Bayer HealthCare AG manufactures products to diagnose, prevent, and treat human and animal disease worldwide. The company operates through four divisions: Animal Health, Pharmaceuticals, Consumer Care, and Medical Care. The Animal Health division offers products for dogs and cats; products against ticks; drugs to treat infectious diseases in livestock and companion animals; products to control endoparasites in pets; and Baycox to control coccidia problems in farm animals. It sells products through veterinarians, pharmacies, and retail stores. The Pharmaceuticals division provides general and specialty medicines for multiple sclerosis, hormonal contraceptive, hemophilia, cancer, hypertension,...
Building Q 30
Janssen Research & Development and Bayer HealthCare to Launch New Trials on Xarelto to Expand Uses of the Drug
Aug 29 14
Janssen Research & Development and Bayer HealthCare plan to launch new clinical trials of the anticoagulant Xarelto to test the effectiveness of the drug against three diseases. Specifically, the new trials will test the anticlotting agent in patients suffering acute coronary syndrome, peripheral artery disease and embolic strokes caused by a clot of unknown origin.
Bayer Gets EU Approval for EYLEA to Treat Visual Impairment Due to DME
Aug 11 14
Bayer HealthCare announced that the European Commission or EU has approved EYLEA, for the treatment of visual impairment caused by diabetic macular edema or DME. The product will hit the markets immediately, with Germany being one of the first launch countries in Europe. The results of two phase 3 studies were very encouraging with the majority of patients with visual impairment due to diabetic macular edema experiencing a significant two-line improvement in visual acuity with aflibercept solution for injection. EYLEA is already approved in many countries for the treatment of neovascular age-related macular degeneration and visual impairment due to macular edema secondary to central retinal vein occlusion.
Bayer HealthCare Receives FDA Approval for Diabetic Macular Edema Medication in US
Aug 7 14
Bayer HealthCare has received the FDA approval for aflibercept solution for injection into the eye for the treatment of diabetic macular edema (DME), in the US. Aflibercept solution for injection has already been approved under the brand name EYLEA in many countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). The approval of aflibercept solution for injection in DME was based on the one year data from the Phase III VISTA-DME and VIVID-DME trials of 862 patients, which compared aflibercept solution for injection 2 milligrams (mg) given monthly, 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In the DME studies, after one year, the mean changes in best-corrected visual acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart for the monthly and every two month treatment arms, were statistically significantly improved compared to the control group and were similar to each other. Across both trials, patients in both aflibercept solution for injection dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group. Bayer HealthCare and Regeneron Pharmaceuticals Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the US. Bayer HealthCare has licensed the exclusive marketing rights outside the US, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales. In the VIVID-DME study, patients receiving aflibercept solution for injection 2 mg every other month (after 5 initial monthly injections) had a mean gain from baseline in BCVA of +10.7 letters, after Week 52. This is equivalent to a gain of more than two lines on the ETDRS eye chart. Patients receiving laser photocoagulation had a mean change from baseline in BCVA of +1.2 letters. Additionally, (33.3 %) of patients receiving aflibercept solution for injection 2 mg every other month achieved an increase of at least 15 letters, a gain of three lines from baseline as one key secondary endpoint compared to the laser treatment group with only (9.1%) achieving a similar gain. In the VISTA-DME study, patients receiving aflibercept solution for injection 2 mg every other month (after 5 initial monthly injections) had a mean gain from baseline in BCVA of +10.7 letters, after Week 52, compared to patients receiving laser photocoagulation who had a mean change from baseline in BCVA of +0.2 letters. Additionally, as reflected by one of the secondary endpoints, (31.1%) of patients receiving aflibercept solution for injection 2 mg every other month achieved an increase of at least 15 letters from baseline compared to the laser treatment group with close to (7.8%) achieving a similar gain. Further secondary endpoints in the VIVD-DME and VISTA-DME studies included the change from baseline in central retinal thickness, diabetic retinopathy severity score and vision related quality of life. In these trials, aflibercept solution for injection was generally well tolerated with similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group.