Monday, April 27, 2015
- Results from a 14,724-patient CV risk study, TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin), showed Merck's (NYSE:MRK) Januvia (sitagliptin) was no worse than (non-inferior) placebo in cardiovascular (CV) risk as measured by the composite CV endpoint. The composite CV endpoint was defined as the composite of time to the first of any of the following confirmed events: CV-related death, nonfatal myocardial infarction, nonfatal stroke or unstable angina requiring hospitalization. The mean followup period was ~three years.
- Also, there was no increase in hospitalization for heart failure in the sitagliptin cohort versus placebo.
- The complete results will be presented on June 8 at the 75th Scientific Sessions of the American Diabetes Association.
- Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
5:42 PM| Comment!
5:04 PM| Comment!
- A joint meeting of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee is on tap for this Wednesday. The two groups will discuss and make recommendations regarding regulatory approval of Amgen's (NASDAQ:AMGN) Biologic License Application (BLA) for talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma.
- Briefing doc
- Amgen's briefing doc
- Teva Pharmaceutical Industries (TEVA -4.3%) is allegedly scheduled to meet with institutional holders of Mylan (MYL -5.5%) this week in an effort to clarify the valuation necessary to close the deal. Some observers think a revised bid will be in the $85 - 95 range. Teva's first offer, which Mylan rejected, was $82.
- Two Phase 3 clinical trials evaluating Tetraphase Pharmaceuticals' (TTPH -5.1%) lead product candidate, eravacycline, show positive results for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
- The first study, IGNITE-1, compared eravacycline to Merck's (MRK -1.1%) Invanz (ertapenem) for the treatment of cIAI. It achieved the primary endpoint of statistical non-inferiority (no worse than) of clinical response at the test-of-cure (TOC) visit. In the microbiological intent-to-treat (micro-ITT) population (n=446) 86.8% of patients receiving eravacycline achieved a clinical cure compared to 87.6% of patients receiving ertapenem (FDA criteria). In the clinically evaluable population (n=477) 92.9% of patients receiving eravacycline achieved a clinical cure versus 94.5% of patients receiving ertapenem (EMA criteria). These results were first reported in December.
- In the lead-in portion of the second study, IGNITE-2, both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg followed by 200 mg or 250 mg) compared favorably with levofloxacin, a broad spectrum antibiotic, for the treatment of cUTI. The primary endpoint, per the FDA's criteria, was the responder rate (defined as both clinical cure and successful microbiological outcome) in the micro-ITT population. The responder rates for 200 mg (n=24), 250 mg (n=28) and levofloxacin (n=23) were 75.0%, 64.3% and 56.4%, respectively. In the microbiologically evaluable population, the primary endpoint was the microbiological response per the EMA's criteria. The respective responses for levofloxacin isolates (n=24) were: 83.3%, 72.7% and 42.9%. Based on these data, the 200 mg dose will be used for the pivotal portion of the Phase 3 that is currently underway.
- The company expects to submit its regulatory applications by the end of the year.
- The data were presented at this week's 25th European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, Denmark.
- Previously: Tetraphase antibiotic non-inferior to ertapenem in Phase 3 study (Dec. 17, 2014)
- A Phase 1b/2 clinical trial evaluating Ziopharm's (ZIOP -8%) gene therapy candidate, Ad-RTS-hIL-12, for the treatment of women with locally advanced or metastatic breast cancer, is underway at Memorial Sloan Kettering in New York. The study, assessing Ad-RTS-hIL-12 + veledimex following standard chemotherapy, will enroll up to 40 patients, including up to eight with HER2+ breast cancer. Following entry into the study, patients will go on a treatment holiday from chemo and enter into an immunotherapy phase of treatment.
- The primary objective is to evaluate the safety and tolerability of Ad-RTS-hIL-12. Secondary endpoints include overall response rate, disease control rate and the impact of treatment on tumor and serum immune biomarkers.
- Veledimex is an oral activator ligand or "gene switch" which is used to control the expression of Interleukin-12 (IL-12), a pro-inflammatory cytokine. The cancer therapy candidate is the product of the company's synthetic biology channel partnership with Intrexon (XON -6.7%).
- Due to the lack of market penetration, Antares Pharma (ATRS -1.8%) terminates the exclusive marketing and promotion agreement with LEO Pharma A/S for Otrexup (methotrexate) injection for the indication of systematic control of severe recalcitrant psoriasis in adults. According to Symphony Health Solutions, total Q1 prescription volume for this indication was <5% of the total written for Otrexup.
- LEO previously paid Antares $10M for the right to commercialize Otrexup. Antares will recognize ($5.2M) from deferred revenue in Q2 for the unamortized portion based on a three-year term.
- The company is evaluating its options, including recruiting a new sales partner.
- A 365-patient Phase 3 clinical trial (COMPLEMENT 2) assessing Danish biotech Genmab A/S's ofatumumab plus fludarabine (FL) and cyclophosphamide (CY) compared to FL and CY alone in patients with relapsed lymphocytic leukemia (CLL) met its primary efficacy endpoint of improved progression-free survival (p=0.0036).
- Licensee Novartis (NVS +0.5%) (via Glaxo), which markets ofatumumab under the brand name Arzerra, plans to analyze the data and then share the findings with regulatory authorities to evaluate the potential for filing for the expanded indication. The FDA cleared Arzerra for treatment-naive patients with CLL where fludarabine-based therapy is considered inappropriate. The European Commission approved it, in combination with chlorambucil or bendamustine, for treatment-naive patients with CLL who are not eligible for fludarabine-based therapy. It is cleared for first-line use in Russia, Iceland, Norway, Luxembourg and Brazil.
- Two identical randomized, double-blind, sham-controlled Phase 3 studies evaluating Otonomy's (OTIC -5.4%) AuriPro for the treatment of middle ear effusion (fluid) in pediatric patients undergoing tympanostomy tube replacement surgery met the primary efficacy endpoint of a statistically significant reduction in the incidence of treatment failures (p<0.001). AuriPro reduced the risk of treatment failure, as measured by the occurrence of post-operative otorrhea (drainage) or any use of rescue antibiotics, by an average of 49% and the rate of post-operative otorrhea or use or rescue antibiotics (in documented otorrhea or otitis media) by an average of 62% (p<=0.004) compared to sham.
- AuriPro is a sustained-exposure formulation of the antibiotic ciprofloxacin. A single administration provides a full course of treatment. The company submitted its New Drug Application (NDA) to the FDA for this indication in late February. If all goes well, the U.S. commercial launch will commence in Q1 2016.
- The results were presented at the American Society of Pediatric Otolaryngology Spring Meetings in Boston, MA.
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