Shire and Rani Therapeutics Enter into Collaboration to Evaluate Use of the Rani Pill™ Technology for the Oral Delivery of Factor Therapy

Cambridge, Mass. – December 5, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the biotech leader in rare diseases, and Rani Therapeutics, an InCube Labs company, today announced a collaboration to exclusively conduct research on the use of the Rani Pill™ technology for the oral delivery of factor VIII (FVIII) therapy for patients with hemophilia A. The collaboration agreement grants Shire an exclusive option to negotiate a license to develop and commercialize the technology for delivery of FVIII therapy following completion of feasibility studies. As part of the collaboration, Shire has also made an equity investment into Rani Therapeutics.

Rani Therapeutics has developed a novel approach for the oral delivery of large molecules, including peptides, proteins, and antibodies, using the Rani Pill, a capsule that delivers an intestinal injection without exposing medication to digestive enzymes. Once the capsule is consumed, it stays protected until it enters the small intestine and delivers medication into the intestinal wall. Since the intestines do not have sharp pain receptors, the intestinal delivery is expected to be pain free.

“Shire is proud to partner with Rani Therapeutics to pioneer the investigation of oral delivery of factor therapy for the hemophilia community,” said Fritz Scheiflinger, Head of Global Research, Shire. “With Shire’s in-depth scientific expertise and leadership position in hemophilia and Rani Therapeutics’ deep experience in engineering and material science, we are excited by the potential of this partnership to reduce the chronic burden of hemophilia on patients’ everyday lives by researching an oral option to deliver FVIII to patients. We strive to provide hemophilia patients with innovative therapies that are effective and do not expose patients to additional risks.”

Hemophilia is a challenging chronic disease that causes longer-than-normal bleeding due to absent or deficient clotting factor in the blood. Those with hemophilia A are missing or deficient in FVIII, while those with hemophilia B are missing or deficient in factor IX. The aim of factor replacement therapy is for bleeding to subside when enough clotting factor has reached the source of the bleed. Currently, no oral therapies exist for the treatment of hemophilia. 

“We are very pleased to collaborate with Shire on the development of oral FVIII delivery,” said Mir Imran, Chairman and CEO, Rani Therapeutics. “With this technology, though early in development in hemophilia, we hope to improve compliance, quality of life and outcomes for patients with hemophilia by offering a painless and more convenient oral delivery.”     

Founded in 2012 and spun out of InCube Labs, Rani Therapeutics has developed a technology platform to convert injectable drugs, such as TNF-alpha Inhibitors, interleukin antibodies and basal insulin, among others, into pills.  With its platform, the company has demonstrated absorption similar to subcutaneous injections in pre-clinical studies, and it has established partnerships with pharmaceutical companies, including Novartis, AstraZeneca and now Shire, to test its platform with selected drugs.

“Rani has the potential to disrupt the industry with its innovative approach to delivering biologics orally,” said David Pyott, Member of the Board of Directors, Rani Therapeutics and former Chairman and Chief Executive Officer, Allergan Inc. “The hemophilia market is an excellent application of Rani’s technology, and we are delighted that Rani is partnering with Shire, a market leader in the space.”

The specific terms of this deal were not disclosed.

For further information from Shire please contact:

For further information from Rani Therapeutics please contact:

NOTES TO EDITORS

About Shire

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.

We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people’s lives with medicines that have a meaningful impact on patients and all who support them on their journey.

www.shire.com

About Rani Therapeutics

Rani Therapeutics has developed a novel approach for the oral delivery of peptides, proteins and therapeutic antibodies which to date can only be delivered through injections. The approach and technology for Rani Therapeutics was developed at InCube Labs, a multi-disciplinary life sciences R&D lab focused on developing breakthrough medical innovations. InCube is led by Mir Imran, a prolific medical inventor, entrepreneur and investor, who has founded more than 20 life sciences companies and holds more than 500 issued and pending patents. Many of Imran’s innovations have resulted in new standards of care, including the first FDA-approved Automatic Implantable Cardioverter Defibrillator. For more information, please visit: www.ranitherapeutics.com and www.incubelabs.com.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.