Three hits for Novartis

Novartis' once-daily Exelon (rivastigmine) transdermal patch for the treatment of Alzheimer's disease, Aclasta (zoledronic acid) - a once yearly treatment for women with post-menopausal osteoporosis, and Galvus (vildagliptin), a new oral treatment for Type II diabetes, all received the blessing of the European Commission's Committee for Medicinal Products for Human Use (CHMP). As a general precursor to EU approval, these three positive opinions will be music to Novartis' ears, with the products hoped to be added to the list of seven approvals the company has already received this year. The final word from the European Commission should come within the next three months. The Exelon patch is the first application of the company's skin patch technology, and has been shown to achieve similar levels of efficacy to Exelon capsules, whilst significantly reducing the incidence of gastrointestinal side-effects common with the oral formulation of the drug. The patch itself can be applied to the back, chest or upper arm, and provides steady levels of medication over 24 hours. Trials of the patch formulation showed improved memory, overall functioning, and ability to perform everyday activities in patients, as well as a three-fold decrease in reports of nausea and vomiting compared with the oral form of the drug. The Exelon patch was approved in the US in early July for the treatment of mild to moderate Alzheimer's disease and Parkinson's disease dementia. Aclasta is a once-yearly treatment for women with post-menopausal osteoporosis, offering a significant alternative to current oral therapies that have to be taken daily, weekly or monthly, according to the company. A single fifteen-minute infusion of the drug provides an entire year's worth of treatment in one go. A survey of clinical data demonstrated a 70 per cent reduction in spine fractures in women using Aclasta compared to placebo, and a 41 per cent reduction in hip fractures. According to Novartis, this is the first time one treatment in a single study has been shown to provide protection against all types of osteoporotic fractures across all major sites - spine, hip and other non-spinal fractures. Aclasta was submitted to the US Food and Drug Administration (FDA) in late 2006 under the brand name Reclast, and is already approved in over 50 countries for the treatment of Paget's disease, a chronic disorder that causes abnormal bone growth. And finally, Galvus, a new once-daily oral medication for Type II diabetes, has also received a positive opinion from the CHMP. The drug, one of a new class of DPP-4 inhibitors, has been recommended in the EU for use in combination with the most common oral diabetes medicines - metformin, a thiazolidinedione (TZD) or sulfonylurea (SU). According to the company, this is the broadest proposed indication for any member of the new DPP-4 inhibitor class. As many Type II diabetes patients require more than one treatment to control their blood sugar levels, a positive safety and tolerability profile of Galvus in combination with the most commonly used drugs is a particular plus point for the treatment. Earlier this year, however, Novartis reported that the FDA had issued the company with an approvable letter regarding the diabetes drug, and has since submitted proposals to the agency for additional studies in renally impaired patients. The drug is already available in Brazil and Mexico. So as Novartis basked in the glow of the good news over the weekend, the focus will now be on waiting to hear from the European Commission who, the company will be hoping, will share the CHMP's positive opinions.