On October 22, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported sales for the third quarter of 2020 (Press release, Ipsen, OCT 22, 2020, View Source [SID1234568750]).

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Q3 2020 Group sales growth of +2.2%1 at constant exchange rates and decrease of -1.8% as reported, driven by Specialty Care sales growth of 5.1%1 despite the continuing negative COVID-19 impact. Positive Q3 performance results in YTD sales growth of +2.8%1 at constant exchange rates and +1.5% as reported.
Confirmation of 2020 full year guidance, with Group sales growth greater than +2.0% at constant currency and Core Operating margin greater than 30.0% of net sales.
Key Q3 pipeline progress:
Cabometyx (cabozantinib): Presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress of the Phase III CheckMate -9ER trial in patients with previously untreated advanced renal cell carcinoma, in which Cabometyx in combination with nivolumab met all key efficacy endpoints of overall survival, progression-free survival and objective response rate. The results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 expression subgroups.
Palovarotene: Presentation at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting of post hoc analyses from the Phase III MOVE trial investigating palovarotene as a chronic and episodic treatment for patients with fibrodysplasia ossificans progressiva (FOP).
Appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020, with responsibility for business development and alliance management.
David Loew, Chief Executive Officer of Ipsen stated: "The Group delivered a resilient performance in the third quarter, despite the continued impact of the pandemic, and I am pleased to confirm our 2020 full year financial objectives. Our pipeline achieved notable progress with incremental positive data on Cabometyx and palovarotene, supporting our intention to bring these important therapies to patients. I look forward to sharing my long-term vision for Ipsen and the outcomes of a comprehensive strategic review at our Capital Markets Day on December 1st."

COVID-19 impact

In the third quarter of 2020, the business recovered gradually from the impact of COVID-19. While the Specialty Care portfolio comprised of differentiated products for critical conditions remained relatively resilient, Somatuline, Decapeptyl and Onivyde sales were negatively impacted by lower patient diagnoses and missed treatments due to the ongoing impact of the pandemic and the challenging hospital environment. In neuroscience, the aesthetics market showed a stronger recovery, while the therapeutics market rebounded more slowly with the gradual re-opening of injection centers. Consumer Healthcare sales, notably Smecta, continued to be negatively impacted across geographies.

The Group continued to realize cost savings in the third quarter, resulting from digital sales detailing, lower travel throughout the Group and the conversion to virtual conference and medical meetings.

2020 Guidance confirmed

The Group confirms the following financial targets for the current year:

Group sales growth greater than +2.0% at constant currency, with an expected negative impact of 1.5% from currencies based on the level of exchange rates at the end of September.
Core Operating margin greater than 30.0% of net sales
Recent pipeline highlights

Positive results of the Phase III CheckMate -9ER trial presented at the ESMO (Free ESMO Whitepaper) Congress, in which Cabometyx in combination with Bristol Myers Squibb’s Opdivo (nivolumab) demonstrated significant improvements across all efficacy endpoints, including superior overall survival (OS), a doubling of median progression-free survival (PFS) and superior objective response rate (ORR) versus sunitinib, with a favorable safety profile in previously untreated advanced renal cell carcinoma (RCC). Key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 expression subgroups. The regulatory filing has been submitted and validated by the EMA, thus beginning the centralized review process.
At the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting, Ipsen presented post hoc analyses from the Phase III MOVE trial investigating palovarotene as a chronic and episodic treatment for fibrodysplasia ossificans progressiva (FOP) in both pediatric and adult patients, with palovarotene demonstrating a 62% reduction in mean annualized new heterotopic ossification (HO) volume relative to untreated patients from a longitudinal Natural History Study (NHS).
The Phase II CLARINET FORTE study results showed that increasing the dose frequency of Somatuline from monthly to bi-monthly achieved a progression-free survival of 8.3 months in patients with progressive midgut neuroendocrine tumors (NETs) and 5.6 months in patients with progressive pancreatic NETs. These results showed no new safety signals associated with this increased dose regimen, potentially delaying the need for additional, more toxic second-line therapies.
Third quarter 2020 sales highlights

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts (currency effects established by recalculating net sales for the relevant period at the exchange rates from the previous period)Q3 2020 Group sales grew 2.2%1 to €633.3 million.

Sales of Specialty Care products reached €580.5 million, up 5.1% year-on-year.

Somatuline sales reached €272.9 million, up 7.1% year-on-year, driven by volume growth in North America, the U.K. and Germany and despite delays in patient diagnoses and treatment due to COVID-19. In the U.S., the performance of Somatuline in Q3 was also negatively impacted by end-user buying patterns.

Decapeptyl sales reached €94.5 million, down 2.8% year-on-year, mainly due to lower sales in China and in some European countries as a result of the impact of COVID-19.

Cabometyx sales reached €76.8 million, growing 20.9% year-on-year, driven by good performance in Major Western European countries, Russia and Brazil.

Onivyde sales reached €27.5 million, up 11% year-on-year, driven by volume growth in the U.S.

Dysport sales reached €87.4 million, down 1.4% year-on-year, impacted by COVID-19 despite a gradual recovery of the therapeutics market and better dynamics in the aesthetics market.

Consumer Healthcare product sales reached €52.8 million, down 21.9%1, with a decrease in Smecta sales of 38% impacted by COVID-19, implementation of hospital central procurement in China and lower performance in France.

Conference call

Ipsen will hold a conference call Thursday, 22 October 2020 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately 15 minutes prior to its start.

Participants can register for the call on the link below:
View Source

Conference ID: 3185126

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

On October 21, 2020 The Salk Institute and BridgeBio Pharma, Inc. (Nasdaq: BBIO) reported a three-year collaboration agreement formed to advance cutting-edge academic discoveries in genetically driven diseases toward therapeutic applications (Press release, BridgeBio, OCT 21, 2020, View Source [SID1234576223]). Under the partnership, BridgeBio will help fund research programs from Salk’s world-renowned innovative cancer research, with the eventual goal of developing new therapeutics for patients in need.

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"Salk is known for its outstanding research, in particular in the field of oncology, so we are excited to enter into this partnership with BridgeBio to advance our discoveries and help develop next-generation therapies," says Salk Vice President and Chief Science Officer Martin Hetzer, Ph.D. "The partnership represents an excellent opportunity for academic research to reach new potential in the clinical setting."

"BridgeBio is focused on partnering with leading academic institutions to accelerate promising research into clinical studies, with a range of therapeutic modalities such as biologics, gene therapies and small molecules," said BridgeBio CEO and founder Neil Kumar, Ph.D. "The Salk Institute is known as a place where great science is occurring—and has occurred for decades—and we feel privileged to have the opportunity to partner with them. Through this partnership, we look forward to translating exciting academic findings into potential treatments and understanding the impact they may bring to patients."

The Salk Cancer Center is one of seven National Cancer Institute (NCI)-designated basic research cancer centers in the United States. Here, researchers are using game-changing technologies to expose the molecular mechanisms underlying tumors in order to develop targeted cancer therapies. Salk is also home to the Conquering Cancer Initiative, which is a scientific and philanthropic endeavor to bring together collaborative cancer researchers to harness new strategies against five deadly cancers: pancreatic, ovarian, lung, brain (glioblastoma) and triple-negative breast. Salk’s scientists aim to identify cancer’s vulnerabilities in order to develop new methods that can attack the tumors while leaving the healthy tissues alone.

BridgeBio partners with academic institutions, like the Salk Institute, to support early-stage research around genetically validated targets. Through close collaboration, BridgeBio aims to rapidly translate novel discoveries into potentially life-saving treatments. The company works across multiple genetically driven diseases and therapeutic areas, helping provide the insights and support needed to rapidly bring the latest scientific advancements from the lab bench to the patient bedside. Its academia-industry collaborations focus on creating partnerships with biomedical research institutes that are built on trust, engagement, science and respect.

On October 21, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO) and the University of Colorado Anschutz Medical Campus reported a collaboration to advance novel research on genetically driven diseases into therapeutic applications for patients (Press release, BridgeBio, OCT 21, 2020, View Source [SID1234576222]).

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"We are grateful to be collaborating with the University of Colorado Anschutz Medical Campus, which is the largest academic health center in the Rocky Mountain region, a world-class medical destination, and home to one of the leading Personalized Medicine Centers in the country. We are excited to work together to translate life-changing discoveries from the lab into potential medicines for patients," said BridgeBio CEO and founder Neil Kumar, Ph.D.

This collaboration comes on the heels of an eight-month pilot collaboration. Under the new, expanded collaboration, BridgeBio will support early-discovery research already underway in CU Anschutz labs and will accelerate promising therapies into the clinic in order to develop and ultimately commercialize therapies for patients. The collaboration’s structure focuses on close partnership, actionable feedback and joint touchpoints between the BridgeBio and the CU Anschutz research teams.

"This collaboration represents a new model between academia and the pharmaceutical industry. It provides all CU Anschutz faculty with the opportunity to translate cutting edge research in genetic science to patients with unmet needs," said Kimberly Muller, Executive Director of CU Innovations. "BridgeBio is uniquely suited as a collaborator as they combine a novel drug discovery platform, with the processes needed to advance multiple individual therapies simultaneously. Together, we will find, develop and deliver breakthrough medicines for genetic diseases to patients as quickly and safely as possible."

BridgeBio is determined to move away from traditional one-off interactions between drug development companies and research institutions and formalize collaborations that are built on trust, engagement, science and respect. The BridgeBio team is committed to acting responsibly with academic researchers who work around the clock to understand the mechanisms of genetically driven conditions and how we can best treat patients by targeting the disease source.

On October 21, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ONA-XR in combination with the antiestrogen anastrozole in patients with recurrent endometrial cancer (Press release, Context Therapeutics, OCT 21, 2020, View Source [SID1234570453]). Sailaja Kamaraju, MD, of the Medical College of Wisconsin, and Kari Wisinski, MD, of the University of Wisconsin Carbone Cancer Center, are the study’s Co-Primary Investigators.

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The Phase 2 trial will include patients who have progesterone receptor positive (PR+), estrogen receptor positive (ER+), HER2 negative (HER2-) metastatic breast cancer who have progressed on prior CDK4/6 inhibitor therapy. Patients will be administered the combination of onapristone extended release (ONA-XR) in combination with the antiestrogen, fulvestrant. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of ONA-XR, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of ONA-XR in these patients, as well as biomarker analyses to explore predictive factors of response to ONA-XR, including activity in patients with ESR1 and PIK3CA mutations.

"Currently, there are limited therapeutic options to treat metastatic breast cancer. Recent preclinical findings, together with Phase 1 study results in patients with metastatic PR+ breast cancers, give us reason to believe that ONA-XR can help these women with PR+ breast cancers," said Tarek Sahmoud, MD, PhD, Chief Medical Officer of Context Therapeutics. [1],[2]. "We believe ONA-XR can make a meaningful difference for patients in the trial."

About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently the subject of an ongoing Phase 2 clinical trials in progesterone receptor positive breast, ovarian, and endometrial cancers. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.

On October 21, 2020 The board of directors of NeoDynamics AB ("NeoDynamics" or the "Company") reported that an extraordinary general meeting is convened to resolve on a directed new share issue to a limited group of investors (the "Share Issue") (Press release, NeoDynamics, OCT 21, 2020, View Source [SID1234568891]). The subscription price is proposed to be SEK 3.71 per share and is decided through an accelerated bookbuilding process. The Share Issue can bring approximately SEK 90 million before transaction costs to the Company. As a result of the Share Issue, Cardeon Futuring Finance ("Cardeon") – with Chairman of the Board Masoud Khayyami together with the the management team – can become one of the larger shareholders of NeoDynamics. The Dutch company Nyenburgh Holding BV ("NYIP") also participates in the Share Issue.

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NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR ANY OTHER JURISDICTION IN WHICH THE PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER OF ANY SECURITIES OF NEODYNAMICS AB (PUBL). PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.

The Share Issue can add a total of 24,243,641 new shares, priced at SEK 3.71 per share. The new shares are priced at a discount of 13.7 percent compared to the closing price of NeoDynamics stock at Spotlight Stock Market on October 21, 2020.

The Company has made the assessment that the subscription price is fair regarding the current industry- and market conditions and that it is in the best interest of both the Company and its shareholders to carry out the Share Issue. The Share Issue is subject to resolution at an extraordinary general meeting to be held on the 19th of November 2020, which will be convened in a separate press release.

The reason to deviate from the shareholders’ pre-emption rights is to ensure the most time and cost-effective financing of the Company’s continued commercialization and widen the number of institutional owners.

The proceeds from the Share Issue will be used to finance ongoing operations. NeoDynamics is planning towards the sale-start of its new ultrasound guided tissue sampling system NeoNovia in UK, Sweden, and Germany by the end of 2020 and in the US during 2021. The system intends to better the process of diagnosing breast cancer.

"NeoDynamics new product, with its micropulse technology, can substantially improve breast cancer diagnosis and establish a new global standard within the field. Cardeon will actively support NeoDynamics in the long run and secure the process of establishing NeoNovia as the future system of high-precision biopsy" – Masoud Khayyami, Chairman Cardeon Futuring Finance.

Cardeon offers funding to innovative and promising Nordic companies in Life Sciences, with the potential to change the global market. Cardeon is the largest shareholder of the publicly traded companies SpectraCure, Lumito, and Prolight Diagnostics. Masoud Khayyami has substantial experience in research, medical, medtech, and biotechnical sectors and solid entrepreneurial experience. He is the CEO of SpectraCure and Chairman of several other companies, including Lumito and Prolight Diagnostics.

Nyenburgh Holding BV is a dedicated investors group within Life Science, based in Amsterdam. NYIP has a strong focus on European biotech and medical companies that develop innovative solutions for people’s health.

"We are glad to welcome a long-term financier as Cardeon, who holds an existing portfolio of innovative companies within the cancer-industry, and we see great synergy possibilities and possible future collaborations on the market for cancer treatment. We also welcome Nyenburgh Holding BV as a new initiated owner" – Anna Eriksrud, CEO NeoDynamics

Through the Share Issue, the Company’s total number of shares can increase by a maximum of 24,243,641 shares, from 36,006,951 to 60,250,592 shares. The share capital can increase by a maximum of SEK 2,424,364.10, from SEK 3,600,695.10 to SEK 6,025,059.20.

In order to finance the Company’s operations until the issue proceeds from the Share Issue has been received by the Company, the Company has entered into a loan agreement with Cardeon regarding a bridge loan (the "Bridge Loan"). The Bridge Loan amounts to a total of SEK 10 million and carries an annual interest rate of 12 percent and a set-up fee of 4 percent of the nominal loan amount. The Bridge Loan, accrued interest and set-up fee are due for payment on December 31, 2020, if repayment has not been made before that date. Repayment of the Bridge Loan, including the set-up fee, to Cardeon is intended to be made by set-off against shares in the Share Issue.