Amylin’s Byetta LAR reports injection site reactions and patient problems with mixing

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Amylin’s Byetta LAR (exenatide LAR) reported injection site reactions and problems with dose mixing in one study. Physicians interviewed by Pharmawire cautioned the delivery system will need to be user-friendly and efficient to ensure effective clinical adoption.

In one 58-patient study entitled ”Patient views of their diabetes treatment experience comparing Exenatide Once Weekly and Exenatide Twice Daily,” 7% of patients (4/58) reported needle clogging problems with the LAR version, but no similar difficulties were reported from patients on regular twice-daily Byetta.

Mona Martin, executive director at Health Research Associates, an international outcomes research firm based in Washington, and lead author on this study said patients on this trial were injection-naive patients. Patients on the Byetta LAR arm reported injection site reactions and difficulties mixing the Byetta LAR formulation, she said.

Other patient difficulties reported in Martin’s study included problems with self-injecting, preparation of Byetta LAR dosing, some patients said it was time consuming, and poor eyesight was also another factor. Positive changes from both drugs were appetite suppression, better mental attitude, and greater awareness about diabetes management, this study found.

However, Martin said that the companies are working on a ”pen-like device” that is more user-friendly, similar to the current Byetta. Patient and physician education will be very important. ”The convenience from the 52-week data dwarfed the [problems with] mixing,” she said.

Other physicians interviewed by this news service also agreed that the attractiveness of a once-weekly GLP-1 agonist such as Byetta LAR may outweigh concerns over current problems with delivery.

While Amylin and Lilly may file an NDA for Byetta LAR as early as Q4 this year, the companies have not yet finessed the delivery system, which means patients or physicians will need to mix it themselves before injecting.

Asked whether controlling bolus would be a problem under this scenario, an Amylin spokesperson said the company planned to make the instructions as easy as possible to understand and that in the meantime it was looking to develop an appropriate pen delivery system.

Professor Anthony Barnett, at the University of Birmingham, UK, said that the delivery system for Byetta LAR would be a “vital component” in the uptake of the technology. “If it is difficult or prone to errors, that might badly affect sales,” he said.

He added that the situation might be compounded if Byetta LAR displayed injection site problems. “Novo is likely to have an excellent delivery device, if past performance is anything to go by,” he said, alluding to the fact that Novo Nordisk’s once-daily GLP-1 agonist, liraglutide, may be on the market ahead of Byetta LAR. Novo has touted the benefits of its needle delivery system for liraglutide, claiming that it is better tolerated than the needle used for Byetta.

Nonetheless, Barnett said, a once-weekly GLP-1 agonist is a “very attractive option”. Amylin will present data at the upcoming American Diabetes Association meeting showing that compliance in an open-label study of Byetta LAR was around 90%, supporting Barnett’s assertion.

Asked whether an incorrect dose might create a problem with bolus control, Professor Jens Holst at the University of Copenhagen, Denmark, said responses to Byetta LAR were “not very sensitive” to variations in dose. “The individual dose is relatively small compared to the depot already in the body – it takes six to seven weeks to build up the plateau concentration.”

”The delivery system is a drawback for LAR,” Holst added in an email to this newswire.

Dr Joel Zonszein, professor of clinical medicine at Albert Einstein College of Medicine in New York, said the only problem he had heard about exenatide was its needle size. ”But I don’t see that as a major limitation as it is once-weekly,” he said.

Amylin has a current market cap of USD 4.10bn.

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