SM Hírek : Accentia Biopharmaceutical's Revimmune Receives the Frost & Sullivan Multiple Sclerosis Product Innovation of the Year Award |
Accentia Biopharmaceutical's Revimmune Receives the Frost & Sullivan Multiple Sclerosis Product Innovation of the Year Award
2008.03.14. 18:08
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News) today announced that Revimmune™, its potential blockbuster therapeutic candidate designed to treat up to 80 autoimmune diseases, has been awarded the Frost & Sullivan 2007 North American Multiple Sclerosis Product Innovation of the Year Award. If approved, Revimmune would be the first product capable of restoring neurological function in patients with relapsing-remitting multiple sclerosis (MS). Accentia intends to file an Investigational New Drug Application (IND), aiming to commence a Phase 3 MS clinical trial this year.
The selection of the Frost & Sullivan Award comes through in-depth interviews and primary market analysis conducted by their industry analyst team. Nominations or submissions for Frost & Sullivan Awards are not accepted.
Frost & Sullivan Analyst, Barath Shankar Subramanian, stated, “The primary endpoint for Accentia’s planned Revimmune Phase 3 study is the restoration of neurological function, which is a paradigm shift from traditional therapies that focus on reducing relapses. Accentia’s innovative positioning and approach to treating autoimmune disease is likely to propel the company as a strong participant in the MS market. In recognition of these factors, Frost & Sullivan is pleased to present Accentia with this Award.”
According to Barath Shankar, the mechanism of action of Revimmune is highly innovative, focusing on eliminating the peripheral immune cells, which include the cells that are causing MS. The therapy selectively spares the hematopoetic stem cells, which then regenerate as a new immune system in two to three weeks that lacks the previous autoimmunity. This could potentially improve neurological function and eliminate the disease.
Revimmune could also potentially alter the high cost of therapy for patients. For those patients utilizing traditional therapies, they incur a lifetime of treatment costs, while with Revimmune there is just a one time cost of the treatment regimen. Additionally, Revimmune has the potential to emerge as an effective treatment for several other autoimmune disorders, giving Accentia the potential of addressing a significantly larger patient population that lacks significant therapies.
Accentia holds the worldwide, exclusive license to Revimmune for the treatment of autoimmune diseases, and the Company intends to file an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune for the treatment of refractory, relapsing-remitting multiple sclerosis.
About Frost & Sullivan
Frost & Sullivan, the Global Growth Consulting Company partners with clients to accelerate their growth. The company’s Growth Partnership Services, Growth Consulting and Career Best Practices empower clients to create a growth-focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents. For more information about Frost & Sullivan’s Growth Partnerships, visit: http://www.awards.frost.com.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase™, a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune™, to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. (OTCBB:BVTI - News) and a royalty interest in Biovest's lead drug candidate, BiovaxID® and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry.
For further information, please visit: http://www.Accentia.net.
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