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Biologics to watch in 2013

02.01.2013 - At the beginning of the new year, 29 monoclonal antibody (mAbs) drugs are in Phase III clinical development.

While around 350 therapeutic mAbs are currently in clinical development globally, only 28 had entered active Phase 2/3 or Phase 3 studies as of January 2013, according to MABS. Additionally one mAb mixture was under evaluation in Phase III. Historically, mAbs that target antigens relevant to cancer have comprised approximately 50% of the mAb clinical pipeline, but in 2013 the picture has changed: 66% or 19 of the antibodies to watch in 2013 are for non-cancer indications.

The non-cancer mAbs include alirocumab (Regeneron; Sanofi, hypercholesterinemia); AMG 145 (Amgen, hypercholesterinemia), epratuzumab (UCB, SLE), gantenerumab (Roche; Alzheimer’s disease), gevokizumab (Xoma/Servier, Non-infectious uveitis), itolizumab (Biocon, Plaque psoriasis), ixekizumab (Eli Lilly and Co., psoriasis), lebrikizumab (Roche/Genentech, rheumatoid arthritis), mepolizumab (GSK, Asthma, COPD etc.), ocrelizumab (Roche/Genentech, multiple sclerosis), reslizumab (Teva, Eosinophilic asthma), romosozumab (Amgen, Postmenopausal osteoporosis), sarilumab (Regeneron; Sanofi, rheumatoid arthritis), secukinumab (Novartis, rheuma, psoriasis), sirukumab (Janssen R&D LLC, rheumatoid arthritis), solanezumab (Eli Lilly and Co., Alzheimer’s disease), tabalumab (Eli Lilly and Co., rheuma, SLE) and vedolizumab (Millenium, Ulcerative colitis; Crohn disease). The mixture of actoxumab and bezlotoxumab (MK-3415A, Merck & Co.) is being evaluated in two Phase 3 studies as a treatment for Clostridium difficile infection.  

The ten cancer mAbs are: elotuzumab (Bristol-Myers Squibb, Abbott, multiple myeloma), farletuzumab (Morphotek, ovarian cancer), inotuzumab ozogamicin (Pfizer; UCB, ALL, NHL), naptumomab estafenatox (Active Biotech, renal cell carcinoma), necitumumab (ImClone LLC, NSCL), nivolumab (Bristol-Myers Squibb, NSCL, renal cell carcinoma), obinutuzumab (Roche/Genetech, Diffuse large B cell lymphoma, CLL, NHL), onartuzumab (Roche/Genetech, NSCL cancer; gastric cancer), racotumomab (CIMAB; Laboratorio Elea S.A.C.I.F. y A, NSCL), and ramucirumab (ImClone LLC, Gastric; liver, breast, colorectal, NSCL cancers).

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-01/biologics-to-watch-in-2013.html

Clinical TrialsFrance

26.08.2016 Adocia said it would discontinue its diabetic foot ulcer programme after its lead product BioChaperone PDGF disappointed in Phase III. The French company will turn the focus on its earlier-stage products.

M&AUKSweden

24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.

FinancingUK

23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.

R&DDenmark

19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.

ResearchUKEU

17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).

Stock marketsGermany

15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).

LicensingDenmark

11.08.2016 Danish Genmab AS has granted Gilead Sciences license to use its DuoBody technology platform to develop bispecific antibodies for the treatment of HIV. The deal is worth up to €252m.

Clinical developmentHungaryIreland

09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.

ImmunotherapySpain

08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.

ApprovalEU

04.08.2016 After a two-year pilot period, the EMA has published its report on its adaptive pathways approach. The agency plans to “explore the concept further” and will continue to accept proposals.

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