Packaging room

The Brussels-based European Chemical Industry Council – CEFIC – announced on 8th December the formation of a permanent work group, the European Fine Chemicals Group, dedicated to the Fine Chemicals Industry. The aim of the EFCG is to fill the existing gap between the European Commission and the economic agents. At the conference, Hovione had an important role in voicing the discrepancies in the inspection procedures for GMP compliance: whilst European manufacturers are inspected and must keep up very costly high-level quality systems, those outside Europe are not subject to any inspection enforcement! 

API material on the EU market was produced by unknown manufacturers and is therefore illegal - and the experiences shared by a recognized API trading company at a recent European API Conference in Lisbon (October 2004) (ref.2), showing that the traceability of API material back to the manufacturer is frequently lacking.
Consequently, the EU’s high standards of quality, safety and efficacy of its medicines, particularly in the highly competitive generic, "me-too" and OTC markets, are starting to be seriously undermined by current API trends.
Unless control over the API supply to the European market is drastically increased, API manufacturers throughout the world who are applying the strict and costly standards of EU regulations and guidelines will have a severe competitive disadvantage against less ethical companies: "Good" APIs and pharmaceutical firms will be pushed out of business by "bad" APIs and pharmaceutical firms.
In order to reduce the risk for the European patients and for the sake of the continuity of API manufacturers who comply with the regulations, the EU must create the legal framework for a uniform level playing field for all API suppliers to the European market based on:

1. A mandatory and effective inspection service that will verify if the API manufacturing processes and controls comply with the ICH/Q7A GMP Guideline and are in accordance with the information included in the respective CEP dossiers, DMFs or MAs.

2. A sampling program to assure quality surveillance of medicines and their APIs.

3. The compulsory requirement to include with every Marketing Authorization a current and appropriate Certificate of GMP compliance issued by the EU inspectorate to the producer of the API.

4. Periodic follow-up inspections to reconfirm the validity of the GMP Certificate.

These provisions will also ensure a better level playing field in the EU market for finished medicines, whilst also reducing operational costs (e.g. a single authority inspection may avoid the need for multiple client audits).”

APIC, Sector Group of Cefic
24 December 2004

1. "Composition and Impurity Profile of Multisource Raw Material of Gentamicin – a Comparison"; Frank Wienen, Ralph Deubner and Ulrike Holzgrabe; Pharmeuropa Vol. 15, No. 2, April 2003

2. "Agents, Brokers, Traders, Distributors, Repackers and Relabellers Issues", Karl Metzger, Welding GmbH & Co. KG., 7th European API Conference, Lisbon, 20 – 22 October 2004

GMP production area

Following is the APIC (CEFIC’s Committee for APIs) Position Paper on the issue:
“Today, it is accepted worldwide that quality and safety of medicines can be built-in only by applying a set of measures and controls during development and production - known under the term "GMP" (Good Manufacturing Practice) - instead of by mere end product testing. This principle applies equally to the active components of medicines (Active Pharmaceutical Ingredients = APIs).
European Authorities recognize the principle of GMP as fundamental, both for medicinal products and for their APIs. However, whereas they have established a tight net of direct enforcement measures by regular inspections of the medicinal products manufacturers, surprisingly they show reluctance to implement the same enforcement on the APIs for the same medicines and are leaving that responsibility completely to the discretion of the finished dosage form producers.
The European API industry association APIC appreciates the incorporation of the GMP principles for APIs into the European drug code. However, a "well-intended" regulation can easily result in the opposite effect if enforcement is not applied and control by the authorities would be absent. The number of API manufacturers increases rapidly and EU producers of finished medicines are subject to increased price competition. The European Commission must create conditions that will ensure that competition never leads to sub-standard medicines. Therefore, the need for action is urgent:
The downward pressure on pricing of medicines in Europe urges EU manufacturers to seek new, lower priced API suppliers. However, such lower prices can originate in part from lower costs because of sub-standard GMP- and regulatory compliance levels at the supplier. So the serious concern of APIC is that this is resulting in EU pharmaceutical companies - also partly without their knowledge - compromising on quality by sourcing from what appear to be sub-standard suppliers. 
Worrying scientific data and other information on APIs that show substantial risks to patient safety in the EU have surfaced in the recent past. Examples are the Gentamicin case (ref.1) - giving strong indications that more than 33% of the gentamicin

New organization of the R&D Business Unit

 

- Higher profit of this Business Unit.

This new organization will no doubt increase opportunities for our colleagues in terms of responsibility and a higher degree of participation in projects, contributing to the development of their careers at Hovione.

Guy Villax, CEO, addressed all staff at the usual end of year general meeting. The main topics of the year in review can be summarized as follows:

GENERAL OVERVIEW
- General sense of uncertainty in the short term
  • The weakness of the dollar hurts our competitiveness
  • The Pharma sector is losing credibility, mainly in US
- Generics business is growing worldwide

COMMERCIAL PERFORMANCE DURING 2004
- Very good results on what we can control (very positive
  sales in dollars, high performance of the production
  lines; the organization is business-oriented, new safety
  plan on course)
- Implementation of new technologies with high demand in
  the market
- Customers are satisfied with the way their problems are
  being solved
- A growing differentiation vs. the competition
- Increased number of audits in Loures, Macau and New
  Jersey

INNOVATION
- Two new patents registered in 2004

SALES PROGRESS
- Sales in USD are growing; unfortunately our main costs
  are in Euro and these are increasing faster. Sales in Euro
  are decreasing and costs getting higher...

EXCLUSIVE MANUFACTURE DOING WELL - NEW PROJECTS ON THE RISE
 

Christmas Celebration

For our Christmas celebrations at the TTC , we had entertainment by "Tara's Travellin Tails". It was of course dedicated to the children, but it was original in that it comprised a show of wild animals. Each animal or insect was shown to the children and an explanation given on how it acted or survived in the wild. At the end of the demonstration the children were allowed to touch some of the animals and as you will see from in the picture they got pretty close to a boa constrictor snake. We think the parents were more unsettled by the snakes than the children...
 

People

In January 2005 two new employees began working at the TTC: Francis Pangulayan, who comes to us from CRUMBS Engineering, Inc. a consulting firm for Bayer Pharmaceutical, and, Filipe Tomás who has been working with us since May 2004 as a temporary employee “on loan” from HQ but became permanent in January 2005. Filipe is now working in the R&D Labs.
 

FDA Inspection

Celebration of the success of the FDA inspection

The HM plant was inspected in November 2004 by the FDA. The inspection was conducted by Karen Moksnes and Susan Ting and lasted three days (one less than expected). Two minor observations were recorded on a Form 483 (both situations are already solved). We celebrated and thanked each one for their contribution to such a successful FDA inspection.

First tech transfer
successfully carried out

The first technology transfer of a new product from NJ to HM was successfully carried out in September 2004. A multidisciplinary team from HM, including staff from Production, Analysis and Quality Control, worked on the last production campaign of IR01 in NJ. Subsequently, they were responsible for the project implementation at HM, assisted by the NJ team involved in this project since the beginning. This procedure, which represents an important investment in support of the tech transfer produced very good results at various levels. With regards to production, we managed to conclude the campaign within the established time frame and with a yield higher than expected; in human terms, the teams – culturally very different - had the opportunity to meet and get to know each others capabilities and work better as a team. Finally, with regards to the client, the TTC proved to be a major success given that this West Coast firm whom we have known for years, was reluctant to work with us because we had no site in the United States. As soon as the TTC opened, they gave us a chance! – now that we have gotten to know each other and showed the customer our capabilities it was not difficult to convince them to transfer the project to Macau!

This is the 12th time Hovione has participated as an exhibitor at CPhI, the largest international tradeshow for raw materials, intermediates and APIs for the Pharmaceutical Industry. Last year CPhI took place in Brussels, from 7th to 9th December - there were 1232 stands and 11,482 visitors. Three days of much activity where Hovione was present with a newly designed stand giving a more state-of-the-art and attractive image. 19 members of the Hovione Group were present. Marketing and Sales had 66 meetings with customers and another 150 visits from firms representing new business opportunities. Purchasing had over 30 meetings with current and new potential suppliers.
This time we focussed on actively promoting our generics under development, our spray drying capabilities and our expertise and technologies for producing enhanced APIs. This new capability and service differentiate us from the competition and is attracting many new business opportunities.
Hovione had two articles published in the Showdaily magazine, read by those present at the Show: “The competitive advantage of non-compliance”, by Guy Villax and “Particle size at Hovione: How small do you want it?” by José Rato.

Hovione and Staff donate €30,000 to the asian Tsunami victims

Ms. Leonor Nobre, Vice President of AMI, receives Hovione’s donation
 

Hovione Stand in CPhI - Brussels

Some colleagues, in the exhibition

Confronted with the tragedy which struck South East Asia, Hovione joined the worldwide solidarity movement and organised a donation campaign amongst the staff, which took place between 4th and 14th January. The Company committed to multiply by 10 the amount thus raised. Individual donations amounted to €2,724 and Hovione made the sum up to a total of €30,000.
Amongst the various humanitarian organisations, Hovione decided to support AMI – “Assistência Médica Internacional” – one of the first NGOs to arrive on the scene of the hardest hit area in Sri Lanka as they have given proof of valuable action in past disasters. Hovione and staff donations are an expression of our solidarity with the millions of people directly affected by this tragedy.
 

Editorship: Isabel Pina, Sofia Villax
Printing: 90 copies
With the collaboration of: Guy Villax (DG); Dave Hoffman and Lavinia Emery (NJ); Eric Ng (HM); Ana Ferreira (RH); Carla Vozone (MV)
Translation: Diane Villax, Manuela Leite and Rita Aragão