Gentamicin/Vancomycin

Multiple biotech companies are scheduled to release their quarterly reports next week. BioSpace takes a quick look at some these companies and the announcements they have made through 3Q2018. Multiple biotech companies are scheduled to release their quarterly reports next week. BioSpace takes a quick look at some these companies and the announcements they have made through 3Q2018. Tuesday, October 23, 2018 Biogen – Boston-based Biogen will release its earnings Oct. 23. The company is coming off a successful presentation of long-term data reports for multiple sclerosis drugs Tysabri and Tecfidera at the 34th Congress of the European Committee for Treatment and Research in MS. At the same time, the company received some criticism during the second quarter for relying on older drugs to fuel its coffers and placing too much developmental funds on a moon-shot Alzheimer’s treatment. As an example, during the second quarter, sales of Tecfidera slipped to $987 million from the $1 billion it earned in the previous quarter. Also, the company’s Alzheimer’s data that has been such an R&D focus, seemed to underwhelm analysts earlier this summer at the Alzheimer’s Association International Conference. Wednesday, October 24, 2018 Alexion Pharmaceuticals – Fresh off the heels of announcing that it will acquire Syntimmune for $400 million in upfront payments, Alexion Pharmaceuticals will announce its Q3 report on Oct. 24. The acquisition will bring Syntimmune’s Phase Ib/IIa therapy SYNT001 for patients with warm autoimmune hemolytic anemia and other indications. This quarter the company also saw positive topline Phase III results for its study of Soliris (eculizumab) in patients with anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder. In September the company noted that it was preparing regulatory submissions in the U.S. and in Europe. In August, the U.S. Food and Drug Administration (FDA) accepted for review Alexion’s Biologics License Application for approval of ALXN1210, an investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria. Thursday, October 25, 2018 Bristol-Myers Squibb –Bristol-Myers Squibb will present its Q3 report on Oct. 25. The second quarter saw the company’s checkpoint inhibitor Opdivo snag regulatory approval for the treatment of metastatic small cell lung cancer (SCLC). But, the drug also flunked a Phase III trial as a treatment option for small cell lung cancer (SCLC) patients who relapsed following platinum-based chemotherapy. BMS is anticipating additional readouts for Opdivo in other cancers over the next half year to 18 months. Opdivo, along with anticlotting drug Eliquis should continue to be strong revenue drivers for BMS during the third quarter, following on the sales success the two drugs showed in the previous quarter. Celgene – Bolstered by the news that Celgene’s multiple sclerosis drug Ozanimod outperformed Biogen’s Avonex (interferon beta-1a) in patients with relapsing multiple sclerosis (RMS), the company will present its quarterly financial report on Oct. 25. Ahead of the report, Leerink analyst Geoffrey Porges said in a note that he anticipates higher than expected earnings this quarter from the company. During the quarter, the company also saw some clinical success with Otezla. In a Phase III trial, Otezla demonstrated a statistically significant improvement in patients with moderate to severe scalp psoriasis. The company also demonstrated some prudence in the quarter by walking away from a licensing deal with B=beleaguered OncoMed Pharmaceuticals . The companies had teamed up to develop OncoMed’s bispecific antibody navicixizumab. Gilead Sciences – With its hepatitis C revenue stream dwindling, Gilead Sciences will likely lean heavily on the future of its CAR-T program, as well as its HIV pipeline when the company presents its quarterly report on Oct. 25. Earlier this month Gilead Sciences released 96-week data from its Phase III study of HIV drug Biktarvy that showed the medication was not inferior to a regimen of abacavir/dolutegravir/lamivudine. Biktarvy, a once-per-day treatment, was approved by the FDA in February. In addition to its HIV drug, Gilead will also point to Yescarta, its CAR-T treatment that received regulatory approval in Europe. Yescarta did see a bit of a setback in the United Kingdom. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for the agency to justify . During the second quarter Gilead did see a reorganization of its leadership following the departure of Chief Medical Officer Andrew Cheng who took over the role of CEO at Akero Therapeutics. Merck & Co. – Merck saw significant momentum during the most recent quarter and that will likely be something the company touts when it shares its latest financial report on Oct. 25. The company saw positive results in its HIV treatment programs that included approval from the U.S. Food and Drug Administration for two new HIV-1 treatments . The FDA gave the go-ahead for Delstrigo, a once-per-day triple combination treatment and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor. Also during the quarter, Merck licensed Dragonfly Therapeutics ’ TriNKET technology platform for a number of solid-tumor programs. Merck researchers will attempt to harness the power of NC cell receptors to potentially develop novel therapeutics targeting solid tumor indications. BioMarin – California-based BioMarin closed out the quarter with $15 million in milestone payments from Pfizer following the approval of breast cancer drug Talzenna, a drug Pfizer obtained from BioMarin following its acquisition of Medivation , which had acquired the drug from BioMarin in 2015. BioMarin will present its quarterly report on Oct. 25. Galapagos NV – A key highlight Belgium-based Galapagos NV will likely point to in its Oct. 25 quarterly report is a significant infusion of $300 million the company gained following its U.S. public offering of new ordinary shares in the form of American Depositary Shares. That surge of funding came one day after Galapagos’ developmental partner Gilead Sciences announced positive results from the FINCH 2 Phase III clinical trial of filgotinib, a JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis. Seattle Genetics – When Seattle Genetics presents its quarterly report on Oct. 25, the company will certainly point to the stellar results from the Phase III ECHELON-2 clinical trial of antibody-drug conjugate Adcetris (brentuximab vedotin) for peripheral T-cell lymphoma. Results showed that Adcetris plus a combination of cyclophosphamide, doxorubicin and prednisone (CHP) demonstrated superior results against the standard of care CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) treatment. Based on these results, Seattle Genetics will submit the data to the FDA for approval by the end of the year. Friday, October 26, 2018 Dr. Reddy’s – On Oct. 26 India-based Dr. Reddy’s Laboratories Ltd. will present its quarterly financial report. For Dr. Reddy, the most recent quarter was highlighted by regulatory approval of a generic version of Suboxone (buprenorphine and naloxone) sublingual film for opioid addiction. Dr. Reddy developed the generic drug in combination with Mylan . During the quarter Dr. Reddy’s regained worldwide rights to its investigational antibacterial product, DFA-02, for the prophylaxis of surgical site infections after terminating a license previously granted to Armis Biopharma. The company closed out the quarter with the sale of its API manufacturing business unit located in Jeedimetla, Hyderabad, to Therapiva, an emerging generics pharmaceutical company.