PennyPerformers.com: "Penny Stocks that Perform" picks are: AMLN, MRGE, MSTR, PARD

Pennyperformers.com "Penny Stocks that Perform" picks are: Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN), Merge Healthcare, Inc. (NASDAQ: MRGE), MicroStrategy(R) Incorporated (NASDAQ: MSTR), Poniard Pharmaceuticals, Inc. (NASDAQ: PARD)

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Jul 9, 2009 -- Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) today announced positive results from a 28-week dose-ranging study of pramlintide/metreleptin, a combination treatment comprising pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, in overweight and obese patients. This Phase 2 study successfully characterized patients who responded best to treatment and also provided important information to inform dose selection.

At 28 weeks, evaluable patients with a starting body mass index (BMI) less than 35 kg/m2 (n=149), and treated with the highest pramlintide/metreleptin doses, experienced significantly more weight loss on average (11%; 22 pounds, p<0.01) than those receiving placebo (1.8%; 4 pounds) or either agent alone (approximately 5%; 10 pounds). Consistent with the physiologic role of leptin in regulating body fat, the weight loss in these patients was predominantly due to a reduction in fat mass (approximately 18 of the 22 pounds lost). These study results confirm previous Phase 2 results with this combination therapy and provide a solid foundation for the Company's ongoing obesity development program.

In the overall evaluable study population, all of the pramlintide/metreleptin combination arms achieved more weight loss than placebo. The magnitude of weight loss was found to be dependent on dosage and baseline BMI. In a pre-specified analysis of evaluable patients with a starting BMI less than 35 kg/m2, weight loss with pramlintide/metreleptin was more than additive compared to that with pramlintide and metreleptin alone, a finding that was not observed in the overall evaluable population.

"Despite their best efforts with diet and exercise alone, most overweight or obese individuals experience progressive weight gain over time. To date, the only highly effective treatment option is surgical and limited to the minority of patients who have advanced to the most severe forms of obesity," said Steven R. Smith, M.D., professor and assistant director of clinical research at the Pennington Biomedical Research Center. "Providing the over 80 million overweight and obese Americans who have a BMI less than 35 kg/m2 with safe treatment options that offer compelling weight loss would be a significant advancement in obesity drug development."

The combination therapy was well tolerated, and no cardiovascular or neuropsychiatric (such as anxiety or depression) safety signals were observed. Consistent with previous clinical experience, the most common side effects seen with pramlintide/metreleptin combination treatment were injection site adverse events and nausea, which were mostly mild or moderate and transient in nature.

"These findings provide us with valuable data that will inform our clinical and product development strategy moving forward," said Christian Weyer, M.D., vice president, corporate development, diabetes and obesity at Amylin Pharmaceuticals. "Our integrated neurohormonal approach to obesity provides a broad research and development platform that has the potential to yield transformational therapies that address a range of unmet patient needs across the various classes of obesity."

Study Details

This Phase 2, 28-week, double-blind, placebo-controlled multi-center study randomized 608 obese or overweight patients with a BMI ranging from 27-45 kg/m2. Patients were well-distributed across this BMI range, with approximately 40% of patients at a starting BMI less than 35 kg/m2. Following a one-week placebo lead-in period, study subjects were randomized in a balanced fashion to receive twice-daily therapy with one of the following eight treatment regimens: 1) placebo/placebo; 2) pramlintide 360 mcg/placebo; 3) metreleptin 5 mg/placebo; 4) pramlintide 180 mcg/metreleptin 2.5 mg; 5) pramlintide 180 mcg/metreleptin 5 mg; 6) pramlintide 360 mcg/metreleptin 1.25 mg; 7) pramlintide 360 mcg/metreleptin 2.5 mg; or 8) pramlintide 360 mcg/metreleptin 5 mg.

Lifestyle intervention was included throughout study (dietary, exercise and behavioral). Body composition was assessed using DEXA scanning at enrollment and again at study termination. Across all treatment arms, approximately 60% (n=360) of patients were deemed evaluable (subjects who completed at least 24 weeks of treatment on study medication and had no major protocol deviations).

As part of an ongoing extension protocol, study participants may continue on therapy for a total of 52 weeks. Data from this study will be submitted for presentation at a future medical meeting and for publication in a peer-reviewed journal.

About Obesity

Obesity is a chronic disorder that affects millions of people and is linked to increased health risk of several medical conditions including type 2 diabetes, non-alcoholic fatty liver disease, high blood pressure, heart disease, stroke, osteoarthritis, sleep disorders and several types of cancers. According to The Obesity Society, obesity is the second leading cause of preventable death in the United States. The total direct and indirect cost attributed to overweight and obesity health issues exceeds $100 billion in the United States each year. Obesity is also rapidly becoming a major health problem in all industrialized nations and many developing countries.

There are different classes of obesity defined by body mass index, or BMI. Overweight is defined as BMI 25 to 29.9 kg/m2, Obesity Class I is BMI 30 to 34.9 kg/m2, Obesity Class II is BMI 35 to 39.9 kg/m2 and Obesity Class III is BMI 40 kg/m2 or more. Of the over 100 million overweight and obese individuals in the United States, over 80 million have a BMI less than 35 kg/m2. It is estimated that approximately two-thirds of patients with type 2 diabetes are overweight or obese, with a BMI less than 35 kg/m2. In addition, approximately three-quarters of individuals with BMI less than 35 kg/m2 without type 2 diabetes have dyslipidemia and/or hypertension.

Amylin's Approach to Obesity Research and Development

Currently, physicians and patients seeking prescription medications for weight loss have limited therapeutic options. New scientific advances have established the key role of neurohormones in the physiological regulation of appetite and energy balance, as well as the importance of studying the interaction among these hormones (within the brain) to uncover their full therapeutic potential. Amylin scientists discovered that combination treatment with neurohormones, such as amylin and leptin, can produce additive and synergistic weight loss in animal models. These findings formed the basis for Amylin's innovative integrated neurohormonal approach to the development of obesity treatments.

About Pramlintide/Metreleptin Combination Treatment

Pramlintide acetate is a synthetic analog of the natural hormone amylin, a neurohormone secreted by the pancreas that is known to play a role in the regulation of appetite, food intake and postprandial glucose concentrations. To date, approximately 8,000 individuals have received pramlintide in clinical trials, including more than 950 in obesity studies. Metreleptin (methionyl recombinant leptin; r-metHuLeptin) is an analog of human leptin, a neurohormone secreted by fat cells that plays a fundamental role in the regulation of energy metabolism and body weight. To date, more than 1,200 overweight or obese individuals have received metreleptin in clinical trials, several of which were 16 weeks or longer in duration. In an initial 24-week, Phase 2 clinical proof-of-concept study in 177 overweight or obese individuals (baseline BMI 27-35 kg/m2), combination treatment with pramlintide/metreleptin (360 mcg/5 mg twice daily) resulted in an average weight loss of 12.7% (25 pounds) from enrollment, significantly more than treatment with pramlintide alone (360 mcg twice daily) who experienced an average weight loss of 8.4% (17 pounds) or metreleptin alone (5 mg twice daily) who experienced an average weight loss of 8.2% (16 pounds).

Amylin Pharmaceuticals

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California.

Jul 9, 2009 -- Merge Healthcare, Inc. (NASDAQ: MRGE), a health IT solutions provider, today announced the release of Frontiers(TM) 4.2.2, a surgery management solution that improves hospital workflow by capturing and charting clinical data throughout the entire perioperative-care process (pre-surgical screening, operating room and recovery). Frontiers automates the demanding clinical and business documentation requirements in the operating room, allowing clinicians and physicians to better focus on patient care.

"We've found the Frontiers' real-time, accurate charting of all clinical data is not only a tremendous time-saver for our clinicians, but also an indispensable solution to charge/procedure capture and transmission for maximum profitability," says Susan McAndrews, RN, MSA, CASC, Vice President of Ambulatory Services at Riverside Health System, Newport News, Virginia. "The entire charting process takes our clinicians and physicians seconds to complete, while at the same time ensures documentation-compliance with all quality, regulatory and best practice standards of performance." McAndrews continues, "By the time the record is transmitted to the Medical Records and Billing departments, the data has been definitively and clearly documented, which ensures compliance with regulations for an itemized record. This upgraded platform has truly made our entire clinical and physician staffs more productive."

Frontiers 4.2.2 introduces the ability to capture each surgery-related charge at the point of care, as well as to transcribe physiological data at any existing Windows(R)-based charting station within a hospital. Using this electronic surgical record, hospital administrators have access to detailed data that can improve enterprise-wide processes while enhancing profitability and compliance efforts. In addition, the new release incorporates significant enhancements that simplify materials, pharmacy, compliance and billing case review workflow.

"We are pleased to deliver these new solutions so quickly after Merge's acquisition of the Frontiers product line. We have rapidly integrated the division into our business while improving product delivery for our customers," said Nancy Koenig, President, Merge Healthcare. "Frontiers' surgery management solution is a critical component of a patient's electronic medical record. Product enhancements that improve system deployment, interoperability and adoption are essential to the patient quality initiatives underlying the national healthcare agenda."

Merge Healthcare develops software solutions that automate healthcare data and diagnostic workflow to create a more comprehensive electronic record of the patient experience. Merge products, ranging from standards-based development toolkits to fully integrated clinical applications, have been used by healthcare providers worldwide for over 20 years.

Jul 9, 2009 -- MicroStrategy(R) Incorporated (NASDAQ: MSTR), a leading worldwide provider of business intelligence (BI) software, today announced that it will host a series of informational events in seven cities in India. The events will provide an overview of MicroStrategy's latest software release, MicroStrategy 9, and how it can provide valuable business insights that can help companies improve decision making, increase productivity, streamline operations, and enhance business performance.

Attendees at the events will learn about many of the new features in MicroStrategy 9, the company's most significant software release in nearly a decade. MicroStrategy 9 extends the performance, scalability, and efficiency of enterprise BI; enables the rapid deployment of departmental BI applications; and provides a seamless consolidation path from departmental BI to enterprise BI. Participants will hear about new products and capabilities in MicroStrategy 9 that support both large, enterprise-wide BI deployments, as well as smaller-scale BI systems for departments and workgroups.

Nine dinner events will be held from July 14, 2009 through July 31, 2009: July 14 - Mumbai, ITC Maratha July 15 - Pune, Le Meridien July 17 - New Delhi, InterContinental Eros Nehru Place July 21 - Hyderabad, Hotel Taj Krishna July 23 - Bangalore, Taj Residency July 24 - Chennai, Sheraton Chola July 28 - Ahmedabad, Le Meridien July 29 - Mumbai, Grand Hyatt July 31 - New Delhi, InterContinental Eros Nehru Place

Sybase, a MicroStrategy technology partner, will be supporting the events, and participants will hear how MicroStrategy and Sybase combine their core expertise in BI, data integration, and data warehouse technologies to help customers efficiently manage their data and rapidly gain insights into business performance. In addition, MicroStrategy reseller partners, InfoCepts, InfoSTEP, Lunexa, OBSI, and Systech, will be co-sponsoring the events.

"India is a vibrant market for business intelligence and we look forward to this series of events, which will provide attendees with practical information to enhance their organization's BI initiatives," said Sanju Bansal, MicroStrategy COO. "These events will demonstrate how companies can empower business users with extensive self-service capabilities, graphically display key business information for actionable insights, and extend BI from small, individual applications into a cohesive enterprise BI operation."

About MicroStrategy

Founded in 1989, MicroStrategy is a global leader in business intelligence (BI) technology. MicroStrategy provides integrated reporting, analysis, and monitoring software that helps leading organizations worldwide make better business decisions every day. Companies choose MicroStrategy for its advanced technical capabilities, sophisticated analytics, and superior data and user scalability.

Jul 9, 2009 -- Poniard Pharmaceuticals, Inc. (NASDAQ: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced the appointment of Gary A. Lyons, to the Company's board of directors. His appointment increases the number of directors on the Poniard board to ten.

"We are pleased Gary is on the board to help guide us as we move toward our goal of commercializing picoplatin in 2010," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "Gary's extensive pharmaceutical business development and commercialization experience will provide an invaluable contribution as we continue the process of identifying and securing a worldwide partner for picoplatin, and executing our strategy of building a commercial stage oncology business."

"I look forward to working with the Poniard board and management team to successfully implement its partnering and commercialization strategy for picoplatin," said Mr. Lyons. "With the pivotal Phase 3 picoplatin data in small cell lung cancer approaching, Poniard is on the cusp of a transformative time in the company's history that I look forward to being a part of."

Gary A. Lyons has served as a consultant to Poniard on matters of corporate and business development activities since April 2009, and the Company expects to expand his consulting arrangement as it moves forward with its commercialization and partnering activities. Gary has served as a Director of Neurocrine Biosciences, Inc. since February 1993 and held various executive positions with Neurocrine, including President and Chief Executive Officer, from February 1993 through January 2008. Prior to joining Neurocrine, Mr. Lyons held a number of senior management positions at Genentech, including Vice President of Business Development, Vice President of Sales, and Director of Sales and Marketing. Mr. Lyons currently serves on the Boards of Directors for Rigel Pharmaceuticals, Inc., Vical, Incorporated, and Facet Biotech, all publicly held biotechnology companies. Mr. Lyons holds a B.S. in marine biology from the University of New Hampshire and a M.B.A. from Northwestern University's J.L. Kellogg Graduate School of Management.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. Picoplatin, the Company's lead platform product candidate, is a new generation platinum chemotherapy. To date, clinical studies suggest that picoplatin has an improved safety profile relative to existing platinum-based cancer therapies. Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors, and is being studied in multiple cancer indications, combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and castration-resistant (hormone refractory) prostate cancers. The Company also is conducting a clinical trial of oral picoplatin in solid tumors.

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