|Kamada Announces Significantly Improved Infusion Rate for Glassia®; Celgene Acquires Late-Stage Product for Crohn’s Disease|
|By Staff and Wire Reports|
|Thursday, 24 April 2014 18:34|
Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces a significantly improved infusion rate for Glassia® (Alpha1-Proteinase Inhibitor -Human); this improvement was recently approved by the U.S. Food and Drug Administration (FDA). Glassia, which is marketed in the U.S. through a strategic partnership by Baxter International Inc., is the first and only ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) approved by the FDA and is indicated as a chronic augmentation and maintenance therapy in adults with alpha-1 antitrypsin deficiency (AATD, or Inherited Emphysema).
This major improvement was achieved following a post-marketing study conducted by Baxter, and it supports the strategic partnership between Kamada and Baxter to improve quality of life for patients treated by Glassia in the U.S. Kamada expects this improvement to significantly increase the number of patients treated by Glassia in the U.S. In addition, this improvement can be further leveraged by Kamada in other geographies and for additional indications currently in clinical development, once approved.
The improved infusion rate is highly important because it reduces the overall time from preparation to finish, which is key for AATD patients who are using this therapy chronically and for life. For the average patient weighing ~70kg, the new infusion rate reduces the weekly infusion time from 70 minutes to 15 minutes. This along with its ready-to-use feature makes Glassia a highly user friendly and convenient product that supports patient quality of life.
“We are very pleased to receive this post-marketing approval for the improved infusion rate for Glassia as it underscores Kamada’s commitment to leverage our technological expertise in plasma-derived protein therapeutics to be the most innovative company in the AAT industry,” stated David Tsur, Co-founder and CEO of Kamada. “As the only commercially available liquid, ready-to-use Alpha1- augmentation product, the enhanced infusion rate further expands Glassia’s competitive edge, and we expect this improvement to significantly increase the number of patients treated by Glassia in the U.S.”
“This improved infusion rate will be used in additional territories that recognize the FDA approval. Importantly, the enhanced infusion rate can be used for our future indications, currently in clinical trials, such as in type 1 diabetes and graft-versus-host disease (GvHD),” added Tsur.
Kamada is expecting to report top-line data from its recently completed Phase 2/3 clinical study in Europe for its innovative inhaled AAT to treat AATD, and has a robust late-stage clinical program utilizing its innovative technology. This program includes conducting a Phase 2 trial for inhaled AAT to treat AATD in the U.S., conducting a Phase 2/3 trial of intravenous AAT to treat type 1 diabetes with interim data expected in 2016, and plans to initiate a U.S. Phase 2 clinical trial of inhaled AAT to treat cystic fibrosis in the second half of 2014 and support a U.S. Phase 2 trial to treat GvHD with Glassia, with plans to initiate additional trials for this indication in the near term. The Company recently completed enrollment in a U.S. Phase 2/3 clinical study of KamRAB® as a post-exposure prophylaxis to treat rabies with product launch expected in 2015.
Celgene Corporation (NASDAQ:CELG) entered into a global license agreement with Nogra Pharma Limited, a private pharmaceutical company based in Dublin, Ireland, to develop and commercialize GED-0301, an oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate-to-severe Crohn’s disease and other indications.
A double-blind, placebo-controlled, multicenter phase II trial of three doses of GED-0301 in 166 patients with active Crohn’s disease has been completed. The data have been submitted to a major medical journal and will be presented at an upcoming medical congress. Based upon these results, Celgene plans to initiate a phase III registration program by year-end 2014.
“GED-0301 is a potentially transformative therapy that demonstrated striking clinical activity in a phase II trial for Crohn’s disease,” said Scott Smith, Senior Vice President and Global Head of Inflammation and Immunology. “It strengthens our expanding pipeline of novel therapies intended to address significant unmet medical need in immune-mediated diseases.”
Under the terms of the license agreement, Nogra Pharma Limited will receive an upfront payment of $710 million, regulatory, development and net sales milestone payments and tiered royalties. Aggregate payments for regulatory and development milestones could potentially be $815 million for multiple indications. Starting from global annual net sales levels of $500 million, aggregate tiered sales milestones could total a maximum of $1,050 million if annual net sales reach $4,000 million.
The license agreement will become effective upon the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, today announced that two abstracts related to ADXS-HPV (ADXS11-001), the Company's lead immunotherapy product candidate, have been selected for poster presentation at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 – June 3, 2014, at the McCormick Place in Chicago, IL.
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, will present new data for Metadoxine Extended Release (MDX or MG01CI) at the upcoming 167th Annual Meeting of the American Psychiatric Association (APA) and 69th Annual Scientific Meeting of the Society of Biological Psychiatry (SOBP), both held in New York, NY.
American CryoStem Corporation (OTCQB:CRYO), a leading biotechnology developer and licensor of patented adipose tissue-based adult stem cell technologies, today announced that its ACS Laboratory division has completed its quarterly laboratory R&D program ahead of schedule, yielding new intellectual property and positive results for expanding and differentiating adipose-derived stem cells (ADSCs).
Apricus Biosciences, Inc. (Nasdaq:APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced that the Spanish Agency for Medicines and Health Products (AEMPS) has granted national phase approval to Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED").
Cerner Corporation (Nasdaq: CERN) today announced results for the 2014 first quarter that ended March 29, 2014, delivering strong levels of bookings and revenue performance.
Chembio Diagnostics, Inc. (Nasdaq:CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, announced today that the Company will release financial results for the first quarter of 2014, before the opening of the market on Thursday, May 8, 2014.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced that HIFU for the primary treatment and salvage therapy of localized prostate cancer are recommended by the European Urology Association in its 2014 Guidelines released in April at the EAU's Annual Congress held in Stockholm.
SoldierSocks, a non-profit foundation focused on helping veterans, announced today that VA Boston Healthcare System (West Roxbury campus) is the next recipient of an Ekso Bionics™ suit (OTCQB:EKSO). The Ekso GT™ will help injured veterans walk again.
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that the company will host a conference call on Thursday, May 1, at 4:30 p.m. EDT to discuss its first quarter 2014 financial results and provide an operational update.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that the 2014 Award for Excellence in Technology Transfer was granted to The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and the Uniformed Services University of the Health Sciences (USU).
GeneNews Limited (TSX:GEN) today announced that its recently formed joint venture, Innovative Diagnostic Laboratory LLP ("IDL"), has added Beckman Coulter Diagnostics' Prostate Health Index (phi) to its menu of advanced cancer assays and has initiated a commercial roll out of this groundbreaking test across the United States.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), today announced that Mike Kosloske, Chief Executive Officer, and Jim Dietz, Chief Financial Officer, of HII will present an overview of the company at the following upcoming investor conferences: Deutsche Bank 39th Annual Health Care Conference, on Thursday, May 8, 2014 at 10:40 a.m. EDT. The conference is being held at The InterContinental Hotel in Boston, Massachusetts. Bank of America Merrill Lynch 2014 Health Care Conference, on Wednesday, May 14, 2014 at 2:20 p.m. PDT. The conference is being held at the Encore at Wynn Las Vegas, Las Vegas, Nevada.
Hemp, Inc. (OTC:HEMP) subsidiary, The Industrial Hemp and Medical Marijuana Consulting Company (IHMMCC), today announced the average trading volume of the companies they have signed consultant agreements with.
IntelGenx Corp. (TSX-V:IGX) (OTCQX: IGXT), a Canadian drug delivery company focusing on oral drug delivery, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, today reported that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of their response to the Complete Response Letter ("CRL") for the VersaFilm™ Oral Film Product New Drug Application ("NDA") and has requested further clarifications.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced the initiation of a Phase 2 trial of its novel, oral Selective Inhibitor of Nuclear Export (SINE) compound Selinexor (KPT-330) in patients with advanced gynecologic malignancies including cervical, ovarian and uterine carcinomas.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced it will release its first quarter 2014 operating results and will host an investor call and webcast at 4:30 p.m. ET on Thursday, May 8, 2014.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that it will be releasing iConnect® Retinal Screening, an, end-to-end retinal screening solution, allowing providers to quickly identify and diagnose patients with diabetic retinal disease.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced record sales of $119.2 million for the quarter ended March 31, 2014, an increase of 15% over sales of $103.9 million for the quarter ended March 31, 2013.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announced today that the U.S. Patent & Trademark Office has granted Neptune a new continuation patent (U.S. Patent No. 8,680,080) relating to the treatment of Alzheimer's.
Oxford Immunotec Global PLC (Nasdaq:OXFD) today announced that it plans to release first quarter 2014 financial results prior to market open on Tuesday, May 6, 2014.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT), a Canadian drug delivery company focusing on oral drug delivery, today reported that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of their response to the Complete Response Letter ("CRL") for the RHB-103 New Drug Application ("NDA") and has requested further clarifications.
Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI), a leading provider of essential hygiene and sanitizing solutions, announced today that its Board of Directors has approved and Swisher has requested to voluntarily delist its shares from the Toronto Stock Exchange ("TSX").