Seeking Alpha: Amylin Bows Out Gracefully

The long drama around the Amylin Pharmaceuticals (AMLN) looks like it has reached its end - Bristol-Myers Squibb (BMY) announced the acquisition of Amylin late Friday night in a deal that will pay Amylin shareholders $31 per share in cash. While some sources have reported the size of the deal as $5.3 billion, it's actually larger than that (about $7 billion) as Bristol-Myers will also be taking on over half a billion in Amylin debt and over $1 billion in financial obligations to Lilly (LLY).

Bristol-Myers is also bringing a partner into this deal. While it technically won't take place until the Bristol-Amylin merger closes, AstraZeneca (AZN) will be buying in as part of the existing diabetes drug partnership between the two companies. For $3.4 billion, AstraZeneca will be getting a 50% interest in Amylin's products and the option to chip in another $135 million for the right to equal say in the management and strategic planning of the collaboration.

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Amylin Bows Out Gracefully

Seeking Alpha: Amylin Goes A Little Wizard Of Oz On Shareholders

"Pay no attention to the man behind the curtain!"
L. Frank Baum, The Wonderful Wizard Of Oz

For a company that owes about 45% of its post-March 28 market cap to buyout rumors, biopharma Amylin Pharmaceuticals (AMLN) continues to be stubbornly silent on the question of whether or not the company is for sale, at what price, and potentially to whom. Management not only refused to address the rumors on its first quarter conference call, but likewise at the annual shareholder meeting.

That leaves investors in a curious position - investors are ostensibly finding out more about what's going on at Amylin from Bloomberg than they are from their own management team. All we really know for certain is that Carl Icahn decided to drop his suit against the company after a private chat with the CEO; the rest is rumor and information from people "familiar with the matter".

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Amylin Goes A Little Wizard Of Oz On Shareholders

Seeking Alpha: Better Days Ahead For GlaxoSmithKline

Britain's GlaxoSmithKline (GSK) is relatively unusual among drug companies today. Not all that much revenue is left vulnerable to patent expirations, the company has a deep pipeline balanced between potential home runs and solid singles and doubles, and only one drug accounts for more than 10% of pharmaceutical sales. While the Street has already rewarded Glaxo with a healthy valuation, there is still a great deal of debate as to the potential of key pipeline candidates and shareholders could yet see upside here if a few key drugs exceed expectations.

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Better Days Ahead For GlaxoSmithKline

Seeking Alpha: Will Amylin Stand To Gain From A Citizen's Petition Challenging Victoza?

In the cutthroat real-world market of selling pharmaceuticals, anything that's bad for your competition is probably good for you. In that sense, a recent Citizen's Petition filed with the FDA calling for the removal of Novo Nordisk's (NVO) Victoza from the market is certainly not a bad development for Amylin Pharmaceuticals (AMLN). Unfortunately, given the often over-heated debate and pancreatitis in GLP-1 drugs, this is not likely to have much real-world influence.

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Will Amylin Stand To Gain From A Citizen's Petition Challenging Victoza?

Seeking Alpha: Amylin Gets Its Yes: Now For The Hard Work

Amylin Pharmaceutical (AMLN) investors got some long-awaited good news Friday afternoon, as the FDA finally granted approval to market Bydureon, an extended-release of Amylin's one-time blockbuster Byetta. Obviously this is a positive development for the company, but now the hard work begins. Amylin's market cap already assumed approval of this drug and now the company has to convince skeptical analysts and investors that it can steer itself to greatness (or buyout) as largely a one-product company.

Don't Tell Me About The Labor Pains, Just Show Me The Baby
Amylin has been working on getting approval of Bydureon since May of 2009, when the company first submitted a New Drug Application (NDA) to the FDA. The first FDA rejection came about a year later when the FDA wanted data on labeling and a risk mitigation strategy. The company resubmitted its response to these fairly routine questions only to get a second rejection in October of 2010 and a request from the FDA for a new trial to assess potential cardiac risk.


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Amylin Gets Its Yes; Now For The Hard Work

Generex - Seriously?

I'm halfway surprised that Generex (Nasdaq: GNBT.OB) can still get anybody to listen to them. But I guess hope dies hard.

The company says that it has results from two "major" Phase 1 studies of Oral-lyn that ...

You know what? Forget it.

I'm not going to give this garbage pile any more of my time. Oral-lyn has been junk from day one and the notion that there is such a thing as a "major" Phase 1 study just proves all over again that this is a company that exists to suck up the capital of credulous retail investors.

Want to invest in a risky diabetes play? Go with Biodel (Nasdaq: BIOD) or MannKind (Nasdaq: MNKD). Go with Amylin (Nasdaq: AMLN), Novo Nordisk (NYSE: NVO), Insulet (Nasdaq: PODD) or DexCom (Nasdaq: DXCM) for something a little more tangible. Hell, take a flyer on Lexicon (Nasdaq: LXRX) and its early-stage diabetes compound.

But for god's sake, don't give Generex any more attention.

Disclosure: I own shares of Amylin and Lexicon

Seeking Alpha: It Might Be Time For Amylin And Lilly To Head To Divorce Court

It's not unusual for business partnerships to have their ups and downs, but it looks like the relationship between biotech company Amylin Pharmaceuticals (AMLN) and major pharmaceutical Lilly (LLY) may well be damaged beyond repair. Between Lilly's decision to market drugs from Boehringer Ingelheim, Amylin's decision to sue in response, and the information revealed through court documents that Lilly was apparently not expecting much from Bydureon, it seems as though the days of constructive partnership are over.

Restraining Order Has Only Limited Benefit
Despite nearly a decade of partnership, Amylin recently filed against Lilly, arguing that Lilly's decision to market competing diabetes drugs with the same salesforce that markets Byetta will compromise the company's sales strategy and revenue potential. Although the agreement between Lilly and BI was reached in January of this year, it is likely that Amylin attempted to resolve this more amicably. What's more, prior to the FDA's approval of linagliptin in mid-May, it was more of a theoretical risk anyway.

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It Might Be Time for Amylin and Lilly to Head to Divorce Court

Maybe It's Time To Abandon Amylin

Dear Amylin,

We've been together a long time and, hey, you were great. But I think it might be time for us to see other people. No, it's not me, it's you.

...

The Latest Problem...
Okay, today's stock reaction to the Duration-6 study is probably overblown, but clearly Amylin (Nasdaq: AMLN) has some serious issues. This latest study basically demonstrated that Amylin's weekly drug Bydureon is less effective in controlling diabetes than a rival daily drug from Novo Nordisk (NYSE: NVO) called Victoza.

Designed to show non-inferiority, the study instead showed that Victoza lowered HbA1c by 1.5%, while Bydureon lowered it by 1.3%. That's not a huge difference, but it is still significant and you can rest assured that Novo Nordisk will market the hell out of it if or when Bydureon is approved. On a somewhat more positive note, Bydureon did show half of the side-effects of Victoza (nausea, diarrhea, and vomiting are common side effects for this class of drugs).

Now that's good (and part of the point of the study was to show a better side effect profile for Bydureon), but there did not appear to be any meaningful difference in drop-out rates, so the side effects of Victoza weren't enough to make its users quit in greater numbers.

Unfortunately, this could have some long-tail effects for Amylin (as well as Lilly (NYSE: LLY) and Alkermes (Nasdaq: ALKS). The FDA is very focused on risk-benefit these days and if Bydureon shows any hint of safety issues (and one could argue there have already been more than hints), the FDA may continue to refuse approval on the basis of Victoza being safer *and* more efficacious (even if less convenient for patients).

What Now?
So, what do I do with Amylin shares? I think this study clips the total market potential for Byrdureon, probably by $300-$500M. So, it could still be a $1B+ drug, but probably not much more than that. Working that all through my model moves the target price down to about $12 - higher than where it's currently trading as I write, but not enough to excite me.

Making matters all the worse, I once had a big gain here. This stock was a big performer a while ago (in the $50s) and I wondered at the time whether I should haven't sold at least half my position and let the rest ride. But oh no, I had to get greedy ... and I paid for it.

Anyways, now I need to figure out what to do. I could hold on and hope for the best, but that's not really a "strategy". I'm also seriously considering selling it and doubling up on Lexicon (Nasdaq: LXRX), another biotech I own that is arguably much more promising at present. A third option is just to go buy another biotech (Ziopharm (Nasdaq: ZIOP)? Celldex (Nasdaq: CLDX))? Luckily, I don't own much and it was never a huge part of the portfolio, so this whole debate is more about a bruised ego than a bruised wallet.

I would probably SELL Amylin ... unless you're really, really patient

Disclosure: I own shares of Amylin and Lexicon

Will Amylin Succeed Where Other Obesity Drugs Fail?

With Vivus (Nasdaq: VVUS) and Arena (Nasdaq: ARNA) going down in flames during FDA panel meetings for their obesity drugs, and Orexigen (Nasdaq: OREX) widely expected to incur a similar fate, the near-term outlook for effective obesity drugs is poor.

Enter Amylin (Nasdaq: AMLN).

Amylin is best known for Byetta, the first-of-its-kind GLP-1 receptor agonist analog. Also known as exenatide, Byetta was derived from research on gila monster spit and has been a relatively successful drug for Amylin and its partner Lilly (NYSE: LLY). Now investor attention has moved on to the company's long-acting version of exenatide called Bydureon. Due to be approved by the FDA any day now, this should be a formidable competitor in a billion-dollar-plus market.

But that is not all that makes Amylin interesting. The company has a promising combination drug therapy for obesity that is currently not getting very much attention. In a 26-week Phase 2 study, a combination of pramlintide and metreleptin showed significant weight loss efficacy - patients in the highest dose group had an average weight loss of 11% (about 22 lbs). Better still, the effect endured in a subsequent 26-week follow-up, while placebo patients experience weight re-gain.

Takeda partnered with Amylin for obesity drugs back in 2009, and the companies are putting this combo therapy into a Phase 3 trial. What makes this even more encouraging is that side-effects were pretty moderate (some injection site reactions and nausea) and there was apparently none of the psychological or cardiovascular effects that so worry the FDA. On top of that, half of the active combination (pramlintide) has been on the market for years, marketed as Symlin by Amylin for Type 1 and Type 2 diabetes. It is not a very successful drug, but the safety profile is pretty well known now, and that should help the FDA's comfort level if the drug makes it that far. 

Now, this is an injected drug combo and that is going to limit the popularity to some extent. Still, I have to think that an effective weight loss aid is going to overcome needle-fear for a meaningful percentage of the target population.

Best of all, this could be the *only* new approved drug (if it gets approved, of course) on the market ... and that could be worth literally billions. So even if Amylin has to deal with competition in the GLP-1 space (and they do), they could have an arguably more lucrative drug on their hands if this combo works.

Oh, and for those who might be wondering ... yes, metreleptin is related to the work on the leptin hormone that Amgen (Nasdaq: AMGN) did years ago (remember the "fat mouse" and the "skinny mouse"?). As it turns out, leptin is not very helpful or effective as monotherapy, but it seems to have some pretty compelling synergies when given with some other compounds. If this works, Amgen will get a piece of the pie, though not a very large one.

I am not sure that I would buy Amylin just for this obesity drug candidate. Then again, it could very well be an important answer to the inevitable question of "ok, now what?" that will spring up once Bydureon is on the market. Of course, Lilly may just elect to take them out before then.

All in all, I think you can buy Amylin here and do pretty well. And who knows? Amylin wouldn't be the first example of a company to win a battle (in this case, a next-gen obesity drug) when most handicappers didn't even have them in the running.

Disclosure - I own shares of Amylin.

A Little Good News From Lexicon

One of my least-successful investments, Lexicon Pharmaceuticals (Nasdaq: LXRX), re-reported some interesting news early today on one of its clinical programs.

Data from a Phase 2a study of LX4211 (a dual SGLT2 and SGLT1 inhibitor) in Type 2 diabetes showed a 1.15 reduction in HbA1c after just 28 days of use in the 150mg group, while the 300mg group showed 1.25 reduction. In this study, the placebo group showed a 0.49 improvement. Keep in mind, though, that this wasn't really "news" - the top line results from this study came out in January of this year.

Nevertheless, those numbers compare to a 1.5 improvement seen in a recently-announced 26-week study of Amylin's (Nasdaq: AMLN) Byetta, and the 1.2 reduction seen in Merck's (NYSE: MRK) Januvia in that same study.

In the big picture, then, these results would be competitive with most of the state-of-the-art diabetes medications. Better still, LX4211 is administered as a once-daily oral medication and so far SGLT1/2 inhibition has not shown any serious side-effects.

As I am an owner of these shares, I have a certain amount of built-in optimism, but I'm under no illusions that the path to approval will be quick or easy. Lexicon is looking at a minimum of five years before this drug could be approvable and will need even more money to make that happen (dilutive financings have already raised the sharecount here to over 330 million shares). And that, of course, assumes that the drug continues to show a competitive degree of efficacy and no serious side-effects.

All in all, it's a good reminder of why I'm holding out hope on this one, but it's definitely not a widows-and-orphans situation.

Disclosure: I own shares in Lexicon and Amylin.