PPD doesn’t expect alogliptin milestone this year

09-Mar-2009 - Last updated on 09-Mar-2009 at 11:35 GMT

Related tags Takeda Food and drug administration

PPD says it is unlikely to receive a $25m (€20m) milestone for US approval of Takeda’s diabetes drug alogliptin this year after the FDA said that cardio vascular (CV) safety data filed as part of the NDA are insufficient.

In December the US Food and Drug Administration (FDA) introduced guidelines calling for further analysis of dipeptidyl peptidase IV (DPP-4) inhibitors like alogliptin after GlaxoSmithKline’s (GSK) Avandia (rosiglitazone) was linked to heart attacks.

PPD, which developed the drug in partnership with Takeda on a contractual basis, could still earn $10m from the alogliptin if it is approved by the European Medicines Agency (EMEA) later this year.

The North Carolina contract research organisation (CRO) may also benefit from additional Takeda business, as it is likely to be in the frame for any additional development and trial work that the FDA requires.

Takeda, which is looking for a drug to replace its bestseller Actos (pioglitazone) ahead of patent expiry in 2011, expressed a considerable degree of frustration with the US agency in a statement issued last Thursday.

The Osaka firm said it had previously been notified that the FDA would be unable to complete its review by the original Perscription Drug User Fee Act (PDUFA) deadline of October 27 due to “internal resource constraints,” two months ahead of the issuance of the new guidelines.

Takeda added that prior to last week’s news the agency had not “[raised] any issues with the data in the alogliptin new drug application (NDA) at that time,” despite having had the figures for several years.

One slight positive for Takeda is that, as yet, the the drug’s revised PDUFA date of June 26, 2009 remains unchanged.

Takeda’s share price plunged 13 per cent to 3,320 Yen on the Tokyo Stock Exchange on March 6 when the story broke, mirroring the market’s view that the delay is bad news for the firm.

Analysts at Nomura Holdings and Credit Suisse cut their rating for Takeda, while KBC Securities Philip Hall told Bloomberg that the latest delay further reduces the chances that alogliptin will hit the shelves before 2011.

Hiroshisa Shimura from UBS AG in Tokyo said the delay also reduces patent life and weakens alogliptin’s standing against competitors like Merck & Co’s Januvia (sitagliptin), which is already generating $1.4bn in revenue each year.