FDA Grants Seven Years' Market Exclusivity to Eagle Pharmaceuticals' Ryanodex; Bristol-Myers Aquires Flexus Biosciences' Pipeline Print E-mail
By Josh Gee   
Monday, 23 February 2015 19:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 23, 2015.
Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) confirmed the U.S. Food and Drug Administration (FDA) has granted seven years of market exclusivity in the U.S. to Ryanodex® (dantrolene sodium) for Injectable Suspension for the treatment of malignant hyperthermia (MH). Ryanodex was designated an orphan drug in August 2013 and was approved by the FDA in July 2014 for this indication.

 “We are very pleased that the anticipated market exclusivity for this important orphan drug has been formally granted”

“We are very pleased that the anticipated market exclusivity for this important orphan drug has been formally granted,” said Scott Tarriff, President and Chief Executive Officer. “The response to Ryanodex has been positive since its launch late last August, and we look forward to further market penetration going forward.”


 

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Bristol-Myers Squibb Company (NYSE: BMY)
and Flexus Biosciences, Inc. announced the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of Flexus, a privately held biotechnology company focused on the discovery and development of novel anti-cancer therapeutics. The transaction has a potential total consideration of $1.25 billion, including $800 million upfront and development milestones that, upon achievement, could total up to $450 million. The transaction has been approved by the boards of directors of both companies and by the stockholders of Flexus.

The acquisition will give Bristol-Myers Squibb full rights to F001287, Flexus’ lead preclinical small molecule IDO1-inhibitor targeted for IND filing in the second half of 2015. In addition, Bristol-Myers Squibb will acquire Flexus’ IDO/TDO discovery program which includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.

“Bristol-Myers Squibb is committed to leading scientific advances in immuno-oncology and our acquisition of Flexus will expand our innovative pipeline with an important approach to enhancing immune responses in cancer,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. “With the addition of a potentially best-in-class IDO1 inhibitor and the broad IDO/TDO programs, Bristol-Myers Squibb will accelerate its ability to explore numerous immunotherapeutic approaches across tumor types, including combinations with our biologic checkpoint and co-stimulatory agents that target different and complementary pathways.”

“Bristol Myers Squibb is a recognized leader in the cancer immunotherapy field, and we are delighted with the opportunity to have their organization advance the development of our potentially best-in-class IDO/TDO inhibitors and to bring more innovative cancer immunotherapies to patients,” said Terry Rosen, Ph.D., Chief Executive Officer of Flexus Biosciences. “With the consummation of this acquisition, we will continue to advance our oncology and immuno-oncology pipeline of Agents for Reversal of Tumor Immunosuppression (ARTIS) in the newly created spin-off, with the strong support of our committed group of investors.”

Bristol-Myers Squibb and Flexus anticipate the transaction will close during the first quarter of 2015. Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Citi acted as exclusive advisor to Flexus on the transaction and Gunderson Dettmer acted as legal counsel. Kirkland & Ellis LLP is serving as legal advisor to Bristol-Myers Squibb in connection with the transaction.



 
Also Monday:




Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, will present a corporate overview at the 35th Annual Cowen and Company Annual Health Care Conference, taking place March 2, 2015 through March 4, 2015 in Boston, Massachusetts.

Amarantus BioSciences Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on developing diagnostics in neurology, and therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that its abstract titled, "The LymPro® Assay: A Biomarker For Alzheimer's Disease Using Blood Samples From Clinically Diagnosed Alzheimer's Disease And Cognitively Intact Subjects," was accepted for poster presentation at the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PDTM 2015) being held March 18-22, 2015, in Nice, France.

Biocept, Inc. (Nasdaq:BIOC)
, a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), today announced that its blood-based diagnostic, OncoCEE-BR™, was used to determine hormonal status of metastatic breast cancer patients in a prospective study performed at the Columbia University College of Physicians and Surgeons in New York City.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
today announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega®) Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM).

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
today announced that Chief Executive Officer Bob Palay is scheduled to present at the Cowen and Company 35th Annual Health Care Conference to be held March 2-4, 2015, in Boston.

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 year of 2014, before the opening of the market on Thursday, March 5, 2015.

Coherus BioSciences, Inc. (Nasdaq:CHRS)
, a late-stage clinical biologics platform company focused on the global biosimilar market, today announced that it will present at the Cowen and Company 35th Annual Health Care Conference on Monday, March 2 at 4:10 pm ET in Boston.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced it has entered into a contractual agreement with Fortified Provider Network ("FPN") for coverage of CombiMatrix's suite of diagnostic laboratory services.

Digirad Corporation (Nasdaq:DRAD)
will release financial results for its fourth quarter and year ended December 31, 2014, before the market opens on Friday, March 6, 2015.

Endocyte, Inc., (Nasdaq:ECYT)
announced today that the company will host a conference call on Monday, March 2, at 8:30 a.m. EST to discuss its fourth quarter and full year 2014 financial results and provide an operational update.

Heat Biologics, Inc. (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that it will host a Key Opinion Leader breakfast focused on current advances in bladder cancer immunotherapy. The event and live webcast will take place on Thursday, February 26 from 8:00am-9:30am Eastern Time in New York City.

Hemispherx Biopharma, Inc. (NYSE:HEB)
, announced today that a new report, issued February 10, 2015 by the Institute of Medicine (IOM) of the National Academy of Sciences, recommends that the disorder previously known as Chronic Fatigue Syndrome (CFS) be changed to Systemic Exertion Intolerance Disease (SEID) – in the Institute's words – "to more accurately capture the central characteristics of the disease".

Histogenics Corporation (Nasdaq:HSGX)
, a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced that Adam Gridley, President and Chief Executive Officer of Histogenics, will present at the Cowen and Company 35th Annual Health Care Conference on March 2, 2015 at 4:50 pm Eastern time at the Boston Marriott Copley Place in Boston.

ICU Medical, Inc. (Nasdaq:ICUI)
, a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced that Company management will be presenting at the Raymond James 36th Annual Institutional Investors Conference to be held on March 1-4, 2015 at the JW Marriott Grande Lakes Hotel in Orlando, Florida and at the 27th Annual ROTH Conference to be held on March 8 – 11, 2015 at the Ritz-Carlton Hotel in Laguna Niguel, California.

Kite Pharma, Inc., (Nasdaq:KITE)
, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that Arie Belldegrun, M.D., FACS, President and Chief Executive Officer, will present a company overview at the Cowen and Company 35th Annual Health Care Conference on Monday, March 2, 2015 at 1:30 p.m. Eastern Time.

Kyocera Communications Inc., North America's leading supplier of ruggedized mobile devices, and Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that they have completed interoperability testing on an integrated mobile healthcare solution for remote patient monitoring.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of innovative enterprise imaging, interoperability, and clinical systems that seek to advance healthcare, announced today the scheduling of its fourth quarter 2014 earnings call, which will be held at 8:30 AM ET on Thursday, February 26th, 2015.

NXP Semiconductors (Nasdaq:NXPI)
has today announced that as a result of a partnership with Sonova – the leading manufacturer of innovative hearing care solutions – they have collaboratively developed Venture, a landmark next-generation hearing instrument platform, which offers users exceptional performance.

Ocera Therapeutics, Inc. (Nasdaq:OCRX)
, a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that company management will be presenting at the 35th Annual Cowen and Company Health Care Conference being held at the Boston Marriott Copley Place in Boston, MA.

Relypsa, Inc. (Nasdaq:RLYP)
, today announced that John A. Orwin, president and chief executive officer, will present at the Cowen and Company 35th Annual Healthcare Conference on March 3, 2015 at 8:40 a.m. ET.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it will hold its quarterly conference call to discuss fourth quarter and fiscal 2014 financial results on Thursday, February 26, 2015 at 4:30pm Eastern Time.

Signal Genetics, Inc. (Nasdaq:SGNL)
(Signal), a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, announced the closing of its previously announced underwritten public offering of 3,214,285 shares of its common stock at a price to the public of $2.80 per share.

Trinity Biotech plc. (Nasdaq:TRIB)
, a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced that late last week it shipped Meritas Troponin I product to the USA for the immediate recommencement of US clinical trials on its Troponin I point-of-care product.

uniQure N.V. (Nasdaq: QURE)
, a leader in human gene therapy, today announced that its management will present a corporate overview at the Cowen and Company 35th Annual Healthcare Conference March 2-4, 2015, to be held at the Boston Marriott Copley Place, Boston, MA, USA.

Versartis, Inc. (Nasdaq:VSAR)
, an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced that Jeffrey L. Cleland, PhD, Chief Executive Officer, is scheduled to present at the Cowen and Company 35th Annual Health Care Conference on Tuesday, March 3, 2015 at The Boston Marriott Copley Place in Boston, Massachusetts.

Vital Therapies, Inc. (Nasdaq:VTL)
, a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of acute liver failure, will visit the Nasdaq MarketSite in Times Square.




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