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To: Jorj X Mckie who wrote (975)5/5/2000 12:15:00 PM
From: wlheatmoon  Respond to of 2850
 
Tom,

here's what i found about Lantus and AVE.

data below....from my look of it,,,there's a fair bit of competition in the injectible insulin sector. this particular drug appears to give a nice result. it is once a day and appears to give excellent control of glucose levels. whether it will be as big as viagra,,,i don't know. there's a fair bit of competition out there,,,and it is still an injectible product. the last article gives some info on genetic engineering and better potential products in the pipeline.

Aventis Pharmaceuticals' Lantus(R) (Insulin Glargine [rDNA Origin] Injection) Approved By FDA For Treatment Of Diabetes

Aventis Pharmaceuticals (NYSE: AVE), the U.S. pharmaceutical business of Aventis Pharma AG, announced today that the U.S. Food and Drug Administration (FDA) has approved LANTUS(R) (insulin glargine [rDNA origin] injection) for the treatment of type 2 and type 1 diabetes. Aventis Pharmaceuticals plans to have product available for patients later this year.

Novo Nordisk (NVO) Files Lawsuit Against Aventis Pharma (AVE) For Patent Infringement

Novo Nordisk A/S (NYSE: NVO) announced today that the company has filed a complaint with the Court of Dusseldorf in Germany against Aventis for patent infringement. In the complaint Novo Nordisk claims that the production and sale of the long-acting insulin analogue Lantus developed by Aventis infringes two German patents held by Novo Nordisk.

a medical journal article---
Drugs 2000 Feb;59(2):253-60; discussion 261-2 Related Articles, Books

Insulin glargine.

Gillies PS, Figgitt DP, Lamb HM

Adis International Limited, Mairangi Bay, Auckland, New Zealand.

[Medline record in process]

Insulin glargine is an extended-action biosynthetic human insulin. It precipitates in the neutral environment of subcutaneous tissue and is thus gradually absorbed into the bloodstream. The addition of small amounts of zinc to the formulation further delays absorption. In small euglycaemic clamp studies, the onset of action of insulin glargine was shown to be later, the duration of action longer and the time-action profile flatter than that of Neutral Protamine Hagedorn (NPH) insulin in patients with type 1 diabetes mellitus and healthy volunteers. Four large clinical trials of up to 28 weeks' duration have shown that a single bedtime dose of insulin glargine, in combination with preprandial short-acting insulin, is as effective or more effective than once or twice daily NPH plus short-acting insulin in improving glycaemic control in patients with type 1 diabetes mellitus. In 3 large comparative trials, insulin glargine decreased glycosylated haemoglobin and/or fasting blood glucose levels to a similar extent to that seen with NPH insulin in patients with insulin-dependent or non-insulin-dependent type 2 diabetes mellitus, either as monotherapy or in combination with oral hypoglycaemic agents. Insulin glargine appears to be well tolerated. A lower incidence of hypoglycaemia, especially at night, was reported in most trials with insulin glargine when compared with NPH insulin.

diabetes.about.com
Engineered Cells for Delivery of Insulin
Dateline: 02/07/00

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A study appearing in the Febuary 4th issue of Science is of great interest to those with diabetes. According to research with mice, cells have been engineered to store insulin until a pill triggers the hormone's release. Researchers say that the experiments show the technique can correct high levels of sugar in the blood, the primary symptom of a common form of diabetes. This may one day offer a needle-free treatment to those who require insulin.

Theoretically this would allow a patient to precisely control insulin levels in the blood by a pill. The technique causes insulin to clump inside a cell with another protein, forming a molecule that is too large to leave the cell. A drug, given as a pill, breaks up the clump, allowing the insulin to flow into the blood stream in a way that mimics the spurt of hormone normally secreted by the pancreas.

Senior author of the study, Tim Clackson states, "The amount of protein (such as insulin) that gets released is directly related to the amount of drug that is given, the more drug you give, the more protein gets released into circulation.The insulin stays in the compartments of the cell and has no toxicity or adverse effects. It just sits there,'' said Clackson. ``Only when the animal receives the drug do the aggregates break apart and then flow into the circulation.''

Even though the initial target of the research is diabetes, the new technique could also be used to deliver any protein that the body needs in spurts, such as growth hormone, proteins that would provide pain relief, appetite control or correct brain chemistry.

According to Clackson the technique is now being tested on larger animals and could be ready for human testing within two years.