Amedisy (AMED) announced it has purchased 2,418,304 of its common shares from KKR (KKR), representing one-half of their holdings in the company and 7.1% of the aggregate outstanding shares of the Company’s common stock. The Company repurchased the shares at 96% of the closing price of the Company’s common stock on June 4, 2018. KKR will maintain its presence on the Amedisys Board of Directors for at least twelve months following the transaction. The aggregate value of the transaction is approximately $178M and will be financed through the use of $140M of available cash with the remainder funded by borrowings under the Company’s existing revolving credit facility. For Amedisys, this transaction will be immediately 6% to 7% accretive to earnings per common share. Post transaction, the Company’s available cash will be approximately $20M and its outstanding borrowings under the credit facility will be $128M resulting in a net leverage ratio of approximately 0.7x. The company is also in advanced discussions with its lenders to significantly expand its borrowing capacity under its senior secured credit facility to allow it to capitalize on its active acquisition pipeline. Following this transaction, Amedisys will have approximately 32M of outstanding shares of common stock.
Monday, June 4, 2018
Mylan Confirms FDA Approval of Biocon’s Fulphila, the First Biosimilar to Neulasta
Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.
Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.
Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA.
#ASCO18: Fabre, Idera, Kyowa Kirin, Portola
There’s plenty of news coming out of the American Society of Clinical Oncology (ASCO)Annual Meeting behind held in Chicago. Here’s a look at a few more of the top stories.
Pierre Fabre and Array BioPharma Update Phase III Melanoma Trial Data
The two companies announced results from the Phase III COLUMBUS trial in BRAF-mutant advanced melanoma. The median overall survival (mOS) was 33.6 months for patients receiving the combination of encorafenib and binimetinib compared to 16.9 months for patients receiving vemurafenib as a monotherapy. The combination also reduced the risk of death compared to vemurafenib monotherapy. The two-year OS with the combination was 58 percent.
Idera Pharmaceuticals’ ILLUMINATE-204 Trial Looks Good in Melanoma
Idera Pharma presented results from its ongoing ILLUMINATE-204 clinical trial of tilsotolimod, its intratumorally-delivered Toll-like Receptor (TLR) 9 agonist in combination with Yervoy (ipilimumab). The data showed an overall response rate (ORR) of 38 percent for the combination, including two complete responses and an ongoing partial response (PR) for 12 months. “We have clinical evidence that tilsotolimod activates both the innate and adaptive immune responses, and when used in combination with a checkpoint inhibitor like ipilimumab, triggers immune responses in previously resistant tumors,” said Adi Diab, lead trial investigator, assistant professor, Department of Melanoma Medical Oncology for University of Texas, MD Anderson Cancer Center, in a statement. “In patients with metastatic melanoma receiving premborlizumab who switched to single agent tipilimumab at the time of disease progression the reported ORR was 13 percent. The ORR was 38 percent observed in the ILLUMINATE-204 study and the duration of response, which is ongoing in most of the responders, is particularly encouraging and suggests that the combination of tilsotolimod and ipilimumab is a very promising strategy for treating patients with metastatic melanoma whose cancer does not respond to PD-1 therapy alone.”
Kyowa Kirin’s Mogamulizumab has Positive Progression Free Survival in Mycosis Fungoides
Tokyo’s Kyowa Hakko Kirin presented additional data from the pivotal MAVORIC trial. The Phase III trial evaluated mogamulizumab versus vorinostat to treat adults with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy. MF and SS are the most common subtypes of cutaneous T-cell lymphoma (CTCL). The primary endpoint was PFS, which had a clinically relevant and statistically significant increase over vorinostat.
Portola Pharmaceuticals’ SYK-JAK Inhibitor Shows Efficacy in Pre-Treated B- and T-Cell Cancers
Portola Pharma announced new interim results from its ongoing Phase IIa trial of cerdulatinib, an oral SYK/JAK inhibitor, in patients with specific subtypes of B and T-cell Non-Hodgkin Lymphoma (NHL), including relapsed/refractory follicular lymphoma (FL) and peripheral T-cell lymphoma (PTCL), and chronic lymphocytic lymphoma/small lymphocytic lymphoma (CLL/SLL). Seven of the 20 patients in the PTCL cohort had a complete response. “Cerdulatinib continues to demonstrate promising results across a wide range of B- and T-cell malignancies, including early indications of the potential for durable responses,” said Paul Hamlin, medical director for the David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, in a statement. “The new signals in relapsed/refractory PTCL and CTCL are particularly compelling when you consider the limited treatment options for patients that fail front-line therapy.”
Agios Pharmaceuticals’ Invosidenib in Early Trial in Acute Myeloid Leukemia Looks Promising
Agios Pharma presented data from a Phase I trial looking at ivosidenib (AG-120) or enasidenib (AG-221) in combination with azacitidine in newly diagnosed isocitrate dehydrogenase (IDH) mutant acute myeloid leukemia (AML). “Patients with newly diagnosed AML who are ineligible for intensive ‘7+3’ chemotherapy typically have poor outcomes and few available treatment options,” said Courtney DiNardo, lead investigator and assistant professor, department of leukemia at the University of Texas MD Anderson Cancer Center, in a statement “With additional patients now treated in the ivosidenib arm of this Phase I study, the updated combination data demonstrate a favorable safety profile and impressive response rates versus those expected with azacitidine alone. I look forward to further demonstrating the clinical benefit of utilizing an IDH inhibitor in combination with traditional frontline AML treatment as part of the ongoing Phase I and randomized trials.”
#ASCO18: Genomic Health Up As TAILORx Data Clarifies Oncotype DX Utility
Genomic Health’s stock skyrocketed Monday on the news of a study in the New England Journal of Medicine that finally answered the question of how doctors should interpret and act upon an intermediate result from the firm’s Oncotype DX breast cancer risk test.
The company’s stock rose nearly 20 percent to $47.49 in afternoon trading on the Nasdaq.
The data, which was also presented over the weekend at the American Society for Clinical Oncology annual meeting in Chicago, showed that women with Oncotype DX recurrence scores from a low-risk threshold of 11 up to a high-risk threshold of 25 appear to benefit equally when treated with endocrine therapy alone compared to hormonal therapy with added chemotherapy, as long as they are over 50 years of age. Though doctors had known from previous studies that a low-risk score could be prognostic and a high-risk score could be predictive, the intermediate scores were trickier to interpret.
Researchers presenting the study estimated that the new classification architecture means that the percentage of individuals with early-stage hormone-receptor positive, HER-2 negative tumors who can confidently avoid chemo is about 70 percent overall.
In a note to investors on Sunday evening, Canaccord Genuity analyst Mark Massaro reiterated his Buy rating for Genomic Health and raised his price target on the firm’s stock to $45 from $41, noting that the TAILORx data “is at least ‘good enough’ to drive some incremental boost to Oncotype DX volumes globally, and perhaps more obviously, turn on reimbursement where coverage is limited (particularly in Germany).”
Genomic Health’s management believes that capitalizing on the TAILORx data can help the firm hit the high end of its 2018 revenue guide, Massaro added, and the company is looking to create some targeted digital ads to drive new doctor ordering for the test. The firm is also expecting payor decisions from France this summer, from Germany in the fall, and from the UK in September that could be affected by the study’s results.
Overall, Massaro is modeling 13 percent growth in revenues for Genomic Health in 2018, driven in part by the TAILORx results.
Cowen analyst Doug Schenkel in a note to investors on Monday added that the study “solidifies the utility of Oncotype in women with early-stage breast cancer, and it could drive increased ordering of Oncotype. Put simply, we see potential material upside to our volume and revenue per test forecasts in the US and abroad over the next several years.”
Schenkel also noted that Genomic Health believes it now has some power with insurers to improve reimbursement prices for its test, which could be important when its commercial contracts come up for renewal.
“We are currently forecasting that the Invasive Breast average revenue per test will increase by 3 percent in 2020 relative to 2018 levels. Based on company commentary and the disproportionate number of patients that are commercially covered (about 80 percent), we believe this forecast is very achievable if not beatable,” he wrote. “An increase in the reimbursement rate of 10 percent compared to today’s levels would lead to a $30 million increase in our 2020 estimated revenues, with all other assumptions unchanged.”
Bayer launches $7 billion cash call to fund Monsanto deal
Bayer launched a 6 billion euros ($7 billion/5.24 billion pounds) rights issue on Sunday, a cornerstone of the financing package for its planned $62.5 billion takeover of seeds maker Monsanto.
Bayer last week won U.S. approval for the Monsanto takeover, clearing a major hurdle for a deal that will create by far the largest seeds and pesticides maker.
The cash call is smaller than initially envisaged by Bayer because Monsanto reduced its debt while the antitrust review dragged on.
Also, Bayer raised 4.5 billion euros more from selling down its stake in plastics maker Covestro than initially expected.
The German drugmaker also grossed 7.6 billion euros in proceeds from selling assets to BASF, as the antitrust reviews were stricter than anticipated, but that did not cut the need to raise money via a share issue because future cash flows to service debts would also be lower.
When the merger was agreed in September 2016, Bayer said it would raise $19 billion worth of fresh equity capital for the takeover deal, parts of which was covered by issuing 4 billion euros in mandatory convertible notes in November 2016.
Bayer has said it would close the transaction very soon, which it needs to do because Monsanto could withdraw from the takeover agreement and seek a higher price after June 14.
Bayer is set to close the transaction on June 7, according to a media report on Sunday.
Bayer will create an agricultural supplies giant with sales of about 20 billion euros, based on 2017 figures, when taking into account the divestments.
At current foreign exchange rates, that compares to about 12.4 billion euros at DowDuPont Corteva Agriscience unit, 11 billion euros at ChemChina’s Syngenta and 7.9 billion at BASF, including businesses to be acquired.
#ASCO18: Sanofi, Regeneron skin cancer med trial results ‘strong’
The New England Journal of Medicine published pivotal data from two trials evaluating cemiplimab in advanced cutaneous squamous cell carcinoma. The results were also presented at the 2018 American Society of Clinical Oncology Annual Meeting. Advanced CSCC, the deadliest nonmelanoma skin cancer, encompasses both patients with metastatic CSCC and those with locally advanced CSCC who are not candidates for surgery; there is currently no approved treatment for these patients. Cemiplimab is an investigational human monoclonal antibody targeting the immune checkpoint PD-1. “The strong results seen with cemiplimab are noteworthy given that advanced CSCC is a very serious condition that currently has no approved treatments once surgery is no longer an option,” said Michael R. Migden, M.D., co-lead author and Associate Professor in the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center. “Advanced CSCC tumors were shown to be responsive to cemiplimab in both metastatic and locally advanced patients, with the results being clinically meaningful and consistent between the Phase 1 and Phase 2 trials.” Cemiplimab is being jointly developed by Sanofi (SNY) and Regeneron (REGN) under a global collaboration agreement.
#ASCO18: Cytomx safety seems improved in early data: Jefferies
CytomX early data point to some safety differentiation, says Jefferies. Jefferies analyst Biren Amin said he thinks some investors may have sought a better efficacy profile from CX-072. However, he notes that the Yervoy combo data provided at ASCO are in the dose-escalation phase and are in heavily pretreated patients, adding that safety seems improved with the CX-072 plus ipi combo. Amin has a Buy rating and $40 price target on CytomX shares, which are down $5.58, or 22%, to $19.96 in afternoon trading
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