MannKind Corp (MNKD)

FDA should approve their inhaled insulin drug Afresa in January 2010 - could change a lot of people's lives - especially with Exubera (competitor inhaled insulin) taken off the shelves. Lots of upside potential here.

With the approval of Afresa this company will be an easy double. Once the label is clear, the big pharmas that have been courting them will fight for a marketing partnership. This couple with their cancer vaccine entering Phase 2 trails will secure Mannkinds place in the Biopharma world.
Never bet against Al Mann. He has sold 3 companies he founded for more than a billion personally.

The MNKD pipeline includes a market disrupting insulin product called Afresa that has been proven, in 40 clinical trials, in thousands of patients, over multiple years, to address diabetes in a way that reduces or eliminates the life and health threatening glucose swings (including hypoglycemia), safely and effectively. Afresa changes the rules of diabetic treatment by allowing diabetics to maintain normal blood glucose levels simply, discreetly and without needles.

Diabetes affects approximately 170M humans worldwide and is increasing, with the WHO predicting 300 million diabetics by 2025. Global sales of diabetes drugs totaled US$27.3 billion last year, making diabetes the No. 4 drug class, according to IMS Health. Decision Resources, one of the world's leading research and advisory firms for pharmaceutical issues, surveyed U.S. and European endocrinologists and found that Afresa (a non-injectable, short-acting insulin with significantly improved efficacy over Novo Nordisk's NovoRapid/NovoLog) would earn a 50 percent patient share in type 1 diabetes alone in the United States and a 58 percent patient share in Europe. I peg current realistic value at closer to $20.

PDUFA date for Afresa is January 16th, and a partnership with a major pharmaceutical company appears inevitable at that time, with sales to begin by mid-year. This assessment totally ignores the value of the cancer vaccine pipeline and drug delivery platform licensing.

Does a fantastic job in controlling fasting and post meal blood glucose levels. Weight loss observed instead of weight gains when diabetics are treated with Afresa. Insulin injection will pretty soon be a thing of past. What makes afresa interesting is that it is better insulin as well as takes the embarasment and pain of needles away. This will simply change the way diabetics are treated. If you are a diabetic - please stop the progression of your disease. I am looking at trying to get this for my dad who lives in a third world country.

In the pipeline mnkd is doing some amazing phase 2 trials for cancer vaccines.

Another amazing thing about mnkd is that the technosphere (inhalation device and carrier molecule) can change the way medicine is delivered to the body especially ones that need to be delivered quickly.

MNKD has a too high valuation compared to its sales potential. It is also loss making at least until 2011.

Going to get approval from the FDA soon. Alfred Mann really doesn't do any wrong. I think he has the money and is taking his time before gaining partnership. The product has advantages over Exubera (pfizer's inhalable), better usability, high dosages per puff (Exuber was 5 units per puff which is nothing for a type user), and good lung function tests.

If they gain approval of from the FDA for their new insulin inhaler then they could corner a market that has previously been in bad shape.

Approval of their inhaled insulin delivery system is likely and the follow-up system is even more impressive. No more needles for insulin users = big sales revenue for MannKind.

Pick up on a drop

It fell hard recently when announcing it would put off finding a partner until after FDA approval of its awesome Inhalable insulin for diabetics. The drop was due to approval timing not the prospects of getting the approval I think.

triple the price in a year....very undervalued...the afresa partnership delay is only a speed bump....if anything it made the company cheaper again for the short term....best time to buy, u will be kicking urself in a year if u dont...keep it on ur watch list

inhalable insulin product

Stemcell research will negate the need for it

No one likes getting stuck with a needle and its product is just like human insulin

With a partnership and FDA approval in the next 12 months this company could be a big winner for investors who get in early.

All the pieces are in place for the new product to go to market. Always bet on Al Mann.

Mannkind has proven the safety of both their insulin and possibly more importantly their technosphere drug transport technology. If AFRESA comes to market it will likely grow to blockbuster sales but on a slower than otherwise trajectory. I believe physicians will be slow to migrate patients to the new technology because many of their established suppliers have had such problems with inhaled insulin. Other drugs will hopefully follow AFRESA making MNKD a potentially monster stock. Buying now at a low Mkt Cap makes the risk reward ratio compelling.

NDA for AFRESA being submitted later this month. No downside to this new therapy for diabetes...expect FDA approval later this year, a major partner announcement soon.

a stock with 45% short interest will not survive for long.