Cipla widens allergic rhinitis drug deal with Meda to include EU, Japan…

Cipla widens allergic rhinitis drug deal with Meda

India’s leading generic maker Cipla has expanded its pact with Meda on azelastine and fluticasone combination for rhinitis to include more markets such as Europe, Japan, Brazil, South Korea and Australia.

Cipla and Meda have been developing azelastine and fluticasone combination to treat allergic rhinitis for the North American markets during the past years.

Azelastine is an antihistamine and fluticasone a corticosteroid; both are indicated for nasal treatment of allergic rhinitis.

Azelastine and fluticasone are the leading drugs in the antihistamine and corticosteroid markets respectively, in the US. Azelastine is a leading nasal antihistamine in the treatment of rhinitis in

the US.

Cipla and its drug development partner Meda believe that the azelastine and fluticasone combination in

a nasal formulation, which is currently in phase III human studies, may give patients with allergic rhinitis a more effective treatment than current therapies.

“This product could become the first combination of an antihistamine and corticosteroid in a nasal formulation, which would strengthen Meda’s position in the allergy area. I’m delighted that we have expanded our rights to this product”, said Anders Lönner, CEO Meda AB, in an official release.

Azelastine and fluticasone combination nasal spray’s clinical studies programme is expected to be completed during the second half of 2010.

Meda and Cipla have now agreed to extend the collaboration to include other key markets such as Europe, Japan, Brazil, South Korea and Australia.

as per the collaboration agreement, Cipla will manufacture and supply azelastine and fluticasone combination nasal product.

Meda will pay Cipla 5 MUSD upon regulatory approval in the first market and up to 10 MUSD as other milestone payments.

Based in Solna, Sweden, Meda AB is a leading international specialty pharma company. Meda’s products are sold in 120 countries worldwide.

Last week, Meda received US Food and Drug Administration (FDA) approval for Astepro (azelastine) nasal spray 0.15% for the treatment of the symptoms of seasonal and perennial allergic rhinitis. Astepro nasal spray 0.15% is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies. Meda plans to launch Astepro (azelastine) in October 2009.

Headquartered in Mumbai Cipla is currently the top generic company in India. Cipla also exports APIs and formulations to several regulated and semi-regulated markets including US, UK and South Africa.

Recently, Cipla’s pharmaceuticals manufacturing facility in Bangalore has been cleared of alleged violations in current good manufacturing practices (cGMP) norms by US FDA.nUSFDA officials had issued warning notices to the Mumbai-based Cipla for deficiencies in manufacturing practices following their inspection in its Bangalore facility.

USFDA inspection team has reportedly found out a few violations in the manufacturing norms mandated by the agency. Subsequently, USFDA asked Cipla to submit report on the corrective measures within 30 days of serving the warning notice, in April.

In May, Cipla received approvals from USFDA for tenofovir disoproxil fumarate tablets. The drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Cipla is allowed to sell the drug in tablet form in dosages of 300 milligram under the President’s Emergency Plan for AIDS Relief program.

Tenofovir disoproxil fumarate tablets are the generic version of Gilead Sciences Inc.’s (GILD) Truvada.

Similarly, Cipla received approvals for stavudine and levetiracetam from the United States Food and Drug Administration (USFDA), in March.

Cipla and Meda have been developing azelastine and fluticasone combination to treat allergic rhinitis for the North American markets during the past years.

Azelastine is an antihistamine and fluticasone a corticosteroid; both are indicated for nasal treatment of allergic rhinitis.

Azelastine and fluticasone are the leading drugs in the antihistamine and corticosteroid markets respectively, in the US. Azelastine is a leading nasal antihistamine in the treatment of rhinitis in the US.

“This product could become the first combination of an antihistamine and corticosteroid in a nasal formulation, which would strengthen Meda’s position in the allergy area. I’m delighted that we have expanded our rights to this product”, said Anders Lönner, CEO Meda AB, in an official release.

Azelastine and fluticasone combination nasal spray’s clinical studies programme is expected to be completed during the second half of 2010.

Meda and Cipla have now agreed to extend the collaboration to include other key markets such as Europe, Japan, Brazil, South Korea and Australia.

As per the collaboration agreement, Cipla will manufacture and supply azelastine and fluticasone combination nasal product.

Meda will pay Cipla 5 MUSD upon regulatory approval in the first market and up to 10 MUSD as other milestone payments.

Based in Solna, Sweden, Meda AB is a leading international specialty pharma company. Meda’s products are sold in 120 countries worldwide.

Last week, Meda received US Food and Drug Administration (FDA) approval for Astepro (azelastine) nasal spray 0.15% for the treatment of the symptoms of seasonal and perennial allergic rhinitis. Astepro nasal spray 0.15% is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies. Meda plans to launch Astepro (azelastine) in October 2009.

Headquartered in Mumbai Cipla is currently the top generic company in India. Cipla also exports APIs and formulations to several regulated and semi-regulated markets including US, UK and South Africa.

Recently,  Cipla’s pharmaceuticals manufacturing facility in Bangalore has been cleared of alleged violations in current good manufacturing practices (cGMP) norms by US FDA.nUSFDA officials had issued warning notices to the Mumbai-based Cipla for deficiencies in manufacturing practices following their inspection in its Bangalore facility.

USFDA inspection team has reportedly found out a few violations in the manufacturing norms mandated by the agency. Subsequently, USFDA asked Cipla to submit report on the corrective measures within 30 days of serving the warning notice, in April.

In May, Cipla received approvals from USFDA for tenofovir disoproxil fumarate tablets. The drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Cipla is allowed to sell the drug in tablet form in dosages of 300 milligram under the President’s Emergency Plan for AIDS Relief program.

Tenofovir disoproxil fumarate tablets are the generic version of Gilead Sciences Inc.’s (GILD) Truvada.

Similarly, Cipla received approvals for stavudine and levetiracetam from the United States Food and Drug Administration (USFDA), in March.