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-- Jun 23, 2009 Abiomed, Inc. (NASDAQ: ABMD | Quote | Chart | News | PowerRating) closed at $8.20 on a volume of 263,050 shares.
Abiomed Announces First FDA-Approved AbioCor(R) Implant at UMDNJ-Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital
End-Stage Heart Failure Patient Receives AbioCor; Recovering Well Post-Surgery
DANVERS, Mass., Jun 24, 2009 -- Abiomed, Inc. (NASDAQ: ABMD), today announced the successful implant of its AbioCor(R) Total Replacement Heart, performed at Robert Wood Johnson University Hospital by Mark Anderson, M.D., associate professor of surgery at UMDNJ-Robert Wood Johnson Medical School and chief of the section of cardiac surgery at both the medical school and Robert Wood Johnson University Hospital. This is the first AbioCor implant since the completion of clinical trials and Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) on September 5, 2006.
The 76-year-old male patient was diagnosed with congestive, end-stage heart failure and did not qualify for a heart transplant or other available therapies, making him eligible for the AbioCor implant. More than one week after the surgery, the patient is showing signs of a strong and stable recovery.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
-- Jun 23, 2009 Novavax, Inc. (Nasdaq: NVAX | Quote | Chart | News | PowerRating) closed at $2.40 on a volume of 1,071,567 shares.
Preclinical Proof-of-Concept Studies Published for Novavax Seasonal Influenza Virus-Like-Particle Vaccine
ROCKVILLE, Md., June 24, 2009 -- Trivalent Virus-Like Particle Vaccine Elicits Protective Immune Responses against a Variety of Seasonal Influenza Strains in Mice and Ferrets
ROCKVILLE, Md., June 24 -- Novavax, Inc. (Nasdaq: NVAX | Quote | Chart | News | PowerRating) announced today publication of the preclinical study results that supported the clinical development of the company's investigational VLP vaccine against the H3N2, H1N1 and B influenza strains. The study, which was conducted by scientists from the University of Pittsburgh, Center for Vaccine Research and Novavax, was published in the June 24, 2009 online issue of PLoS ONE. The vaccine contains three VLPs mixed together in a single formulation; each made up of the hemagglutinin (HA), neuraminidase (NA) and matrix 1 (M1) proteins from the representative strains. These proteins are important for broad protection against influenza, which is responsible for nearly 200,000 hospitalizations and 36,000 deaths in the U.S. each year. The vaccine is currently in Phase 2 clinical testing.
In this study, mice and ferrets received intramuscular injections of VLP vaccine which induced HAI antibodies against all three influenza strains represented in the vaccine and against a variety of drifted strains. All of the ferrets who received a vaccine dose of 15 mcg/strain, the dose used for currently licensed vaccines, developed HAI titers greater than or equal to 1:40. This level of antibody has been shown to be important for protection against flu in human studies of influenza vaccines. In addition, approximately 50% of ferrets developed HAI titers greater than or equal to 1:40 against drifted H3N2 strains from the 1999, 2002, and 2005 influenza seasons. The vaccine was also protective, reducing the amount of influenza virus in the nose of ferrets that were challenged with the H3N2 strain from the 2005-6 season.
ABOUT NOVAVAX
Novavax, Inc. (Nasdaq: NVAX | Quote | Chart | News | PowerRating) is a clinical-stage biotechnology company creating novel vaccines, including H1N1, to address a broad range of infectious diseases worldwide using advanced proprietary virus-like-particle (VLP) technology. The company produces these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches. Additional information about Novavax is available at www.novavax.com and in the company's various filings with the Securities and Exchange Commission.
-- Jun 23, 2009 Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC | Quote | Chart | News | PowerRating) closed at $1.41 on a volume of 12,823,756 shares.
Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Completed NDA submission could lead to marketing approval in Q4-2009
SEATTLE, June 24, 2009 -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC | Quote | Chart | News | PowerRating) announced today that it has completed the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTI requested priority review, which if granted could lead to an approval decision from the FDA in the fourth quarter of 2009. Pixantrone is currently available in Europe on a named-patient basis.
"This is a major milestone for CTI and is the cornerstone of a turnaround strategy for us in meeting our goals of becoming a profitable operating business," said James A. Bianco, M.D., Chief Executive Officer of CTI. "With more than 76,000 pages and 500,000 hyperlinks this submission represents the hard work of many CTI employees dedicated to making a difference in the lives of patients with cancer. This also represents a significant advance in the treatment of patients with relapsed/refractory aggressive NHL, a patient population which the FDA has acknowledged represents an unmet medical need."
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.
-- Jun 23, 2009 NPS Pharmaceuticals, Inc. (NASDAQ: NPSP | Quote | Chart | News | PowerRating) closed at $4.46 on a volume of 261,692 shares.
NPS Pharmaceuticals President and CEO Dr. Francois Nader Recognized By Ernst & Young as 2009 Entrepreneur of the Year Finalist in New Jersey
BEDMINSTER, N.J., Jun 24, 2009 -- NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), announced today that Francois Nader, MD, president and chief executive officer of NPS, was recognized as a finalist in the Ernst & Young Entrepreneur Of The Year(R) 2009 Award in New Jersey. According to Ernst & Young LLP, the awards program recognizes entrepreneurs who demonstrate extraordinary success in the areas of innovation, financial performance, and personal commitment to their businesses and community. Dr. Nader was named a finalist by a panel of independent judges and recognized last night at a gala event sponsored by Ernst & Young at the Teaneck Marriott at Glenpointe.
About NPS Pharmaceuticals
NPS Pharmaceuticals is developing new treatment options for patients with rare gastrointestinal and endocrine disorders. The company is currently conducting two Phase 3 registration studies. Teduglutide, a proprietary analog of GLP-2, is being evaluated as GATTEX(TM) in a Phase 3 registration study known as STEPS for intestinal failure associated with short bowel syndrome and in preclinical development for gastrointestinal mucositis and other pediatric indications. NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) is being evaluated in a Phase 3 registration study known as REPLACE as a hormone replacement therapy for hypoparathyroidism. NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Kyowa Kirin, Nycomed, and Ortho-McNeil. Additional information is available athttp://www.npsp.com.
-- Jun 23, 2009 Gentiva Health Services, Inc. (Nasdaq: GTIV | Quote | Chart | News | PowerRating) closed at $15.46 on a volume of 179,109 shares.
Gentiva(R) Health Services Acquires Louisiana Home Health Agency
ATLANTA, June 24, 2009 -- Gentiva Health Services, Inc. (Nasdaq: GTIV), a leading provider of comprehensive home health services, announced today that it has acquired Mid-State Home Health, one of central Louisiana's top-three home healthcare providers.
Established in 1991, Mid-State covers a 50-mile radius from its base in Alexandria that extends across 11 parishes in central Louisiana. Gentiva does not currently operate in this coverage area, but does provide services in an adjacent area.
About Gentiva Health Services, Inc.
Gentiva Health Services, Inc. is a leading provider of comprehensive home health services, delivering innovative, high quality care to patients across the United States. Gentiva is a single source for skilled nursing; physical, occupational, speech and neurorehabilitation services; hospice services; social work; nutrition; disease management education; help with daily living activities; respiratory therapy and home medical equipment; infusion therapy services; and other therapies and services. For more information, visit Gentiva's web site,http://www.gentiva.com, and its investor relations section at http://investors.gentiva.com. GTIV-G
-- Jun 23, 2009 Cepheid (Nasdaq: CPHD | Quote | Chart | News | PowerRating) closed at $9.13 on a volume of 736,581 shares.
New England Journal of Medicine Study Highlights Need for Rapid, PCR-based Group B Streptococcus (GBS) Testing at Time of Admission for Labor and Delivery
SUNNYVALE, Calif., June 24, 2009 -- Cepheid (Nasdaq: CPHD | Quote | Chart | News | PowerRating) today noted that a new article, Evaluation of Universal Antenatal Screening for Group B Streptococcus, published in the June 2009 issue of the New England Journal of Medicine concluded that rapid, PCR-based testing at the time of admission for delivery may improve the accuracy of Group B streptococcal (GBS) screening over the normal antepartum testing done at 35-37 weeks of gestation.
GBS disease is one of the most common infections in the first week following birth and is a leading cause of infant mortality and serious neonatal infections such as sepsis, pneumonia and meningitis. Transmission of GBS occurs from colonized women to their babies during childbirth.
About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD | Quote | Chart | News | PowerRating) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See http://www.cepheid.com for more information.
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