March 2 (Bloomberg) -- AstraZeneca Plc Chief Executive Officer David Brennan said the U.K. drugmaker still plans to ask for approval of a new diabetes medicine early next year, after a similar Novartis AG treatment was delayed on safety concerns.

AstraZeneca, based in London, bought rights to the product, called saxagliptin, and another drug from Bristol-Myers Squibb Co. in January for $1.35 billion. This week, Novartis said the Food and Drug Administration wants more data on its Galvus, and analysts said the pill may be delayed for more than a year.

Saxagliptin, Galvus and Merck & Co.'s Januvia belong to a new class of drugs, which use the body's own mechanisms to control blood sugar, in the $15 billion global diabetes market. While skin lesions have been seen in animal tests of Galvus and saxagliptin, AstraZeneca isn't anticipating FDA requests for more data, Brennan said yesterday in an interview. The U.K. drugmaker dropped its experimental Galida diabetes drug last year and needs new products to help spur growth.

``We haven't seen anything that would suggest to us that we have a particular issue,'' Brennan said. ``It seems for this class of products, each one has a slightly different profile so the discussions that we had last (with the FDA) suggest to us that we're on the right track.''

AstraZeneca is paying the majority of development costs for the medicine between 2007 and 2009. Analysts including Sanford Bernstein's Gbola Amusa say that AstraZeneca may have to do additional trials for saxagliptin, which is also associated with the skin lesions seen in laboratory animals in Galvus studies.

Shares of AstraZeneca fell 7 pence to 2,803 pence at the close of trading in London.

Trial Results

Initial results from late-stage trials of saxagliptin, a so- called DPP-4 inhibitor, will be released at the American Diabetes Association meeting in June, Brennan said.

The diabetes market is expected to be worth $25 billion by 2011, Les Funtleyder, analyst with Miller Tabak & Co, said. Amusa expects saxagliptin to attain annual sales of $750 million.

The FDA is concerned that a byproduct of Novartis' Galvus may build up in patients with kidney problems and lead to skin lesions. The regulators requested monkey toxicity data from Bristol-Myers, which developed saxagliptin, but didn't change the trial's protocol, Amusa said.

Post-Approval Reporting

AstraZeneca and Bristol-Myers will likely have to do ``more robust'' post-approval reporting and data collection, Brennan said.

``We just look at the situation with Novartis this week and say, we got to be sure we understand this issue because it's significant,'' Brennan said. ``Based on our review of the program we saw through due diligence -- which was not complete but included discussions with the FDA -- we saw all the data, we saw pre-clinical as well as data in the non-human primates and clinical data.''

DPP-4 inhibitors are a new class of medicines that work by increasing and prolonging the action of natural hormones in the body called incretins. This helps to lower high blood sugar levels by ensuring a timely release of insulin in patients with the most common form of diabetes, known as Type 2.

``That whole class of drugs has a slight cloud over them at the moment,'' Andrew Fellows, analyst at Helvea in London, said in a Feb. 28 interview. ``There's a question mark over whether that was a sensible investment'' for AstraZeneca.

Diabetes Sufferers

The World Health Organization estimates more than 180 million people suffer from diabetes, with this number likely to double by 2030. The condition can damage the heart, kidneys, blood vessels, nerves and cause blindness over time.

People of African and Caribbean, Latin American and Asian descent are more susceptible to the disease, according to a study in today's Lancet.

AstraZeneca said Jan. 11 that it bought saxagliptin and another earlier-stage compound, dapagliflozin. Dapagliflozin, which is in phase II trials, blocks the kidney's absorption of glucose from urine and could be taken in combination with other diabetes drugs.

The U.K.'s second-largest drugmaker after GlaxoSmithKline Plc said acquiring the drugs will cause research spending to rise to 0.5 percent of sales this year and 1 percent in 2008.

To contact the reporter on this story: Etain Lavelle in London at at elavelle1@bloomberg.net.

Last Updated: March 2, 2007 11:47 EST