Allergan plc, of Dublin, and its subsidiaries, along with Qualicaps Co. Ltd., reached a settlement on litigation with Zydus Pharmaceuticals (USA) Inc., of Pennington, N.J., and Cadila Healthcare Ltd., of Ahmedabad, India, regarding U.S. Patent No. 6,649,180 and Allergan's Delzicol (mesalamine) product. The '180 patent is listed in the Orange Book in connection with Delzicol and is slated to expire on April 13, 2020. Allergan agreed that, if approved by the FDA, Zydus and Cadila may be able to market generic versions of Delzicol in the U.S. beginning March 1, 2020, or earlier under certain circumstances. Additional terms were not disclosed.
AOP Orphan Pharmaceuticals AG, of Vienna, and Pharmaessentia Corp., of Taipei, Taiwan, announced results from the PROUD-PV study, a pivotal phase III study in polycythemia vera (PV). The experiment assessed the efficacy and safety of ropeginterferon alfa-2b versus hydroxyurea (HU) in patients with polycythemia vera. This study is part of the development program to support marketing authorizations of ropeginterferon alfa-2b (AOP2014/P1101) in Europe and in the U.S. Ropeginterferon alfa-2b, a long-acting, mono-pegylated proline interferon, administered once every two weeks is expected to be the first interferon approved for PV worldwide, and the only approved first-line treatment for PV in the U.S. At 12 months, complete hematologic response (CHR) was achieved in a high proportion of patients and non-inferiority was demonstrated (43.1 percent for ropeginterferon alfa-2b vs. 45.6 percent for HU in the intent-to-treat-population, p=0.0028). The pre-specified primary endpoint, which was a composite of CHR and spleen length normality, was confounded by the fact that the median spleen length was almost normal at baseline and the observed change was not clinically relevant (21.3 percent for ropeginterferon alfa-2b versus 27.6 percent for HU in the intent-to-treat-population, p=0.2233). Ropeginterferon alfa-2b showed significantly better tolerability than HU.
Breckenridge Pharmaceutical Inc., of Boca Raton, Fla., launched the abbreviated new drug application (ANDA) for armodafinil tablets in 50 mg, 150 mg and 250 mg strengths, following final approval by the FDA. The product is a generic version of Nuvigil, marketed by Cephalon Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., of Jerusalem. The drug is indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift work disorder. Breckenridge and Cephalon previously inked a confidential settlement that included a license to market the ANDA 180 days after the initial launch of generic versions of Nuvigil. Natco Pharma Ltd., of Hyderabad, India, which owns the ANDA, is participating in the launch.
Casi Pharmaceuticals Inc., of Rockville, Md., said that the China FDA accepted its import drug registration application for Evomela (melphalan) for injection for review. The compound received FDA approval earlier this year for multiple myeloma patients as a high-dose conditioning treatment prior to autologous stem cell transplantation and as palliative treatment for patients who are not candidates for oral therapy.
Cempra Inc., of Chapel Hill, N.C., said Toyama Chemical Co. Ltd., of Tokyo, a subsidiary of Fujifilm Holdings Corp., has begun phase III clinical trials with solithromycin, a ketolide antibiotic, in Japan for patients with community-acquired bacterial pneumonia (CABP) and other respiratory infections. Earlier this year, Toyama completed a phase II study of 135 Japanese patients with mild to moderate CABP. These data, and the data from Cempra's studies, were reviewed by Japan's Pharmaceuticals and Medical Devices Agency before finalizing the phase III study protocol. Toyama owns exclusive rights to develop and commercialize solithromycin in Japan for respiratory tract infections and other indications in adults and pediatric patients.
CSL Ltd., of Melbourne, Australia, said it advanced three therapies based on targeted monoclonal antibody (MAb) technologies into phase I studies in Australia. CSL324 is an anti-GCSFR MAb that could be used to treat rare inflammatory diseases caused by overactive neutrophil activity. CSL324 works by regulating white blood cell activity in autoimmune disease to prevent overactive neutrophils from destroying healthy tissue. The phase I trial will explore proof of biological concept, with particular focus on identifying effective therapeutic dosing. CSL312 is an anti-factor XIIa MAb in development to treat multiple indications, including hereditary angioedema, and to prevent thrombosis. CSL346 is an anti-VEGF-B MAb that could be used to control glucose absorption in insulin-resistant patients with type 2 diabetes by targeting fatty acid metabolism.
Daiichi Sankyo Co. Ltd., of Tokyo, said the FDA granted fast track designation to its HER2-targeting antibody-drug conjugate, DS-8201, to treat HER2-positive unresectable and/or metastatic breast cancer in patients who progressed after prior treatment with HER2-targeted therapies, including ado-trastuzumab emtansine, or T-DM1 (Kadcyla, Roche Holding AG). In other news, Daiichi Sankyo announced preliminary safety and efficacy data from a phase I study of DS-3032, an investigational oral selective MDM2 inhibitor, suggesting that DS-3032 may be a promising treatment for hematological malignancies including relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Preliminary results from the dose escalation part of the phase 1 study of DS-3032 found that the maximum tolerated dose of DS-3032 was determined to be 160 mg once daily for 21 days in a 28 day cycle based on results from 37 patients who received at least one dose of DS-3032. Complete remission was seen in two patients with relapsed/refractory AML receiving 120 mg and 160 mg of DS-3032 with a duration of approximately four months and 13 months, respectively. One patient with high-risk MDS receiving the 120 mg dose of DS-3032 achieved marrow complete remission with platelet improvement for four months. Each of the three patients experiencing a complete response showed a TP53 gene mutation while receiving treatment, which was not identified at the start of the study.
H. Lundbeck A/S, of Valby, Denmark, and Otsuka Pharmaceutical Co. Ltd., of Tokyo, said the FDA determined that the supplemental new drug application for the expanded labeling of Abilify Maintena, an intramuscular depot formulation of atypical antipsychotic aripiprazole, for the maintenance treatment of bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed. The PDUFA date is July 28, 2017.
Innovus Pharmaceuticals Inc., of San Diego, signed an exclusive license and distribution agreement with J&H Co. Ltd. for the commercialization of Zestra in South Korea. The exclusive 10-year agreement includes a minimum of $2 million per year in sales to the company for a total of $20 million over the life of the agreement. It's Innovus' 15th partnership outside the U.S.
Japan's Pharmaceutical and Medical Devices Agency is joining an international collaboration on API good manufacturing practice inspections that includes Australia's Therapeutic Goods Administration, the EMA, the FDA, Health Canada and the World Health Organization. Participants in the collaboration share information on inspections of API manufacturers located outside the participating countries. The goal is to increase cooperation and mutual reliance between regulators and ensure the best use of inspection resources worldwide.
Living Cell Technologies Ltd. (LCT), of Melbourne, Australia, and Auckland, New Zealand, completed the placement of approximately 74.1 million shares to institutional and professional investors, priced at 8.5 cents apiece, to raise $6.3 million. The company said funds will be used to continue research and development, including completion of the phase IIb trial of Ntcell to treat Parkinson's disease, and to increase manufacturing efficiency. If the trial is successful, LCT said it will apply for provisional consent to treat paying patients in New Zealand and will prepare for commercialization. Hunter Capital Advisors acted as sole lead manager for the placement.
Luye Pharma Group Ltd., of Hong Kong, completed its acquisition of the transdermal drug delivery systems business from Acino Pharma AG, of Aesch, Switzerland. Financial terms were not disclosed.
Mars Innovation, of Toronto, and the Korea Health Industry Development Institute signed a five-year global partnership to commercialize the advances in biomedical and health care innovations, expected to generate approximately 10 startups, collectively valued at more than $100 million. The agreement calls for a joint commercialization platform with collaboration from Ontario and South Korea biomedical companies and health institutions.
Minomic International Ltd., of Sydney, closed an oversubscribed financing round of A9.2 million (US$6.8 million) by raising another A5 million (US$3.7 million). Funds will support commercialization of the company's cancer diagnostic test, Micheck, and its first-in-human trial examining the monoclonal antibody, MIL-38, to detect and treat prostate and other cancers. The company also plans to advance additional therapeutic agents from its monoclonal antibody technologies.
Oncolys Biopharma Inc., of Tokyo, said its board resolved to execute a license agreement with Jiangsu Hengrui Medicine Co. Ltd., of Lianyungang, China, for oncolytic virus telomelysin, to secure the exclusive license in mainland China, Hong Kong and Macau, following a conclusion of May letter of intent. Under the terms, Oncolys will be eligible to receive an up-front payment and development and sales milestones. Further financial and contractual details were not disclosed. (See BioWorld Today, May 23, 2016.)
Shionogi & Co. Ltd., of Osaka, Japan, presented data at the Asia-Pacific Congress of Clinical Microbiology and Infection in Melbourne, Australia, from a phase II study of S-033188, a cap-dependent endonuclease inhibitor targeting influenza. Data from the 400-patient, randomized trial showed that 40-mg S-011388 was associated with a shorter time to alleviation of systemic symptoms compared with placebo, such as feverishness/chills (median 23 hours vs. 28.8 hours, p=0.0216), headache (37.9 hours vs. 43.7 hours, p=0.0304), fatigue (31.1 hours vs. 42.7 hours, p=0.0463) and aches and pains (25.4 hours vs. 41.9 hours, p=0.0145) and provided more rapid resolution of fever (28.9 hours vs. 45.3 hours, p<0.0001). With regard to respiratory symptoms, nasal congestion was more rapidly resolved with 40-mg S-033188 vs. placebo (21.9 hours vs. 42.8 hours, p=0.0081); however, sore throat and cough tended to persist despite rapid viral clearance in patients treated with S-033188. Shionogi has initiated a phase III program targeting otherwise healthy individuals and those at high risk of influenza-associated complications.
Solasia Pharma K.K., of Tokyo, said that it inked an agreement with Meiji Seika Pharma Co. Ltd., also of Tokyo, for licensing and distribution of episil (SP-03) oral liquid in Japan. Solasia will be responsible for obtaining approval of episil in Japan to treat pain associated with oral mucositis, and Meiji will commercialize, distribute and promote the drug. Under the terms, Solasia will receive upfront and milestone payments, as well as tiered royalties.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said it will invest more than €100 million (US$106 million) to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany. Takeda is enrolling patients in its TIDES (Tetravalent Immunization against Dengue Efficacy Study) phase III trial testing a live-attenuated tetravalent dengue vaccine candidate, TAK-003.
Uni-Bio Science Group Ltd., of Hong Kong, said it entered an agreement with Beijing Sun-Novo Pharmaceutical Research Co. Ltd., of China, to co-develop multiple small-molecule drugs. The first project planned is Acarbose tablets to treat type 2 diabetes. Under the terms, Sun-Novo will complete the chemistry, manufacturing and control processes and the bioequivalence study of Acarbose, and then transfer the production technology to Uni-Bio Science's subsidiary. Uni-Bio apply to the China FDA for drug licenses and commercialize the product following approval. The companies plan to start in 2017 and aim to launch sales in the market around 2020 to 2021.