Amgen Inc. (NASDAQ:AMGN) said Wednesday it submitted a BLA to FDA for ABP 501, a biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).
Amgen said the application includes Phase III comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. Spokesperson Kelley Davenport told BioCentury that Amgen believes its application "will support extrapolation and regulatory approval of ABP 501 in all available Humira indications when reviewing the totality of evidence required to establish biosimilarity."
Humira is approved to treat moderate to severe RA, chronic plaque psoriasis, Crohn's disease and ulcerative colitis, as well as psoriatic arthritis and ankylosing spondylitis.
Amgen said it submitted data from studies that "support the transition of adalimumab patients to ABP 501," which suggests it will seek to market the biosimilar to existing patients as well as new ones.
Amgen engaged in patent notification procedures outlined in the Biologics Price Competition and Innovation Act of 2009, Davenport said. "Amgen fully intends to meets its obligations under the BPCIA both in the role of innovator and biosimilar applicant," she said.
The submission is Amgen's first of a biosimilar. The company said it believes ABP 501 is the first Humira biosimilar submitted to FDA.
Several other companies are developing biosimilar versions of Humira. Merck & Co. Inc. (NYSE:MRK) has conducted a Phase III trial of SB5 in partnership with Samsung Bioepis Co. Ltd., a joint venture between Biogen Inc. (NASDAQ:BIIB) and Samsung Group (Seoul, South Korea). Baxalta Inc. and Momenta Pharmaceuticals Inc. began a Phase III trial in October of M923. Pfizer Inc. (NYSE:PFE) is conducting a Phase III trial of PF-06410293.
Amgen, which made the announcement after market close, was up $1.17 to $163.95 on Wednesday.
The Heptares Therapeutics Ltd. subsidiary of Sosei Group Corp. (Tokyo:4565) granted Teva Phamaceutical Industries Ltd. (NYSE:TEVA) exclusive, worldwide rights to develop preclinical, small molecule calcitonin gene-related peptide (CGRP) antagonists to treat migraine.
Heptares received $10 million up front and is eligible for $400 million in milestones, plus royalties.
In August, Heptares CEO Malcolm Weir told BioCentury intranasal or subcutaneous small molecule CGRP antagonists could fill a gap between more advanced mAb and oral programs for migraine (see BioCentury, Aug. 17).
Teva intends to start a Phase III study early next year of TEV-48125, its humanized mAb that blocks CGRP from binding to its receptor, to treat migraine.
Sosei shed Y60 to Y5,470 on Wednesday. The news was announced after market hours in Tokyo.
Kadmon Corp. LLC (New York, N.Y.) said it granted Jinghua Pharmaceutical Co. Ltd. (Nantong, China) an exclusive license to develop and commercialize Kadmon's human mAbs against VEGF receptor 2 (VEGFR-2; KDR/Flk-1) and PD-L1 in Greater China. Jinghua also licensed Kadmon's technology to discover and develop additional human mAbs in China.
Kadmon received $10 million in an upfront equity investment from Jinghua and is eligible for $40 million in milestones, plus 10% royalties. Kadmon did not respond to an inquiry.
Aduro Biotech Inc. (NASDAQ:ADRO) gained $4.42 (16%) to $31.47 Wednesday after it allayed investor concerns about a listeriosis infection in one patient receiving CRS-207 and GVAX Pancreas cancer vaccine in a Phase IIa trial. Aduro said all of its clinical trials will continue as planned.
The move nearly completed a round-trip in trading for Aduro, which fell 16% Tuesday after it disclosed in a regulatory filing Monday that a pancreatic cancer patient treated with CRS-207 and GVAX Pancreas developed listeriosis.
On a conference call Wednesday, CSO Thomas Dubsensky said the infection was likely attributable to a protocol violation. The patient remains on study treatment.
CRS-207 is a live-attenuated strain of Listeria monocytogenes that expresses human mesothelin. GVAX Pancreas is an allogeneic cancer vaccine engineered to secrete GM-CSF. The regimen has Orphan Drug designation from FDA to treat pancreatic cancer and mesothelioma, and breakthrough designation to treat pancreatic cancer.
A brain imaging study out of Yale University has identified the Sustained Attention Network, a set of neural connections whose strength -- measured by functional MRI (fMRI) -- can predict clinical scores of patients with ADHD. The findings underscore the biological basis of the disorder and provide insight into the neural circuits that mediate attention. The group also suggested that the SAN could be developed as a biomarker for clinical trials.
Researchers identified the network, which comprises a variety of cortical and subcortical areas, by correlating the strength of all possible connections among 268 brain regions with the performance of healthy individuals on an attention-demanding task. The researchers showed that the network's strength could also be measured when subjects were resting and not performing a task. Resting state measurements alone predicted performance on the attention task.
The group also applied the model to resting state fMRI data from a cohort of ADHD patients and found that it accurately predicted their clinical scores.
FDA granted accelerated approval to Fluad, an MF59-adjuvanted influenza vaccine from Novartis AG (NYSE:NVS; SIX:NOVN), to prevent seasonal influenza in people aged 65 and older. The vaccine is the first seasonal flu vaccine FDA has approved containing an adjuvant.
BioCentury Extra will not publish on Thursday, Nov. 26, or Friday, Nov. 27, in observance of the Thanksgiving holiday in the U.S. BioCentury Extra will resume publishing on Monday, Nov. 30.
Turing Pharmaceuticals AG said it will provide discounts of up to 50% to hospitals on the price of Daraprim pyrimethamine; however, it will not cut the toxoplasmosis drug's list price. The Nov. 24 BioCentury Extra mischaracterized Turing's plans.
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