I read recently about two insulins where the lawyering has gotten pretty intense. One is the sad tale of a me-too insulin that just got approved in the United States, but can't be sold here, and the other is an insulin delivery system that's not approved in the U.S., but which you apparently can buy in Equador, Algeria, and Lebanon. And previously could also get in India.
First, the insulin that's approved but can't be sold. A press release, FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar™ (insulin glargine injection, describes the situation: "the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement. Under the Drug Price Competition and Patent Term Restoration Act ("Hatch Waxman"), the FDA cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly earlier." Basaglar is an insulin glargine look-alike (or biosimilar), which is covered by patents under the brand name Lantus. So the lawyers are squelching Lilly's attempt to grab market share. And also squelching, maybe (we can hope, right?), some price competition between Lilly and Sanofi if they both were to sell the same insulin?
Second, there's an insulin delivery system called Oral-lyn™ that hasn't had any Phase III trials in the US. Heck, they've done practically no studies in the US, per ClinicalTrials.gov: There was one study that's now listed as "unknown" status, and a Treatment Use (compassionate use) IND that's "no longer available." Sounds like the manufacturer simply isn't interested in the U.S. market. They did submit results of a 12-week open-label Phase III study on 209 T2DM patients in India last year, as requested by the Drugs Controller General (India) (DCGI), but there's been no update on the manufacturer's website about what's cooking since then: they are delaying a conference call about the product "As Generex wishes the conference call to be as informative, comprehensive, and up-to-date as possible, management considers it appropriate to schedule the call once the DCGI's review of the dossier is complete. A further announcement with the date and other particulars of the call will be made in due course."
Why would any company go to the great lengths to develop a new insulin delivery system, but not try for approval in the United States? It's hard for me to fathom.
In May, 2005, I wrote a blog for another website (which is no longer available on line) which I titled "Oral insulin available soon - in Equador." Quoting that blog:
I wrote that in 2005. Since then, there are no active studies in the US, and no further publications re "oralin" in PubMed.
But one thing that Generex is willing to do in the U.S. is to sue: one financial writer panned the drug and the manufacturer at a financial website, with articles like
Just goes to show you what can happen when corporate lawyers get into the pharmaceutical industry. If your mega-company can't make enough money developing and selling drugs, use the law to block the competition, or if you're a small company, maybe you can sue the stuffings out of a journalist.
Disclaimer: I previously worked in pharmacovigilance (drug safety) for Sanofi (the manufacturer of Lantus) and with Pfizer, who developed another alternative form of insulin administration (Exubera).