Bayer HealthCare : FDA Grants Orphan Drug Status to Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis

March 11, 2010 – Bayer Schering Pharma AG, Germany, announced that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for the ciprofloxacin dry powder inhaler (DPI) for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency (EMA)... Bayer HealthCare's Press Release -

Bayer Schering Pharma : Progress in Clinical Program for Riociguat

October 6, 2008 – Based on positive Phase II trial findings, Bayer Schering Pharma will move into Phase III trials with its oral agent riociguat (BAY 63-2521). Riociguat is the first member of a new class of vasodilating agents called soluble guanylate cyclase (sGC) stimulators. It is being investigated as a new approach for the treatment of different forms of pulmonary hypertension. Riociguat demonstrated significantly improved exercise capacity in a Phase II study in patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) as compared to baseline values. The Phase III program for these indications is planned to be initiated in late 2008... Bayer Schering Pharma's Press Release -

Bayer HealthCare and Nektar Therapeutics : Amikacin Inhale Shows Promising Results in Phase II Study

May 19, 2008 , 2008 - Bayer HealthCare together with Nektar Therapeutics (Nasdaq: NKTR), today presented positive preliminary Phase II data on their unique drug-device combination Amikacin Inhale at the American Thoracic Society (ATS) annual meeting. Amikacin Inhale, currently being studied for the adjunctive treatment of Gram-negative pneumonia in intubated and mechanically-ventilated patients, achieved over 1000 times greater lung exposure to the antibiotic amikacin as compared to intravenous route of administration.
This shows that targeting antibiotic therapy to the site of infection might offer superior bacterial eradication and increased efficacy, which may result in a higher likelihood of the patient's survival. Currently, Gram-negative pneumonia carries a mortality risk as high as 50 percent in mechanically-ventilated patients(1)... Nektar Therapeutics' Press Release -

Bayer and Onyx , Update on Phase 3 Trial of Nexavar in Patients With Non-Small Cell Lung Cancer

Feb. 18, 2008 - Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that a Phase 3 trial evaluating Nexavar® (sorafenib) tablets in patients with non-small cell lung cancer (NSCLC) was stopped early following a planned interim analysis, when the independent Data Monitoring Committee (DMC) concluded that the study would not meet its primary endpoint of improved overall survival. The Phase 3 ESCAPE (Evaluation of Sorafenib, Carboplatin And Paclitaxel Efficacy in NSCLC) trial evaluated Nexavar when administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC). Safety events were generally consistent with those previously reported. However, higher mortality was observed in the subset of patients with squamous cell carcinoma of the lung treated with sorafenib and carboplatin and paclitaxel versus those treated with carboplatin and paclitaxel alone... Onyx's Press Release- Bayer HealthCare's Press Release-