Osiris (OSIR) announced that it has entered into an agreement and plan of merger with Smith & Nephew (SNN) pursuant to which Smith & Nephew will acquire Osiris for $19.00 per share in cash, a total of approximately $660.5M in cash. This offer represents a 37% premium to the company's 90-day volume-weighted average stock price. The transaction was unanimously approved by the boards of both companies. Completion of the transaction is expected in Q2, pending the successful completion of the tender offer and all other closing conditions. Osiris' employees are expected to join Smith & Nephew on completion. Until that time, Osiris will continue to operate as a separate and independent company.
https://thefly.com/landingPageNews.php?id=2877853
Tuesday, March 12, 2019
Tactile Systems meetings suggest 'strong' momentum, says William Blair
William Blair analyst Margaret Kaczor says meetings with Tactile Systems management did not change her outlook calling for "several years of strong" 20%-plus sales growth and operating margin expansion. Management provided some positive incremental details around Flexitouch Plus demand within Veteran's Affairs, payer rate changes, and salesforce outlook, Kaczor tells investors in a research note. The analyst believes Tactile Systems' underlying momentum "remains strong" and sees a number of operational and new product initiatives that should prove guidance achievable, if not beatable. She keeps an Outperform rating on the shares.
https://thefly.com/landingPageNews.php?id=2877854
https://thefly.com/landingPageNews.php?id=2877854
Myriad signs deal with UnitedHealthcare to bring prenatal tests in-network
Myriad Genetics (MYGN) disclosed last night that on March 7, it signed an amendment to its existing contract with UnitedHealthcare (UNH) to bring its prenatal tests in-network. The new agreement takes effect on April 1, 2019.
https://thefly.com/landingPageNews.php?id=2877856
https://thefly.com/landingPageNews.php?id=2877856
Athenex price target lowered to $29 from $35 at RBC Capital
RBC Capital analyst Kennen MacKay lowered his price target on Athenex to $29 after it Q4 earnings miss, saying the termination of its KX-391 China partnership kept it from achieving a $14.5M revenue milestone. The analyst is keeping his Outperform rating on the shares however, noting that the company's "API/specialty-pharma business is continuing to execute ahead of mid-2019 phase 3 Oraxol data".
https://thefly.com/landingPageNews.php?id=2877863
https://thefly.com/landingPageNews.php?id=2877863
Roche Tecentriq, Companion Diagnostic OKd for Triple-Negative Breast Cancer
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Roche’s Genentech for Tecentriq (atezolizumab) plus chemotherapy, Abraxane, to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in patients whose tumors expressed PD-L1. The specifics of the cancer are determined by an FDA-approved assay, developed by Roche, which was also given approval.
The drug was granted accelerated approval based on progression-free survival (PFS). Under this approval process, confirmatory clinical trials have to be continued, or the approval can be canceled. The FDA’s Accelerated Approval Program focuses on conditional approval for drugs that fill an unmet medical need for a serious or life-threatening illness.
The accelerated approval was built on data from the Phase III IMpassion130 trial, showing that Tecentriq plus nab-paclitaxel significantly cut the risk of PFS by 40 percent compared with nab-paclitaxel alone in PD-L1-positive patients with TNBC who hadn’t received previous chemotherapy. Genentech indicates that overall survival (OS) data were “immature,” and more data would be provided to the FDA and presented at an upcoming medical meeting.
Safety and adverse event-data for the combination was consistent with the known safety data for individual drugs. No new safety signals were observed with the combination.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors. When it inhibits PD-L1, it allowed the activation of T-cells, allowing these immune cells free rein to attack the cancer.
“The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need,” stated Sandra Horning, Roche’s chief medical officer and head of Global Product Development. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.”
Along with the drug combo, the FDA approved the Ventana PD-L1 (SP142) Assay as the first companion diagnostic to identify TNBC patients eligible for treatment with Tecentriq and Abraxane.
Triple-negative breast cancer refers to the lack of expression of the three most common proteins associated with cancer growth—estrogen receptor, progesterone receptor and HER2/neu.
“Triple negative breast cancer is an aggressive disease that, until now, has had limited treatment options,” stated Michael Heuer, chief executive officer of Roche Diagnostics. “This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time.”
The test was engineered to improve visual contrast of tumor-infiltrating immune cell staining. In TNBC, PD-L1 is mostly expressed on tumor-infiltrating immune cells instead of on the tumor cells themselves.
The assay is available on the company’s fully automated BenchMark ULTRA instrument. It utilizes the OptiView DAB IHC Detection Kit with OptiView Amplification Kit. It was previously approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma and as a predictive test in second-line non-small cell lung cancer (NSCLC) with Tecentriq.
Akebia Positive Phase 3 Studies in Anemia Due to Chronic Kidney Disease
Akebia Therapeutics, Inc. (Nasdaq:AKBA) today announced positive top-line results from two phase 3 active-controlled pivotal studies evaluating vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in Japanese subjects with anemia due to chronic kidney disease (CKD). These studies were conducted by Akebia’s development and commercialization collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation (MTPC). Each study, one in non-dialysis dependent subjects and one in hemodialysis-dependent subjects, met its primary endpoint. In addition, results from two phase 3 single-arm studies conducted by MTPC in peritoneal dialysis subjects and hemodialysis subjects further support vadadustat’s potential in these indications. MTPC expects to submit a Japanese New Drug Application in 2019.
“Collectively, these data provide further confirmation of vadadustat’s potential to meaningfully transform the treatment paradigm for patients with anemia due to CKD,” said John P. Butler, President and Chief Executive Officer of Akebia. “These results add to our dataset demonstrating the potential for vadadustat to effectively manage hemoglobin levels in both dialysis-dependent and non-dialysis dependent patients, including those who convert from erythropoiesis stimulating agents.”
FDA Approves Pfizer Oncology Biosimilar to Herceptin
Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2
“This is an important milestone in the U.S. which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, Global President, Pfizer Oncology. “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”
The FDA approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between TRAZIMERA and the originator product. This includes results from the REFLECTIONS B327-02 clinical comparative study that was recently published in the British Journal of Cancer, which showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between TRAZIMERA and the originator product in patients with first line HER2 overexpressing metastatic breast cancer.3
“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients,” said Dr. Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the Breast Oncology Program at the Stanford Women’s Cancer Center.4 “With the availability of biosimilars like TRAZIMERA in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need.”
Pfizer has a robust portfolio of potential biosimilar candidates in mid- to late-stage development.5 TRAZIMERA is Pfizer’s first oncology monoclonal antibody (mAb) biosimilar and Pfizer’s fifth biosimilar to be approved by the FDA.2,6,7,8,9 TRAZIMERA was also approved for use in the EU in July 2018 for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.10
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