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Today 2 of Amylins largest Institutional holders Icahn and Black Bear ( offshore-Eastbourne) each filed slates of 5 BOD
canidates. The 10 total verses the current 12 BOD members,many that came from LLY.
Both Icahn and Eastbourne are holding most of their shares in the low 20's.
Amylin is set to get a decision on Monotherapy for Byetta BID
from the FDA
Amylin is set to get a decision from the FDA to file their NDA (a line extension) by June. It is unclear if the review period will be 6 months.
In aprx May ,Amylins obesity Phase2B results will come out. The Praminitide(already approved)+ Leptin(Amylin bought the total Library from Amgen)
Yesterday Amylin said they have been in partner talks and will then announce a partner,so the war has started.....
My guess is $45 dollars. Sound high ? perhaps,but then again I know someone who lost 40 lbs on Pramlintide )
Amylin ,next Ichan takeout ?
Carl Icahn increased his stake in Amylin recently and has filed a 13-D to put his board members on Amylins BOD.
Icahns buys were at $26 (8 % of the co) and 8 dollars (1%)
Eastbourne who has worked with Icahn and is AMLNs 2nd largest
shareholder (most bought at $21) wants a takeover.
Whats interesting is that Amylins obesity drug which may be larger than the projected 2-3B Byetta LAR, results are due in May, and Amylin has said they are in partner talks.
Obviously Lilly wants the company but AMGN may be the surprise here.
The stock has been under accumulation since the market crash
If the FDA says Monotherapy and file the LAR ( its only a line extension btw), it will get very interesting. Safe to say Amylins a strong buy here
Ten Worst Financial Newsletters of 2008
BI Research -56.3%
Louis Navellier's Emerging Growth -57.6%
Medical Technology Stock Letter -61.2%
Oberweis Report -63.4%
Linde Equity Report -63.6%
Ruff Times -65.2%
Dines Letter -72.1%
Equities Special Situations -74.3%
International Harry Schultz Letter -75.6%
Charlie Buck's Win Before You Buy -82.0%
Monotherapy Update - Delayed!
Amylin, Lilly Update on FDA Review of BYETTA(R) (exenatide) Injection Monotherapy Submission
It is likely that this review will not be complete by the end of 2008, and may extend into 2009.
3years ago the FDA gave Amylin a approvable letter when Byetta BID was approved.Monotherapy should be a simple task,even for these incompetents...
If its politics( new admin soon ) or whatever its safe to say Pharmas are in big trouble in trying to get anything approved. Sad,the drug industry is one of the few we lead in in the world, give the Govt a chance to screw it up
All small potatoes when next April , Amylins pramlintide(approved) combo with Leptin ( from Amgen) reports
With a weight loss of 15% , the obesity partner will be quite the catalysts.
Obesity is the holy grail of Biotech investing . Arenas drug is just ok
ConjuChem is 16 pennies for good reason.LAR bests anybody and anyone that works with diabetics knows it.-BY FAR.
I guess I could fill up this post why,but anyone thats wants to see why Byetta is the ONLY drug that has cardio advatages shold read the ACCORD trial.The data was presented at last summers ADA meeting.The biggest problem with Byetta is Amylin the company- the management has failed at sales and with the FDA (stalled manufacturing approval)...oh the pancreatitus scares was total bullchit. I expect the Byetta franchaise to be taken over by LLY
Fortunately AMLN has a "duration trial ongoing with data due in the first qtr that will be used instead to show bioequililency of the mfgd product.As usual the press gets the story half right.
Amylins largest shareholder getting wind of the delay filed an SEC doc trying to push a sale (presumably to Lilly) yesterday.
The short covering yesterday was obvious
Probably a good move on AMLN at 7.80
The FDA is awaiting data from AMLN in the first quarter from the duration trial for NDA filing confirmation.(this is the seond of 3 options for manufacturing approval - the first was discussed this morning)
I say the company is sold off ( Lilly )
How sad that the company holds the best diabetic drug but cant deal with the FDA. The mfg plant sits as the company cant handle errounous Press stories or manufacturing duties
AMLNs largest shareholder Eastborne is in discussions to sell the company(announced in a SEC doc filed yesterday ( they obviously got wind ) for they feel the same way- Bad amangement in Biotech is as important as the drugs themselves
Now that Traders and the Media have done their dirty deed, the reality of the Pancreatitis scare from endocrinologists reviewed for Bio century
also a link to Dr Joe who has 550 patients on Byetta...
http://enews.endocrinemetabolic.com/2008/09/byetta-does-not-cause-pancreatitis.html
as Forbes Publishes "Byetta kills two more!" hedge funds make big money spreading lies about a valuable drug...
BioCentury Vol 16, #39, Pg. A15-16
Byetta Does Not Cause Pancreatitis
Review of the records of deaths from patients who died of pancreatitis seems to have no reason to believe that Byetta plays a role in their deaths.
Remember that the “FDA Amendments Act requires dissemination of safety data, including in cases where causality has not been definitely determined.”
These deaths were all in type 2 patients, a diabetes group that has three times more common incidence of diabetes when compared to the general population. One million patients have taken Byetta which gives a rate of 0.34 events per 1,000 patient years.
The causes of death were as follows.
• Morbid obesity with extensive gallstone disease.
• Patient had stopped taking Byetta some months before the pancreatitis.
• Two patients died of complications of gall bladder surgery.
• One died of recurrent leukemia 2.5 months after recovering from pancreatitis.
David Nathan, Chief of the Diabetes Unit at Massachusetts General Hospital sees any cause is “not clear.”
“I’ve had 550-plus patients on Byetta and not a hint of pancreatitis,” Joseph Prendergast, founder and medical director of the Endocrine Metabolic Medical Center, told BioCentury. “I would think that we must get the information on those people who died, all their previous history, how it was used, and what kind of physician was using it.”
He added: “I don’t consider it to be a problem, and I surely don’t consider it to be related to the drug.”
Kenneth Burman, chief of the endocrine section at Washington Hospital Center, Washington, DC also did not find a reason to attribute pancreatitis to Byetta. The other endocrinologists at his center have not hesitated to use Byetta as before.
Update is as stupid as the first
Heres the real reason for todays "News"
This "pancreatsis " is a scam
The REAL reason is the huge short interest
Date Short Interest Avg Daily Share Volume Days To Cover
7/31/2008 28,139,799 3,490,152 8.062629
Those of us who understand that there is no "link" yet there appears to be one in the financial press.In fact pancreatis which diabetics are prone to is LESS for those using Byetta than the general population. Note the FDA advises for Physicians not to stop using the drug.
Sometimes..........(always).... Money (media)is more powerful than science.
Lame PR ? or "connection"
Insmed has an article in the Wasington Post
better to have an ex Congressman and active PR dept verses
financing or a partner. I wonder if getting delisted will affect Insmed FOB program ?
Insmed just had one with no questions allowed.Hopefully a quiet period before some news.Insmed has hired RBC for stategic alternatives...Maybe RBC can get them new management ? )
Lilly Diabetes Drug Shows a Life-Extending Promise
Todays NYTimes
Note: Unfortunately the article has many errors,( nausea is transient etc..the one below is the NEJOM )
By ALEX BERENSON
Published: August 5, 2008
Can Byetta, an injectable drug that lowers blood sugar, really help people with diabetes to live longer?
Possibly, according to the results of a major clinical trial presented at the American Diabetes Association annual conference. In the trial, called Accord, patients with Type 2 diabetes were prescribed Byetta or any of several other diabetes medicines. Patients who took Byetta had a much lower chance of dying, about 75 percent lower, than those who took any other drug.
The finding, presented in June, has generated a stir among diabetes researchers, although so far it has attracted little public notice. Neither Eli Lilly or Amylin, the companies that jointly market Byetta, is publicizing the findings, in part because no one is sure whether the reduction in the death rate is real or a chance finding. Only about 825 patients in the 10,000-patient Accord trial took Byetta, and those who did were likelier to be healthier than other patients.
"We don't know whether it's the drug or the healthy participant," said Dr. Michael Miller, professor of biostatistics at Wake Forest University and the lead statistician on the Accord trial.
The trial's finding came as a surprise even to Lilly and Amylin, said Dr. James Malone, the global medical director of Byetta for Lilly.
"We were not aware of the results before they were presented at A.D.A., and I was sitting in the audience and my jaw just dropped," Dr. Malone said. The trials that Lilly and Amylin have conducted on Byetta, have not shown a reduction in mortality in patients taking the medicine, but they were not intended to do so.
Although Byetta has been a moderate success in the market, with sales expected to reach about $700 million this year, prescriptions are short of what analysts had forecast when the medicine was introduced in 2005.
For the Accord finding to be proved, it must be tested in a large trial that would compare the cardiac health and overall death rates of thousands of patients, half receiving Byetta and half receiving a placebo. So far, Lilly and Amylin have not committed to undertaking such a trial, which would take years and cost tens of millions of dollars.
Further complicating the issue is that the two companies are working a reformulated version of Byetta, which could be injected once weekly instead of twice daily, and they may prefer to run the trial on the new medicine, which has not yet been approved by the Food and Drug Administration.
Dr. Malone said the two companies hoped to make a decision on holding a large mortality trial by the end of the year.
Even so, the finding adds to an emerging body of evidence that Byetta — the first in a new class of diabetes medicines called incretin mimetics — may work better than other diabetes medicines, at least for people who can tolerate its side effects, which can include severe nausea.
Byetta is less likely than other diabetes medicines to cause hypoglycemia, or dangerously low blood sugar. In addition, while most diabetes medicines cause patients to gain weight, patients on Byetta typically lose several pounds each year on the medicine. Weight gain is associated with cardiovascular problems, the most common causes of death for people with diabetes.
"My suspicion is that when you look at the determinants of mortality, which were weight gain and hypoglycemia in that study, Byetta would be the antimortality drug, because it's associated with weight loss and less hypoglycemia," said Dr. Alan Garber, an endocrinologist and professor of medicine at Baylor.
In addition, animal trials offer some evidence that Byetta may directly benefit the heart, Dr. Malone said.
Byetta, generically called exenatide, is a synthetic version of a protein originally discovered in the venom of a lizard, the Gila monster. It encourages digestion and the production of insulin. Byetta is currently approved for use alongside other diabetes drugs, and Lilly and Amylin have asked the F.D.A. to approve it as a monotherapy as well.
When Byetta was introduced in 2005, prescriptions for it grew rapidly. But for the last year, Byetta prescriptions have been roughly flat at about 250,000 a month.
Doctors say that some patients cannot tolerate the nausea that Byetta can cause and others do not like injecting the medicine twice daily. Concerns about pancreatitis, an inflammation of the pancreas that can be fatal in rare cases, have also hurt the drug, although Byetta has not been proved to cause pancreatitis.
Dr. Joel Zonszein, an endocrinologist at Montefiore Medical Center in the Bronx, said some primary care doctors do not like to prescribe Byetta because they must teach patients how to give injections, a time-consuming process. "It is a drug that is difficult to prescribe," Dr. Zonszein said.
Meanwhile, prescriptions for Januvia, a medicine in pill form from Merck that works in a somewhat similar way as Byetta, have taken off since Merck introduced it in October 2006. More than 500,000 patients a month are being given prescriptions for Januvia or Janumet, which combines Januvia with a second diabetes medicine in a single pill.
"Januvia has been effectively marketed in the primary care community," said Dr. John Buse, vice chairman for the Accord study and professor of medicine at the University of North Carolina, Chapel Hill. "I think there is some misunderstanding about the relationship between Januvia and Byetta among primary care providers."
Dr. Buse said that the data from Accord was intriguing but not enough to persuade him that Byetta could reduce deaths in diabetes patients.
"The number of patients in Accord that were treated with exenatide was a very small proportion of the total patients in Accord, and they got exenatide relatively late in the trial," he said. He said he hoped Lilly and Amylin would decide to invest in the trial necessary to test Byetta's effect on mortality.
"They need to do it," he said.
**************************************
New England JOurnal of Medicine
"This was the second time at ADA this year that a ballroom full of physicians heard comments favorable to Amylin's exenatide from highly-respected leaders in high-impact symposia on treatment strategy," said Russo. "A key message is that how glucose control is achieved is important and that all medications are not created equal there."
Effects of Intensive Glucose Lowering in Type 2 Diabetes
The Action to Control Cardiovascular Risk in Diabetes Study Group
and
Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes
The ADVANCE Collaborative Group
http://content.nejm.org/cgi/content/full/358/24/2560
Another lame PR from Insmed?
The "Congressional hearing sounds fancy,but check? who else will be there? Congress ? : ), It will be held at the U.S. Capitol Complex in Washington. I think we should thank the "Honorable Bill Thomas " who Insmed just hired for the room where it will be presented.The title of the "briefing"sounds heady but what does the presentation really encompass?
from the PR
"Specifically, he will discuss the Company's latest developments, including release of Phase I data demonstrating the bioequivalence of Insmed's first FOB candidate, INS- 19, to Amgen's Neupogen® (patent expiration in 2013), the Company's affiliation with The Honorable Bill Thomas and the benefits of potential price competition and increased innovation in the field of biotechnology."
Whew ! Thats a mouthful, Ill bet there is a huge crowd!,but in reality its a Insmed PR about Insmed
We see this for what it is,and I am only half mocking for Insmed who recently hired Thomas for PR reasons also recently hired "RBC Capital" for "strategic alternatives",
Insmed is in trouble,they are running out of operating cash by the CEOs own admission "just into the fourth quarter".They have been unable to get a deal and this lays squarely at the feet of Dr Allan.Long ago,many of us investors were calling for investment help,now Insmed is pushing hard.
This PR was picked up from a few sources - Market watch !
and the PR firm was also a relatively recent hire after a partner failed to materialized as promised "by years end (2007), which btw - was promised to be a "breakout year " by the CEO.
Lame?,perhaps, but Insmed is trying.The company would be better served by a competent management team that would put together a coherent strategy of Science and finance.Insmed has waited till the 8th inning to start, I hope its not too late
I still hope for a takeover by a company that can do a better job for investors and patients
Naked Shorting Rule Change for Fannie and Freddie-- Wall Street JOurnal ( will "consider "wider markets)
SEC Curbs Shorting of GSE Stocks,
Considers Limits for Wider Market
By KARA SCANNELL
July 15, 2008 2:12 p.m.
WASHINGTON--The Securities and Exchange Commission announced an emergency action aimed at reducing short-selling aimed at Wall Street brokerage firms, Fannie Mae and Freddie Mac, and will immediately begin considering new rules to extend new requirements to the rest of the market.
SEC Chairman Christopher Cox said the SEC would institute an emergency order requiring any traders to pre-borrow stock before shorting Fannie Mae and Freddie Mac, the embattled government-sponsored entities that own more than half the nation's mortgages. It would also apply to the stocks of Lehman Brothers, Goldman Sachs, Merrill Lynch and Morgan Stanley. The order is a near-term fix and will expire in 30 days.
Mr. Cox said the SEC "will undertake a rulemaking to address the same issues" across the market.
The move will likely limit short-selling for the two mortgage entities, which have seen their stock prices fall sharply in recent weeks. Wall Street has been calling for the SEC to address short-selling, which some believe is contributing to market volatility and could be used to manipulate shares of financial stocks.
It comes as short-interest, or the amount of outstanding short positions, is at an all-time high for NYSE Euronext-listed stocks.
Short-selling, a legitimate trading strategy geared to profit from falling stock prices, has long been a lightning rod issue, so changes that cover the entire market will likely be hotly debated. Companies have complained that short-sellers target their stocks with the purpose of driving them down, while short-sellers have been credited with identifying a company's true market value.
Under current rules, a short-seller must locate shares to borrow, which are later replaced with stock bought at a lower price. Some market watchers have been concerned that traders were borrowing the same shares from the same lender over and over, and driving down stock prices.
Under the emergency order, traders will be required to borrow the stock and the lender would then take it out of the market and not allow other traders to use it to satisfy requirements that they've located stock.
INSM for Sale ? ))
"to examine a number of various strategic alternatives
means they are for Sale.....
_______________________________________________________________________
Insmed Retains RBC Capital Markets as Strategic Financial Advisor
RICHMOND, Va., July 14, 2008, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq CM: INSM), a developer of follow-on biologics and biopharmaceuticals for unmet medical needs, today announced that the Company has retained the services of RBC Capital Markets (RBC) to act as its strategic financial advisor.
"Insmed's Board of Directors and senior management team are dedicated to enhancing shareholder value and will be utilizing RBC's experience and expertise to examine a number of various strategic alternatives that may achieve this end," said Geoffrey Allan, President and CEO of Insmed. "We firmly believe that Insmed has one of the most advanced follow-on biologics platforms in the U.S. and that follow-on biologics represent a multi-billion dollar opportunity. We are confident that this process to prioritize strategic alternatives aimed at leveraging our significant assets will lead to enhanced value for all of our stakeholders."
There is nothing special about Insmeds purity in INS-19
Insmed will have to do so in latter stage trials beginning hopefully BCS next year.
Teva,Ratiopharm ,CT Arzneimittelhave all have cleared the safety, purity and potency guidlines for a biologic in Europe.
Insmed has not paid for the facility they are Leasing it.
Insmed does NOT have a "approved FDA facility". The FDA approves each applications manufacturing capabilities.Insmed has been approved for Iplex ( which except for a small rev from Italy)
Iplex has been taken off the market. You are inferring a FDA approved biologics plant - that is false.
Glover can tell you all he wants.Insmed willl have a hard time competing against manufacturing plants of competitors.
Rather than listening to Companyspeak you should do some unbiased DD.The fact is we dont know what the pricing will be for a couple of years and at that time you can judge.Like dew dilligence,I take a view that a US manufacturer has higher costs
You are correct- the first entries into a market get the largest chunk. If there is a pathway next year Insmed will never competet against the likes of TEVA. Insmed has been unable to partner biologics ? Why ? you inject marketing and cash in ? How do you know anything of such a deal?
If the reg pathway comes in 2009,Insmed will be playing catchup- lets hope for Insmeds sake it takes a while,for Insmed may never get a running start.
Please read Dew dilligence opinion regarding COGS
Caveat emptor with INSM—I think their FoB program will likely end up losing money.
The European Medicines Agency has approved four biosimilar versions of Neupogen
Tevagrastim, from Teva
Ratiograstim and Filgrastim, from ratiopharm;
Biograstim, from CT Arzneimittel.
Insmed plans to ask for a meeting with the FDA to discuss potentially initiating a Phase III clinical trial program for INS-19.", although there appears not to be much movement on biosimilars in an Election year.
Insmed has been unable to obtain a partner,although the Company said they would have one last year
Insmed is facing a delisting decision shortly and has enough cash to enter the fourth quarter.
Insmeds Steve Glover who gave the presentaion was the former
production head of Andrx who was under fire from the FDA for quality production issues.Andrx was then acquired by Watson and Glover found Insmed.Maybe Glover will get Insmed a deal to be taken over. )
North 4000 Read msg 63798
Byetta is the only diabetic drug proven to help with cardiovascular.
FDA expected to raise the bar on diabetes drugs
The FDA concerns from the ADVANCE trial that glucose control did not address concern (weight gain and cardiovascular problems. ) All diabetic drugs and combination of diabetic drugs in the trial except one were implicated. Byetta
Byetta is the only diabetes drug on the market that can offer substantial and sustained weight loss, decreased blood pressure, lowered triglycerides, lowered LDL cholesterol with increased HDL cholesterol, and improved beta cell health in addition to substantial improvements in both fasting and postprandial blood sugar.
From this years ADA -
BYETTA® Treatment has "sustained improvements" For Three And A Half Years Associated With Reductions In Cardiovascular Risk Factors In People With Type 2 Diabetes
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a study that showed BYETTA® (exenatide) injection sustained improvements in blood sugar levels and progressive weight loss through three and a half years of therapy. BYETTA treatment was also associated with improvements in cardiovascular risk factors in people with type 2 diabetes. These findings were presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago.
People with type 2 diabetes are at increased risk for various cardiovascular problems, including high blood pressure and cholesterol. In this study, 151 people with type 2 diabetes who had taken part in a 30-week placebo-controlled trial were followed in open-label extension studies. After three and a half years, participants using BYETTA (10 mcg) twice daily with oral medication showed sustained reductions in blood sugar as measured by A1C (-0.8 +/- 0.1 percent) and fasting blood glucose (-24 +/- 4 mg/dL), consistent with findings from previous studies.
Treatment with BYETTA in combination with common oral medications was also associated with progressive weight loss (-11.68 +/- 1.1 lbs), improved triglyceride levels (-44.4 +/- 12.1 mg/dL or 12 percent), and lower systolic and diastolic blood pressure (-3.5 +/- 1.2 mmHg or 2 percent and -3.3 +/- 0.8 mmHg or 4 percent, respectively). Results also showed an increase in HDL, or "good" cholesterol levels after three and a half years (+8.5 +/- 0.6 mg/dL or 24 percent) and a decrease in LDL, or "bad" cholesterol levels (-11.8 +/- 2.9 mg/dL or 6 percent).(1,2)
"The sustained improvements in blood glucose control and the secondary benefits of progressive weight loss seen with BYETTA are well documented," said David Kendall, Executive Director, Medical Affairs, Amylin Pharmaceuticals, Inc. "These studies document that BYETTA may have additional and important effects on cardiovascular disease risk factors providing interesting areas for further study, including additional metabolic advantages of weight loss in people with diabetes."
BYETTA was generally well-tolerated in this study, and the side effects were consistent with those seen in previous studies. In clinical trials and post-approval adverse event reports, the most common side effect is mild-to- moderate nausea, which affects fewer than half of patients and usually decreases over time.
Because I can read an SEC document dated yesterday.
I am not convinced of anything,I actually want Amylin to go it alone,but my post(using "fodder) was the accumulation and Mr Icahns MO.
I am happy for Dr Baron.I have met him,enjoyed a couple of his talks and wish him well.Amylin could have put out a positive PR
for such a longtime contributor, and I assure you many of the investors of AMLN are thinking exactly the same things : )
I'm not "tryin " anything.
Your source ,since the company didnt say this in their PR
(2 week notice(
anything else of course was conjecture ,Ichan buying and control of the Company are facts
TIA - if you can source your post
Shakeup or Buyout at AMLN ( Amylin Pharma)
There are 4 entities that have gobbled up all AMLN shares for a voting majority and this does not include Playmakers Goldman Sachs (#5) and Carl Icahn (#6)
Icahn has been pushing down the SP and swallowing every share the last 2 weeks.He also has had "discussions with management " which yesterday yielded the resignation of the longtime head of R&D - Dr A Baron.
Amylin has a great pipline is undervalued and owned by just a few players so the Icahn story is great fodder for speculation. but SP is increasing is one of the things that WILL happen in the not too distant future. A buyout of course first comes to mind. Lilly would love the Diabetes franchaise and everyone wants the Obesity franchaise.
The new 600 M manufacturing plant is absolutely huge and is
producing LAR.
Icahn will not stand for the flattening sales seen for Byetta BID when LAR (long acting Byetta comes to market( 1-2 years depending). Many think Lilly itself is the cause of stalling sales protecting its Insulin franchaise till LAR,but Icahn is making plans now.
Go ahead try and Buy some : ))
Insmed iniatiates a P1 F.O.B : )))))
Hey Dew ! thought you might like this piece of fluff
http://biz.yahoo.com/prnews/080416/nyw031.html?.v=101
Eastbourne trying to Buy 20% of the company
Wellington Fidelity and Marisco(13%) round out the big 4
Short Interest is very high
Amylin should beat the estimates for the quarter thanks in part to slowly rising scripts and a 6% price increase.
A move to file by years end is the next Question that needs to be asked. The FDA MAY let them do it or ask for a bioequivilancy test ( 6 mos) delay