The company is financially strong; sales growth is exceptional and earnings continue to surprise. Baxter has a solid balance sheet.

Over the past twelve months, sales grew by nearly 10%; significantly better than its five year growth rate of 6.76%. Earning grew by 21.19% as compared to one year ago and this was also stronger than its five year growth rate of 14.03%. Gross profit, operating profit and net profit margins are all above their five year averages. The consensus EPS estimate for FY09 is $3.74 compared with reported FY08 EPS of $3.16.

So what is there not to like? The medical equipment, supplies and distribution business is one bright spot in an otherwise dismal market. I believe the market has driven prices in this industry to unsustainable levels; momentum has displaced the fundamentals.

Herman Saftlas, the Standard & Poor’s analyst that covers Baxter sees continued growth ahead and higher margins. He gives the company a twelve month target price of $65. Alex Kolb at Zacks Investment Research also sees a bright future for Baxter. Barron’s also makes a strong case for Baxter.

Changes are coming to the healthcare industry. Medicare and Medicaid reimbursement rates will be cut under the Obama administration’s healthcare plan. Hospitals and other healthcare facilities will tighten inventories. How material these reductions will be to Baxter are hard to quantify.

Baxter is certainly a strong company and I take no issue with the analyst’s predictions of the future. However, my analysis pays more attention to free cash flow than it does to earnings. Growth needs to be paid for with cash and free cash flow is, in my opinion, the best metric to use in this regard.

I estimate that Baxter will generate $1.97 in free cash flow over the next twelve months as compared to $1.43 in FY08. I note that long term debt and other long term liabilities total $5,541 billion.

My value estimation, based on the fundamental factors I consider important, leads me to conclude that Baxter’s fair market value is approximately $37.56.

Disclosure: I have no position in Baxter International.

Good Article? Pull it from here:
A Short Story: Baxter International

Cisco Systems [CSCO: 20.38, +0.12 (+0.59%)] Recent Price $17.04 Value Range 21.86 – $38.41
Cisco Systems, Inc. designs, manufactures and sells Internet protocol (IP)-based networking and other products related to the communications and information technology (IT) industry, and provides services associated with these products and their use. The Company provides a line of products for transporting data, voice, and video within buildings, across campuses, and around the world. Its products are designed to transform how people connect, communicate and collaborate. Cisco Systems, Inc.’s products, which include primarily routers, switches, and products that the Company refers to as its technologies, are installed at enterprises, public institutions, telecommunications companies, commercial businesses and personal residences. In November 2008, the Company acquired Jabber Inc. In January 2009, the Company acquired Richards-Zeta Building Intelligence, Inc

CSG Systems International [CSGS: 18.91, +0.09 (+0.48%)] Recent Price $15.47 Value Range $21.39 – $28

CSG Systems International, Inc. (CSG) is a provider of outsourced solutions that facilitate customer interaction management on the behalf of its clients, generating approximately 95% of its revenues during the year ended December 31, 2007, from the North American cable and Direct Broadcast satellite (DBS) communications markets. The Company’s solutions also support a number of other industries, such as financial services, utilities, telecommunications, and home security. CSG’s solutions manage customer interactions, such as set-up and activation of customer accounts, sales support and marketing, order processing, invoice calculation (customer billing), production and mailing of monthly customer invoices, management reporting, electronic presentment and payment of invoices, automated and interactive messaging, and deployment and management of the client’s field technicians to the customer’s home. In May 2008, CSG completed the acquisition of DataProse, Inc.

Forest Laboratories [FRX: 29.17, +1.52 (+5.50%)] Recent Price$26.21 Value Range$51.57 – $64.09

Forest Laboratories, Inc. and its subsidiaries develop, manufacture and sell both branded and generic forms of ethical drug products, which require a physician’s prescription, as well as non-prescription pharmaceutical products sold over the counter. The Company’s products in the United States consist of branded ethical drug specialties marketed directly or detailed to physicians by its sales forces, Forest Pharmaceuticals, Forest Therapeutics, Forest Healthcare, Forest Ethicare and Forest Specialty Sales. Forest Laboratories, Inc.’s products include Lexapro, the Company’s selective serotonin reuptake inhibitor (SSRI) for the treatment of major depression and generalized anxiety disorder (GAD); Namenda, its N-methyl-D-aspartate (NMDA) antagonist for the treatment of moderate to severe Alzheimer’s disease; Bystolic, its novel beta-blocker for the treatment of hypertension, and Campral, for the maintenance of alcohol abstinence.

Robert Half International [RHI: 22.94, +0.31 (+1.37%)] Recent Price $18.22 Value Range $26.27 – $30.14

Robert Half International Inc. provides specialized staffing and risk consulting services through such divisions as Accountemps, Robert Half Finance & Accounting, OfficeTeam, Robert Half Technology, Robert Half Management Resources, Robert Half Legal, The Creative Group and Protiviti. The Company, through its Accountemps, Robert Half Finance & Accounting, and Robert Half Management Resources divisions, is a specialized provider of temporary, full-time project professionals in the fields of accounting and finance. OfficeTeam specializes in skilled temporary administrative support personnel. Robert Half Technology provides information technology professionals. Robert Half Legal provides temporary, project and full-time staffing of attorneys and specialized support personnel within law firms and corporate legal departments. The Creative Group provides project staffing in the advertising, marketing, and Web design fields

Advance Auto Parts [AAP: 56.29, +0.81 (+1.46%)] Recent Price 33.63 Value Range 10.02 – 12.07

Advance Auto Parts, Inc. (Advance) operates within the United States automotive aftermarket industry, which includes replacement parts (excluding tires), accessories, maintenance items, batteries and automotive chemicals for cars and light trucks (pickup trucks, vans, minivans and sport utility vehicles). The Company is a specialty retailer of automotive parts, accessories and maintenance items to do-it-yourself (DIY) and do-it-for-me (DIFM) customers in the United States, based on store count and sales. Advance operates in two business segments: Advance Auto Parts (AAP) and Autopart International (AI). The AAP segment consists of its store operations within the United States, Puerto Rico and the Virgin Islands, which operates under the trade names Advance Auto Parts, Advance Discount Auto Parts and Western Auto. The AI segment consists solely of the operations of Autopart International, which operates as an independent, wholly owned subsidiary.

American Eagle Outfitters [AEO: 13.80, +0.76 (+5.83%)] Recent Price 9.64 Value Range 0.63 – $0.75

American Eagle Outfitters, Inc. is a retailer that operates under the American Eagle Outfitters, aerie by American Eagle and MARTIN + OSA brands. The Company designs, markets and sells its own brand of clothing targeting 15 to 25 year-olds. American Eagle also operates ae.com, which offers additional sizes, colors and styles of AE merchandise and ships to 41 countries worldwide. AE’s original collection includes standards, such as jeans and graphic Ts, as well as essentials like accessories, outerwear, footwear, basics and swimwear under its American Eagle Outfitters, American Eagle and AE brand names. The aerie collection is available in aerie stores, predominantly all American Eagle stores and at aerie.com. The collection includes bras, undies, camis, hoodies, robes, boxers, sweats, leggings, fitness apparel and personal care for the AE girl. MARTIN + OSA is a concept targeting 28 to 40 year-old women and men, which offers refined casual clothing and accessories.

Bed Bath & Beyond [BBBY: 38.45, +1.1425 (+3.06%)] Recent Price$24.00 Value Range $ 8.03 – $9.73

Bed Bath & Beyond Inc. and subsidiaries is a chain of retail stores, operating under the names Bed Bath & Beyond (BBB), Christmas Tree Shops (CTS), Harmon and Harmon Face Values (Harmon) and buybuy BABY. The Company sells a range of merchandise principally, including domestics merchandise and home furnishings as well as food, giftware, health and beauty care items and infant and toddler merchandise. In March 2007, the Company acquired buybuy BABY. In May 2008, the Company announced the formation of a joint venture with Home & More, S.A. de C.V., a privately held home products retailer operating in Mexico

Brown-Forman Corporations [[BF-B]] Recent Price $48.18 Value Range $8.17 – $10.28

Brown-Forman Corporation manufactures, bottles, imports, exports and markets a variety of alcoholic beverage brands. Its principal beverage brands are Jack Daniel’s Tennessee Whiskey, Southern Comfort, Finlandia Vodka, Herradura Tequila, Gentleman Jack, Jekel Vineyards Wines, Jack Daniel’s Single Barrel, Jack Daniel’s Ready-to-Drinks, Bel Arbor Wines, Bolla Wines, Bonterra Vineyards Wines, Old Forester Bourbon, Canadian Mist Blended Canadian Whisky, Pepe Lopez Tequilas, Chambord Liqueur, Sanctuary Wines, Don Eduardo Tequila, Sonoma-Cutrer Wines, Early Times Kentucky Whisky, Tuaca Liqueur, el Jimador Tequila, Stellar Gin, Five Rivers Wines and Woodford Reserve Bourbon. The Company’s core brand in its portfolio is Jack Daniel’s, which is a spirits brand and American whiskey brand. Its other brands are Southern Comfort and Canadian Mist. Its largest wine brands are Fetzer, Korbel and Bollab.

CLARCOR [CLC: 35.11, +0.17 (+0.49%)] Recent Price $32.82 Value Range $12.18 -$17.86

CLARCOR Inc. conducts business in three segments: Engine/Mobile Filtration, Industrial/Environmental Filtration and Packaging. The Company’s Engine/Mobile Filtration Segment sells filtration products used on engines and in mobile equipment applications, including trucks, automobiles, buses and locomotives, and marine, construction, industrial, mining and agricultural equipment.. The Company’s Industrial/Environmental Filtration Segment centers on the manufacturing and marketing of filtration products used in industrial and commercial processes and in buildings, and infrastructures of various types. The Company’s consumer and industrial packaging products business is conducted, through a wholly-owned subsidiary, J.L. Clark, Inc. (J.L. Clark). In May 2008, the Company acquired a 30% share in BioProcess H2O LLC (BPT), a Rhode Island-based manufacturer of industrial waste water and water reuse filtration systems. The Company acquired 100% of the Keddeg Company on December 29, 2008

Cree [CREE: 54.39, -0.91 (-1.65%)] Recent Price $21.84 Value Range $4.51 – $6.20

Cree, Inc. develops and manufactures semiconductor materials and devices based on silicon carbide (SiC), gallium nitride (GaN) and related compounds. The Company focuses its expertise in SiC and GaN on light emitting diodes (LEDs), which consist of LED chips, LED components and LED lighting solutions. It also develops power and radio frequency (RF) products, including power switching and RF devices. The majority of Cree, Inc. products are manufactured at its main production facility in Durham, North Carolina, in a six-part process, which includes SiC crystal growth, wafering, polishing, epitaxial deposition, fabrication and testing Additionally, it packages certain LED components and power and RF products at its North Carolina facilities, its facility in Huizhou, China and in other foreign countries through the use of subcontractors. It also operates research and development facilities in Goleta, California and Hong Kong. In February 2008, it acquired LED Lighting Fixtures, Inc.

Edwards Lifesciences [EW: 60.005, +1.065 (+1.81%)] Recent Price $61.10 Value Range $16.74 – $21.24

Edwards Lifesciences Corporation (Edwards Lifesciences) is a global player in products and technologies designed to treat cardiovascular disease. The Company focuses on specific cardiovascular opportunities, including heart valve disease, critical care technologies and peripheral vascular disease. The products and technologies provided by Edwards Lifesciences to treat cardiovascular disease are categorized into five areas: Heart Valve Therapy; Critical Care; Cardiac Surgery Systems; Vascular, and through 2007, Other Distributed Products

Interactive Data Corp [IDC: 0.00, N/A (N/A)] Recent Price$24.42 Value Range $4.90 – $6.34

Interactive Data Corporation is a global provider of financial market data, analytics and related services to financial institutions, active traders and individual investors. The Company’s customers use its offerings to support their portfolio management and valuation, research and analysis, trading, sales and marketing, and client service activities. It markets and sells its services either by direct subscriptions or through third-party business alliances. Its offerings are developed and delivered to customers through four businesses that consist of its two operating segments: Institutional Services and Active Trader Services. In May 2007, the Company completed the acquisition of the assets comprising the market data division of Xcitek LLC, as well as the market data assets of its affiliate Xcitax LLC. In August 2008, announced the closing of its acquisition of Kler’s Financial Data Service S.r.l. In December 2008, the Company acquired a 79% interest in NTT DATA Financial Corporation

ITT Educational Services [ESI: 55.72, +1.60 (+2.96%)] Recent Price $128.87 Value Range$23.33 – $33.99

ITT Educational Services, Inc. (ITT/ESI) is a provider of postsecondary degree programs in the United States based on revenue and student enrollment. As of December 31, 2007, the Company offered diploma, associate, bachelor and master degree programs to approximately 53,000 students. All of its institutes are authorized by the applicable education authorities of the states, in which they operate and recruit, and are accredited by an accrediting commission recognized by the United States Department of Education (ED). All of its programs were degree programs, except for a few diploma programs offered at six institutes that are being converted to degree programs. As of December 31, 2007, it offered 29 degree programs in various fields schools of study: information technology (IT); electronics technology; drafting and design; business; criminal justice, and health sciences. In October 2008, the Company announced that it has opened its first ITT Technical Institute in Mississippi.

Makita Corporation [MKTAY: 28.725, +0.0149 (+0.05%)] Recent Price $22.81 Value Range $1.71 – $2.00

Makita Corporation (Makita), incorporated on December 10, 1938, is principally engaged in manufacturing and sale of a range of power tools for professional users worldwide. Makita’s power tools consist of drills, grinders and sanders and portable woodworking tools, primarily saws and planers. The Company also produces gardening and household products and provides parts, repairs and accessories. During the fiscal year ended March 31, 2008 (fiscal 2008), approximately 85% of Makita’s sales were outside of Japan. The Company specializes in power tools manufacturing and sales, as a single line of business, and conducts its business globally. As of March 31, 2008, Makita had over 100 service depots outside of Japan. As of fiscal 2008, 28 of these service depots were located in the United States, and 19 of these service depots were located in China.

NIKE Incorporated [NKE: 72.89, +1.03 (+1.43%)] Recent Price $48.68 Value Range $15.83 – $21.46

NIKE, Inc. (NIKE) is engaged in the design, development and worldwide marketing of footwear, apparel, equipment, and accessory products. NIKE sells athletic footwear and athletic apparel. It sells its products to retail accounts, through NIKE-owned retail, including stores and Internet sales, and through a mix of independent distributors and licensees, in over 180 countries around the world. Its products include running, training, basketball, soccer, sport-inspired urban shoes, and childrens shoes. It also markets shoes designed for aquatic activities, baseball, bicycling, cheerleading, football, golf, lacrosse, outdoor activities, skateboarding, tennis, volleyball, walking, wrestling, and other athletic and recreational uses. On March 3, 2008, the Company acquired Umbro Ltd. (Umbro). On April 17, 2008, it completed the sale of its Bauer Hockey subsidiary.

Paychex [PAYX: 25.87, +0.37 (+1.45%)] Recent Price $26.93 Value Range$4.55 – $6.26

Paychex, Inc. (Paychex) is a provider of payroll and integrated human resource and employee benefits outsourcing solutions for small to medium-sized businesses in the United States. The Company’s Payroll and Human Resource Services product lines offer a portfolio of products and services that help clients to meet their payroll and human resource needs. Its Payroll services are provided through either its Core Payroll or Major Market Services, and include payroll processing, payroll tax administration services, employee payment services, and other payroll-related services, including regulatory compliance. Paychex’s Human Resource Services primarily include human resource outsourcing services, which include Paychex Premier Human Resources and its Professional Employer Organization; retirement services administration; workers’ compensation insurance services; health and benefits services; time and attendance solutions, and other human resource services and products.

Raytheon [RTN: 45.49, +0.43 (+0.95%)] Recent Price $47.80 Value Range 12.68 – $19.58

Raytheon Company designs, develops, manufactures, integrates, supports and provides a range of technologically advanced products, services and solutions for governmental customers in the United States and worldwide. The Company operates through six business segments: Integrated Defense Systems (IDS), Intelligence and Information Systems (IIS), Missile Systems (MS), Network Centric Systems (NCS), Space and Airborne Systems (SAS) and Technical Services (TS). During the year ended December 31, 2007, the Company completed the sale of Raytheon Aircraft Company (Raytheon Aircraft) and Flight Options LLC (Flight Options), two former operating commercial aviation businesses. In October 2007, the Company acquired Oakley Networks, Inc., a privately held technology company based in Salt Lake City, Utah, which provides cyber security and data leakage prevention systems. In April 2008, the Company acquired SI Government Solutions. In July 2008, the Company acquired Telemus Solutions, Inc

Rockwell Collins [COL: 57.00, +0.65 (+1.15%)] Recent Price $38.90 Value Range $12.94 – $15.93

Rockwell Collins, Inc. (Rockwell Collins) is a player in providing design, production and support of communications and aviation electronics for military and commercial customers worldwide. The Company’s products and systems are primarily focused on aviation applications. Its Government Systems business also offers products and systems for ground and shipboard applications. Rockwell Collins also provides a range of services and support to its customers through its network of service centers worldwide, including equipment repair and overhaul, service parts, field service engineering, training, technical information services and aftermarket used equipment sales. Rockwell Collins operates in multiple countries. Rockwell Collins serves its worldwide customer base through its Commercial Systems and Government Systems business segments. On November 24, 2008, Rockwell Collins acquired SEOS Group Limited. In April 2008, the Company completed the acquisition of Athena Technologies, Inc.

Strayer Education [STRA: 149.57, +2.65 (+1.80%)] Recent Price $222.04 Value Range $15.89 – $23.60

Strayer Education, Inc. is a post-secondary education services corporation. The Company offers academic programs through its wholly owned subsidiary, Strayer University, Inc., both in traditional classroom courses and through Strayer University Online. The Strayer University is an institution of higher learning that offers undergraduate and graduate degree programs in business administration, accounting, information technology, education, and public administration at 47 campuses in Alabama, Delaware, Florida, Georgia, Kentucky, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia, Washington, D.C., via the Internet through Strayer University Online, providing its working adult students a program offering over the Internet. It also owns Education Loan Processing, Inc. (ELP), which was organized to administer the Company’s student loan portfolio. As of December 31, 2007, the Company had more than 32,087 students enrolled in its programs.

- Ronald Sommer

Disclosure: This article was taken from the website Measured Approach with the permission of the original author.  Please refer to the original author for disclosure information. We hold a position in FRX.

SkyePharma [[SKP.L]] [[SKYEF.PK]] has a pending NDA for a new asthma drug, Flutiform, which is the Company’s most important pipeline product. On 5/22/09, SkyePharma announced that the NDA was accepted for review by the FDA and noted that the regulatory review time line for asthma treatments is typically longer than the standard 10-month PDUFA decision deadline of 1/23/10.

On 6/9/09, SkyePharma provided info on FDA communication in the form of a 74-day letter which confirmed that the NDA is sufficiently complete to permit a review. However, the FDA has given preliminary notice of potential review issues which the Company stated will likely require additional clinical work to provide more data on Flutiform dosing. The potential FDA review issues are not expected to have an impact upon the development of Flutiform for Europe or Japan.

Par Pharma [PRX: 27.13, -0.05 (-0.18%)]: On 6/10/09, MonoSol Rx, announced that the new drug application (NDA) for ondansetron orally dissolving film strip (ODFS) has been accepted for review by the FDA with an expected PDUFA action date during 1Q10. Ondansetron ODFS was developed using MonoSol Rx’s proprietary PharmFilm technology to deliver the anti-emetic therapy ondansetron in a thin film strip that rapidly dissolves on the tongue. MonoSol Rx and its partner Strativa Pharma (the proprietary products division of PRX) are seeking FDA approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

On 6/10/09, Watson Pharma [WPI: 44.48, +0.33 (+0.75%)] announced that it filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its guaifenesin/pseudoephedrine extended-release 600mg/60mg and 1200mg/120mg tablets prior to the expiration of patents owned by Reckitt Benckiser [RB: 0.00, N/A (N/A)] [RBGPF: 0.00, N/A (N/A)] for Mucinex D. Reckitt Benckiser filed suit seeking to prevent Watson from commercializing its products prior to expiration of U.S. patent numbers 6,372,252 and 6,955,821.

Reckitt’s suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson’s ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, WPI believes it is the first applicant to file an ANDA for a generic version of Mucinex D and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

NeurogesX [NGSX: 6.05, +0.09 (+1.51%)]: On 6/10/09, NGSX announced that the FDA agreed to its proposed study to evaluate Qutenza in patients with post-herpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. As part of its ongoing NDA review, the FDA wants to determine whether pretreatment with an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program. The NDA is supported by clinical studies of Qutenza which was applied after a 60-minute pre-treatment with an over-the-counter (OTC) topical anesthetic.

The study protocol involves enrolling about 20 patients with PHN to receive the Qutenza patch application after a 60-minute pretreatment with an FDA-approved topical anesthetic (2.5% lidocaine / 2.5% prilocaine). Based on the expected short-term nature of the study, NGSX believes that it could potentially complete enrollment, analyze the data, and submit an NDA amendment prior to the assigned PDUFA date. Submission of this amendment during the review cycle may result in an extension of the PDUFA date (likely to be a minor three-month delay from the current PDUFA action date of 8/16/09).

Trinity Biotech [TRIB: 5.9999, -0.0001 (-0.00%)]: On 3/10/09, TRIB provided the following update on the Company’s new haemostasis (blood clotting) analyzer, Destiny Max, which has already been launched in markets outside the US. TRIB announced the submission of a 510(k) to the FDA on 12/23/08. TRIB expects to receive clearance and launch the Destiny Max high throughput coagulation analyzer in the US market toward the end of 2Q09.

On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient’s average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.

- Mike Havrilla

Disclosure: Long TRIB. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.

BioMimetic Therapeutics [BMTI: 9.66, +0.08 (+0.84%)]: On 6/17/09, BMTI announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009 (4Q09). A modular submission breaks the PMA document into three sections or “modules” filed at different times that together become a complete application. The modular approach allows the applicant to potentially resolve any concerns noted by FDA earlier than would occur with a traditional PMA application and may ultimately shorten the review timeline.

On 5/7/09, BMTI announced that the Company completed enrollment in its Augment Bone Graft 436-patient North American pivotal clinical trial in foot and ankle fusions in December 2008 and is on track with patient follow-up. The primary endpoint is based on the fusion rate at six months as assessed on CT scans. The Company expects to release top line data from the trial in the second half of 2009 (2H09).

BioSante Pharma [BPAX: 1.39, -0.01 (-0.71%)]: On 6/17/09, BPAX announced that based upon a review of study conduct and blinded data from the LibiGel Phase 3 Cardiovascular and Breast Cancer Safety Study, the LibiGel Safety Study External Executive Committee has recommended continuation of the LibiGel Phase 3 clinical program. A very low cardiovascular event rate has occurred thus far in the clinical trials. The Executive Committee evaluated study information from over 1,000 women enrolled totaling approximately 600 women-years of exposure in the Phase 3 LibiGel safety study.

BPAX stated that its objective is to submit a NDA for FDA approval of LibiGel in late 2010 or early 2011 for the proposed treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. In addition to the Phase 3 cardiovascular and breast cancer safety study, BPAX is conducting two LibiGel Phase 3 efficacy trials. The Phase 3 efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement).

pSivida Corp. [PSDV: 3.46, 0.00 (0.00%)]: On 6/15/09, PSDV announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company’s lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye.

Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010. PSDV stated that the newly-published results support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase 2 trials are currently underway; and other degenerative conditions such as retinitis pigmentosa.

NeuroMetrix [NURO: 0.6803, -0.0497 (-6.81%)]: Status of pending 510k submissions to the FDA as of NURO’s SEC 10Q filing on 5/15/09 includes the following: The ADVANCE NCS/EMG System is a comprehensive platform for the performance of traditional nerve conduction studies and invasive electromyography procedures. The system was launched during 2Q08 and is used primarily by neurologists, physical medicine & rehabilitation physicians, hand surgeons, and other specialists.

NURO submitted a 510(k) application to the FDA on the (1) signal detector in December 2008 and filed an application on the (2) stimulator for the device in April 2009 for marketing clearance of a product designed to precisely deliver pharmacologic agents such as anesthetics and corticosteroids in close proximity to nerves for regional anesthesia, pain control, and the treatment of focal neuropathies. The FDA does not issue decision date deadlines for medical device 510(k) submissions.

NPS Pharma [NPSP: 6.65, -0.13 (-1.92%)]: On 5/5/09, NPSP provided the following update for GATTEX (teduglutide): Patient enrollment continues in STEPS, an international, double-blind, placebo-controlled Phase 3 registration study to confirm that GATTEX is well tolerated and reduces parenteral nutrition (PN) dependence in short bowel syndrome (SBS) patients. The company continues to expect the last patient to enroll in STEPS before the end of the first quarter of 2010. NPS believes positive results from STEPS will enable it to seek U.S. marketing approval for GATTEX for patients with PN-dependent SBS.

On 5/5/09, NPSP provided the following update on NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection): Enrollment is proceeding in REPLACE, a Phase 3 registration study evaluating NPSP558 for the treatment of adults with hypoparathyroidism. NPS continues to expect to complete patient enrollment before the end of the first quarter of 2010. NPS believes positive results from REPLACE will enable it to seek U.S. marketing approval for NPSP558 for patients with hypoparathyroidism.

On 3/9/09, Acrux [[ACR.AX]] [[ARUXF.PK]] announced that its Testosterone MD-Lotion development program achieves key milestone and will be commercialized as Axiron. Achieved enrollment of 150 men in a pivotal Phase 3 open-label trial as planned with trial results expected 3Q09 and a FDA submission anticipated by the Compnay during December 2009.

Javelin Pharma [JAV: 0.00, N/A (N/A)]: On 6/15/09, JAV reported results from a new Phase 1 pharmacokinetic and safety study of Dyloject in patients with mild to moderate renal (kidney) and mild hepatic (liver) impairment. Dyloject was well tolerated in these higher risk patient populations. The elimination rate of Dyloject’s active ingredient diclofenac was statistically indistinguishable in all three patient groups compared with matched healthy controls.

The Company plans to file a NDA for Dyloject with the FDA for U.S. marketing approval during the fall of 2009 at the same dose used in these studies. Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the U.S. and already marketed in the U.K. In December 2008, JAV released top-line results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness across all five primary study endpoints.

- Mike Havrilla

Disclosure: Long BDSI. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 14.96, +0.24 (+1.63%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09. In December, the FDA accepted the Company’s BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA action date by three months to 8/1/09.

BioDelivery Sciences [BDSI: 2.4501, +0.1201 (+5.15%)] has a pending Onsolis (BEMA fentanyl) NDA resubmission for the proposed treatment of breakthrough cancer pain through a small, dissolving polymer delivery system for the opiate painkiller fentanyl designed for quick absorption through the cheek. On 12/15/08, BDSI announced in a press release that the FDA requested conversion of the originally submitted risk minimization action plan (RiskMAP) to a Risk Evaluation and Mitigation Strategy (REMS) and informed the Company that all other aspects of the NDA review were complete.

Given this information, the prospects for Onsolis approval appear excellent, with an approval decision possible as early as Friday 6/12/09 or the following Monday based on a Class II (six-month) review by the agency on the resubmission of the required REMS by BDSI. In the same press release, BDSI provided guidance for expected approval of the Onsolis approval during the first half of 2009.

Earlier this year, BDSI raised $6M in cash from partner Meda AB (STO:MEDAA) ($2.3B U.S. Dollar market cap) from a $3M expanded marketing agreement (which includes all countries except Taiwan and South Korea) and a $3M advance of the $30M milestone payment triggered by FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents about 22% of the Company’s current market cap of $123M, in addition to double-digit royalties that will be received on product sales, an additional $30M possible in sales-related milestone payments, and a $5M milestone payment that is due upon EU approval/launch.

While I do not typically hold small and micro-cap bio-med stocks through binary events such as FDA decisions and clinical trial results, BDSI is an exception for me and the Company expects to generate positive operating cash flow this year if Onsolis is approved. Also, the Company is debt free with a promising mid-stage pipeline based on its drug delivery technology platform that can be funded through milestone payments and royalties from Meda AB (which expects peak sales exceeding $200M for Onsolis).

Osteotech [OSTE: 6.40, -0.01 (-0.16%)]: On 6/10/09, OSTE announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech’s proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures.

A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.

Human Genome Sciences [HGSI: 29.6861, +0.1361 (+0.46%)]: On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.

HGSI and GlaxoSmithKline [GSK: 38.84, +0.06 (+0.15%)] have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is being developed by HGSI and GSK under a co-development and commercialization agreement entered into in August 2006.

Transcept Pharma [TSPT: 7.32, -0.15 (-2.01%)]: On 6/11/09, TSPT announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09.

Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

- Mike Havrilla

Disclosure: Long BDSI. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.

A video presentation is available at ProActiveNewsRoom.com for MuGard, in addition to more information and links at the landing page for Access Pharma at the Pro-Active Global Media website. Please visit the research section of BioMedReports.com to view or download the PDF stock research report for ACCP written by Griffin Securities, in addition to the Company’s corporate presentation. Access Pharma also has a social media presence on Facebook and Twitter for investors and other interested parties to stay informed on the latest developments for the Company.

On 6/4/09, ACCP announced that new thiarabine preclinical data will be published shortly in the journal “Cancer Chemotherapy and Pharmacology” which demonstrates that thiarabine combined with clofarabine provides much greater anti-tumor activity than achieved by either agent used alone (e.g. in one colorectal cancer model, 66% of mice were cured of their tumors). The publication is based on work conducted by the Company’s collaborators at the Southern Research Institute, and the paper is entitled “Enhancement of the in vivo antitumor activity of clofarabine by 1-beta-D-[4-thio-arabinofuranosyl]-cytosine” (thiarabine).

President and CEO,  Jeffrey Davis, stated that, “Thiarabine has been in two Phase 1/2 solid tumor trials and was shown to have significant anti-tumor activity. Access is working with leukemia and lymphoma specialists at M.D. Anderson Cancer Center in Houston to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and other indications. Additionally, we are actively seeking co-development partners, and believe that thiarabine could have applications in certain solid tumors as well.”

On 6/1/09, Access provided an update on its clinical development plan for ProLindac, which is a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. The Company recently announced positive safety and efficacy results from its Phase 2 mono-therapy clinical study of ProLindac in late-stage, heavily pretreated patients with ovarian cancer. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.

ACCP has scaled-up manufacturing in order to begin the next phase of clinical development for Prolindac and the Company plans to conduct several combination trials in different solid tumor types both as Company-sponsored trials and in conjunction with its two previously announced co-development partners. Access is currently in discussion with potential North American and European partners for co-development of ProLindac while the Company is working with its existing partners in Asia to design and manage new clinical trials for the compound.

Since I first wrote about Access in early May and compared the Company to Cell Therapeutics [CTIC: 0.3802, +0.0012 (+0.32%)], the average volume and share price have made steady progress with increases of about 100% and 50%, respectively, as the small and micro-cap bio-pharma space is currently very popular with investors and traders. Even with the increase in share price, ACCP trades at a fully diluted market cap of just $48M at the closing price of $2.20 today, accounting for 11.3M shares outstanding and 10.6M shares of common stock convertible under preferred shares (even though this is not reflected by financial data providers such as Yahoo and Google Finance).

ACCP projects that it will have sufficient liquidity to fund operations at the current level (net cash burn rate for 1Q09 was $0.5M) through 1Q10 based on its current cash/equivalents ($2.2M at the end of 1Q09) and expected upfront, royalty, and milestone payments. At the end of 1Q09, ACCP we had convertible note outstanding in the principle amount of $5.5M that is due 9/13/11. During 2H09, Access plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail, Pexiganan), which could provide additional upside catalysts for the stock price and cash to fund the continued development of the Company’s pipeline.

- Mike Havrilla

Disclosure: Long ACCP. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.

Nephros [NEPH: 0.00, N/A (N/A)] has surged by over five-fold in just two weeks from 14 cents to 82 cents from the time of my initial article on extreme FDA trades on pending medical device decisions. NEPH.OB still has three separate FDA 510(k) applications pending at the agency, which are outlined below.

The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for End-Stage Renal Disease (ESRD) patients while addressing the critical financial and clinical needs of the care provider. The HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, according to the Company. On 11/14/08, Nephros submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA has requested additional information. Nephros replied to the FDA inquiries on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company for an estimated decision date of Friday 6/12/09 or Monday 6/15/09.

On 10/7/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (DSU filters) to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA requested additional information, and Nephros provided a formal response to the agency on 2/24/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided (5/26/09), but a response from the agency is still pending.

Bovie Medical [BVX: 2.12, 0.00 (0.00%)] currently has two pending medical device applications at the FDA, and the Company is working toward two additional 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology. While the two pending medical device applications outlined below do not have firm decision dates, my estimate for a possible FDA decision is currently some time during 3Q-4Q09 based on the review cycle for the Company’s previous medical device filings.

On 3/3/09, BVX announced the filing of a 510(k) pre-market notification application (PMA) for regulatory clearance of its ICON GS electrosurgical generator and handpiece (J-Plasma system). The technology utilizes a gas ionization process producing a stable thin focused beam of ionized gas that can be controlled in a wide range of temperatures and intensities for greater surgical precision which is minimally invasive.

On 5/19/09, BVX announced a 510(k) submission to the FDA seeking pre-market clearance for a laparoscopic SEER device for solid organ resection. The laparoscopic SEER is a line extension of the Saline Enhance Electrosurgical Resection (SEER) device that Bovie launched earlier this year and will address the growing market of minimally invasive liver resection. The laparoscopic SEER allows the surgeon to dissect and achieve hemostasis with a single device resulting in less instrument utilization and fewer instrument changes in a minimally invasive approach.

Nanosphere [NSPH: 3.10, +0.06 (+1.97%)] has three 510(k) applications pending at the FDA with estimated decisions during 2H09, including diagnostic assays for cystic fibrosis and hemochromatosis (a disorder in which excessive amounts of iron are absorbed and accumulate in the body in tissues and organs such as the heart and liver), along with a second generation version of its Verigene System that incorporates automated sample processing.

In March 2009, BioForm Medical [BFRM: 0.00, N/A (N/A)] announced the results of a clinical trial evaluating the mixing of lidocaine with RADIESSE dermal filler, which demonstrated an approximate 60% reduction of pain when RADIESSE dermal filler was mixed with lidocaine, and comparable safety and effectiveness of mixed and non-mixed RADIESSE dermal filler. The results were submitted to the FDA under a PMA supplement with an estimated decision during 3Q-4Q09 since the FDA does not issue decision date deadlines for medical device filings.

On 5/26/09, iCAD Inc. [ICAD: 1.66, -0.03 (-1.78%)] announced that it submitted data to the FDA seeking 510(k) marketing clearance of its VeraLook computer-aided detection (CAD) technology for CT colonography (CTC), or “virtual” colonoscopy. iCAD’s VeraLook product uses advanced algorithms to detect and highlight potential polyps warranting closer review by a radiologist. VeraLook has the potential to reduce oversight errors that could occur during review of a virtual colonoscopy exam, due to the large number of images (approximately 1500) generated by the CT system.

On 6/4/09, Electro-Optical Sciences [MELA: 6.97, -0.25 (-3.46%)] announced the submission to the FDA of its Premarket Approval (PMA) application for MelaFind, a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma. Positive top line data from the MelaFind pivotal study, the largest prospective clinical study ever conducted in melanoma detection, were announced in February 2009 and subsequently presented at several major international dermatology meetings in March and May. The Company’s final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% (lower confidence bound) and MelaFind specificity was statistically significantly higher than that of study clinicians.

During 1Q09, Cardium [CXM: 0.4613, -0.0087 (-1.85%)] submitted an application for FDA 510(k) clearance of the UroCool pelvic cooling catheter system. Cardium intends to advance InnerCool’s therapeutic cooling and warming products into corresponding markets through the strategic sale of the business to a large and diversified medical device company or through various vertical partnering opportunities with established companies having existing sales and marketing organizations but with a continuing need for innovative, high-value content products.

- Mike Havrilla

Disclosure: None. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.

The depressed Medical Equipment and Supplies industry has faced many headwinds recently. The recession has directly caused a general slowdown in elective procedures coupled with ongoing reductions in hospital capital expenditures. The Department of Justice in the last year has brought many lawsuits to the companies mentioned above and the FDA has increased inspections of manufacturing facilities because of safety concerns. Similarly, another headwind they face is the increasing value of the dollar. The bottom lines of these companies have been adversely affected since a large portion of the industry derives revenues outside of the United States.

When the market does rebound, you should position your portfolio properly to capture the upside, but you must be proactive in doing so. I feel that Stryker Corp. is the best holding within this space to capture this aforementioned upside. In order for a company to be well positioned for an economic recovery and even to weather the current market turbulence, it must have a strong balance sheet since “cash is king” in the current credit environments. Stryker is known year after year for having one of the better balance sheets in the industry. Currently, its total cash and marketable securities stand at $2.2 billion with no total debt . In addition, let’s not forget to mention that free cash flow was up 51% from $160.0 million to $242.0 million in the most recent quarter.

Stryker, once known for consistent double digit growth, operates in two segments: Orthopaedic Implants and MedSurg Equipment. The Orthopaedic Implants segment represented 61% of sales in the last quarter while the MedSurg Equipment segment totaled 39% of total sales. Within the Ortho Segment, Stryker is well known for its well constructed hip, knee, and spine business. These segments have caused headaches for the long-term Stryker investor last year due to the elective nature of these procedures. On the flip side of the business, 60% of sales within the MedSurg segment come from capital equipment, which obviously is seeing a slowdown from decreasing hospital expenditures.

These two issues are ripe for the picking once we see a recovery, since hospitals will start to increase capital spending once admissions pick up. When we see a stabilization or a slight decrease in unemployment, the consumer will be able to get enough insurance coverage to help pay for these elective procedures that they have put off. With a strong balance sheet, successful business model, and effective management, Stryker Corp. is where your money should be when the economy recovers.

The rest of this free research report “Stocks For An Economic Recovery” which includes commentary on all sectors is available for download at the following link.

- Ryan Savitz

Disclosure: The fund the author manages is long TEVA.

1.) Angiotech Pharma [ANPI: 0.4301, +0.008 (+1.90%)] – currently trading at $2.14, market cap = $182 million

ANPI has an FDA-approved dialysis catheter (HemoStream) that is sold through its direct sales force. The Company has identified 5-Fluorouracil (”5-FU”), a drug previously approved by the FDA for treatment of various types of cancer, as a compound that may help to prevent certain types of infection in patients receiving selected types of implantable devices, including certain dialysis catheters. ANPI is currently developing this 5-FU anti-infective technology for its HemoStream dialysis catheter line, and expects to file for a 510(k) clearance to market this product candidate in the U.S. during 2009.

On 5/8/09, ANPI provided an update in its SEC 10Q filing for the Zilver PTX paclitaxel-eluting peripheral vascular stent, which is currently being evaluated in multiple clinical trials by partner Cook Medical, Inc. as a specialized stent product incorporating Angiotech’s proprietary paclitaxel technology that is designed for placement in diseased arteries in the limbs to restore blood flow. In July 2007, Cook announced that the first U.S. patients in a randomized pivotal human clinical trial of Zilver PTX were treated in a study that is designed to randomize patients to receive either the Zilver PTX stent or balloon angioplasty. Data from this clinical trial is intended to be used to support submission to the FDA for approval in the U.S. to market the device.

In September 2008, Cook announced it had completed enrollment in its pivotal human clinical trial for the Zilver PTX. The 420 patients enrolled in Cook’s randomized trial include peripheral artery disease patients treated in Germany, the U.S., and Japan. On the same date, Cook announced that it had enrolled an additional 780 patients in the E.U, Canada, and Korea in a clinical registry to evaluate the safety of the Zilver PTX device. Those data have been used for submission in Europe for CE Mark approval to market the device in the E.U. while a submission with the FDA is pending.

On 3/9/09, ANPI presented complete data for the Bio-Seal study at the 2009 Society of Interventional Radiology in San Diego, CA. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). Based on info in the Company’s 10Q filing on 5/8/09, data from this clinical trial study has been submitted to the FDA, which has responded to the submission with additional questions about the study.

ANPI has responded to the FDA and upon further review by the agency, ANPI may either receive 510(k) clearance to market Bio-Seal in the U.S. or be required to respond to additional questions or conduct additional clinical studies. The product has already received CE Mark approval for marketing in Europe. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture.

2.) Acadia Pharma [ACAD: 1.038, +0.018 (+1.76%)] – currently trading at $2.32, market cap = $86 million

On 5/11/09, ACAD provided the following update along with its quarterly financial results: Enrollment was completed in the Company’s first pivotal Phase 3 trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.

3.) Repros Therapeutics [RPRX: 0.599, +0.089 (+17.45%)] – currently trading at $7.41, market cap = $112 million

On 5/11/09, RPRX reported that its Proellex clinical programs are progressing well and according to plan. RPRX completed enrollment of its first Pivotal Phase 3 clinical trial (ZPU-303) for the chronic treatment of uterine fibroids and expect the first Pivotal Phase 3 clinical trial for the treatment of anemia associated with uterine fibroids (ZPU-301), to be fully enrolled mid-2009, which would then lead to top-line results in each study by the end of this year. RPRX expects top-line results from its other two complementary Pivotal Phase 3 studies, ZPU-302 (anemia) and ZPU-304 (chronic symptoms), during Q1 of 2010 (1Q10).

The two New Drug Applications (NDA) for anemia associated with uterine fibroids and chronic symptoms of uterine fibroids are scheduled to be submitted to the FDA during the second half of 2010 (2H10). The endometriosis program for Proellex has reached the end of Phase 2, and it is Company’s intent to discuss the results of study ZPE-201 with the FDA during an End-of-Phase II Meeting, mid-2009. Taking the feedback and input from the FDA into account, RPRX will then initiate two well-controlled Pivotal Phase 3 studies for the endometriosis indication during the second half of this year.

4.) Santarus, Inc. [SNTS: 2.24, -0.05 (-2.18%)] – currently trading at $2.32, market cap = $134 million

On 6/9/09, SNTS announced that Schering-Plough [SGP: 28.15, 0.00 (0.00%)] HealthCare Products, Inc. has submitted its response to the FDA complete response letter (CRL) for an over-the-counter (OTC) Zegerid branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough received the complete response letter in January 2009 for its New Drug Application (NDA) seeking approval to sell Zegerid in the U.S. OTC heartburn market. The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ proprietary technology. If Schering-Plough receives FDA approval of its NDA for an OTC Zegerid product, SNTS will earn a $20 million regulatory milestone.

5.) BioSpecifics Technologies [BSTC: 25.725, -0.725 (-2.74%)] – currently trading at $19.85, market cap = $119 million

On 4/28/09, the FDA accepted for priority review (six-month) Auxilium’s [AUXL: 27.76, +1.14 (+4.28%)] BLA for Xiaflex (clostridial collagenase for injection) for the treatment of Dupuytren’s contracture. AUXL filed the BLA on 2/27/09 and included data from 1,082 subjects and over 2,600 injections. The PDUFA decision date is 8/28/09 for the Xiaflex BLA. If approved by the FDA, AUXL plans to launch Xiaflex in the U.S. within 60 days during 2H09.

On 2/2/09, AUXL announced the completion of enrollment in a randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial for Xiaflex for Peyronie’s disease. Over 120 patients were enrolled and all dosing was completed on 4/30/09 with top-line results from the study expected during 4Q09 based on Auxilium’s guidance provided along with quarterly results on 5/6/09.

On 2/3/09, BSTC received $6.375 million of the $75 million upfront payment paid to AUXL by Pfizer [PFE: 16.3875, +0.1075 (+0.66%)] and will receive 8.5% of the $410 million in potential additional milestone payments that may be made by PFE to AUXL. Of these additional milestone payments, $150 million are tied to regulatory milestones and $260 million are based on sales milestones. In addition, BSTC will continue to receive milestone and royalty payments from AUXL in accordance with its original agreement.

- Mike Havrilla

Disclosure: None. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.

On 6/8/09, NeuroSearch announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as a novel treatment for obesity (weight management). The FDA endorses the overall Phase 3 plan for tesofensine in obesity, including the filing of an NDA based on 12 months safety and efficacy data. NeuroSearch will now finalize Phase 3 preparations and an SPA (Special Protocol Assessment) request for submission to the FDA, while continuing discussions with potential license partners.

The main conclusions from the End of Phase II discussions with the FDA include the following: (1) The proposed dose regimen of 0.25 mg or 0.5 mg tesofensine daily in Phase III was endorsed. (2) The proposed pivotal Phase 3 program for tesofensine in weight management was endorsed by the FDA and will consist of four placebo-controlled clinical studies, comprising a total of approximately 5,700 obese patients with and without co-morbidities (such as Type 2 diabetes, hypertension and dislipidemia). (3) Two of the four trials are powered to show superior weight loss effectiveness for tesofensine compared to sibutramine (marketed as Reductil and Meridia). (4) The safety and efficacy assessment within and across the Phase 3 studies and the filing of the NDA for tesofensine for weight management based on 12 months data were also endorsed by the FDA.

Earlier results from a Phase II Proof of Concept study with tesofensine in obesity, TIPO-1, has shown a placebo-corrected average weight loss of approximately 10% after 24 weeks of daily treatment with 0.5 mg tesofensine. The results from TIPO-1 have been published in The Lancet (The Lancet, Volume 372, Issue 9653, Pages 1906-1913, 29 November 2008) with the conclusion that tesofensine produces a weight loss at least twice that of currently approved anti-obesity drugs. The safety data base for tesofensine includes more than 1,500 patients having been exposed to treatment with tesofensine and hereof more than 1,300 on relevant dosing.

- Mike Havrilla

Disclosure: None. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.