Galvus EU Approval

Galvus EU Approval

This morning Novartis (NYSE:NVS) announced that Galvus® received regulatory approval in Europe. According to the company’s press release “Galvus is not recommended for patients with liver impairment, and liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. Due to limited experience, Galvus is not recommended for patients with moderate or severe renal impairment or congestive heart failure. Galvus should not be used in patients with type 1 diabetes.”

During their most recent earnings call the company expressed doubts as to whether they would continue pursuing regulatory approval in the US. Based on the label the company received with the approval in Europe and the fact the Januvia has a huge lead in the US market, Diabetic Investor suspects the company will not spend more money trying to get Galvus approved in the US.

It will be interesting to see whether Januvia, which has also had a label warning regarding a severe form of skin cancer, has another issue as usage increases. Merck (NYSE:MRK) has positioned Januvia as a replacement for Avandia and sales reps have called Januvia an oral form of Byetta. The main selling point used by reps is that drug is as effective as current therapies but with fewer side effects. According to physicians and patients interviewed by Diabetic Investor, Januvia is a hit or miss proposition working in some patients but not in others. We’ve also heard reports of a wide variety of side effects but so far nothing that would warrant another label change.

Yesterday Novo Nordisk (NYSE:NVO) announced that Liraglutide their once daily GLP-1 will be submitted to the FDA before the end of the second quarter. Amylin (NASDAQ:AMLN) has also publicly stated that the once-a-week version of Byetta will be submitted to the FDA in the first half of 2009, possibly late 2008. Given the superior performance of both of these drugs and the added benefit of weight loss Diabetic Investor sees physicians using both drugs earlier in the treatment cycle. While both drugs are taken via injection Diabetic Investor does not see that one fact as an obstacle to wide spread adoption. As we pointed out yesterday Byetta which is injected twice a day is well on its way to blockbuster status.

Investors should not ignore the increased usage of insulin for Type 2 patients. Like metformin, insulin has a long history, its side effects are well known and when used properly is very effective. Now that Lilly (NYSE:LLY) has improved their insulin delivery systems Diabetic Investor sees insulin usage accelerating within the type 2 market.

Given their broad portfolio of products, excellent delivery systems and huge sales force Diabetic Investor sees Novo Nordisk as the big winner going forward. We further believe Liraglutide and Byetta can co-exist until the once-a-week version of Byetta is available. It should be noted that as widely anticipated as LAR is Amylin must be careful not to repeat the mistakes made when Byetta first came to market and they were unable to meet demand.

Finally with this move towards injectable therapies investors should take a serious look at Becton Dickinson (NYSE:BDX) the worldwide leader in needle technology. BD has a strong market presence and will surly benefit from this shift in therapy options for type 2 patients.

David Kliff
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