FRANCE — Ipsen, a leading global biopharmaceutical company, has made the decision to permanently discontinue the distribution of NutropinAq (somatropin) cartridges.

Somatropin is a type of human growth hormone that is used to treat a variety of conditions such as growth failure due to growth hormone deficiency (GHD), chronic renal insufficiency (CRI), or Turner Syndrome (TS) in children and adolescents, as well as adult patients with GHD.

After careful consideration of the impact of any actions on prescribers and users of its medicines, Ipsen has decided to discontinue the distribution of NutropinAq cartridges across countries where it holds the marketing authorization, including the E.U., UK, and Australia.

The discontinuation will take place at the latest by April 2024. According to Ipsen, the decision to discontinue the distribution of NutropinAq cartridges will not negatively impact the continuity or quality of care of patients who require somatropin.

NutropinAq has been available on the market for many years and was originally introduced when few alternative treatment options existed.

To ensure that doctors who manage patients that may be impacted are fully informed and to allow significant time for alternative treatment options to be discussed and an approach agreed upon for their ongoing care, Ipsen is reaching out to these healthcare professionals.

The company is also communicating with other key organizations and relevant authorities to ensure that the discontinuation process is conducted in a professional and positive way, minimizing any disruption.

In terms of business development, Ipsen recently completed the acquisition of Albireo Pharma, Inc., a leading innovator in bile-acid modulators to treat rare liver conditions, in March 2023.

Ipsen acquired all issued and outstanding shares at a price of US$42.00 per share in cash, plus one non-transferable contingent value right of US$10.00 per share.

In addition, Ipsen has several promising drugs in its pipeline. The U.S. Food and Drug Administration recently accepted the supplemental New Drug Application for a second Bylvay indication, for patients with Alagille syndrome, with a Prescription Drug User Fee Act (PDUFA) action date set for 15 June 2023.

Furthermore, the PDUFA action date in the U.S. for the resubmitted New Drug Application for palovarotene as a potential treatment for fibrodysplasia ossificans progressiva (FOP) is set for 16 August 2023, following a request for re-examination of the negative opinion from the CHMP5 received in January 2023.

To support its growth and pipeline development, Ipsen has appointed Dr. Sandra Silvestri as its new Executive Vice President, Chief Medical Officer, and Head of Global Medical Affairs, Patient Safety, and Patient Affairs, effective May 5, 2023.

As a key member of Ipsen’s Executive Leadership Team (ELT), Dr. Silvestri will report directly to Ipsen’s Chief Executive Officer, David Loew.

David Loew, Ipsen’s CEO, expressed his enthusiasm for the new appointment, stating that he and the entire ELT are thrilled to have Dr. Silvestri join the company.

He acknowledged that Dr. Silvestri’s extensive experience in various medical fields would be a valuable asset to the company as they continue to develop and deliver innovative and effective specialty medicines to people around the world.

In recent years, the development of new and innovative therapies for growth hormone deficiency (GHD), chronic renal insufficiency (CRI), and Turner Syndrome (TS) has revolutionized the treatment landscape, providing patients with a wider range of effective treatment options.

Multiple alternative therapies are available in the market to treat growth hormone deficiency (GHD), including Genotropin (somatropin) and Norditropin (somatropin), which are synthetic and recombinant human growth hormones respectively, manufactured by Pfizer and Novo Nordisk.

Other options include Omnitrope (somatropin) by Sandoz, Saizen (somatropin) by Merck KGaA, and Zomacton (somatropin) by Ferring Pharmaceuticals, all of which are also recombinant human growth hormones used to treat GHD in both children and adults.

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