|ARIAD Announces Commercial Availability of Iclusig; Medtronic Reports Early FDA Approval for CorValve System|
|By Staff and Wire Reports|
|Friday, 17 January 2014 20:01|
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced the commercial availability of Iclusig® (ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States. ARIAD has begun shipping Iclusig to Biologics, Inc., its exclusive specialty pharmacy, which is now filling prescriptions from physicians and distributing the cancer medicine to patients.
“We are pleased to again have Iclusig commercially available to patients in the United States,” stated Marty J. Duvall, executive vice president and chief commercial officer for ARIAD. ”Iclusig is now in our distribution channel with Biologics, and our dedicated sales force will begin promoting Iclusig immediately. We are highly confident in our commercial launch of Iclusig and look forward to reporting on our progress on a quarterly basis.”
Last month, the U.S. Food and Drug Administration (FDA) approved revised U.S. Prescribing Information (USPI) and a communications Risk Evaluation and Mitigation Strategy (REMS) for Iclusig that allowed for the immediate resumption of its marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers. Iclusig is now indicated for the treatment of adult patients with:
* T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, or * Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated.
The starting dose of Iclusig remains 45 mg daily.
On November 1, 2013, there were approximately 640 patients receiving Iclusig obtained through commercial channels in the U.S. Since then, Iclusig was made available through emergency and single-patient investigational new drug (IND) applications, which were reviewed and approved by the FDA on a case-by-case basis. The FDA has approved more than 370 INDs since early November, and more than 300 patients have received Iclusig at no cost through this process. ARIAD expects most of these patients, many of whom received a three-month supply of Iclusig, to transition from the IND program to commercial therapy by the end of the first quarter of 2014. The Iclusig IND program is now closed to new patients with Philadelphia-positive leukemias.
In addition to providing specialty pharmacy services, Biologics will help transition patients from the Iclusig IND program to commercial product. Biologics will further support the ARIAD Patient Access and Support Services (ARIAD PASS™) program by managing ARIAD's reimbursement and patient access services and co-pay support programs by conducting benefits investigations and prior authorizations to assess and assist with patient eligibility. Iclusig is currently priced in the U.S. at approximately $125,000 per year. The new annual cost of Iclusig is approximately a 17 percent premium to second-generation TKIs.
Medtronic, Inc. (NYSE: MDT) announced the U.S. FDA approval of the self-expanding transcatheter CoreValve® System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Untreated, these patients have a risk of dying approaching 50 percent at one year.
The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which demonstrated that the CoreValve System is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported.
The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA). At one month, the rate of stroke was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the U.S. pivotal Trial, demonstrated even better survival and stroke performance. [i]
"The low rates of stroke and valve leakage with the CoreValve System - two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life - set a new standard for transcatheter valves," said Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, and co-principal investigator of the Trial. "The CoreValve U.S. Pivotal Trial was rigorously designed and applied clinical best practices. The trial results have redefined optimal TAVR outcomes in the areas that matter most to physicians and their patients, and the results are especially remarkable given the complex medical conditions and extreme frailty of this population."
Actavis plc (NYSE: ACT) today confirmed that the United States District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals, Inc. and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).
BioMed Realty Trust, Inc. (NYSE: BMR) today announced the tax treatment of its 2013 distributions as follows: Security Description: Common Stock, CUSIP: 09063H107, Ticker Symbol: BMR.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that CEO Mark McDonough is scheduled to participate in the RedChip Emerging Growth Showcase at 2:00 pm EST on Thursday, January 23, 2014, at www.redchip.com.
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 Mark J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the Noble Financial Capital Markets "X" Tenth Annual Equity Conference.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced the first scientific presentation of results from the Phase 1b portion of its ongoing ALPINE (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) Phase 1b/2 clinical study of OMP-59R5 (anti-Notch 2/3) in patients with advanced pancreatic cancer. OMP-59R5 is part of OncoMed's collaboration with GlaxoSmithKline (GSK).
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented data today from its ongoing Phase 1b clinical trial of demcizumab (OMP-21M18; anti-DLL4) in first-line Stage IV pancreatic cancer patients at the 2014 Gastrointestinal Cancers Symposium being held in San Francisco, California.
Onconova Therapeutics, Inc. (Nasdaq:ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that it will webcast a presentation by Dr. E. Premkumar Reddy of recent studies regarding the mechanism of action for rigosertib.
Sharps Compliance Corp. (Nasdaq:SMED) announced today that it will release its second quarter and six month results for the period ended December 31, 2013 before the opening of the financial markets on Tuesday, January 28, 2014.