Loramyc’s excipient shows BioAlliance the whey

03-Sep-2008 - Last updated on 13-Mar-2017 at 19:18 GMT

Drug delivery specialist BioAlliance Pharma says that its decision to focus on the oncology and infectious disease markets helped it reduce its half-year 2008 losses.

The Parisian firm posted a shortfall of just under €8m ($11.6m) for the six months ended June 30, a reduction of 9.5 per cent on the loss it posted in the first half last year.

Turnover for the period was €4.9m, up from the €312,000, largely due to the contribution made by the firm’s muco-adhesive antifungal therapy Loramyc (miconazole lauriad).

BioAlliance licenses Loramyc, which combats opportunistic infections in immuno-compromised patients, to Handok in South-East Asia, NovaMed in China and its SpeBio joint venture in the UK in return for fees and royalty payments based on sales.

The company also has a deal with Par Pharmaceuticals in the US, and plans to submit a new drug application (NDA) to the Food and Drug Administration (FDA) when an ongoing Phase III study is completed later in the year.

In France, where BioAlliance markets Loramyc itself, the product generated sales of €330,000 in the first half of the year and has a 5 per cent share of the oropharyngeal candidiasis market.

Buccal delivery platform

Loramyc is based on BioAlliance’s lauriad oral delivery technology that adheres to mucous membranes, releasing miconazole at the site of infection for a sustained period. The gingival tablet disintegrates when drug release has ended.

The tablet’s matrix, which is formed from concentrated milk protein, lends the product its mucoadhesive properties. The “natural” excipient, which is widely used in the food industry, becomes hydrated and sticks to proteins on the surface of the buccal membrane.

The lauriad technology is also being assessed in a variety of potential applications, including in cancer pain and recurrent viral infection. The most advanced of these development products is acyclovir lauriad, which is in late-stage Phase III trials for the treatment of labial herpes.

Development of BioAlliance’s Transdrug delivery platform is proving more problematic. In July, the firm announced that it had suspended a Phase II trial of a Transdrug-based doxorubicin product in patients with primary liver cancer.

BioAlliance explained that it had stopped the study after the data safety monitoring board (DSMB) overseeing the programme identified several severe adverse reactions. Investigations are ongoing.

On a more positive note, in August BioAlliance announced that it had in-licensed exclusive European rights to a thin-film formulation of the anti-emetic ondansentron. The product, which was developed by Applied Pharma Research (APR) and Labtec, is designed to prevent nausea and vomiting in cancer patients receiving chemotherapy.