Patrick Girondi, the founder of San Rocco Therapeutics (SRT), met with Health and Human Services Secretary Robert F. Kennedy Jr. and FDA officials last month to discuss an affordable, advanced gene therapy treatment for sickle cell disease (SCD) and thalassemia, after decades of legal battles with Big Pharma.
Girondi has asked Sec. Kennedy and U.S. Attorney General Pam Bondi to investigate a conspiracy by some of the most prominent names in the pharmaceutical industry, which continue to block his affordable gene therapy treatments. He said the delay has cost money and countless lives due to the delay of a cheap and effective cure for SCD.
SRT legal counsel had met with the New York attorney general's office several times since 2019, but instead, Letitia James focused her office's resources on prosecuting then-former President Donald Trump.
A former financial trader and musician from the South Side of Chicago, Girondi is author of the 2022 Wall Street Journal bestseller, “Flight of the Rondone: High School Dropout VS Big Pharma—The Fight to Save My Son's Life."
His project for a cure for thalassemia and SCD began 32 years ago, when his infant son, Rocco, who is now 34, was diagnosed with the blood disorder. This led Girondi to search for a cure to save his son's life.
The crisis led him to move to Italy and establish Errant Gene Therapeutics, later known as San Rocco Therapeutics.
However, Girondi said powerful players in the pharmaceutical and medical industries saw his patents as a potential threat and undercut his efforts to promote their lucrative investments in gene therapy treatments for SCD.
Girondi believes that lust for profit was far more important to them than delivering affordable treatments for millions of patients with SCD around the world.
“A key player,” Girondi claims, “is Nick Leschly. Nick managed to set gene therapy back a decade, decimated the hope of patients, demolished Bluebird Bio and its sham spin-off, 2Seventy Bio, destroyed $4 billion in investor funds, and at the same time pocketed over $130M, mostly through insider trading.
Leschly, who is the son of the former CEO of SmithKline Beecham (later GSK), Jan Leschly, is one of the most highly paid pharmaceutical executives in the world.
Nick made $24 million in 2018 alone, mostly by selling shares in Bluebird.
In court documents, Girondi accused his rivals of conducting multiple acts of sabotage, fraud, and intellectual property theft of his firm's medicines and patents over the years, with the assistance of some of his former partners, including a top New York-based medical research center.
"Big Pharma and the mafia engage in violent crime for profit, relying on a strict, criminal structure to insulate the bosses from punishment. To protect their racket, in twenty years, the pharmaceutical industry paid over four billion dollars in bribes to our government officials," Girondi alleges.
"The FBI estimated that the mafia was responsible for 200 deaths a year and that John Gotti made up to $10 million annually. Yet, the drug industry kills more than 100,000 Americans, and the drug bosses' combined incomes are over $1 billion each and every year," he added.
Court documents claim that one of SRT's original partners, New York's Memorial Sloan Kettering Cancer Center, was caught entering into a secret agreement with Bluebird Bio, one of Girondi's rivals.
Leschly and the medical center's CEO at the time, Craig B. Thompson, were accused by Girondi of illegally secretly selling one of his gene therapy patents to Bluebird Bio in return for Agios Pharma receiving funding from Third Rock Ventures (TRV).
Thompson is the founder of Agios Pharma and was sued for IP theft by the University of Pennsylvania, where he was employed for 11 years. Third Rock Ventures launched and was a substantial stakeholder in both Bluebird Bio and Agios.
The clandestine Bluebird/MSK agreement allegedly effectively rigged the market in Bluebird's favor at the expense of SRT and hurt its chances to compete with Bluebird's Lyfgenia, a potentially riskier product.
Lyfgenia was approved at $3,100,000 per patient, far more than Bluebird’s original price target and well above SRT's $800,000 treatment.
Girondi told the Kennedy Beacon that Lyfgenia is a bad imitation of SRT’s first-generation product, which he said was stolen by Bluebird. SRT’s latest patented product, Minirolu, is 30 percent more efficient than Lyfgenia, according to Girondi.
"We were in patients before Bluebird. Bluebird-treated patients have had instances of leukemia and myelodysplastic syndrome. We have treated patients who have had no adverse side effects," said Girondi.
Girondi filed a civil RICO suit in April 2023 against Third Rock Ventures and Bluebird Bio for conspiring to commit intellectual property theft.
The case was dismissed on a technicality, according to Girondi, who stated on “Soft White Underbelly” last week that he plans to refile the RICO charges.
The hour-and-forty-minute “Soft White Underbelly” podcast, taped less than a week ago, had over 60,000 views, thousands of thumbs-ups, and over 400 comments.
Since the SRT’s lawsuit in 2017, Bluebird has fallen from a value of $11.8 billion to about $30 million and is reportedly actively looking for a buyer to save it from bankruptcy.
According to the Kennedy Beacon, Carlyle and SK Capital Partners placed a Feb. 21 bid to purchase Bluebird for $29 million, including the assumption of roughly $450 million in debt.
“TSVT [2seventy bio], another piece of the puzzle,” according to Girondi, “traded at $40 in 2021 and was just bought under by BMS [Bristol Myer Squibb] for $5 a share.”
"Billions in insider trading has been committed by the Leschly group and Bluebird/TSVT management is in a hurry to get these transactions completed at any price and safeguard their billions in insider trading," he explained. Behind all of this is a brewing scandal involving the sabotage of San Rocco Therapeutics' gene therapy product for SCD and Thalassemia."
"In 2013, JP Morgan projected an eventual Bluebird product price of $750,000. Because of the sabotage, Bluebird was able to jack up the price to $3,100,000 per patient," Girondi alleges.
“There are 100,000 SCD patients in the U.S," Girondi noted. "One hundred thousand patients times the price difference is $235 billion in fraud. By far, the largest scandal of any sort in the world’s history."
Girondi told TrialSite News in an interview that he hopes to have his gene therapy vector in the open clinical trial, which is going through a protocol update by the end of the year, with Europe following within twelve months.
"San Rocco’s gene therapy platform, entering U.S. and European clinical trials by year-end, promises to upend the current market landscape," he added.
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