>> NEW YORK, Oct 16 (Reuters) - As the first two drugs in a new diabetes-treatment class near U.S. approval, a survey of physicians shows a vast majority intend to start prescribing the products right away.
Merck & Co.'s <MRK.N> Januvia is expected to win clearance any day, while Novartis AG's <NVS> Galvus may be approved next month. Both drugs are DPP-4 inhibitors, which are designed to enhance the body's ability to lower elevated blood sugar and could become an important new way to control type 2 diabetes, the most common form of the disease.
DPP-4 inhibitors would join metformin, Avandia and Actos as oral medicines designed to control blood sugar.
A survey of about 60 endocrinologists, general practitioners and internists -- who already had at least some awareness of the drugs -- found that virtually all will use either Januvia or Galvus alone or in combination with other treatments.
Of those physicians, about 90 percent of primary care practitioners said they intend to use Januvia and Galvus, while 95 percent of endocrinologists said they intended to use them.
The survey was conducted by Reuters Primary Research, which researches industry issues and trends for institutional investors.
"The fact that 90 percent of (surveyed) physicians said that they would use them from the get-go is a big number," said Mara Goldstein, head of health care research for Reuters Primary Research.
The survey found no major difference in how doctors may use Januvia and Galvus, including how they may prefer the new drugs over older therapies. The survey did not ask which the doctors would prefer, Januvia or Galvus.
Some doctors seem willing to use the newer drugs as a replacement for Byetta, which was launched in June 2005 by Eli Lilly and Co. <LLY> and Amylin Pharmaceuticals Inc. <AMLN> and had sales of nearly $100 million in the second quarter.
Of the surveyed doctors who were open to using the new therapies, when asked about the likelihood of switching to either Januvia or Galvus from Byetta, more than 70 percent said they would be somewhat to very likely to change treatments.
Goldstein said those results reinforce the concern among investors that physicians will prescribe other drugs before turning to Byetta.
"That's how it (Byetta) has kind of been viewed, as the last stop before insulin," Goldstein said. <<
ZURICH, Nov 13 (Reuters) - Novartis AG <NVS> has asked the U.S. Food and Drug Administration to extend its review period for diabetes drug Galvus by three months to consider new clinical trials data, the Swiss company said on Monday.
The new results provide further evidence that skin problems in a preclinical animal study have not been seen in clinical studies with patients treated for Type 2 diabetes, Novartis said in a statement.
"It was our decision," said Novartis spokesman John Gilardi "It's a setback but we're still confident of getting it to the market quickly."
The Food and Drug Administration review period for the oral drug has been extended from end-November until the end of February 2007.
Novartis still hopes to launch Galvus next year in the United States, in a neck-and-neck race with rival Merck & Co Inc's <MRK> Januvia, which gained FDA approval last month.
Galvus and Januvia are competing intensely to enter the lucrative market of oral treatments for Type 2 diabetes.
Both have been touted by analysts as potential $1 billion-a-year plus sellers.
They represent the first of a class of drugs called DPP-4 inhibitors, which work by enhancing the body's own ability to lower blood sugar levels.
Analysts believe DPP-IV drugs are likely to become a popular treatment in the oral anti-diabetes market, since they are not associated with weight gain, a major side effect of many diabetes drugs. <<
Merck Announces JANUMET(TM), the Trademark for its Investigational Combination Therapy of Sitagliptin Phosphate and Metformin for Type 2 Diabetes
Relates to comments by upndown1313 and others regarding combing medications into an easy to use form. Having an easy to use (i.e., one pill, not many, per day form of a medication for diseases where the patient population may not want to keep track of multiple medications or complicated dosing schedules) could be beneficial.
Friday December 1, 8:30 am ET
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced the trademark JANUMET(TM) for MK-0431A, the Company's investigational oral medicine combining sitagliptin phosphate with metformin for type 2 diabetes. JANUMET is designed to provide an additional treatment option for patients who need more than one oral agent to help control their blood sugar and is currently under standard review by the U.S. Food and Drug Administration (FDA). Merck expects FDA action on the New Drug Application (NDA) by the end of March 2007. The Company is also moving forward as planned with regulatory filings in countries outside the United States.
Data supporting JANUMET were previously disclosed earlier this year at the 66th annual meeting of the American Diabetes Association (ADA) as well as the 42nd annual meeting of the European Association for the Study of Diabetes (EASD). Data presented at the ADA included a 24-week, double-blind study of patients who had inadequate glycemic control with metformin (at least 1,500 mg daily). In this study, sitagliptin phosphate 100 mg once daily added to patients inadequately controlled on metformin led to a significant additional mean reduction in A1C of 0.7 percent compared with placebo (pgreater than or equal to 0.001). The concurrent administration of sitagliptin phosphate with metformin was generally well tolerated, with no increased incidence of hypoglycemia or gastrointestinal adverse events compared with the placebo arm of the study. Body weight changes were similar between the treatment groups.
Data presented at the EASD meeting demonstrated a significant mean placebo-subtracted reduction in A1C of 2.1 percent from a mean baseline A1C of 8.8 percent (primary analysis of all patients treated, p less than 0.001) with sitagliptin phosphate 50 mg twice daily and metformin 1,000 mg twice daily in patients as initial therapy. This study included another arm with sitagliptin phosphate and a lower dose of metformin and also monotherapy and placebo arms. Full results from this study for JANUMET plus other data supporting sitagliptin phosphate will be presented next week at the 19th World Diabetes Congress in Cape Town, South Africa.
In the study presented at EASD, simultaneous treatment with sitagliptin phosphate and metformin was generally well tolerated and showed no meaningful differences in tolerability compared to metformin alone. Side effects of simultaneous treatment with sitagliptin phosphate 50 mg twice daily and metformin 1,000 mg twice daily compared to metformin 1,000 mg twice daily alone included diarrhea (9 percent vs. 10 percent, respectively), nausea (6 percent vs. 8 percent, respectively), abdominal pain/discomfort (3 percent vs. 5 percent, respectively) and vomiting (3 percent vs. 1 percent, respectively).
In studies of sitagliptin phosphate administered in combination with metformin, the most common side effects reported include nasopharyngitis, back pain, arthralgia and cough.
Selected cautionary information for JANUVIA(TM) (sitagliptin phosphate), a component of JANUMET
One of the components of JANUMET is sitagliptin phosphate, marketed under the trademark JANUVIA(TM). JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
To achieve plasma concentrations of JANUVIA similar to patients with normal renal function, lower doses are recommended in patients with moderate renal insufficiency and in patients with severe renal insufficiency or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis. Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. Safety and effectiveness of JANUVIA in pediatric patients have not been established. There are no adequate and well-controlled studies in pregnant women. JANUVIA should be used during pregnancy only if clearly needed. Caution should be exercised when JANUVIA is administered to a nursing woman.
In clinical trials, JANUVIA demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with JANUVIA (greater than or equal to 5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection and headache.[/b[ [Out of curiosity, why would these be side effects? Thanks in advance.]
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