Novartis : by Ray Sahelian, M.D.

Novartis by Ray Sahelian, M.D.

Novartis is Europe's second-largest pharmaceuticals company by market capitalisation, Created in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis is currently organized into four divisions:

• Pharmaceuticals, which comprises activities in innovation-driven prescription medicines
• Sandoz, which comprises activities in generic prescription drugs
• Consumer Health, which comprises activities in OTC, Animal Health, Medical Nutrition, Gerber (formerly Infant & Baby) and CIBA Vision
• Vaccines and Diagnostics is a new division (April 2006) focused on the development of preventive treatments and tools. The division has two business units formed following the recent completion of the acquisition of Chiron Corporation: Novartis Vaccines, and Chiron, the blood testing and molecular diagnostics unit.

Medicines made by Novartis
Aclasta - Swiss drugmaker Novartis reports clinical tests had shown its once-yearly Aclasta medicine had proved effective in reducing incidence of bone fracture in women with postmenopausal osteoporosis. According to data from phase III trials, Aclasta showed benefits across the most common fracture sites -- hip, spine and non-spine -- with the effects sustained over three years. According to Novartis, osteoporosis patients currently taking Merck & Co Inc.'s oral alendronate Fosamax can be switched to Aclasta and maintain the beneficial bone effects for 12 months after a single dose. Aclasta could be the first drug in the multibillion-dollar osteoporosis market, currently dominated by once-a-week treatments, to be administered once a year. Aclasta met the study's two primary endpoints as patients experienced a 70 percent risk reduction in new spine fractures and a 40 percent risk reduction in hip fractures, Novartis said. According to Novartis, the trials showed adverse effects experienced with the drug -- which will be known as Reclast in the United States -- were comparable to placebo. The most common side effects associated with intravenous injection of Aclasta included fever, muscle pain, flu-like symptoms and bone pain. Most occurred within three days of administration of the drug and were resolved within three days of onset, Novartis said. Aclasta, which is also known as zoledronic acid, has been approved in about 50 countries, including the European Union, for the treatment of Paget's disease. Dr. Sahelain comments: I am always cautious regarding introducing new drugs to my patients until several years have passed. It is not uncommon for side effects to be discovered after introduction of a drug. Plus, how do we know using this drug with other drugs many patients are using won't cause problems that could not be identified when the drug is used alone?
Adelphan (hydrochlorothiazide) - Treatment for hypertension
Anafranil (hydrochloride) - Tricyclic antidepressant
Angiscein For ophthalmic angiography and angioscopy
Anturan (sulfinpyrazone) Long-term treatment of gout
Apresoline (hydralazine) Periferal vasodilator
AquaSite Provides up to two hours of longer-lasting hypotonic relief
Aredia (pamidronate disodium) Inhibitor of cancer-related bone loss
Brinerdin (reserpine, clopamide, dihydroergocristine, hydralazin) Antihypertensive agent
Butazolidin (phenylbutazone) Non-steroidal anti-inflammatory drug
Calcitonin nasal spray and calcitonin oral pills
Clozapine is manufactured by Novartis pharmaceuticals.
Exjade - May 2007 - Severe kidney failure and some deaths have been reported in patients using Novartis AG's iron overload drug Exjade. The problems with Exjade, which removes excess iron from certain organs in patients receiving blood transfusions, were found in post-marketing reports for the drug, which was approved in late 2005
Prexige - November 2006 - Canada has approved the limited use of Novartis arthritis drug Prexige, the first new medication to be allowed in a class of drugs that had come under question because of possible heart problems. Novartis announced the Canadian approval for treating arthritis in the knee, hours after it said the European Union approved the same drug for knees and hips. Prexige is one of several COX-2 inhibitors, drugs that were originally designed to be safer long-term treatments than ibuprofen, naproxen or aspirin -- known as traditional non-steoroidal anti-inflammatory drugs or NSAIDs. But after research emerged showing COX-2 inhibitors may increase the risk of heart attacks, Merck & Co. Inc. pulled its drug Vioxx from worldwide markets in 2004 and Canada banned Pfizer Inc.'s Bextra. Celebrex, also made by Pfizer, is the only COX-2 product currently sold in Canada.
Pimecrolimus cream is sold by Novartis, under the trade name Elidel.

Reclast - Swiss drugmaker Novartis A said in August, 2008 it had won U.S. approval to sell the first once-a-year treatment for the bone-thinning disease osteoporosis. Reclast is administered annually in a 15-minute infusion for women with post-menopausal osteoporosis. Reclast will compete with osteoporosis pills that are taken daily, weekly or monthly.
Terbinafine ( Lamisil ) cream 1% - made by Novartis Consumer Health, Parsippany, NJ.
Tyzeka is manufactured by Novartis Pharma Stein AG, Stein, Switzerland and marketed and distributed by Idenix Pharmaceuticals, Inc., Cambridge, MA.
Zelnorm Zelmac (tegaserod maleate) - A medicine used for the short-term treatment of women who have irritable bowel syndrome. Starting in April 2007, Swiss pharmaceutical maker Novartis AG will stop selling Zelnorm drug to relieve constipation after it was linked to higher chance of heart attack, stroke and worsening heart chest pain that can become a heart attack. Novartis agreed to withdraw Zelnorm at the FDA's request. Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation. Doctors who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate.

Novartis sales January 2008
Swiss drugmaker Novartis AG missed forecasts with a 42-percent drop in fourth-quarter net profit, hit by generic competition and a one-off restructuring charge. The company's problems are similar to much of the pharmaceuticals industry, which faces declining sales of franchises, a lack of significant new drugs, increasing generic competition and tougher regulatory hurdles. Novartis suffered a series of setbacks in 2007, including delays to important drugs like Galvus for diabetes and the withdrawal of bowel treatment Zelnorm in the United States.