SAN DIEGO, Feb. 15, 2007 (PRIME NEWSWIRE) -- MediciNova, Inc. (Nasdaq:MNOV) (Hercules Market of the Osaka Securities Exchange: Code Number: 4875), a biopharmaceutical company focused on accelerating the global development and commercialization of innovative pharmaceutical products, today announced its financial results for the fourth quarter and year ended December 31, 2006.
A detailed discussion of financial results and all compound development programs can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2006, filed February 15, 2007 and available through investors.medicinova.com/sec.cfm. Company management will discuss financial results, corporate strategy and clinical progress at a conference call at 1:30 pm Pacific Time on February 15th investors.medicinova.com.
2006 Results Summary
The per share loss in 2006 was ($3.52), compared to ($2.88) per share in 2005. R&D expenses increased to $32.2 million in 2006 from $22.7 million in 2005 reflecting the advance of multiple clinical trials. G&A expenses increased from $7.5 million in 2005 to $9.6 million in 2006, due to stock based compensation and an increase in legal and accounting fees.
Cash and cash equivalents decreased from $139 million in 2005 to $104 million in 2006. The company completed a U.S. public offering of 1 million common shares on February 1, 2007, at an offering price of $12 per share, for net proceeds of approximately $10.5 million, net of underwriter's commission and offering costs.
Key 2007 events to date
* February 1: Closed a 1 million share U.S. public offering at $12/share for aggregate net proceeds of approximately $10.5 million. * January 22: Initiated a Phase II study of MN-305 in insomnia. * January 16: Announced results of a Phase II/III trial of MN-001 in 305 moderate-to-severe interstitial cystitis patients. While MN-001 was well-tolerated, MN-001 did not show a statistically significant clinical benefit compared to placebo on the primary endpoint.
"A very eventful 2006 culminated with our new listing on the Nasdaq Global Market," said Dr. Yuichi Iwaki, Chairman and Chief Executive Officer of MediciNova. "Before gaining the listing, we made significant advances in our clinical programs, elected three new directors and appointed a chief financial officer, in-licensed two new compounds, received five notices of patent allowance and presented Phase I clinical data at ASCO. We look forward to continued progress with several milestones in 2007."
Key 2006 events
* December 18: Launched Phase II clinical program for MN-221 in status asthmaticus. * December 7: MediciNova listed on the Nasdaq Global Market under the symbol "MNOV". * November 16: Initiated Phase III program for MN-001 in bronchial asthma. * November 9: Appointed Shintaro Asako as chief financial officer. * October 31: Acquired two novel antithrombotic agents (MN-447 and MN-462) from Meiji Seika Kaisha, Ltd. * October 31: Completed one-for-ten reverse stock split to facilitate the Nasdaq listing. * August 31: Appointed Mr. Masatsune Okajima as vice president and head of Japanese office. * June 13: Initiated clinical development program of MN-221 in status asthmaticus. * June 11: Reported results from a 416-patient Phase II/III Generalized Anxiety Disorder trial of MN-305. * June 4: Presented MN-029 Phase I safety and tumor blood flow reduction results at ASCO meeting. * May 11: Elected Arlene M. Morris and Alan W. Dunton, M.D., to board of directors. * March 30: Initiated Phase I study of MN-246 as oral treatment for urinary incontinence. * January 31: Completed enrollment of a 297-patient Phase II trial of MN-166 in multiple sclerosis patients. * January 12: Elected Jeff Himawan, Ph.D. to board of directors. * January 4: Received notices of allowance for two key patent applications for MN-001.
Clinical Progress
MediciNova's pipeline includes six molecules in clinical development for eight medical indications representing significant potential markets. The company's strategy is to rapidly advance compounds through clinical development, and, at the appropriate decision points, continue internal development or seek development partners for late-stage trials and commercialization. The summaries below focus on those compounds with news in 2006.
MN-001
This orally administered small molecule inhibits inflammatory mechanisms (e.g., leukotriene receptors, 5-lipoxygenase, phosphodiesterase IV) associated with diseases like asthma and interstitial cystitis.
During 2006, the company received three U.S. Patents regarding certain compositions, uses and manufacturing processes for MN-001, extending patent protection through at least 2023.
Following positive results in a Phase II asthma study, MediciNova initiated a Phase III trial of MN-001 to randomize approximately 705 subjects with bronchial asthma recruited at up to 90 clinical sites in the United States. The primary endpoint is the change from baseline in mean forced expiratory volume in one second (FEV1); there are a number of secondary endpoints.
MN-029
This novel small-molecule Vascular Disrupting Agent is in development for treatment of solid tumor cancers. MN-029 selectively disrupts newly-formed tumor blood vessels, shutting down tumor blood flow and causing central necrosis of solid tumors. On June 4, 2006, MediciNova investigators presented results from the first Phase I study at the 2006 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia. MN-029 significantly reduced tumor blood flow, a pharmacologic marker believed to predict clinical efficacy, at doses that were well tolerated.
MN-166
This novel, orally administered compound is being evaluated for the treatment of Multiple Sclerosis (MS). It inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase, all inflammatory mechanisms that may be involved in MS. MN-166 was found to have beneficial effects in several pilot clinical studies in Japan. In July 2005, MediciNova initiated a randomized, double-blind, placebo-controlled multi-center Phase II clinical trial in MS patients in Eastern Europe. Enrollment was completed in January 2006, and results are expected in the first quarter of 2007.
MN-221
MediciNova is developing MN-221, a highly selective beta2-adrenergic receptor agonist, as a treatment for acute asthma exacerbations (status asthmaticus). These are long-lasting, severe asthma episodes in which symptoms do not respond to initial bronchodilator or corticosteroid therapy. This is a crisis situation that can cause death; emergency treatment and in some cases, hospital admission are indicated. As a result, MediciNova has developed an intravenous formulation of MN-221 appropriate for hospital use. A Phase II trial was initiated in December 2006 to evaluate the efficacy and safety of MN-221 in 28 mild-to-moderate asthma patients.
MN-246
This novel, potent and highly selective beta3-adrenergic receptor agonist is under development by MediciNova for the treatment of urinary incontinence. It represents a potential new treatment approach that may have advantages over existing therapies, including increasing bladder volume while decreasing involuntary bladder contractions without the anti-cholinergic side effects associated with current treatments. The company completed a Phase I safety, tolerability and pharmacokinetics study in healthy volunteers.
MN-305
A novel, potent and highly selective serotonin 5-HT1A receptor agonist, MN-305 was under development for the treatment of anxiety disorders, beginning with Generalized Anxiety Disorder (GAD). This orally bioavailable compound showed preliminary evidence of efficacy in animal models and in an open-label study conducted in Japan by Mitsubishi Pharma Corporation in a group of patients with a variety of anxiety disorders. In February 2006, MediciNova completed enrollment in a randomized, double-blind, placebo-controlled multi-center Phase II/III clinical trial of 416 subjects in the United States. Results showed a positive improvement trend on all efficacy measures, but the data did not reach statistical significance on the primary endpoint. Based on an unexpected finding in the GAD studies, MediciNova initiated a Phase II study in insomnia subjects in January, 2007.
About MediciNova
MediciNova, Inc. is a biopharmaceutical company that acquires well characterized small-molecule drugs through strategic alliances with Japanese and other international pharmaceutical companies and accelerates their development in a diversified portfolio of therapeutic product candidates targeting significant disease markets. MediciNova's pipeline, which includes six compounds in clinical development, targets a variety of prevalent medical conditions, including asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, solid tumors, Generalized Anxiety Disorder, preterm labor, and urinary incontinence. For more information on MediciNova, please visit www.medicinova.com.
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This press release may contain "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements regarding clinical trials supporting efficacy of one of our product candidates as well as the potential novelty of that candidate as a treatment for disease. These statements are based on certain assumptions made by the Company's management that are believed to be reasonable at the time. Such statements are subject to a number of risks and uncertainties, many of which are beyond the control of the Company, including the results of clinical studies and other risks and uncertainties, including those described in the Company's filings with the Securities and Exchange Commission. These assumptions, risks and uncertainties could cause the Company's actual results to differ materially from those implied or expressed by the forward-looking statements.