On July 27, 2017 Takeda reported 1st Quarter FY2017 results (Press release, Takeda, JUL 27, 2017, View Source [SID1234519935]).

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Underlying Revenue grew +6.6% with growth across all regions (U.S. +13.5%, Japan +1.6%, Europe & Canada +4.6%, Emerging Markets +6.0%). Takeda’s Growth Drivers (GI, Oncology, CNS and Emerging Markets) maintained their strong momentum to deliver growth of +14.7%.
– GI (Gastroenterology) +23.2%, led by continued success of ENTYVIO and TAKECAB
– Oncology +12.2%, driven by NINLARO, ADCETRIS, and ICLUSIG and ALUNBRIGTM
– CNS +29.8%, spearheaded by TRINTELLIX in the U.S.
– Emerging Markets +6.0%, with double-digit growth in the key markets of Russia and Brazil
Reported revenue grew +3.3%, with the positive contribution from Takeda’s Growth Drivers offsetting the impact of unfavorable currencies (-0.4pp) and divestitures (-2.9pp).
Double-digit EPS growth driven by Revenue growth and significant margin gains
Underlying Core Earnings grew +29.4%, with a margin increase of 350bps driven by an improvement in Gross Margin and continued OPEX discipline.
Reported operating profit was up +27.5%, driven by strong underlying growth. Takeda realized a one-time gain in Q1 FY2017 of 106.3 billion yen from the sale of shares of Wako Pure Chemical Industries, Ltd. This was similar in size to the Teva JV transaction gain of 102.9 billion yen in Q1 FY2016, and therefore the impact on our year-on-year growth rate was minimal.
Underlying Core EPS was up +35.7%, reflecting strong Core Earnings growth and a phasing benefit from tax rate. Reported EPS increased +45.8% to 186 yen per share.
Significant progress on Cash Flow and reduced net leverage
Operating Free Cash Flow increased +50.3% to 55.5 billion yen.
Sale of non-core assets generated an additional 128 billion yen of cash.
Net Debt / EBITDA drops from 2.7x at end of FY2016 to 2.1x
James Kehoe, Chief Financial Officer of Takeda, commented:
"Takeda delivered a strong start to the year on both revenue and profitability, driven by the continued strength of our Growth Drivers and good progress on our cost management initiatives. We are executing well against our key priorities of growing the portfolio, rebuilding the pipeline, and boosting profitability, and the first quarter results confirm our confidence in the full-year outlook for double-digit EPS growth."
Reported Results for Q1 (April – June) FY2017
(billion yen)

FY2016 Q1

FY2017 Q1

Growth

Reported

Underlying2

Revenue

434.0

448.2

+3.3%

+6.6%

Core Earnings1

77.1

106.3

+37.9%

+29.4%

Operating Profit

152.9

195.0

+27.5%

–

Net Profit3

99.5

144.8

+45.5%

+35.7%

EPS

127 yen

186 yen

+45.8%

–

Core EPS

71 yen

103 yen

+44.5%

+35.7%

1 Core Earnings is calculated by taking reported Gross Profit and deducting SG&A expenses and R&D expenses. In addition, certain other items that are non-core in nature and significant in value may also be adjusted.
2 Underlying growth compares two periods of financial results on a common basis, showing the ongoing performance of the business excluding the impact of foreign exchange and divestitures from both periods.
3 Attributable to the owners of the company.
Takeda maintains its Management Guidance and Reported Forecast for FY2017, projecting double-digit EPS growth.
FY2017 Management Guidance

Guidance (growth %)

Underlying Revenue

Low single digit

Underlying Core Earnings

Mid-to-high teen

Underlying Core EPS

Low-to-mid teen

Annual dividend per share

180 yen

FY2017 Reported Forecast
(billion yen)

FY2016 Results

FY2017 Forecast

% change

Revenue

1,732.1

1,680.0

-3.0%

Core Earnings

245.1

257.5

+5.0%

Operating Profit

155.9

180.0

+15.5%

Net Profit

114.9

138.0

+20.1%

EPS

147 yen

177 yen

+20.1%

Exchange Rate
(annual average)

1 US$= 109 yen
1 euro= 120 yen

1 US$= 110 yen
1 euro= 120 yen

For more details on Takeda’s FY2017 first quarter results and other financial information please visit View Source

La Jolla Pharmaceutical has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On July 26, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported that two abstracts describing both pooled safety and tolerability data and the mechanism of REOLYSIN, also known as pelareorep, have been selected for poster presentation (display) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress (Press release, Oncolytics Biotech, JUL 26, 2017, View Source [SID1234519895]). The abstracts will be published online on the ESMO (Free ESMO Whitepaper) website at 3:05 ET on Wednesday, August 30. The conference is taking place from September 8-12, 2017, in Madrid, Spain.

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"The pooled analysis of patients treated with intravenous pelareorep is the largest safety database available for this class of agents in combination with chemotherapy," said Dr. Andres Gutierrez, Chief Medical Officer at Oncolytics Biotech. "While our efficacy in metastatic breast cancer announced earlier this year at AACR (Free AACR Whitepaper) was captivating, the safety component of pelareorep increases the benefit-risk ratio of the therapy and supports its further development. We are particularly excited to present these results as other immuno-oncology agents in the same class have had limited or no experience with systemic administration."

Publication number: 1193P
Title: Pooled data analysis of the safety and tolerability of intravenous Pelareorep in combination with chemotherapy in 500 + cancer patients
Lead Author: Dr. Andres Gutierrez, Oncolytics Biotech

Publication number: 523P
Title: Mechanism of Pelareorep (Pel)-mediated cell death in a Phase I study in combination with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC)
Lead Author: Dr. Sanjay Goel, Montefiore Medical Center, NY

The Company also announced that it has been granted an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA), taking place in August 2017. The meeting will address registration pathways for REOLYSIN for the treatment of metastatic breast cancer, the indication for which the FDA has granted Fast Track designation. The Company expects to announce the outcome of this meeting in the fourth quarter of 2017.

On June 26, 2017 Eisai Co., Ltd. reported that it has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (HCC) (Press release, Eisai, JUL 26, 2017, View Source [SID1234528955]). This follows the application in Japan. Lenvatinib for the treatment of HCC is designated as an orphan drug by the FDA.

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This application is based on the results of the REFLECT study (Study 304), a multicenter, open-label, randomized, global Phase III trial comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for HCC, as a first-line treatment for 954 patients with unresectable HCC.(1)

In the REFLECT study, lenvatinib met the primary endpoint and demonstrated an overall survival (OS) treatment effect by the statistical confirmation of non-inferiority compared to sorafenib. Developing first-line treatments for HCC is challenging, and over the past 10 years, four previous first-line Phase III studies investigating other agents compared to sorafenib have failed to achieve this endpoint in OS.(2)

Additionally, lenvatinib showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of Progression Free Survival (PFS), Time To Progression (TTP), and Objective Response Rate (ORR). In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.
Liver cancer is the second leading cause of cancer related death and is estimated to be responsible for 750,000 deaths per year globally (27,000 per year in the US, 62,000 per year in Europe), with 780,000 cases newly diagnosed each year (30,000 per year in the US, 63,000 per year in Europe).(3) HCC accounts for 85 percent to 90 percent of liver cancer cases. Treatment options for unresectable HCC are limited and the prognosis is very poor, making this an area of high unmet medical need.

Lenvatinib is approved as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, and in Europe, under the brand name Lenvima. Additionally, lenvatinib in combination with everolimus is approved for the treatment of renal cell carcinoma (RCC) in over 35 countries, including the United States and in Europe. In Europe, lenvatinib was launched under the brand name Kisplyx for RCC.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of lenvatinib as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to patients with cancer, their families, and healthcare providers.

About lenvatinib mesylate (generic name, "lenvatinib", product name: Lenvima/ Kisplyx)

Discovered and developed in-house, lenvatinib is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other proangiogenic and oncogenic pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRalpha; KIT; and RET) involved in tumor proliferation. Currently, Eisai has obtained approval for lenvatinib as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, and in Europe, under the brand name Lenvima. Additionally, Eisai has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 35 countries, including the United States and in Europe. In Europe, the agent was launched under the brand name Kisplyx for RCC. A Phase III study of lenvatinib in separate combinations with everolimus and pembrolizumab in renal cell carcinoma (first-line) was initiated and is underway. A Phase Ib/II study to investigate the agent in combination with pembrolizumab in select solid tumors (non-small cell lung cancer, renal cell carcinoma, endometrial cancer, urothelial cancer, head and neck cancer, and melanoma) and a Phase Ib study in HCC are also underway. Following the submission of applications in Japan (June 2017), the United States and Europe (July 2017), Eisai also plans to submit an application for lenvatinib for the treatment of HCC in China within the latter half of fiscal 2017.

About the RELECT study (Study 304)(1)

The REFLECT study (A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable HCC) is a multicenter, open-label, randomized, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg (=/>60 kg) or 8 mg (<60 kg) once a day, depending on baseline body weight (n= 478) or sorafenib 400 mg twice a day (n= 476). Treatment was continued until disease progression or unacceptable toxicity.

On July 25, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris: OXI.PA) reported that provides additional detail about its agreement to acquire Georgetown Translational Pharmaceuticals Inc. (GTP) and how the deal will add value to Oxis. Further, Oxis International Inc. has initiated a name change to GT Biopharma Inc. as part of its acquisition and 14C filing (Press release, OXIS International, JUL 25, 2017, View Source [SID1234539563]).

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On June 26, Oxis announced that it had executed a binding LOI agreement to acquire GTP, a move that will deliver new management and a class of close-to-market Central Nervous Systems (CNS) products to Oxis.

Oxis agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close before Sept. 30.

The slide deck (www.oxis.com) highlights several benefits of the acquisition for Oxis and its shareholders, including:

The acquisition of GTP’s leading candidate, Pain Brake, a pain-relief drug expected to be submitted to the FDA as a New Drug Application in 15 to 18 months.
The acquisition of drug candidate GTP-004 for the treatment of myasthenia gravis, a rare muscular disease. The only approved drug for this disease carries significant GI side effects, limiting the tolerable dose. GTP-004 combines the existing drug with an approved treatment of GI disease, reducing side effects and allowing patients to tolerate a more effective dose.
The acquisition of GTP-011, a treatment for motion sickness. This is a repurposed version of an existing drug. It was designed to reduce or eliminate side effects in some elderly patients, allowing them to treat motion sickness without side effects that resembled symptoms of Alzheimer’s Disease.
A new management team at Oxis (soon to be GT Biopharma). GTP co-founder Dr. Kathleen Clarence-Smith, a respected and experienced leader in the pharmaceutical industry, will become CEO of the combined companies. Additionally, a Chief Medical Officer, who formerly served as CMO with Pfizer, will join Oxis under the deal.
Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016 in a deal that, with milestones, could reach $1 billion.

Dr. Clarence-Smith also held executive management positions with Sanofi, Roche, Otsuka Pharmaceutical and Prestwick Scientific Capital. She is co-founder and a managing member of KM Pharmaceutical Consulting in Washington, D. C.

Dr. Clarence-Smith’s vast experience will be extremely beneficial to Oxis’ development of drugs in its pipeline, including OXS-1550, which is in an FDA Phase 2 clinical trial, and its highly valued TriKE platform oncology assets, which are set to go into FDA clinical trials soon.

Oxis’ lead drug candidate, OXS-1550 (DT2219ARL), is a novel drug that binds to targets and destroys cancer cells, due to the action of the drug’s cytotoxic payload. OXS-1550 has demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. It is currently in an FDA-approved Phase 2 trial at the University of Minnesota.

Anthony J. Cataldo, who is Oxis’ Chief Executive Officer, will become Executive Chairman of the combined companies after the deal closes. He said, "Dr. Clarence-Smith’s leadership will be extremely valuable to Oxis. There are not many Biotech executives that have successfully sold their company to big pharma and have navigated several drugs through FDA approval like Dr. Clarence-Smith."

"I am excited by the prospect of joining Tony’s (Anthony J Cataldo) team following his highly successful creation of Lion Biotechnologies, Inc. (now Iovance Biotherapeutics, Inc: Trading – IOVA). As founder of Oxis Biotech, it appears he has delivered again with oncology assets that are well positioned to be in the forefront of the next generation of targeted immunotherapies," said Dr. Clarence-Smith.

"Our existing oncology products (FDA Phase 2 OXS 1550 clinical trial and upcoming FDA TriKE phase 1 clinical trial) have now reached the point where Dr. Clarence-Smith’s experience in taking drugs through FDA approvals and into the market, will bring significant value to our shareholders," Mr. Cataldo said.

The agreement to acquire GTP marks another major value-added inflection point for the shareholders of Oxis. The company continues to progress with recently announced partnership and milestone accomplishments.