Array BioPharma to Report Financial Results for the First Quarter of Fiscal 2019 on October 30, 2018

On October 23, 2018 Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the first quarter of fiscal 2019 and hold a conference call to discuss those results on Tuesday, October 30, 2018 (Press release, Array BioPharma, OCT 23, 2018, View Source [SID1234530078]). Ron Squarer, Chief Executive Officer, will lead the call .

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Date: Tuesday, October 30, 2018

Time: 9:00 a.m. Eastern Time

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Spectrum Pharmaceuticals Receives FDA Approval of KHAPZORY™ (levoleucovorin) for injection

On October 23, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications (Press release, Spectrum Pharmaceuticals, OCT 23, 2018, View Source [SID1234530063]):

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• Rescue after high-dose methotrexate therapy in patients with osteosarcoma.

• Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination.

• The treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

KHAPZORY is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.

"KHAPZORY is the first levoleucovorin product approved by the FDA that contains sodium in its formulation," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "This NDA submission was part of the lifecycle management of our legacy product, FUSILEV. Our focus remains on the development of novel, targeted therapeutics including poziotinib and ROLONTIS."

Spectrum is currently evaluating strategic options on the launch of KHAPZORY. Product supply will be available in January.

Important Safety Information for KHAPZORY

Contraindications

• KHAPZORY is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid, or folinic acid.

Warnings and Precautions

• Increased gastrointestinal toxicities with fluorouracil: Gastrointestinal toxicities, including stomatitis and diarrhea, occur more commonly and may be of greater severity and of prolonged duration. Deaths from severe enterocolitis, diarrhea, and dehydration have occurred in elderly patients receiving weekly d,l-leucovorin and fluorouracil. Do not initiate or continue therapy with KHAPZORY and fluorouracil in patients with symptoms of gastrointestinal toxicity until those symptoms have resolved. Monitor patients with diarrhea until it has resolved as rapid deterioration leading to death can occur.

• Drug interaction with trimethoprim-sulfamethoxazole: Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jiroveci pneumonia in patients with HIV infection increased treatment failure and morbidity.

Adverse Reactions

• The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue were stomatitis (38%) and vomiting (38%).

• The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer were stomatitis (72%), diarrhea (70%), and nausea (62%).

Drug Interactions

Leucovorin products increase the toxicity of fluorouracil.

Use in Specific Populations

Levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm. Refer to methotrexate and fluorouracil prescribing information for additional information.

Blueprint Medicines to Report Third Quarter 2018 Financial Results on Tuesday, October 30, 2018

On October 23, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Tuesday, October 30, 2018 to report its third quarter 2018 financial results and provide a corporate update (Press release, Blueprint Medicines, OCT 23, 2018, View Source [SID1234530079]).

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To access the live conference call, please dial 1-855-728-4793 (domestic) or 1-503-343-6666 (international), and refer to conference ID 7598866. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Quest Diagnostics Reports Third Quarter 2018 Financial Results

On October 23, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the third quarter ended September 30, 2018 and updated its outlook for full-year 2018 (Press release, Quest Diagnostics, OCT 23, 2018, View Source [SID1234530338]).

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"We grew revenues and continued to deliver strong earnings growth in the third quarter," said Steve Rusckowski, Chairman, President and CEO. "We had a productive quarter, announcing three acquisitions and a Professional Lab Services agreement. We are updating our full-year revenue guidance to reflect lower than expected revenue performance this year, which has been affected in large part by industry headwinds we called out in the previous quarter. Looking ahead, our acquisition pipeline, along with our expanding health plan access, including UnitedHealthcare beginning January 1, position us well for growth in 2019."
ng, general and administrative expenses for the three and nine months ended September 30, 2017 have been restated to reflect the impact of new revenue recognition rules that became effective January 1, 2018 and were adopted on a retrospective basis. Under the new rules, the Company reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were classified as bad debt expense within selling, general and administrative expenses.

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

The updated outlook for revenue growth in 2018 represents management’s estimates for 2018 versus 2017 reported revenues adjusted to reflect the impact of new revenue recognition rules that became effective January 1, 2018. Full-year 2017 revenues adjusted to reflect the new rules were $7,402 million. See note 5 of the financial tables attached below.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as restructuring and integration charges, excess tax benefit ("ETB") associated with stock based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed in listen-only mode by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467, passcode: Investor; or via live webcast on the Company’s website at www.QuestDiagnostics.com/investor.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-483-9044 for domestic callers or 203-369-1586 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 23, 2018 until midnight Eastern Time on November 6, 2018. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Deciphera Pharmaceuticals Initiates a Phase 1b/2 Clinical Trial of Rebastinib in Combination with Paclitaxel to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced or Metastatic Solid Tumors

On October 23, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that it has initiated an open-label, multicenter, Phase 1b/2 study of rebastinib in combination with paclitaxel to assess safety, tolerability, pharmacokinetics and efficacy in patients with advanced or metastatic solid tumors (Press release, Deciphera Pharmaceuticals, OCT 23, 2018, View Source [SID1234530064]).

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"We are excited to initiate this Phase 1b/2 clinical trial of rebastinib, our small molecule switch control inhibitor of TIE2," said Michael D. Taylor, Ph.D., Deciphera’s President and Chief Executive Officer. "In preclinical testing rebastinib has shown activity as a single agent and when combined with paclitaxel, we observed synergistic reductions in circulating tumor cells and ablating distant metastases. As a result, we believe rebastinib has the potential to be an important new therapy for cancer patients when combined with chemotherapy. In addition to the Phase 1b/2 clinical trial with paclitaxel, we intend to initiate a second Phase 1b/2 clinical trial of rebastinib in combination with carboplatin in the coming months."

In this two-part Phase 1b/2 clinical trial, rebastinib will be evaluated for the treatment of patients with advanced or metastatic solid tumors in combination with paclitaxel. Part 1 is designed to evaluate the safety, tolerability and pharmacokinetics of 50 mg and 100 mg rebastinib twice daily (BID) when administered in combination with paclitaxel, and to determine the recommended phase 2 dose (RP2D) of rebastinib in combination with paclitaxel, in patients with advanced or metastatic solid tumors that are refractory to standard therapies. In part 2, the safety, tolerability and efficacy of the RP2D of rebastinib in combination with weekly paclitaxel will be assessed across multiple cohorts, including: breast cancer, ovarian cancer, and endometrial cancer. This trial will enroll up to 36 evaluable patients in part 1 and up to 132 evaluable patients in part 2. For more information about the clinical trial design please visit www.clinicaltrials.gov (NCT03601897).

"There is an increasing understanding of the mechanisms by which tumors co-opt the surrounding microenvironment to grow, survive and become more invasive. TIE2 kinase is involved in multiple mechanisms favoring a pro-tumoral microenvironment, including the regulation of a population of immunosuppressive macrophages, promotion of tumor angiogenesis, and participation in perivascular pumps that lead to tumor cell intravasation and distal metastasis," said Oliver Rosen, M.D., Chief Medical Officer at Deciphera. "Certain of these macrophages express TIE2 and we believe selective inhibition of this kinase with rebastinib in combination with paclitaxel is a promising approach to treating these patients."

About Rebastinib
Rebastinib is an investigational, orally administered, potent and selective inhibitor of the TIE2 kinase, the receptor for angiopoietins, an important family of vascular growth factors in the tumor microenvironment that also activate pro-tumoral TIE2 expressing macrophages. In a Phase 1 clinical trial, biomarker data have demonstrated rebastinib-induced increases in the TIE2 ligand angiopoietin 2, secondary to TIE2 inhibition. Rebastinib is currently being evaluated in a Phase 1b/2 clinical trial in combination with paclitaxel (NCT03601897) and an investigator sponsored Phase 1b trial in patients with metastatic breast cancer in combination with paclitaxel or eribulin (NCT02824575).