MediciNova is a biopharma developer which has steadily built up a portfolio of diverse clinical and preclinical candidates in the novel, small molecule therapeutics space by pursuing an aggressive strategy of forming strategic alliances with other pharma developers (primarily Japanese). This in-licensing strategy born out of the company’s ability to successfully cultivate business relationships with key industry developers, both in Japan and around the world, has granted MNOV the rights to some very strong product candidates.
MediciNova currently has two prominent, core candidates, alongside four other clinical-stage compounds and two pre-clinical targets. While the company is constantly working at the entire portfolio, as well as seeking out new candidates in other unmet or underserved areas, with commercial emphasis on developing for U.S. markets, MNOV is currently heavily focused on developing their two most promising core candidates MN-221 and Ibudilast (MN-166/AV411).
MN-221 was identified by and is being developed for its profound impact capability in combating acute exacerbations of asthma (prolonged episodes of asthma characterized by not responding to standard bronchodilator/corticosteroid therapies) and COPD (chronic obstructive pulmonary disease). While a variety of beta-agonist agents exist, typically offered in inhaler format, severe cases, and the worsened condition of COPD which becomes an underlying condition, are essentially unmet, with an alarming number of cases eventuating in hospitalization and a significantly higher mortality rate. MN-221 is a novel, highly-selective receptor agonist, acting as a high-performance beta(2)-adrenergic receptor agonist in lung tissue and thanks in large part to the selectivity, a vastly superior agonist in beta(1)-adrenergic receptors in heart tissue as well, making it superior to extant, less selective beta(2)-adrenergic receptor agonists currently out there (as shown in extensive Phase II/IIa clinical trials).
CDC data clearly indicates the size of the market, with asthma-related emergency visits rising over 13% between 1992 and 2006 despite sweeping advances in asthma treatment options. This shows a strong correlation to the company’s market analysis, with the 440k asthma-related hospital discharges in 2006 alone boldly underlining the existence of a large, unmet demand segment that, unfortunately, also showed some 2.5k deaths in 2006. Furthermore, National Heart, Lung and Blood Institute data shows asthma-associated total direct hospital costs in 2007 were $4.7B in the U.S. alone. It should be readily apparent that even without adding in the relevant COPD data, there is a massive market here being largely ignored. COPD data from the American Lung Association places direct/indirect costs at around $26.7B and $15.9B respectively for the same year, adding to the obviousness of an unmet medical need for precisely the kind of safe, effective treatment MN-221 represents.
The recent August 23, 2012 news release by MNOV offered further positive data from a multi-day, repeat-dose clinical trial of MN-221 in stable, moderate-to-severe chronic COPD patients. The preliminary pharmacokinetic and efficacy findings, combined with the absence of any clinically significant safety concerns, in light of the demonstrated ability to produce improved pulmonary function, means MNOV potentially has its hands on a real winner.
Turning to the second core candidate Ibudilast (MN-166/AV411), we have a portfolio including MN-166 which could be a real multiple sclerosis treatment and the first-in-class AV411 Phase II-staged compound, as well as its proprietary analogs for neuropathic pain and drug addiction. Already approved in Japan for over 20 years (cerebrovascular disorders and bronchial asthma), ibudilast is considered an NME (new molecular entity) in the U.S. and Europe, but has been prescribed to over 1M patients in Japan and elsewhere for the other indications with solid safety returns. With broad applications in various anti-inflammatory, glial attenuating capacities, this group of drugs has seen trialing in neuropathic pain and could evolve into a powerful multiple sclerosis treatment (which is just a systemic central nervous system inflammation ultimately), also seeing extensive trialing/studies in opioid-induced withdrawal and even methamphetamine addiction.
The other non-core candidates MNOV has in its holster range from targets in bladder disease (interstitial cystitis, MN-001) and even solid tumor cancers (MN-029), to premature birth/preterm labor prevention (MN-221), urinary incontinence (MN-246), and anxiety disorders (MN-305). MN-305 is something to think about in particular, because when one looks at the extremely lucrative anti-depressant and SSRI space (selective serotonin reuptake inhibitor), it is immediately apparent that a safer offering without the serious side effects, especially if it is fast-acting instead of taking up to weeks to kick in, could alone drive shareholder returns. MN-305 benefits from the same orally bioavailable compound properties found throughout the MNOV portfolio’s other candidates and this fact alone makes the commercialization vectors tantalizing.
To get a closer look at this dynamic biopharma developer, take a look at the company’s website located at: www.MediciNova.com
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