, 50% of the animals developed cirrhosis. In contrast, none of the 10 CRV-431-treated rats developed cirrhosis.
Maruho Co. Ltd., of Osaka, Japan, and Excelra, of Hyderabad, India, will collaborate to discover and develop therapies in dermatology. The deal gives Maruho access to Excelra’s drug repurposing platform, which includes more than 10 million associations among drug-disease target triads. No financial terms were released.
Neon Therapeutics Inc., of Cambridge, Mass., is restructuring to focus on its personal and precision neoantigen-targeted T-cell therapy candidates. The company expects to file a CTA in Europe by the end of 2019 to evaluate its lead neoantigen program, NEO-PTC-01, in patients with metastatic melanoma who are refractory to checkpoint inhibitors. Neon plans to stop additional development on its cancer vaccine programs, NEO-PV-01 and NEO-SV-01, and cut its headcount by 24%. The company will conduct follow-up from its NT-002 clinical trial of NEO-PV-01 in first-line patients with untreated advanced or metastatic non-small-cell lung cancer and plans to report data in the third quarter of 2020. The restructuring will save Neon approximately $35 million annually and allow the company to operate into the third quarter of 2020. The company is exploring its strategic options.
Onconova Therapeutics Inc., of Newtown, Pa., granted Montreal’s Knight Therapeutics Inc. exclusive rights to commercialize rigosertib to treat myelodysplastic syndromes (MDS) in Canada. Onconova could receive clinical, regulatory and sales-based milestone payments up to CA$33.95 million (US$25.6 million) and tiered double-digit royalties on net sales. Rigosertib, Onconova’s lead candidate, is a small molecule designed to block cellular signaling by targeting RAS effector pathways. Onconova is developing oral and I.V. versions and is testing single-agent I.V. rigosertib in second-line higher-risk MDS patients and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients.
Phio Pharmaceuticals Corp., of Marlborough, Mass., extended and expanded its research collaboration with Stockholm’s Karolinska Institute to develop self-delivering RNAi immunotherapies against targets involved in T-cell and NK cell differentiation and/or tumor-induced stress response. The goal is to produce antitumor adoptive cell therapy grafts and to enter the clinic. No financial terms were released.
Therapix Biosciences Ltd., of Tel Aviv, Israel, will appeal its notice of delisting from Nasdaq by asking to meet with a Nasdaq hearings panel. The hearing request stays the delisting until the panel makes a decision. On May 23, Therapix was advised it no longer complied with the minimum $2.5 million stockholders' equity requirement for continued listing. On July 5, the company submitted a plan to regain compliance and Nasdaq granted an extension enabling the company to regain compliance with the Stockholders' Equity Requirement until Nov. 18. When a merger with Canadian cannabis company Destiny Bioscience Global Corp. failed, Therapix was notified on Nov. 19 that its American depositary shares would be suspended from trading on Nasdaq at the opening of business on Nov. 29.
Viiv Healthcare Ltd., of London, an HIV-focused company majority owned by London-based Glaxosmithkline plc, with Pfizer Inc., of New York, and Shionogi Ltd., of Osaka, Japan, as shareholders, said it will develop broadly neutralizing antibody (bNAb) N6LS for the treatment and prevention of HIV-1, as part of an exclusive licensing agreement between GSK and the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. N6LS is an antiviral bNAb that works by binding to a specific site (gp120) on the surface of HIV that prevents its entry into uninfected immune system cells (CD4+ T-cells). Viiv anticipates initiating a phase IIa study with material manufactured by the NIAID Vaccine Research Center that will evaluate the efficacy, safety, tolerability and pharmacokinetic profile of N6LS in adults living with HIV.
Vizient Inc., of Irving, Texas, signed an agreement with Fresenius Kabi AG, of Bad Homburg, Germany, to supply six critical-care drugs under Vizient’s Novaplus private label pharmacy program. The list includes propofol as well as five other acute, life-saving drugs: protamine, phenylephrine, oxytocin, thiamine and magnesium sulfate.
Vor Biopharma Inc., of Cambridge, Mass., which develops engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, and Maxcyte Inc., of Gaithersburg, Md., disclosed a clinical and commercial license agreement under which Vor will use Maxcyte’s Flow Electroporation technology to produce eHSCs and initiate IND-enabling studies to accelerate its progress toward the clinic. Vor obtains nonexclusive clinical and commercial use rights to Maxcyte’s Flow Electroporation technology and the ExPERT platform to develop up to five engineered cell therapies, including VOR-33, Vor’s lead eHSC candidate, which is in development for acute myeloid leukemia. In return, Maxcyte will receive undisclosed development and approval milestones and sales-based payments in addition to other licensing fees.