July 2005 Issues

  The Patient Perspective on Lilly/Amylin's Byetta (exenatide) - Quick Pulse

Summary: Byetta (exenatide, exendin-4), a first-in-class incretin mimetic, is off to a good start with patients. It was approved by the FDA in April 2005 and launched in June 2005. In order to gauge the reaction of patients who have tried Byetta as well as determine the likelihood of those patients remaining on Byetta, internet diabetes message boards and user groups were scanned. Twenty patients were identified who have started Byetta, and they were interviewed for their opinion of the drug and the outlook for their continued use.

. American Diabetes Association (ADA)

Summary: Several dual PPAR-α/γ agonists have failed for toxicity, and safety issues raise questions about the approvability of the two leading agents – AstraZeneca’s Galida, which is associated with elevated creatinine; and Bristol-Myers Squibb/Merck’s Pargluva, which causes weight gain, heart failure, and edema. ♦ Doctors are very receptive to Lilly/Amylin’s Byetta, predicting 13%-16% of their patients will be on it within a year. The weight loss is expected to trump the injections and nausea – if the nausea is as mild as the companies are portraying it. ♦ There was no real excitement about inhaled insulin, but experts predicted Pfizer/Sanofi- Aventis/Nektar’s Exubera will get FDA approval, but other promising inhaled insulins and other delivery systems are close on Exubera’s heels. ♦ A one-year pilot study of Lilly’s Arxxant, a PKC-β inhibitor for diabetic nephropathy, looked promising. ♦ Sanofi-Aventis racked up another win with its diet drug, Acomplia. It not only helped diabetic patients lose weight, but it improved their glycemic scores as well.

Eyecare Update

Summary: To check on trends in the eyecare field, an industry expert and 22 ophthalmologists (refractive surgeons) were interviewed about the outlook for refractive surgery, and 63 optometrists were asked for their perspective on refractive surgery referrals as well as issues relating to contact lenses, age-related macular degeneration (AMD), and dry eye therapies.

  American Psychiatric Association (APA) - Quick Pulse

Summary: The APA meeting conflicted with another medical conference this year, so this is not a comprehensive report but, rather, a look at a few specific topics from APA including alcoholism, schizophrenia, and brain stimulation for major depression.

  American Society of Retina Specialists

Summary: Genentech’s Lucentis appears to be a big advance in wet AMD, but it was upstaged by another Genentech drug – Avastin, another anti-VEGF agent approved to treat colorectal cancer. Avastin is available now, while Lucentis won’t be FDA approved for at least another 12-18 months, and Avastin is far, far cheaper than Lucentis is expected to be. So, retinal specialists are starting to use Avastin off-label, raising questions about whether Lucentis or other new drugs in development for AMD can ever find a market. Doctors are disappointed with Macugen and many report preferring QLT/Novartis’s Visudyne plus a steroid. Thus, Macugen use is expected to decrease significantly. Retinal specialists are extremely dubious about Occulogix’s Rheopheresis treatment for dry AMD. The data may be sufficient for FDA approval, but convincing doctors to use it may be more difficult.