Healthcare Industry News: BiovaxID
News Release - June 14, 2006
Accentia Biopharmaceuticals Launches MD Turbo(TM) in the United StatesFirst Commercial Product to Provide Breath-Activated Delivery and Dose-Counting Capabilities for Traditional Asthma Inhalers
TAMPA, Fla.--(HSMN NewsFeed)--June 14, 2006--Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI ), announced that it has initiated the commercial launch of MD Turbo, which is now available by prescription. Accentia's commercial subsidiary, TEAMM Pharmaceuticals, began presenting MD Turbo to pharmacists on May 30th and will begin physician promotion on June 19th.
"MD Turbo is the first and only available product that transforms over 90% of dispensed metered-dose inhalers into a breath-activated, dose-counting inhaler. This allows physicians to continue prescribing the drugs of choice for their patients, only now in combination with an easy-to-use, handheld product to overcome the delivery challenges patients often face," said Gary Cantrell, Executive Vice President of Sales and Marketing for Accentia's subsidiary, TEAMM Pharmaceuticals, Inc. "This is something the market has needed for a long time. We are delighted to offer a unique product that we believe can make a significant contribution in the treatment of asthma and COPD."
It is well recognized that delivery of medication directly into the lungs is the best method of treating patients with asthma or chronic obstructive pulmonary disease (COPD). However, it is often difficult for patients to coordinate the press-and-breathe action required for using traditional inhalers. Studies have shown that coordinating the depression of the canister and the inhalation of the medication can be difficult for over 50% of patients.(1),(2),(3) This was the basis for the design of MD Turbo product by the developer, Respirics, Inc.
One challenge posed by the design of the traditional inhaler is that it does not allow the patient or caregiver to know how much drug is left in the canister, without manually tracking the doses. The Allergy and Asthma Network Mothers of Asthmatics (AANMA) conducted a study in 2003 with 500 families to determine whether patients tracked doses correctly. Less than 25% of those surveyed said they could identify the number of doses remaining. Another 25% said they had found their inhalers empty when needed, resulting in calls to emergency response centers by these patients 8% of the time.(4)
MD Turbo was designed to counteract the problems of coordination and dose-counting identified by physicians and MDI users, providing for a simplified, and more efficient and cost-effective method of treating asthma and COPD using an inhaler.
MD Turbo is available by prescription throughout the United States. For more information, visit www.mdturbo.com.
About MD Turbo
More than 37 million patients in the United States suffer from asthma or chronic obstructive pulmonary disease (COPD). Most of those patients rely on traditional metered dose inhalers (MDIs) for delivery of medications to treat their disease. Inhalation therapy is standard treatment for delivery of medication for respiratory diseases as it provides for delivery of medication directly into the lungs for maximum effect and quickest onset of action, and avoids or minimizes undesirable side effects associated with systemic absorption.
Proper use of MDIs requires patients to coordinate activation of the device with the inhalation of the medication. Published studies have demonstrated that regardless of age or experience using an MDI, over 50% of patients cannot coordinate the press-and-breathe action required for MDIs use. As a result of poor technique, the patient may not receive the intended dose of medication and therefore have less control of his or her disease. Using breath-activation has been proven to nearly triple the amount of drug deposited to the lung.(1),(2),(3).
MD Turbo is the first product that converts the traditional MDI into a breath-activated device, and accommodates over 90% of the metered-dose inhalers dispensed to asthmatics or patients suffering from COPD. MD Turbo is designed to provide improved drug delivery to the lungs for patients using MDIs by minimizing the problems associated with incorrect inhalation technique. The MDI is inserted into MD Turbo and the patient places his or her mouth around the mouthpiece and inhales slowly to actuate the MDI. Alternatively, the patient can trigger MD Turbo by depressing a recessed button on the back of the device. A second feature incorporated into MD Turbo is a dose counter that automatically counts down the doses each time the inhaler is activated. When the counter reaches 20 or fewer doses, the number display will start to flash to alert the patient or caregiver that the canister is approaching empty. Since many of the MDIs are used in an asthma attack or crisis, this feature was designed to help avoid a medical emergency caused by an empty canister.
About Accentia Biopharmaceuticals, Inc.
Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNase(TM) and BiovaxID(TM). The Company's SinuNase product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkins' lymphoma. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial. In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, Inc. has a portfolio of currently marketed products plus a pipeline of additional products under development by third parties. For further information, please visit our web site: www.accentia.net.
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include statements relating to MD Turbo, products, product candidates, product development programs, the FDA or clinical trial process including the commencement, process or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
(1) Pederson S, Frost L, Arnfred T. Errors in inhalation technique and efficiency in inhaler use in asthmatic children. Allergy. 1986;46: 118-124.
(2) Crompton GK. Problems patients have using pressurized aerosol inhalers. Eur J Respir Dis. 1982;63(suppl 119):101-104.
(3) Chapman KR, Love L, Brubaker H. A comparison of breath-actuated and conventional metered-dose inhaler inhalation techniques in elderly subjects. Chest.1993;104(5):1332-1336.
(4) Sander N, Fusco-Walker SJ, Chipps B. MDIs:can you count on them? Poster presented at the 61st Annual Meeting of the American College of Allergy, Asthma & Immunology; November 7-12,2003; New Orleans, LA.
Source: Accentia Biopharmaceuticals
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