Business Standard

A COMMERCIAL FEATURE

What's this ?

Commercial Feature is a Business Standard Digital Marketing Initiative.

The Editorial/Content team at Business Standard has not contributed to writing or editing these articles.

For further information, please write to assist@bsmail.in

US FDA accepts application of Sun Pharma's partner Merck for tildrakizumab

Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis

BS B2B Bureau  |  Mumbai 

Sun Pharma ropes in Mitsubishi Tanabe to distribute products in Japan

Sun Pharmaceutical Industries Ltd has announced that the US Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for filed by its partner, & Co Inc. The US FDA filing acceptance follows the acceptance of the regulatory filing of by the European Medicines Agency (EMA) in March 2017. is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. 

In 2014, acquired worldwide rights to from Merck, known as MSD outside the US and Canada. Funded by a subsidiary, is responsible for the completion of phase 3 trials in patients with mild-to-moderate plaque psoriasis and, as appropriate, submission of a biologics license application to the US FDA. 

is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch. Post-approval in the US, will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product. is eligible to receive milestone payments and royalties on sales of  

Abhay Gandhi, CEO - North America Business, Sun Pharma, said, “At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers. The acceptance of the regulatory filing by the US FDA marks a significant milestone as we seek to advance for as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis.”

For European market, has a licensing agreement with Almirall for the development and commercialisation of for psoriasis. Under terms of the license agreement, Almirall is able to lead European studies, and participate in larger global clinical studies for psoriasis indication. The agreement between and Almirall remains subject to the exclusive license agreement between and

Psoriasis, a chronic immune disease that appears on the skin, affects an estimated 7.5 million people in the US and approximately 125 million people worldwide. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed.

RECOMMENDED FOR YOU

US FDA accepts application of Sun Pharma's partner Merck for tildrakizumab

Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis

Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis
Sun Pharmaceutical Industries Ltd has announced that the US Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for filed by its partner, & Co Inc. The US FDA filing acceptance follows the acceptance of the regulatory filing of by the European Medicines Agency (EMA) in March 2017. is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. 

In 2014, acquired worldwide rights to from Merck, known as MSD outside the US and Canada. Funded by a subsidiary, is responsible for the completion of phase 3 trials in patients with mild-to-moderate plaque psoriasis and, as appropriate, submission of a biologics license application to the US FDA. 

is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch. Post-approval in the US, will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product. is eligible to receive milestone payments and royalties on sales of  

Abhay Gandhi, CEO - North America Business, Sun Pharma, said, “At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers. The acceptance of the regulatory filing by the US FDA marks a significant milestone as we seek to advance for as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis.”

For European market, has a licensing agreement with Almirall for the development and commercialisation of for psoriasis. Under terms of the license agreement, Almirall is able to lead European studies, and participate in larger global clinical studies for psoriasis indication. The agreement between and Almirall remains subject to the exclusive license agreement between and

Psoriasis, a chronic immune disease that appears on the skin, affects an estimated 7.5 million people in the US and approximately 125 million people worldwide. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed.

image
Business Standard
177 22

US FDA accepts application of Sun Pharma's partner Merck for tildrakizumab

Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis

Sun Pharmaceutical Industries Ltd has announced that the US Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for filed by its partner, & Co Inc. The US FDA filing acceptance follows the acceptance of the regulatory filing of by the European Medicines Agency (EMA) in March 2017. is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. 

In 2014, acquired worldwide rights to from Merck, known as MSD outside the US and Canada. Funded by a subsidiary, is responsible for the completion of phase 3 trials in patients with mild-to-moderate plaque psoriasis and, as appropriate, submission of a biologics license application to the US FDA. 

is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch. Post-approval in the US, will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product. is eligible to receive milestone payments and royalties on sales of  

Abhay Gandhi, CEO - North America Business, Sun Pharma, said, “At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers. The acceptance of the regulatory filing by the US FDA marks a significant milestone as we seek to advance for as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis.”

For European market, has a licensing agreement with Almirall for the development and commercialisation of for psoriasis. Under terms of the license agreement, Almirall is able to lead European studies, and participate in larger global clinical studies for psoriasis indication. The agreement between and Almirall remains subject to the exclusive license agreement between and

Psoriasis, a chronic immune disease that appears on the skin, affects an estimated 7.5 million people in the US and approximately 125 million people worldwide. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed.

image
Business Standard
177 22