Dr Reddy's eyeing SkyePharma delivery system

By Pete Mansell

- Last updated on GMT

Related tags Dr reddy Food and drug administration Skyepharma

UK drug delivery specialist SkyePharma has signed an agreement with
India's Dr Reddy's Laboratories for a feasibility study of an
unnamed product using two of SkyePharma's proprietary drug delivery

The costs of the study will be met by Dr Reddy's and SkyePharma will also receive a "small" upfront payment, the two companies said.

If the feasibility study is successful, full development activities will begin later this year, they added.

Further details were thin on the ground, although SkyePharma's chief executive officer, Frank Condella, noted that the company hoped to extend the collaboration to other products.

SykePharma is not revealing which of its technologies are involved in the collaboration, nor the therapy area the two companies are exploring.

"We wanted to keep our powder dry" until the feasibility study was completed, commented SkyePharma's chief operating officer, Ken Cunningham, although he said the agreement would hopefully lead to further work both with Dr Reddy's and other companies.

Cunningham also stressed the importance of the collaboration in terms of Dr Reddy's being an international company with a "good reach" into the US and European markets.

Another benefit was access to Indian laboratory services, with the potential to leverage more cost-effective development opportunities.

"We will be looking at what Dr Reddy's can do, as well as what we can do," Cunningham commented.

SkyePharma has a history of development partnerships, with companies including GlaxoSmithKline, Roche, Schiele, Novartis, AstraZeneca, Nitec and Abbott, for both approved and pipeline drugs incorporating the UK company's oral, inhalation and topical drug delivery technologies.

As Cunningham noted, SkyePharma has accepted that deals of this kind entail a lower royalty rate but, as things stand, "we are not spending a large amount on development".

One drain on finances, though, has been Skyepharma's key pipeline asset, the potential blockbuster asthma treatment Flutiform (fluticasone/formoterol).

Some of that pressure was eased in May 2006 when SkyePharma finally licensed Flutiform to Kos Pharmaceuticals for the US market, subsequently acquiring a new partner when Kos was acquired by US pharmaceutical stalwart Abbott Laboratories.

More recently came the announcement that the planned new drug application (NDA) for Flutiform in the US would be delayed after the Food and Drug Administration (FDA) asked for another clinical study to provide extra efficacy data on the bronchodilator/steroid combination supplied in SkyePharma's proprietary non-CFC metered-dose aerosol inhaler.

In December, however, SkyePharma said it had amended its agreement with Abbott for the US development and commercialisation of Flutiform, so that Abbott would assume the responsibility and costs for the additional Phase III trials required by the FDA and for filing the US NDA.

This will save SkyePharma around $20m in anticipated R&D expenses.

In return, it has agreed to reduced milestone payments due on acceptance of the Flutiform NDA and eventual approval.

The net impact is that SkyePharma may receive up to $124.5m in total milestones for Flutiform, rather than the $165m previously quoted.

Once the existing development programme for Flutiform (which includes a completed safety study and three efficacy trials on schedule to finish in April 2008), is over, SkyePharma will "look at taking certain products further [in development] ourselves" , Cunningham added, although the strategy will always be "mix and match", he added.

The company has just sustained another regulatory delay, this time involving Requip XLTM (ropinirole), the extended-release formulation of GlaxoSmithKline's (GSK) drug for idiopathic Parkinson's disease that employs SkyePharma's GeoMatrix technology.

The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for the Requip XLTM NDA in the US to give the agency more time to review some additional food-effect data recently submitted by GSK.

Following the approvable letter issued for Requip XLTM last December, and GSK's subsequent response to the FDA, a final decision on the NDA had been expected during the current quarter.

That deadline has now moved to the second quarter.

Cunningham said he was optimistic that a US launch of Reqip XLTM was achievable in the second quarter, as GSK should be "ready to go" by then.

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