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Ipsen reports strong double-digit sales growth in First Quarter 2019 and confirms Full Year 2019 financial targets

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.

Kyowa Hakko Kirin Submits the Partial Change Approval Application of KHK7580 (evocalcet) in Japan

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]).

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.

EpimAb Biotherapeutics is Granted US Patent on Core Bispecific Antibody Technology

On April 24, 2019 EpimAb Biotherapeutics, an emerging biopharmaceutical company based in Shanghai, reported that the United States Patent and Trademark Office (USPTO) has granted the U.S. Patent No. 10,266,608 entitled "Fabs-In-Tandem Immunoglobulin and Uses Thereof" (Press release, EpimAb Biotherapeutics, APR 24, 2019, View Source [SID1234535333]). Based on EpimAb’s globally filed first application, this patent broadly covers bispecific antibodies obtained utilizing the company’s FIT-Ig technology in a composition of matter claim.

"This patent underscores the novelty of EpimAb’s approach in bispecific antibody generation and forms an important foundation of EpimAb’s growing IP portfolio," said Dr. Chengbin Wu, Founder and CEO of EpimAb Biotherapeutics. "The first granted patent in a major pharmaceutical market like the US therefore represents a significant milestone for EpimAb and takes us another step towards our goal to become a leading innovator in cancer biologics."

EpimAb is developing multiple programs based on its FIT-Ig platform for the treatment of various cancers. Its most advanced product candidate EMB-01, a cMet/EGFR bispecific with a novel mechanism of action was discovered and rapidly developed to the clinic by EpimAb. It is currently being investigated in a clinical Phase I/II trial in the USA and China. A second FIT-Ig molecule is currently under preclinical development with further molecules following soon, rapidly growing EpimAb’s pipeline of bispecific antibodies.

ZETAGEN THERAPEUTICS, INC. RECEIVES PATENT FOR REGULATION OF BONE GROWTH AND BONE DEGRADATION USING SMALL-MOLECULE

On April 23, 2019 Zetagen Therapeutics, Inc., a private, US-based biotechnology company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 102656437 to the Company (Press release, Zetagen Therapeutics, APR 23, 2019, View Source [SID1234643688]). This patent, entitled Neurogenic Regulation of Bone Growth and Bone Degradation, covers the use of methods for promoting controlled bone creation and destruction as a means to repair large bone segmental defects. This patent follows the previously issued U.S. Patent No. 10208306 and South African PCT. 2017/00029 covering the use of a method for stimulating bone growth using a small molecule.

"This latest patent issuance is a significant piece of our Global IP Strategy. This provides the opportunity to further develop our therapies to aid patients afflicted by metastatic lesions," said Joe C. Loy, CEO of Zetagen Therapeutics, Inc.

The new patent is part of an expanding and comprehensive portfolio of patents, patent applications and other intellectual property covering the composition, synthesis, manufacturing, formulations and uses for the treatment of a variety of metastatic bone lesions and osteologic interventions. Zetagen exclusively licensed its platform technology from the State University of New York in 2016.

Cytura Therapeutics to Develop a New Class of Drugs Targeting genomic instability in cancer

On April 23, 2020 Cytura Therapeutics reported the successful closure of a Seed financing round (Press release, Cytura Therapeutics, APR 23, 2019, View Source [SID1234572898]). The funding is provided by a syndicate led by Thuja Capital Healthcare (Seed) Fund II and includes BOM Brabant Ventures, the Centre for Drug Design and Discovery (CD3) – KU Leuven and the Gemma Frisius Fund. Cytura Therapeutics will use the new funding to advance its first proprietary small molecule program and to further expand their pipeline of new disruptive drugs, targeting genomic instability.

The company will be based at the Pivot Park Life Science Campus in Oss and collaborate with the Amsterdam UMC and the Centre for Drug Design and Discovery (CD3) of the KU Leuven. Genomic instability is a major problem in cancer progression and therapy resistance. By targeting genome instability this approach could be applied both as a stand-alone as in combinations therapy. On the latter, there is a large group of patients who will at first respond to the applied therapy and later on become resistant during treatment.

"One of the biggest issues in cancer treatment is that the disease has the ability to change its nature over time caused by the increasing genomic instability. Cytura’s R&D efforts are focused on the development of small molecules that will slow down or stop this genomic instability. I am committed to find this medicine which could lead to real advancements in the fight against cancer."