Replies to post #119545 on Biotech Values

[mcbio]

Yes, NVO talked about next generation of insulin in great detail. Basically the focus are three directions: ultra long acting (ULA), ultra fast acting (UFA), oral. The most advanced in NVO pipeline is ULA degludec which is in phase III currently. Oral and UFA are in phase I.

It was a great presentation, a must for anyone interested in diabetes/insulin market. I believed and continue to believe anyone investing in pharma/biotech must have large exposure to diabetes market, which is growing, and will continue to grow really fast worldwide.

Thanks jq. I'm off to a bad start in my BIOD position but I think I will do fine as long as Phase 1 data due in 3Q this year is good on at least one of their two UFA insulin candidates. Should presumably be a low hurdle for Phase 1 success. I do expect BIOD is going to have to raise cash sometime soon, presumably after they report Phase 1 data.

[DewDiligence]

Did you buy back in?

[DewDiligence]

NVO’s Investor Day webcast corroborated the contention of other pharma companies (e.g. #msg-59590951, bottom) that operating margins in emerging markets are at least as high as they are in developed markets. This is a point that I think many investors continue to overlook.

[DewDiligence]

One astonishing factoid from NVO’s webcast is that insulin-pen penetration in the US is only 27%.

[DewDiligence]

Firms Seek Novel Insulin-Delivery Options

http://www.boston.com/business/healthcare/articles/2011/05/16/nj_boston_firms_seek_insulin_injection_options/

›May 16, 2011
by Arlene Weintraub

MonoSolRx Inc., a New Jersey company, hopes to start human trials this year of an insulin product packaged in edible film that can be stuck to the inside of the cheek, where it dissolves and distributes insulin, the drug most patients with diabetes take as an injection several times a day.

Delivering insulin without painful needle sticks has long been the Holy Grail of the pharmaceutical industry. Companies all over the world have tried to make pills or an inhalable drug, mostly to no avail. For example, Pfizer Inc.’s inhaled insulin, Exubera, made it to market but failed to catch on; the company dropped it in 2007. It’s somewhat surprising that the dream to develop alternatives is still alive. But it is, at companies in the Boston and New York areas.

MonoSolRx in January said its film product performed well in a monkey study. The company did not provide many details, saying the film delivered “an active therapeutic dose’’ of insulin, as it had in pigs. The company is planning to start human trials in Switzerland this year.

Another New Jersey company, Emisphere Technologies Inc., in December announced an exclusive licensing deal with the Danish drug giant Novo Nordisk to develop oral insulin. Many attempts to make an insulin pill have failed because the protein is quickly degraded by stomach acid. The companies have not predicted how long it will take them to develop a viable product.

Entrega, formed by Boston-based Enlight Biosciences in January, is working on oral versions of several biologic drugs, including insulin. The start-up has remained largely under wraps, but MIT inventor Robert Langer [co-founder of MNTA] is on its advisory board, as are executives from Genentech Inc. and Johnson & Johnson.

Alkermes Inc. isn’t quite an example of an oral-insulin project that’s still alive, but it’s worth noting. The Waltham company had a pact with Eli Lilly & Co. to develop inhaled insulin, but that project died in 2008, when Lilly decided to shelve it. In January of this year, an Alkermes spinoff, Civitas Therapeutics, secured $20 million in funding to resurrect Alkermes’ technology for inhaled drugs. But Civitas isn’t going near the insulin market; it’s investigating the technology for use in Parkinson’s disease.‹

[DewDiligence]

The new formulation of Lantus is moving directly from phase-1 to phase-3. (Source: today’s CC)