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 27, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), reported that it has amended its license agreement with Takeda Oncology for IPI-549, Infinity’s potentially first-in-class immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma) (Press release, Infinity Pharmaceuticals, JUL 27, 2017, View Source;p=RssLanding&cat=news&id=2289511 [SID1234519908]). Under the amended agreement, Infinity will no longer have an obligation to pay Takeda future royalties on worldwide net sales of selective inhibitors of PI3K-gamma, including IPI-549.

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In exchange for eliminating the royalty obligation, Infinity issued to Takeda an unsecured $6.0 million convertible note that matures on July 27, 2018, and accrues interest at an annual rate of eight percent. The company is obligated to pay the principal amount together with any accrued interest on or before the maturity date in cash or in shares of Infinity common stock, at the election of Takeda. The share payment price would equal the average closing price of Infinity’s common stock for the 20 days prior to the payment date.

"Our decision to enter this amendment underscores Infinity’s belief in the potential of IPI-549 to be an oral, selective first-in-class inhibitor of PI3K-gamma for the treatment of a broad range of solid tumors, and we are continuing to advance our Phase 1 study evaluating IPI-549 both as a monotherapy and in combination with Opdivo, a PD-1 immune checkpoint inhibitor," stated Adelene Perkins, Infinity’s chief executive officer. "This amendment reduces the total royalty burden on any future net sales of IPI-549 to four percent due to Mundipharma and Purdue from a previous agreement."

Infinity remains obligated to pay development, regulatory and commercial milestones to Takeda for IPI-549. The remaining milestones comprise up to a total of $5 million in development milestones, up to $50 million in success-based regulatory milestones, and up to $115 million in commercial milestones, which are due once certain sales thresholds have been met.

Under a previous agreement, Infinity is obligated to pay Mundipharma International Corporation Limited and Purdue Pharmaceutical Products L.P. a four percent royalty in the aggregate on worldwide net sales of IPI-549, which steps down to one percent in the U.S. after a certain sales threshold is met.

About IPI-549 and the Ongoing Phase 1 Study

IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor to an anti-tumor phenotype and is able to overcome resistance to checkpoint inhibition.1,2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors.3 The study includes monotherapy and combination dose-escalation phases, in addition to a monotherapy expansion cohort and combination expansion cohorts. The expansion cohorts evaluating IPI-549 plus Opdivo will include patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). Patients enrolled in these combination expansion cohorts represent a difficult-to-treat population, as they must have demonstrated initial resistance or subsequently develop resistance to a PD-1 or PD-L1 therapy immediately prior to enrolling in the study. Overall, the study is expected to enroll approximately 175 patients.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On July 27, 2017 AstraZeneca and MedImmune, its global biologics research and development arm, reported progression-free survival (PFS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, JUL 27, 2017, View Source [SID1234519897]).

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The combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving PFS compared to SoC in patients whose tumours express PD-L1 on 25% or more of their cancer cells (as determined by the VENTANA PD-L1 (SP263) assay).

As a secondary endpoint, although not formally tested, Imfinzi monotherapy would not have met a pre-specified threshold of PFS benefit over SoC in this disease setting.

The trial will continue to assess two additional primary endpoints of overall survival (OS) for Imfinzi monotherapy and OS for the Imfinzi plus tremelimumab combination. Final OS data from both primary endpoints are expected during the first half of 2018.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "While the results from the MYSTIC trial for progression-free survival in first-line Stage IV non-small cell lung cancer compared with standard of care are disappointing, the trial was designed to assess overall survival and we look forward to evaluating the remaining primary endpoints of overall survival for both mono- and combination therapy."

AstraZeneca recently received accelerated approval from the US FDA for Imfinzi in previously-treated patients with locally advanced or metastatic urothelial carcinoma (mUC).

About MYSTIC

The MYSTIC trial is a randomised, open-label, multi-centre, global Phase III trial of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus SoC in treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally-advanced or metastatic (Stage IV) 1st-line NSCLC. Lung cancer is an unapproved use of Imfinzi.

The trial is being conducted in 167 centres across 17 countries, including the US, Canada, Europe, parts of Asia including Japan, Korea, Thailand, Taiwan and Vietnam, and in Russia and Australia. Primary endpoints include PFS and OS.

About Imfinzi

Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response.

Imfinzi continues to be studied in multiple monotherapy trials and combination trials with tremelimumab and other potential new medicines in immuno-oncology. Imfinzi is being assessed in Phase III trials as a monotherapy in various stages of NSCLC, in small-cell lung cancer (SCLC), in mUC and in head and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is being assessed in Phase III trials in mUC, NSCLC, SCLC and HNSCC and in Phase I/II trials in hepatocellular carcinoma (HCC) and haematological malignancies.

About Tremelimumab

Tremelimumab is an investigational human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being investigated in an extensive clinical trial programme in combination with Imfinzi, in NSCLC, mUC, HNSCC, HCC and blood cancers.

About AstraZeneca in NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined.

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of NSCLC across all stages of disease and lines of therapy. We aim to address unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa and Tagrisso and ongoing FLAURA and ADAURA trials. Our extensive late-stage immuno-oncology programme focuses on 75-80% of patients with NSCLC without a known genetic mutation. Our portfolio includes Imfinzi (durvalumab), an anti-PDL1 antibody, which is in development as monotherapy (ADJUVANT, PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with tremelimumab, an anti-CTLA-4 (MYSTIC, NEPTUNE and POSEIDON trials).

On July 27, 2017 NewLink Genetics Corporation (NASDAQ: NLNK) reported first patient dosed in the Phase 1 study of NLG802, a novel prodrug of indoximod. NLG802 is an investigational agent targeting the IDO pathway and represents an important step in the company’s strategic planning and intellectual property (IP) management (Press release, NewLink Genetics, JUL 27, 2017, View Source [SID1234519909]).
The NLG802 trial is a Phase 1 open-label clinical trial for patients with advanced solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses. The trial will utilize a standard 3+3 dose-escalation design.

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"Preclinical data for NLG802 have shown an advantageous pharmacokinetic profile in preclinical models and were presented in April at the AACR (Free AACR Whitepaper) annual meeting," said Charles J. Link, Jr., MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "NLG802 further expands the lifecycle and IP surrounding our evolving immuno-oncological platform."

Trial specific information is available on clinicaltrials.gov

About NLG802
NLG802 is an investigational, orally available prodrug of indoximod, a small molecule targeting the IDO Pathway. The IDO Pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape. NewLink Genetics is currently evaluating NLG802 in a Phase 1 dose-escalation clinical trial in cancer patients to assess the safety and pharmacokinetics of NLG802.