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	<title> &#187; QDose</title>
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		<title>MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study</title>
		<link>http://mdtx.com/2008/08/06/microdose-announces-positive-results-from-the-qdose-inhaled-insulin-glucose-clamp-study/</link>
		<comments>http://mdtx.com/2008/08/06/microdose-announces-positive-results-from-the-qdose-inhaled-insulin-glucose-clamp-study/#comments</comments>
		<pubDate>Wed, 06 Aug 2008 15:18:39 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[QDose]]></category>

		<guid isPermaLink="false">http://www.microdosetech.com/mdtx/?p=465</guid>
		<description><![CDATA[MicroDose Technologies, Inc. (PRNewsFoto/MicroDose Technologies, Inc.)
MONMOUTH JUNCTION, N.J., Aug. 6 /PRNewswire/ &#8212; MicroDose Technologies, Inc., a privately held drug delivery and specialty pharmaceuticals company, today announces top line results from a glucose clamp study of the QDose inhaled insulin product. MicroDose, through its joint venture with Vectura Group plc, QDose Limited, has developed a highly [...]]]></description>
			<content:encoded><![CDATA[<p>MicroDose Technologies, Inc. (PRNewsFoto/MicroDose Technologies, Inc.)<br />
MONMOUTH JUNCTION, N.J., Aug. 6 /PRNewswire/ &#8212; MicroDose Technologies, Inc., a privately held drug delivery and specialty pharmaceuticals company, today announces top line results from a glucose clamp study of the QDose inhaled insulin product. MicroDose, through its joint venture with Vectura Group plc, QDose Limited, has developed a highly efficient, rapid acting, insulin inhaler, based upon MicroDose&#8217;s proprietary electronic inhaler technology and Vectura&#8217;s dry powder insulin formulation.<span id="more-465"></span> The QDose inhaled insulin product offers dose titration capability over a broad range of dose strengths, in a single inhalation. The inhaler also provides active dose feedbacks to the patient in an easy to use, pocket-sized device.</p>
<p>The study employed the widely used and validated glucose clamp technique, and results demonstrated that:</p>
<ul>
<li>The inhaled insulin formulation was safe and effective</li>
<li>Peak levels of insulin activity were achieved more quickly following the inhaled insulin than those from the subcutaneous insulin injection</li>
<li>Relative bioavailability of inhaled insulin was approximately 18% during the 3 hour period following dosing; higher than the publishedvalues for the currently marketed inhalation product</li>
<li>Administration of the same total dose of inhaled insulin from either a single blister or two &#8220;half strength&#8221; blisters led to equivalent activity; an advantage over the currently marketed inhalation product.</li>
</ul>
<p>The study was a randomized, crossover, open-label glucose clamp study,designed to confirm the high relative bioavailability of the QDose insulin formulation previously observed, and to demonstrate the product&#8217;s dose titration capability. The results confirmed the faster onset of action seenwith the QDose inhaled formulation compared with subcutaneous insulin. The relative bioavailability observed in this study compares favorably with available information on competitor inhaled insulin programs.</p>
<p>The study was conducted in the United States at Profil Institute for Clinical Research, Inc (Profil) in San Diego, with 14 healthy male volunteers, using a glucoseclamp technique. Profil has research facilities in the US and Germany and is the leading institute in the world for euglycaemic, hyperglycaemic and hypoglycaemic glucose clamps.</p>
<p>Anand Gumaste, Ph.D., Chief Executive Officer of MicroDose, commented: &#8220;Treatment of diabetes with insulin has historically been challenging, having to overcome the psychological barriers to injection, allowing for individual patient titration of dose, all while satisfying the varying needs of a broad continuum of patient populations. The QDose product&#8217;s ability to meet these needs, coupled with its user friendly aspects, gives it a significant advantage in the market place. We are currently seeking a licensing partner for the continued development and  commercialization of this unique product.&#8221;</p>
<p>About MicroDose Technologies</p>
<p>MicroDose Technolog ies, Inc., based in Monmouth Junction, New Jersey, is a leading privately-held drug delivery and specialty pharmaceuticals company, developing advanced pulmonary, fixed-dose-combination oral dosage, and other technologies for the pharmaceutical and biotechnology industries.</p>
<p>MicroDose Technologies has a two-fold business strategy, 1) to create improved partnered products by combining its proprietary drug delivery technologies with pharmaceutical company compounds, and 2) to develop products in-house using its proprietary delivery technologies with generic drug substances.</p>
<p>MicroDose&#8217;s dry powder inhaler platform is a handheld, low cost, breath activated technology which utilizes piezo electronics to efficiently deliver a broad range of compounds independent of inhalation effort. Partnered programs for the inhaler include; a multi-product development and licensing agreement with Novartis for its proprietary respiratory compounds, and an inhaler for the systemic delivery of a nerve agent antidote for the US Department of Defense in co-development with the University of Pittsburgh. In addition, MicroDose has undisclosed collaborations ongoing with major pharmaceutical partners in the respiratory market segment.</p>
<p>MicroDose&#8217;s second drug delivery platform, PolyCap(TM), is a fixed-dose-combination oral dosage technology, which allows two or more drugs to be combined in a single capsule, but separated by a physical barrier. Internal development programs utlilizing PolyCap(TM) are underway in the areas of diabetes, hypertension and hyperlipidaemia. PolyCap(TM) is also available for license to pharmaceutical partners for their combination product needs.</p>
<p>About Diabetes Diabetes is a chronic health condition where the body is unable to produce or adequately use insulin. Diabetes is broadly grouped into two types &#8212; Type I and Type 2. Type 2 diabetics make up approximately 90% of<br />
all diabetics and the incidence of Type 2 diabetes is growing rapidly.</p>
<p>According to the World Health Organization, diabetes is reaching epidemic proportions. Approximately 194 million people worldwide suffer from the disease, and it is estimated that the number of people with diabetes will more than double by 2030. Predictions are that one in three children in the U.S. born five years ago will develop diabetes. Direct healthcare costs may be as much as $286 billion worldwide. It is widely accepted that early intervention for Type 2 diabetics by treatment with insulin improves outcomes. However, as Type 2 diabetics are reluctant to inject insulin the introduction of non-invasive insulin delivery formats, such as inhalable insulin, is likely to have greater impact on outcomes and become the preferred means for delivering insulin for Type 2 diabetics.</p>
<p>The first inhalable insulin product, Pfizer&#8217;s EXUBERA(R), was approved by the European Commission on January 26th 2006 and by the FDA on January 27th 2006. Following the launch of EXUBERA(R) inhaled insulin has become<br />
available for diabetics and the way is being paved for next generation products.</p>
<p>About Glucose Clamp Technique</p>
<p>Glucose clamp technique is a technique that maintains a constant blood glucose level in human subjects by perfusion or infusion with glucose; the  technique is used in studies to obtain evidence of the effectiveness and bioavailability of preparations of insulin in healthy human volunteers, and patients who suffer from diabetes. Glucose clamp techniques represent the gold standard for pharmacodynamic and pharmacokinetic studies to describe the time-action profiles of glucose-lowering drugs; the effects of these drugs administered by various routes of administration can be studied individually, and then compared. For example, the effects of inhaled versus subcutaneous insulin.</p>
<p>The European regulatory authority EMEA expressly refers to the glucose clamp technique in an EMEA/ CPMP Note for Guidance.</p>
<p>SOURCE MicroDose Technologies, Inc</p>
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		<title>Bristol-Myers Squibb And QDose Announce Collaboration To Develop Inhaled Insulin For The Treatment of Diabetes</title>
		<link>http://mdtx.com/2003/09/10/bristol-myers-squibb-and-qdose-announce-collaboration-to-develop-inhaled-insulin-for-the-treatment-of-diabetes/</link>
		<comments>http://mdtx.com/2003/09/10/bristol-myers-squibb-and-qdose-announce-collaboration-to-develop-inhaled-insulin-for-the-treatment-of-diabetes/#comments</comments>
		<pubDate>Wed, 10 Sep 2003 15:05:06 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[QDose]]></category>

		<guid isPermaLink="false">http://www.microdosetech.com/mdtx/?p=455</guid>
		<description><![CDATA[NEW YORK, NEW YORK (September 10, 2003) &#8212; Bristol-Myers Squibb Company (NYSE: BMY) and QDose, a joint venture between MicroDose Technologies, Inc. and Quadrant Drug Delivery, Ltd., today announced that the companies have entered into a licensing agreement for the QDose inhaled insulin product.

According to the terms of the agreement, Bristol-Myers Squibb will obtain worldwide [...]]]></description>
			<content:encoded><![CDATA[<p>NEW YORK, NEW YORK (September 10, 2003) &#8212; Bristol-Myers Squibb Company (NYSE: BMY) and QDose, a joint venture between MicroDose Technologies, Inc. and Quadrant Drug Delivery, Ltd., today announced that the companies have entered into a licensing agreement for the QDose inhaled insulin product.<br />
<span id="more-455"></span></p>
<p>According to the terms of the agreement, Bristol-Myers Squibb will obtain worldwide exclusive rights to the product and, with support from QDose, will take the lead on development, manufacturing and commercialization of the licensed product.</p>
<p>&#8220;MicroDose is pleased to collaborate with Bristol-Myers Squibb, a recognized leader in diabetes treatment with proven development and commercialization capabilities,&#8221; said Anand V. Gumaste, president and chief executive officer, MicroDose Technologies. &#8220;The QDose inhaled insulin product is currently in Phase I development. By coupling the MicroDose novel dry powder inhaler (DPI) and Quadrant engineered particles with the strong product development, marketing and sales capabilities provided by Bristol-Myers Squibb, we are confident that we can rapidly advance this product through the development process.&#8221;</p>
<p>According to the terms of the license agreement, Bristol-Myers Squibb will pay a $1 million upfront payment to QDose and will pay an additional $29 million in milestone payments based on the achievement of certain development and regulatory events. Bristol-Myers Squibb will also pay royalties on sales.</p>
<p>&#8220;The incidence of diabetes mellitus continues to increase at a rapid rate,&#8221; said Raj Uppal, chief executive officer, Quadrant Drug Delivery. &#8220;The disease, as well as the complications associated with the condition, place a tremendous burden on health care systems throughout the world. We are pleased to be able to participate in this joint venture and to utilize the Quadrant Drug Delivery proprietary dry powder formulations of insulin in developing new, patient friendly and convenient approaches to managing diabetes.&#8221;</p>
<p>The World Health Organization projects an increase in diabetes cases from 177 million worldwide in 2003 to 370 million by 2030. The U.S. Centers for Disease Control and Prevention projects that one in three 3 Americans born in 2000 will eventually develop the condition.</p>
<p>&#8220;As a leader in the field of diabetes, Bristol-Myers Squibb is committed to developing therapy options that may help patients to better manage their condition,&#8221; said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. &#8220;Through this collaboration with MicroDose Technologies and Quadrant Drug Delivery, we hope to further develop an inhaled insulin product that may offer patients an alternative route of administration that either complements or replaces insulin injections.&#8221;</p>
<p>MicroDose Technologies, Inc., based in Monmouth Junction, New Jersey, is a privately held drug delivery company, developing advanced pulmonary, solid oral dosage, and needle free transdermal products for the pharmaceutical industry. The MicroDose DPI is a handheld, low cost, breath activated device, which makes novel use of piezo electronics to efficiently deliver a broad range of compounds independent of inhalation effort. The device is the first totally electronic DPI and represents the next generation in inhaler technology both in performance and ease of use.<br />
Quadrant Drug Delivery, Ltd. is a privately owned company based in Nottingham, U.K. It provides specialist drug formulation and stabilization technologies to the pharmaceutical and biotechnology industries with particular emphasis on dry powder drug delivery to the lungs. Quadrant&#8217;s proprietary approaches can improve product performance by increasing the efficiency of delivery of medicines to the lungs and systemic circulation as well as stabilizing labile molecules offering the potential for room temperature stable products.</p>
<p>Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. This press release contains &#8220;forward-looking statements&#8221; as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management&#8217;s current expectations and involve significant risks and uncertainties that may cause results to differ materially from those set forth in the statements. Among other risks, there can be no guarantee that the product described in this release will receive regulatory approval, or that it will prove to be commercially successful. This and other risk factors are discussed in the Company&#8217;s offering documents and in the Company&#8217;s periodic communications to shareholders. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.</p>
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