Takeda, PPD to begin safety study on diabetes drug

Takeda Pharmaceutical Co. Ltd. said Friday it will start a study to assess the cardiovascular risks for its developing diabetes alogliptin, delaying any regulatory application by about two years.

The Japanese drug developer said the Food and Drug Administration agreed to the study design. The study was requested by the agency as part of the drug approval process.

In December, the FDA instituted tougher cardiovascular safety standards for diabetes drugs and in March Takeda said those standards would apply to its application for alogliptin. In June, Takeda confirmed the FDA would not approve the drug, lacking a cardiovascular safety study.

Takeda is developing alogliptin with Wilmington, N.C.-based Pharmaceutical Product Development Inc.

"We are committed to conducting this study to satisfy the cardiovascular safety requirements, leading to the enhancement of the product profile of alogliptin," said Dr. Nancy Joseph-Ridge, general manager of the pharmaceutical development division at Takeda.

The company expects to submit interim results that should meet criteria for approval in about two years.

Alogliptin is part of the DPP-4 class of diabetes drugs, which works by controlling blood sugar. Whitehouse Station, N.J.-based Merck & Co. already markets a drug in that class, called Januvia, while New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca received FDA approval for their drug Onglyza in July.

Other potential competitors in the diabetes drug market include drugs from the GLP-1 class, which also control blood sugar. They include San Diego-based Amylin Pharmaceuticals Inc. and Indianapolis-based Eli Lilly & Co.'s exenatide LAR, which is a long-lasting version of the current drug Byetta. Denmark-based Novo Nordisk meanwhile is seeking approval for its GLP-1 drug, liraglutide.

Shares of Pharmaceutical Product Development lost 13 cents to $20.09 in morning trading.

Novo Nordisk Diabetes Drug Victoza Gets EU Approval

Danish pharmaceutical company Novo Nordisk A/S (NOVO-B.KO) said Friday the European Commission has given market authorization for its closely-watched diabetes treatment Victoza in the 27 European Union member states.

Novo Nordisk will launch Victoza in the U.K., Germany and Denmark during the summer and in other European markets during the second half of 2009 and throughout 2010.

Victoza, also known as Liraglutide, belongs to a relatively new kind of diabetes drug class known as GLP-1 analogues. In contrast to conventional treatment with insulin, the drug doesn't risk pushing blood glucose dangerously low and it also helps patients to lose weight.

Analysts and investors have seen significant sales potential for the drug, which in April was recommended for European approval by a regulatory committee, only weeks after a Food and Drug Administration panel reached a split vote on whether to recommend it for a launch in the U.S.

It is still uncertain whether Victoza will be launched in that country although Novo Nordisk is in dialogue with the FDA and hopes for approval "within months."

Novo Nordisk Chief Scientific Officer Mads Krogsgaard Thomsen told Dow Jones Newswires his company will launch Victoza on the first European markets in "very few weeks".

He said the drug should gain a strong position on the market for diabetes treatment since it has proven in tests to be more efficient compared both with conventional insulin treatment and with Eli Lilly & Co's (LLY) and Amylin Pharmaceutical's (AMLN) competing GLP-1 analogue, Byetta.

Still, he said competition is bound to turn more intense. "All companies want to have a stake in the GLP-1 field," he said. "That is why it is important for us to have approval now, and market early."

A launch on the large European market is important for the company, although only worth about a third of an equivalent U.S. launch since it tends to be more difficult there to get reimbursement for expensive drugs, said Alm Brand analyst Michael Friis Jorgensen. He has a buy rating on Novo Nordisk.

According to Novo Nordisk, Victoza is around 50% more expensive than modern insulin at a cost per daily use of roughly EUR3.

Novo Nordisk said Friday's European approval doesn't change its expectations for its financial results in 2009. At 1022 GMT, the company's shares were down 0.5% at DKK290.50, against a 1% drop in the broader Copenhagen market.

The market authorization was in line with expectations and already reflected in Novo Nordisk's share price, which explained the lack of any significant market reaction Friday, said Alm Brand's Jorgensen.

Drugmakers vie for lucrative diabetes market

TRENTON, N.J. - Major pharmaceutical companies are fighting harder over the millions of patients with diabetes, a lucrative area because the pool of customers keeps growing with the obesity epidemic — and they will need daily drugs or insulin for life.

As the American Diabetes Association conference opened Friday, companies began presenting research on experimental drugs, including a few in a new class, and data on existing drugs for which they hope to capture many more customers.

Meanwhile, Boehringer Ingelheim Pharmaceuticals Inc. has jumped into the diabetes field and will be reporting on two experimental drugs and its diabetes pipeline.

"Why wouldn't you get in?" said Miller Tabak analyst Les Funtleyder. "It's a big market, it's a chronic market and there's unmet need."

230 million people have diabetes

More than 230 million people worldwide are estimated to have diabetes — nearly an eightfold jump since 1985 — and nearly 4 million died of the blood sugar disorder in 2007, according to the World Diabetes Foundation. Up to half of patients can't keep their blood sugar levels at their goal with their current medicines, diet and exercise. That increases risk of complications including blindness, amputations and kidney damage.

Those patients are targets for drugmakers hoping their new products will muscle aside older drugs, or at least be added to ones patients already are taking. Global sales of diabetes drugs totaled $27.3 billion last year, making them the No. 4 class, according to IMS Health.

"We need innovation in detecting and monitoring diabetes, in therapeutic effectiveness and in convenience of administering treatment," said Erik Gordon, an analyst and professor at the University of Michigan's Ross School of Business.

Among expected conference highlights, according to analysts:

Data on a a new "smart" insulin pump from Medtronic Inc. that continually monitors blood sugar to prevent dangerously low levels as well as spikes.

New reports on an experimental, long-acting version of Byetta, sold by Eli Lilly and Co. and Amylin Pharmaceuticals Inc., which improves blood glucose control by signaling the pancreas to make the right amount of insulin after a meal and reducing appetite — and often weight, too. It is an injected twice a day; the new version, if approved, would be once a week.

Edward Jones Senior healthcare analyst Linda Bannister will be watching for safety data on it, because some earlier research on drugs in its class, the GLP-1 stimulators, indicated possible risk of thyroid cancer and inflammation of the pancreas, the organ that makes insulin.

It "has the potential to be a strong competitor if the risks are manageable," Bannister said, adding long-acting Byetta offers patients long-term blood sugar reduction and "most importantly for some, weight loss." That's key because many diabetes drugs cause weight gain.

The drug should be launched next year if approved, boosting total Byetta sales from $430 million last year to $2.2 billion in 2013, Cowen & Co. analysts forecast.

Novo Nordisk Inc. will present late-stage data on blood sugar and weight control with its GLP-1 drug, once-a-day liraglutide. And Britain's GlaxoSmithKline PLC has mid-stage data on its GLP-1, albiglutide, given as infrequently as once a month.

Glaxo also will present data on rates of hospitalization and death from cardiovascular problems in patients taking its Avandia, versus two other drugs. Avandia sales dropped after a 2007 journal report suggested it can raise chances of heart attack and cardiac death.

Bristol-Myers Squibb Co. and Boehringer Ingelheim are reporting on experimental SGLT-2 inhibitors, which appear to block the kidneys from reabsorbing glucose — and perhaps prevent kidney damage. Some diabetes specialists say more data on risks and benefits is needed.

Bristol-Myers is presenting mid-stage data on dapagliflozin, taken with insulin and widely used diabetes pills.

When blood sugar is high, DPP-4 inhibitors boost insulin production and reduce glucose production in the liver. They became the first new class of diabetes pills in nearly a decade when Merck & Co. launched Januvia late in 2006.

Merck will try to boost use with studies on how well Januvia works along with insulin, generic metformin and another drug. But Pfizer Inc. and partners Bristol-Myers and AstraZeneca LP are presenting data on their experimental DPP-4 inhibitors, which could become Januvia competitors