Merck KGaA Partners with Calla Lily on Callavid Intravaginal Drug Delivery Platform

Merck KGaA has entered a partnership with Calla Lily Clinical Care to advance Callavid, an intravaginal drug delivery platform designed to address patient challenges in women's health therapeutics, with initial focus on fertility and pregnancy applications.

Merck KGaA has entered a partnership with medtech company Calla Lily Clinical Care to advance the development of Callavid, an intravaginal drug delivery platform. The collaboration aims to solve longstanding patient challenges in women's health therapeutics.

The collaboration structure will leverage Merck's scientific resources and regulatory experience while allowing Calla Lily to advance its technology through clinical development. In April 2025, the medtech company secured £1 million in funding from the National Institute for Health and Care Research (NIHR), which will be used to move toward late-stage clinical trials.

The Callavid platform seeks to overcome challenges that patients face when self-administering vaginal medications. This includes concerns with positioning, dosing accuracy, and medication leakage. It incorporates a tampon-shaped device integrated with an absorbent liner. The system is said to allow for straightforward insertion, maintain position during drug absorption, and facilitate smooth removal.

Initial target indications are in fertility and pregnancy, where the platform seeks to offer the world's first drug-device combination product to help prevent threatened miscarriages, and for IVF luteal phase support. Callavid can also support menopausal therapies, targeted cancer treatments, and live biotherapeutics (LBPs) to reduce antibiotic use and antimicrobial resistance (AMR).

The company is conducting two clinical trials to obtain marketing authorization for the use of 400mg progesterone Callavid for 2 indications: IVF/ART luteal phase support and prevention of threatened miscarriage. Given the supportive environment of the UK NICE's updated medical guideline on threatened miscarriage and the source of public funding for the first trial, the company is pursuing initial regulatory approval for its first product.

The Callavid intravaginal drug delivery platform was inspired by the co-founder's own personal experience from multiple failed IVF cycles, which involved hundreds of painful intramuscular injections as well as leaky pessaries and suppositories. The platform was designed to eliminate this burden.

The partnership evolved from Calla Lily's participation in the Merck Innovation Challenge in October 2024. A spokesperson for Merck stated that the company has been at the forefront of fertility treatment for decades, supporting fertility experts to deliver their best care to patients, and will continue to explore and innovate across women's health with one clear goal in mind: to improve the patient experience and outcomes for those undergoing fertility treatment.

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References

  1. Calla Lily, Merck partner on intravaginal drug delivery platform | BioWorld · www.bioworld.com
  2. Merck Partners with Calla Lily on intravaginal drug tech - BioXconomy · www.bioxconomy.com