60 Degrees Pharmaceuticals LLC, of Washington, said Singapore General Hospital (SGH) received a grant from Singapore's National Medical Research Council to support a phase II trial among dengue fever patients. The company and SGH will evaluate the safety and effectiveness of antiviral celgosivir and disease-modifying agent modipafant. Earlier animal studies suggest those drugs could prove effective in dengue fever patients. The trial is set to start in March 2016.
Astex Pharmaceuticals, of Pleasanton, Calif., a unit of Otsuka Pharmaceutical Co. Ltd., of Tokyo, said clinical data for the hypomethylating agent, guadecitabine (SGI-110), were published in The Lancet Oncology. The first-in-human trial of 93 heavily pretreated patients (74 with acute myeloid leukemia, or AML, and 19 with myelodysplastic syndrome, or MDS) suggested that guadecitabine was well tolerated, easily administered and biologically and clinically active in patients, with dose-related DNA demethylation associated with clinical responses in patients treated with guadecitabine. The data informed the design of the company's phase II study in treatment-naïve and relapsed/refractory AML and MDS and the recently launched 800-patient global phase III ASTRAL-1 study.
Beigene Ltd., of Beijing, has established its first good manufacturing practices-certified manufacturing facility for commercial use at Biobay in the Suzhou Industrial Park in Suzhou, China. The new 9,000-square-meter (96,875 square foot) facility expands the company's production facilities and will supply materials for future clinical trials and subsequent commercial demand. It is expected to be completed by 2017.
Benitec Biopharma Ltd., of Sydney, priced its U.S. IPO of 1.5 million American depositary shares (ADSs), representing 30 million fully paid ordinary shares of Benitec and warrants to purchase another 500,000 ADSs, or 10 million fully paid ordinary shares, at $9.21 apiece per ADS and 1 cent per warrant, for expected gross proceeds of $13.8 million. Each ADS represents 20 ordinary shares of Benitec. The warrants, which have an exercise price of $5.50 apiece, may be exercised immediately and expire on Aug. 21, 2020. Benitec granted the underwriters a 45-day option to purchase up to 225,000 additional ADSs and/or 75,000 warrants to purchase ADSs to cover overallotments. The company said proceeds from the offering will advance its therapeutic programs, which are based on gene silencing programs using its DNA-directed RNA interference, or ddRNAi, technology. The ADSs and warrants began trading Tuesday on Nasdaq as BNTC and BNTCW, respectively. Shares slumped to $7.97 for a loss of $1.24, or 13.5 percent, on the day. The IPO closed by Aug. 21. Maxim Group LLC is sole book-running manager.
Bioquiddity Inc., of San Francisco and Hong Kong-based Lee's Pharmaceutical Ltd. have signed a strategic license and supply agreement for the registration and commercialization of Bioquiddity's ropivacaine and propofol infusion pharmaceutical products in the People's Republic of China, Taiwan, Hong Kong and Macau.
Cardiome Pharma Corp., of Vancouver, British Columbia, said that its subsidiary, Correvio International Sàrl, has entered an exclusive license and supply agreement with Shanghai-based Eddingpharm Co. Ltd. to distribute and commercialize Aggrastat (tirofiban hydrochloride) in China. Finanicial terms of the agreement include milestone payments and minimum annual commercial commitments, but the specifics of those payments were not disclosed. Cardiome is already working with Eddingpharm on another cardiovascular therapy, Brinavess (vernakalant), for which Eddingpharm plans to initiate phase I studies in the near-term, and upon successful completion, begin a registration phase III program by year-end. Under the terms of that agreement, Eddingpharm provided Cardiome an up-front payment of $1 million and specific annual commercial goals for Brinavess. Cardiome is also eligible to receive regulatory milestone payments of up to $3 million.
Celltrion Healthcare Co. Ltd., of Incheon, South Korea, notified the FDA that Janssen Biotech Inc., of Horsham, Pa., part of Johnson & Johnson, has filed a patent infringement complaint against its Remsima, a proposed biosimilar to Janssen's Remicade (infliximab). Under the Biologics Price Competition and Innovation Act (BPCIA), an applicant for a biosimilar or interchangeable product must notify the agency within 30 days after being served with an infringement complaint. The FDA is then required to publish a notice of the complaint in the Federal Register. That notice was published in Monday's Federal Register. The litigation follows completion of the BPCIA patent exchange dance by Celltrion and Janssen. The latest of the remaining U.S. Remicade patents protecting Remicade will expire in September 2018. (See BioWorld Insight, Aug. 17, 2015.)
Daiichi Sankyo Co. Ltd., of Tokyo, said it enrolled the first patient in ETNA-AF-Europe (Edoxaban Treatment in routiNe clinical prActice - Atrial Fibrillation - Europe), and started the ETNA-VTE-Europe (Edoxaban Treatment in routiNe clinical prActice - Venous ThromboEmbolism - Europe) registries, both of which are designed to collect information on how once-daily Lixiana (edoxaban), a once-daily, factor Xa inhibitor, is being used in real-world settings. ETNA will aim to collect data from about 30,000 patients taking edoxaban during a follow-up period of up to four years.
Engeneic Ltd., of Sydney, said the first patient was dosed in its phase I Tailored-EDV (Engeneic Dream Vector) trial at the Northern Cancer Institute in Sydney. The open-label feasibility study is investigating a single delivery agent (epidermal growth factor receptor-EDV) packaged with clinician's choice of therapy in patients with advanced solid tumors who have no additional curative treatment options. The study is enrolling patients with a variety of intractable tumor indications, including triple-negative breast cancer, non-small-cell lung cancer and metastatic colorectal cancer, who will be dosed intravenously with a combination of EGFR-EDVs, chemotherapy and functional nucleic acids, such as siRNA, which may address issues of chemotherapy resistance. The trial is designed to expand data on the EDV nanocell technology and help to inform the appropriate indications and payloads to pursue in phase II trials. (See BioWorld Today, July 15, 2015.)
Legochem Biosciences Inc., of Daejeon, South Korea, said it signed a license and commercialization agreement with Fosun Pharma, of Shanghai, China, part of the Fosun Pharma Group, for one of Legochem's next-generation antibody-drug conjugate (ADC) products and related technology for the Greater China market. The agreement is for a maximum of KRW20 billion (US$16.9 million). The companies also inked a memorandum of understanding for three other ADC targets. Under the terms, Fosun will obtain commercial rights in the Greater China area including Mainland China, Hong Kong, Macau and Taiwan, and will develop the product, while Legochem will receive milestones and royalties, and retain commercial rights outside China. Further financial terms were not disclosed.
MMJ Phytotech Ltd., of Sydney, received through a subsidiary approval in Israel to commence a phase I study to assess the safety and performance of its oral capsule formulations. Initial stability studies have indicated an extended shelf life of the oral capsule formulation at room temperature, providing the potential to increase market share by lower product costs and increased patient compliance, the company said. The new trial will start by November, with first results expected in the first quarter of next year.
Mylan NV, of Hertfordshire, UK, received an FDA warning letter citing conditions at three of its drug manufacturing facilities in Bangalore, India, including two that were part of its 2013 acquisition of Agila Specialties. Inspections of the plants revealed contamination risks in aseptic areas stemming from torn gloves and gowns and workers' behavior, such as bumping into each other in fill areas or leaving barriers open while performing other duties. A number of other problems were cited, including the failure to determine the root cause of contaminated product or defects. Several of the violations were recurrent and long-standing, the FDA said. Thus, the problems noted by the inspectors "raise questions about the ability of [Mylan's] current corporate quality system to achieve overall compliance" with good manufacturing practices, according to the letter. Although acknowledging that Mylan acquired the Agila facilities recently, the FDA said a Sept. 9, 2013, warning letter should have put the drugmaker on notice about the problems at the plants. "Even without this warning letter, your corporate quality system should have detected and corrected the forgoing violations without FDA intervention," the agency concluded.
NMT Pharmaceuticals Pte Ltd., of Singapore, said it signed an agreement with Cao Pharmacueticals Inc., of Houston, to acquire exclusive worldwide licensing rights to further develop and market CZ-48, an anticancer product that was co-developed by NMT and Cao. CZ-48 is an analogue of camptothecin, which is stable and resistant to inactivation while circulating in the bloodstream. According to terms, the two companies will secure funding for Cao for its operations and clinical trials in the U.S. No further financial terms were disclosed.
Phosplatin Therapeutics Inc., of New York, said it granted a regional license for its platinum agent, PT-112, to a U.S.-based pharmaceutical company with extensive operations in China for development and commercialization in China and certain adjacent territories. The agreement grants the partner the rights to develop and market PT-112 in greater China for use in the treatment of oncology indications. PT-112 is a member of the phosphaplatin family of compounds, in phase I development in the U.S. against solid tumor. Under terms of the agreement, Phosplatin has granted its partner exclusive development and commercialization rights to PT-112 in China, as well as the Hong Kong SAR, the Macau SAR, and Vietnam. The partner also has options to add Taiwan and South Korea to the territories covered by the agreement. In exchange, Phosplatin is eligible to receive up-front and milestone payments as well as tiered royalties based on commercial sales in the territory, though exact terms were not disclosed.
Presage Biosciences Inc., of Seattle, said it received a strategic investment from Takeda Ventures Inc., the venture capital arm of Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. Terms of the transaction were not disclosed. The company's CIVO platform technology can be used to evaluate up to eight combinations of drugs or individual compounds, both investigational and approved, all without exposing patients to the toxicity of systemic dosing.
Researchers from the Reproductive Medicine Network have identified two new genetic variants that predict an increased risk of polycystic ovarian syndrome (PCOS), as well as replicated a third association that had been previously identified. PCOS is a frequent cause of infertility. Aside from its reproductive symptoms of anovulation and excessive levels of androgen, the disorder is also characterized by metabolic issues. In their work, the authors analyzed women of European descent in a three-stage meta-analysis procedure, and they identified three loci that were associated with increased PCOS risk. One of those loci had been identified before in a GWAS of women of Asian descent. One of the new loci is also linked to luteinizing hormone levels, and so the authors concluded that "these findings implicate neuroendocrine changes in disease pathogenesis." The paper appeared in the Aug. 18, 2015, issue of Nature Communications.
Specialised Therapeutics Australia Pty Ltd., of Melbourne, Australia, said it struck an exclusive license and commercialization deal with Pharmamar SA, of Madrid, to market and distribute oncology drug Aplidin (plitidepsin) in Australia and New Zealand. Under the terms, Pharmamar will receive an up-front payment, royalties and additional remunerations for regulatory and sales milestones. Specific terms were not disclosed.
Swedish Orphan Biovitrum AB, of Stockholm, with partner A. Menarini Australia Pty. Ltd., of Sydney, received marketing authorization in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis, a rare form of juvenile chronic arthritis.
Sygnis AG, of Heidelberg, Germany, said it signed a distribution agreement with Shanghai-based Nanodigmbio Co. Ltd. for the commercialization of its product portfolio in China. The company granted Nanodigmbio the rights to promote, market and sell all existing, as well as future, products including the Trueprime products for primer-free whole-genome amplification as well as Sunscript thermostable reverse transcriptase kits for the translation of RNA into DNA.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said the EMA has accepted the marketing authorization application for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. The submission was primarily based on the results of the first pre-specified interim analysis of the pivotal phase III trial TOURMALINE-MM1, an international, randomized, double-blind, placebo-controlled trial of 722 patients designed to evaluate the superiority of ixazomib plus Revlimid (lenalidomide, Celgene Corp.) and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory disease. Patients continue to be treated to progression and will be evaluated for long-term outcomes.
Vical Inc., of San Diego, said the FDA granted a qualified infectious disease product designation to the company's antifungal candidate, VL-2397, for treatment of invasive aspergillosis. In preclinical studies to date, VL-2397 has demonstrated faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. Vical has an exclusive worldwide license to VL-2397 under a March agreement with Tokyo-based Astellas Pharma Inc.
Visterra Inc., of Cambridge, Mass., reported that new preclinical results for VIS410, a monoclonal antibody in development for the treatment of seasonal and pandemic influenza, were published online in the Proceedings of the National Academy of Sciences. In the paper, "A Broadly Neutralizing Human Monoclonal Antibody is Effective Against H7N9," Visterra scientists and scientists at the Massachusetts Institute of Technology, University of Hong Kong and Utah State University describe preclinical data demonstrating that VIS410 binds to a wide range of representative group 1 and group 2 influenza viruses, and the antibody protected mice challenged with the H3N2 and H7N9 virus. Additionally, the paper presents preclinical data that VIS410 demonstrated a synergistic effect with Tamiflu (oseltamivir, Roche AG), an existing small-molecule antiviral drug. Visterra said the data support the continued development of the candidate as a single-administration treatment for seasonal and pandemic influenza A. (See BioWorld Today, Oct. 2, 2014.)