|Positive Results From Pfizer's Phase 3 Study PROFILE 1007 Evaluating XALKORI®; Alexion Wins Aid for 300 Jobs|
|By Staff and Wire Reports|
|Tuesday, 19 June 2012 19:14|
Pfizer Inc. (NYSE:PFE) announced today that the PROFILE 1007 study met its primary endpoint, demonstrating that XALKORI® (crizotinib) significantly improved progression-free survival (PFS) when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). PROFILE 1007 is the first randomized Phase 3 study in ALK-positive advanced NSCLC patients.
"These results are important because they demonstrate, for the first time, that XALKORI is superior to standard chemotherapy in prolonging survival without progression in patients with previously-treated ALK-positive advanced NSCLC," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit. "This study provides further support for the precision medicine approach to drug development being taken at Pfizer by demonstrating how knowledge about the underlying genetic abnormalities within a cancer can be used to improve the standard of care for that disease."
The adverse events observed on crizotinib and chemotherapy in PROFILE 1007 were generally consistent with their respective known adverse event profiles. Full efficacy and safety data from this study will be presented at an upcoming medical congress.
Pfizer is committed to the development program for XALKORI, and continues to study the therapy in several ongoing trials including PROFILE 1014 (A8081014), a Phase 3, open-label, randomized, two-arm study to evaluate the safety and efficacy of XALKORI in comparison with pemetrexed plus cisplatin or carboplatin in patients previously untreated for ALK-positive advanced NSCLC.1 In addition, PROFILE 1005 (A8081005)is an ongoing Phase 2 open-label, single-arm study on the efficacy and safety of XALKORI in patients with ALK-positive advanced NSCLC who have failed more than one line of treatment with prior chemotherapy.
Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) is expected to create up to 300 new jobs after moving its headquarters to New Haven with as much as $51 million in state aid, Gov. Dannel P. Malloy announced Tuesday.
Malloy announced the economic development move as part of his "First Five" initiative intended to spur large-scale business development.
Alexion, which posted profit of $175.3 million on sales of $783.4 million in 2011, was founded in 1992 in New Haven's Science Park. It moved in 2000 to Cheshire, where it employs more than 350 workers.
State aid includes a 10-year loan of $20 million at a 1 percent interest rate with principal and interest deferred for five years, loan forgiveness of $16 million to $20 million based on the creation of 200 to 300 full-time jobs, and a $6 million grant to build laboratories and equipment.
Alexion says it will establish its global headquarters at a new site to be built in New Haven by 2015. The drug developer's only approved product, the rare blood disorder treatment Soliris, treats paroxysmal nocturnal hemoglobinuria, or PNH, which causes a breakdown of red blood cells and leads to anemia.
The drug was approved in late 2011 also as a treatment for a second condition, atypical hemolytic uremic syndrome, which often leads to kidney failure and death.
Spokesman Irving Adler said Alexion anticipates growth with new uses for Soliris and research and development into more pharmaceutical compounds.
The company had other options for locating its new headquarters, he said, mentioning a site where it operates in Smithfield, R.I., and a research and development office in Cambridge, Mass. Connecticut's state aid was "a factor in our decision, absolutely," Adler said.
The Republican minority in the state legislature on Tuesday demanded a public hearing to review the Alexion deal. Senate Republican Leader John McKinney and his House counterpart, Rep. Lawrence Cafero, said they want to know what kinds of jobs will be created, if the state worked with Alexion and Cheshire officials to keep the company in Cheshire and what, if anything the state is doing to help Cheshire and local taxpayers absorb the cost of the company's loss.
Cafero said it's unclear that $51 million in state incentives is necessary to keep Alexion in Connecticut.
AeroGrow International, Inc. (PINKSHEETS: AERO) ("AeroGrow" or the "Company"), makers of the AeroGarden® line of indoor gardening products, will host a conference call on Tuesday, June 26, 2012, to review operational results for the quarter and fiscal year ended March 31, 2012.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announces that the Company has learned that two putative class action lawsuits have been filed against it alleging failures to disclose certain information under U.S. federal securities laws.
As Bio-Solutions Corp. (PINKSHEETS: BISU) launches Type2 Defense™, a state-of-the-art functional beverage for the management of Type 2 diabetes™,* President and CEO Bill Gallagher announces that the company will be operating out of San Antonio, Texas -- a move that places Bio-Solutions at the geographic hub of cutting-edge research in the fight against diabetes.
Chembio Diagnostics, Inc. (NASDAQ: CEMI), a leader in point-of-care diagnostic tests for infectious diseases, reported today that data from a study evaluating performance characteristics (sensitivity and specificity) of three pre-market rapid point-of-care tests (one oral fluid and two finger-stick assays) in settings providing services to young adults who inject drugs was recently published online in the Journal of Clinical Virology and is expected to be published in the July 2012 print edition.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the latest additions to its growing bariatric surgery portfolio of products and services designed to improve patient and surgeon experiences with weight loss surgery and other procedures.
Crown Dynamics Corp. (OTCBB: CDYY) today announced that United Kingdom retailing giant Boots will begin carrying AIR® Breathe, and the essential-oil infused AIR® Decongest and Sleep/Snore products.
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM N.V. (NYSE, Euronext: DSM KON), announced today that several countries have granted patents or have given statements of patent allowance to its proprietary XD® high cell density process technology.
TV personality John O'Hurley joins the National Lipid Association (NLA), Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company (NYSE: LLY), in announcing the results of the USAGE survey, "Understanding Statin use in America and Gaps in Education," the largest known U.S. survey involving more than 10,100 statin users.1
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation from the European Medicines Agency (EMA) of the acceptance of submissions of Marketing Authorization Applications (MAAs) for alogliptin and pioglitazone combined in a single tablet and alogliptin and metformin combined in a single tablet.
ImmunoCellular Therapeutics, Ltd. (NYSE MKT: IMUC), a clinical stage biotechnology company that is focused on developing new immune-based products to treat and diagnose cancer, announced today that Manish Singh, PhD, President and Chief Executive Officer of the Company will be presenting at the 2012 BIO International Convention being held June 18th - 21st, 2012, at the Boston Convention and Exhibition Center in Boston, Massachusetts.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that its upcoming Analyst Day will be webcast live on Thursday, June 21, 2012 at 4:30 pm ET.
Life Technologies Corporation (NASDAQ: LIFE) today announced it has partnered with The Hospital for Sick Children (SickKids) to advance pediatric genomic research on the Ion Proton™ Sequencer.
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the developer of a novel Biopump™ technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced it has raised gross proceeds of approximately $9.5 million (approximately $8.4 million net) through the sale of 1,944,734 units (the “Units”), with each Unit consisting of one share of the Company’s Common Stock, $0.0001 par value per share (the “Common Stock”), and a warrant to purchase 0.75 of one share of Common Stock (the “Warrants”).
MeadWestvaco Corp. (NYSE: MWV), a global leader in packaging and packaging solutions, introduced Shellpak® Renew, a new package designed to meet patient and pharmacist needs.
MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed MelaFind®, a breakthrough device intended to help dermatologists detect melanoma when it is still curable, announced today that it received the American Business Awards 2012 Business Innovation of the Year award, and its Chairman, President and CEO, Dr. Joseph Gulfo, was honored with the Maverick of the Year award.
Neuralstem, Inc. (NYSE MKT: CUR) announced that the first patient to receive stem cell transplantation in both regions of the spinal cord has been treated in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).
OncoSec Medical Inc. (OTCBB: ONCS), a company developing the OncoSec Medical System (OMS) ElectroOncology therapies to treat advanced-stage solid tumors, announced the Commissioner of Patents, Commonwealth of Australia Patent Office recently granted a new Method of Use patent (Patent Application No. 2007224275, "Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection") for the company's OMS ElectroOncology treatment platform.
Palatin Technologies, Inc. (NYSE MKT: PTN) today announced that a Phase I clinical trial being conducted by AstraZeneca of AZD2820, a subcutaneously-administered peptide melanocortin-4 receptor partial agonist under development for the treatment of obesity, has been halted. AZD2820 is a clinical candidate under development by AstraZeneca from a collaborative research program with Palatin Technologies.
PAREXEL International Corporation (NASDAQ: PRXL) announced today that it will be presenting at the NASDAQ OMX Investor Conference in London.
Following a recent business trip to China, Andrew Schneider, CEO of Rotoblock Corp. (OTCBB: RTBC), said there is a critical need for non-incinerator-based medical waste treatment.
Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) announced today testing results for an early-user study of the Company's robotic single-site surgical platform.
Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), which specializes in non-addictive treatments for chronic pain syndrome disorders, announces that Chief Executive Officer Seth Lederman, M.D. will present at the inaugural Marcum MicroCap Conference to be held June 20th at the Roosevelt Hotel in New York City.
The board of directors of Walgreen Co. (NYSE:WAG) (NASDAQ:WAG) today announced an increase in the quarterly dividend of 22.2 percent to 27.5 cents per share from the previous rate of 22.5 cents per share.
Kohlberg Kravis Roberts & Co. L.P. (together with its affiliates, “KKR”) announced that Walgreen Co. (NYSE: WAG) (NASDAQ: WAG), the largest drug store chain in the US, and Alliance Boots GmbH, the leading international pharmacy-led health and beauty group, have agreed to form a strategic partnership to create the first global pharmacy-led, health and wellbeing enterprise.
Walgreen Co. (NYSE:WAG) (NASDAQ:WAG), the largest drug store chain in the U.S., and Alliance Boots GmbH, the leading international pharmacy-led health and beauty group, today announce that they have entered into a strategic transaction designed to bring together the strengths and expertise of both companies to create the first global pharmacy-led, health and wellbeing enterprise.
XTL Biopharmaceuticals Ltd. (TASE:XTL) (OTC:XTLBY), a biopharmaceutical development company, announced today it will acquire Kitov Pharmaceuticals Ltd. in consideration for shares as well as cash milestone payments throughout Kitov's development and business progress of up to $48 million, which may be payable in XTL shares.