Metformin chemical structure
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Fortamet

Metformin (Glucophage®, Fortamet®, Riomet®) is an anti-diabetic drug from the biguanide class (its other members are the withdrawn agents phenformin and buformin). more...

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Uses

The main use for metformin is for the treatment of diabetes mellitus, especially when it is concomitant with obesity and insulin resistance.

It is also being used increasingly in polycystic ovary syndrome (PCOS) and non-alcoholic steatohepatitis, two other diseases that feature insulin resistance; these indications are still considered experimental.

Metformin is the only anti-diabetic drug that has been proven to reduce the complications of diabetes, as evidenced in a large study of overweight patients with diabetes (UKPDS 1998).

Metformin is often prescribed to type 2 diabetes patients in combination with rosiglitazone maleate. This drug actively reduces insulin resistance, complementing the action of the metformin. In 2002, the two drugs were combined into a single product, Avandamet, marketed by GlaxoSmithKline. . In 2005, all current stock of Avandamet was seized by the FDA and removed from the market. This was due to problems at the manufacturing plants, not to any medical issues resulting from the drugs use. The drug pair continued to be prescribed separately in the absence of Avandamet itself, which was readily available by the end of that year.

Mechanism of action

Despite its therapeutic benefits, the mechanism of action of metformin is uncertain. Its mode of action appears to be reduction of hepatic gluconeogenesis; the "average" person with type 2 diabetes has three times the normal rate of gluconeogenesis. Metformin treatment reduces this by one third to two thirds. It is has been shown that metformin also decreases intestinal absorption of glucose. A third mechanism is that metformin improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Zhou et al (2001) showed that metformin stimulates the hepatic enzyme AMP-activated protein kinase.

Side-effects

The most serious side effect of metformin is lactic acidosis. However, this complication is rare if the contra-indications are followed, as it seems limited to those with impaired liver and/or kidney function.

Phenformin was withdrawn because of an increased risk of lactic acidosis (up to 60 cases per million patient-years). In recent studies it was revealed that, as long as it is not prescribed to patients who are at risk, metformin is much safer, and the risk of lactic acidosis approximates that of people who are not on the medication (Salpeter SR et al 2003).

The most common side effect of metformin is gastrointestinal upset. This includes diarrhea, cramps, nausea and vomiting. In a clinical trial of 286 subjects, 53.2% of the 141 who were given Metformin IR (as opposed to placebo) reported diarrhea, and 25.5% reported nausea/vomiting (source: Drug Facts & Comparisons 2005).

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Andrx pulls plug on brands
From Drug Store News, 2/14/05 by Michael Johnsen

FORT LAUDERDALE, Fla. -- Andrx has decided to exit the branded business altogether after waiting some 14 months for the approval of Pfizer's Cardura XL.

Andrx originally acquired the U.S. distribution rights to the extended-release alpha-blocker in November 2003 for an agreed upon $35 million. At the time, the approval for the benign prostatic hyperplasia treatment was expected to come in the summer of 2004, and projected sales were expected to reach in excess of $100 million annually, as reported by David Buck, an analyst with the Buckingham Research Group.

With Cardura XL yet to be approved and Andrx's current brand portfolio operating on a $31 million deficit for the nine months ended Sept. 30, company directors opted to focus on core competencies. "Our board and management have been evaluating our overall strategy and have concluded that Andrx should focus on ... controlled-release pharmaceuticals and distribution, as well as initiatives ... that will cause our controlled-release technologies to be employed in the development of new brand products for third parties," said Andrx Chief Executive Officer Thomas Rice.

In contrast with its branded efforts, Andrx recorded a profit of $104.8 million on revenues of $303.3 million from the sales of generic products and a profit of $37.4 million on revenues of $495 million from distribution agreements.

Andrx exercised its right to terminate the Cardura XL agreement with Pfizer when the drug was not approved by Dec. 31. Andrx is expected to receive a refund of the $10 million the company paid in connection with the deal.

The challenge for Andrx now may be in persuading another company to assume its brand portfolio. "We are unsure about Andrx's ability to find a buyer willing to pay much of a multiple to sales," remarked A.G. Edwards analyst Al Rauch. Branded products Altoprev [lovastatin extended release] and Fortamet [metformin HC1 extended release] have only three years of marketing exclusivity, and generics companies are challenging patents that extend beyond this time."

In addition, the future for the supplier's two cough-cold formulations, Entex PSE and Entex LA, is "uncertain," according to the company, amid speculation that Entex PSE may have to be pulled from the market following Adams Respiratory Therapeutics' Food and Drug Administration approval for an over-the-counter version of pseudoephedrine and guaifenesin, Mucinex D, in June 2004.

Andrx optimistically anticipates the sale of its branded business within roughly six months and has engaged Banc of America Securities to broker the deal.

COPYRIGHT 2005 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2005 Gale Group

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