Alert: MNOV Medicinova, Inc. + 23.16%
by, 07-03-2012 at 09:25 AM (639 Views)
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today announced that an End-of-Phase 2 meeting pertaining to the development of MN-221 for the treatment of acute exacerbations of asthma has been scheduled with the United States Food and Drug Administration (FDA).
The Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) of the FDA reviewed MediciNova's meeting request submission and granted an End-of-Phase 2 meeting scheduled for October 22, 2012. In advance of the meeting, MediciNova will provide DPARP with a MN-221 briefing package including the recent Phase 2 trial outcomes and the company's proposed pivotal trial(s) and additional development plans.
In addition to representatives from MediciNova, several individuals with clinical expertise in asthma exacerbations, regulatory affairs, manufacturing, or biostatistical fields will participate as part of the MediciNova team.
MN-221 is a novel, highly selective beta(2)-adrenergic receptor agonist in development for the treatment of acute exacerbations of asthma and COPD. An acute asthma or COPD exacerbation is defined as a long-lasting and severe episode that is not responsive to the standard bronchodilator or corticosteroid therapy. Patients with an asthma/COPD exacerbation typically go to the emergency room (ER) for treatment. If treatment in the ER is not successful, the patient may be admitted to the hospital.
Current inhaled beta-agonist treatments for asthma and COPD exacerbations are limited by bronchoconstriction or insufficient airflow due to inflammation and airway constriction, reducing the amount of inhaled drug that can get into the lungs. In addition, the amount of inhaled treatments a patient can tolerate is limited due to the potential for cardiovascular side effects, such as increased heart rate.
MN-221 is designed to treat acute exacerbations via intravenous infusion, bypassing constricted airways to deliver the drug directly to the lungs. Preclinical studies showed MN-221 to have a high affinity for the beta(2)-adrenergic receptor, found primarily in the lungs, and a much lower affinity for the beta(1)-adrenergic receptor found primarily in cardiac tissue. These studies showed no worrisome increase in heart rate when MN-221 was administered.
MN-221's improved delivery to the lungs and its cardiac safety profile may help fill an unmet need for patients with asthma or COPD exacerbations, helping them to breathe easier and avoid a costly hospital stay.
MediciNova acquired an exclusive, worldwide (excluding Japan), sublicensable license to MN-221 from Kissei Pharmaceutical Co., Ltd.
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a commercial focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential, and patent coverage of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, asthma, interstitial cystitis, solid tumor cancers, generalized anxiety disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova's current strategy is to focus on its two prioritized product candidates, MN-221, for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations, and ibudilast (MN-166) for neurological disorders. MN-221 is involved in clinical trials under U.S. INDs. MN-166 is being developed in Phase 1b/2 trials for pain and drug addiction, largely through Investigator INDs and outside funding. Proof-of-concept Phase 2b trial(s) in Progressive MS are pending. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of both the MN-221 and ibudilast/MN-166 programs. Additionally, MediciNova will seek to monetize opportunistically its other pipeline candidates. For more information on MediciNova, Inc., please visit www.medicinova.com.
The MediciNova, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3135
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding our expectations on the ability to advance MN-221 through a successful Phase 3 trial, expectations about our end of Phase 2 meeting with the FDA, expectations about the trial design for a Phase 3 trial and our implied expectation that we will be able to obtain additional financing to fund a Phase 3 clinical trial, progress and expectations on future progress in the development of our drug candidates, and any implication as to the results of our development, partnering and funding efforts or that the company will have the ability to execute on its priorities. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, risks and uncertainties inherent in clinical trials including the preliminary results of the Phase 2 trial of MN-221 for the treatment of acute exacerbations of asthma, including the failure to meet the primary endpoint in the Phase 2 trial and the expected need to design the Phase 3 trial to mitigate against improved outcomes in the standard of care population and the uncertain outcome of the end of Phase 2 meeting with the FDA, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the regulatory authorities, risks relating to the completion of the joint venture in China, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2011 Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
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