IngentaConnect Clindamycin/Tretinoin: Clindamycin Phosphate/Tretinoin Gel

Abstract:

Connetics Corporation (USA) has licensed a first-in-class, dual-action 1% clindamycin/0.025% tretinoin aqueous gel [Clindamycin phosphate/tretinoin gel, Velac^®, Velac^® Gel] from Yamanouchi Europe BV. The product combines the anti-inflammatory and antibacterial properties of clindamycin with the beneficial effects of tretinoin [all-trans-retinoic acid], and is in phase III trials for the treatment of acne.

On 1 April 2005, Yamanouchi merged with Fujisawa to form Astellas Pharma.

Connetics has exclusive development and commercialisation rights for clindamycin/tretinoin gel in the US and Canada, and has non-exclusive rights to the product in Mexico. Under the licensing agreement terms, Connetics initially paid Yamanouchi a $US2 million licensing fee, as well as milestone payments and royalties on future products. In the fourth quarter of 2002, a $US2 million milestone payment was made to Yamanouchi following the initiation of pivotal phase III trials in the US and Canada, and in the third quarter of 2004 a $US3 million milestone payment was made to Yamanouchi following the filing of an NDA to the US FDA.

In March 2004, Connectics reported that clindamycin/tretinoin is approved in Europe. It appears that this approval was specifically for France.

In October 2004, Connetics announced that the US FDA has accepted its NDA filing for clindamycin/tretinoin. Two pivotal phase III trials of clindamycin/tretinoin have been conducted in the US and Canada. These trials included 2219 patients with acne who received 12 weeks' treatment in the double-blind, placebo- and active-controlled trials. Results of these trials were reported in March 2004. Connetics anticipates launch of the product during mid-2005. An action date of 25 June 2005 has been given by the FDA for it to respond to the NDA submission.

Phase III trials in patients with acne in Europe have shown clindamycin/tretinoin gel to be as effective and safe as other leading topical therapies. Data from a combined analysis of six controlled efficacy and safety trials of clindamycin/tretinoin have been reported.

The patent for clindamycin/tretinoin gel is held by Yamanouchi in the US and internationally.

Other analysts, at CIBC World Markets, were quoted saying that Evoclin™ represents Connetics' ‘first foray’ into the acne market (followed by others, such as Velac^®), a market that has been valued at $US1.7 billion, of which that for topical antibiotics is worth approximately $US500 million.