Press Room

Press Release / Oct 31, 2001

Hovione's factory in Macau supplies antibiotic against anthrax

Anthrax fear increases sales dramatically

Hovione PharmaScience Ltd., with a manufacturing site in Taipa Island, Macau, increased its doxycycline production in order to meet increased demands from US, provoked by the bioterrorists attacks with Anthrax. Together with Bayer’s Ciprofloxacine, the product manufactured by Hovione is an antibiotic specifically approved by the US FDA (Food and Drug Administration) to fight Anthrax in its three forms of infection: cutaneous, gastric or inhaled.

This product has more than three decades of commercial activity (which is already a remarkable survival for an antibiotic) Hovione has had a stable production of doxycycline for more than 10 years. In these last three weeks, Hovione received purchase orders similar to 3 times the annual sales to the US. It is enough quantity to treat more than two millions patients, during the 60 days advised treatment. Hovione Macau confirms its engagement in supplying these needs and to assure there will no shortage of doxycycline in the drugstores, either in the US or in any other country.

Hovione supplies this product to more than 30 countries, in the Americas, Europe, Australia, and Asia, including Pakistan, India and Iran, being concerned with the supply of pharmaceuticals in accordance to human health needs. An increase in demand has also occurred in the second half of the 90s, with an outbreak of plague in India, and also before the Gulf War.

Legislation and flexibility benefits production in Macau

In September, ways to supply the foreseen increase in demand after the first strikes, were analyzed and the alterations to the production of the Macau site, the site more suitable to manufacture doxycycline, were authorized. These changes naturally forced a complex re-structuring of our priorities, in order to meet and supply at fast as possible the American market. This task will continue until the end of this year.

Accordingly to Carlos Costa, Director of Hovione Macau: “ We have in Macau a more favorable legislation which allows to change rapidly the production plans. In Lisbon, we are obliged to inform the authorities of the nature and quantities of all new products that we are going to manipulate in the future. Well, this only our clients know, we cannot guess.” The European legislation, named EINECS, requires that extensive studies are carried out on any new product which crosses European borders, delaying in many months any investigational project or production line. Similarly, IPPC, which regulates industrial licensing, makes any new industrial project more bureaucratic, slowing the process and hindering its flexibility.

The Hovione Macau site began its active pharmaceutical ingredients production in December 1986 and was approved by the FDA the following year. This site today has 150 professionals and manufactures the more stable Hovione products. The Macau factory is responsible for one third of Hovione total production. With a sales volume of 15 million dollars (16,5m Euro), Hovione in Macau will make additional sales of doxycycline corresponding to 4,5 million dollars (5m Euro).

Hovione is an international company, which develops and produces with high quality and state-of-the-art technology active pharmaceutical ingredients. Founded in 1959, Hovione has two approved factories by the FDA, in Loures (Portugal) and in Macau, and a Technology Transfer Center in New Jersey (USA).

Hovione began its activity with the manufacture of generic products, developing in its R&D laboratories its own chemical synthesis processes. In the 90s, the company developed the second part of the business, with outsourcing to the large pharma and biotech companies. In outsourcing, Hovione develops all technical services, since laboratorial development until the regulatory approval and commercial production, becoming the essential link to the pharmaceutical multinationals that research new medicines.

Hovione is the biggest investor in R&D in the Portuguese pharmaceutical industry and already developed more than 100 chemical synthesis process and has more than 500 patents all over the world, of which 400 are still in use.

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Hovione is bringing momentum to the intranasal field after announcing that its lead single-use nasal dry powder device, developed in collaboration with Industrial Design Consultancy Ltd (IDC), is now available for commercial partnerships. The milestone marks the transition from prototype to a fully integrated intranasal drug delivery platform that spans Hovione’s end-to-end partnership capabilities–from API synthesis through advanced formulation and particle engineering to drug product manufacturing, including device supply and advanced analytical tools for nasal performance characterization. The platform’s single-use device is designed to be manufacturable at scale and to leverage existing advanced particle engineering and drug product manufacturing capabilities, a practical advantage that can shorten timelines to clinic and commercialization while reducing development risk and cost. The device’s patented mechanism supports targeted nasal deposition, including access to the upper olfactory region. This enables rapid systemic absorption and potential nose-to-brain delivery pathways that are increasingly important for CNS and emergency-use indications. Beyond the single-use format, Hovione and IDC are advancing a multi-dose variant to broaden applicability across dosing regimens and therapeutic areas. The collaboration is backed by an intellectual property portfolio and initial patent grants, positioning the platform as a turnkey option for pharma partners seeking a single integrated supplier for both drug substance and device. This development arrives as intranasal delivery gains traction for systemic, CNS and rapid-onset therapies. This is precisely the focus of the upcoming 4th Nasal Formulation & Delivery Summit, for which Hovione is a key sponsor. The annual summit unites formulation, delivery and product development leaders to tackle drug-device compatibility, translational preclinical models, and strategies for scalable, regulatory-ready intranasal programs. Hovione’s recent progress will be highly relevant to attendees looking to de-risk nose-to-brain and systemic intranasal programs. Read the full article at News-Medical.net    

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