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Why Amylin Deserves More Respect

The major problem with AMLN is the management: it is highly incompetent and focused exclusively on self enrichment at the company shareholders expense. Their honesty and integrity are highly questionable.

As long as the present management is in place, AMLN has very marginal future.

What Amylin's Established Drugs Are Worth Alone

It is correct. Buying AMLN, one does not need their overhead and all other expenses.

As for R&D, nobody knows what they do. $300M is a lot of PH III clinical trials. Furthermore, regarding to Byetta and LAR, AMLN's partner LLY must share at least 50% of R&D expenditure.

Amylin: A Discounted Option on Byetta's Outcome

Unfortunately, the author does not know what he is talking about.

The present AMLN Board and Sr. management are highly malignant and toxic to the company. This cancerous tumor has to be removed ASAP.

Amylin's Pullback Is Unjustified

Speaking about Carl Icahn at ImClone:
- Carl was very lucky
-- ImClone's Erbitux the only competition from another EGFr-drug Pani was out of the game for at least 3-4 years or even for ever due to disastrous PACCE trial
-- German Merck KGaA was successfully running all Erbitux registration trials in mCRC and Lung cancers

- Carl positive actions
-- Removed the old Board and some of bad management
-- Cut waste and expenses
-- Cut Board and management bonuses and compensations
-- Accelerated pipeline activities
-- Renegotiated the Erbitux partnership agreement with Bristol
-- Settled all outstanding lawsuits against ImClone
-- Negotiated the merger with LLY

- Carl has failed to
-- Bring a new capable management team keeping a lot of losers. His new CEO was just a "yes-man".
-- Settle a feud with Merck KGaA resulting in many headaches for ImClone and now for LLY

Summary
Carl did help ImClone and its shareholders a lot.

Amylin's Pullback Is Unjustified

Doc Jones MD,

I am NOT a MD or know much about endocrinology. But, I am a scientist and know something about oncology.

Ten years ago, I review C-225 (now known as Erbitux) small Ph II clinical data in H&N cancer and put my money on it.

The last year, ImClone, Erbitux's developer, was sold to LLY for $6.5B It was a very good investment for me. It is of interest mention that in mid 1990s, LLY owned Erbitux, found it totally useless, and gave it back to the inventor for free.

Now, few history points related to oncology. It still a mystery for the scientific community:
- After studying Erbitux for the last 15 years and over 150+ clinical trials all over the world, scientists still do not know why it works and when (OK, K-ras testing helps a lot)...
- Erbitux from ImClone and Pani from Amgen are both EGFr-drugs. They are "almost" absolutely identical having the exact same mechanism of action. Even more, due to superior Pani affinity, overwhelming majority of scientists and clinicians (many of whom were investigators in various Erby and Pani clinical trials) expected that Pani will be much superior to Erbitux. Erbitux was on a "death row" expecting to be killed by Pani.
Well, PACCE PhIII trials in mCRC has been terminated following early safety review: the death rate in Pani-arm was much higher than in a placebo-arm. Now, Pani is going to nowhere.
- Presently, Avastin is the "wonder" oncology drug. The FDA likes it. Medical community worships it. DNA, Avastin's developer, was just sold to Roche for a fortune. There is only one small problem: independently conducted clinical trials in mCRC, breast, lung cancer did NOT show any overall survival benefits. I hope you got my message.
- I can go on and on.

The bottom line
- Only clinical trials provide real and accurate answers to effectiveness and safety of drugs. Everything else are just hunches, guesses and speculations.
- Cancers are very poorly understood and very unpredictable
- Malignant tumors kill in very unpredictable and brutal ways. Consequently, any potentially cancer-promoting drug must be prevented from reaching the general patient population
- "Similar" drugs are not identical or even "close"

Amylin's Pullback Is Unjustified

Jack,

You are correct. Byetta and liraglutide are distinct molecules even they do belong to the same "class."

FDA Scientific Advisory Committee concluded that Liraglutide (a diabetes drug made by Novo Nordisk (NVO)) posed a significant risk in causing thyroid tumors in humans. The vote was 12:1 to support such conclusion.

Unfortunately many people on Wall-Street have no clue about a degree of devastation cancer can bring to people and their families. In a case if the FDA give a "green light" to Liraglutide, it will be an incredible travesty to our health care exposing a great number of patients to cancer devastation and consequences.

Assuming that, at best for Liraglutide, it approval will be delayed by at least a few years, Byetta with it superior to other diabetic drugs efficacy profile will be able to substantially penetrate the huge diabetic market.

The major problem with AMLN is its management: highly incompetent, highly greedy and corrupt. It is of interest that Amylin reminds me ImClone. As soon as ImClone got rid off its old Board and CEO, the company, in spite of Wall-Street insinuations and lies, was able to move forward successfully and be sold later to LLY at a very substantial premium.

In my opinion, as soon as Amylin will get a new management and LAR Byetta approved, it can be sold in two years at ~$6B+ or for $50+ per share. The present AMLN price below $10 is just ridiculous.

Which Diabetes Drugs Will Win Out?

I agree there is nothing wrong with "me-too". So far, we have somewhat free-market system.

Consequently, drug companies must have freedom developing drugs they feel are appropriate. Some competition is good for everyone: companies and patients.

At the same time, in America, we have a major problem with the FDA:
- They are not either consistent or objective in the drug evaluation process and being too much influenced by "special" interests
- Very often, the FDA approves drugs without any clinical benefits to patients
- Finally, but not last, the FDA provide avenues for drugs comparative studies giving physicians and patients opportunities to make intelligent choices selecting the most appropriate drugs

In any case, the best marketing should not be a guidance for selecting the most appropriate treatment drug(s) for specific patients.

Amylin Facing Crisis of Confidence

They most serious problem with Amylin is it management.

The most unexplained issue with Amylin is Eli Lilly (LLY), the key partner on Byetta. LLY has done nothing regarding to Byetta development clinical trials and its marketing or assisting Amylin in dealing with the FDA.

Since there is no possibility to substantially improve and/or change Amylin's Board and the management, the only one possibility left is to sell Amylin. The only potential buyer for Amylin is LLY. But it will not happen soon since LLY presently has no cash (following the purchasing of ImClone) or Amylin's Board desire to sell the company at this juncture.

It is pity to see what Amylin's Board and the management have done destroying the company value.

5 Potential Buyout Targets in Biotech - Barron's

Unfortunately, American Big Pharma companies became more marketing organizations rather than new drug development companies.

It appears that, at the time when companies like ImClone are developing new super-drugs like Erbitux capable of savings thousands of lives, the Wall Street green-mailers, speculators, extortionists and biotech companies stock price manipulations greatly endanger new drugs development process doing great disservice to people all around world.

The above article is discussing how Big Pharma, with their zillion-dollars executives compensation packages, has failed in development of drugs and now is in a process of ripping off the most innovative and successful biotech companies and its shareholders.

These Big Pharma acquisition activities add nothing to new drug development but greatly endanger so many lives that could be saved by new drugs.