|Aveo Pharma regains cancer drug rights. Covance rises on research pact|
|By BioMedReports.com Staff|
|Thursday, 30 September 2010 19:08|
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 30, 2010.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that AVEO has regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299 (also known as SCH 900105), its anti-hepatocyte growth factor (HGF) antibody candidate.
AV-299 is a potent, functional anti-HGF antibody that was discovered by AVEO through its Human Response Platform. Data from Phase 1 clinical trials of AV-299 indicate a favorable tolerability profile and good combinability with EGFR inhibitors, erlotinib (Tarceva®) and gefitinib (Iressa®). In June 2010, AVEO initiated a Phase 2 clinical trial evaluating AV-299 in combination with gefitinib versus gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). In conjunction with the Phase 2 trial initiation, AVEO received an $8.5 million milestone payment from Merck under the terms of the license agreement. Top-line efficacy data from the AV-299 Phase 2 trial are expected in late 2011.
"AVEO is very pleased to regain worldwide rights for the development and commercialization of AV-299," stated Tuan Ha-Ngoc, president and chief executive officer of AVEO Pharmaceuticals. "AVEO now holds significant commercialization rights to all oncology products in our pipeline, and we believe that we are well-positioned to move toward our goal of becoming a fully-integrated commercial organization. Our expected year-end 2010 cash balance remains unchanged, and we reaffirm that AVEO has sufficient capital to take us beyond data from TIVO-1, our ongoing Phase 3 clinical trial of tivozanib in patients with renal cell carcinoma. We look forward to sharing top-line TIVO-1 data in mid-2011."
"Merck is pleased with our history of collaborating with AVEO, and would welcome the opportunity to work with AVEO again in the future," said David Nicholson, Ph.D., senior vice president and head of worldwide licensing and knowledge management at Merck. "The decision to return this program to AVEO is a result of portfolio prioritization."
Shares of Aveo gained $1.15 or 11.51% to $11.14.
Covance Inc. (NYSE:CVD) today announced the signing of definitive agreements with sanofi-aventis (EURONEXT: SAN and NYSE: SNY) for Covance to become sanofi-aventis' R&D partner. Over the next ten years, Covance expects to provide drug development services to sanofi-aventis, with estimated payments ranging from approximately $1.2 billion to $2.2 billion. Sanofi-aventis will sell their Porcheville, France and Alnwick, United Kingdom sites and facilities to Covance for approximately $25 million and Covance will maintain employment on these sites for at least the next five years. The transaction is expected to be completed before the end of the year.
"A key strategy for sanofi-aventis is to transform its R&D model and discover new medicines through the use of novel technologies and innovative partnerships," declared Marc Cluzel, M.D., PhD, Executive Vice-President, Research & Development, sanofi-aventis. "This alliance with Covance will help us preserve hundreds of valuable jobs in Porcheville and Alnwick, while driving our R&D efficiency for the benefit of the patients."
Shares of Covance rose more than 10% or $4.61 to $46.79.
Dyax Corp. (NASDAQ: DYAX) and CMIC Co., Ltd, (CMIC) announced today an agreement to develop and commercialize subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE) and other angioedema indications in Japan. DX-88 has been approved by the U.S. Food and Drug Administration (FDA) and is marketed as KALBITOR (ecallantide) for the treatment of acute attacks of HAE in patients 16 years of age and older.
Under the terms of the agreement, Dyax will receive $4 million upfront and $102 million in future development and sales milestones for DX-88 in HAE and other angioedema indications. CMIC is solely responsible for all costs associated with development, regulatory activities, and commercialization of DX-88 for all angioedema indications in Japan. CMIC will purchase drug product from Dyax on a cost-plus basis for clinical and commercial supply. Additionally, Dyax is eligible to receive royalties of 20%-24% on net product sales.
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Inovio Pharmaceuticals and the University of Pennsylvania have received a grant of $3.1 million from the National Institutes of Health (NIH) Director’s Office to further fund Inovio’s universal SynCon flu vaccine development.
Teva Pharmaceuticals Industries Ltd. (NASDAQ:TEVA) and OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced today the initiation of SYNERGY, a global Phase 3 trial evaluating custirsen (also known as OGX-011/TV-1011) as first line therapy for the treatment of castrate-resistant prostate cancer (CRPC). The SYNERGY trial is the second of three Phase 3 trials to be initiated under a global collaboration and license agreement between Teva and OncoGenex to develop and commercialize custirsen.Also Thursday:
Accelrys, Inc. (NASDAQ: ACCL), the leading scientific informatics software and services company, today announced the release of version 3.3 of the Isentris® data access, analysis, and decision support system (previously Symyx Isentris). Isentris 3.3 drives faster, better informed scientific decisions by enabling scientists to display, manipulate, and compare spectral, chromatographic, and XY graphical data.
BioClinica™, Inc. (NASDAQ: BIOC), a global provider of clinical trial management services, has issued the following statement: The Board of Directors of BioClinica supports management, their extensive industry-specific knowledge, insight and business acumen.
BIOLASE Technoogy, Inc. (NASDAQ: BLTI), the world's leading dental laser company, is pleased to announce that its Board of Directors has appointed Federico Pignatelli the permanent Chief Executive Officer of BIOLASE. Previously, Pignatelli was the interim Chief Executive Officer of BIOLASE.Pignatelli has agreed to continue at an annual salary compensation of $1.00 as Chief Executive Officer.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that Robert Perez, Cubist' EVP and COO, will participate in a panel discussion on Tuesday, October 5, at 2 p.m. Eastern Time, at Citi's 5th Annual Biotech Day being held at the Westin Waterfront Hotel in Boston.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that it has entered into binding securities purchase agreements in a private placement transaction with several accredited investors for a Series A non-voting convertible preferred stock offering, with gross proceeds of $6.3 million, before deducting offering expenses, and expects to close the transaction today.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the Jefferies 2010 Global SpecPharma and European Healthcare Conference on Tuesday, October 5, at 2:30 p.m. BST (9:30 am ET). The conference will be held at the Waldorf Hilton in London.
Lantronix, Inc. (NASDAQ: LTRX), a leading provider of secure, remote management and device networking solutions, today launched AccessMyDevice™, a new enterprise-grade, Internet-based service enabling business and technology professionals to easily view, manage, control and service virtually any device from a web browser.
Meridian Bioscience, Inc., (NASDAQ:VIVO) today announced that it has received an approved medical device license from Health Canada for its new molecular amplification assay, illumigene C. difficile.
Neuro-Biotech Corporation (PINKSHEET: MRES) (OTCQB:MRES) in acquiring licenses to commercialize 12 Neuro-biomarkers has first focused on SymPath(R) and is now ready to give you the opportunity to shed some light about this Neuro-biomarker of the Sympathetic Nervous System (SNS).
Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced that Daron Evans, Chief Financial Officer, will present at the 9th Annual BIO Investor Forum Wednesday, October 6, 2010 at 8:30 a.m. (Pacific Time) at the Palace Hotel in San Francisco, California.
NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, today announces that Jerry McLaughlin, Vice President of Commercial Operations, will present a brief company overview at the Safeguard Scientifics, Inc. (NYSE: SFE) Investor Day 2010 event on Tuesday, October 5, 2010.
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company, and Affitech A/S (COPN: AFFI), the antibody medicines company, today announced that the companies have agreed to amend certain terms of their worldwide license agreements for Brazil, Russia and other countries of the Commonwealth of Independent States (CIS) to expedite the development of a fully human antibody called AT001/r84 for these territories.
PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has received a Phase 2 grant in the amount of $986,000 from the National Institute of Health (NIH) to support the development of defensin mimetic antimicrobial compounds for the treatment of oral candidiasis.
PPD, Inc. (Nasdaq: PPDI) today announced it has opened an office in Novosibirsk, Russia, building on the growth of its Phase II-IV clinical development services in Eastern Europe. PPD will provide clinical monitoring services in key therapeutic areas from this location.
Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that it has selected a novel lead drug candidate to be developed as a disease modifying treatment for Parkinson's Disease, PBT434.
Pro Pointer, Inc. (PINKSHEETS:PPII), through its wholly owned subsidiary Coenzyme-A Technologies, Inc., is pleased to announce that the company remains focused on its business plan and is diligently working towards the introduction and marketing of several new products, including its latest innovative proprietary formula the "PURE COENZYME-A."
Repligen Corporation (Nasdaq:RGEN) reported today that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.
Rite Aid Corporation (NYSE: RAD) today announced sales results for September.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that posters highlighting two of the Company's second generation microRNA-based diagnostic assays were presented by the Company's clinical laboratory director, Dr. Tina B. Edmonston, at the American Association for Cancer Research's (AACR) Molecular Diagnostics in Cancer Therapeutics Development Conference, held September 27-30, 2010 in Denver, Colorado.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutic discovery and development, today announced that the Company's President and Chief Executive Officer, Noah D. Beerman, will present a corporate overview at the 9th Annual BIO Investor Forum on Wednesday, October 6, 2010 at 2:30 p.m. PT in San Francisco.
Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) today announced that the United States District Court for the Southern District of New York has dismissed the Class Action originally filed on November 25, 2008, and captioned Richard Sagall vs. Savient Pharmaceuticals, Inc., et al., against the Company and two of its former officers.
Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces that shareholders of Movetis NV have tendered 99.18% of the shares of Movetis (Euronext Brussels: MOVE) during the initial acceptance period of the tender offer which closed on September 27, 2010.
Stellar Biotechnologies, Inc. (TSX-V: KLH) (PINKSHEETS: SBOTF) received payment of US$ 288,000 for a filled order of Stellar KLH/SUBUNIT from French biotechnology and active immunotherapy technology-platform company, Neovacs SA, for its Phase IIa human trials with its KLH-based vaccine for rheumatoid arthritis (RA) which has moved to a higher dose group, and its upcoming Phase I trial for Lupus.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that Donald Kufe, M.D., Professor of Medicine, Dana-Farber Cancer Institute and Harvard Medical School, has been appointed to the Board of Directors effective September 28, 2010.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Application (BLA) for Neutroval (granulocyte colony-stimulating factor) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.
Valiant Health Care, Inc. (OTCBB:VHCI) (PINKSHEETS: VHCI) announces that it has executed a term sheet with Atlantic Medical Supply, Inc., a Florida corporation ("AMS"), under which it will acquire all of the outstanding shares of AMS in exchange for cash, shares of Valiant's common stock and options to purchase shares of Valiant's common stock.
Walgreens (NYSE: WAG)(NASDAQ: WAG) has launched the first ongoing, nationwide Safe Medication Disposal Program, a safe and environmentally responsible way to dispose of unused or expired medications.
XenaCare Holdings, Inc. (OTCBB:XCHO) announced today that it has signed a private label marketing agreement with Renaissance Publishing LLC covering three of its clinical supplement products.