|Amgen Declares a Head-to-Head Phase III Win for Humira biosimilar; Conatus Reports Acceptance of Abstract for AASLD Meeting|
|By David Fowler|
|Wednesday, 08 October 2014 18:57|
Amgen (NASDAQ: AMGN) has claimed gaining regulatory approval for its biosimilar of Humira, AbbVie's (NYSE: ABBV) megablockbuster anti-inflammatory drug. The Big Biotech reports now that its clone of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis.
Amgen didn't spell out the actual data, but it declared victory in the first of two planned Phase III studies comparing its follow-on drug with Humira (adalimumab), which made $10.7 billion last year for use against a range of diseases like psoriasis, rheumatoid arthritis, Crohn's disease, ulcerative colitis and more. Humira currently accounts for 60% of AbbVie's revenue and loses patent protection in the U.S. in 2016 and in Europe in 2018.
The primary endpoint of the Phase III was the Psoriasis Area and Severity Index, or PASI, percent improvement from baseline to week 16 of treatment.
Amgen was in the first wave of developers to stake out a plan to manufacture biosimilars, and Humira is a prime target in the field. Most analysts expect these biosimilars will carve 20% to 30% off the price of the branded biologic, a hefty discount but nothing close to the huge price cuts associated with traditional generics.
Amgen is also likely to face a host of newly approved biologics with a better efficacy and safety profile for psoriasis, including one of its own experimental therapies. Novartis ($NVS), Celgene ($CELG) and a partnership of AstraZeneca ($AZN) and Amgen for brodalumab have all been hard at work. And Amgen is not alone in developing biosimilars to Humira. Sandoz started its Phase III program for its knockoff at the end of last year. And Coherus, which is targeting niche markets, also has one in the pipeline.
"Results from Amgen's biosimilar Phase III plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the company's commitment to provide patients with access to high-quality medicines," said Dr. Sean Harper, the head of R&D at Amgen. "We look forward to continuing to leverage our experience and expertise in biotechnology to bring biosimilars to patients."
Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) announced its late-breaking abstract was accepted for a poster presentation at The Liver Meeting(R), the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014. The poster, entitled "Rapid and statistically significant reduction of markers of apoptosis and cell death in subjects with mild, moderate and severe hepatic impairment treated with a single dose of the pan-caspase inhibitor, emricasan," will be presented on Monday, November 10, 2014. The abstract is available at www.aasld.org/.
In the abstract, Conatus disclosed that its lead drug candidate, the orally active pan-caspase protease inhibitor emricasan, reduced key biomarkers in a recently completed, single-dose, pharmacokinetic (PK)/pharmacodynamic (PD) Phase 1 clinical trial in subjects with mild, moderate or severe hepatic impairment (defined using the Child-Pugh criteria). Emricasan was administered to 28 subjects with hepatic impairment and 8 matched control subjects, and serial blood samples were collected over a 48 hour period. Levels of three key biomarkers of apoptosis (caspase-cleaved cytokeratin 18), cell death (full-length cytokeratin 18), and caspase enzymatic activity (caspase 3/7) were elevated at study baseline correlating to disease severity, and demonstrated rapid and statistically significant reductions after a single 50 mg oral dose of emricasan in all hepatic impairment subjects.
"We are encouraged by emricasan's ability to reduce key disease-elevated biomarkers of caspase activity, apoptosis and cell death rapidly after even a single dose," said Conatus President and Chief Executive Officer, Steven J. Mento, Ph.D. "Our ongoing Phase 2 trials in patients across a broad spectrum of liver disease are designed to assess whether reductions of these potential drivers of liver disease progression result in corresponding clinical benefit."
The company is conducting three clinical trials investigating the PK and PD activity of emricasan in patients with impaired organ function to support dose selection and prioritization for advancement in its overall clinical development program: the Phase 1 clinical trial in patients with various degrees of hepatic impairment described above; a Phase 1 clinical trial in patients with severe renal impairment; and a Phase 2b clinical trial in patients with acute-on-chronic liver failure (ACLF) who may have simultaneous impairment of both liver and kidney function as well as other organ involvement. Preliminary PK data from the Phase 1 hepatic impairment trial and Phase 1 severe renal impairment trial were sufficient to identify the appropriate patients for inclusion in a recently initiated Phase 2 clinical trial in patients with liver cirrhosis. Since patients with variable degrees of liver and kidney function are expected to be assessed in future clinical trials, final PK data from all three of the above clinical trials will be evaluated in the aggregate after completion of the ACLF trial, and are expected to inform on optimal dosing of emricasan in future studies in potential target patient populations.
Abattis Bioceuticals Corp. (OTCQX:ATTBF) (CSE:ATT), a specialty biotechnology company focused on cultivating, licensing, and marketing proprietary ingredients, bio-similar compounds, equipment, and consulting services to North American medicinal markets, today announced that through its wholly owned subsidiary, Northern Vine Canada Inc. ("Northern Vine"), Experion Biotechnologies Inc. ("Experion") has received a written update from the Fraser Valley Regional District on the amended zoning regulations for its property which has now been approved for… "the use of cultivation, growth, storage, or distribution, testing, or research, of marijuana for medical purposes as lawfully permitted and authorized under the applicable federal or provincial law."
Accuray Incorporated (Nasdaq:ARAY) announced today that it will report results for its first quarter ended September 30, 2014 on October 29, 2014 after the market closes.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced the appointment of world renowned oncologist and research scientist, Dr. Samir N. Khleif, to the Company's Board of Directors.
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that clinical trial results related to its investigational drug RAPIVAB (peramivir injection), an intravenous (I.V.) neuraminidase inhibitor for the treatment of influenza, will be presented at the IDWeek Conference in Philadelphia October 8-12, 2014.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, October 23, at 4:30 p.m. ET to discuss third quarter 2014 financial results and provide a general business update.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that Douglas Winship, Vice President of Regulatory Operations, will present top-line safety and efficacy results from Catalyst's Phase 3 FirdapseTM trial at the 139th Annual Meeting of the American Neurological Association being held at The Baltimore Waterfront Marriott, October 12-14.
Cerulean Pharma Inc. (Nasdaq:CERU), a leader in Dynamic Tumor Targeting™, today announced the addition of Susan L. Kelley, M.D., to the company's board of directors.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today preliminary data for its investigational antiviral brincidofovir (BCV, CMX001) showing improved survival for patients with adenovirus in the open-label pilot portion of the Phase 3 AdVise Trial.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced that its late-breaking abstract was accepted for a poster presentation at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014.
The Cooper Companies, Inc. (NYSE:COO) today announced that CooperSurgical, its women's healthcare unit, has acquired EndoSee Corporation, a developer of an office-based disposable hysteroscopy system.
Coronado Biosciences, Inc. (Nasdaq:CNDO) has formed a wholly owned subsidiary, Journey Medical Corporation (JMC), to acquire and license dermatology products. Under the leadership of Claude Maraoui, CEO, JMC will begin building a portfolio of dermatological assets focused on acne, steroid responsive dermatoses, pigmentation and antifungals for promotion to dermatologists and pediatricians.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the Notice of Allowance of a U.S. patent application covering methods of treating patients having any HER2/neu expressing cancer by administering NeuVax™ (nelipepimut-S) in combination with Herceptin® (trastuzumab; Genentech/Roche).
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver and intestinal diseases, today announced upcoming presentations of data at the upcoming American Academy for the Study of Liver Diseases (AASLD) Annual Meeting (the Liver Meeting®), being held in Boston, Massachusetts from November 7-11, 2014.
Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced publication of positive data from three studies evaluating the company's drug eluting sinus implants.
Medgenics, Inc. (NYSE:MDGN) will host a conference call and live audio webcast on Wednesday, October 15, 2014 at 9 a.m. EDT to discuss third quarter 2014 financial and operational results and to provide initial clinical data from the ongoing MDGN-201 clinical trial, "Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients and End-Stage Renal Disease (ESRD) Dialysis Patients using TARGTEPO™ (formerly known as EPODURE™ BioPump™).
MediciNova, Inc., (Nasdaq:MNOV) a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it has received feedback from FDA's Division of Gastroenterology and Inborn Errors Products regarding the study protocol and drug substance information for a Phase 2 clinical trial of MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH).
MRI Interventions, Inc. (OTCQB:MRIC) today announced its participation as an exhibitor at two major medical conferences this Fall.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the appointment of R. Bryan Riggsbee as executive vice president, Chief Financial Officer, and Treasurer effective October 16, 2014.
Natus Medical Incorporated (Nasdaq:BABY) today announced that the Company will release its 2014 third quarter financial results before the market opens on Wednesday, October 22.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announced today that it will be holding a conference call on Wednesday October 15 at 9:00 AM (ET) to present its results for the second quarter ended August 31, 2014.
RedChip Companies, Inc., an international small-cap research, investor relations, and media company, today announced that "The RedChip Money Report: Small Stocks Big Money"™ television program is featuring interviews with NETGEAR (Nasdaq:NTGR), Akers Biosciences (Nasdaq:AKER), and TOP Ships (Nasdaq:TOPS) this week on Bloomberg television.
Vical Incorporated (Nasdaq:VICL) announced today the issuance of six U.S. patents that provide broad coverage of DNA vaccines for herpes simplex virus type 2 (HSV-2), containing specific gene sequences and formulated with Vical's Vaxfectin® adjuvant.