May 29, 2019, SAN DIEGO, CALIF.— Gilead Sciences, manufacturer of high-priced tenofovir HIV drugs Atripla, Complera, Stribild, Truvada, and Viread, signed a $2-billion-plus deal with biotech company Goldfinch Bio to develop and market drugs that treat certain kidney diseases, thus announcing its plan to pursue a human genetics approach to drug discovery and development according to a press release issued by Gilead. This comes after multiple scientific studies and hundreds of lawsuits claiming that Gilead’s HIV medications are actually the cause of kidney disease in patients on these drugs.
As part of the deal, Gilead agreed to pay $55 million upfront to Goldfinch in order to obtain the exclusive rights to license specific products coming out of Golfinch’s “Kidney Genome Atlas” (KGA)—a comprehensive registry of patients with kidney disease. The KGA integrates genomic, transcriptomic, and proteomic data with patient clinical profiles in order to discover genetic variants associated with kidney disease.
Goldfinch presented its KGA on April 15, 2019 at the International Society of Nephrology World Congress 2019 in Melbourne, Australia, according to an article by BioSpace. Less than a month later, the companies announced their new partnership, worth more than $2 billion.
Goldfinch, and now Gilead, hopes the discoveries from their KGA will advance their understanding of the molecular causes of kidney disease and “drive their development pipeline,” as Goldfinch president and chief executive officer Anthony Johnson reportedly told the audience in Melbourne.
The KGA currently consists of data from patients with rare kidney disease but the companies are working to expand the scope of the database to include diabetic kidney disease, or DKD. When the two companies announced their partnership, they spoke about their grand vision of pursuing a “human genetics approach to drug discovery and development” by sequencing DNA from a large cohort of diabetic patients with and without kidney disease.
As Gilead works with Goldfinch to develop another line of hugely profitable drugs to treat kidney disease, studies linking Gilead’s HIV medications Atripla, Complera, Stribild, Truvada, and Viread to kidney disease are being published and more patients are coming forward with complications after taking these medications.
Lawsuits are being filed against Gilead Sciences for negligent design and withholding safer alternative medications. The legal claims allege that the drug maker already had produced new medications that were analogous to their tenofovir (TDF) containing drugs, but with an upgraded delivery system that would not damage patients’ kidneys. Gilead withheld these newer safer drugs while marketing and selling the riskier HIV medications that allegedly were causing kidney deficiency, kidney disease and renal failure.
Some studies have found an association between the active ingredient, tenofovir disoproxil fumarate (TDF), in drugs like Atripla and Truvada and decreased kidney function in certain patients. Other studies have found a link between TDF-containing drugs and bone density disorders (osteoporosis, osteomalacia, etc.) in patients taking the drugs. Mineral and bone disorders are also somewhat common in people who have kidney disease.
The Truvada label carries warnings for both kidney problems, including kidney failure, and bone problems, including bone pain, softening, or thinning which can lead to fractures. Patients who have taken Truvada or other TDF drugs and experienced these types of complications are now filing lawsuits against Gilead, accusing the company of manufacturing a defective product and failing to adequately warn about its risks.
As Gilead prepares to defend itself in court against these lawsuits, it is planning to make millions if not billions of dollars on novel drugs that treat kidney disease—the very disease its other multi-million-dollar products are accused of causing.
If you took Truvada, Truvada for PReP, or another TDF-containing drug and experienced kidney disease or bone density issues, you can help hold Gilead accountable by filing a lawsuit. Call the team of experienced attorneys and case managers at Schmidt National Law Group today at 800-631-5656.