Dexamethasone/Piperacillin/Tazobactam

Nicholas Kartsonis, head of clinical research in infectious diseases and vaccines at Merck Research Laboratories, noted that additional treatment options are needed for critically ill patients with respiratory infections. Merck ’s antibacterial drug Recarbrio hit its primary endpoints in a Phase III trial for use in adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). This morning the company announced results from the Phase III RESTORE-IMI 2 show that Recarbrio (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) met both the primary and key secondary endpoints of statistical non-inferiority at day 28 all-cause mortality and clinical response at early follow up, respectively, compared to Pfizer’s Zosyn (piperacillin/tazobactam). The primary and secondary endpoints of the Phase III trial were met in the modified intent-to-treat population, Merck said. Rates of adverse events observed in the trial were similar in both groups. Merck plans to present the full data from the trial at a scientific congress in 2020. Nicholas Kartsonis, head of clinical research in infectious diseases and vaccines at Merck Research Laboratories, noted that additional treatment options are needed for critically ill patients with respiratory infections. By focusing on the particular patient population in the Phase III RESTORE-IMI 2 trial, Kartsonis said Merck has “generated robust clinical evidence” for the use of Recarbrio in patients with hospital-acquired and ventilator-associated bacterial pneumonia. Kartsonis added that the company plans to share the data with regulatory agencies as the company looks to move forward with the drug. In July, Recarbrio was approved for use in patients adult patients who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections, including pyelonephritis, caused by a number of Gram-negative microorganisms, including Klebsiella pneumoniae. Recarbrio is made up of imipenem, a penem antibacterial drug; cilastatin sodium, which is a renal dehydropeptidase inhibitor; and relebactam, which is a beta-lactamase inhibitor. Relebactam has received the U.S. Food and Drug Administration’s Qualified Infectious Disease Product designation and Fast Track status for the treatment of hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Data from the late-stage Recarbrio trial comes about three months after Merck’s Zerbaxa won approval under Priority Review for treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain bacteria. Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are life-threatening hospital-related pulmonary infections that can particularly impact patients who are already dealing with severe underlying medical conditions. There is a high mortality rate associated with these illnesses. A recent report from the Foundation for the National Institutes of Health Biomarkers Consortium noted that ventilated patients with HABP have a 39% higher rate of mortality than those with VABP, 27%. In addition, Pseudomonas aeruginosa is the most common Gram-negative pathogen in HABP/VABP and is becoming increasingly difficult to treat. hbspt.forms.create({ portalId: "4413123", formId: "c4dda430-e2b0-4083-86f3-ccce0c1d4479" });

Pfizer has reported a major rise in sales for the first quarter, thanks to the contribution of Wyeth, but like at Merck & Co, charges from that acquisition pushed the drug giant’s earnings down. Net profit fell 26% to $2.03 billion, while turnover came in at $16.75 billion, an increase of 54%, and 48% of that rise was due to Wyeth products. Sales of Pfizer’s own drugs actually slipped 1%. Biopharmaceutical sales leapt 44% to $14.51 billion and revenues from the cholesterol blockbuster Lipitor (atorvastatin) edged up 1% to $2.76 billion, though US sales fell 10% to $1.31 billion, hit by competition from other statins, notably the generic version of Merck & Co’s Zocor (simvastatin). Generic competition also hurt the blood pressure treatment Norvasc (amlodipine), which fell 23% to $368 million. On the positive side, sales of Lyrica (pregabalin), for epilepsy, fibromyalgia and neuropathic pain, increased 6% to $723 million, while the kidney cancer treatment Sutent (sunitinib) jumped 28%% to $259 million. The COX-2 inhibitor Celebrex (celecoxib) inched up 1% to $570 million and the erectile dysfunction drug Viagra (sildenafil) brought in $479 million, up 5%, while the glaucoma drug Xalatan (latanoprost) had sales of $422 million (+4%). The smoking cessation drug Chantix/Champix (varenicline) rose 7% to $189 million. The figures were boosted by a number of Wyeth products, notably the antidepressant Effexor (venlafaxine), which contributed $716 million, the pneumococcal disease vaccine Prevnar ($286 million) and the arthritis and psoriasis therapy Enbrel (etanercept; $802 million outside North America). Wyeth’s antibiotic Zosyn/Tazocin (piperacillin/tazobactam) brought in $264 million, while the Premarin (conjugated oestrogens) range of hormone replacement therapies contributed $256 million to Pfizer’s coffers. Pfizer’s new ‘diversified’ division, which includes animal and consumer health products, plus nutritional items and capsules for drugs made by Wyeth, saw revenues climb 210% to $2.14 billion. US healthcare reforms reduced first-quarter revenues by $56 million. The latter effect will impact sales by about $300 million this year, said chief financial officer Frank D’Amelio, but he noted that the company is sticking by its earnings forecast of $2.10-$2.20 per share, with revenues expected to be $67-$69 billion. However, for 2012, Pfizer is targeting turnover of $65.2-$67.7 billion, down $800 million on a previous guidance.