Replies to post #115812 on Biotech Values

[RockRat]

Further, Victoza could be competing with Amylin drugs in obesity. You and I have both been skeptical of Bydureon. I do not know how widely that view was held, but I would not put it at the top of an over-hyped list. Whatever. I am wondering where this leaves Amylin's commercial future. With drugs specifically targeted at obesity failing right and left, exenatide seemed to have a good shot at that indication, and my take was a large part of AMLN's valuation was based on that possibility. But NVO is also looking at this:

http://clinicaltrials.gov/ct2/show/NCT00978393?term=liraglutide&rank=17

Results early this summer.

Meanwhile, Byetta trials in this indication are more numerous and ongoing. The most definitive one will produce results in 2013. But a trial in patients with gastric restriction (lap band) should be completing soon. I think a couple of other minor studies -- scintigraphy in diabetic subjects, post prandial sugar snacking by youg re-diabetics -- have been completed.

That leaves the Takeda program with Symlin & metreleptin. The go/no go P2 study should produce results by late next year.

Regards, RockRat

[north40000]

AMLN/ALKS/LLY

Judging from my reading today, there is a host of analysts, media writers, commentators and other assorted stone-throwers with little or no knowledge of what HbA1c level really means to either a normal person, or a T1 diabetic or a T2 diabetic. Some education:

http://www.nlm.nih.gov/medlineplus/ency/article/003640.htm

>>Why the Test is Performed

Your doctor may order this test if you have diabetes. It is used to measure your blood sugar control over several months. It can give a good estimate of how well you have managed your diabetes over the last 2 or 3 months.

The test may also be used to screen for diabetes.

You have more glycated hemoglobin if you have had high levels of glucose in your blood. In general, the higher your HbA1c, the higher the risk that you will develop problems such as:

* Eye disease
* Heart disease
* Kidney disease
* Nerve damage
* Stroke

This is especially true if your HbA1c remains high for a long period of time.

The closer your HbA1c is to normal, the less risk you have for these complications.
Normal Results

An HbA1c of 6% or less is normal.

If your HbA1c is above 6.5% you may be diagnosed with diabetes.

If you have diabetes, try to keep your HbA1c level at or below 7%. However, you and your health care provider must decide what a normal HbA1c level is for you.

Talk with your doctor about the meaning of your test results.
What Abnormal Results Mean

Abnormal results mean that your blood glucose levels have been above normal over a period of weeks to months.

If your HbA1c is above 7%, it means that your diabetes control may not be as good as it should be.[Many T2 diabetics have levels of 8%, 9%, or even 11%]

High values mean you are at greater risk of diabetes complications. If you can bring your level down, you decrease your chances of long-term complications.

Ask your doctor how often you should have your HbA1c tested. Usually, doctors recommend testing every 3 or 6 months.[snip]<<
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Another useful info source from NVO:

http://www.novomedlink.com/products/NovoLogMix/A1C-reductions.aspx?WT.srch=1&WT.mc_id=DC_HCP_Paid_Google_Search_NovoLogMix_A1C_1014200
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From wikipedia:

http://en.wikipedia.org/wiki/Glycated_hemoglobin

>>HbA1c eAG (estimated average glucose)
(%) (mmol/L) (mg/dL)
5 5.4 (4.2–6.7) 97 (76–120)
6 7.0 (5.5–8.5) 126 (100–152)
7 8.6 (6.8–10.3) 154 (123–185)
8 10.2 (8.1–12.1) 183 (147–217)
9 11.8 (9.4–13.9) 212 (170–249)
10 13.4 (10.7–15.7) 240 (193–282)
11 14.9 (12.0–17.5) 269 (217–314)
12 16.5 (13.3–19.3) 298 (240–347)

+++++++++++++++++++++++++++++++++++++++++++++++++++++++

I have been a T1 diabetic for 54 years, diagnosed at age 19 in 1957.
I am controlled only with insulin. So far I have no detectable side effects from this autoimmune condition. I think I know diabetes as well as, if not better than, most on this board in light of my experience.

My HbA1c levels are habitually in the area of 6.2%-6.6%,sometimes as low as 5.7%. My doctors--internists or endocrinologists---are
not concerned if my levels vary by 1.2% from one test to the next, the non-inferior difference between Bydureon and Victoza described in today's press release. There may be a statistical difference, but not a pragmatic difference, between 1.3% and 1.5%
lowering of 2-3- month HbA1c levels.
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If I had the authority, I would fire whoever wrote or approved today's PR from AMLN/LLY. I suspect that could be a lot of individuals. The PR was too incomplete, assuming knowledge on the part of media, analysts, commentators and other stone-throwers that simply was and is not present.

Comments from clinicians or endocrinologists are welcome.

[DewDiligence]

Bydureon Scorecard 3/3/11

 
           1-day       1-day  
        % Change in  Change in  
        Share Price  Market Cap  
 AMLN      -25%       -$550M 
 ALKS      -11%       -$150M 
 NVO        +3%       +$1.8B

FWIW

[p3analyze]

Was "Not Non-inferior" also "statistically inferior"? Was it also clinically inferior?