India Pharmaceuticals: Mylan Analyst Day Highlights - Biocon, Natco, Strides :Morgan Stanley Research
Quick Comment - Key takeaways from Mylan's Analyst Day, as relevant to Indian pharmaceutical industry, are summarized below.
Bio-similar partnership with Biocon (Overweight) for MAbs and insulin analogs - Mylan mentioned that it has been working with Biocon for the past five years and that the partnership is progressing well. Right from the beginning, it wanted to approach product development for the global launch (and not any specific continent). It expects to launch in non-US markets earlier than in the US. Presently, generic Herceptin is in Phase III clinical trials, and generic Glargine is likely to enter Phase III in 1H14 (dossier submission in 1H16).
Copaxone update - MYL continues to believe that it targets to launch its generic Copaxone in May 2014. It is tied up with Natco for manufacturing. Natco's facility has been inspected by FDA. It has engaged with opinion leaders and remains optimistic on the potential generic switch.
Agila acquisition - MYL remains confident of closing its Agila acquisition by 4Q13, not withstanding pending FDA queries and pending regulatory approvals. It is working with authorities to overcome these issues.
Morgan Stanley is acting as financial advisor to Mylan Inc. ("Mylan") in relation to the proposed acquisition of Agila Specialties Private Limited from Strides Arcolab Limited, as announced on 27 February 2013. Mylan has agreed to pay fees to Morgan Stanley for its financial services. Please refer to the notes at the end of the report.
Bio-similar partnership with Biocon (Overweight) for MAbs and insulin analogs - Mylan mentioned that it has been working with Biocon for the past five years and that the partnership is progressing well. Right from the beginning, it wanted to approach product development for the global launch (and not any specific continent). It expects to launch in non-US markets earlier than in the US. Presently, generic Herceptin is in Phase III clinical trials, and generic Glargine is likely to enter Phase III in 1H14 (dossier submission in 1H16).
Copaxone update - MYL continues to believe that it targets to launch its generic Copaxone in May 2014. It is tied up with Natco for manufacturing. Natco's facility has been inspected by FDA. It has engaged with opinion leaders and remains optimistic on the potential generic switch.
Agila acquisition - MYL remains confident of closing its Agila acquisition by 4Q13, not withstanding pending FDA queries and pending regulatory approvals. It is working with authorities to overcome these issues.
Morgan Stanley is acting as financial advisor to Mylan Inc. ("Mylan") in relation to the proposed acquisition of Agila Specialties Private Limited from Strides Arcolab Limited, as announced on 27 February 2013. Mylan has agreed to pay fees to Morgan Stanley for its financial services. Please refer to the notes at the end of the report.
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