The market looks like angry, probably very angry, as stocks are in a severe selloff mood. There will be many explanations like usual, but it is difficult for us to speculate this time over the correctness of the offered explanations, including the Iran Saudi Arabia crisis, which led to an increase in the oil price whose decrease has caused the previous market’s bad mood.
Like all other industrial sectors, the biotech sector is painted with the red blood color, except for two biotech firms: The battered Sunesis (SNSS) and the promising Kite Pharma, (KITE). The Latter firm’s stock was trading up more than $2 in early morning and has given up to the wave of selling, yet, showing fierce resistance at the base line.
Regarding Sunesis, the resistance against the market’s extreme selloff seems to be the outcome of some refreshing news announcing that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed refractory acute myeloid leukemia (AML) in patients aged 60 years and older. The validation confirms that the submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Under Centralized Review, the CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU approval within three months.
The MAA submission will be reviewed in the Centralized Procedure, which if authorized, provides a marketing license valid in all 28 EU member states.
That’s the news, which, although it is surely better than rejecting the application, it does not mean that the drug would be approved.
WeWe heard no news about this firm today, or in the past week, except some change of directors and officers. Some unofficial talk about acquisition and an article asserting that the firm is ready to beat cancer.
heard no news about this firm today, or in the past week, except some change of directors and officers. Some unofficial talk about acquisition and an article asserting that the firm is ready to beat cancer.
Regardless of the reasons or causes that led to the stocks’ selloff, the market has always experienced such periods of frightening craze that are followed by all other possibilities from rallying, to being paralyzed foe a while.
Investors in the stock market are used to this reality, yet, they are also used to get frightenened, temporarily pessimistic, angry and then forget it all and resume their interrupted game.
Analyzing The NEWS While Giving Valuable Information on the Galapagos/Gilead Collaboration Agreement.
Questioning why Gilead Sciences (GILD) has gotten interested in collaborating with Galapagos NV (GLPG) on its drug JAK inhibitor drug filgotonib for inflammatory diseases when AbbVie (ABBV) abandoned the same drug and so did Johnson & Johnson is not a bad reasoning. The problem, however, is that those who are questioning are looking at the half empty glass when the glass is half full. Indeed, Abbvie did abandon ship, but because it had already its own JAK 1 inhibitor ABT-494 and Johnson & Johnson did the same because of special circumstances that the firm was experiencing in 2014.
The ignored half full part of the glass was the JAK inhibitors’ demonstrated promising very promising results in clinical trials on inflammatory diseases, including Galapagos’ JAK inhibitor filgotonib and Incyte’s (INCY) JAK 1 & JAK 2 inhibitor, baricitinib developed with Eli Lilly (LLY).
Filgotinib is a highly selective JAK1 inhibitor discovered and developed by Galapagos using its proprietary target and drug discovery technology platform. The DARWIN study results demonstrated filgotinib’s rapid onset of action, potential efficacy, safety and tolerability by rheumatoid arthritis patients. The phase 3 trial for rheumatoid arthritis is due to start anytime now.
Results from the FITZROY phase 2 study for moderate to severe cases of Crohn’s diseasedemonstrated filgotinib’s safety and efficacy as once-daily, oral induction treatment The study achieved the primary endpoint of clinical remission with a significantly higher score in patients treated with filgotinib versus patients receiving placebo. The drug was also well-tolerated, which strengthens its favorable safety profile. Filgotinib is the first JAK inhibitor to show efficacy in Crohn’s disease.
Barcitinib: Incyte’s JAK 1 and JAK 2 Inhibitor
Baricitinib is a once-daily oral selective JAK1 and JAK2 inhibitor developed for the treatment of inflammatory and autoimmune diseases. In the late pivotal trials baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays.
On Nov. 7, 2015 Eli Lilly and Company and Incyte announced detailed data from the pivotal phase 3 RA-BEGIN study, which showed baricitinib alone and in combination with methotrexate were superior to methotrexate monotherapy in helping patients achieve clinical remission. The finding revealed superiority of baricitinib over methotrexate in improving multiple measures of the signs and symptoms of rheumatoid arthritis.
In the RA-BEGIN trial, 584 patients who had limited or no prior treatment with methotrexate and who had never received other conventional or biologic disease-modifying anti-rheumatic drugs (DMARDs) were randomized to methotrexate once weekly, baricitinib 4 mg once daily, or baricitinib daily in combination with methotrexate weekly for up to 52 weeks. The weekly methotrexate dose was increased from 10 mg to 20 mg over 8 weeks.
Improvements compared to methotrexate were seen for baricitinib alone and in combination with methotrexate as early as week 1 for all components of the ACR response (swollen and tender joint counts, pain, patient and physician global assessment of disease activity and physical function). These improvements were maintained at weeks 24 and 52.
Safety: The incidence of treatment-emergent adverse events and serious adverse events, including serious infections, was similar across treatment groups through week 52. No cases of tuberculosis or spontaneous gastrointestinal perforation were reported during the study. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Compared to methotrexate, baricitinib monotherapy was associated with lower rates of liver abnormalities, lymphopenia and adverse events leading to interruption, while the combination of baricitinib plus methotrexate was associated with increases in non-serious infections and adverse events leading to permanent discontinuation.
Lilly and Incyte announced top-line results in December 2014 for the first phase 3 trial of baricitinib, RA-BEACON, in February 2015 for the second, RA_BEACON, in September 2015 for the third,RA-BEACON and in October 2015 for the fourth, RA-BEAM. The companies plan to submit additional detailed data from all four studies for presentation in scientific meetings and publication in peer-reviewed journals in 2016.
JAK-dependent cytokines are implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. The trend towards treating inflammatory and autoimmune diseases with JAK inhibitors has increased as a results of promising studies, including late pivotal studies.
Although new targeted biological treatments have improved by far the treatment of inflammatory and auto-immune diseases, still many of these diseases still require treatments that produce faster halting of pain, of disease progression, in addition to sustained remissions.
That’s why Gilead has embarked on Galapagos’ drug filgotonib, in addition to that the market for inflammatory and autoimmune diseases is huge. That’s why we also believe that Incyte is walking with steady steps on the road towards becoming one of the Top-tier biotech small group.