Abbvie Inc., of North Chicago, said the expiration date of the offers to exchange any and all outstanding notes of certain series issued by Allergan Finance LLC, Allergan Inc., Allergan Sales LLC and Allergan Funding SCS for new notes to be issued by Abbvie have been extended from Jan. 31 to Feb. 28.
Aeterna Zentaris Inc., of Charleston, S.C., said it has regained compliance with Nasdaq’s minimum bid price for continued listing.
Akari Therapeutics plc, of New York and London, released preclinical data indicating that PAS-nomacopan (the long-acting form of Akari’s lead drug, nomacopan) significantly reduced both retinal inflammation and intraocular VEGF. PAS-nomacopan lowered intraocular levels of VEGF as effectively as an anti-VEGF antibody; 74% and 68% reduction, respectively, compared to saline control. By inhibiting VEGF and complement, and reducing retinal inflammation, nomacopan has the potential to treat multiple pathways implicated in back-of-the-eye diseases. Also, PAS-nomacopan, with its longer half-life, offers potential for less frequent injections, which is critical in the treatment of back-of-the-eye diseases, the company said.
Anika Therapeutics Inc., of Bedford, Mass., closed its acquisition of Parcus Medical, a, privately held sports medicine company. Under previously disclosed terms, Anika acquired all outstanding membership interests of Parcus Medical in exchange for an up-front payment of approximately $35 million in cash from the company’s existing balance sheet. Parcus Medical unit holders will be eligible to receive an additional $60 million contingent upon the achievement of certain commercial milestones.
Aytu Bioscience Inc., of Englewood, Colo., and Innovus Pharmaceuticals Inc., of San Diego, said the registration statement containing a joint preliminary proxy statement/prospectus in connection with Aytu's proposed acquisition of Innovus is now effective following the companies' filing with the U.S. SEC. Aytu and Innovus have now set their respective special shareholder meetings for Feb. 13, during which the companies' shareholders will vote on the merger agreement. When the deal is complete, Aytu will have more than 35 consumer products for treating diabetes, men's health, sexual wellness and respiratory health.
Bavarian Nordic A/S, of Copenhagen, Denmark, completed the sale of its priority review voucher (PRV) to an undisclosed buyer. Upon completion, the company received a cash consideration of $95 million. Bavarian Nordic was awarded the PRV in September upon approval of Jynneos (MVA-BN) to prevent smallpox and monkeypox by the FDA. A PRV entitles the holder to FDA priority review of a single NDA or BLA, which reduces the target review time and may potentially lead to an expedited approval.
Emmaus Life Sciences Inc., of Torrance, Calif., reported that there are inaccuracies in a draft evidence report by ICER, which examines the effectiveness and value of crizanlizumab, voxelotor and L-glutamine in treating sickle cell disease (SCD). Emmaus said there will be a negative impact on the SCD community. The FDA approved Emmaus’ Endari (L-glutamine oral powder) in July 2017. And although the ICER draft report appropriately cites the efficacy and safety data of Endari, the company said, the draft failed to accurately translate the data into an economic-based model due to what the company calls inaccurate assumptions.
Eyepoint Pharmaceuticals Inc., of Watertown, Mass., and Ocumension Therapeutics Ltd., of Shanghai, announced an exclusive license agreement for the development and commercialization of Dexycu (dexamethasone intraocular suspension) 9% to treat postoperative inflammation following ocular surgery in mainland China, Hong Kong, Macau and Taiwan. Dexycu is currently marketed by Eyepoint in the U.S. Eyepoint maintains worldwide development and commercialization rights outside of the territories licensed to Ocumension. Under the terms of the deal, Eyepoint will receive an up-front payment of $2 million and royalties on product sales by Ocumension. Eyepoint is eligible to receive up to an additional $12 million if certain future prespecified development, regulatory and commercial sales milestones are achieved by Ocumension. In exchange, Ocumension will receive exclusive rights to develop and commercialize the product in the agreed upon territories. Eyepoint will also be the exclusive supplier of Dexycu to Ocumension for clinical use and commercial sale.
Geovax Labs Inc., of Atlanta, said it signed a letter of intent with Bravovax Co. Ltd., of Wuhan, China, to jointly develop a vaccine against the new coronavirus (known as 2019-nCoV). Under the terms, Geovax will use its MVA-VLP vaccine platform and expertise to design and construct the vaccine candidate using genetic sequences from the ongoing coronavirus outbreak originating in Wuhan. Bravovax will provide further development, including testing and manufacturing support, as well as direct interactions with Chinese public health and regulatory authorities.
Helsinn Group, of Lugano, Switzerland, granted exclusive licensing rights to commercialize Akynzeo (netupitant/palonosetron) and Onicit (palonosetron hydrochloride) in Russia and the CIS region for the prevention of chemotherapy-induced nausea and vomiting (CINV) to Berlin-Chemie AG, of Berlin. Akynzeo, a fixed-dose combination anti-emetic therapy targeting both critical pathways of acute and delayed CINV, was granted registration in Russia in October, and the product will be launched in the country this year. Onicit, an anti-emetic for the prevention of CINV, was registered in Russia in 2011 and will be relaunched with Akynzeo. Besides Russia, the licensing agreements with Berlin-Chemie cover Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine and Uzbekistan. Helsinn will retain all international development rights.
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, reported real-world data on Xermelo’s (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome at the ASCO 2020 Symposium. Xermelo is FDA-approved to treat carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy but is not currently approved for any other use. Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12 months demonstrated significant mean tumor size reduction of 0.59 cm after initiation of telotristat ethyl.
Nanthealth Inc., of Culver City, Calif., offered new real-world data on treatment patterns for patients with advanced colorectal cancer (CRC) during a poster session at the 2020 Gastrointestinal Cancer Symposium sponsored by the American Society of Clinical Oncology. The firm’s presentation examined therapeutic preferences and treatment patterns among advanced CRC patients using data from Nanthealth’s Eviti Connect, an evidence-based treatment intelligence and web-based oncology decision support platform. Detailed information from 6,325 treatment plans was analyzed to identify treatment patterns using regorafenib (Stivarga, Bayer AG) and trifluridine plus tipiracil (Lonsurf, Taiho Pharmaceutical Co. Ltd.) for advanced CRC patients as third-line of therapy. Across all 6,325 treatment plans submitted for that patient population, regorafenib (n=217) or trifluridine plus tipiracil (n=144) was the submitted treatment in 361 (5.5%) of the treatment plans, making them the ninth and 13th most frequently requested drugs (excluding growth factors, anti-emetics and leucovorin) in that setting. While the total number of treatment plans for regorafenib was higher than that for trifluridine plus tipiracil, the submission of the combo has increased over time, consistent with the drug’s more recent introduction into the market, Nanthealth said. Separately at the symposium, the company disclosed results of a 50-gene breast cancer RNA subtype classifier applied to 167 colorectal CRC patients. The analysis showed that conventional testing methods may miss potentially actionable HER2 signaling in CRC patients vs. Nanthealth’s approach.
Ningbo Newbay Medical Technology Co. Ltd., of Ningbo, China, a subsidiary of Ningbo Tai Kang Medical Technology Co. Ltd., said it entered a licensing agreement with Genentech, of South San Francisco, a member of the Roche Group, under which it was granted exclusive global rights to further develop and commercialize GDC-0570, a small-molecule Pan-PIM inhibitor that is active against multiple myeloma and prostate cancer in preclinical models. Under the terms, Genentech will receive an up-front payment and will be eligible to receive milestone payments linked to clinical, regulatory and commercial successes, as well as royalty payments.
Novo Nordisk A/S, of Bagsvaerd, Denmark, and Highres Biosolutions Inc., of Beverly, Mass., agreed to collaborate on the design of a robotic platform for high-throughput biologics engineering and characterization. The integration of a multisystem robotics platform with sophisticated software control architecture will enable a digital transformation and accelerated discovery for Novo Nordisk’s peptide and large-molecule therapeutics research, the companies said. Financial terms were not disclosed.
Oncoceutics Inc., of Philadelphia, said the National Brain Tumor Society has committed to providing more than $200,000 in funding, with the potential for multiple years, to support a phase II trial of ONC-201, the first imipridone dopamine receptor D2 antagonist (DRD2), in a molecular subset of high-grade gliomas. The study will evaluate the efficacy of single-agent ONC-201 in patients who have a recurrent form of high-grade glioma that exhibits low expression of epidermal growth factor receptor, which is associated with elevated DRD2 expression and ONC-201 sensitivity.
Oncolytics Biotech Inc., of San Diego, said a poster presentation highlighting statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer was presented at the 2020 Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology in San Francisco. The drug is an intravenously delivered immuno-oncolytic virus. Results correlate CEACAM6 levels with long-term benefit in patients with pancreatic cancer, the company said.
Pharmamar SA, of Madrid, Spain, and Bionical Emas Ltd., of Derbyshire, U.K., disclosed the launch of an expanded access program for lurbinectedin to treat patients in the U.S. with relapsed small-cell lung cancer (SCLC) who are unable to enter clinical trials and for whom there are no appropriate alternative treatments. The drug is an inhibitor of trans-activated RNA polymerase II transcription. In December, Pharmamar filed an NDA for the treatment of relapsed SCLC with the FDA under the accelerated approval program.
Pieris Pharmaceuticals Inc., of Boston, disclosed in an 8-K filing posted late Jan. 24 that Aska Pharmaceutical Co. Ltd., of Tokyo, said it does not intend to exercise its option to obtain an exclusive license to develop and commercialize PRS-080, a candidate targeting hepcidin, in Japan and certain other Asian markets territories under the Feb. 27, 2017, option agreement. Aska’s decision was based on a strategic portfolio review as well as certain commercial considerations. In view of Pieris’ strategic focus in immuno-oncology and respiratory diseases, including the continued development of PRS-343, PRS-344 and PRS-060, the company said it does not intend to continue the development of PRS-080.
Sorrento Therapeutics Inc., of San Diego, said, after reviewing the latest acquisition proposal in consultation with advisors, the company’s board determined the offer significantly undervalues Sorrento and is not in the best interest of company stockholders. The board unanimously rejected the acquisition proposal. Further details were not disclosed. Sorrento’s management said it continues to execute on the core drug development and to pursue multiple potential strategic alliances and transactions.
The National Comprehensive Cancer Network Oncology Research Program disclosed plans to evaluate futibatinib (TAS-120), an inhibitor of the fibroblast growth factor receptor (FGFR), from Taiho Pharmaceutical Co. Ltd., of Tokyo, The project will include preclinical, translational and clinical trials using futibatinib as a monotherapy and in biologically relevant combination regimens for malignancies with FGFR 1-4 aberrations. The project will be the first of the network’s research programs to study an FGFR inhibitor. Specific research areas will be determined by a group of cancer research experts from member institutions who form a request for proposals development team. The research funding is supported by a $2 million grant from Taiho.
Tilt Biotherapeutics Ltd., of Helsinki, said it signed a license agreement with Biotheus Inc., of Guangdong, China, under which it granted Biotheus rights for development and commercialization of oncolytic virus TILT-123 in greater China (including Mainland China, Hongkong, Taiwan and Macau). The license agreement includes an up-front payment as well as milestone payments linked to finishing of various phases of clinical development and obtaining marketing approvals. Under the agreement, Tilt is eligible to receive up-front and milestone payments as well as significant royalties on future sales.
Veloxis Pharmaceutical A/S, of Copenhagen, which is being acquired by Asahi Kasei Pharma Denmark A/S, part of Tokyo-based Asahi Kasei Corp., decided to request Nasdaq Copenhagen to remove trading and listing of the company’s shares. The last trading day is expected to be Feb. 24. The firms agreed in November to the $1.3 billion takeover by Asahi Kasei, which gets control of Envarsus XR, an improved formulation of tacrolimus for prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus and for use in de novo transplant patients.