Press Room

Dear Sirs, Hovione thanks the FDA for the opportunity to present comments and suggestions on the draft guidance for industry “Request for Quality Metrics”. Hovione has been in business for 56 years supplying services as a CDMO to Innovators, and APIs to the generics industry to enable it to offer high quality affordable medicines. Our first FDA inspection was in 1982. We employ 1345 employees and supply to 50 countries. In each of the last 5 years we were the manufacturer behind 1 to 3 NDA approvals per year, in addition to being the referenced DMF holder for multiple ANDA approvals. I have been CEO of Hovione for almost 20 years. For about 40 years I have been fortunate to have had a front row seat at watching the global pharmaceutical industry evolve. My first words on this guidance are of amazement and congratulations to FDA for giving a role to “quality culture” [109] in its compliance requirements. The USA is fortunate to have the World’s gold standard regulator, the one that pushes innovation and is continuously raising the bar. Quality Metrics is another feather in its cap. The Quality Metrics guidance amounts to a major innovation in FDA practice as it allows it to focus on quality and good performers rather than just on non-compliance and poor performers. We are very much used to an FDA that excels at using the stick, this guidance announces that FDA will learn to use the carrot. This is good because patients want capsules full of quality, not capsules full of compliance. Hovione is in full support of the proposed guidance in terms of concept and its proposed mechanics. Implementing the proposed Quality Metrics will entail considerable work for tens of thousands of people but that is very little compared to the benefit to the patient, to the quality and reliable supply of medicines in the US and elsewhere. If you do not measure you cannot manage, having mandatory quality metrics should set the industry on a journey towards better quality medicines. We also hope it will also provide patients, clients, prescribers and payors with an objective measure of quality that enables them to differentiate between manufacturers of both APIs and FDFs.  


FDA Draft Guidance for Industry: Request for Quality Metrics – FDA-2015-D-2537

Nov 26, 2015

In-depth Process and Product Expertise – This is Key to CDMO Support of Orphan Drug and Breakthrough Therapy Development & Commercialization As older blockbuster drugs lose patent protection and generic competition increases, many pharmaceutical companies are focusing discovery efforts on therapies with the potential to treat multiple niche populations. Increasingly, innovative small and emerging pharma firms are developing new drug candidates with orphan or breakthrough therapy status that are ultimately licensed or sold to large brand manufacturers. These companies rely heavily on contract manufacturing and development organizations (CDMOs) that can provide in-depth scientific expertise and achieve under rapidly accelerated timelines the development of cost-effective, robust, reliable processes that consistently yield high-quality products.   Until recently, most pharmaceutical firms were not interested in the development of small-volume drugs due to fears of limited returns. With the age of the blockbuster drug now history, many drug companies are finding that niche therapies, particularly those that may treat numerous indications, not only provide patients with life-saving medications, but also realize attractive financials if developed in a streamlined and cost-efficient manner. There are over 7,000 different types of rare diseases and disorders, yet only a couple of hundred approved therapies designated as orphan drugs. According to EvaluatePharma, although the average Phase III development time for orphan drugs is not shorter than that for non-orphan drugs, the Phase III drug development costs for the former are half those of the latter, and the anticipated return on investment for a Phase III/filed orphan drug is nearly twice that for a non-orphan drug. As a result, EvaluatePharma estimates that the orphan drug market is growing at an annual rate of 11%, more than double that of the overall prescription drug market (5%), and by 2020 will reach $176 billion in annual sales and account for 19% of the total non-generic prescription market. In 2013 alone, 260 orphan drug designations were granted. In 2014, the FDA approved 15 NDAs and seven BLAs with the orphan drug designation, along with 24 supplemental approvals. Many companies are also pursuing the new breakthrough designation established in 2012 by FDASIA, the Food and Drug Administration Safety and Innovation Act. A candidate qualifies for breakthrough therapy designation if preliminary clinical evidence suggests that the drug may have substantial improvement over available therapies on at least one clinically significant endpoint. The development and approval times for breakthrough therapies are typically half that of the seven years for conventional drugs, and both the sponsor and CDMO benefit from greater FDA guidance and communication with the agency. FDA’s CDER approved 14 breakthrough therapies in 2014 and nine in 2015 as of August 21.  Of the firms pursuing the development of orphan drugs and breakthrough therapies, many are small or emerging pharmaceutical or biopharmaceutical companies focused on niche, small molecule therapies. These companies often have limited resources in terms of laboratory, analytical, and manufacturing equipment (indeed, some are virtual companies in that respect) and depend heavily on service providers to perform crucial process and formulation development, validation, regulatory compliance, and manufacturing activities. The choice of CDMO can therefore have a direct impact on the success or failure of the new drug. Read article here  


In-depth Process and Product Expertise

Nov 01, 2015

Developing an Orally Inhaled Dry Powder Formulation - A Complex Itinerary and a Technological Challenge The delivery of an orally inhaled API to the deep lung can be performed using different drug-delivery platforms, such as nebulizers, pressurized metered dose inhalers (pMDI), and dry powder inhalers (DPI). DPIs are increasingly becoming a more important drug delivery option and are expected to hit double-digit figures, reaching global sales of $31.5 billion in 2018 DPIs are conventionally formulated using a carrier-based approach, in which the API is size-reduced until it reaches an inhalable particle size and is further blended with a lactose carrier to enable dose metering and to improve powder flowability and dispersibility. Even though this formulation approach is the most commonly used, it presents several drawbacks. To overcome the limitations, as well as to address the renewed interest in pulmonary delivery of biotherapeutics and other advanced therapies, several alternative particle engineering approaches have been devised over the years, such as the production of composite particles by spray-drying where the API is embedded in an excipient matrix. Although the development of a DPI seems straightforward, it is a complex area that integrates multiple fields of knowledge. In a general way, the success of a DPI produced using a carrier-based formulation approach will be determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance. In this article, Gonçalo Andrade, business development manager at Hovione, spoke to Pharmaceutical Technology about the key considerations when developing an orally inhaled dry-powder inhalation formulation. Read the article here


Developing an Orally Inhaled Dry Powder Formulation

Jun 01, 2015

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