|Pfizer Statement on U.S. FDA Approval of Over-the-Counter Nexium® 24HR; FDA Approves Biogen Idec’s ALPROLIX™|
|By Staff and Wire Reports|
|Friday, 28 March 2014 19:18|
The U.S. FDA approved over-the-counter Nexium® 24HR (esomeprazole 20mg) marking a key step towards providing those who suffer from frequent heartburn broader access to a brand doctors and patients have trusted for years.
In 2012, Pfizer acquired exclusive global rights from AstraZeneca to market non-prescription Nexium®. The addition of Nexium® 24HR to the Pfizer Consumer Healthcare portfolio expands the breadth of categories in which we help consumers better manage their health, and extends the value of the world’s leading prescription acid blocker brand.
“Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer,” said Paul Sturman, President, Pfizer Consumer Healthcare. “The FDA approval of Nexium® 24HR is a significant milestone in executing against our plan.”
We continue to work closely with AstraZeneca and retail partners to make Nexium® 24HR available to consumers in the U.S., with other markets in Europe expected to follow this year.
Biogen Idec (NASDAQ: BIIB) announced the U.S. FDA has approved ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body. ALPROLIX is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.
The approval of ALPROLIX is the first significant advance in hemophilia B treatment in more than 17 years. The therapy is clinically proven to reduce bleeding episodes with a favorable safety and tolerability profile. It is developed using a process called Fc fusion and is the first hemophilia therapy to demonstrate prolonged circulation in the body, which has been shown in adults and adolescents with hemophilia to extend the time between prophylactic infusions.
“The FDA approval of ALPROLIX is a significant milestone for the hemophilia B community, and represents an important first step in our commitment to transform the care of people with hemophilia,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “ALPROLIX offers people with hemophilia B the ability to prevent or reduce bleeding episodes with prophylactic infusions starting at least a week apart. We believe this new therapy will help more people with hemophilia and their caregivers realize the benefits of this treatment approach.”
The National Hemophilia Foundation (NHF) recommends routine prophylaxis as optimal for the treatment of people with severe hemophilia. Studies show people with severe hemophilia who follow this type of regimen experience fewer bleeding episodes and their related risks. Complications of bleeding episodes may range from severe swelling and pain to arthritis, joint damage and physical disability.1,2,3
“Hemophilia has a significant impact on people whom it affects, throughout their lives,” said Patrick F. Fogarty, M.D.,4 assistant professor of medicine at the Hospital of the University of Pennsylvania, and director, Penn Comprehensive Hemophilia and Thrombosis Program. “ALPROLIX addresses a critical need by allowing people with hemophilia B to maintain factor levels with prophylactic infusions once weekly or once every 10 days. We hope this will facilitate use of prophylactic therapy.”
Hemophilia B is a rare, chronic, inherited disorder in which the ability of a person’s blood to clot is impaired, which can lead to recurrent and extended bleeding episodes. Therapies for hemophilia B can be administered either on a schedule to help prevent or reduce bleeding episodes (prophylaxis), or to help control a bleeding episode when it occurs (on-demand). According to NHF guidelines, traditional hemophilia B therapy requires prophylactic infusions two or more times a week.
“The hemophilia community is excited about new therapy options for the prophylactic management of hemophilia B,” said Val Bias, chief executive officer of the National Hemophilia Foundation. “This approval is a significant step forward because it provides an important new option and expanded choice for the hemophilia B community.”
The approval of ALPROLIX is based on results from the global, Phase 3 B-LONG study, as well as interim pharmacokinetic (measurement of the presence of the therapy in a person’s body over time) and safety data from the Phase 3 Kids B-LONG study. B-LONG study results showed that adults and adolescents with severe hemophilia B achieved prevention or reduction of bleeding episodes with prophylactic infusions at least a week apart. The study included two prophylaxis regimens – the weekly prophylaxis arm and the individualized-interval prophylaxis arm, in which the dosing interval started at once every 10 days. The overall median dosing interval with individualized-interval prophylaxis was 12.5 days; during the last six months of the study, the median interval was 13.8 days. More than 90 percent of all bleeding episodes were controlled by a single ALPROLIX infusion.
No participants in the B-LONG study developed inhibitors (neutralizing antibodies that may interfere with the activity of the therapy) to ALPROLIX. There were no reports of vascular clots or serious allergic reactions. Across the routine prophylaxis and on-demand therapy arms, adverse reactions were reported in 8.4 percent of participants. These adverse reactions included headache, oral paresthesia (abnormal sensation in the mouth), dizziness, dysgeusia (taste alteration), breath odor, fatigue, infusion site pain, palpitations, obstructive uropathy (an obstructing clot in the urinary collecting system) and hypotension (low blood pressure). Each event occurred in two or fewer study participants.
An interim analysis from an ongoing, multi-center Phase 3 pediatric study – Kids B-LONG –showed no inhibitors were detected, and the increase in half-life (a measure of the time therapy remains in the body) seen with ALPROLIX was consistent with data reported in adults and adolescents.
ALPROLIX was recently approved by Health Canada for the treatment of hemophilia B and is currently under review by regulatory authorities in several other countries, including Australia and Japan.
Advaxis, Inc. (Nasdaq:ADXS), today announced the full exercise of the over-allotment option granted to the underwriters to purchase an additional 612,000 shares of its common stock at a public offering price of $3.00 per share in connection with its previously announced underwritten public offering of 4,080,000 shares of common stock, bring the total gross proceeds from the offering to approximately $14,076,000, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.
Akers Biosciences, Inc. (AKR.L) (Nasdaq:AKER), a leading designer and manufacturer of rapid diagnostic screening and testing products, reports its financial results for the fiscal year ended December 31, 2013.
Amedisys, Inc. (Nasdaq:AMED), a leading home health and hospice company, today announced that it will be closing 29 care centers (23 home health and six hospice) and consolidating another 25 care centers (21 home health and four hospice) with care centers servicing the same markets.
Analogic Corporation (Nasdaq:ALOG), enabling the world's medical imaging and aviation security technology, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the SonixGPS® Nerve Block Needle Kit.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that Florida Hospital Memorial Medical Center has selected the Authentidate InscrybeMD® telehealth solution using the Electronic House Call™ device (EHC) to provide clinical services to their patients remotely.
Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics to prevent and treat heart disease, today announced Co-founder and Scientific Advisory Board Chairman, Dr. Eduardo Marbán, M.D., Ph.D., will present at the American College of Cardiology 63rd Annual Scientific Session and Expo, taking place March 29-31, 2014 in Washington, DC.
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, today named Katherine L. Davis as the Company's non-executive Chairman of the Board.
GenVec, Inc. (NASDAQ: GNVC) today reported financial results for the fourth quarter and year ended December 31, 2013.
LipoScience, Inc. (Nasdaq:LPDX) today announced the termination of its relationship with Health Diagnostics Laboratory, Inc., one of its laboratory customers.
LiveWire Ergogenics, Inc.(OTCQB: LVVV) announced today that it has shipped its first order of CBD Hemp Energy Chews to Cannaceutix, Ltd who will feature them at the 4th Annual Michigan THC Expo in Detroit, Michigan from March 28-30, at the Cannafruit booth #12.
Modern Mobility Aids Inc. (OTC Pink: MDRM) (PINKSHEETS: MDRM) an emerging company operating in the field of governmentally authorized medical marijuana and cannabis science is pleased to announce the appointment of Dr. Peter J. Rothbart, M.D., F.R.C.P.C., D.A.B.P.M to the medical advisory team.
Organovo Holdings, Inc. (NYSE MKT: ONVO), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, today provided guidance on topics to be discussed at an upcoming Retail Investor Conference on April 10, 2014.
Pazoo, Inc. (OTCQB: PZOO) (German WKN#: A1J3DK) is pleased to report that the first $50,000 payment was made on the signing of a Binding Letter of Intent this week to acquire a 40% interest in MA & Associates, LLC.
Last month Plandaí Biotechnology, Inc. (OTCQB: PLPL) closed a licensing agreement with Diego Pellicer, Inc. that will allow the company to use the Diego Pellicer name for its Phytofare™ cannabis extract in medical and pharmaceutical marijuana applications.
Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, announced it has scheduled a conference call for Monday, March 31, at 4:15 p.m. (EDT) to discuss the Company's financial results for its full year 2013 and provide an update on its business initiatives.
Texas Rare Earth Resources Corp. (OTCQX: TRER), a heavy rare earths exploration company, is pleased to announce that it has joined the Borderplex Alliance.
Vitamin Blue, Inc. (PINKSHEETS: VTMB) announced today that it has begun selling a new line of grow tents for medical marijuana online.