The Tide is Turning in Amylin’s Favor

The Tide is Turning in Amylin’s Favor

As Diabetic Investor predicted in our most recent issue entitled “Amylin – How This Will Play Out”, the tide is turning in the company’s favor. In the issue we stated;

“The issues currently facing Amylin will begin to be resolved favorably. This will start with the upcoming label change in Byetta which will be minor in nature. This will be followed by the FDA panel meeting for liraglutide. According to well placed sources the reason for the panel meeting has little to do with pancreatitis rather a structural issue with liraglutide. While Diabetic Investor does not expect the panel to vote against liraglutide don’t surprised if they recommend additional studies be performed, which would further delay the drug from competing with Byetta.”

As we have already seen from the data the company has released the concerns over pancreatitis are unfounded. Although the FDA and the company have not released what labels changes will be forthcoming, given this growing body of evidence it appears the change will be minor as Diabetic Investor predicted.

The company is also getting a boost from the results of the DURATION-2 study which compared the once-weekly version of Byetta (Byetta LAR) to Januvia and Actos. According to the study patients using Byetta LAR experienced a reduction in A1C of 1.7% over three months compared to a reduction of 1% for patients on Januvia and 1.4% for patients on Avandia. Even more significant patients on LAR experienced an average weight loss of 6.2 pounds at 26 weeks, compared to 1.9 pounds for patients on Januvia and a weight gain of 7.4 pounds for patients on Avandia.

The difference between LAR, Januvia and Avandia would have been even greater had the therapies been compared head to head. Study participants received the maximum doses of Januvia and Avandia and were also allowed to remain on metformin. As Diabetic Investor has pointed out in the past with Januvia in particular the A1C lowering comes mainly from the metformin component and when used as a monotherapy Januvia produces rather lackluster results. Given that Avandia is already a dead duck due to cardiovascular concerns, this is the first study that gives LAR a leg up on Januvia which has enjoyed an incredible lucky streak since the drug came to market. Merck (NYSE:MRK) has positioned Januvia as an oral form of Byetta basically telling physicians that patients will enjoy all the benefits of Byetta without twice daily injections.

Diabetic Investor has known all along that Byetta was superior to Januvia in both A1C lowering and weight loss and the results of the DURATION-2 study confirm this. Given that LAR is taken just once a week compared to multiple doses of Januvia each day physicians will soon have the option of putting patients on a drug that only needs to be taken once-a-week, where there is no need for glucose monitoring and no complex dosing options.

Also helping Amylin (NASDAQ:AMLN) today is the release of the material Novo Nordisk (NYSE:NVO) will use during their Thursday panel meeting with the FDA for liraglutide their once-daily GLP-1. Again Diabetic Investor accurately predicted that once this data became public the company could be asked to do more studies before the FDA would approve the drug. Looking over the mounds of data presented by Novo and the questions the FDA are asking it wouldn’t surprise Diabetic Investor at all if the FDA asked the company to conduct another pre-approval study.

In the points of discussion released by the FDA people should pay close attention to point number three in the Cardiovascular Safety section where it states; 

“In the cardiovascular event analyses, comparators of all active control, all add-on placebo control, and total comparator were used. Results were qualitatively similar for liraglutide vs. total comparator, and liraglutide vs. active comparator. However, comparisons to placebo were sensitive to analytical method, often yielded point estimates >1 (not favoring liraglutide) and often yielded 95% confidence interval upper bounds of >1.8. Analyses were stratified by study, and lower baseline risk did not appear to contribute. Please discuss the relevance of these differences noted by type of comparator to the liraglutide program, and the role of these separate types of comparators in the evaluation of the cardiovascular risk for future diabetes drug applications.”

Without going into a complex discussion the highlighted area is what concerns the FDA and appears to be outside the range that was outlined in their new guidelines for approving diabetes drugs. Simply put the concern is that Liraglutide could actually INCREASE cardiovascular risk. Given the heightened sensitivity to this issue due to the Avandia controversy and the new guidelines expect some serious fireworks during Thursday’s panel meeting when this question is discussed.

Also somewhat surprising is the FDA questions on Thyroid Tumors. According to Novo’s briefing document, “Treatment related C-cell proliferative changes were reported on the 104-week rodent carcinogenicity studies. Through a series of mechanistic studies it was found that GLP-1 agonists can activate rodent C-cells causing calcitonin release. Continued activation may later be followed by C-Cell proliferation in rodents. In non-human primates neither calcitonin release nor C-cell proliferation was observed in studies up to 87 weeks’ duration at high expenses.”

Although Diabetic Investor does not believe this issue by itself would derail Liraglutide combined with the possible increase in cardiovascular risk it’s likely the FDA will take a very hard look before giving full approval. It should also be noted that this C-Cell issue is not present with Byetta which should further heightens the FDA interest.

One might think that all of this news would be good enough on its own but it gets even better for Amylin. In today’s Wall Street Journal in an article entitled “Eli Lilly is On the Hunt for Acquisitions” it states “Eli Lilly & Co. Chief Executive John Lechleiter said the drug maker is looking for acquisitions of as much as $15 billion now that it has digested ImClone Systems.

"I got hungry again about three weeks after ImClone got closed" in late November, Dr. Lechleiter said in an interview.”  

The article goes onto state; “He said Lilly wants to make more deals like its $6.5 billion takeover of ImClone, which added biotech cancer therapies already on the market and in development to Lilly’s oncology line-up. He did not say which companies he is looking at.

Given that Lilly (NYSE:LLY) is already partnered with Amylin, that Lilly desperately needs LAR to remain a player in the growing diabetes space and Amylin’s current share price is trading well below its fair value this could end up with another Diabetic Investor prediction coming true with Lilly acquiring Amylin.

If only to add fuel to this fire, it doesn’t hurt matters any that Carl Icahn and Eastbourne Capital, two of Amylin’s major shareholders are trying to take control of the company’s board. It’s well known that both Icahn and Eastbourne would like nothing better than to take control and then sell the company to the highest bidder.

With the tide turning in Amylin’s favor the stars are beginning to align for Amylin shareholders. As Diabetic Investor noted back in early March; “In the end one thing is certain Amylin’s days as an independent company are coming to an end. The question is no longer if the company will be sold; the question now becomes who will buy them, what price they will pay and will Lilly sell out as well.”

Looking over all this news the only amendment to that statement might be how much Lilly is willing to pay for Amylin rather than risk losing a potential mega-blockbuster like Byetta LAR to a competitor. 

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