|Horizon Pharma Issues Update on CV Risk of NSAIDs; KaloBios Initiates Phase 2 Expansion Portion of Study of KB004|
|By Staff and Wire Reports|
|Tuesday, 11 February 2014 20:33|
Horizon Pharma, Inc., (NASDAQ: HZNP), a commercial stage, specialty pharmaceutical company which markets two gastroprotective nonsteroidal anti-inflammatory drugs (NSAIDs), VIMOVO(R) (naproxen/esomeprazole magnesium) and DUEXIS(R) (ibuprofen and famotidine), announced that the FDA joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee was split on whether the data show adequate differences in cardiovascular risk among NSAIDs to support labeling change for NSAIDs due to cardiovascular (CV) risk. The committee found that there was not enough data at this time to differentiate among the NSAIDs. During the discussion, the committee did recognize the risk of gastrointestinal (GI) events when taking NSAIDs. The FDA will take the committee's discussion into consideration and will make the final determination in this matter.
"Osteoarthritis and rheumatoid arthritis are often highly debilitating and the source of significant distress for millions of people, yet the potential cardiovascular risks associated with NSAIDs can be a treatment barrier for many patients," said Alfonso E. Bello, M.D., director of clinical research, Illinois Bone and Joint Institute and clinical associate professor of medicine, University of Illinois College of Medicine. "The committee discussion reinforces the potential CV risk of NSAIDs and the need for physicians to discuss this with their patients. While the committee vote was split, the committee did acknowledge the potential to differentiate naproxen from the other NSAIDs. While we still need to determine how best to manage the CV risk, we can manage the more common risk of GI events through gastroprotection."
"Recognizing that individuals respond differently to NSAIDs, we make available two prescription strength NSAID options, VIMOVO(R) and DUEXIS(R), both of which have demonstrated a significant reduction in gastrointestinal ulcers, allowing prescribers the ability to treat a broad range of arthritis patients," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma. "We are committed to bringing safe and effective treatment options to patients."
KaloBios Pharmaceuticals (Nasdaq: KBIO) announced that the company has begun treating patients in the Phase 2 expansion portion of study KB004-01 evaluating KB004, the company's anti-EphA3 Humaneered® monoclonal antibody (mAb).
"We are pleased to have begun the Phase 2 portion of our Phase 1/2 study, which will focus on EphA3 positive patients only," said Nestor A. Molfino, MD, MSc, Chief Medical Officer of KaloBios. "The ongoing Phase 1 dose-escalation portion of this study has shown some signs of clinical activity, and has demonstrated KB004 to be well-tolerated, with transient infusion reactions being the most common side effects."
The Phase 2 expansion portion of the study will be comprised of both low dose and high-dose cohorts, and the company is currently targeting enrollment of 10 AML patients at the low dose of 20 mg, as well as 10 AML patients and 10 MDS patients at the high dose. All patients will be prescreened prior to treatment for EphA3 expression and must be refractory to or unsuitable for the current standard of care. The primary endpoint for this portion of the study is clinical activity, and secondary endpoints include pharmacokinetic measurements. The company will continue to evaluate safety and tolerability as well.
"We expect to complete enrollment of at least one of the two currently planned indications for this Phase 2 expansion portion by the end of this year, and would expect to announce top-line data for the AML or MDS cohorts mid-2015. Given the open label nature of the study, we will be monitoring patient responses closely throughout the trial," said Dr. Molfino.
Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, and SynCo Bio Partners B.V. (SynCo), one of the leading GMP contract manufacturers of biopharmaceuticals, announced today that they have signed an agreement for SynCo to manufacture Advaxis' novel drug candidate, ADXS-HPV.
AeroGrow International, Inc. (OTCQB: AERO), which sells the Miracle-Gro AeroGarden® line of high-output, soil-free indoor gardens, seed pod kits and accessory items, announced results for the quarter ended December 31, 2013, the third quarter of AeroGrow's 2014 fiscal year.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, announced today that a jury in the OrthoTec, LLC vs. Surgiview S.A.S. case pending before the Superior Court of California, Los Angeles County, reached a verdict.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases, today announced that William D. "Chip" Baird, Chief Financial Officer and Bradley L. Campbell, Chief Operating Officer, will participate in a presentation and fireside chat at the 2014 Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 1:25 p.m. ET.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, and Epocrates, the developer of the #1 medical application among U.S. physicians, today announced two point-of-care innovations to improve providers' access to information in moments of care.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has selected a new drug development candidate, BMN 250, a novel fusion of alpha-N-acetyglucosaminidase (NAGLU) with a peptide derived from insulin-like growth factor 2 (IGF2), for the treatment of Sanfilippo B syndrome or Mucopolysaccharidosis type IIIB (MPS IIIB). BioMarin has initiated IND-enabling studies and expects to initiate clinical studies with BMN 250 in mid-2015.
In a release issued under the same headline earlier today by Cellectar Biosciences, Inc., formerly known as Novelos Therapeutics. Inc. (OTCQX:NVLT) please note that in the seventh paragraph, a change has been made.
CollabRx, Inc. (Nasdaq:CLRX) today announced financial results for the third quarter of fiscal year 2014, which ended December 31, 2013.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today the installation of its Focal One device at the ESKULAP Private Hospital in Bydgoszcz, Poland.
The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign(TM) group of skilled nursing, rehabilitative care services, assisted living, home health and hospice care and urgent care companies, announced today that it expects to issue its fourth quarter and fiscal year 2013 financial results on Thursday, February 13, 2014.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today the pricing of its initial public offering of 5,000,000 shares of common stock at a price to the public of $13.00 per share.
ImmuDyne, Inc. (OTCQB:IMMD) announced today that it has established a partnership with leading physicians of the Stone Center of New Jersey for its new nutritional supplements; iNR Wellness and iNR Wellness MD.
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced that trading of NephroGenex (Nasdaq:NRX), a drug development company focusing on kidney disease, commenced on The NASDAQ Stock Market on February 11, 2014.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced results for the fourth quarter and year-end 2013.
Novelos Therapeutics, Inc. (OTCQX:NVLT), a biopharmaceutical company developing novel agents for the detection and treatment of cancer, announced that, effective today, its corporate name will be "Cellectar Biosciences, Inc."
Onconova Therapeutics, Inc. (Nasdaq:ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that Ramesh Kumar, Ph.D., President and CEO, will present at the 2014 Leerink Global Healthcare Conference in New York, NY.
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today financial results for the fourth quarter and full year ended December 31, 2013.
Revance Therapeutics, Inc. (Nasdaq:RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, announced today the closing of its initial public offering of 6,900,000 shares of common stock at a public offering price of $16.00 per share.
SANUWAVE Health, Inc. (OTCBB:SNWV) today announced that it has signed an agreement with Wirthlin, a Dentons Innovation Group Partnership (Wirthlin-Dentons), to provide strategic advisory services and to establish a joint venture company that will license its dermaPACE® device and create a sales and distribution system for the GCC – defined as the Kingdom of Saudi Arabia, United Arab Emirates, Kuwait, Qatar, and Bahrain.
Sigma-Aldrich Corporation (NASDAQ: SIAL), a leading Life Science and High Technology company, announced an increase of 7% in its quarterly cash dividend to $0.23 per share.
ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of innovative products that process and store adult stem cells, announced today it will report financial results for the fiscal second quarter ended December 31, 2013, on Friday, February 14, 2014.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the first patient has been enrolled in an open-label Phase 2 study to assess safety and clinical effects of triheptanoin, also known as UX007, in patients severely affected by long-chain fatty acid oxidation disorders (LC-FAOD).
Utah Medical Products, Inc. (Nasdaq:UTMD) announces that its Board of Directors approved a quarterly cash dividend of twenty-five cents ($.25) per share of common stock payable on April 2, 2014 to shareholders of record at the close of business on March 18, 2014.
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related conditions and central nervous system disorders, today announced it has made significant progress in preparing for the market launch of ZohydroTM ER (hydrocodone bitartrate) extended-release capsules, approved by the U.S. Food and Drug Administration in October 2013.