Xemplar Sign Development, Manufacturing Agreement With MAP for Inhaler Products

In-Pharmatechnologist.com (Associated Press)
PharmaManufacturing.com.
07/06/2006

MAP Pharmaceuticals has awarded the manufacturing of the metered-dose components of its new inhaler devices to Xemplar. 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.

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. The product is currently Phase I clinical trials in the US and is expected to reach Phase II trials later this year.

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.

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.”