Pharmaceutical News: Bulgaria Pharmaceuticals and Healthcare Report Q1 2012

Bulgaria Pharmaceuticals and Healthcare Report Q1 2012

Business Monitor International’s Bulgaria Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on Bulgaria’s pharmaceuticals and healthcare industry.

BMI View: Out-of-pocket spending will continue to be the main driver behind the growth of Bulgaria’s pharmaceutical market, though this feature also makes the market highly vulnerable to the wider economic situation. In terms of absolute values, government funding for healthcare is expected to improve marginally, although its relative contribution to the overall healthcare spending in the country will continue to decline, partly due to the difficulties regarding the collection of insurance contributions.

Business Environment Rating: Despite its composite score being 1% lower on a quarter-on-quarter (qo- q) basis, Bulgaria remains 13th in BMI’s latest Pharmaceutical and Healthcare Business Environment Ratings (BERs) for emerging Europe. The lower composite score is due to a slight downgrade in its rewards component, which is still well below the regional average. Bulgaria also has relatively pronounced risks, scoring 56 out of 100 for this category, although it is on par with the regional average.

Fleming Pharmaceuticals Sells Ocean, Nephrocaps, Other Branded Products to Valeant

Fleming Pharmaceuticals announced today that, effective December 22, 2011, it has sold its rights to its branded Ocean®, Nephrocaps®, Magonate® and ProBarimin QT® products to Valeant International (Barbados) SRL (“Valeant”). Valeant has appointed its affiliate, Valeant Pharmaceuticals North America LLC, to act as distributor of these products in the U.S.

Fleming also manufactures contract products for a broad customer base, including the federal government. Fleming has retained rights to manufacture and market its widely-known product ThyroShield, one of two FDA-approved potassium iodide medicines used in nuclear emergencies to block the thyroid gland from absorbing radioactive iodine to avoid thyroid cancer. In addition, Fleming has retained its contract services business relating to the development, manufacture and testing for specialty pharmaceutical companies and its physical headquarters in St. Louis, Missouri.

Due to the excess capacity anticipated as a result of the sale of the announced four products, Fleming is now considering proposals from a number of pharma manufacturers for its Midwestern manufacturing capability. A private investment banking firm, Douglas Group, St. Louis, has been retained to facilitate consideration of potential merger or sale for the remaining Fleming operations.

Biotechnology Pharmaceutical Company Selects NewCardio’s QTinno for Thorough QT Trial

NewCardio, Inc., NWCI
+8.15% a
cardiovascular diagnostic solutions developer, announced today that a biotechnology pharmaceutical company, which is focused on discovering and developing small molecule therapeutics for disorders of the central nervous system (CNS), has selected QTinno®, NewCardio’s automated cardiac safety solution, for an upcoming Thorough QT trial. Fully automated ECG analysis, empowered by QTinno, will be delivered by the ECG core lab of a top 3 Clinical Research Organization (CRO) under the terms of an existing Master Services Agreement with NewCardio.

The current study timeline anticipates initiating the study in January, with completion in the April timeframe. QTinno was selected, and specifically written into the protocol by the drug development sponsor, based on its proven ability to enable the CRO to deliver high-quality results in a much more timely and cost effective manner than the current core ECG lab methodologies. It is anticipated that the study will generate approximately $250,000 in revenue for NewCardio.

Greg Sadowski, NewCardio’s Chief Operating Officer, commented, “We are excited to participate in this TQT trial for an emerging biotech with our CRO partner. QTinno’s selection for this study, based on the performance in prior studies, provides clear evidence of the pharmaceutical company’s confidence, not only in the accuracy and precision of QTinno’s fully automated ECG analysis, but also in the FDA’s willingness to accept drug safety data from properly validated technology such as QTinno.”

About QTinno Technology

NewCardio’s patented QTinno 3-D ECG software technology is a novel, fully automated program for evaluating QT and other timing intervals relevant for assessing drug cardiac toxicity in drug development. It provides fast, accurate and precise QT data from a broad range of challenging ECGs and enables reliable, automated identification of key cardiac events. Pharmaceutical sponsors and clinical research organizations, which are mandated by the FDA to test new drugs for potential cardiac toxicity, are expected to benefit from QTinno’s faster, more accurate and less expensive assessment of cardiac status.

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