On October 25, 2017 GlaxoSmithKline reported Q3 sales of £7.8 billion, +4% AER, +2% CER (Press release, GlaxoSmithKline, OCT 25, 2017, View Source [SID1234521165]).

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Financial highlights

Sales growth in Pharmaceuticals and Consumer Healthcare; Vaccines sales flat
Pharmaceuticals sales £4.2 billion +3% AER, +2% CER; Vaccines £1.7 billion +5% AER, flat at CER; Consumer Healthcare £2.0 billion +5% AER, +2% CER
Improved Total operating margin of 23.9% (+4.9 points, including 0.2 points currency benefit) and EPS (24.8p), primarily reflecting reduced transaction-related charges related to valuations of Consumer Healthcare and HIV businesses
Improved Adjusted Group operating margin of 31.5% (+1.0 point, no currency effect) primarily reflecting leverage from sales growth, focus on costs and benefits of restructuring. Pharmaceuticals 34.0% (-0.3 points, no currency effect); Vaccines 41.3% (+1.6 points, including 0.3 points adverse currency effect); Consumer Healthcare 20.0% (+3.9 points, including 1.3 points currency benefit)
YTD free cash flow £1.6 billion (9 months 2016: £1.3 billion)
19p dividend declared for quarter. Continue to expect 80p for FY 2017
Guidance for 2017 Adjusted earnings per share growth maintained at 3% to 5% CER
Product and pipeline highlights

New product sales of £1.7 billion, +44% AER, +40% CER, driven by continued strong performance from Tivicay/Triumeq in HIV, Relvar/Breo Ellipta and Nucala in Respiratory and meningitis vaccines
Trelegy Ellipta approved in the US for COPD and positive opinion received in Europe. Positive results from landmark IMPACT study show benefits of Trelegy Ellipta in reducing COPD exacerbations compared to dual therapies
Shingrix vaccine for shingles approved in US and Canada
Phase III results for Nucala (mepolizumab) in COPD published in New England Journal of Medicine with regulatory filings planned for this year
In Oncology, CHMP PRIME designation granted for 2857916 (BCMA antibody-drug conjugate) for relapsed and refractory multiple myeloma and new data to be presented at an upcoming scientific conference; option exercised from Adaptimmune to develop T-cell therapy (NY-ESO-1) for multiple tumour types
Q3 2017 results infographic
Emma Walmsley, Chief Executive Officer, GSK said:

“Performance in the quarter showed continued progress with sales growth and improved operating margins. This was driven by targeted cost savings and restructuring and integration benefits, which particularly benefited Vaccines and Consumer Healthcare, and also supported investment in our new products and R&D pipeline. Adjusted earnings per share for Q3 were 32.5p and we remain on course for our full-year earnings guidance, with cash generation continuing to improve. We are also pleased that we have secured major approvals for Trelegy Ellipta in COPD and Shingrix, our shingles vaccine.”

On October 25, 2017 Varian (NYSE:VAR), the world’s leading manufacturer of medical devices and software for treating and managing cancer, reported its fourth-quarter and full-year fiscal 2017 results (Press release, Varian Medical Systems, OCT 25, 2017, View Source [SID1234521176]). All fourth-quarter comparisons in this announcement are year-over-year unless noted otherwise.

Summary

($ in millions except EPS) Q4 2017 Q4 2016 FY 2017 FY 2016
Revenues (from Continuing Operations) $ 739.0 $ 747.2 $ 2,668.2 $ 2,621.1
Growth Reported (1 )% 2 %
Growth Constant Currency (2 )% 2 %
Gross Margin 42.1 % 42.6 % 43.3 % 42.5 %
GAAP Net Earnings (1) $ 82.7 $ 94.3 $ 257.1 $ 325.3
GAAP Net Earnings per Diluted Share (1) $ 0.89 $ 1.00 $ 2.75 $ 3.39
Net Cash Provided by Operating Activities $ 129.6 $ 151.9 $ 399.1 $ 356.3
Non-GAAP Net Earnings (1) (2) $ 100.6 $ 97.7 $ 335.1 $ 354.9
Non-GAAP Net Earnings per Diluted Share (1) (2) $ 1.09 $ 1.03 $ 3.60 $ 3.70

(1) GAAP Net Earnings and Earnings Per Diluted Share and Non-GAAP Net Earnings and Non-GAAP Earnings Per Diluted Share refer only to continuing operations. GAAP and Non-GAAP Earnings Per Diluted Share, for the quarter and fiscal year ended September 29, 2017, were calculated based on diluted shares of 92.6 million and 93.2 million, respectively. For the quarter and fiscal year ended September 30, 2016, the number of diluted shares was 94.5 million and 96.0 million, respectively.
(2) Non-GAAP Net Earnings and Non-GAAP Earnings Per Diluted Share are defined as GAAP Net Earnings and GAAP Earnings Per Diluted Share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, restructuring and impairment charges and significant litigation charges or benefits and legal costs.

"We finished a transformative year for the company with a solid quarter highlighted by robust gross order growth," said Dow Wilson, CEO of Varian. "During the year, we extended our industry leadership with successful launches of the Halcyon and HyperArc treatment platforms, grew our global footprint and continued to build capabilities to grow beyond our core market. We also booked two more proton orders in the quarter, bringing our total for the year to six."

The company ended the quarter with $716 million in cash and cash equivalents and $350 million of debt. Net cash provided by operating activities was healthy at $130 million in the fiscal fourth quarter and $399 million for the fiscal year, supported by improved cash collections. During the fiscal fourth quarter, the company invested $25 million to repurchase 250,000 shares of common stock.

Gary Bischoping, Varian’s chief financial officer, added, "While the quarter’s profitability results came in short of our expectations, I’m pleased with our team’s ongoing operational and financial discipline. We have more work to do, but we made solid progress toward our long-term objectives. Our orders growth, improving gross margin rate this past year, and continued working capital efficiencies has me looking forward to our next fiscal year."

Oncology Systems Segment
In the fiscal fourth quarter, Oncology revenues for the segment totaled $686 million, up 1 percent in dollars and in constant currency. For the full year, revenues were up 1 percent at $2.5 billion. Gross orders were $964 million, up 7 percent in dollars and in constant currency. Gross orders in the Americas increased 1 percent in dollars and 2 percent in constant currency, with North America growing 8 percent in dollars. In EMEA, gross orders rose 32 percent in dollars and 29 percent in constant currency, to $321 million driven by robust growth in France, Germany, Poland and India; in APAC gross orders declined 10 percent in dollars and 9 percent in constant currency where strong growth across a majority of the region was offset by significant declines in Japan.

Proton Therapy Segment
Revenues in the fourth quarter were down 23 percent at $52 million. For the full year, revenues were up 12 percent at $182 million. In the quarter, the company booked orders totaling $74 million, including orders for ProBeam Compact projects in China and India. For the full fiscal year, proton therapy orders totaled $229 million, more than double the previous year.

Outlook for Full Fiscal Year 2018
We expect the following for fiscal year 2018:
· Revenues to grow by 2 to 4 percent
· Non-GAAP operating earnings to range between 18 and 19 percent of revenue
· Non-GAAP net earnings per diluted share from continuing operations to be in the $4.20 to $4.32 range
· Cash Flow from Operations to be between $475 million and $550 million

We have assumed no change to share count year over year and a tax rate of 23 percent.

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call
Varian Medical Systems is scheduled to conduct its fourth quarter fiscal year 2017 conference call at
2 p.m. PT today. To hear a live webcast or replay of the call, visit the investor relations page on our company’s web site at www.varian.com/investor where it will be archived for a year. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering confirmation code 13669524. The telephone replay will be available through 5 p.m. PT, Friday, October 27, 2017.

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At AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy took place October 1-4, 2017 in Boston, MA, Anaeropharma has presented its new research outcomes regarding cancer immunotherapy titled “Anti-PD-1 antibody scFv producing recombinant Bifidobacterium exerts antitumor effect in a larger fraction of the treated mice comparing to full length anti-PD-1 antibody” (Press release, Anaeropharma Science, OCT 24, 2017, View Source [SID1234521147])

On October 24, 2017 Asana BioSciences, LLC, an oncology focused, clinical stage biopharmaceutical company, reported that it will present updates regarding three of its lead molecules at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) to be held in Philadelphia, PA, October 26-30, 2017 (Press release, Asana BioSciences, OCT 24, 2017, View Source [SID1234521148]).

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“The presentations will highlight the well differentiated profile of our clinical and preclinical programs, including first disclosure on our next clinical candidate ASN007, a potent ERK1/2 inhibitor.”
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“We are very pleased with the progress made in advancing our oncology portfolio,” said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. “The presentations will highlight the well differentiated profile of our clinical and preclinical programs, including first disclosure on our next clinical candidate ASN007, a potent ERK1/2 inhibitor.”

The presentation details are as follows:

1. A Phase 1 PK/PD study of ASN003, a novel, highly selective BRAF and PI3K dual inhibitor, in patients with advanced solid tumors.

Authors: Drew Rasco1, Nehal Lakhani2, Ryan Sullivan3, Monica Mita4, Jaimini Shah5, Helena Usansky5, Sanjeeva Reddy5, Niranjan Rao5, Louis J. Denis5, Anthony Tolcher1, Keith Flaherty3. 1START San Antonio, San Antonio, TX; 2START Midwest, Grand Rapids, MI; 3Mass Gen Hosp CC, Boston, MA; 4Cedars-Sinai Medical Center, Los Angeles, CA; 5Asana BioSciences.
Session: PO.B21 – Therapeutic Agents: Small-Molecule Kinase Inhibitors
Poster # B 147; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

2. ASN007, a novel oral ERK1/2 inhibitor, shows robust antitumor activity in RAS mutant cancer models.

Authors: Sanjeeva Reddy, Dhanalakshmi Sivanandhan, Purushottam Dewang, Niranjan Rao, Roger A. Smith and Scott Thompson.
Session: PO.B21 – Therapeutic Agents: Small-Molecule Kinase Inhibitors
Poster # B 150; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

3. ASN004, a novel 5T4-targeted Dolaflexin ADC, causes complete and durable tumor regressions in a variety of tumor xenograft models.

Authors: Roger A. Smith, David J. Zammit, Sanjeeva P. Reddy.
Session: PO.B19 – Therapeutic Agents: Biological
Poster # B 109; Hall E
Date/Time: Sunday, October 29, 2017 at 12:30pm – 4:00pm EDT

ASN003 is a potent and highly selective inhibitor of both B-RAF and PI3 kinases. RAS-RAF-MEK and PI3K-AKT-mTOR are two major pathways involved in tumor cell signaling and growth. Components of these pathways are frequently mutated in a broad range of tumors. Selective BRAF inhibitors induce dimerization of RAF proteins, leading to paradoxical activation of the RAF-MEK-ERK cascade. This activation is a major limitation for the clinical use of selective RAF inhibitors, as it leads to resistance and results in side effects in the skin limiting their use in patients with BRAF mutant tumors. In addition, elevated signaling through the PI3K/AKT pathway, with or without concomitant MAPK reactivation, represents an alternative path to resistance to BRAF inhibitors. Preclinical data with ASN003, demonstrates broad anti-proliferative activity in tumor cell lines and strong tumor growth inhibition in tumor xenograft models, including BRAF inhibitor resistant models. ASN003 is currently in Phase I clinical development in patients with advanced solid tumors, including melanoma, colorectal cancer and non-small cell lung cancer. ASN003 is well tolerated and shows the potential to be developed as a monotherapy or in combination with checkpoint inhibitors or standard of care.

ASN007 is a potent inhibitor of the extracellular-signal-regulated kinases, ERK1 and ERK2 (ERK1/2), key players in the RAS/RAF/MEK (MAPK) signaling pathway. This pathway is frequently hyper-activated in a wide range of cancers through mutations in upstream targets such as BRAF, RAS and receptor tyrosine kinases. Inhibition of ERK1/2 offers a promising therapeutic strategy for these cancers, particularly those driven by RAS mutations. ASN007 shows potent anti-proliferative activity in cancer lines that are selectively driven by the MAPK-pathway, including RAS mutant cell lines. Furthermore, ASN007 demonstrates strong inhibition of tumor growth in multiple BRAF and KRAS mutant patient-derived and cell line-derived xenograft models, including those that are resistant to BRAF and MEK inhibitors. The IND-submission is planned to evaluate safety and efficacy in patients with advanced solid tumors, including BRAF and KRAS mutant cancers.

ASN004 is an Antibody Drug Conjugate (ADC) that targets the 5T4 oncofetal antigen that is expressed in a wide range of malignant tumors, while very limited expression is found in normal tissues. ASN004 demonstrates robust antitumor activity leading to complete tumor regressions in multiple human tumor xenograft models with no development of resistance to ASN004 treatment. The IND-enabling program for ASN004 is near completion and a First-in-Human Phase 1 trial is being planned in 2018.

Xspray Pharma AB presenterar idag resultaten av en klinisk pilotstudie avseende läkemedelskandidaten HyNap-Dasa (Press release, Xspray, OCT 24, 2017, View Source [SID1234523285]). Pilotstudien undersökte HyNap-Dasas biotillgänglighet av dasatinib som idag marknadsförs som Sprycel för behandling av kronisk myeloid leukemi (KML). För de undersökta HyNap-Dasa-kompositionerna låg de två kritiska parametrarna för absorption av dasatinib i kroppen, AUC och Cmax, nära de värden som observerades för Sprycel. Bolaget avser att med små justeringar ta en vald HyNap-Dasa-komposition vidare till en generisk produkt på den amerikanska marknaden (med regulatorisk ANDA-procedur).

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I den avslutade kliniska Fas I-studien deltog 12 friska försökspersoner. Biotillgängligheten för olika formuleringar av HyNap-Dasa testades i jämförelse med Sprycel. Resultaten är positiva och bekräftar validiteten av Xsprays formuleringsverktyg. De redan planerade studier som krävs för att kunna ta HyNap-Dasa till slutliga registreringsstudier kommer nu att utföras som planerat.

"Jag är mycket nöjd med att vi uppnått studiens primära syfte att få fram underlag för vår produktkomposition för planerade studier under första halvåret 2018. Studien visar att den uppnådda absorptionsprofilen av vår HyNap-Dasa komposition är lik originalets och att det verktyg vi har tagit fram fungerar för att justera både AUC och Cmax till de nivåer som krävs för att visa bioekvivalens. Detta är ett viktigt steg i utvecklingen av vårt generiska läkemedel baserat på vår RightSize teknologi. Vi har nu en klar bild av hur formuleringen ska vara sammansatt i kommande studier. Det gör att vi med stor sannolikhet kan hålla vår tidplan för de registreringsstudier som planeras framöver," säger Per Andersson, verkställande direktör.

De kliniska resultaten i sammandrag:

Den totala biotillgängligheten av dasatinib från den valda kompositionen av HyNap-Dasa, mätt som ytan under kurvan AUC, var 7% högre jämfört med Sprycel.
Den maximala koncentrationen av dasatinib i plasma, Cmax, var 13% högre för HyNap-dasa kompositionen jämfört med Sprycel.
Resultaten visar att formell bioekvivalens (Cmax och AUC inom området 80-125% av originalläkemedlet) kan uppnås med ett större antal försökspersoner.

Studieresultaten är i linje med bolagets plan för kliniska studier som finns presenterad i det prospekt som togs fram i samband med introduktionen på First North i slutet av september. Planen är att genomföra nödvändiga studier för att kunna ha en färdig produkt godkänd för försäljning på den amerikanska marknaden 2020 eller senast 2021.