Earlier this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) released an interesting report, Biopharmaceutical Companies Developing Record 183 Medicines to Treat Diabetes and Related Conditions. The PhRMA report states that "America's pharmaceutical research and biotechnology companies are working on 183 new medicines to treat [diabetes] and related conditions. All of the medicines in this report are either in clinical trials or awaiting approval by the U.S. Food and Drug Administration."

Some observations as I peruse the list:

The list was current as of April 27, 2009, and some of the information is already outdated: for example Byetta is now approved as monotherapy, but at the time the list was generated, the manufacturer had not yet received approval. Ditto for Onglyza (saxagliptin), which is now approved as another DPP-4 inhibitor, that competes with Januvia (sitagliptin). There inevitably are other new drugs in the pipeline that hadn't started human clinical trials last spring, that would be included if the listing were to be redone this month.

Some of the drugs that are listed were approved previously, and are seeking new indications: Avandia (rosiglitazone), which has been approved since 2000, is on the list because of the manufacturer is seeking approval to market it for prevention of T2DM. Another approved drug, Byetta (exenatide), makes the list as the manufacturer is seeking approval for use in T2DM in adolescents, and is being evaluated for once-weekly therapy and for intranasal and transdermal administration. By the time you add up everything for Byetta, there are six entries out of the 183 that are for this one drug. And the report has some listed under "B" for "Byetta," and others listed under "e" for "exenatide."

It should be pointed out that many of the drugs on the list are "me-too" or "me-three" drugs. Such drugs are in the same class as other drugs that are already approved, and may be better (or worse) than the ones that are already approved, but if they make it to market, they might make a profit for the manufacturer -- and might help hold down the prices for that class of drugs. An example: netoglitazone, now in Phase I trials, is another "glitazone," in the same class as Avandia and Actos.

Many of the drugs listed have no information about what they are or how they work: for example, ONO-5129, from a company called Ono Pharma USA is listed as a drug for T2DM that's in Phase II. Googling the drug's codename gives more information: it is a a PPAR receptor agonist ("glitazone") from a Japanese drug company, called Ono Pharmaceutical Co., Ltd. Or, in other words, it's yet another glitazone; this one from a Japanese company.

Some of the information is mildly inaccurate: for example DiaPep277 is in Phase III trials, not phase II.

Indeed, some of the "medicines" are not what are usually thought of as medications: an insulin pen, to me, is a device for delivering insulin. Stem cell therapy is on the list, as is islet cell transplantation therapy.