Panacea Biotec shares touched a new 52-week high on Tuesday after Sanofi Healthcare India agreed to not commercially produce its fully liquid hexavalent vaccine Shan6 in India, directly or indirectly, and withdrew its opposition to the former’s patent on hexavalent vaccine as part of a settlement, Panacea said in a filing on Monday evening announcing details of the agreement.
Panacea had petitioned the Delhi High Court in May 2021, seeking to restrain Sanofi from marketing its fully liquid hexavalent vaccine. It had contended marketing of Sanofi vaccine would infringe the patent for its wP-IPV based fully liquid hexavalent vaccine EasySix.
The suit was filed after Sanofi received marketing approval for Shan6, a whole cell Pertussis based hexavalent vaccine (DTwP-HepB-Hib-IPV) from the Drugs Controller General of India. When the suit was listed before the Delhi High Court, after elaborate submissions from both parties, Sanofi submitted an undertaking that it would not manufacture or market any product which infringes the amended claims of Panacea patent, IN272351.
“We are pleased to inform you that the parties have reached a settlement, and pursuant to the joint application filed by the parties, the said suit has been disposed of by the Hon’ble Delhi High Court on September 13, 2024, in terms of the settlement agreement...”, Panacea said. The company’s shares closed 4.99% higher on the BSE at ₹349.55 apiece.
Sanofi has agreed to withdraw oppositions filed by it against Panacea Biotec’s patent on hexavalent vaccine, the post grant opposition and the opposition to the amendment thereof and file necessary applications before the Indian Patent Office. Panacea will forego its claim for damages and rendition of accounts in the proceedings as regards Sanofi as prayed for in the suit.
EasySix is the first innovative fully-liquid hexavalent vaccine from the country and protected by patents in several countries, including in India, Panacea said.
The company said it had developed the world’s first whole-cell pertussis (wP) and inactivated polio vaccine (IPV) based fully liquid hexavalent vaccine -- EasySix -- to vaccinate against Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Haemophilus influenza type b and Inactivated Polio.
The company introduced the vaccine in India in March 2017 and expected it to be made part of government vaccination/immunization programmes, since the wP-IPV-based hexavalent vaccination is an immunisation alternative to the current pentavalent and standalone IPV vaccines.
In October 2021, World Health Organization and Strategic Advisory Group of Experts on Immunization approved adoption of the hexavalent vaccine in the global immunisation programme. Gavi and the Pan American Health Organization adopted the hexavalent vaccine in June 2023 and May 2023 respectively. UNICEF estimated the demand for wP-IPV-based hexavalent vaccine for Gavi countries to be 19 million doses in 2025 and more than 100 million doses by 2030, the company said.
Panacea Biotec is expanding manufacturing capacity for the drug substance antigens used in EasySix to meet demand from U.N. agencies and public health organisations. The U.S. International Development Finance Corporation (DFC) had recently agreed to provide a long-term loan of upto $20 million for the project, the company said.
Published - September 17, 2024 11:07 pm IST
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