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San Diego Sleeper, Sorrento Therapeutics Inc., Fast-tracked For FDA Approval


A California-based pharmaceutical company, Sorrento Therapeutics Inc. (NASDAQ: SRNE) boasts two promising, near-term drug therapies – one that treats cancer and another that treats the severe pain associated with cancer. Both are close to potential FDA approval and marketing.

Sorrento’s cancer therapy drug, Cynviloq, is similar to Celgene’s near billion dollar drug Abraxane®. Last year, the FDA agreed that if Sorrento could establish bioequivalence to Abraxane, it could obtain approval for the treatment of metastatic breast and lung cancer without conducting costly and lengthy large scale clinical trials. As a result, Cynviloq could be on the market as soon as 2016, making it, says Sorrento’s President and CEO, Dr. Henry Ji, “a potential major competitor to the blockbuster drug, Abraxane.”

Chief Commercial Officer, George Uy, knows the market well. He was on the team that developed Abraxane and helped make it successful. In an exclusive interview with BTV, He pointed out that analysts “forecast that Abraxane, by the year 2017, would be reaching about $2 billion in terms of sales for the three indications: breast, lung and pancreatic cancer.”

Sorrento’s other near-term therapy is aimed at relieving pain in those suffering from terminal cancer. Dr. Mike Royal, Executive VP Clinical and Regulatory Affairs and pain specialist, explains that, once approved, one shot of Sorrento’s Resiniferatoxin is enough to kill pain nerves. He says “you can do this with relative impunity because these nerves do not take care of normal sensation like touch or sharp pain sensation or muscle control.” He adds that it is an improvement on current practices because “you take someone with chronic cancer pain who’s near end of life and they’re suffering and they’re taking so much in the way of opiates, which come with a lot of baggage and side effects like cognitive dysfunction, sedation, urinary retention and constipation, just to name a few.”

Clinical trials have so far been small but promising. “Two of the patients went from being bed-ridden or wheelchair-bound to walking,” says Dr Royal, “which is pretty amazing.”

And it would have its own place in the market. “It’s actually transformative,” says Executive VP and Chief Business Officer Amar Singh. “There’s really not a drug out there that compares even closer to this drug because a simple injection of this drug has a potential to provide complete relief to the patient in pain.”

Animal tests for Resiniferatoxin have proved so promising that it has created new market opportunities for Sorrento. George Uy says, “One of the immediate plans of the company is to spin off an animal health company in itself.” Dr. Royal adds, “This looks like it will not only do great things for humans but great thing for dogs as well.”


Sorrento’s management team has deep roots in big and small pharma, both developing and marketing new therapies. George Uy calls President & CEO, Dr. Henry Ji, a “visionary,” and Executive VP and Chief Business Officer, Amar Singh, calls him a “creative genius”. Dr. Ji is the inventor of the highly diverse, fully human antibody library called the G-MAB® library from which Sorrento is building a deep pipeline of therapeutic antibodies and antibody drug conjugates (ADCs) to address unmet needs in treating cancer and other diseases.


Sorrento Therapeutics has a strong balance sheet. “We have approximately $50 million in the bank and we have the two drugs,” says Dr. Henry Ji. “So we have enough cash to get the two drugs into the new drug application (NDA) stage.”


In addition to the animal health company, Sorrento has a pipeline of many products, including therapeutic antibody candidates in the immune-modulating space, an emerging market that Citi Bank analysts predict will be worth about $354 billion dollars.


Analyst Raghuram (Ram) Selvaraju is with Aegis Capital Corp, the company that up-listed Sorrento to the NASDAQ. Selvaraju says, “The financing that we did for them in conjunction with the up-listing was participated in by very blue chip high profile health care focused investors.” He points out that the market for Sorrento’s cancer drug, Cynviloq, is already very strong. “Abraxane is slated to do somewhere around $900 million in sales this year…. The idea with Cynviloq is to launch it as a bio equivalent to Abraxane, which means that it could be prescribed by any doctor who would typically write a prescription for Abraxane or substitute it if a prescription for Abraxane has been written.” He points out that one of Sorrento’s potential strategy “is to price it at a discount to Abraxane and allow market dynamics to do the rest. So they don’t need to field the massive sales force in support of Cynviloq.”

Moreover, Selvaraju says, “There’s the possibility, of course, that Celgene would regard this as such a threat they could potentially either buy Sorrento or license Cynviloq just in order to keep it off the markets so that they could continue making money with Abraxane. Celgene actually bought Abraxis BioScience, a company that originally developed Abraxane back in 2010, for $2.9 billion. So there’s a lot at stake here for Celgene.”

“So with those two aspects to its platform we think Sorrento is an intriguing potential opportunity in the oncology space.”


Follow Sorrento Therapeutics Inc. on the NASDAQ at the symbol SRNE and find them on-line at


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