MonoSol and APR deal puts more drugs on film
MonoSol Rx and Applied Pharma Research have agreed to expand their working partnership to produce and market current prescription drug products in film form. This method of drug delivery has gained much momentum recently as an innovative and novel form of administering medication.
The new terms closely follow the original partnership formed in March of this year, where along with German contract manufacturers Labtec, resulted in the European approval of Ondansetron RapidFilm – the first prescription drug product approved worldwide in dosage form based on film strip technology.
The deal extension intends to identify and develop a film formulation of prescription drug zolmitriptan, a treatment for migraines in adults. Currently available in swallowable tablet, an oral disintegrating tablet, and a nasal spray the drug faces initial patent expiration in 2013.
In order to prolong the drug’s commercial value specialist companies have turned to advanced drug delivery technologies to differentiate products and extend product life cycles.
“Several near-term opportunities exist to transition currently approved drugs to film formulations as a means to improve compliance, differentiation and marketability," said Paolo Galfetti, CEO of APR.
Film technology
MonoSol has become a central player in promoting the use of its film technology in delivering drugs that would otherwise be formulated in the more traditional delivery formulations such as a pill or tablet.
Its PharmFilm product is the pharmaceutical company’s proprietary technology, which MonoSol claims is more stable, durable and quicker dissolving than other conventional dosage forms.
The film carries low doses of prescription products in doses up to 80mg, enabling buccal and sublingual delivery. The film also incorporates drug taste-masking technology and dissolves rapidly in the mouth without the need for water.
Collaborations
MonoSol have entered into a number of collaborations in which the versatility of its PharmFilm technology has opened up many business opportunities.
In 2008, the company entered into an agreement for thin film pharmaceutical products with Hikma Pharmaceutical to develop, manufacture and market a broad range of generic and in-licensed pharmaceutical products across the Middle East and North Africa, the United States and Europe.
In the same year, MonoSol and UK-based Midatech Group announced a partnership to develop new drug formulations combining biocompatible nanocells and PharmFilm delivery technologies.
2009 saw MonoSol and Strativa Pharmaceuticals submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the orally dissolving film strip (ODFS) formulation of ondansetron.
In January of this year, the two companies signed a new licensing and development agreement to potentially develop three new products. The deal meant that Strativa could licence exclusive US commercialisation rights for the products that were developed using the PharmFilm technology.
Film market
Film technology is a product that according to Technology Catalysts could well become a $2bn market by the end of this year. Driven by the need for non-invasive drug delivery, film is an attractive alternative to tablet and capsule, especially for patients who have difficulty swallowing.
The development of an oral dosage form that does not require swallowing benefits both the consumer and the pharmaceutical industry. Even more so, regulatory agencies such as the FDA have approved the change in dosage form for drug products as long the safety or effectiveness of the product is guaranteed.
In addition, its flexibility means that it has the potential to deliver a variety of drugs, particularly when a fast onset of action is required.
Classes of drugs that could potentially benefit from film delivery include hypnotics, NSAIDs and pain killers, 5HT1 agonists for migraine treatment, antiallergics, and treatments for the oral cavity.
