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Message: 3 Things Investors Should Know About MannKind Corp.
MannKind Corp. (NASDAQ: MNKD), a biopharmaceutical company engaged in the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer, last week released its second-quarter financial results.
MNKD, whose lead product candidate is AFREZZA (insulin human) inhalation powder, reported a net loss of $36.6 million, or $0.23 per share for the second quarter.
MNKD also hosted a conference call following the release of its latest quarterly results. The key points to come out of the conference call, the full transcript of which can be read on Seeking Alpha, include;
Update on Clinical Trials COO Hakan S, Edtrom said that MNKD has screen over 87% of the patients required for Study 171 and 83% for study 175. The clinical trials are required for resubmission of AFREZZA NDA. Screening in both studies is expected to be completed in September. MNKD is also in the final stages of human factors validation study for Dreamboat inhaler, which will show the ability of patients to use AFREZZA appropriately. This study is expected to be completed well in advance of resubmission.
AFREZZA’s Value CEO Mann sees AFREZZA as a significant weapon in the fight against diabetes. Mann noted in the conference call that AFREZZA is not like other inhaled insulin. While other programs for inhalation of insulin were aimed at eliminating prandial injections, AFREZZA offers much more. Of course, AFREZZA’s delivery mode, through Dreamboat inhaler, is very convenient and easy to use, Mann believes that this is not the drug’s significant feature. The most important thing about AFREZZA is that it will become a critical tool throughout the entire diabetes spectrum and not just a prandial insulin for basal/bolus therapy and Type 1 and Type 2 diabetes.
The Type 2 diabetes market currently stands at approximately 92% of the total. According to Mann, in the dominant Type 2 diabetes market only around 30% of patients today use insulin at all. Most of these patients need prandial insulin at some stage, which is a good opportunity for AFREEZA. But the major opportunity for the drug, according to Mann, is the 70% of the Type 2 that do not use insulin at all. Most of these pre-insulin Type 2 patients use oral pills or injected GLP-1 analog. But, with convenient prandial insulin like AFREZZA, these patients would have an alternative, which has never been available to them.
Search for Partner With MNKD progressing towards resubmission of AFREZZA NDA, a key question is what kind of partner the company may be looking for? CEO Mann said that the ideal partner company for MNKD would be the one that has some type of endocrine metabolic disease knowledge and presence in terms of sales force. Mann also said that the company is looking for a global partner, however, it has not excluded the option of having a strong regional partner since the U.S. will be the company’s major market initially.
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