MRSA related Press Releases

Usage of Zyvox Has Flattened or Declined in the Major European Markets While Uptake of Cubicin and Tygacil Has Climbed Yea

Thu, 15 Dec 2011 12:21:26 -0500

MRSA Infections are a Key Driver of Zyvox and Cubicin Usage, According to New Report from Arlington Medical Resources

EXTON, Pa.--(BUSINESS WIRE)-- Arlington Medical Resources (AMR), a provider of premier market intelligence for the pharmaceutical and diagnostic imaging industries, reports that in Europe, Pfizer’s Zyvox is the most frequently prescribed branded product to patients with methicillin-resistant Staphylococcus aureus (MRSA) infections, excluding Italy where Cubist/Novartis’s Cubicin is the leading branded MRSA therapy. However, use of Zyvox has flattened or declined in the EU5 (France, Italy, Germany, Spain, United Kingdom), while uptake of Cubicin and Pfizer’s Tygacil has steadily increased in the last five years.

AMR’s soon-to-publish report entitled Hospital Insight Series: MRSA Infections (Europe) also finds that MRSA infections are a key driver of Zyvox and Cubicin usage as evidenced by data showing that approximately one-third of hospital use of these drugs is attributable to the treatment of patients with a confirmed MRSA infection.

The report findings reveal that 40 percent of physicians in the EU5 indicate they are using increasingly higher doses of vancomycin to treat MRSA infections; ID specialists most often cite decreased susceptibility to vancomycin and the need to effectively manage complicated and difficult-to-treat infections as the main reasons to “push” dosing of vancomycin. Together with the need to monitor vancomycin drug levels, a physician-reported weakness of vancomycin, these perceived shortcomings of vancomycin drive the uptake of alternative therapies in Europe. The analysis finds that Zyvox tends to be the preferred alternative therapy for MRSA patients with hospital-acquired pneumonia or complicated skin and skin structure infections (cSSSIs) who are not successfully treated with vancomycin while Cubicin is the vancomycin alternative in patients with MRSA bacteremia.

“ID specialists are continuing to rely heavily on Zyvox and Cubicin in MRSA patients, particularly those with cSSSIs, while many physicians report that they are beginning to decrease their use of vancomycin for this and other infections,” said Dr. Perez-Cheeks. “In addition, increased physician comfort with Zyvox and Cubicin along with the addition of these drugs to hospital MRSA guidelines are key reasons clinicians have increased usage of these products in the last year.”

Physician awareness of emerging therapies including Theravance/Astellas’s telavancin, Forest/AstraZeneca’s ceftaroline, Durata’s dalbavancin, Nabriva’s BC-3781 and Trius/Bayer’s torezolid (tedizolid) varies widely with few physicians citing awareness of BC-3781 and torezolid. Of these new therapies, telavancin is the furthest along in development in Europe. However, despite the availability of telavancin in the United States since 2009, its recent EMA approval and a continuous stream of data publications, only half of EU5 infectious disease specialists indicate being aware of the drug.

“Among European infectious disease specialists who are aware of telavancin, there is concern across the board about its potential to cause or exacerbate renal impairment,” said Dr. Perez-Cheeks. “Requisite monitoring of telavancin-treated patients for impaired kidney function will likely be a barrier to uptake of the drug.”

About AMR

AMR (www.AMR-data.com) serves the market intelligence needs of the pharmaceutical and diagnostic imaging industries. Research includes clinical inpatient databases that directly link anti-infective drug with indication/procedure, formulary and stocking status tracking studies, drug purchasing audits and diagnostic imaging procedure volume/contrast media usage audits. AMR is a Decision Resources Group company.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

CONTACT:

Decision Resources
Lisa Osgood, 781-993-2606
losgood@dresources.com
or
Decision Resources Group
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

MEDIA:

Logo

Fujifilm Diosynth Biotechnologies and ContraFect Corporation Announce Development and Manufacturing Collaboration for Nove

Tue, 25 Oct 2011 10:21:30 -0400

Fujifilm Diosynth Biotechnologies and ContraFect Corporation announced today that they have signed a contract to support the process development and cGMP manufacture of CF-301, ContraFect’s Staphylococcal-specific bacteriophage lysin

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Fujifilm Diosynth Biotechnologies and ContraFect Corporation announced today that they have signed a contract to support the process development and cGMP manufacture of CF-301, ContraFect’s Staphylococcal-specific bacteriophage lysin. CF-301 is ContraFect’s lead compound and displays potent activity against all forms of Staph infections, including methicillin-resistant (MRSA) and vancomycin-resistant strains (VISA/VRSA).

The initial part of the program will utilize Fujifilm Diosynth Biotechnologies’ pAVEway™ advanced protein expression technology to establish a high productivity process. The pAVEway™ technology is a platform based on a unique set of protein expression plasmids that can incorporate a range of vectors developed by Fujifilm Diosynth Biotechnologies using DNA looping to tightly control protein production at high and reproducible expression levels. The program will be executed at Fujifilm Diosynth Biotechnologies site in Billingham, United Kingdom.

Founded in 2008 by Dr. Robert Nowinski, who serves today as the company’s Chief Executive Officer and Chairman of the Board, ContraFect is a biotechnology company pioneering the use of lysins to treat life-threatening infectious diseases. “CF-301 is a protein that differs from antibiotics and is effective against all current and potential drug-resistant Staph infections,” remarked Dr. Nowinski. “ContraFect has now completed its laboratory research on CF-301 and has moved to pre-clinical development with an eye towards its IND submission in Q2 2012 and our first in man clinical trials later that year.”

Fujifilm Diosynth Biotechnologies brings to the development of CF-301 over 25 years of biopharmaceutical contract development and manufacturing experience with over 150 projects, including commercial manufacturing of four licensed products. “We are delighted to be selected by ContraFect for development of CF-301,” said Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies UK business. “By combining the application of our pAVEway™ expression technology with our extensive knowledge and experience, we are well positioned to have a long and successful partnership between our companies. This partnership with ContraFect is very much in line with our goal to be a solutions provider to our clients.”

“ContraFect Corporation is very pleased to work with Fujifilm Diosynth Biotechnologies to bring CF-301 through clinical development and to the market,” said Dan Couto, ContraFect’s Vice President of Product Development. “Fujifilm Diosynth Biotechnologies’ vast experience with microbial production and large scale integration mitigates many typical risks in CMC biologics development, thus assuring material supply to our patients for this unmet medical need.”

About Fujifilm Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is an industry-leading Biologics Contract Development and Manufacturing Organization. Fujifilm Diosynth has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems. The company offers a comprehensive list of services from cell line development, including its proprietary pAVEway™ system, to process development, analytical development, clinical and commercial manufacturing. Fujifilm Diosynth Biotechnologies is also located in Billingham, UK as FUJIFILM Diosynth Biotechnologies UK Limited. Both sites have been FDA-approved for the production of commercial products. For more information, please visit: www.fujifilmdiosynth.com.

FUJIFILM Holdings Corporation, Tokyo, Japan, brings continuous innovation and leading-edge products to a broad spectrum of industries, including electronic imaging, digital printing equipment, medical systems, life sciences, graphic arts, flat panel display materials, and office products, based on a vast portfolio of digital, optical, fine chemical and thin film coating technologies. The company was among the top 16 companies around the world granted U.S. patents in 2010, and in the year ended March 31, 2011, had global revenues of $25.8 billion*. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.

*at an exchange rate of 86 yen to the dollar.

About ContraFect Corporation

ContraFect Corporation is a biotechnology company pioneering the use of monoclonal antibodies and lysins to treat life-threatening infectious diseases. ContraFect's initial products include agents to treat diseases such as MRSA (drug resistant staphylococcus bacteria), other serious bacterial infections, and influenza.

ContraFect’s scientific approach is based on the following principles:

Monoclonal antibodies for the treatment of life threatening bacterial and viral diseases
Lysins for the treatment of drug-resistant gram positive bacteria, such as staphylococcus (MRSA), streptococcus and intestinal infections
Transition from conventional monotherapy to a combinatorial approach using multi-therapy antibody and Lysin treatments
Address the growing challenge of drug-resistance and therapy escape mechanisms used by pathogens

All product and company names herein may be trademarks of their registered owners.

CONTACT:

Fujifilm Diosynth Biotechnologies
Bridget Hall, +44 (0)1642 367320
bridget.hall@fujifilmdb.com
or
Anitra B. Johnson, 919-337-4409
Anitra.johnson@fujifilmdb.com
or
ContraFect Corporation
Barry Kappel, Ph.D., MBA
VP Business Development
914-207-2300
bkappel@contrafect.com

KEYWORDS: United Kingdom United States Europe North America North Carolina

INDUSTRY KEYWORDS: Health Biotechnology Genetics Hospitals Pharmaceutical Other Health Manufacturing Other Manufacturing

MEDIA:

Logo

Roche Diagnostics Supports Fight Against MRSA as a Sponsor of Annual World MRSA Day on October 1

Wed, 28 Sep 2011 11:20:48 -0400

Third annual event held to pay tribute to patients and families, issue call-to-action to eradicate healthcare-associated infection epidemic

INDIANAPOLIS, Sept. 28, 2011 /PRNewswire/ -- As part of its ongoing work in the prevention and control of serious infections in healthcare settings, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today its sponsorship of the 3rd Annual World MRSA Day. The kick-off event and global MRSA summit will be held on October 1, 2011, at Loyola University Stritch School of Medicine in Maywood, Ill.

Organized by the MRSA Survivors Network, World MRSA Day highlights the importance of a comprehensive approach to controlling MRSA (methicillin-resistant Staphylococcus aureus), a type of bacterium that is resistant to common antibiotics and can cause serious infections. High rates of infection and mortality and high costs of treatment due to healthcare-associated infections (HAIs) caused by MRSA are a critical issue for healthcare facilities worldwide. The goal for the event is to raise widespread awareness of the need for greater MRSA prevention, screening, treatment and education.

"Roche applauds the MRSA Survivors Network for bringing this important issue to the forefront and we are honored to be a sponsor of World MRSA Day," said Jack Phillips, president and CEO of Roche Diagnostics Corporation. "Healthcare-associated infections caused by MRSA are preventable, and we believe that more education, together with effective screening and infection control programs, can significantly reduce the spread of MRSA and its consequences."

The kick-off event, which features MRSA expert and former CDC scientist William R. Jarvis, M.D., as keynote speaker, will be broadcast live via web stream starting at 10:30 a.m. central time on Oct. 1 and can be viewed at www.worldmrsaday.org and www.MRSAsurvivors.org.

About HAIs and MRSA screening

Healthcare-associated infections (HAIs) caused by MRSA are a tremendous burden for healthcare systems and hospitals and are associated with significant healthcare costs. The Centers for Disease Control and Prevention (CDC) has estimated that approximately 18,000 persons die of invasive MRSA HAIs in U.S. healthcare facilities annually – more than from HIV/AIDS – underscoring the need for comprehensive infection control programs, along with more rapid and reliable MRSA screening methods. In response to this public health issue, an increasing number of states have passed legislation requiring mandatory reporting and/or screening for HAIs.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.

All trademarks used or mentioned in this release are protected by law.

For further information, please contact:
Betsy Cox
Director, Corporate Communications
Roche Diagnostics Corporation
Indianapolis, IN
(317) 521-3911
betsy.cox@roche.com

SOURCE Roche Diagnostics

PURE Bioscience Presents PURE Hard Surface at American Correctional Association’s Annual Congress

Mon, 08 Aug 2011 07:22:29 -0400

SDC-Based Disinfectant and Sanitizer Kills Bacteria and Viruses in 30 Seconds; Effective against MRSA and NDM-1 Positive Bacteria

SAN DIEGO--(BUSINESS WIRE)-- PURE Bioscience, Inc. (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, is exhibiting its PURE™ Hard Surface disinfectant and food contact surface sanitizer at the American Correctional Association (ACA) 141^st Congress of Correction in Kissimmee, Florida from August 5 – 10. The ACA is the oldest corrections association and represents more than 20,000 active professional members. The ACA’s annual Congress of Correction is the largest gathering of corrections personnel in the U.S.

PURE recently announced a major amendment to its PURE Hard Surface label, which added additional pathogens, including Hepatitis B, Hepatitis C and multiple Carbapenem-resistant bacteria as well as reduced virus kill times to as quickly as 30 seconds. The independent studies supporting the EPA registration show that PURE Hard Surface offers unparalleled efficacy against dangerous and resistant pathogens while remaining an EPA Category IV (least toxic) product. In addition, its odorless and non-flammable formula makes PURE Hard Surface ideal for use in the communal settings of correctional facilities, along with the recently introduced low-foam PURE Commercial Floor Cleaner concentrate made with environmentally preferred surfactants.

“Studies have indicated that transmission prevention in closed settings is difficult, time consuming and expensive,” said Jeff Donnell, Vice President, Business Development, for PURE Bioscience. “We’re excited to present to ACA members the convenience, cost- and life-saving benefits of integrating PURE Hard Surface into both routine and critical cleaning protocols, and appreciate the opportunity to broaden awareness of PURE Hard Surface to federal, state and local corrections professionals and administrators, as well as to corrections healthcare professionals.”

“Our recent EPA registration of expanded claims for PURE Hard Surface elevates it far above the competition as the responsible choice for law enforcement and corrections officials tasked with controlling dangerous outbreaks of Staph and other resistant bacteria throughout institutional populations and among employees,” added Donnell.

PURE Bioscience’s long-term case study with the Tulsa County jail demonstrates the power of its product to control the spread of disease. More than five years have passed since the implementation of PURE’s product into cleaning and maintenance protocols, and outbreaks of Staph and resistant Staph have been eliminated from the Tulsa facility. PURE’s SDC-based disinfectant is also being used by the Palm Beach County Sheriff’s office.

PURE recently exhibited at the 71^st Annual National Sheriffs’ Association Conference and Exhibition in St. Louis, Missouri.

About PURE Hard Surface

U.S. EPA-registered PURE Hard Surface disinfectant and food contact surface sanitizer provides an unparalleled combination of high efficacy and low toxicity with 30-second bacterial and viral kill times and 24-hour residual protection. PURE Hard Surface completely kills resistant pathogens like MRSA and Carbapenem-resistant Klebsiella pneumoniae (NDM-1) and also effectively eliminates dangerous fungi and viruses including HIV, Hepatitis B, Hepatitis C, Norovirus, Influenza A, Avian Influenza and H1N1 as well as hazardous food pathogens such as E. coli, Salmonella and Campylobacter. PURE Hard Surface delivers powerful broad-spectrum efficacy while remaining classified as least-toxic (Category IV) by the US EPA, and its active ingredient, SDC, has been determined Generally Recognized as Safe (GRAS) for use as a biocide on food processing equipment, machinery and utensils.

About PURE Bioscience, Inc.

PURE Bioscience, Inc. develops and markets technology-based bioscience products that provide solutions to numerous global health challenges, including Staph (MRSA). PURE’s proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate-based antimicrobials, represent innovative advances in diverse markets and lead today’s global trend toward industry and consumer use of “green” products while providing competitive advantages in efficacy and safety. Patented SDC is an electrolytically generated source of stabilized ionic silver, which formulates well with other compounds. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it. PURE is headquartered in El Cajon, California (San Diego metropolitan area). Additional information on PURE is available at www.purebio.com.

This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project,” "expect" or similar expressions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s cash position and liquidity requirements, acceptance of the Company's current and future products and services in the marketplace, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

CONTACT:

PURE Bioscience Investor Contact:
Lippert/Heilshorn & Associates
Don Markley, Senior Vice President
310-691-7100
dmarkley@lhai.com
or
PURE Bioscience Media Contact:
Gutenberg Communications
Michael Gallo, 212-239-8594
mgallo@gutenbergpr.com

KEYWORDS: United States North America California Florida Missouri

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Other Health Manufacturing Chemicals/Plastics Environment

MEDIA:

Excelimmune Completes $10.5 Million Series B Financing

Tue, 31 May 2011 08:23:02 -0400

WOBURN, Mass.--(BUSINESS WIRE)-- Excelimmune, Inc. today announced the final closing of a $10.5 million Series B financing. Proceeds from the Series B will enable Excelimmune to advance Staphguard, a human recombinant polyclonal antibody (HRPA) candidate against methicillin-resistant Staphylococcus aureus (MRSA), toward the clinic, enhance the Company’s discovery platform and complete proof-of-principle for its manufacturing systems. The Series B funding was provided by a syndicate of new and existing high net worth individual investors.

“The continued support from investors underscores the significant potential of our unique HRPA approach to treating nosocomial infectious disease,” said Quinton Zondervan, Chief Executive Officer of Excelimmune. “In addition to doubling Excelimmune’s size over the past year, this funding provides us with the capital required to enter the next stage of our product and technology development.”

“Excelimmune has attracted significant interest from potential partners,” added Joy Barton, who heads business development at Excelimmune. “We believe collaborating with industry partners will enable us to expand the application of our HRPA technology beyond infection into new therapeutic areas.”

Excelimmune presented positive results from a preclinical study at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). In the study, at a MRSA dose 100 percent lethal in the control group, the group treated with Staphguard experienced 100 percent survival.

“With complete survival achieved at an antibody concentration far lower than typically required for monoclonal antibodies, the Staphguard preclinical study establishes proof-of-principle of Excelimmune’s polyclonal approach,” said Vincent Coljee, Ph.D., Chief Scientific Officer at Excelimmune. “We believe this approach is particularly well suited to addressing complex antigens such as those expressed by bacteria and other infectious agents.”

About Human Recombinant Polyclonal Antibodies

Human recombinant polyclonal antibodies are mixed populations of therapeutic antibodies that bind to multiple regions (epitopes) on a specific antigen or to multiple antigens (of bacteria, viruses and other microorganisms), in contrast to monoclonal antibodies, which only bind to one specific epitope. By binding to multiple regions, the polyclonal antibodies allow the body to fight off illness more readily. The antibodies are cloned from naturally occurring human antibodies in a laboratory and are then manufactured for human medical use.

About Excelimmune

Excelimmune, Inc. is a biopharmaceutical company specializing in the development of recombinant polyclonal antibodies to create novel therapies for treating disease in humans. Excelimmune’s antibody therapies harness the diversity and effectiveness of the human body’s adaptive immune system. The company is initially focusing on the treatment of infections caused by Staphylococcus aureus, including the drug resistant superbug, MRSA. This next generation technology is also believed to be applicable in the treatment of other pathogenic bacteria and viruses, disease causing proteins, and cancer. Excelimmune, founded in 2006, is a private company located in Woburn, Mass. www.excelimmune.com.

CONTACT:

Excelimmune:
Quinton Zondervan, 617-497-4303 x10
CEO
or
Media:
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Pharmaceutical

MEDIA:

Logo

Furiex Acquires Full Exclusive License Rights to Develop and Commercialize JNJ-Q2 (fluoroquinolone)

Tue, 19 Apr 2011 09:26:49 -0400

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) announced today that it has acquired full exclusive license rights to develop and commercialize the compound JNJ-Q2 under its existing development and license agreement with Janssen Pharmaceutica N.V. (Janssen). Furiex acquired these rights as a result of Janssen’s decision not to exercise its option under the agreement that gave Janssen the opportunity to continue development of JNJ-Q2.

JNJ-Q2 is a novel broad-spectrum fluoroquinolone antibiotic. Furiex has completed a successful Phase II study for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is currently conducting a Phase II study in patients with community acquired bacterial pneumonia (CABP). Furiex intends to progress development of JNJ-Q2 based on positive results from the completed Phase II ABSSSI study, which were announced in November 2010. Furiex may owe payments to Janssen based on future regulatory milestones and, if the product is approved, sales milestones and royalties.

A description of Janssen’s research and development approach, recently posted on the company’s website, indicates that, after a broad strategic review of its portfolio in infectious diseases, Janssen will direct its R&D investments toward antivirals and vaccines, and will not be investing in the development of new antibacterial therapies at this time. “Our work with Janssen has enabled us to position JNJ-Q2 for a successful Phase III development program. We are confident in both the clinical data and the market opportunity for JNJ-Q2 and are energized by the opportunity that has been created by Furiex’s acquisition of rights to the product,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “JNJ-Q2 has the potential to be an important treatment for skin infections, which commonly involve methicillin resistant Staphylococcus (“Staph”) aureus (MRSA), and for which there are limited treatments with both intravenous and oral formulations. When patients with serious infections present to clinics or hospitals, it generally takes days to identify the causative pathogen. For this reason, we believe JNJ-Q2, which reliably covers a large spectrum of pathogens, including bacteria with emerging resistance, is a very attractive development candidate for the growing skin and pneumonia markets.”

“Furiex plans to evaluate strategic partnering and financing options to fund the initiation and completion of Phase III clinical trials for JNJ-Q2,” said Fred Eshelman, Pharm.D., chairman of Furiex. “Acquiring rights to JNJ-Q2 allows us to focus on Phase III development for the ABSSSI indication. We plan to move forward with the ABSSSI indication ahead of the CABP indication. We believe that staggering these programs will enable the product to get to market sooner. To this end, Furiex is planning an End of Phase II meeting with the FDA this year to begin the transition process to Phase III development for ABSSSI. We look forward to advancing the development of JNJ-Q2 and providing further details regarding this program as it progresses.”

About JNJ-Q2

JNJ-Q2 is a Phase III-ready investigational novel fluoroquinolone antibiotic that has been shown to be effective in a Phase II study of acute bacterial and skin and skin structure infections (ABSSSI). In this study, JNJ-Q2 demonstrated favorable efficacy for both early clinical response endpoints (based on the new FDA guidance) as well as all clinical cure endpoints for the intent to treat population. JNJ-Q2 has a low propensity for development of drug resistance and exhibits a broad range of antibacterial activities in vitro: these include methicillin resistant Staph aureus (MRSA), fluoroquinolone-resistant Staph aureus, Streptococcus pneumoniae (including multi-drug resistant strains), gram positive, gram negative, atypical respiratory pathogens (such as legionella and mycoplasma), and anaerobic bacteria, which are associated with abscesses of skin and other organs. Because of emerging resistance to currently marketed antibiotics, there is a large and growing unmet need for antibiotics such as JNJ-Q2, which can treat a broad range of bacterial pathogens. The availability of IV and oral formulations for JNJ-Q2 differentiates it from a number of other products for MRSA infections, which require intravenous administration. JNJ-Q2 is also in Phase II development for community acquired bacterial pneumonia.

About Methicillin-Resistant Staphylococcus aureus (MRSA)

MRSA is a strain of the bacteria Staphylococcus aureus (“staph”) which commonly causes skin and soft tissue infections and is resistant to many antibiotics. Although MRSA had previously been a hospital-acquired pathogen, its incidence has been rising in the community, and it has become the most frequent cause of skin and soft tissue infections presenting to emergency departments in the United States (New England Journal of Medicine 2006; 355:666-674). There are a limited number of antibiotics approved to treat MRSA, and their frequent usage has led to emergence of multi-drug resistant bacteria. Thus, there is significant unmet medical need for new antibiotics such as JNJ-Q2 that provide flexible (hospital and outpatient) treatment options for MRSA.

About Furiex

Furiex Pharmaceuticals is a drug development collaboration company using innovative clinical development design to accelerate and increase value of partnered drug programs by advancing them through the drug discovery and development process in a cost-efficient manner. Development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a strong, diversified product portfolio and pipeline with multiple therapeutic candidates including late-stage assets and two products on the market. The company's mission is to develop innovative medicines faster and at less cost, reducing the expense of health care globally while providing life-improving therapies for patients. For more information, visit www.furiex.com.

Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: the potential need for additional financing to advance development programs; our potential need for, and reliance on, partners to successfully develop, market and sell products; the risks of continuing the research and development activities of our existing candidates; the ability to obtain regulatory approval for our compounds; time required to gain regulatory approvals; the demand for our potential products, if and when approved; and the costs of defending or prosecuting any patent opposition or litigation necessary to protect our proprietary technologies; and the other risk factors set forth from time to time in Furiex’s Annual Report on Form 10-K and other SEC filings, copies of which can be found on our website.

CONTACT:

Furiex Pharmaceuticals, Inc.
Media/Analysts/Investors:
Sailash Patel, 919-456-7814
sailash.patel@furiex.com

KEYWORDS: United States North America North Carolina

INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Pharmaceutical Research Science

MEDIA:

Logo

Cubist Pharmaceuticals Revises 2010 Net Revenue Guidance

Tue, 14 Dec 2010 16:22:56 -0500

- Total Net Revenue 2010 Guidance revised to a range of $634 Million to $640 Million

- U.S. Net Product Revenue Guidance revised to a range of $598 Million to $605 Million

LEXINGTON, Mass.--(BUSINESS WIRE)-- Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced revised guidance ranges for 2010 total net revenues based on lowered expectation for 2010 U.S. net product revenues from CUBICIN® (daptomycin for injection). The company now anticipates 2010 total net revenues in the range of $634 to $640 Million, reflecting the new guidance range for 2010 U.S. net product revenues of $598 to $605 Million. Guidance for 2010 international revenues is unchanged, at around $25 Million.

“Cost pressures in U. S. hospitals continue to impact sales of branded therapies in the hospital setting. Based on U.S. sales data for CUBICIN through the first part of December, we now expect that results for Q4 will bring 2010 U.S. net revenues below the guidance range we provided as part of our Q3 Earnings call,” said Cubist President and CEO Mike Bonney. “We continue to articulate the clinical benefits of the drug for appropriate patients, and we are continuing to develop the story around the economic impact that CUBICIN can have in the hospital overall.”

About CUBICIN

CUBICIN® (daptomycin for injection) is approved in the U.S. and many other markets as therapy for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided endocarditis caused by methicillin-resistant S. aureus (MRSA), and complicated skin infections caused by certain Gram-positive bacteria, including MRSA. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com.

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN® (daptomycin for injection), the first antibiotic in a class of anti-infectives called lipopeptides. The Cubist clinical product pipeline currently consists of a Phase 2 program focused on the development of a novel cephalosporin to address certain serious infections caused by multi-drug resistant (MDR) Gram-negative organisms; and a Phase 2 program for the treatment of CDAD (Clostridium difficile-associated diarrhea). Cubist is also working on several pre-clinical programs being developed to address areas of significant medical needs. These include an anti-infective program for the treatment of respiratory syncytial virus (RSV) in children, therapies to treat various serious bacterial infections, and agents to treat acute pain. Cubist is headquartered in Lexington, Mass. Additional information can be found at Cubist’s web site at www.cubist.com.

Cubist Safe Harbor Statement

This press release contains forward-looking statements regarding our 2010 revenue guidance. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following as they relate to the rest of 2010: the level of acceptance of CUBICIN by physicians, patients, third-party payors and the medical community; the ability to increase market penetration of CUBICIN, particularly as the growth of the market for CUBICIN slows or even declines; any changes in the current or anticipated ordering patterns, market demand or medical need for CUBICIN; any unexpected adverse events related to CUBICIN; the effectiveness of our sales force and our sales force's ability to access targeted physicians; competition in the markets in which we and our partners market CUBICIN; the ability of our international distributors and licensors to effectively market and sell CUBICIN in their territories; and a variety of other risks common to our industry. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent annual and quarterly reports with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings, which are incorporated in this press release by this reference. Forward-looking statements speak only as of the date of this release, and Cubist undertakes no obligation to update or revise these statements, except as may be required by law.

Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.

CONTACT:

Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Senior Director, Corporate Communications
eileen.mcintyre@cubist.com
or
Weber Shandwick
Tara Murphy, 617-520-7045
tara.murphy@webershandwick.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical Professional Services Finance Research Science

MEDIA:

Logo

PRESS RELEASE: Scientists Identify Factor Key to Severity of Community-Associated Methicillin-Resistant Staph Infections

Maureen Martino — Tue, 13 Nov 2007 09:44:23 -0500

Scientists Identify Factor Key to Severity of Community-Associated Methicillin-Resistant Staph Infections

Newly described proteins in drug-resistant strains of the Staphylococcus aureus bacterium attract and then destroy protective human white blood cellsâ€”a key process ensuring that S. aureus survives and causes severe disease, according to scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

S. aureus disease is a global public health concern because some strains, including community-associated methicillin resistant S. aureus (CA-MRSA), have developed resistance to existing antibiotics. The NIAID scientists hope to use this finding to advance development of new therapeutic treatments.

In a study published online in Nature Medicine, Michael Otto, Ph.D., and his colleagues at NIAIDâ€™s Rocky Mountain Laboratories (RML) describe how novel members of the phenol-soluble modulin (PSM) protein family help determine disease severity and eliminate immune defense mechanisms against CA-MRSA.

â€œThis elegant work helps reveal the complex strategy that S. aureus has developed to evade our normal immune defenses,â€ says Anthony S. Fauci, M.D., NIAID director. â€œUnderstanding what makes the infections caused by these new strains so severe and developing new drugs to treat them are urgent public health priorities.â€

Up until a year ago, most scientists studying S. aureus believed they had narrowed their search for the cause of severe CA-MRSA infections, focusing on the Panton-Valentine leukocidin (PVL) toxin produced by certain strains. But then last year, Dr. Otto and his RML colleagues published a study indicating that PVL does not play a major role in CA-MRSA infections (see related News Release).

Given the scope of the problem in the United States, Dr. Ottoâ€™s group continued its search to understand why the CA-MRSA strains cause widespread and often severe infections in otherwise healthy people. Until now, no one had examined what role PSMs have in Staphylococcus infection.

The RML group identified previously unknown PSMs secreted by S. aureus and identified the genes that encode those PSM proteins. They then compared PSM production between CA-MRSA and the most prominent hospital-associated MRSA strains. The research team found PSM genes in all MRSA strains, but production of the proteins was typically higher in CA-MRSA strains known for severe virulence, according to Dr. Otto.

To determine whether PSMs contribute to virulence, the scientists developed test strains using the most widespread isolates of CA-MRSA, called USA300 and USA400. Each test strain had a certain combination of PSM-encoding genes removed so the researchers could ascertain whether those genes affected virulence. The scientists then observed how laboratory mice responded to the test strains. By doing so, they pinpointed the psm-alpha gene cluster (which makes PSM-alpha protein) as playing an essential role in determining CA-MRSA virulence and, ultimately, disease severity.

To understand how PSMs contribute to virulence, Dr. Otto and colleagues next examined the role of the molecules in S. aureus evasion of human immune defenses. They observed that the psm-alpha genes generated the most resistance activity and the PSM-alpha proteins were best at destroying most immune cells that help protect against infection and disease. In all instances, the PSM-alpha molecules caused the greatest destruction of white blood cells, an effect that occurred rapidly.

What was remarkable, says Dr. Otto, is that a specific sensing mechanism likely enabled S. aureus to secrete PSMs at the ideal time when host immune cells were weakest and most vulnerable to destruction. Likewise, PSM production slowed when the bacterial survival was most jeopardized.

â€œWeâ€™re not saying the psm-alpha gene cluster is the only element contributing to the virulence and survival of CA-MRSA, but it is a major factor,â€ says Dr. Otto.

Next, he and his RML colleagues will examine whether the simple presence of the psm-alpha genes create havoc with the immune system, or whether some unknown trigger causes these genes to be expressed in a harmful way. Dr. Ottoâ€™s group also is continuing to study the molecular details of how PSMs function. Ultimately they hope to identify new candidate therapeutics for CA-MRSA by studying the roles of the different PSM genes.
--------------------------------------------------------------------------------

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)â€”The Nation's Medical Research Agencyâ€”includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov

PRESS RELEASE: CDC estimates 94,000 invasive drug-resistant staph infections occurred in the U.S. in 2005

Maureen Martino — Wed, 17 Oct 2007 13:29:33 -0400

CDC estimates 94,000 invasive drug-resistant staph infections occurred in the U.S. in 2005

Study establishes baseline for MRSA infection estimates
Methicillinâ€“resistant staph aureus (MRSA) caused more than 94,000 lifeâ€“threatening infections and nearly 19,000 deaths in the United States in 2005, most of them associated with health care settings, according to the most thorough study of lifeâ€“threatening infections caused by these bacteria, experts with the Centers for Disease Control and Prevention (CDC) report.

The study in the Oct. 17 edition of the Journal of American Medical Association (JAMA) establishes the first national baseline by which to assess future trends in invasive MRSA infections. MRSA infections can range from mild skin infections to more severe infections of the bloodstream, lungs and at surgical sites.

The study found about 85 percent of all invasive MRSA infections were associated with health care settings, of which twoâ€“thirds surfaced in the community among people who were hospitalized, underwent a medical procedure or resided in a longâ€“term care facility within the previous year. In contrast, about 15 percent of reported infections were considered to be communityâ€“associated, which means that the infection occurred in people without documented health care risk factors.

The 2005 rates of invasive infection were highest among people 65 years of age or older. Black people were affected at twice the rate of whites, which could be due to higher rates of chronic illness among blacks.

â€œThese numbers show that many families are being affected by these drugâ€“resistant infections,â€ said Denise Cardo, M.D., director of CDCâ€²s Division of Healthcare Quality Promotion. â€œHealthcare facilities need to make MRSA prevention a greater priority. The closer we get to 100 percent compliance with CDC recommendations, the greater the impact on patient health and safety.â€

Experts arrived at the new national estimate by projecting from the number of invasive MRSA cases from nine U.S. sites. The sites included the state of Connecticut; the Atlanta metropolitan area; the San Francisco Bay area; the Denver metropolitan area; the Portland, Ore., metropolitan area; Monroe County, N.Y.; Baltimore City, Md.; Davidson County, Tenn.; and Ramsey County, Minn. All the sites were part of CDCâ€²s Active Bacterial Core surveillance program, which actively tracks a number of pathogens in the United States representing a population of 38 million Americans.

In health care settings, MRSA occurs most frequently among patients who undergo invasive medical procedures or who have weakened immune systems and are being treated in hospitals and health care facilities such as nursing homes and dialysis centers.

For more information on MRSA, please visit http://www.cdc.gov/ncidod/diseases/submenus/sub_mrsa.htm. For more information on CDCâ€²s guidelines for the prevention of MRSA in health care settings, visit http://www.cdc.gov/ncidod/dhqp/ar_mrsa_prevention.html.