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Chris DeMuth Jr. • 20 Comments
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Andrew Walker, CFA • 56 Comments
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Thu, Jun. 23, 4:03 PM
Wed, Jun. 22, 7:21 AM
- Thinly traded nano cap Pluristem Therapeutics (NASDAQ:PSTI) is up 11% premarket on light volume in response to its announcement of preclinical data that suggest its PLX-PAD cells may be effective in treating Duchenne muscular dystrophy.
- In a mouse model study, PLX-PAD cells reduced an enzyme called creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by ~50% compared to placebo. In addition, analyses of tissue samples showed reduced levels of inflammation and necrosis (death of most of the cells in an organ or tissue) and evidence of regeneration of muscle tissue.
- PLX cells are mesenchymal-like adherent stromal cells derived from full term human placentas that may be administered without the need for HLA matching. According to the company, PLX-PAD (peripheral artery disease) cells have demonstrated the ability to stimulate the growth of new blood vessels in preclinical models inducing muscle tissue regeneration and improving muscle function.
- PLX-PAD is currently under development for the treatment of critical limb ischemia, intermittent claudication (leg cramps caused by the obstruction of arteries), muscle injury, pulmonary arterial hypertension and preeclampsia.
- DMD-related tickers: (NASDAQ:SRPT)(NASDAQ:BMRN)(NASDAQ:SMMT)(NASDAQ:PTCT)(NYSE:PFE)(OTCQB:MRNA)
Fri, Jun. 17, 7:53 AM
- ARIAD Pharmaceuticals (NASDAQ:ARIA) initiates the rolling submission of its New Drug Application (NDA) to the FDA seeking approval of Breakthrough Therapy- and Orphan Drug-tagged brigatinib for the treatment of patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to Pfizer's (NYSE:PFE) XALKORI (crizotinib). The company will request accelerated review of the filing, expected to be completed in Q3.
- Brigatinib is an oral inhibitor of an enzyme called anaplastic lymphoma kinase (ALK). The abnormal expression of ALK is a key driver of certain types of non-small cell lung cancer, neuroblastomas and anaplastic large cell lymphoma. It is not generally expressed in normal adult tissues so it is a promising therapeutic target.
Thu, Jun. 16, 4:48 PM
- A Phase 3 clinical trial, OASIS, evaluating Paratek Pharmaceuticals' (NASDAQ:PRTK) omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) met all efficacy endpoints.
- The 645-subject study assessed IV-to-oral once-daily omadacycline compared to twice daily linezolid [Pfizer's (NYSE:PFE) ZYVOX] over a 7-14-day course of therapy.
- The primary endpoint for the FDA was Early Clinical Response (ECR) at 48-72 hours after the first dose in the modified Intent-to-Treat population (mITT) (patients without an infection that could be caused by a single species of Gram-negative bacteria). In this group, omadacycline was shown to be non-inferior (no worse than) to linezolid. The ECR for each medication was 84.8% and 85.5%, respectively.
- The co-primary endpoints for the European Medicines Agency were an assessment of clinical response at the post-treatment evaluation (PTE) in the mITT and clinically evaluable (CE) populations. In both groups, omadacycline again demonstrated non-inferiority to linezolid. In the mITT population at PTE, the clinical success rates for omadacycline and linezolid were 86.1% and 83.6%, respectively. In the CE population at PTE, the clinical success rates were 96.3% and 93.5%, respectively. Omadacycline showed comparable clinical success rates to linezolid across the most common ABSSSI pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
- Treatment-emergent adverse events were similar between the two groups. The most common were gastrointestinal events (18.0% for omadacycline vs. 15.8% for linezolid), including nausea (12.4% vs. 9.9%) and vomiting (5.3% vs. 5.0%).
- Omadacycline, a tetracycline antibiotic known as an aminomethylcycline, has broad spectrum activity against Gram-positive, Gram-negative and atypical bacteria.
- OASIS is the first of two pivotal studies that will support regulatory applications in the U.S. and Europe.
- Complete results will be presented at an upcoming scientific conference.
- Shares are up 18% after hours on robust volume.
Tue, Jun. 14, 10:22 AM
- Shire plc (SHPG -1.6%) acquires global rights to Pfizer's (PFE) PF-00547659 for all indications. The human monoclonal antibody binds to gastrointestinal endothelial adhesion molecule called mucosal addressin cell adhesion molecule 1 (MAdCAM-1) which binds to a receptor on lymphocytes (a type of white blood cell). It is currently in mid-stage development for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis and Crohn's disease.
- Financial and other terms are not disclosed.
Tue, Jun. 14, 9:47 AM
- Privately held Northbrook, IL-based Marathon Pharmaceuticals submits a New Drug Application (NDA) to the FDA seeking approval of lead product candidate deflazacort for the treatment of Duchenne muscular dystrophy (DMD).
- According to the company, one of its pivotal studies showed treatment with deflazacort improved muscle strength compared to placebo at week 12.
- Deflazacort is a steroid called a glucocorticoid. It is a derivative of prednisone with less side effects.
- DMD-related tickers: (SRPT +0.2%)(BMRN +2.4%)(SMMT)(PTCT +3.5%)(PFE +0.2%)(OTCQB:MRNA)
Sun, Jun. 12, 5:55 PM
- An open-label Phase 3 clinical trial, INO-VATE ALL, evaluating Pfizer's (NYSE:PFE) antibody-drug conjugate, Breakthrough Therapy-tagged inotuzumab ozogamicin (IO), in 326 adult patients with relapsed/refractory CD22-positive acute lymphoblastic leukemia (ALL) showed its superiority compared to chemotherapy. The results were presented at the 21st Congress of the European Hematology Association in Copenhagen.
- The proportion of complete responders who were treated with IO (80.7%) was statistically significantly greater than those receiving investigator-choice chemo (29.4%) (p<0.001) as was median progression-free survival (5.0 months versus 1.8 months, respectively; p<0.001). Median overall survival also favored IO (7.7 months vs. 6.7 months) but it was not statistically valid.
- Other endpoints in IO's favor were the rates of minimal residual disease (remission) (78.4% vs. 28.1%, respectively) and median duration of response (4.6 months vs. 3.1 months, respectively). More patients in the IO group proceeded to stem cell transplant (SCT) (41%) than the chemo group (11%) (p<0.001).
- The most common treatment-emergent hematologic adverse events for both IO and chemo were cytopenias (reduction in the number of blood cells). Febrile neutropenia, a fever along with other signs of infection in patients with neutropenia (low levels of a type of white blood cell called neutrophil granulocytes) was 16% in IO patients and 22% in those treated with chemo.
- Other adverse events in the IO group were nausea (32%), headache (28%) and pyrexia (fever) (27%). The most common chemo-related adverse events were nausea (47%), pyrexia (43%) and diarrhea (40%).
- One notable IO-related adverse event was an 11% rate of any-grade veno-occlusive liver disease (VOD), a condition where some of the small veins in the liver are obstructed. It is a complication of high-dose chemo, but only occurred in 1% of the chemo patients in this study. Five IO patients developed VOD during treatment and 10 developed VOD after subsequent SCT. In the chemo group, no patients developed VOD during treatment and one developed it after SCT.
- Inotuzumab ozogamicin is an investigational antibody-drug conjugate comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed in ~90% of B-cell cancers, linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is internalized into the cell where the cytotoxin calicheamicin is released to kill the cell. It originates from Pfizer's collaboration with UCB's Celltech. Pfizer is solely responsible for the manufacturing and clinical development.
- ALL is an aggressive form of leukemia with a poor prognosis. The five-year survival rate is less than 10%.
Sat, Jun. 11, 5:50 PM
- Two Phase 3 clinical trials, VERTIS Mono and VERTIS Factorial, evaluating ertugliflozin for the treatment of type 2 diabetes met their primary endpoints showing statistically significant reductions in blood glucose (A1C). The results were presented at the 76th Scientific Sessions of the American Diabetes Association in New Orleans, LA.
- Patients treated with either of two doses (5 mg or 15mg) of ertugliflozin as monotherapy in VERTIS Mono experienced reductions in A1C of 0.99% and 1.16%, respectively, greater than placebo (p<0.001). In addition, many more patients in the treatment group achieved the A1C treatment goal of A1C less than 7.0% than placebo (28.2%, 35.8% and 13.1%, respectively; p<0.001).
- VERTIS Factorial, assessing the co-administration of ertugliflozin and JANUVIA (sitagliptin), showed that the two drugs taken together were more effective than either alone. The A1C reduction in the co-administration group (either 5 mg or 15 mg of ertugliflozin with 100 mg of sitagliptin) was 1.5% compared to 1.0% for 5 mg of ertugliflozin alone, 1.1% for 15 mg of ertugliflozin alone and 1.1% for sitagliptin alone (p<0.001). The percentage of patients taking the two tablets together who achieved the goal of A1C less than 7.0% was also greater (52.3% and 49.2%) versus the single therapy cohorts (26.4%, 31.9% and 32.8%, respectively).
- Ertugliflozin inhibits sodium-glucose co-transporter 2 (SGLT2), a protein that facilitates glucose reabsorption in the kidney. Inhibiting SGLT2 increases the excretion of glucose which lowers blood glucose levels.
- Merck (NYSE:MRK) and Pfizer (NYSE:PFE) are co-developing and co-commercializing ertugliflozin under their April 2013 global collaboration agreement. They plan to submit New Drug Applications to the FDA for ertugliflozin alone and two fixed-dose combination tablets (ertugliflozin+sitagliptin; ertugliflozin+metformin) by the end of this year.
- Another Phase 3 study, VERTIS CV, assessing ertugliflozin's effect on improving CV outcomes in type 2 diabetics is ongoing. According to ClinicalTrials.gov, the estimated study completion date is June 2020.
Wed, Jun. 8, 3:50 PM
- In a joint meeting, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 9-6 recommending approval of Pfizer's (PFE +1.2%) Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the around-the-clock treatment of chronic severe pain.
- The vote was 9-6 against labeling Troxyca ER as abuse-deterrent by the oral route of abuse, but 11-4 in favor of labeling as abuse-deterrent by the nasal route of abuse and 9-6 in favor of the same labeling for the IV route of abuse.
- FDA briefing doc
- Errata to FDA briefing doc
- Pfizer briefing doc
Tue, Jun. 7, 7:52 AM
- Pfizer's (NYSE:PFE) second Phase 3 study in its OPAL development program, OPAL Beyond, evaluating XELJANZ (tofacitinib citrate) for the treatment of psoriatic arthritis (PsA) met its primary endpoints.
- The 395-subject study assessed the safety and efficacy of 5 mg and 10 mg of tofacitinib administered twice daily in adult patients with active PsA who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi), the first trial to focus exclusively on this patient population.
- Patients treated with both doses of tofacitinib showed a statistically significant (p<0.0001) improvement in their PsA compared to placebo as measured by ACR20 (20% improvement in symptoms) and HAQ-DI score (health assessment questionnaire).
- Results from OPAL Broaden, reported in April, were also positive. A long-term extension study, OPAL Beyond, is ongoing. According to ClinicalTrials.gov, the completion date is February 2019. Data from the three trials will support global regulatory applications.
- The FDA approved XELJANZ for the treatment of rheumatoid arthritis in November 2012.
Tue, May 31, 9:57 PM
- Pfizer (NYSE:PFE) prices its $5B aggregate principal value of notes. The offering consists of five tranches: $1.25B of 1.200% notes due 2018; $850M of 1.450% notes due 2019; $1.15B of 1.950% notes due 2021; $1.25B of 2.750% notes due 2026 and $500M of 4.400% notes due 2044.
- Net proceeds will be used for general corporate purposes, including the repayment of a portion of outstanding commercial paper.
- Closing date is June 3.
Wed, May 25, 9:00 AM
- According to Bloomberg, Celgene (NASDAQ:CELG) is considering a bid for Medivation (NASDAQ:MDVN), currently trying to hold off Sanofi (NYSE:SNY). Other suitors supposedly in the mix are Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN) and Amgen (NASDAQ:AMGN).
- Sanofi is trying to replace Medivation's board after it rejected its per-share offer of $52.50.
- Previously: Amgen another possible Medivation suitor (May 5)
Tue, May 24, 7:39 AM
- In a presentation to investors, Eli Lilly (NYSE:LLY) says it has the potential to launch 20 new products in the period 2014 - 2023 and an average of two new indications for already-approved products per year during the same period.
- Lilly's R&D activities focuses on five therapeutic areas: diabetes, oncology, immunology, neurodegeneration and pain.
- In diabetes, the company targets glucose control, metabolic control and end-organ protection. In oncology: tumor cell signaling, tumor microenvironment and immuno-oncology. Five new molecules will be in human testing by the end of this year, as many as 11 by the end of 2018. Immunology key events: Taltz (ixekizumab) recently launched, baricitinib under regulatory review. Neurodegeneration: seven Alzheimer's-focused molecules in human testing. Pain: two late-stage candidates in development: galcanezumab for cluster headache and migraine and tanezumab for osteoarthritis pain, chronic lower back pain and cancer pain [in partnership with Pfizer (NYSE:PFE)].
- A replay of the webcast will be available for 90 days on the company's investor website.
Mon, May 23, 10:12 AM
- Exelixis (EXEL +6.7%) moves up on average volume in response to its announcement of positive results from a Phase 2 study, called CABOSUN, assessing lead cancer candidate cabozantinib for the first-line treatment of patients with advanced intermediate- or poor-risk renal cell carcinoma (RCC). The study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) compared to sunitinib malate [Pfizer's (NYSE:PFE) SUTENT].
- CABOSUN is an open-label, active-controlled study that randomized 150 advanced RCC patients 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, four weeks on, two weeks off).
- The company intends to meet with regulators to discuss the development and submission strategy for the first-line indication. The FDA approved cabozantinib, branded as CABOMETYX, last month for the treatment of RCC patients who have received prior angiogenic therapy.
- Final results will be presented at a future medical conference.
- Previously: FDA approves Exelixis' lead cancer drug cabozantinib; shares up 9% premarket (April 26)
Fri, May 20, 8:19 AM
- The European Medicines Agency (EMA) accepts for review Pfizer's (NYSE:PFE) Marketing Authorization Application (MAA) seeking approval of TRUMENBA (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals at least 10 years old.
- TRUMENBA was approved in the U.S. in October 2014.
Pfizer, Inc. is a research-based, global biopharmaceutical company, which engages in the manufacture of vaccines and injectable biologic medicines. It operates through the following segments: Global Innovative Pharmaceutical, Global Vaccines, Oncology and Consumer Healthcare, and Global... More
Industry: Drug Manufacturers - Major
Country: United States
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