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Perrigo Company plc Reports Third Quarter 2018 Financial Results

On November 8, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the third quarter ended September 29, 2018 (Press release, Perrigo Company, NOV 8, 2018, View Source [SID1234530975]).

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Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Reported net sales for the third quarter of calendar year 2018 were approximately $1.1 billion, which included new product sales of $35 million, partially offset by discontinued products of $9 million. Adjusted net sales decreased 5.7% on a constant currency basis. Unfavorable currency movements impacted net sales by $12 million.

Reported net loss was $68 million, or $0.49 per diluted share, versus net income of $45 million, or $0.31 per diluted share, in the prior year. Excluding charges as outlined in Table I, third quarter 2018 adjusted net income was $150 million, or $1.09 per diluted share, versus adjusted net income of $197 million, or $1.39 per diluted share, for the same period last year.

CHC Americas segment reported net sales were relatively flat compared to last year. Strong net sales in the smoking cessation, infant formula and dermatological categories coupled with new product sales of $13 million, were offset by lower net sales in the animal health and gastrointestinal categories and discontinued products of $1 million. Excluding the animal health business, net sales in the CHC Americas segment grew approximately 3%, on a constant currency basis.

CHC Americas third quarter reported gross profit margin was 31.0%. Adjusted gross profit margin was 32.7%, lower than the prior year due primarily to the animal health business, operating inefficiencies and relatively higher input costs.

Reported third quarter operating margin was (20.8)%. Third quarter adjusted operating margin was 19.0%, lower than the prior year due primarily to adjusted gross margin flow through.

CHC International net sales increased approximately 1%, excluding $2 million in net sales from exited businesses in 2017 and unfavorable foreign currency movements of $10 million. Growth was driven by net sales in the analgesic, anti-parasite and personal care categories in addition to new product sales of $19 million. Partially offsetting this growth were lower net sales in the lifestyle category and non-branded U.K. businesses. Discontinued products were $5 million.

Third quarter reported gross margin was 46.6%. Adjusted gross margin increased 120 basis points over the previous year to 52.6%, driven primarily by adjusted gross margin improvement initiatives including new product margin contributions.

Reported operating margin was (0.6)%. Adjusted operating margin expanded 230 basis points to 18.7% driven by gross margin flow through and improved operating leverage
RX reported net sales of $179 million were lower due primarily to challenging market dynamics in a number of authorized generic products and customer service challenges, resulting in lower sales volumes. Discontinued products were $4 million.

Reported gross margin was 41.0%. Adjusted gross margin was 52.3%, 260 basis points lower than the same quarter last year, due primarily to unfavorable product mix.

Reported operating margin was 20.1%. Adjusted operating margin was 31.9% compared to 42.4% in the prior year, due primarily to a 580 basis points increase in R&D investments as a percentage of net sales, compared to the prior year and adjusted gross margin flow through. R&D as a percentage to net sales was approximately 11% in the quarter.

Impairment

During the three months ended September 29, 2018, the animal health reporting unit continued to experience declines in its year-to-date financial results and had additional indications of impairment due to changes in channel dynamics, a strategic decision to re-prioritize our brands, and a decline in the forecasted outlook of the reporting unit. As a result, the Company realized an impairment in goodwill and intangible assets in this reporting unit within CHC Americas of approximately $213 million.

Guidance

The Company now expects calendar year 2018 net sales to be approximately $4.72 billion. The Company also expects calendar year 2018 adjusted diluted EPS in the range of $4.45 to $4.65, primarily due to revised expectation in the RX segment. In addition, reduced margin expectations in the CHC Americas segment are expected to be partially offset by improved margin expectations in the CHC International segment.

Conference Call

The Company will host a conference call at 8:30 a.m. EST (5:30 a.m. PDT), November 8, 2018. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID #4651574. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Thursday, November 8, until midnight November 15, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10125751.

Marker Therapeutics to Present at Three Upcoming Healthcare Conferences

On November 8, 2018 Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company, reported that its President and CEO, Peter L. Hoang, will participate in three upcoming healthcare conferences. Mr. Hoang will participate in a panel discussion titled "Drug Pricing and Development Challenges" at the CEO Life Sciences and Pharmaceuticals Symposium on November 13, 2018 in New York City, and will give corporate overviews at the Piper Jaffray 30th Annual Healthcare Conference on November 27, 2018 in New York City and at the Evercore ISI HealthconX Conference on November 28, 2018 in Boston (Press release, Marker Therapeutics, NOV 8, 2018, View Source [SID1234530974]).

November Conferences
November Conferences
CEO Life Sciences and Pharmaceuticals Symposium
Title: Drug Pricing and Development Challenges
Date: Tuesday, November 13, 2018
Time: 5:00pm – 6:30pm (EST)
Location: Yellow Room, 107 East 16th Street, New York City

Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27, 2018
Time: 12:00pm – 12:25pm (EST)
Location: Lotte New York Palace, Holmes 1, 4th Floor

Evercore ISI HealthconX Conference
Date: Wednesday, November 28, 2018
Time: 10:35am – 10:55am (EST)
Location: Boston Harbor Hotel, South Atlantic Room, 2nd Floor

Webcasts for the Piper Jaffray and Evercore ISI conferences will be made available at View Source

National Institute for Health and Care Excellence (NICE) Recommends Jazz Pharmaceuticals’ Vyxeos® (Daunorubicin and Cytarabine) for Adults with Specific Types of Secondary Acute Myeloid Leukaemia (AML)

On November 8, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending Vyxeos 44 mg/100 mg powder for concentrate for solution for infusion for routine use on the National Health Service (NHS) in England and Wales for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)1 – two types of secondary AML (Press release, Jazz Pharmaceuticals, NOV 8, 2018, View Source;p=RssLanding&cat=news&id=2376093 [SID1234530972]).

"This is the first new chemotherapy in forty years for adults with specific types of newly diagnosed secondary AML, a particularly aggressive cancer that typically affects older people and has a high mortality rate," said Dr. Nigel Russell, Professor of Haematology, Faculty of Medicine & Health Sciences at the University of Nottingham. "I am pleased that NICE has recognised the value of this medicine for adults with secondary AML. In time, it is expected to become the standard of care for this specific group of older AML patients."

Patients diagnosed with t-AML or AML-MRC have a very poor prognosis and have the poorest survival of all AML diagnostic subgroups.2,3 Thus they are classified as having high risk disease because of these poor outcomes. In the UK, the expected number of these high-risk AML cases is 680 per year.4 Its incidence increases with age and accounts for approximately 25% of all AML cases in the UK.4

"A diagnosis of acute myeloid leukaemia can have a huge emotional impact on the lives of patients, as well as their family and friends," said Zack Pemberton-Whiteley, Patient Advocacy Director at Leukaemia Care. "We welcome the decision to recommend this treatment for adults with high-risk AML. Leukaemia Care has been working with NICE to enable patients to access this important new medicine, where options have been previously limited."

"Jazz is delighted that Vyxeos will now be made routinely available on the NHS in England and Wales as people with therapy-related AML or AML with myelodysplasia-related changes have had limited treatment options until now," said Iain McGill, senior vice president, Europe and Rest of World at Jazz Pharmaceuticals. "We believe that it is a meaningful medicine for patients with this rapidly progressing and life-threatening blood cancer."

Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine. It is the first chemotherapy to demonstrate a significant overall survival advantage versus the current treatment standard, 7+3 chemotherapy, in a Phase 3 study of older adult patients with newly diagnosed t-AML or AML-MRC,5 and the first chemotherapy treatment option specifically for people who have these types of high-risk AML.

Notes to Editors

About Vyxeos
It is an advanced liposomal formulation that has been shown in vitro to deliver a synergistic combination of daunorubicin and cytarabine to leukaemia cells for a prolonged period of time. Based on data in animals, the liposomes accumulate and persist in high concentration in the bone marrow, where they are preferentially taken up intact by leukaemia cells.6 It is the first product developed with the company’s proprietary CombiPlex platform, which enables the consideration and design of various combinations of therapies.

It received Orphan Drug Designation (ODD) by the European Commission in January 2012 with retention of the ODD reaffirmed in July 2018 following assessment by the Committee for Orphan Medicinal Products (COMP), and by the U.S. Food and Drug Administration (FDA) in September 2008 for the treatment of AML. It received Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. In August 2018, the European Commission approved it for the treatment of adults with newly diagnosed t-AML or AML-MRC in all European Union Member States, as well as Iceland, Norway and Liechtenstein.

View the Summary of Product Characteristics here.

About CombiPlex
The CombiPlex proprietary technology enables the design and rapid evaluation of various combinations of therapies to deliver enhanced anti-cancer activity. The CombiPlex technology seeks to identify the most synergistic ratio of drugs in vitro and fix this ratio in a nano-scale delivery complex that maintains the synergistic combination after administration. CombiPlex utilizes two proprietary nano-scale delivery platforms: liposomes to control the release and distribution of water-soluble drugs and drugs that are both water- and fat-soluble (amphipathic), and nanoparticles to control the release and distribution of non-water-soluble (hydrophobic) drugs.

About AML
Acute myeloid leukaemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body’s new blood cells. AML cells crowd out healthy cells and move into the bloodstream to spread cancer to other parts of the body.7 The median age at diagnosis is 72 years old, with rising age associated with a progressively worsening prognosis.4 There is also a reduced tolerance for intensive chemotherapy as patients age.8 Patients with t-AML or AML-MRC have the lowest survival rates compared with people with other forms of leukaemia.2,3 A haematopoietic stem cell transplant (HSCT) may be a curative treatment option for patients.9

Intensity Therapeutics Highlights INT230-6 Data in Advanced Solid Tumors at Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting

On November 8, 2018 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, reported additional data from a Phase 1/2 clinical study of INT230-6, the Company’s novel lead product candidate designed for direct intratumoral injection, and preclinical research highlighting the Company’s proprietary DfuseRxSM technology were presented in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C (Press release, Intensity Therapeutics, NOV 8, 2018, View Source [SID1234530971]). INT230-6 is comprised of two proven, potent anti-cancer agents and a unique molecule that causes rapid drug dispersion throughout tumors and diffusion into cancer cells.

The presenting author and a study investigator, Anthony Olszanski, MD, Vice Chair of the Department of Hematology/Oncology and Director of the Phase 1 Developmental Therapeutics Program at Fox Chase Cancer Center, said, "We are pleased to share post-treatment imaging of a patient with heavily pretreated cutaneous squamous cell carcinoma who had two deep tumors in the upper arm. Following treatment with INT230-6, scans revealed increased tumor necrosis. In addition, a patient with a chordoma achieved excellent tumor reduction, with some non-injected lesions also decreasing in size, following treatment with INT230-6 as monotherapy, even when administered at low doses. These encouraging results, in addition to a very promising safety profile, support the continued evaluation of INT230-6 in patients with advanced solid tumors."

INT230-6 was discovered using Intensity’s DfuseRxSM technology platform. Preclinical research demonstrated the enhanced ability of INT230-6 to saturate murine pancreatic cancer tumors, compared to the drug alone.

"Our preclinical animal data of INT230-6 shows its ability to disperse and saturate a tumor with drug when administered at the proper dose-to-tumor volume ratio," said Lewis H. Bender, Founder and CEO of Intensity Therapeutics. "When dosing intratumorally, proper drug dispersion is critical in order to treat the entire tumor effectively, especially in regions away from the blood vessels that are hypoxic. Data also show that our highly efficient tumor-killing product, INT230-6, induces a strong adaptive immune response to attack untreated lesions and metastases."

Ian B. Walters, MD, Chief Medical Officer of Intensity, added, "The latest data from Intensity’s clinical study evaluating INT230-6 in patients with different types of solid tumors continues to indicate that INT230-6 can be safely injected, even into deep tumors. The vast majority of the active components of INT230-6 stay inside the tumor, and most reports are limited to mild to moderate local discomfort from the injection."

Intensity plans to add more North American clinical sites, as well as international sites, to the Phase 1/2 clinical study of INT230-6. The Company also plans to move into combination arms with an anti-PD-1 antibody and begin Phase 2 expansion cohorts in specific tumor types next year.

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

About the Phase 1/2 Clinical Study

INT230-6 is being evaluated in a Phase 1/2 clinical study in patients with different types of advanced solid tumor malignancies. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The study includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in patients receiving INT230-6. For more information, please visit www.clinicaltrials.gov (NCT03058289).

Spectrum Pharmaceuticals Reports Third Quarter 2018 Pipeline Update and Financial Results

On November 8, 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 financial results for the three-month period ended September 30, 2018 (Press release, Spectrum Pharmaceuticals, NOV 8, 2018, View Source [SID1234530968]).

"In Q3 at the World Conference on Lung Cancer, MD Anderson presented poziotinib interim data in a heavily pre-treated population with exon 20 mutations, which demonstrated strong anti-tumor activity against this difficult-to-treat mutation," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We also actively expanded the poziotinib clinical program on multiple fronts including the initiation of two first-line cohorts in our pivotal ZENITH20 trial and the opening of study sites in Europe. Closing out the year, we expect to receive a response on the poziotinib BTD request and file a BLA with the FDA for our novel G-CSF, ROLONTIS."

Clinical Program Overview:

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations:

Updated interim data from the MD Anderson Phase 2 trial in heavily pre-treated, non-small cell lung cancer (NSCLC) patients with exon 20 mutations were presented at the World Conference on Lung Cancer in September.
In evaluable patients with EGFR exon 20 mutations, the confirmed overall response rate (ORR) was 43% and disease control rate was 90%. Median progression free survival (PFS) was 5.5 months (ITT).
In evaluable patients with HER2 exon 20 mutations, the confirmed overall response rate (ORR) was 42% and disease control rate was 83%. Median progression free survival (PFS) was 5.1 months (ITT).
EGFR-related toxicities (including rash, diarrhea, and paronychia) were manageable and required dose reductions in 60% of patients. Discontinuation due to poor tolerance was rare (approximately 3% of patients).
Spectrum submitted a request for Breakthrough Therapy Designation for poziotinib in previously treated metastatic NSCLC with EGFR exon 20 mutations and expects a response from the FDA by the end of 2018.
Spectrum’s Phase 2 ZENITH20 trial studying poziotinib in NSCLC patients with EGFR or HER2 exon 20 insertion mutations is well underway and enrolling in four distinct cohorts.
First-line cohorts in both EGFR and HER2 were initiated in the third quarter of 2018.
Enrollment in the EGFR, previously treated cohort is expected to be completed by the first quarter of 2019.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF:

Spectrum had a positive pre-BLA meeting with the FDA in the third quarter of 2018 and expects to file for a BLA in the fourth quarter of 2018.
Data from the RECOVER Phase 3 study will be presented in a poster session at the San Antonio Breast Cancer Symposium in early December 2018.
Financial Guidance

Spectrum is refining its full year 2018 revenue guidance and is now between $100-$110 million, revised from $95-$115 million. Additionally, Spectrum currently anticipates that its current cash and marketable securities will be sufficient to fund operations into 2020.

Three-Month Period Ended September 30, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $24.6 million in the third quarter of 2018. Product sales in the third quarter included: FOLOTYN (pralatrexate injection) net sales of $11.3 million, EVOMELA (melphalan) for injection net sales of $6.9 million, BELEODAQ (belinostat) for injection net sales of $3.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $1.5 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.1 million, and FUSILEV (levoleucovorin) net sales of $0.6 million.

Spectrum recorded net loss of $68.7 million, or $0.66 loss per basic and diluted share, in the three-month period ended September 30, 2018, compared to net loss of $18.3 million, or $0.22 loss per basic and diluted share, in the comparable period in 2017. Total research and development expenses were $21.1 million in the quarter, as compared to $13.8 million in the same period in 2017. Selling, general and administrative expenses were $19.8 million in the quarter, compared to $18.5 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $17.5 million, or $0.17 loss per basic and diluted share, in the three-month period ended September 30, 2018, compared to non-GAAP net loss of $9.2 million, or $0.11 loss per basic and diluted share, in the comparable period in 2017. Non-GAAP research and development expenses were $20.2 million, as compared to $13.2 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $16.6 million, as compared to $16.1 million in the same period in 2017.

Conference Call

Thursday, November 8, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 3075918

International: (973) 796-5077, Conference ID# 3075918
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.