News in brief, June 27, 2007

Novartis blood pressure drug set for EU approval
The Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval for Novartisí blood pressure treatment Rasilez (aliskiren). The CHMP issued the positive opinion based on data from more than 7,800 patients in 44 clinical studies. The Commission is expected to make a decision in the next three months and usually follows the CHMPís recommendations. The clinical trial program showed that Rasilez provided significant blood pressure reductions for 24 hours and beyond3. Furthermore, Rasilez provided added efficacy when used in combination with other commonly used blood pressure medications. According to Novartis, Rasilez is the first new type of blood pressure drug in ten years. Studies estimate that nearly one billion people may have high blood pressure and that nearly 70 per cent of patients with high blood pressure never reach healthy blood pressure levels. As a result, they live at risk of complications like heart attack, stroke, blindness and premature death, creating a strong need for new therapies.

Euro survey shows increasing complexities of CKD anaemia management
The European Renal Association ñ European Dialysis Transplant Association (ERA-EDTA) says 47 per cent of nephrologists in the UK believe the management of Chronic Kidney Disease (CKD) patients has grown increasingly complex in the last five years. Half of those believe it is due to a rise in diabetes and heart disease amongst CKD anaemia patients, which suggests a need for more proactive intervention. The ERA-EDTA carried out the CKD Anaemia Physician Behaviours Survey polled 369 nephrologists across five European countries: Germany, France, Italy, Spain and the UK. The survey was investigating unmet needs and real world challenges faced by doctors managing CKD patients. Results show that nearly half (42.2 percent) of UK patients are referred to nephrologists at an advanced stage of the disease - CKD stage four or above, which is broadly consistent with the rest of Europe. When questioned on how to optimise CKD anaemia management, the majority of UK nephrologists (67 percent) called for increased education and understanding of CKD in primary care, and almost all of the participating UK nephrologists (84 percent) called for routine eGFR (estimated glomerular filtration rate) testing in the primary care setting in order to improve early diagnosis and referral.

AZ combination asthma treatment finally on US market
AstraZeneca (AZ) has launched its asthma combination therapy Symbicort (budesonide/formoterol) pressurised Metered Dose Inhaler (pMDI) one year after it was first approved by the US Food and Drug Administration (FDA). It is now available for the long-term maintenance treatment of asthma in patients 12 years of age and older. Symbicort is a combination of two asthma medications ñ budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta agonist (LABA). According to AZ, Symbicort offers patients improved asthma control as early as day one that is sustained over 12 weeks. U.S. studies have also demonstrated that SYMBICORT pMDI delivers a significant improvement in lung function within 15 minutes of beginning treatment. Symbicortt pMDI is approved for patients whose disease is not adequately controlled on another asthma-controller medication or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.

Rimonabant rejection casts shadow over other obesity drugs

The US rejection of sanofi-aventis' obesity drug Zimulti (rimonabant) could scupper the sales of other weight loss drugs, while highlighting the difficulties of developing new anti-obesity medications.

According to Bank of America analysts, the bar for approval in the area of obesity had been raised. Other analysts have added that the FDAís ruling could also affect Pfizer and Merck & Co, both of which are developing drugs in the class known as CB-1 antagonists.

Leerink Swann analysts have said that they expect that large pharmaceutical companies developing CB-1s may now look more closely at their development programmes, adding that the outlook for the class was now in doubt.

With obesity now a worldwide health concern, treatments to combat the problem have been pushed through, only to cause serious side-effects. For example, 10 years ago Wyeth withdrew drugs in its fen-phen diet-pill combination over safety concerns. Also, Roche's Xenical (orlistat) did not produce the blockbuster sales the Swiss company had envisaged. Last week GlaxoSmithKline (GSK) launched alli, which is an OTC half-strength version of Xenical.

Morgan Stanley analysts said that little data were available on the products from Merck and Pfizer, but that studies done prior to human testing had pointed to evidence of toxicity. They described the FDA advisory panel's vote as being clearly a negative for the entire class.

As of December 2006, Pfizer's CB-1 antagonist, CP-945598, was one of eight drugs the company had in phase III testing for various conditions. It also has an extensive phase III programme, with a study of more than 4,000 patients planned, according to Leerink Swann analsysts.

Pfizer Animal Health moves jobs to Michigan

Pfizer Animal Health is consolidating its research in Kalamazoo, Michigan, and will move jobs there from abroad and the surrounding area, according to a company statement.

The moves, which will begin in Q3/ 4 2007, will bring 550 employees to the companyís Kalamazoo operations by 2009.

Some 65 new jobs will be added to the site as the company relocates employees from Sandwich, England, and others working at Pfizerís Richland Township farm in Kalamazoo County.

The 8,500-hectare farm will continue as Pfizerís global centre in veterinary medicine research, the company said in a statement. Pfizer recently completed USD 50m in laboratory and building investments there. Many of the companyís animal-medicine products were developed, at least partially, in Kalamazoo County.

Pfizer Animal Health posted USD 2.3bn in sales in FY06. Its products include drugs for obesity, nausea and antibiotic protection in dogs, as well as antibiotic and antiparasitics for cattle, dairy animals, dogs and cats.

The plan is subject to the approval of worker groups and local labour laws in England. If approved, some workers there will be offered transfers, and all will be eligible to bid on openings in Kalamazoo and other Pfizer locations, the company added.

Indiaís Cadila acquires Brazilís Nikkho
Indiaís Cadila Healthcare is acquiring Brazilian Quimica e Farmaceutica Nikkho do Brasil Ltda for USD26m. The price matches Nikkhoís posted sales in FY06. The Brazilian pharma market the largest of the Latin American markets and is estimated at USD8bn. Cadila is making the acquisition through Zydus Healthcare Brazil; the acquisition is funded by internal accruals. This is the second acquisition for Cadila, which acquired Nippon Universal Pharmaceutical in Japan in April 2007. The acquistion enables Zydus to market branded speciality products across Brazil and boost its existing generic business in that country ñ Cadila currently has 13 generic products marketed in Brazil. Nikkho markets 22 products under 13 different brands product, comprising of a wide range of therapeutic segments such as general medicine, pediatrics, gynecology, neurology, gastroenterology, otolarngology, respiratory, dermatology, and others.