Skåne University Hospital initiates pharmacokinetic clinical trial with Azanta’s Angusta®
Hellerup, Denmark, December 3, 2014. Azanta A/S, a privately owned Danish specialty biopharmaceutical company, announced today the initiation of a pharmacokinetic clinical trial for one of its lead product candidates, Angusta®, for cervical ripening and induction of labor. The clinical trial is led by Dag Wide-Swensson, Associate Professor at the Department of Obstetrics and Gynecology at Skåne University Hospital (Malmo and Lund) and sponsored through an educational grant by Azanta.
The clinical trial is a randomized, open label, comparative, parallel design bioavailability clinical trial of two misoprostol formulations, Azanta’s Angusta® 25 µg dispersible tablets vs. Pfizer Inc’s Cytotec® 200 µg tablets, following single oral or sublingual administration and comparison of the relative safety of the two formulations following repeat dosing until labor.
Dr. Claus Møller, Chief Executive Officer of Azanta, commented: “We are delighted to initiate this clinical trial together with Skåne University Hospital, in investigating the oral and sublingual route of administration of Angusta®, our proprietary 25 µg formulation of misoprostol, as compared to the reference product. Currently, there is no oral misoprostol product commercially available in Europe or in the United States indicated for cervical ripening and induction of labor. We believe there is an unmet medical need for a product of this type.”
Associate Professor Dag Wide-Swensson, who is the responsible physician for obstetrics and gynecology at Skåne University Hospital, added: “We are excited to initiate this clinical trial at our birth hospitals in Malmo and Lund. There are no data available in the literature on the pharmacokinetics of misoprostol in women at term. We expect that this clinical trial will shed light on the applicability of applying a misoprostol product developed for the right indication at the right strength and for the preferred routes of administration. In this clinical trial, we intend to compare the oral and the sublingual route of application of the two formulations in a total of 72 women being induced to go into labor. Angusta® has been developed as a dispersible tablet for oral or sublingual use, whereas the comparison product, Cytotec®, has been developed for oral use for a non-obstetric indication.”
Angusta® is Azanta’s proprietary 25 µg formulation of misoprostol for cervical ripening and induction of labor. In 2015, Azanta intends to file for regulatory approval in Europe through the decentralization procedure and in the United States under a 505(b)(2) New Drug Application with the United States Food and Drug Administration. If approved, Azanta intends to market Angusta® itself or through partnerships. There can be no assurance that Angusta® or any of our other product candidates will receive regulatory approval. Azanta currently provides Angusta® on a compassionate use basis in Denmark and Finland.
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About Angusta® and cervical ripening.
Induction of labor is extensively performed all over the world. Labor induction is indicated in cases where continuation of pregnancy is hazardous to the mother and/or her fetus, but is also conducted as an elective labor induction (non-medical reason). In 2004 and 2005, one in every five deliveries in the United Kingdom was induced. Unpublished data from the World Health Organization (WHO) Global Survey on Maternal and Perinatal Health, which included 373 healthcare facilities in 24 countries and nearly 300,000 deliveries, showed that 9.6% of the deliveries involved labor induction. In the US, in 2012, the rate of induction of labor was 23.3%.
Where induction of labor is indicated, the WHO recommends the application of misoprostol 25 µg orally every 2nd hour or misoprostol 25 µg vaginally every 6th hour. Low-dose oral misoprostol (20-25 µg 2-hourly) is considered by WHO safer and more effective than vaginal misoprostol as it:
Resulted in more women giving birth vaginally within 24 hours
Was associated with lower caesarean section rates
Resulted in fewer women requiring oxytocin augmentation
(Reference: WHO recommendations for induction of labor, 15 Feb 2011).
Angusta® is a dispersible tablet containing 25 µg misoprostol.
About Azanta A/S
Azanta A/S is a Danish privately owned specialty biopharmaceutical company developing treatments for orphan oncology and women’s health. Indications. In addition to Angusta®, Azanta is currently focused on the development of Nimoral®, its proprietary reformulation of nimorazole, as a radiosensitizer for the treatment of squamous cell carcinoma of the head and neck. To support its operations and to subsidize its development of Angusta®, Nimoral® and other orphan oncology and women’s health product candidates, Azanta currently markets and distributes a portfolio of specialty pharmaceutical products pursuant to third party distribution arrangements. These products address a number of therapeutic areas, including addiction, women’s health and oncology.
For further information, please visit www.azanta.com.
Tel: + 45 – 70 25 95 45
Fax: + 45 – 70 25 95 46