The History of MannKind

[StevieRay]

Below are the significant events in the history of MannKind from 2008 to present (Aug 2013).

March 10, 2008 – MannKind Corporation Response to Recent Market Events
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1117005&highlight=

September 16, 2008 – MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes
Study 009 meets its primary endpoint of non-inferiority to a rapid-acting insulin analog
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1197424&highlight=
MKC-TI-009:
www.clinicaltrials.gov/ct2/show/NCT00308308?term=Mannkind+009&rank=2

MannKind and Pfizer Announce Collaboration for Certain Exubera Patients to Transition to MannKind's Inhaled Insulin Therapy
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1197571&highlight=

September 17, 2008 – MannKind Unveils Proposed Trade Name at Dedication of Danbury Manufacturing Facility
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1198182&highlight=

December 4, 2008 – MannKind Reports Positive Results from Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1232470&highlight=

MKC-TI-030
www.clinicaltrials.gov/ct2/show/NCT00308737?term=Mannkind+030&rank=3

MKC-TI-102
www.clinicaltrials.gov/ct2/show/NCT00309244?term=Mannkind+102&rank=2

December 18, 2008 – MannKind Reports Top-Line Results from Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1237514&highlight=

January 13, 2009 – MannKind Reports Successful Completion of Device Bioequivalence Trial
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1244150&highlight=

February 26, 2009 – MannKind Updates Status of NDA Submission for AFRESA
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1260757&highlight=

March 9, 2009 – MannKind Agrees with Pfizer on the Purchase of Frankfurt Insulin Manufacturing Plant
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1263905&highlight=

March 16, 2009 – MannKind Submits NDA for AFRESA for Treatment of Diabetes
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1266517&highlight=

May 18, 2009 – FDA Accepts MannKind's Submission and Files NDA for AFRESA
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1289301&highlight=

June 6, 2009 – Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1296805&highlight=

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1296806&highlight=

June 8, 2009 – MannKind Unveils Next-Generation Inhalation System
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1297195&highlight=

June 22, 2009 – MannKind Closes Acquisition of Insulin Assets from Pfizer
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1300930&highlight=

July 14, 2009 – MannKind Announces Positive New Market Survey Information Regarding AFRESA(R)
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1307656&highlight=

September 29, 2009 – Study Shows AFRESA(R) Provides Rapid Suppression of Endogenous Glucose Production in Diabetes Patients
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1336383&highlight=

October 2, 2009 – AFRESA(R) Phase 3 Data Show Sustained Glycemic Control, Normal Lung Function in Patients over Four Years of Treatment
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1337942&highlight=

MKC-TI-010:
www.clinicaltrials.gov/ct2/show/NCT00754624?term=mannkind+4+year&rank=1

October 29, 2009 – Studies Show Early Promise of MannKind's Cancer Immunotherapy Program in Melanoma, Prostate Cancer and Other Solid Malignancies
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1348392&highlight=

MKC1106-MT-001:
www.clinicaltrials.gov/ct2/show/NCT00688090?term=mannkind+MKC1106-MT&rank=3

MKC1106-PP-001:
www.clinicaltrials.gov/ct2/show/NCT00423254?term=mannkind+MKC1106-PP&rank=1

January 8, 2010 – MannKind Updates Status of New Drug Application
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1373077&highlight=

March 15, 2010 – FDA Requests Additional Information Regarding AFREZZA(TM) in Complete Response Letter to MannKind
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1402294&highlight=

June 10, 2010 – AFREZZA Demonstrates Non-Inferiority Compared to Standard Therapy in Controlling Blood Sugar Levels in Type 1 Diabetes Patients
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1436769&highlight=

MKC-TI-117:
www.clinicaltrials.gov/ct2/show/NCT00700622?term=mannkind+16+week&rank=1

July 20, 2010 – FDA Accepts AFREZZA Complete Response Resubmission and Sets Target Action Date
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1449461&highlight=

October 19, 2010 – MannKind Announces Initiation of Phase 2 Trial of Cancer Vaccine for Advanced Melanoma
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1484426&highlight=

MKC1106-MT-001:
www.clinicaltrials.gov/ct2/show/NCT00688090?term=mannkind+MKC1106-MT&rank=3

November 15, 2010 – New Findings Show Bioequivalence, Ease-of-Use and Efficiency of MannKind's Drug Delivery Platform
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1496733&highlight=

December 28, 2010 – MannKind Updates Status of New Drug Application for AFREZZA(R)
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1510884&highlight=

January 19, 2011 – MannKind Corporation Receives Complete Response Letter from the FDA for AFREZZA(R)
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1517413&highlight=

April 8, 2011 – MannKind Provides Regulatory Update
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1548452&highlight=

August 11, 2011 – MannKind Confirms Design of Pivotal Studies
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1595828&highlight=

May 31, 2012 – Pre-Clinical Data Demonstrates Promising Potential of MannKind’s IRE1α Inhibitor to Treat Multiple Myeloma
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1701400&highlight=

May 31, 2013 – MannKind Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1825999&highlight=

June 17, 2013 – MannKind Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1830246&highlight=

August 14 2013 – MannKind Announces Positive Clinical Data for AFREZZA; Both AFFINITY Phase 3 Studies Meet Primary Endpoints
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1847436&highlight=

MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1847440&highlight=

CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1847570&highlight=

[StevieRay]

Here’s a letter written by a short hedge fund manager attempting to influence several FDA Officers by expressing his concerns over the efficacy and safety of the inhaler changes.
Note the date is December 25, 2010. Immediately after receiving this letter the FDA informs MannKind that it will not be able to complete the review of the New Drug Application for Afrezza and that it needed an additional 4 weeks.
Soon after the FDA then issued a complete response letter with the principal issue raised by the FDA (short hedge fund manager) concerned the usage of in vitro performance data and clinical pharmacology data to bridge the two inhalers.

[liane]

SR,

You might also want to put a copy of these links in our Resource Center at the bottom of the page. Great job consolidating.

[StevieRay]

SEC CHARGES FDA CHEMIST WITH ADDITIONAL INSIDER TRADING
www.sec.gov/litigation/litreleases/2011/lr21987.htm

Evidently, Chen didn’t receive the memo in time and ended up losing only about 60K. Based on his past trading, he seemed to be on a very good winning streak trading on FDA inside information.

Read the SEC Complaint and search for MNKD to see the actual trades made.
SEC Complaint

Chart: Tracking the Trades

[StevieRay]

Aug 26, 2013 13:17:45 GMT -5 liane said:

SR,

You might also want to put a copy of these links in our Resource Center at the bottom of the page. Great job consolidating.

Ok, good idea!  Done!

[liane]

I love the history you posted Stevie Ray. I have a history question for the board. I have been involved with MNKD since mid 2010, and this pre-dates my knowledge base. What happened on or about Sept 20 2009 until around Oct 5. During this time the stock price plummeted from ~12 to ~5. I know it is not either CRL, and it is not the withdrawal of Exubera from the market (which was 2007). Thanks in advance.

[StevieRay]

Looks like it took a dive soon after the release of positive news on Oct 2, 2009
    "AFRESA(R) Phase 3 Data Show Sustained Glycemic Control, Normal Lung Function in Patients over Four Years of Treatment
    Long-Term Study in Adults with Type 2 Diabetes Presented at the 45th Annual Meeting of the European Association for the Study of Diabetes"

I'm not much into "conspiracy theories" and I'm not too paranoid but I do believe there are some BIG negative forces against MannKind.  Afrezza will be very disruptive to the market and will change the status quo.

But this is just a guess.  I too was not around until after the second CRL.

[StevieRay]

Ok Liane, I think I found it! According the SEC filing below a potential partnership agreement failed to materialize by the time frame previously specified (3Q09). I'm surprised there wasn't a PR.
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTY1NDQ0MzcmRFNFUT0wJlNFUT0wJlNRREVTQz1TRUNUSU9OX0VOVElSRSZzdWJzaWQ9NTc%3d

"Item 7.01 Regulation FD Disclosure.

We had previously disclosed that we had set a goal of entering a marketing partnership for AFRESA, our ultra rapid-acting insulin product candidate, before the end of 2009, with an internal objective of the end of the third quarter. We made substantial progress toward a definitive agreement with a lead potential partner; however, as the discussions progressed, we came to believe that it would be more productive to complete a partnership after we have received a response from the United States Food and Drug Administration, or FDA, regarding our new drug application for AFRESA. We believe that we and our potential partners will be better able to address appropriate deal terms and structure once the label for AFRESA is clarified. Since we do not expect a response from the FDA before January 2010, we believe that we will not conclude a deal before the end of 2009. We continue to believe that AFRESA represents a significant commercial opportunity. "

[liane]

Thanks SR.

[wellsbro]

Liane,

Word at the time was that they had a potential partnership ready to be inked ( possibly with Astra Zeneca) but Al and the potential partner disagreed about potential revenue and royalties. Matt addressed this in a late 2009 interview but I was unable to track it down.

[liane]

Thanks wellsbro.

I've been looking at 5 year charts trying to anticipate the magnitudes of run-ups and sell-offs. I knew most of the major events, but this major sell-off had me baffled. Mystery solved.