Ascendis Pharma and Royalty Pharma Enter into $150 Million Royalty Funding Agreement

On September 5, 2023 Ascendis Pharma A/S (Nasdaq: ASND) and Royalty Pharma plc (Nasdaq: RPRX) reported that Ascendis has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma based on U.S. net SKYTROFA revenue (Press release, Ascendis Pharma, SEP 5, 2023, View Source [SID1234634875]).

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"This transaction reflects the significant value of SKYTROFA. We are pleased to partner with Royalty Pharma, a leading funder of innovation across the biopharma industry, and look forward to partnering with them in the coming years," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "With this funding, we continue to reduce our cost of capital and provide added flexibility to support our global commercial capabilities to bring our TransCon products to patients as fast as possible."

"We are excited to partner with Ascendis, a global, integrated biopharmaceutical company focused on endocrine rare disease and oncology," said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. "SKYTROFA, as the first U.S. approved weekly growth hormone therapy for pediatrics, addresses significant unmet patient need, which is underscored by its strong launch. We look forward to Ascendis’ continued success in reaching as many patients as possible with this important therapy as well as the potential for label expansion in additional indications."

Under the terms of the agreement, Ascendis Pharma receives an upfront payment of $150 million in exchange for a 9.15% royalty on U.S. net SKYTROFA revenue, beginning on January 1, 2025. The royalty payments to Royalty Pharma will cease upon reaching a multiple of 1.925x, or 1.65x if Royalty Pharma receives royalties in that amount by December 31, 2031.

Evercore acted as financial advisor and Latham & Watkins and Mazanti-Andersen acted as legal advisors to Ascendis on the transaction. Goodwin Procter, Kromann Reumert and Fenwick & West acted as legal advisors to Royalty Pharma.

About SKYTROFA (lonapegsomatropin-tcgd)
SKYTROFA (lonapegsomatropin-tcgd) is a prodrug of somatropin, administered once weekly, and designed to provide sustained release of active, unmodified somatropin. The unmodified, unbound parent drug released from lonapegsomatropin is recombinant human growth hormone (hGH; somatropin) that binds to growth hormone receptors throughout the body, with the identical 191 amino-acid sequence and size (22 kDa) as endogenous growth hormone and the growth hormone in daily products. SKYTROFA was developed as TransCon hGH and approved in 2021 by the U.S. Food & Drug Administration for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). SKYTROFA has been studied in over 300 children with GHD across the Phase 3 program which consists of the heiGHt Trial (for treatment-naïve patients), the fliGHt Trial (for treatment-experienced patients), and the enliGHten Trial (an ongoing long-term extension trial), with some patients on SKYTROFA for over four years.

Allogene Therapeutics Announces Participation in September Investor Conference

On September 5, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will participate in an upcoming investor conference in September (Press release, Allogene, SEP 5, 2023, View Source [SID1234634874]).

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Baird 2023 Global Healthcare Conference
Tuesday, September 12, 2023
12:45PM PT/3:45PM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

Alkermes to Participate in Two Upcoming Investor Conferences

On September 5, 2023 Alkermes plc (Nasdaq: ALKS) reported that management will participate in fireside chat presentations at two upcoming investor conferences (Press release, Alkermes, SEP 5, 2023, View Source [SID1234634873]).

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Morgan Stanley 21st Annual Global Healthcare Conference

Date/Time: Monday, September 11, 2023 at 11:20 a.m. EDT (4:20 p.m. BST)

Cantor Fitzgerald Global Healthcare Conference

Date/Time: Wednesday, September 27, 2023 at 11:30 a.m. EDT (4:30 p.m. BST)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

AIM ImmunoTech to Present at the H.C. Wainwright 25th Annual Global Investment Conference

On September 5, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that Thomas K. Equels, Chief Executive Officer of AIM, will present at the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 in New York, NY and virtually (Press release, AIM ImmunoTech, SEP 5, 2023, https://aimimmuno.com/aim-immunotech-to-present-at-the-h-c-wainwright-25th-annual-global-investment-conference/ [SID1234634872]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Monday, September 11 at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (aimimmuno.com). The webcast replay will be archived for 90 days following the event.

Medivir reports promising interim data, including a first complete response in phase 1b/2a HCC study with fostrox in combination with Lenvima

On September 4, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported promising interim safety and efficacy data from its ongoing phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima in advanced hepatocellular carcinoma (HCC) patients for whom current first- or second-line treatment has proven ineffective or is not tolerable (Press release, Medivir, SEP 4, 2023, https://www.prnewswire.com/news-releases/medivir-reports-promising-interim-data-including-a-first-complete-response-in-phase-1b2a-hcc-study-with-fostrox-in-combination-with-lenvima-301916719.html [SID1234634866]).

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The interim results confirmed the previously announced favorable safety and tolerability profile. No new or unexpected safety events and the combination continues to be tolerable.

The phase 2a dose expansion part of the study is ongoing and is now fully recruited. Data from phase 1b/2a is planned to be presented at an upcoming scientific congress.

– "We are excited about the interim data from the phase 1b dose escalation part. HCC patients, for whom current first- or second-line treatment has proven ineffective, is a difficult-to-treat patient group and expectation regarding clinical benefit and tumor shrinkage is low. This is why it is so encouraging to see that overall response is shown in 3 out of 6 patients and even more so that a complete response was recorded in one patient. Considering that the medical need for a new, effective treatment for HCC is large, these are very encouraging data for the future development of fostrox," says Dr. Pia Baumann, CMO at Medivir.

As a reminder, Medivir will be hosting an Expert Perspectives Webcast on the Evolving Treatment Landscape and the Unique Treatment Challenges in HCC later this week on Friday September 8th at 13:00 CET/07:00 EST. Dr Pia Baumann, CMO at Medivir, will also participate in the webcast and provide additional comments regarding the development of fostrox and data.

The webcast will be streamed via a link on the website: www.medivir.com/investors/presentations

The presentation will be available on Medivir’s website after the webcast.

About fostrox

Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.