FDA Grants Breakthrough Therapy Tag to Daiichi Sankyo Leukemia Med

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

‘There have been limited advances over the past several decades for the treatment of relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis. Quizartinib is the first FLT3 inhibitor to significantly improve overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory AML with FLT3-ITD, an underlying driver of this subtype of AML,’ said Arnaud Lesegretain, Vice President, Oncology Research and Development and Head, AML Franchise, Daiichi Sankyo. ‘We are excited that quizartinib has received Breakthrough Therapy designation and we look forward to working closely with the FDA to bring this potential new treatment option to patients as quickly as possible.’

Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial benefit over currently approved treatments, in order to more quickly bring new treatment options to patients with serious diseases. Significant unmet medical need exists in relapsed/refractory AML, as available treatment options are limited and there are no approved targeted therapies for patients with relapsed/refractory FLT3-ITD AML.

The designation was granted based on the results of the pivotal phase 3 QuANTUM-R study of quizartinib, which were presented during the plenary program at the 23rd Congress of the European Hematology Association in June 2018. QuANTUM-R is the first randomized phase 3 study to show that a FLT3 inhibitor, quizartinib, prolongs overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML.

The safety profile observed in QuANTUM-R appears consistent with that observed at similar doses in the quizartinib clinical development program. Incidence of treatment-emergent adverse events was comparable between patients who received single agent quizartinib (n=241) and those who received salvage chemotherapy (n=94). The most common adverse events (>30 percent, any Grade) in patients treated with quizartinib included nausea, thrombocytopenia, fatigue, musculoskeletal pain, pyrexia, anemia, neutropenia, febrile neutropenia, vomiting and hypokalemia.

https://bit.ly/2MkfRq6

Varian Announces Acquisition of humediQ Global GmbH

Varian (NYSE: VAR) today announced the acquisition of privately-held humediQ Global GmbH, the manufacturer of IDENTIFY, an automated patient identification, positioning and motion management system for radiation therapy. This acquisition expands Varian’s motion-management portfolio and is part of the company’s long-term growth and value creation strategy.

IDENTIFY incorporates patient safety, quality, efficiency and surface-guided features in an automated workflow solution for surface-guided radiation therapy (SGRT). The IDENTIFY system features a palm reader for patient identification, a radio frequency identification (RFID) reader for proper accessory verification and placement on the treatment couch, automatic synchronization with the oncology information system, and SGRT cameras for proper patient positioning and motion monitoring throughout the treatment.

“Varian is focused on enabling sophisticated high-quality cancer care safely and effectively, around the globe,” said Kolleen Kennedy, president of Varian’s Oncology Systems business. “Varian and humediQ Global share a common mission in the worldwide fight against cancer and we are pleased to welcome the humediQ Global employees to the expanding Varian family in the region and add the comprehensive IDENTIFY solution to our portfolio.”

“The IDENTIFY solution combines improved patient safety, an enhanced clinical workflow and surface guided imaging for high-quality radiation therapy treatments,” said Christian Hieronimi, CEO of humediQ Global. “We are excited to join Varian and bring this solution to as many patients as possible worldwide. We share a passion for innovation, quality, and patient centered care and look forward to continue that mission together.”

https://bit.ly/2vLgIJg

Antares in Development Pact with Pfizer for Rescue Pen Device

Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”)today announced that it has entered into an agreement with Pfizer Inc. (“Pfizer”) to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot® auto injector and an undisclosed Pfizer drug. Pfizer will pay for the development of the product and will be responsible for obtaining FDA approval of the combination product. The parties intend to enter into a separate supply agreement pursuant to which Antares will provide fully packaged commercial ready finished product to Pfizer at cost plus margin and Pfizer will then be responsible for commercializing the product in the United States, pending FDA approval. Antares will then receive royalties on net sales on the combination product.

“We are excited to begin our partnership with Pfizer, one of the world’s premier biopharmaceutical companies, on this important project to develop a rescue pen utilizing our QuickShot technology,” said Robert F. Apple, President and Chief Executive Officerof Antares. “This development agreement between Antares and Pfizer further expands our portfolio of pipeline partnered products. Additionally, it increases the potential number of products utilizing our innovative QuickShot auto injector technology platform. We look forward to working closely with Pfizer throughout the development phase of this combination product and assisting them with the FDA drug device approval process.”

https://bit.ly/2LWj9Uy

Lower NHS referrals dent Spire Healthcare’s profit view

 Spire Healthcare shares hit a record low on Monday after it warned of sharply lower full-year core earnings on fewer referrals from Britain’s publicly funded National Health Service (NHS).

Spire generates a third of its revenue from work carried out on behalf of the NHS, which has been operating with an about 1 billion pound ($1.3 billion) deficit and a shortage of beds and staff.

Companies such as Spire, BMI Healthcare and Nuffield Health have helped the NHS cope with the shortage, but their earnings and revenue have taken a hit as the NHS prioritises emergency cases and makes cuts elsewhere, focusing on essential health services.

Spire shares were down 22 percent at 193 pence at 1040 GMT on London’s FTSE 250 <.FTSE> index.

“The current difficult market conditions – also seen by other operators – had a greater impact on our business in the seven months to July 31, 2018 than we had expected,” Chief Executive Officer Justin Ash said in a statement on Monday.

Revenue linked to the NHS fell 9.5 percent in the first-half.

Shares of the company have mostly underperformed the UK mid-cap index <.FTMC> since the company warned on revenue and core earnings margins last year.

(Graphic: Spire stock
has mostly underperformed the UK mid cap index – https://tmsnrt.rs/2vmfa9d

BID REJECTION

Spire rival Ramsay Health Care, Australia’s biggest private hospital operator also took a charge and cut its outlook for profit growth in June on a slump in business from the NHS.

Difficult trading conditions and belt-tightening by the NHS has also forced Netcare, which has been in Britain for a decade through a controlling stake in BMI Healthcare, to exit operations in the country.

Spire last year rejected a takeover offer from South African private hospitals operator Mediclinic International which has a stake of almost 30 percent. The cash and paper bid valued Spire shares at around 298 pence.

Spire said it expects revenue growth in the second half of the year, and sees benefits from its investments in telephony and central marketing paying off.

The company started cost saving plans in other areas of its business and now expects capital expenditure for 2018 at 90 million pounds, 10 million pounds lower than a previous forecast. Capital expenditure was 118 million pounds in 2017.

“With our renewed focus on the private market, we are seeing encouraging momentum and expect our top line to recover through the second half of 2018 and increasingly in 2019 and beyond, while the benefit of our major cost savings initiatives will accelerate through next year,” Ash added.

Ash took over at the end of last October. Jitesh Sodha was named chief financial officer last month.

“While the announcement of a cost savings plan is helpful, it is difficult to reconcile this with the overspend in H1 2018,” Liberum analysts said in a note.

Spire Healthcare said on Monday its revenue fell 1.1 percent to about 475 million pounds ($616.7 million) in the first half of the year.

https://bit.ly/2ANhzPC

Rite Aid cuts FY adjusted EBITDA view to $540M-$590M

Rite Aid cuts FY adjusted EBITDA view to $540M-$590M from $615M-$675M

https:///2MnOgo5

Foundation Medicine publishes new data on blood cancer biomarkers

Foundation Medicine (FMI) announced the publication of the results of a large study demonstrating that its novel, investigational assay to measure blood tumor mutational burden can help predict response to the anti-PD-L1 immunotherapy, atezolizumab, in patients with previously treated non-small cell lung cancer. The study, published in the journal Nature Medicine, was the result of a collaboration between Foundation Medicine and Genentech, a member of the Roche Group (RHHBY), and demonstrates the potential of bTMB to expand precision oncology approaches for patients with advanced cancers, including metastatic lung cancer. In addition, these results show that bTMB may be an independent predictor of clinical benefit, regardless of PD-L1 expression as assessed by immunohistochemistry. In the study, clinical data for the novel bTMB assay was reported from a retrospective analysis of more than 1,000 samples from patients with previously treated, advanced NSCLC who participated in Genentech’s Phase II POPLAR and Phase III OAK clinical trials. The study used samples from the POPLAR trial to identify a range of bTMB thresholds that correlated with clinically meaningful outcomes, which were then confirmed using samples from the OAK study. Within the OAK study, patients with bTMB greater than or equal to 16 total mutations showed significantly improved progression-free survival when treated with atezolizumab as compared to those patients with bTMB greater than or equal to 16 total mutations treated with docetaxel chemotherapy. This bTMB assay is being prospectively evaluated in two Genentech studies: in the Phase III Blood First Assay Screening Trial as a companion diagnostic assay to validate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients, and in the single arm Phase II Blood First-Line Ready Screening Trial evaluating atezolizumab monotherapy in first-line NSCLC. In April 2018, the U.S. Food and Drug Administration granted a Breakthrough Device designation for Foundation Medicine’s new liquid biopsy assay, which will expand upon its current liquid biopsy assay to include genomic biomarkers for microsatellite instability and bTMB. If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.

https://bit.ly/2ANqHUc

Protagonist Therapeutics reinstates clinical development of colitis med

Based on a re-read of endoscopy results from a Contract Research Organization (CRO) that revealed errors, Protagonist Therapeutics (NASDAQ:PTGX) will resume clinical development of PRG-100 in ulcerative colitis (UC) patients.

The company terminated its Phase 2b study in March due to an unexpectedly high remission rate in the control group (24%). The re-examined data, showing a much lower placebo effect, demonstrated a dose-dependent treatment benefit.

CEO Dinesh V. Patel, Ph.D. says, “The discontinuation of the PROPEL study was an unfortunate consequence of a human error in the endoscopy readouts provided by the CRO. Based upon an established, safe, and specific mechanism for IBD, PTG-100 offers compelling, patient-focused differentiation by virtue of being an oral drug. We look forward to meeting with the FDA during the second half of 2018 to discuss next steps and plan to present the PROPEL data at a future medical conference. Overall, we also view this data as supportive of the concept of GI-restricted, oral targeted therapy approach for the treatment of IBD. In addition, the most recent financing of $22 million enables us to continue further development of PTG-100.”

Previously: Protagonist bails on mid-stage of PTG-100 in UC (March 26)

Previously: Protagonist Therapeutics secures $22M equity financing (Aug. 6)

https://bit.ly/2OOHtVZ