One thing that all sides agree on in the tripartite fight over control of Amylin's board of directors is that the launch of exenatide once weekly, the long-acting version of its diabetes drug Byetta, is crucial to the company. A successful launch could add hundreds of millions of dollars to Amylin's revenues.
But even though the company has already submitted its new drug application to the FDA, it has still not yet made a decision on what the brand name of exenatide once weekly will actually be.
Until now, analysts and media reports had been referring to the drug as "Byetta LAR" (for "long-acting release") or "once-weekly Byetta." For instance, the investor slideshow of Carl Icahn, who wants to take over the company, repeatedly refers to the drug as "Byetta LAR."
But Amylin told BNET that the company has not, in fact, made a decision as to whether the Byetta brand will applied to exenatide once weekly. Alice Izzo, Amylin's executive director of corporate affairs, told BNET:
We haven't announced what the brand name is ... We have been silent on it ... we just want to give ourselves the flexibility to manage that.She said that the company usually announces the brand name in the release following approval.
Not extending the Byetta brand to the once-weekly version of the drug would be a surprising move, given that despite its troubles, Byetta is a well-known brand name among diabetes doctors and has built up considerable equity. The word "Byetta" has already been approved as a drug name by the FDA -- not a small consideration in its favor. And a non-Byetta name could also potentially cause confusion among prescribers who would have to remember that the two differently named substances are actually made from the same active ingredient, exenatide.
Amylin's "flexibility" on the Byetta name came to light after BNET published an item on Amylin's proposed Ohio production facility. BNET had called it a "Byetta factory." That was wrong, Amylin senior director for corporate affairs Anne Erickson said in an email:
Erickson: The product supply agreement is for exenatide once weekly, not Byetta (as it's written in the title of your article). Byetta will not be manufactured at the Ohio facility, exenatide once weekly will.BNET took down the information about the factory to correct the error, but that prompted a question as to what, exactly, the difference was between Byetta and exenatide once weekly. Here's the email exchange:
BNET: ... can you confirm that exenatide once weekly will NOT be marketed using the name Byetta? My understanding is that exenatide is the generic name for Byetta, and that exenatide once weekly is essentially a once weekly version of Byetta.The statement that "Exenatide once weekly will not be marketed as Byetta LAR ... and Byetta will not be part of the brand name" was a surprise, given that Byetta makes about $600 million a year in sales. OK, so the drug was associated with a tiny number of pancreatitis cases, but many diabetics who use it love it -- especially the weight-loss side effect. Why throw the baby out with the bath water?
Erickson: You are correct. Exenatide once weekly will not be marketed as BYETTA. Exenatide is the active ingredient in BYETTA(R) (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies. Exenatide once weekly is an investigational sustained release medication for type 2 diabetes that is injected subcutaneously and administered only once a week.
BNET: Let me get this straight: Exenatide once weekly will NOT be marketed as "Byetta LAR" or in any way use the Byetta name, even though it is made with the same substance as Byetta?
Erickson: As for exenatide once weekly and Byetta, you are right. Exenatide once weekly will not be marketed as Byetta LAR. The LAR (which stands for long acting release) is a term some of the analysts use when referring to exenatide once weekly. Exenatide once weekly is the generic name and Byetta will not be part of the brand name.
That notion prompted a phone conversation with Izzo, who, as you can see, pulled back from the idea that Amylin was going to abandon Byetta for exenatide once weekly. We'll have to wait until after the FDA's decision to find out how Amylin resolves the enigma.
- See previous coverage of Amylin:
- Amylin v. Icahn Slideshow Battle: Tear Up Lilly-Byetta Agreement!
- Amylin v. Eastbourne Slideshow Battle; It's All About the Stock Price
- In U-Turn, Amylin Lays Off 200; Move Validates Icahn's Arguments
- Amylin Trial Testimony: Debt Not Structured With Interest or Principal Payments in Mind
- The War for Amylin: Lilly Not Interested; Icahn Calls the Company a "Dictatorship"
- Amylin CEO Got 11% Pay Rise Despite Losses; Company Paid $355K for Lawyer to Move House
- Amylin Q1: "Icahn Doesn't Know Who Our CEO Is"
- In War for Amylin, Icahn and Eastbourne Win a Battle: "Poison Pill" Revoked
- Amylin Founder Resigns, Suggests Chairman Follow; Icahn and Eastbourne Likely Delighted
- Inside Amylin's Anti-Icahn Suicide Pact
- Amylin Battle Heats Up as Eastbourne Capital Touts Rival Directors' Slate to Icahn's
- Icahn Moves on Amylin; Will Lilly Step Up?
- Behind the Byetta Crisis: Is This Drug Really All That and a Bag of (Fat-Free) Chips?
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