Nektar, Mannkind Suffer from Pfizer's (Discontinued) Inhaled Insulin Effects

I don't usually do more than one post a day, but this really caught my eye. In an ongoing review of Pfizer's (PFE) (now discontinued) inhaled insulin (Exubera), an increased chance of lung cancer has turned up among participants in the clinical trials. Six of the over four thousand patients in the trials on Exubera have since developed the disease, versus one of the similarly-sized control group. Six isn't many, but with that large a sample size, it's something that statistically can't be ignored, either.

The concerns would have to be, naturally, that this number could increase, since damage to lung tissue might take a while to show up. This, needless to say, completely ends Nektar's (NKTR) attempts to find another partner for Exubera. Their stock got severely treated Wednesday (down 25% as I write), but things are even worse for another small company, Mannkind (MNKD), that's been working on their own inhaled insulin for years now (down 58% at the moment).

There's no guarantee that another inhaled form would cause the same problems, but there's certainly no guarantee that it wouldn't, either. Whether this is an Exubera-specific problem, an insulin-specific one, or something that all attempts at inhaled proteins will have to look out for is just unknown. And unknown, in this case, is bad. It's going to be hard to make the case to find out if this is the sort of potential problem waiting for your new product. Inhaled therapeutics of all sorts took a huge setback Wednesday.

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[paul collins]

ATTENTION: WALL STREET WAKE UP!

Safe Oral Insulin called ORAL-LYN by Generex in PHASE3 6 Month Trial in North America Already approved in INDIA sales starting Expecting to be approved world wide PHASE3 Trails across the Globe

The street.com writes Aprill 9 2008
Meanwhile, small-cap Generex Biotechnology (GNBT - Cramer's Take - Stockpickr), which has an oral insulin product -- absorbed through the mouth and designed not to enter the lungs -- in late-stage development, saw its shares edge up 12.2% to $1.20 on more than double normal volume.

June 2007 ANALYST NOTES:

GENEREX’ ORAL-LYN OFFERS SIGNIFICANT ADVANTAGES OVER
EXISTING INSULINS Many Type II diabetic patients who would benefit from
insulin therapy are not started on insulin because of the inconvenience and
dis comfort of insulin injections. This situation has led several companies to
develop alternate technologies for insulin delivery. We believe that Generex’
Oral-lyn has advantages over other non-injectable insulin solutions. While many
of these systems deliver insulin to the lungs and bronchial tree, Oral-lyn delivers
insulin to the oral mucosa, avoiding the potential risks of chronic lung tissue
exposure to insulin. Additionally, pharmacokinetic studies have shown that Orallyn
reaches peak circulating levels in 30 minutes compared to 60 minutes with
injected insulin. This more rapid onset will offer patients a better quality of life by
providing more flexibility at meal times, and better glycemic control.
INSULIN – A FAST GROWING MARKET The diabetic patient population is large
and growing rapidly, from 21 MM patients in the US alone in 2007 to an
estimated 48 MM in 2050. This growth will not be limited to the US and EU, but
will also be in the emerging markets of India and China. Among the leading
companies, we believe that Generex’ insulin delivery technology offers great
potential to both patients and investors. Currently, the insulin market is
dominated by only three companies - Eli Lilly (LLY, Not Rated), Novo Nordisk
(NVO, Not Rated) and Sanofi Aventis (SNY, Not Rated), recording blockbuster
insulin sales of >$7 BN in 2005. By 2010 the global market for insulin is projected
to be worth around $12 BN. Given such a large number of diabetic patients , we
believe Generex has a large and rapidly expanding potential market opportunity.

INITIATING COVERAGE WITH A MARKET OUTPERFORM RATING Our
analysis therefore derives a fair value of $6 (P/E multiple of 25x our 2012 EPS
estimate of $1.62 discounted at an annual rate of 45%) for Generex shares and a
rating of Market Outperform. Our analysis indicates that Generex’ oral insulin,
Oral-lyn, could be a significant player in the non-injectable insulin market. We
believe that Oral-lyn’s product profile, combined with strong clinical data and
expected rapid growth in the global diabetic population, could result in >$600 MM
in revenues by 2013. Generex also has two other smaller products in diabetes
and an early-stage cancer vaccine pipeline.

Generex Biotechnology "market outperform"

Wednesday, January 16, 2008 9:22:33 AM ET
Rodman & Renshaw

NEW YORK, January 16 (newratings.com) - Analysts at Rodman & Renshaw reiterate their "market outperform" rating on Generex Biotechnology Corp (ticker: GNBT). The target price is set to $6.

In a research note published this morning, the analysts mention that the execution of the company?s low-risk Oral-lyn pre-commercialization activities and the preparations for the late-stage Phase III clinical trial are on track. Generex Biotechnology is a leading player in the alternative drug delivery market, the analysts add.