Inhaler to deliver powerful anti-flu drugs

Sankyo Company of Japan and Australian firm Biota Holdings have jointly licensed the dry powder inhaler technology from Hovione, and will be applying it to the delivery of long acting neuraminidase inhibitors (LANI) owned by the two companies.

LANIs are active against the influenza virus, and the novel compound that has been developed remains active for several days only needing to be taken once a week, unlike other existing medicines that require twice daily treatments.

The companies claim that the high potency and reduced frequency of administration of the LANIs offer a practical solution to the problem of pandemic stockpiling, particularly pertinent given the current worldwide concerns regarding the availability of sufficient influenza vaccine in the face of potential flu pandemics.

Fears of a flu pandemic has transformed the fortunes of Roche's orally-administered Tamiflu (oseltamivir) product, currently the top-selling of just two neuraminidase inhibitors on the market.

First launched in the US in 1999, sales had been lacklustre and after an initial period of growth and by 2004 had started to decline.

But publicity surrounding bird flu in 2004 rapidly reversed that trend, and the Swiss company invested in a 10-fold increase in production capacity to meet surging demand for the drug.

The tactic paid off, with sales ballooning from just CHF 330m ($206m) in 2004 to CHF 1.6bn in 2005 and a whopping CHF 2.6bn last year.

Hovione, more well-known for its active pharmaceutical ingredient (API) development and manufacturing, came up with a low-cost disposable inhaler designed specifically for the anti-influenza indication, and hopes the long-acting product could capture a slice of that lucrative market.

The TwinCaps product developed by the company is the latest inhaler offered by the company, in addition to the FlowCaps reusable capsule-based inhaler that has been launched in India by Ranbaxy for use with asthma medications.

"The TwinCaps inhaler was specifically designed for the influenza indication," Isabel Pina of Hovione told In-PharmaTechnologist.com.

"It had to be disposable, and therefore very economic.

Since most influenza patients are inhaler naïve, the device is so easy to use that it does not require detailed instructions.

The patient just moves a container containing two doses from side to side, aligning each in turn with the mouthpiece and inhaling."

The TwinCaps inhaler holds the powdered drug product in two plastic compartments, and can hold doses of 5-10mg of active ingredient.

The emitted dose from the inhaler exceeds 80 per cent; the fine particle fraction (the amount of drug deposited in the lung) that can be achieved with the inhaler depends on the formulation of the drug, but is in the range of 30 to 80 per cent of the emitted dose.

The TwinCaps inhaler is available for worldwide licensing, but Hovione refused to comment on anticipated revenues to be generated by the product.

In addition to developing the inhaler itself, Hovione also worked on the formulation of the Biota and Sankyo's lead clinical candidate, CS-8958, to ensure that it was deliverable by inhalation and compatible with the TwinCaps inhaler.

Sankyo and Biota will remain responsible for the clinical development of the drug, which is expected to start shortly, and CS-8958 has already completed Phase I clinical trials in a prototype inhaler.

Biota has experience working with inhalable neuraminidase inhibitors, having first developed zanamivir, a first in-class antiviral drug for the treatment and prevention of influenza.

Biota licensed the drug to GlaxoSmithKline (GSK) in 1990 and it was launched worldwide in 1999 under the brand name Relenza.

The drug is delivered using a disk inhaler device, and generated revenues of £91m (€143m) for GSK in 2006.