Amylin’s Other Profit Injection

What I hear is that the pharma industry (and Wall Street) is holding its breath for Amylin’s next big thing: Exenatide (produced in partnership with Eli Lilly & Co.). This is another injectable product (derived from lizard saliva, of all things!) that, if approved by the FDA in a few months, will be offered in a pen delivery system. This one’s mainly for Type 2 diabetics, and clinical studies have shown “marked reductions in blood sugar as measured by A1C, a measure that reflects a person’s average blood sugar levels over the prior three- to four-month period.”

Um, any patients out there really excited yet?

Yes, analysts expect the market for Symlin to be $300 million annually, at most, while Exenatide has the potential to become a $1 billion a year drug (!!)

Great, if it can help people. But what bothers me is that the news is all about the commercial potential, and which drug might “outperform” others in terms of sales numbers. Amylin’s stock has jumped, and all the buzz is about when and how much it might climb further once Exenatide hits the streets?!

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4 Responses

  1. Glenn
    Glenn March 23, 2005 at 4:08 pm | | Reply

    I enjoyed reading your Blog. Very nice. I wonder how you can build your Blog, take care of your Diabetes and still have time to enjoy life. I just wanted to tell you that for around two years now I have been taking Pramlintide(Amylin)three times a day (with very little injections missed)in addition to keeping my insulin pump working and taking care of my Type 1 diabetes. This doesn’t leave me any time at all to complain about diabetes. Glenn

  2. Amy Tenderich
    Amy Tenderich March 24, 2005 at 9:47 am | | Reply

    Hi Glenn,
    Thanks for your input. Two answers to your question:
    1) I have a wonderfully supportive family. NEVER underestimate the value of this.
    2) I am a writer who sits in front of her PC in a home office alot, which makes it somewhat convenient to blog. It’s my outlet!
    So you’re benefitting from the Amylin drug? We’d love to hear more about that…

  3. Al Parker
    Al Parker April 25, 2005 at 5:19 am | | Reply

    I am NOT a diabetic.I came to this bd looking for information myself,and find

    But what bothers me is that the news is all “about the commercial potential”

    a few other posts imply this also-

    Exenatide has “commercial potential”for its results with diabetics has been remakable.
    The NIH is currently studying(and this has been shown in trials already)that yes the lizard spit- enhances beta cell prolifieration!- enhances Insulin production.!- Patients loose weight !
    No wonder,many are excited about the “commercial potential” !-
    Forget all that anti -capitalism crap – look at what will benfit diabetics! Exenatide will REPLACE Insulin for many diabetics!.There will be no testing since it is a FIXED dose!The “injection” is virtually painless.

    Pharmaceutical Company’s as the bad guy is a political message.Look at the medical issue here!

  4. AmyT
    AmyT April 25, 2005 at 9:23 am | | Reply

    Hi Al,
    Thanks for your input.

    If Amylin’s drugs are so beneficial, then I am delighted! My beef on the “commercial potential” was the way the media deals with the new drug announcement, focusing on profitability rather than the medical issue, as you say.

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Amylin’s Symlin Not so Hot?

The FDA approval of Symlin is making big headlines, and last week I had a bunch of relatives contact me, as they tend to do, when something new and “hot” appears on the diabetes scene. The drug is targeted toward Type 1 diabetics who don’t achieve good BG control despite insulin treatments. It was apparently 18 years in the making, and is the first new drug to be marketed to Type 1 diabetics since insulin in the 1920s. It also marks Amylin Pharmaceuticals, Inc. (San Diego, CA) debut as a commercial company -– because it is their first drug to gain FDA approval.

It sounded exciting, until I learned that Symlin is another injection (!) that one uses in combination with insulin (but in a separate syringe), to help lower BG in the three hours following meals. It produces a major risk of hypoglycemia (!).

A respected endocrinologist I’ve been corresponding with had this to say about Symlin:

1) I have no idea how many people with diabetes who are already taking insulin will be willing to take a different shot with every meal. Sounds like a MAJOR challenge to even the best of marketers!

2) I am extremely concerned that no studies have been done in children, hence we have no idea of what effects might be (good or bad) in this age group, yet the label doesn’t restrict its use to adults. I blame the FDA for this.

3) This product took a long time to come to market, because it has very marginal efficacy and major hypoglycemia events (note the black warning box on the label, which is a first for hypoglycemia in a diabetes product, I believe).

I have read that Symlin has gone through rigorous clinical trials, and in fact, I’m trying to get in touch with an acquaintance of mine who was apparently part of a Symlin study. But so far, it sounds like the drug may not be so hot after all?

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13 Responses

  1. Kathleen Weaver
    Kathleen Weaver March 20, 2005 at 10:34 am | | Reply

    I’ve actually run into someone on the insulin pumpers list that has been in clinical trial with this. He seems to think it is okay.

    I can see pumpers using it — I am not sure I can see other insulin dependent people using it.

    They are, however, marketing it to the Type 2 population which is larger and more lucrative.

    I know that I’m not going to ask for it, and with an A1C of around 6.2, I doubt my doctor would suggest it.

  2. Linda
    Linda April 23, 2005 at 7:10 pm | | Reply

    Understanding Symlin

    Amazed, was my reaction to your blog on Symlin.

    Some of the blog comments seems to imply a profit motive for the introduction of Symlin- this is clearly silly.
    The main backer’s daughter is on Symlin,and yes he is now a rich man,but richer still, as his daughters
    disease(16 year old Symlin T1 user) is much more in control.

    “Apparently the main benefit is requiring less insulin”.
    There are many benefits ,and yes many have insulin reductions when using symlin.(average 20-25%) is my informed opinion

    My opinion is that Symlin greatest benefits is reducing excursions post meal and stabilizing HbA1c
    You may see the label which some have termed “dangerous”.No this is a powerful drug that needs proper therapy introduction,which is why only endos introduce the drug.
    The label at Symlin.com shows the magnitude and speed of Postprandial Blood Glucose Fluctuations with insulin alone and insulin+symlin(in a nutshell most insulin only users sugars+50% in the next hr and a half,I+S- a 15% decline.The swings is blood sugars and the complications should be understood well here by diabetics

    posted
    ” requiring multiple injections throughout the day. It seems like massive inconvenience with a lot of as-yet-unknown risk.”

    Inconvience? ask those diabetic who have been “injecting” themselves for years(my husband for one)- diabetic complications are greatly reduced because of the above. The unknown risk you speak of is very well known , once there is a proper iniation of therapy(4 weeks or less) ,INSULIN induced hypoglcemia – events are very rare.

    posted
    “In order to push approval of this drug, the FDA allowed the manufacturer to put off studying the drug’s effect on children until September 2007.”

    This sounds conspiratorial. Because of the compexity of iniation of therapy children are not immediately canidates
    BTW-Texas Children’s Hospital has just concluded a trial involving children and Symlin(off label)

    then there is this ?
    “Sounds like the Powers That Be have their doubts about this drug as well. Maybe the idea is to let consenting adults be the guinea pigs for the first few years”

    Symlin has a great safety profile for those that are informed.Many diabetics need to be instructed and educated on Symlin therapy.Its a powerful drugs with great results,but needs proper introduction of therapy.

    Weight loss is substantial with Symlin,so much in fact that the Company is also introducing Symlin as a weight loss drug (morbid obese)for non diabetics.If you need to know why this is important,time and space prevent it.

    I would like to know whom you have talked to (You said you querying several doctors and a number of patients who chose to stay on Symlin after participating in a study- not names but numbers ,reaction Drs or “endo”- I will respond with actual participants , since your post sounds like you “heard”).The rate of continued compliance off label was very high with symlin. Are you a T2 diabetic ?

    Linda

  3. Amy Tenderich
    Amy Tenderich April 23, 2005 at 10:02 pm | | Reply

    Hi Linda,

    Thanks for your feedback. What is your stake in Symlin? Are you a patient?

    I am a Type 1, yes, and I do think that an additional set of injections is a massive inconvenience — even for those on the pump.

    My beef with the profit motive came from the way the media handled the announcement, as noted in my post at http://amy_tenderich.typepad.com/diabetes_mine/2005/03/amylins_other_p.html. I do think the pharma industry backs drugs largely based on their money-making potential.

    Are you on the pump? Have you tried Symlin? I would love to hear about your experiences. You noted that it is “a powerful drug with great results, but needs proper introduction of therapy.” What would this entail?

    - AT

  4. linda
    linda April 25, 2005 at 11:24 am | | Reply

    AT,
    My husband is the canidate.I did want you to answer on some of the endos you had talked to.Clearly the post above shows this endo is not educated on Symlin

    “A respected endocrinologist”

    This product took a long time to come to market, because it has very marginal efficacy and major hypoglycemia events

    The above statement is very uneducated.Maginal efficacy is not the measure of this “First in class drug”.
    The hypoglycemia is INSULIN induced(which is why insulin is reduced in therapy introduction.NOT Symlin induced.when introduction of therapy is finished,hypoglycemia is not seen.
    It is true, the drug is VERY misunderstood
    and BTW Symlin is a synthetic hormone(exact replacement) of what the pancreas excreats with insulin.Missing a hormone? Diabetics are missing two .
    Linda

  5. AmyT
    AmyT April 25, 2005 at 1:52 pm | | Reply

    Yes, Linda, I noted that Symlin is yet ANOTHER synthetic hormone. That’s a lot of “stuff” to be putting into your body. So WHY do you suppose this drug is so misunderstood? And HOW exactly? Apparently the drug also has a lot of fans, but that’s not always a measure of value … See Corante’s “The Price of Desperation” at http://www.corante.com/pipeline/archives/2005/04/18/the_price_of_desperation.php

  6. Joe
    Joe May 5, 2005 at 7:43 pm | | Reply

    Here’s an article suggesting that mixing pramlintide and insulin is allowable.

    http://www.ajhp.org/cgi/reprint/62/8/816.pdf

  7. julie
    julie October 31, 2005 at 6:33 am | | Reply

    I am now taking symlin and in 4 days I have lost 3 pounds and have better blood sugar control than I have had in over a year. I am on the pump so I did not want to go back to needles. I decided that I would try this anyway because I am a type 1 and only 32. I weighed the risked and decided without symlin I would be facing major complications. It is worth the shot for those of us who do not want to go blind or lose limbsor have a stroke etc…

  8. mark
    mark December 5, 2006 at 9:47 am | | Reply

    Who is to judge the humbug of another injection when normal blood sugars is the top priority?
    If the inconvience of another injection is your motivating factor, perhaps you see yourself as a victim here.
    Symlin, God love ya! You give me somthing I have needed in conjuction with the insulin to keep my blood sugars normal.Last a1c 5.1, I will take that as being my cure in my lifetime of diabetes.

  9. Tori
    Tori December 17, 2006 at 6:41 am | | Reply

    I have been taking Symlin for the last 6 mos. I have recently stopped taking it due to the fact that it has made me horribly ill. My DR says that because Symlin is a synthetic hormone that it has wrecked havoc on my endocrine system. It has made my body loose electrolytes, it has made me tired and weak, it has made me have irregular menstrual cycles, not to mention the normal side effects of nausea, vomitting and diarrhea. YUCK! I will never take this medication again nor will I ever suggest that anyone take it. I am still living with the affects of this Symlin and I haven’t taken it in a month.

  10. Andrea
    Andrea February 26, 2007 at 7:54 pm | | Reply

    I am a 28 and a T1 diabetic since 1991, on the pump since 98. I have been on Symlin for 3.5 years (got in the last stage of the trials in 2003) and have lost 50 pounds over that time. I am eating like a ‘normal’ person, something I hadn’t done since losing the normal functions of my pancreas and then having my sugars spiral out of control in college (leading to the rapid weight gain).

    What amylin (the hormone diabetics are also missing) does is to help the body digest foods and put them to use, much like insulin is the key that lets the sugar into the cells to be used for food. The difference between the hormones is one of degree — without insulin, we die. It is much more important than amylin — though now that I have it (Symlin, the synthetic version) in my system, I will never go without it again. Do you know that feeling you get after a meal, even a big one, where you still feel strangely hungry? Not ravenous, but you aren’t quite full and sometimes, or all the time, you keep eating just to make sure your sugar? Symlin helps your body to digest the food properly and you do NOT feel that way after meals. You feel full, and for those who haven’t felt that way in years, it is amazing. Truly, this drug has given me back a degree of normalcy that I was seeking, and it gave me back my metabolism.

    Yes, the biggest personal obstacle to overcome was thinking about going back to injections after 5 years of being completely needle-free. And it is definitely no picnic — three shots a day never will be fun. But I did it for many years, and of course I got used to it again. My boyfriend, now fiance, was so supportive and that definitely helped. Please believe that this is a decision every T1 should consider, especially if you have issues with glucose control. My A1C’s are down below 7 and I never thought that was possible!! There were concerns here about hypoglycemia — it is something you will experience in the initial stages, but for most people once you adjust to the symlin (you will need less insulin — they work TOGETHER) you will be fine.

  11. Kerry B. Marino
    Kerry B. Marino October 2, 2007 at 7:13 pm | | Reply

    Hi, I am a diabetic of 35 years. I have had enough of marginal control, even on an insulin pump for the last 13 years. I started Symlin on July 27th, 2007. What a difference. My HbA1c dropped a point in less than 2 months. Did you know that your A1c is about 65% controlled by post meal blood glucose? Most people don’t know this. That is why post meal glucose normalization is so key to good control. I wish this had been available 30 years ago. I am actually looking forward to my next visit and A1c report. I’m shooting for a sub 6 number. As for the inconvenience of “another injection,” I can only say that you need to try it before you shoot it down. I did for a least a year. What a dunce I was. Have not lost weight yet, since I have been on crutches since May 23, 2007, due to a broken foot bone, but I have also not gained weight. Actually, I did knock off 8 lbs of 16 that I initially gained being off of my feet, so, I cannot say that I have not experienced weight loss.
    As for the nausea, it is your body getting used to something that it had floating around in it at one point, that has been absent for far too long. With time, it goes away, and you have a wonderful feeling of fullness after a considerably smaller meal than you are used to eating. Also, for me, I said “Goodbye” to my sweet tooth. I can look at tantalizing chocolate cake and actually refuse it. Wow! I wish I had way more space to tell you all about this product.

    Kerry Marino

  12. Missy
    Missy November 6, 2007 at 12:05 pm | | Reply

    Andrea and Kerry, THANK YOU!! My doctor has just prescribed Symlin for me, and I am so excited! I cannot wait to know what it feels like to feel “full” again! (I have had diabetes most of my life, for 22 years.) I am VERY concerned about the complications of this disease, and feel blessed to be alive at this point in time, so I can make use of Symlin. Thank you for your comments, I had read a few comments suggesting Symlin didn’t really help much, but your words really struck a chord in me. I know exactly the feelings you described, because I feel them myself. I really don’t mind another injection (pumper for 5 years), since it will help take better care of my health. Once again, THANK YOU!!

  13. Kerry B. Marino
    Kerry B. Marino December 22, 2007 at 10:06 am | | Reply

    Well, it has been nearly 5 months since I started Symlin. I have been walking again for 2 months now, recovering from a Jone’s Fracture. I have lost 24 pounds since I began Symlin. I am only 4 pounds away from reaching my first target weight of 250 lbs. I am shooting for 180 lbs by the end of 2008. As for the Hemoglobin A1c, I just got the the results from my last visit to the doc. I am down to 6.2. I think that translates to an average of 135 mg / dl over the previous 3 month period. I am currently titrating upward to the type 2 dose of Symlin since I have antibodies to almost every type of insulin. I will keep posting as more things develop.

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