Novartis AG Announces Results from its Phase III Expedition Trial Program for QVA149
May 20 15
Novartis AG announced for the first time detailed results from its phase III EXPEDITION trial program for QVA149 (indacaterol/glycopyrronium) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In the US, QVA149 and glycopyrronium (NVA237) are currently investigational. The findings were presented at the American Thoracic Society (ATS) International Conference in Denver, May 15-20. The EXPEDITION trial program consists of two efficacy studies (FLIGHT 1 & 2) and one safety study (FLIGHT 3). The FLIGHT 1 and 2 studies met their primary endpoints, with QVA149 27.5/12.5 mcg demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at week 12, compared to its individual components indacaterol 27.5 mcg and glycopyrronium 12.5 mcg and placebo, all dosed twice-daily1,2. In these studies, QVA149 also demonstrated improvements for all secondary endpoints at week 121,2,3,4. This included the key secondary endpoint of health status, as well as trough FEV1, peak FEV1, dyspnea (breathlessness) and reduced use of rescue medication versus the mono-components and placebo1,2,3,4. Health status was assessed using the St. George's Respiratory Questionnaire (SGRQ) score a measure of health-related quality of life while dyspnea was measured by the Transitional Dyspnea Index (TDI) total score3,4. A pooled analysis of FLIGHT 1 and 2 found that QVA149 27.5/12.5 mcg had similar safety outcomes at 12 weeks compared to its mono-components indacaterol 27.5 mcg and glycopyrronium 12.5 mcg, as well as placebo5. In FLIGHT 3, the incidence rates of adverse events (AEs) and serious adverse events (SAEs) for QVA149 27.5/12.5 mcg and QVA149 27.5/25 mcg, each given twice daily, were similar to those of once-daily indacaterol 75 mcg over a 52-week treatment period6.
Microbix Provides Update on U.S. VIRUSMAX Litigation
May 15 15
Microbix Biosystems Inc. announced that the U.S. District Court in the Eastern District of Texas has provided its decisions on a litigation between Microbix and Novartis. In the matter of whether Novartis has infringed the 18 patent claims asserted by Microbix on its patent 7,270,990 in the United States, the court ruled in favor of Novartis, the defendant. Concerning the defendant's counterclaim seeking a declaratory judgment of patent invalidity, the court dismissed it without prejudice. All other claims and counterclaims asserted between the parties were likewise dismissed without prejudice. Court administration costs, which are not expected to be material, are the responsibility of Microbix. Both parties have the right to appeal the court's decisions. Microbix is reviewing the ruling of the Court and assessing its approaches to enforcing the patent claims relating to its VIRUSMAX® technology. Microbix will provide further comment about these legal matters once its assessments are completed and as it deems to be prudent or required.
Novartis AG Announces Earnings Results from Continuing Operations Results and Group Results for the First Quarter Ended March 31, 2015; Provides Earnings Guidance for Full Year 2015
Apr 23 15
Novartis AG announced earnings results from continuing operations results and group results for the first quarter ended March 31, 2015. For the quarter, from continuing operations the company reported net sales of USD 11,935 million against USD 12,767 million a year ago. Operating income was USD 2,785 million against USD 2,815 million a year ago. Net income was USD 2,306 million or USD 0.96 per share against USD 2,454 million or USD 0.99 per share a year ago. Free cash flow was USD 1,465 million against USD 1,152 million a year ago. Core operating income was USD 3,651 million against USD 3,800 million a year ago. Core net income was USD 3,199 million or USD 1.33 per share against USD 3,333 million or USD 1.35 per share a year ago. Continuing operations net income was growing less than operating income mainly due to a lower contribution from associated companies, partly offset by lower financial expenses. EPS was growing ahead of net income due to the lower number of average outstanding shares. Free cash flow was increased by USD 0.3 billion compared to the prior-year period. This was primarily due to hedging gains and lower net working capital, partially offset by a negative currency impact on operations As of March 31, 2015, the net debt stood at USD 17.8 billion compared to USD 6.5 billion at December 31, 2014. The increase of USD 11.3 billion was driven by the outflows from the acquisition of oncology net assets from GSK of USD 16.0 billion
For the quarter, the company reported total group results that net sales were USD 12,483 million against USD 14,022 million a year ago. Operating income was USD 15,407 million against USD 3,489 million a year ago. Net income was USD 13,005 million or USD 5.40 per share against USD 2,968 million or USD 1.21 per share a year ago. Free cash flow was USD 1,226 million against USD 765 million a year ago. Core operating income was USD 3,549 million against USD 3,657 million a year ago. Core net income was USD 3,116 million or USD 1.29 per share against USD 3,212 million or USD 1.31 per share a year ago.
The company's outlook for full year 2015 remains unchanged. Group net sales in 2015 are expected to grow mid-single digit (cc), after absorbing the impact of generic competition, which is expected to be as much as USD 2.5 billion compared to USD 2.4 billion in 2014. Group core operating income is expected to grow ahead of sales at a high-single digit rate (cc) in 2015.