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Xemplar moves to fill inhaler manufacturing gap

By Kirsty Barnes , 01-Jun-2006

MAP Pharmaceuticals has awarded the manufacturing of the metered-dose components of its new inhaler devices to Xemplar, who is one of the few contract manufacturers in the world that can take on such a challenge and is now upping manufacturing capacity to meet future demand in this evolving market.

The new deal is an extension of MAP's existing relationship with inhalation product developer and manufacturer, Xemplar, who has already been helping the pharma firm in the development, formulation and processing of MAP's proprietary Tempo inhaler products.

Tempo is a breath synchronized plume controlled inhaler that automatically adjusts to each patient's inspiration pattern without requiring electronics. Tempo also features a novel aerosol flow controller that ensures efficient and consistent dose delivery, according to MAP.

Under the new deal, Xemplar will now manufacture and fill the Hydrofluoroalkane (HFA) aerosol metered-dose component of the Tempo inhalers and also be responsible for additional development activities, including process engineering for MAP's preclinical and clinical products.

HFA metered-dose inhalers are the accepted environmentally friendly replacement for chlorofluorocarbon (CFC) inhalers, however, Xemplar, along with UK-based Inyx and Cardinal Health, are the only three contract manufacturers in the world who have the capability to commercially make and fill these new devices, Charles Eck, president of Xemplar Pharmaceuticals told In-PharmaTechnologist.com.

HFA inhalers are not filled the same way as HFC inhalers as the drug product needs to be filled under pressure through the valve into the can. It has taken those in the industry who have been working on this process between 10 and 15 years to develop," said Eck.

"Any company wanting to move into this area of manufacturing would need at least five years to develop the expertise required. There are also not a lot of trained people in this field and most of those that are work for big pharma companies."

Only five large pharma companies - 3M, GlaxoSmithKline, Schering-Plough, AstraZeneca and Boehringer Ingelheim - as well as a couple of smaller firms such as SkyePharma, have also developed this new production process in-house for their own products in development.

"Any other pharma firms wanting to develop such products need to find a contract manufacturer who can do it for them, and we are here to fulfil that need," said Eck.

"This is a niche area of the drug delivery device market that we only see growing in demand and we have positioned ourselves well to benefit."

The pulmonary drug delivery market alone is currently worth $13bn (€10.5bn) and is tipped to grow to $25bn over the next decade as it encompasses new therapeutic areas, with diabetes and asthma treatments expected to play a large part of that growth.

Under the new deal, Xemplar's initial product manufacturing activities will be focused on a Tempo product for treating migraines. The product is currently Phase I clinical trials in the US and is expected to reach Phase II trials later this year.

MAP will make the drug product at its facilities in Mountain View, California, and an undisclosed contract manufacturer will make the actual drug delivery device.

Xemplar will also be responsible for manufacturing additional Tempo-based therapeutics presently under development at MAP, including a drug for asthma and chronic obstructive pulmonary disease (COPD), as well as a drug to treat metabolic disease.

To cope with the new manufacturing demand, the company is expanding its existing production facility in Fall River, Massachusetts, adding 12,000 square feet of commercial space designed specifically for the production of pressurized metered dose inhaler products, nasal sprays and dry powder inhalers.

As part of the new agreement, MAP will provide an interim, interest free loan, as well as funding for technical assistance to Xemplar to support the expansion.

Armed with this added capacity Xemplar will be looking to find many new manufacturing agreements with other companies for all types of pressurized metered dose inhalers, nasal sprays and dry powder inhalers, to add to the deal it now has in place with MAP.

"Companies that are developing these devices are now realising that they need more than just a device, they need a whole product if they then want to be able to successfully sell them on to big pharma companies. We can fill this need because we can help companies in both the development stages and the manufacturing stages of the products," said Eck.

"We can currently meet demand for small quantities of these products for clinical trial purposes but the expansion will give us capacity to produce and fill around 20m units a year."

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