On April 24, 2019 Syros Pharmaceuticals presented the corporate presentation (Presentation, Syros Pharmaceuticals, APR 24, 2019, View Source [SID1234535354]).

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On April 24, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of the fiscal year ended December 31, 2019 (Press release, Chugai, APR 24, 2019, View Source [SID1234535351]).

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Chugai reported record high revenues and profits for the first quarter of 2019 driven by contribution from new products including the hemophilia A treatment Hemlibra and the immune checkpoint inhibitor Tecentriq, and strong growth of mainstay products in Japan and overseas. Revenues increased by a little less than 5% as the double-digit sales growth driven mainly by the contribution of new products and strong exports outweighed the remarkable decrease in royalties and other operating income in the absence of one-time income from the transfer of long-term listed products reported last year. Operating profit achieved a double-digit increase due to a better cost to sales ratio as the proportion of in-house products increased in the total product mix.

Domestic sales increased to ¥99.3 billion (+6.9%). Contribution from new products including the hemophilia A treatment Hemlibra created by Chugai and the immune checkpoint inhibitor Tecentriq, and the strong growth of mainstay products chiefly in bone and joint diseases area have exceeded the negative impact from the NHI drug price revisions last year and generic competition.
Oncology: Sales increased driven by the contribution from new products such as Tecentriq and Gazayva as well as solid growth of Perjeta and Alecensa, despite the negative impact from last year’s NHI drug price revisions and generic competition facing Rituxan.
Bone and joint diseases: Sales recorded a double-digit growth due to strong sales of mainstay products such as the anti-rheumatic agent Actemra and the osteoporosis agent Edirol.
Renal diseases: Sales were almost flat while sales of the renal anemia agent Mircera and the secondary hyperparathyroidism treatment Oxarol approximated the previous year’s level.
Others: Sales increased primarily due to favorable market penetration of new products such as the hemophilia A treatment Hemlibra, despite the negative impact from the transfer of long-term listed products last year.
Overseas sales increased to ¥38.4 billion (+20.4%) due to increase in exports of Alecensa and Actemra to Roche.
Royalties and other operating income decreased to ¥16.6 billion (-26.9%) due to a decrease in other operating income in the absence of one-time income from the transfer of long-term listed products reported last year, despite royalties and profit sharing income related to Hemlibra increased.
Billion JPY Q1 2019 Q1 2018 % change
Sales 137.7 124.7 +10.4%
Domestic sales 99.3 92.9 +6.9%
Oncology 52.0 48.6 +7.0%
Bone and joint diseases 24.2 21.6 +12.0%
Renal diseases 7.9 8.0 -1.3%
Others 15.2 14.6 +4.1%
Overseas sales 38.4 31.9 +20.4%
[Core operating profit]
Core gross profit increased to ¥90.6 billion (+8.0%) due to sales growth and the better cost to sales with a higher proportion of in-house products in the total product mix, despite the remarkable decrease in royalties and other operating income.
Core operating expenses grew by a low single-digit percentage to ¥42.7 billion (+3.9%), more modestly than the growth in Core gross profit. As a result, Core operating profit totaled ¥47.9 billion (+11.9%).

On April 24, 2019 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, May 1, 2019 to report its first quarter 2019 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, APR 24, 2019, View Source [SID1234535349]).

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To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 5435957. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On April 24, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales for the first quarter of 2019 (Press release, Ipsen, APR 24, 2019, View Source [SID1234535347]).

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Q1 2019 Group sales growth of 17.0% as reported, or 15.8%1 at constant exchange rates and consolidation scope driven by:
Specialty Care sales growth of 17.6%1, with continued strong momentum across all major products and geographies
Consumer Healthcare sales growth of 3.3%1

Full Year 2019 guidance confirmed following the completion of the acquisition of Clementia Pharmaceuticals on 17 April:
Group sales growth greater than 13.0%1 at constant exchange rates and consolidation scope. Based on the current level of exchange rates, there is an expected +2.0% impact from currencies.
Core Operating Income margin around 30.0% of net sales (excluding incremental investments in pipeline expansion initiatives)

David Meek, Chief Executive Officer of Ipsen stated: "With robust double-digit sales growth in the first quarter, Ipsen is on track for another year of outstanding business execution. The Specialty Care business continues to thrive across all major products and geographies with volume and market share gains. We are accelerating the ongoing transformation of Ipsen by executing on our external innovation strategy to strengthen the R&D pipeline with novel first and best-in-class assets.

"Notably, in the first quarter, we announced and completed the acquisition of Clementia Pharmaceuticals, a company focused on the treatment of rare and severely-disabling bone disorders. Palovarotene is a largely de-risked near-term launch opportunity with significant upside potential. Together, with our new colleagues from Clementia, we will leverage our combined scientific and development expertise to deliver new treatments to patients with high unmet medical needs."

Conference call

Ipsen will host a conference call on Wednesday 24 April 2019 at 2:30 p.m. (Paris time, GMT+1). A conference call will take place and a web conference (audio and slides) will be available at www.ipsen.com. Participants should dial in to the call approximately 5 to 10 minutes prior to its start. No reservation is required to participate in the conference call.

Standard International: +44 (0) 2071-928-000

France and continental Europe: + 33 (0) 1 76 70 07 94

UK: 08-445-718-892

U.S.: 1-6315-107-495

Conference ID: 9846139

A recording will be available for 7 days on Ipsen’s website.

1 At constant exchange rates and reflecting a change in the consolidation method for joint arrangements related to the Consumer Healthcare Schwabe partnership. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

On April 24, 2019 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Masashi Miyamoto, "Kyowa Hakko Kirin") reported that it has submitted a supplemental application of KHK7580 (evocalcet)*1 for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy*2 to the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Kyowa Hakko Kirin, APR 24, 2019, View Source [SID1234535342]).

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This application is based on the interim result (24 weeks) of the phase 3 study that evaluates the efficacy of KHK7580 for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy. The primary endpoint is the percentage of subjects whose corrected serum calcium level is maintain ≤ 10.3 mg/dL for 2 weeks in the evaluation period in a time frame up to 24 weeks. The primary endpoint was met with a 77.8% result, which exceeds the threshold set in the protocol.

KHK7580 was also granted Orphan Drug Designation for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy by the MHLW on March 4, 2019.

"We are delighted to submit the supplemental application for evocalcet," said Mitsuo Satoh, Ph.D., Head of Research and Development Division of Kyowa Hakko Kirin. "As it was granted Orphan Drug Designation by the MHLW, we believe that evocalcet has the potentials to provide more efficient treatment for hypercalcemia patients with parathyroid carcinoma and primary hyperparathyroidism."

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

*1 About KHK7580 (evocalcet)
KHK7580 is a small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). Kyowa Hakko Kirin signed a license agreement of KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some parts of Asia in March 2008. On March 2018, Kyowa Hakko Kirin received approval of KHK7580 for secondary hyperparathyroidism in maintenance dialysis patients and later on May 2018, the product was launched in Japan market, named Orkedia Tablets.

*2 About Hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism under inability parathyroidectomy or relapse after parathyroidectomy
Parathyroid carcinoma and primary hyperparathyroidism (PHPT) are diseases in which serum calcium levels elevates due to over autonomous secretion of parathyroid hormone (PTH) from tumors of the parathyroid gland. Parathyroidectomy (PTx) is the only reliable method to treat parathyroid carcinoma and PHPT. Control of hypercalcemia can prove challenging in cases of PHPT where PTx cannot be considered because of concomitant diseases or where PHPT recur after PTx and parathyroid carcinoma, although patients with such hypercalcemia are very rare. Hypercalcemia causes symptoms of fatigue, polyuria, thirst, and renal impairment and severe hypercalcemia can result in death due to a hypercalcemic crisis.