Sunday, March 17, 2013

How Severe Is That Media for Diabetes Drugmakers? - Motley Fool

Three months ago, I presented my most readily useful postulations of where diabetes drugs could be headed in the not-so-distant future. It is not that the current FDA-approved medications do not help get a handle on the illness where in actuality the body either doesn't produce enough insulin or resists its effects; it's that the current medications have far too many possible unwanted effects and/or do not work quickly enough. That week brought an ideal illustration to us, with FiercePharma reporting a study by JAMA Internal Medicine quantified the risk of developing pancreatitis based on two existing Type 2 diabetes remedies. The study found that Januvia by Merck (NYSE: MRKAA), and Byetta, which AstraZeneca (NYSE: AZNAA) and Bristol-Myers Squibb (NYSE: BMYAA) purchased if they jointly bought Amylin Pharmaceuticals, doubled a patient's odds of developing pancreatitis. Because diabetes tends to cause swelling of the pancreas to start with now some of this is often taken with a grain of salt. In reality, regardless of the FDA implementing a harder warning label on Byetta's packaging after six patient deaths, four of these could not be causally linked to Byetta usage. Still, this represents a reminder that while our current type 2 diabetes remedies are good, they could be significantly better. It also places Merck's hit Januvia -- which accounted for $4.09 million, or around a large number of total revenue -- directly in the spotlight. Mixed with Janumet, its newer diabetes treatment that combines Januvia with metformin, Merck utilizes Januvia in certain form or appearance for pretty much 15% of its sales. When it is became too dangerous for diabetics to get, sales may falter and so can Merck. The news is even more dismal for Merck considering that multiple promising revolutionary diabetes treatments are working their ways through the medical pipeline and starting to find their way onto drugstore shelves. Among the most interesting pathways in diabetes remedies is SGLT-2 inhibitors, which help alleviate problems with glucose reabsorption and operate in the kidneys. A lot more intriguing, SGLT-2 inhibitors have now been demonstrated to reduce A1C levels and to contribute to weight loss, that will be the opposite of what all of the medications currently in the marketplace do -- even though, I will point out, none are indicated for weight-loss or control. AstraZeneca and Bristol-Myers' Forxiga, for example, has received acceptance from the European Medicines Agency for diabetes. Although it was refused approval in the U.S. because possible cancer risks, I believe that further safety data can lead to an approval in the U.S of. The much more interesting SGLT-2 inhibitor is Johnson & Johnson's (NYSE: JNJAA) Invokana. Not only did Invokana averagely lower A1C levels in trials, nonetheless it did so better than Merck's Januvia. A few weeks before, meaning that Invokana would easily take market share from Januvia would have already been a difficult market given Januvia's short listing of negative effects compared to Invokana's importance of patients to urinate more often, as my Foolish friend Brian Orelli observed in June. With a study showing that pancreatitis dangers are doubled for Januvia customers, perhaps the pendulum swings just a little easier in Invokana's course. The growth of glucokinase activators could also take a minor hit. Amgen's (NASDAQ: AMGNAA) AMG 151 -- that I outlined three days before as an interesting long-term type 2 diabetes therapy option -- is undertaking multiple combination studies with existing drug metformin, or Merck's Januvia. This study may possibly prove to be nothing more than hot air in the wind as Januvia's gains seem to have far outweighed its dangers until recently. But, as newer solutions become available, that risk-reward profit will shrink, and further studies like that introduced by JAMA Medical JournalAwill aid drain Januvia faster than Merck would like. Can Merck defeat the patent cliff?This titan of the pharmaceutical industry stumbled into 2013 and continues to fight patent expirations and pipeline problems. Is Merck still a solid dividend play, or should people be looking elsewhere? In a fresh quality study report on Merck, The Fool fights every one of the company's moving parts, its important market opportunities, and causes to both buy and sell. Today to learn more -- and obtain a whole year of free updates -- just click here to state your copy.

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