Abbvie Inc., of North Chicago, said it strengthened its manufacturing capabilities following the opening of a small-molecule active pharmaceutical ingredient (API) facility at a Singapore manufacturing site. It will support the growth of the company’s oncology and women’s health pipeline. The 120,000-square-meter site, located in the Tuas Biomedical Park, is Abbvie’s first manufacturing facility in Asia and will also include a biologics manufacturing facility that is expected to be fully operational by the end of 2018. Those facilities represent an investment of more than $400 million (US$294 million) in Singapore and will employ more than 250 new employees.
Aegerion Pharmaceuticals Inc., of Cambridge, Mass., said Juxtapid (lomitapide), for patients with homozygous familial hypercholesterolemia (HoFH), has been approved in Japan. The decision was based on a phase III study in Japanese patients, which evaluated the safety and efficacy of the medicine to reduce LDL-C levels in nine patients with HoFH. The findings were consistent with the known safety and efficacy profile of the drug. The company’s shares (NASDAQ:AEGR) closed Thursday at $3.06, up 57 cents or 22.9 percent.
Albireo Ltd., of Boston, disclosed positive topline results from a pivotal phase III trial with elobixibat in chronic constipation conducted in Japan. Elobixibat met the primary endpoint, change in the number of weekly spontaneous bowel movements (SBMs) from baseline to the first treatment week compared with placebo, with high statistical significance. The SBM endpoint is the endpoint required to support regulatory approval to treat chronic constipation in Japan. EA Pharma Co. Ltd., of Tokyo, exclusive licensee of elobixibat to treat gastrointestinal disorders in Japan and other select countries in Asia, conducted the trial. Albireo expects that EA will file a new drug application for elobixibat in Japan in the first quarter of 2017. Elobixibat inhibits the ileal bile acid transporters (IBAT and also sometimes referred to as the apical sodium-dependent bile acid transporter) in the terminal ileum to increase secretion and motility in the large bowel without negatively affecting the small intestine, the company said.
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said its partner Otsuka Pharmaceutical Co. Ltd., of Tokyo, gained approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Iclusig (ponatinib), a kinase inhibitor, to treat chronic myeloid leukemia resistant or intolerant to previous drug treatment and relapsed or treatment-resistant Philadelphia chromosome-positive acute lymphoblastic leukemia. Ariad will receive a $10 million milestone payment from Otsuka, according to their collaboration agreement inked in December 2014.
Athenex Inc., of Buffalo, N.Y., and Sungen Pharma LLC, of Hong Kong, signed a joint venture agreement to launch and market seven undisclosed pharmaceutical products, both injectable and solid oral dosage, in the U.S. Many of those products are therapeutically relevant to the Athenex pipeline of products under development, the companies said. All of the products are approved by the FDA and will be launched in the near future by Athenex, the company said.
Cheng Fong Chemical Co. Ltd., an API manufacturer, received an FDA warning letter citing filthy conditions at its plant in Taoyuan City, Taiwan. During an inspection in April, an FDA investigator noted filth, insects, wet layers of an unidentified material on the floors and foul odors in the cold rooms used to store raw materials and intermediates used in producing the API. Company officials told the investigator that the rooms had never been cleaned. The investigator also saw corrosion, pitting, dirt and leaks on and around the company’s drug manufacturing equipment. In a response to the FDA, the company acknowledged that the poor condition of its equipment was the likely source of complaints about foreign matter in a batch of its API. The agency cited Cheng Fong for not adequately investigating the customer complaints. Rather than evaluating the reserve samples for the batch that generated the complaints, the company evaluated a different batch. Although it found foreign matter in the second batch, too, the company didn’t expand the investigation to other batches, identify the particles in either batch or take adequate measures to prevent future contamination, according to the FDA letter.
Chugai Pharmaceutical Co. Ltd., of Tokyo, and Maruho Co. Ltd., of Osaka, Japan, said they entered a license agreement in which Chugai granted Maruho rights to develop and market nemolizumab (CIM331), an anti-IL-31 receptor A humanized monoclonal antibody in the skin disease area, for the Japanese market. Nemolizumab currently is in development for atopic dermatitis and pruritus in hemodialysis patients by Chugai. Under the terms, Chugai will receive up-front and other payments from Maruho. Specific terms were not disclosed. The development and marketing of nemolizumab for pruritus in hemodialysis patients will be continued solely by Chugai.
Cytokinetics Inc., of South San Francisco, said the Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the 2016 amendment to its license with Tokyo-based Astellas Pharma Inc. originally inked in 2013 and amended in 2014. In July, the companies expanded the collaboration related to the research, development and commercialization of skeletal muscle activators. The up-front payment of $65 million from Astellas to Cytokinetics is now due and payable within 30 days. (See BioWorld Today, July 28, 2016.)
Daiichi Sankyo Co. Ltd., of Tokyo, agreed to acquire a license to the Azymetric and Effector Function Enhancement and Control Technology , or EFECT, platforms developed by Zymeworks Inc., of Vancouver, British Columbia, to develop a bispecific antibody. Zymeworks is set to receive an undisclosed up-front technology access fee and research support and is eligible for additional payments upon the achievement of undisclosed preclinical, clinical and commercial milestones, plus double-digit tiered royalties on global sales. Zymeworks also agreed to license immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop and commercialize multiple bispecific products globally in exchange for royalties on product sales. Additional terms were not disclosed.
Emmaus Life Sciences Inc., of Torrance, Calif., said it raised $20 million in gross proceeds in a private placement from Korean-based public companies KPM Tech Co. Ltd. and Hanil Vacuum Co. Ltd. KPM and Hanil acquired $17 million and $3 million, respectively, of Emmaus’ shares of common stock at $4.50 per share. As part of the transaction, Emmaus will invest $13 million in KPM shares and $1 million in Hanil shares. The company will use the remaining net proceeds of approximately $6 million, for working capital and general corporate purposes.
Galapagos NV, of Mechelen, Belgium, said it completed discussions with regulatory authorities in the U.S. and Europe to initiate the filgotinib phase III DIVERSITY study in Crohn’s disease and the phase IIb/III SELECTION study in ulcerative colitis. Both studies will investigate the efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in patients with moderately to severely active disease, including those with prior antibody therapy failure. The studies will recruit approximately 1,300 patients each from the U.S., Europe, Latin America, Canada and Asia/Pacific. The SELECTION study will include a futility analysis to serve as the phase IIb portion of the integrated study. Men and women in both the SELECTION and DIVERSITY studies will be randomized to receive placebo, 100 mg or 200 mg filgotinib. In the U.S., men may receive 200 mg if they failed at least one anti-TNF and vedolizumab (Entyvio, Takeda Pharmaceutical Co. Ltd.). The filgotinib phase III program also will contain a dedicated male patient testicular safety study. Patient dosing is expected to begin this quarter. Galapagos has a global collaboration with Gilead Sciences Inc., of Foster City, Calif., to develop and commercialize filgotinib in inflammatory indications. Gilead initiated the FINCH phase III program in rheumatoid arthritis last month. Earlier this week, Galapagos reported positive phase II findings of the oral Janus kinase-1 inhibitor in Crohn’s. (See BioWorld Today, Dec. 18, 2015, Aug. 24, 2016, and Sept. 27, 2016.)
Glaxosmithkline plc (GSK), of London, agreed Friday to pay $20 million in civil penalties to resolve U.S. SEC charges of Foreign Corrupt Practices Act (FCPA) violations. The charges stem from a scandal in China, in which company sales reps were accused of bribing doctors and hospitals, from 2010 through June 2013, to use GSK drugs to increase their sales bonuses. As part of the settlement, GSK also agreed to periodically report to the SEC on the status of its FCPA compliance and remediation efforts. The SEC penalty comes on top of court action in China that included a $490 million fine for the company and suspended prison sentences for a few GSK executives. (See BioWorld Today, Sept. 22, 2014.)
Pharmaxis Ltd., of Frenchs Forest, Australia, said Bronchitol has received marketing approval in Russia to treat pediatric and adult cystic fibrosis patients. Russia will be the drug’s largest market so far, the company said. The approval was granted via the country’s laws to provide access to innovative drugs, and Bronchitol is now designated an orphan drug.
Regenerx Biopharmaceuticals Inc., of Rockville, Md., said Regentree, its joint venture with Gtreebnt Co. Ltd., of South Korea, started a second phase III trial in dry eye syndrome and will begin patient enrollment shortly. The double-masked, placebo-controlled trial is expected to enroll about 500 patients, who will be treated for 28 days with RGN-259, the company’s preservative-free eye drop formulation of thymosin beta 4. The primary endpoints are intended to replicate and confirm results from the previous phase IIb/III trial showing both a statistically significant improvement in inferior corneal staining and a statistically significant improvement in ocular discomfort, when subjects are challenged in a controlled adverse environment at the end of treatment. The trial is expected to be completed during the second half of 2017.
Replicel Life Sciences Inc., of Vancouver, British Columbia, has provided an update on the licensing and co-development of its RCH-01 product with Shiseido Co., of Tokyo. The autologous cell therapy is under clinical investigation for the treatment of androgenetic alopecia at Tokyo Medical University Hospital and Toho University Ohasi Medical Center. Shiseido has an exclusive marketing license to the product for certain Asian countries. Replicel said that because of financial constraints, it has not been able to proceed with its plans to initiate a phase II trial of RCH-01 and that situation has caused Shiseido to allegedly breach the co-development obligations, which Replicel denies. “While there is a clear obligation on our part to transfer data from such a trial when it is available, there is no express or implied obligations in the agreement as to when such a trial would have to be initiated or completed,” noted Replicel’s president and CEO, Lee Buckler, in a release. Since the signing of the development agreement, the company said it has been working closely with Shiseido on the technology transfer, optimizing several features of the product’s manufacturing and continuing to add to the body of science as it relates to the product and its intended function. Separately, the company said it intends to settle a $374,071.63 debt owed to certain creditors by the issuance of 719,368 units, consisting of one common share of the company and one share purchase warrant entitling the holder to purchase one additional share for a period of two years at $1.10 each.
Sage Therapeutics Inc., of Cambridge, Mass., reported results on secondary endpoints from its phase II trial of SAGE-547 in severe postpartum depression (PPD) at the Marcé Society for Perinatal Mental Health meeting in Melbourne, Australia. Secondary endpoints, including the Edinburgh Perinatal Depression Scale and the Patient Health Questionnaire showed improvement through 30 days in the SAGE-547-treated group compared to the placebo group, demonstrating a strong durability of effect from SAGE-547 for more than three weeks following the end of treatment. Those data are consistent with top-line results reported in July showing SAGE-547 achieved the primary endpoint with a statistically significant reduction in the Hamilton Rating Scale for Depression (HAM-D) compared to placebo at 60 hours and maintained at similar magnitude through the 30-day follow-up. A similar statistically significant response was observed on other secondary endpoints, including the Montgomery-Åsberg Depression Rating Scale and Remission from depression, as determined by a HAM-D of less than 7. The FDA granted breakthrough therapy designation to SAGE-547, an allosteric modulator of both synaptic and extra-synaptic GABAA receptors, for the treatment of PPD. (See BioWorld Today, July 13, 2016.)
Sun Pharmaceutical Industries Ltd., of Mumbai, reported data from two pivotal, phase III studies (resurface 1 and 2), which achieved the primary endpoint for tildrakizumab, an investigational IL-23p19 inhibitor, in patients with moderate to severe plaque psoriasis, at the European Academy of Dermatology and Venereology Congress in Vienna. In the trials, an average of 63 percent of patients achieved 75 percent of skin clearance (Psoriasis Area Sensitivity Index, or PASI 75) by week 12 after only two injections, and 77 percent achieved 75 percent skin clearance after 28 weeks and three injections of the 100-mg dose of tildrakizumab (64 percent and 80 percent in reSURFACE 1, 61 percent and 74 percent in reSURFACE 2). Similarly, an average of 57 percent and 66 percent of patients had a Physician’s Global Assessment (PGA) score of “clear” or “minimal” with the 100 mg dose at weeks 12 and 28 respectively. Those receiving the 200-mg dose also saw an average of 64 percent and 78 percent of patients achieving PASI 75 at weeks 12 and 28, respectively. Also, 59 percent and 69 percent of the patients had PGA score of “clear” or “minimal” at weeks 12 and 28, respectively. Additional data showed that a higher number of patients on tildrakizumab achieved PASI 90 and 100 compared to placebo and Enbrel (etanercept, Amgen Inc.).
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said two interim reports from the ongoing, open-label Gemini long-term safety study describing data of long-term Entyvio (vedolizumab) treatment in patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease have been published in the Journal of Crohn’s & Colitis. Data showed that patients with moderately to severely active ulcerative colitis experienced clinical and health-related quality of life improvements with continued vedolizumab treatment, the company said. For patients with moderately to severely active Crohn’s disease, the clinical benefits of vedolizumab continued with long-term treatment regardless of prior TNF antagonist exposure, it added.
Australia’s Therapeutic Goods Administration is seeking comment on whether it should adopt several EU guidelines for drugs and biologics. The guidelines cover product-specific bioequivalence and the evaluation of drugs for a range of diseases such as Duchenne and Becker muscular distrophy, amyotrophic lateral sclerosis and cancer. Comments on the guidelines are due by Nov. 9.
Vivus Inc., of Mountain View, Calif., lined up a $70 million payment from Metuchen Pharmaceuticals LLC, of Cranford, N.J. in an agreement providing Metuchen a fully paid, perpetual license for exclusive rights to commercialize Stendra (avanafil) in the U.S., Canada, South America and India. Vivus will be responsible for the manufacture and supply of the erectile dysfunction drug to Metuchen for a mutually agreed term. For a period of 180 days, Metuchen has the option to assume the manufacturing and supply rights of Stendra for its territories. Metuchen will also be responsible for royalties due to Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, based on net sales.