SORRY MEANT LUNCH MACHINE Tekturna Approval Pumps Up Novartis By Robert Steyer | 03/06/07 - Shares of Novartis (NVS - Get Report) climbed Tuesday after the Swiss drug giant received U.S. approval for its blood pressure treatment Tekturna. There are fewer drug markets more crowded than the one for treating hypertension, but the Novartis drug has captured Wall Street's attention because it's the first in a new class called renin inhibitors. Renin is a kidney enzyme linked to the regulation of blood pressure. The once-a-day pill will be available in U.S. pharmacies this month, and the Food and Drug Administration says it can be prescribed by itself or with other blood-pressure drugs. Tekturna, which was developed with Switzerland's Speedel, also is under review by European Union regulators. If Tekturna does what Novartis hopes, the company will have a diverse and formidable lineup of blood-pressure medications. Diovan, a member of the angiotensin-receptor blocker class, produced $4.22 billion in sales last year. Lotrel, which contributed $1.35 billion to revenue, combines two other classes of drugs -- an ACE inhibitor and a calcium-channel blocker. n December, the FDA approved Novartis' Exforge, which combines the main ingredients in Diovan and Pfizer's (PFE - Get Report)Norvasc. Exforge won't be available until late September, when the U.S. patent on Norvasc expires. Shares of Novartis recently were up $3.18, or 5.8%, to $56.73, with trading volume more than double the daily average. The stock jump indicates that investors believe Tekturna can provide substantial sales for Novartis A closer look at new FDA actions: Novartis' Tekturna Author: Monica Holmberg, PharmD Novartis? Tekturna For the first time in over 10 years, an antihypertensive medication of a new class has received approval from the FDA for the treatment of hypertension in adult patients. 1 Novartis? Tekturna (aliskiren) is described as a direct renin inhibitor and is the first in this new class of antihypertensive medications to be approved.
BUT THEN ....... JANUARY 11, 2012 Tekturna Hypertension Drug Linked to Stroke and Kidney Problems among Diabetes Patients By Pintas & Mullins Law Firm Share Tweet this Post Share on Facebook Share on LinkedIn Share on Google+ Our drug recall attorneys at Pintas & Mullins Law Firm are warning of new research that shows the blood pressure drug Tekturna (Aliskiren) may increase the risk of stroke or serious heart and kidney problems. This is a major setback for the hypertension drug that could potentially lead to a recall, according to recent reports by Bloomberg News. Tekturna is sold by Novartis and was originally approved in 2007 to lower blood pressure. Tekturna was the 16th best selling drug in 2010 for drug maker Novartis, who recently conducted a study to determine whether the medication could help patients suffering from type 2 diabetes and renal impairment. The ALTITUDE study evaluated the effectiveness of Tekturna in reducing or delaying heart and kidney events, along with the drug’s ability to resuscitate sudden death or heart attack patients. Shockingly, the clinical trial came to a halt in January of 2012 when serious safety issues were revealed. Instead of benefiting from the medication, Tekturna study participants actually suffered an increased rate of hypertension, stroke, and renal complications. As a precautionary measure, Novartis issued a drug warning to healthcare professionals, urging them to stop treating diabetic patients with Tekturna and to consider other, safer alternative treatments as necessary. The drug maker also pledged to stop promoting Tekturna for use in combination with other drugs such as ACE-inhibitors until federal regulators determine whether further changes need to be made. However, for many patients who already suffered serious side effects, these warnings came too late. The large number of adverse health events recently exposed through clinical trials will likely hurt Novartis financially. Tekturna brought in close to $450 million in sales during the first nine months of 2011, and sales are expected to plummet now that the company has stopped advertising the dangerous drug. Over 1,000 sales jobs could be lost as a direct result of the clinical findings. Analysts suspect that the drug may eventually be sold to another company or completely removed from the market. Even more concerning to our defective drug lawyers is the harm that many patients have already suffered or the potential harm that they may suffer in the future as a result of using the medication. We are aware that Novartis engaged in off-label marketing, recklessly promoting the use of Tekturna for diabetes patients. In addition to a lack of evidence supporting any positive health benefits for the diabetic population, research now shows that these patients may be seriously harmed by use of the drug. Drug manufacturers owe a legal duty to patients to conduct appropriate tests for the drugs that they sell. Manufacturers are also required to provide adequate warnings to doctors and patients. When a patient is seriously harmed by a defective drug such as Tekturna, legal recourse may be available. An experienced drug recall lawyer can help protect your legal rights and aggressively pursue a cause of action against the drug manufacturer. Compensation may be available for pain and suffering, lost wages, and medical expenses tied to use of the drug. It is clear to our drug recall attorneys that Novartis recklessly marketed and engaged in off-label promotions of a dangerous drug that resulted in devastating side effects for patients. A Tekturna lawsuit can help individuals recover for the injuries that they suffered, and hold the drug maker legally responsible for the harm that they caused. Diabetes patients who used this medication should be aware of dangerous side effects, including kidney and heart damage, hypotension and hyperkalemia, and stroke. If you or a loved one experience any of these symptoms, it is important to contact a drug recall attorney today to protect your rights.
Once upon a time , Chapter 2 A New Star for Novartis? Blockbuster Hopes for Starlix By David Mendosa Last Update: February 14, 2000 If the U.S. Food and Drug Administration approves Starlix® (nateglinide) later this year as expected, it could be just the ticket to turn around the fortunes of its manufacturer, Novartis AG (ADR: NVTSY). Starlix promises to be an important drug to help control type 2 diabetes. Starlix is a smart drug. Headquartered in Basel, the Swiss pharmaceuticals giant Novartis was born in 1996 from the $63 billion merger of Swiss drugmakers Ciba-Geigy Ltd. and Sandoz Ltd. The plan was to create the world's first life-sciences company, applying technologies learned from plant genetics to both pharmaceuticals and agricultural businesses. Instead, Novartis in December announced its plans to spin off its crop protection and seeds businesses and merge them with the agrochemical business of another pharmaceuticals giant, London-based AstraZeneca Plc (NYSE:AZN). The new company, Syngenta AG, will be headquartered in Basel and listed on the Swiss, London, New York, and Stockholm Stock Exchanges. This shift in strategy more narrowly focuses Novartis on its pharmaceutical business at a time when its drug portfolio is mature and it faces increasing competition from generics. In the United States—the world's fastest growing drug market—its market share is declining. Key to that strategy is the "blockbuster" potential of Starlix and two other drugs awaiting FDA approval (for gastro-intestinal treatment and asthma and allergies). Each of these drugs could generate peak annual sales of $1 billion or more, Novartis Chief Financial Officer Raymund Breu declared at a news conference last year. Another news report following a Starlix research presentation at the September meeting of the European Association of the Study of Diabetes in Brussels stated that Novartis management expects Starlix to generate peak sales of 1 billion Swiss francs per year, the equivalent of more than $600 million at the current exchange rate. Whether we are talking dollars or francs, this is no small claim. For this new drug to generate this sort of revenue in a crowded field, Starlix will have to have exceptional qualities. It does. Until 1995, the sulfonylurea class of drugs was the only choice in the United States other than insulin for treating type 2 diabetes. Certainly you had a choice of brand, but they all work the same way, by squeezing more insulin out of your beta cells and improving insulin's ability to get glucose into the rest of your body. The explosion of drugs available for controlling blood glucose began when Glucophage (metformin) became available in 1995, quickly followed drugs in three other classes. Novartis already has a catchy concept to drive its Starlix marketing efforts. It is, the company says, a smart drug. "Novartis believes it can offer an advancement in therapy, differentiated from other competitor agents," its annual report says. "As a ‘smart drug,' with its effect directly proportional to ambient blood glucose levels, Starlix is expected to bring improved disease control." No other company is marketing any diabetes drug as a smart drug. "I thought that was a very smart idea on their part to come up with that," laughs William Biggs, an endocrinologist practicing in Amarillo, Texas. He says that Novartis invited him along with other endocrinologists to test and preview the drug. It's a smart drug, Biggs says, because Novartis found that as soon as glucose levels dropped to a normal range the insulin production stopped. "They've got good data on that."
Oh why is Marjorie Gatlin still working there? She was primary to these two costly failures with Starlix and Tekturna.
