Pharming Group inks US marketing deal for RUCONEST®

Ticker: PHAR · Form: 6-K · Filed: 2024-09-26T00:00:00.000Z

Sentiment: neutral

Topics: marketing-agreement, distribution, pharmaceuticals

TL;DR

Pharming inks US marketing deal for RUCONEST® with Ascendia Pharmaceuticals.

AI Summary

Pharming Group N.V. announced on September 26, 2024, that its subsidiary, Pharming Healthcare Inc., has entered into a marketing and distribution agreement with Ascendia Pharmaceuticals LLC for the drug RUCONEST® in the United States. This agreement is effective immediately and aims to expand the reach of RUCONEST® within the US market.

Why It Matters

This agreement allows Pharming to leverage Ascendia's expertise to increase RUCONEST®'s market penetration in the US, potentially boosting sales and patient access.

Risk Assessment

Risk Level: low — The filing is a routine announcement of a marketing agreement, not indicating significant new risks.

Key Players & Entities

FAQ

What is the specific nature of the agreement between Pharming Healthcare Inc. and Ascendia Pharmaceuticals LLC?

Pharming Healthcare Inc. has entered into a marketing and distribution agreement with Ascendia Pharmaceuticals LLC for RUCONEST® in the United States.

When was this agreement announced?

The agreement was announced on September 26, 2024.

Which subsidiary of Pharming Group N.V. is involved in this agreement?

Pharming Healthcare Inc. is the subsidiary involved in the agreement.

What product is the subject of this marketing and distribution agreement?

The product is RUCONEST®.

In which geographical region will Ascendia Pharmaceuticals LLC market and distribute RUCONEST®?

Ascendia Pharmaceuticals LLC will market and distribute RUCONEST® in the United States.

From the Filing

0001828316-24-000031.txt : 20240926 0001828316-24-000031.hdr.sgml : 20240926 20240926060253 ACCESSION NUMBER: 0001828316-24-000031 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20240926 FILED AS OF DATE: 20240926 DATE AS OF CHANGE: 20240926 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Pharming Group N.V. CENTRAL INDEX KEY: 0001828316 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: P7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39822 FILM NUMBER: 241326063 BUSINESS ADDRESS: STREET 1: DARWINWEG 24 CITY: LEIDEN STATE: P7 ZIP: 2333 CR BUSINESS PHONE: 31 (0)71 5247 400 MAIL ADDRESS: STREET 1: DARWINWEG 24 CITY: LEIDEN STATE: P7 ZIP: 2333 CR FORMER COMPANY: FORMER CONFORMED NAME: Pharming Group Group N.V. DATE OF NAME CHANGE: 20201014 6-K 1 pharmingannouncesmarketing.htm 6-K Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of September Commission File Number: 001-39822 Pharming Group N.V. (Exact Name of Registrant as Specified in Its Charter) Darwinweg 24 2333 CR Leiden The Netherlands (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F ☒ Form 40-F ☐ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐ Furnished as Exhibit 99.1 to this Report on Form 6-K is a press release of Pharming Group N.V., or the Company, dated September 26, 2024. EXHIBIT INDEX Exhibit No. Description 99.1 Pharming announces marketing authorization in the U.K. for Joenja® (leniolisib) SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Pharming Group N.V. By: /s/ Sijmen de Vries Name: Sijmen de Vries Title: CEO Date: September 26, 2024 For media and investors only Pharming announces marketing authorization in the U.K. for Joenja® (leniolisib) Indicated for adult and pediatric patients 12 years of age and older with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) Leiden, the Netherlands, September 26, 2024: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM / Nasdaq: PHAR) announces that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. Leniolisib, an oral, selective PI3Kδ inhibitor, is the first treatment approved in the U.K. specifically for APDS, a rare and progressive primary immunodeficiency. Leniolisib is currently under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England. Sijmen de Vries, Chief Executive Officer of Pharming, commented: “The MHRA approval of Joenja®, the first treatment option specifically indicated for APDS, is an important milestone for people in the U.K. living with this debilitating disease. To date, management of APDS has relied on the treatment of the diverse symptoms associated with APDS or for some patients, the need to undergo hematopoietic stem cell transplantation. We are therefore delighted that this produc

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