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 Cancer Research UK reported that the charity’s commercialisation arm, Cancer Research Technology, has been brought together with the Charity’s research funding teams to form a new in-house division called Research and Innovation (Press release, Cancer Research Technology, JUL 27, 2017, View Source [SID1234523163]).

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The move will increase the ease with which funded research can progress toward the development of new therapeutics, diagnostics and other innovations that ultimately deliver benefits to cancer patients and the wider population.

Dr Iain Foulkes, Cancer Research UK’s executive director of research and innovation, said: "It’s become clear that the more integrated we are as an organisation, the more we can ensure that our incredible network of discovery science, translational research and clinical development activities are brought to bear in the development of new advances that benefit patients.

"Partnership plays an incredibly important role in this – we can’t advance the discoveries our researchers make in isolation – and with this move we can engage partners sooner and bring our network of capability together with their expertise to accelerate progress.

"Our goal is to be the world leading cancer research and innovation organisation. Partners need to understand what we do and how to engage with our funded scientists and our portfolio of research. We have a broad research strategy spanning discovery science, cancer prevention, big data, therapeutic innovation and early detection. This move we are making will help us develop effective strategic partnerships to advance our work in these areas."

All commercialisation activity will be carried out by Cancer Research UK’s Commercial Partnerships team* and the CRT Discovery Laboratories will become the CRUK Therapeutic Discovery Laboratories. With exclusive rights to over £350m of world-class cancer research annually, we are able to offer unique opportunities to commercial partners looking for early involvement in new discoveries.

The move will also benefit researchers, enabling them to progress their projects through cross-disciplinary or industry interactions, while industry partners will benefit from academia’s high-risk research and innovative thinking.

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 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.