Oral Biologics Delivery Could Be The Key For Biosimilars To Gain Market Share From Blockbuster Drugs

Doctors believe moving Rheumatoid Arthritis and Crohn's Disease patients from AbbVie's injectable Humira^® (adalimumab) to an oral adalimumab would improve patient compliance

Santa Clara, CA and San Jose, CA /PRNewswire/ - Frost & Sullivan, the global research and consulting organization, and Rani Therapeutics, the pioneer in oral biologics, today announced the results of a research study that points the way for biosimilar companies to take market share from blockbuster drugs, and for pharmaceutical companies with blockbusters to protect their position. Large molecule drugs such as anti-TNF alpha antibodies (Humira^® and Enbrel^®), are currently only available to patients via an injection.

The Frost & Sullivan research included a survey of more than 500 patients, and more than 100 physicians including rheumatologists and gastroenterologists. It is no surprise that 88 percent of patients and 86 percent of rheumatologists and gastroenterologists cited that they would likely switch from Humira injections to once-daily adalimumab pills, if an effective oral alternative existed.

According to the research, more than 62 percent of patients and 86 percent of physicians reported that patients either skip their injection or consistently fail to inject the drug as prescribed. The report also shows that 70 percent of rheumatologists and 92 percent of gastroenterologists believe that transitioning from injections to a pill would significantly increase patient compliance rates.

"What is clear from our research is that patients and physicians are overwhelmingly in favor of replacing a syringe with a pill. There are millions of patients suffering from chronic diseases, and our research shows that convenience and reducing pain are hugely important to quality of life," said Charlie Whelan, Director of Consulting for Frost & Sullivan's Healthcare & Life Sciences practice.

"Humira is the #1 selling drug in the world, yet this research shows that its sales and AbbVie's revenues could potentially be threatened by oral adalimumab because of a fear of needles and the associated lack of patient compliance. Combine those challenges with patent expiration and the increasing threat of biosimilars, which are forecast to hit the market in the coming years, and it's the perfect storm," said Mir Imran, Chairman & CEO of Rani Therapeutics.

Imran continued, "There has never been a better time for innovation in drug delivery. Oral delivery of biologics is the next transformational event for pharmaceutical companies, and those that find alternatives to needles and differentiate based on drug delivery will be the big winners."

Founded by Imran in 2012 and spun out of InCube Labs, Rani has an oral delivery platform for many of the injectable drugs used by patients with arthritis, diabetes, osteoporosis, multiple sclerosis, and other diseases and conditions. Imran is a prolific medical inventor, entrepreneur and investor who has spent close to 40 years developing and commercializing medical innovations. Fifteen of Imran's innovations have been acquired and many of his innovations have resulted in new standards of care, most notably, the first FDA-approved automatic implantable cardioverter defibrillator.

The survey was commissioned by Rani Therapeutics, which has developed a pain-free, robotic pill capable of delivering therapeutic antibodies such as adalimumab orally. The company is backed by global pharmaceutical companies, including Novartis, AstraZeneca, Shire Pharmaceuticals, and GeneScience Pharmaceuticals.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today's market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community.

About Rani Therapeutics
Rani Therapeutics has developed a novel approach for the oral delivery of large drug molecules including peptides, proteins and 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. Mir has founded more than 20 life sciences companies and holds more than 400 issued and pending patents in the U.S. For more information, visit www.ranitherapeutics.com and www.incubelabs.com.