Amgen’s (AMGN) and UCB's drug Evenity (romosozumab), which, in long and large 24 months of clinical investigation has demonstrated superior results in reducing new vertebral, non vertebral and clinical bone fractures, has demonstrated a heart-related side effects. At the weekend Amgen announced results from Phase 3 trials demonstrating that its product Evenity (romosozumab) met the primary and secondary endpoints of the trials, which relate to  reducing the …

As a matter of fact, we consider Incyte’s (INCY) drug epacadostat’s good results extremely important. The reason? Two facts are currently settled in researchers’ and oncologists’ minds. These are: 1. Checkpoint inhibitors require effective combination therapy to boost their limited efficacy, or at least to improve their efficacy, especially in solid tumors. 2. IDO inhibition is recognized as central for immunotherapy success. Both facts have been proven …

PTC THERAPEUTICS Why Buying Emflaza? Buying Emflaza, a steroid approved by the FDA for Duchenne muscular dystrophy (DMD) from Marathon Pharmaceuticals invited an intractable headache to PTC Pharmaceuticals’ shareholders and scrutiny by some law makers. The cause of the law makers’ involvement has been the Marathon’s pricing Emflaza at $89,000, but PTCT shareholders had several question marks revolving around the motive for buying this drug …

AKEBIA THERAPEUTICS? Akebia Therapeutics (AKBA) whose stock trades on the NASDAQ is outperforming. The firm’s drug vadadustat — an oral hypoxia-inducible factor (HIF) stabilizer in Phase 3 trial for anemia associated with chronic kidney disease (CKD) is attracting attention, which led to a lucrative agreement. The enthusiasm towards this firm’s product vadadustat stems from the fact that it is an orally administered drug, which makes …

GENE EDITING Sangamo Biosciences: Is it a Comeback? Genome editing allows the creation of therapeutics that can modify the genome in a living cell, providing unprecedented reach that would help the creation of treatments for genetic diseases. The dream about emerging solutions through genome editing techniques, which could correct genetic mutations causing diseases seems to be turning into reality. Among the innovative firms in this …

AT A GLANCE IMPORTANT NEWS A New FDA Commissioner The U.S. Senate Voted in Favor of Scott Gottlieb as the FDA Chief – Dr. Gottlieb, a medical doctor graduated from Mount Sinai – He held a high ranking position in the FDA during George W. Bush’s Presidency – Senators who voted for based their choice on Mr. Gottlieb’s knowledge of the FDA and of the …

Positive results were announced from Array’s (ARRY) Part 2 of the Phase 3 COLUMBUS study evaluating the firm’s MEK inhibitor drug binimetinib, and its BRAF inhibitor drug encorafenibin in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The part 2 of the Phase 3, which intended to compare progression free survival (PFS) in patients treated with binimetinib plus encorafenib (COMBO300) to patients treated with encorafenib …

Indeed, Saving One Life is Important. Yet, Important Too is Saving Many Lives The Risk Vs. The Reward We keep repeating that the CAR-T treatment is created to stay, not because somebody loves the firms developing the CAR-T immunotherapy, but because this novel approach to cancer is saving the lives of the condemned. In addition, many reasons exist that make oncologists and regulators believe that …

EPIZYME Many oncologists, we believe, must be impatient to learn about the outcome of a first-in-class cancer drug based on epigenetics in upcoming oncology conventions. The drug tazemetostat was created and is being developed by Epizyme. Epizyme (EPZM) is a clinical-stage biotech company having proprietary platform, which  enabled it to identify and develop small molecule inhibitors of chromatin modifying proteins (CMPs), such as tazemetostat. CMPs, …

Novartis signed two different separate licensing agreements with two development-stage firms, Bluebird (BLUE) and Celyad (CYAD). The signing of the agreements, enabled Novartis to license the two firm’s proprietary technologies, both related to improving Novartis’ genetically engineered immunooncology CAR- T cells. CELYAD The Celyad/Novartis Agreement Celyad announced a non-exclusive license agreement with Novartis for its US patents issued for the production of allogeneic CAR-T cells. …

MERCK Merck (MRK) has beaten analysts’ expectations generating $9.4 billion for revenues in the first quarter of 2017. Its GAAP EPS was $0.56 for the first quarter of 2017 and the Non-GAAP EPS $0.88 for the first quarter of 2017. The outperformance occurred in spite of the declining sales of some aging drugs, which is a normal recurrent phenomenon especially with the increase in break-through …

MIGRAINE Migraine might have a new potent preventive treatment on the market in the near future. The new breakthrough approach towards migraine treatment aims at targeting and inhibiting calcitonin gene–related peptide (CGPR). Four drug developing firms have ongoing clinical trials with drugs targeting CGPR. These are Amgen/Novartis product erenumab (AMG334); Alder Pharmaceuticals’’ product ALD403 and Teva Pharmaceuticals’ product TEV-48125. Each of the monoclonal antibodies has …

ImmunoGen is one of two firms Prohost selected for investment on February 2011 based on the promises of its novel antibody-drug conjugate (ADC). An ADC drug is an antibody that carries highly potent cancer-killing agent attached to the antibody by a linker. The linker is designed to release an exceptionally toxic agent only as the ADC reaches the cancer cells in order not to harm …

Prohost Letter #408 AT A GLANCE - Continued from the Previous Prohost Letter #408 In the Past issue #407, we picked the following firms: NEUROCRINE BIOSCIENCES (NBIX) Treating Tardive Dyskinesia CYTOMX Improving On Cancer Immunotherapy CELYAD SA (CYAD) Bringing Solutions To Immunotherapy Problems Please Read the articles written about these firms in the Issue #407 In This Issue We Add  NEW LINK GENETICS...

Prohost Letter #407 AT A GLANCE - Firms Added to Prohost Portfolio PROHOST IS PICKING NEUROCRINE BIOSCIENCES   On March 27, a few days before the FDA approves Neurocrine’s (NBIX) drug Ingrezza, (valbenazine) capsules for adults with tardive dyskinesia (TD), we posted an article titled “Time for Transformation and Achievements”. In the article, we stated that Neurocrine Sciences Ingrezza will highlight Neurocrine Biosciences and its …

Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to determine the most appropriate doses. The FDA also stated that additional data are necessary for further characterization of safety concerns across treatment arms. The timing …

On March 27, we wrote about how positive results of Neurocrine Biosciences (NBIX) drug Ingrezza on Tardive Dyskinesia (TD) will highlight Neurocrine Biosciences and its Scientists. We wrote: The results published online by The American Journal of Psychiatry demonstrate that Phase 3 trial with Ingrezza conducted on patients with tardive dyskinesia showed significant and meaningful reduction in symptoms. We elaborated on the trial that provided …

CANCER IMMUNOTHERAPY 2 Nonstop Improvements and Nonstop Discoveries In CAR-T Immunotherapy As we said in the article about checkpoint inhibition as cancer immunotherapy, the approaches that aim at enabling the immune system to fight cancer cells were created to stay and improve and become the gold standard for cancer treatment. Chimeric antigen receptor T cell (CAR-T) therapeutics are speeding their way towards approval in 2017. …

The FDA Approves Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection First HCV Direct-Acting Antivirals Approved for Adolescents Gilead Sciences (GILD) announced that the FDA has approved its supplemental application for its HCV drugs HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg) for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection and its HCV drug SOVALDI® …

CANCER IMMUNOTHERAPY Nonstop Improvements and Nonstop Discoveries Checkpoint inhibitors and CAR-T immunotherapy are created to stay and succeed and change the way cancer has been treated for decades. The reason is that the successful results from some early attempts to enable the immune system to attack and fight cancers through these new immunotherapy approaches were unmatched in the history of cancer treatments. These successes, though, …