On February 8, 2017 GSK reported continued momentum in 2016 through broadly-based sales growth, improved cash flow and further pipeline progression (Press release, GlaxoSmithKline, FEB 8, 2017, View Source [SID1234517667]).

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Summary:

Group sales £27.9 billion, +6% CER on a reported basis , +5% CER pro-forma
– Pharmaceuticals £16.1 billion, +3% (+4 % pro-forma); Vaccines £4.6 billion, +14% (+12% pro-forma); Consumer Healthcare £7.2 billion, +9% (+5% pro-forma)

New product sales more than doubled to £4.5 billion; Q4 £1.4 billion, +71% CER. Driven by HIV (Tivicay, Triumeq), Respiratory (Relvar/Breo, Anoro, Incruse, Nucala) and Meningitis vaccines (Bexsero, Menveo)
– New Pharmaceutical products sales represented 24% of 2016 Pharmaceuticals sales; 27% of Q4 sales

Improved core operating leverage across all three businesses
– Group core operating profit margin 27.9%; Pharmaceuticals 34.1%; Vaccines 31.7%; Consumer 15.5%
– Incremental annual cost savings of £1.4 billion delivered in 2016, with total annual cost savings now at £3.0 billion including currency benefit of £0.2 billion

2016 core EPS 102.4p, +12% CER

2016 total EPS 18.8p, -99% CER, primarily reflecting comparison with £9.2 billion profit in 2015 from disposal of marketed Oncology assets

2016 net cash flow from operations of £6.5 billion (2015: £2.6 billion), reflecting improved operating performance and the net benefit of exchange rate movements

GSK and Shionogi have agreed to remove the Shionogi put option and first two exercise windows of GSK’s call option in relation to ViiV Healthcare. Liability for put option of £1.2 billion de-recognised to equity

23p dividend declared for Q4 delivering total dividend for 2016 of 80p. Continue to expect 80p dividend for 2017

Continued progress by the Group expected in 2017 although core EPS growth subject to uncertainty of timing and impact of possible generic competition to Advair in the US
– In the event of no generic competition to Advair in the US, expect 2017 core EPS growth to be 5-7% CER
– In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, expect full year 2017 US Advair sales of ~£1 billion at CER (US$1.36/£1) with core EPS flat to a slight decline in percentage terms at CER
– January 2017 average exchange rates, if applied to whole of 2017, would benefit Sterling turnover by around 6% and core EPS by around 9%

Sustained pipeline progress with multiple milestones expected in 2017/18:
– Filed 4 assets with regulators in H2 2016 (Shingrix; Closed Triple; Benlysta SC; sirukumab), with regulatory decisions expected by end 2017
– 4 key phase III starts in Q4 for assets in HIV, respiratory and anaemia
– Continue to expect key data on between 20-30 assets by end 2018 in areas including HIV, respiratory, immuno-inflammation, oncology and vaccines


Outlook assumptions and cautionary statements
Assumptions related to 2017 guidance and 2016-2020 outlook
In outlining the expectations for 2017 and the five-year period 2016-2020, the Group has made certain assumptions about the healthcare sector, the different markets in which the Group operates and the delivery of revenues and financial benefits from its current portfolio, pipeline and restructuring programmes.

For the Group specifically, over the period to 2020 GSK expects further declines in sales of Seretide/Advair. The introduction of
a generic alternative to Advair in the US has been factored into the Group’s assessment of its future performance. The Group assumes no premature loss of exclusivity for other key products over the period. The Group’s expectation of at least £6 billion of revenues per annum on a CER basis by 2020 from the New Pharmaceutical and Vaccine products listed on page 31 includes contributions from the current pipeline asset Shingrix. This target is now expected to be met up to two years earlier. The Group also expects volume demand for its products to increase, particularly in Emerging Markets.

The assumptions for the Group’s revenue and earnings expectations assume no material interruptions to supply of the Group’s products and no material mergers, acquisitions, disposals, litigation costs or share repurchases for the Company; and no change
in the Group’s shareholdings in ViiV Healthcare or Consumer Healthcare. They also assume no material changes in the macro-economic and healthcare environment.

The Group’s expectations assume successful delivery of the Group’s integration and restructuring plans over the period 2016-2020. Material costs for investment in new product launches and R&D have been factored into the expectations given. The expectations are given on a constant currency basis and assume no material change to the Group’s effective tax rate or the tax regulatory environment in which it operates.

Assumptions and cautionary statement regarding forward-looking statements
The Group’s management believes that the assumptions outlined above are reasonable, and that the aspirational targets described in this report are achievable based on those assumptions. However, given the longer term nature of these expectations and targets, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macro-economic activity, changes in regulation, government actions or intellectual property protection, actions by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, "forward-looking statements". Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Other than in accordance with its legal or regulatory obligations (including under the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation
to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the US Securities and Exchange Commission (SEC). All readers, wherever located, should take note of these disclosures. Accordingly,
no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements.

Forward-looking statements are subject to assumptions, inherent risks and uncertainties, many of which relate to factors that are beyond the Group’s control or precise estimate. The Group cautions investors that a number of important factors, including those
in this document, could cause actual results to differ materially from those expressed or implied in any forward-looking statement. Such factors include, but are not limited to, those discussed under Item 3.D ‘Risk factors’ in the Group’s Annual Report on Form
20-F for 2015 and those discussed in Part 2 of the Circular to Shareholders and Notice of General Meeting furnished to the SEC
on Form 6-K on 24 November 2014. Any forward looking statements made by or on behalf of the Group speak only as of the date they are made and are based upon the knowledge and information available to the Directors on the date of this report.

On February 7, 2017 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, and the Providence Cancer Center reported the presentation of preclinical and early clinical data from two investigator-initiated Phase 1 clinical trials of GR-MD-02 used in combination with approved cancer immunotherapies (Filing, 8-K, Galectin Therapeutics, FEB 7, 2017, View Source [SID1234517663]). Data presented today at the 9th GTCBio Immunotherapeutics & Immunomonitoring Conference in San Diego, CA by Dr. William L. Redmond, Providence Cancer Center, has been posted.

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"Preclinical results in mouse models of multiple types of cancers show
ed important anti-tumor and increased survival effects of combining GR-MD-02 with different types of immune modulators, providing a compelling case for progressing studies into human patients with cancer" said William L. Redmond, Ph.D., Associate Member, Laboratory of Cancer Immunotherapy, and Director, Immune Monitoring Laboratory, Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR. "We are pleased that our translational medicine team is conducting two phase 1 clinical trials which were initiated under the direction of principal investigator Brendan D. Curti, M.D., Director of the Providence Biotherapy Program at Providence Cancer Center."

GR-MD-02 was combined with pembrolizumab (KEYTRUDA) in patients with advanced melanoma, and this study has been expanded to patients with oral/head and neck cancer (OHN) and non small cell lung cancer (NSCLC) (View Source). Six subjects with advanced melanoma have been enrolled in the lowest dose cohort (2 mg/kg) with no safety concerns related to GR-MD-02. To date, one partial response and one mixed response has been observed. Below is a chest CT scan of the patient with a partial response showing a marked reduction in tumor size at week 12 of therapy, after 3 doses of combined GR-MD-02 and pembrolizumab.

Baseline CT Scan
Week 12 Therapy CT Scan
LOGO
GR-MD-02 was also combined with ipilimumab (Yervoy) in patients with advanced melanoma (View Source). Seven subjects treated with the lowest two dose cohorts of GR-MD-02 (1 and 2 mg/kg) have been completed with no safety signals identified due to GR-MD-02. In these low dose initial cohorts, there were no notable changes in the peripheral immune signature. Due to changes in the standard of care for metastatic melanoma (i.e., approval of KEYTRUDA), recruitment has been slowed significantly.
"We are encouraged by these early safety results and look forward to further data on the safety and efficacy of GR-MD-02 used in combination with pembrolizumab (KEYTRUDA) in patients with metastatic melanoma, OHN, or NSCLC", said Dr. Curti. "While we cannot conclude from the one partial response in the pembrolizumab study that the response was related to GR-MD-02, it provides us with a clinically relevant signal to follow as GR-MD-02 doses are escalated. We hope to report additional data in early 2018 when we anticipate a decision on progressing to phase 2. This decision will be based on the response rate of the combination of pembrolizumab with GR-MD-02 as compared to historical response rates to pembrolizumab alone."

About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.

On February 7, 2017 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported that a Phase 1 clinical trial studying Actimab-M in multiple myeloma has been initiated (Press release, Actinium Pharmaceuticals, FEB 7, 2017, View Source [SID1234517653]).

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Actimab-M is comprised of the CD-33 targeting monoclonal antibody HuM-195 coupled to the alpha-particle emitter actinium 225. CD33 is an antigen found on hematopoietic cells in certain blood cancers. It is commonly associated with myeloid malignancies including AML, but recent research has shown that CD33 can also be found on malignant cells of approximately 25%-35% of all multiple myeloma patients. Furthermore, the expression of this marker increases in relapsed and refractory myeloma. In addition, it predicts for a very aggressive course of disease. This makes CD33 a potential target for the treatment of this usually fatal disease. Although treatable, multiple myeloma is currently not considered curable and almost all patients eventually relapse or become refractory to available treatments as their condition progresses. In this new trial, Actimab-M will be used in patients who have progressing disease after 3 prior multiple myeloma treatment regimens or are refractory to QUAD (Caflizomib, Lenalidomide, Pomalidomide, Dexamethason).

“I am very excited to lead in the development of this novel and promising approach,” said Dr. M. Yair Levy of Texas Oncology – Baylor Charles A. Sammons Cancer Center. “Relapsed and refractory multiple myeloma is an area of high unmet medical need that we hope to address with Actimab-M. Myeloma is a very radiosensitive cancer, and does not present with the neutropenia and thrombocytopenia of AML. I would expect tolerability of this treatment to be better in this disease. Based on my previous experience with Actimab-A in AML and my research in the area of multiple myeloma, I believe that this targeted treatment could prove efficacious and be a part of our growing armamentarium against this disease.”

Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals said, “We are incredibly excited to see the initiation of this trial for Actimab-M in multiple myeloma. Not only does this mark the beginning of the expansion of our clinical pipeline beyond AML, it also demonstrates the broad applicability of our radioimmunotherapy technologies that we intend to progress into new indications and patient populations. Further, this reinforces Actinium’s commitment to developing therapies for patients with unmet needs. We look forward to providing updates as this trial progresses.”

About Multiple Myeloma

Multiple Myeloma is a blood cancer characterized by malignant transformation of the type of white blood cells called plasmocytes. These cells accumulate in the bone marrow and eventually lead to serious bone and kidney damage. Multiple Myeloma is the second most commonly diagnosed blood cancer after Non-Hodgkin Lymphoma with estimated about 30,000 new cases per year in the US. Almost 100,000 people in the US currently live with the disease. Average age at diagnosis is 70, and only 2% of cases occur in people younger than 40 years. There is currently no cure for Multiple Myeloma, although a number of drugs have been approved for treatment of the disease. However, most patients eventually stop responding to available treatments, which results in a high unmet medical need for relapsed and refractory forms of the disease.

About Actimab-M

Actimab-M is comprised of the anti-CD33 monoclonal antibody HuM-195 coupled to actinium 225, an alpha-particle emitting radioisotope, and is the same construct of Actinium’s Actimab-A, which is currently being studied in a Phase 2 clinical trial in patients newly diagnosed with acute myeloid leukemia (AML) who are over the age of 60. Actimab-A is being studied in AML at fractionated doses of 2.0 μCi/Kg administered via infusion on day 1 and day 7 as a single cycle while Actimab-M is being studied in multiple myeloma as a single infusion up to 1.0 μCi/Kg for up to 8 cycles not to exceed 4.0 μCi/Kg total per patient. The Phase 1 trial for Actimab-M is a multicenter, open label, dose-escalation study. Patients will be administered a starting dose level of 0.5 μCi/Kg of Actimab-M via infusion on day 1 of each cycle for up to 8 cycles with each cycle lasting 42 days. If this dose level is deemed safe, a second dose level of 1.0 μCi/kg will be explored for up to 4 cycles also of 42 days per cycle. Total dose received per patient is not to exceed 4.0 μCi/kg. In the event of dose limiting toxicities (DLTs) at the 0.5 μCi/Kg dose level, a dose level of 0.25 μCi/Kg will be explored. The Phase 1 trial will estimate maximum tolerated dose (MTD), assess adverse events, measure response rates (objective response rate, complete response rate, stringent complete response rate, very good partial response rate and partial response rate) as well as progression free survival (PFS) and overall survival (OS).