The new agreement between BioProgress and an unnamed US over-the-counter pharmaceuticals firm could double the UK company's capacity to manufacture cellulose films for drug encapsulation, according to chief executive Graham Hind.
And once BioProgress completes its own film plant in the UK, due to start operations in September next year, it will be the first independent facility for manufacturing pharmaceutical grade films outside the main multinationals.
Once completed, the UK facility will operate 54 machines, which would be more than enough capacity to handle even the largest products in the OTC category, he said.
This hike in capacity is crucial for BioProgress if it is to make the most of its opportunity in the US OTC market. The volumes of capsules sold in this sector are staggering; in the OTC analgesic sector alone, 33 billion capsules are sold every year in the US. It would take 33 of BioProgress' machines to cope with the encapsulation of one major product, Johnson & Johnson's Tylenol (paracetamol).
The size and capacity of the US facility has not yet been decided, according to Hind. It was designed to overcome the logistical problems of shipping BioProgress' cellulose film across the Atlantic, and provides additional capacity that can be used for BioProgress' other partners.
Although the identity of BioProgress' partner has not been divulged, the company already has relationships with Bristol-Myers Squibb and Procter & Gamble, both of which have OTC franchises. Industry observers have also suggested that the partner could be in the OTC analgesic category, which would bring Wyeth and J&J onto the radar.
There has also been speculation as to which of BioProgress' technologies is the subject of the deal. Its NROBE system for encapsulating powdered drugs is considered more likely to address the prescription drug market, and in any case is subject to an exclusive deal with FMC Biopolymer.
SEPTUM, used to separate two substances within a single capsule, is also more likely to address prescription drug applications. That leaves SWALLOW for liquid-filled capsules and TABWRAP for tablet coating, and the latter technology seems the most likely to find an application in the US OTC market where coated tablets are commonly-used.
The latter has long been considered the most likely technology to spearhead a move into the OTC sector, as it does not require any change in the composition of the active and, unlike NROBE for example, does not require a radical reformulation.
It also promises cost advantages over rival technologies for coating tablet, according to Hind. For example, gelatine film coating, which is a technology peculiar to the US market, requires manufacturer to create a tablet core, pre-coat it, ship it to the gelatine coating facility and then transfer it back for further processing and packaging. Using TABWRAP, customers can coat their core presses on an in-house machine.
BioProgress also claims that TABWRAP has advantages in time, cost and ease-of-use over the sugar-based tablet-coating technologies preferred in Europe, which requires processing of cores in a pan coater, as well as cumbersome drying, polishing and checking procedures.