By Emmie Jaskiewicz
September 23rd, 2012 8:30am
Reuters news is reporting that German pharmaceutical giant Bayer has requested that European regulators approve their newly developed non-oral hormonal contraceptive skin patch. Industry insiders believe that this move is designed to broaden Bayer’s market share of the birth control industry and seize a portion of the patch-based hormone delivery product sales that has been dominated by rival Johnson and Johnson.
Both Bayer and J&J have seen enormous amounts of litigation regarding the safety of their newer “4th generation” contraceptive products. Both companies have expended millions of dollars settling thousands of suits accusing them of misleading both doctors and patients as to the risks and benefits of their contraceptive products.
Attorney Christopher Paulos, of the Levin Papantonio law firm, who has represented hundreds of women injured by Bayer’s first foray into the newer-generation oral contraceptive market, Yasmin and Yaz, stated on Friday that he believes, “Bayer’s efforts to expand their market share are designed to transition themselves into a position where they can once again enjoy proprietary control of a branded drug while their other revenue streams from their older contraceptive products continue to rapidly slow due to crowding of the market and the fact that their products have been routinely linked to an increased risk of fatal and/or debilitating blood clots.”
According to Reuters, the hormonal patch-based contraceptive, to be produced for Bayer by Swiss company Acino, was, according to Bayer’s own statements and filings with the European Medicines Agency, shown to be effective with a good safety profile in clinical trials involving 4,200 women.
However, detailed results will not be available until presented at the FIGO World Congress of Gynecology and Obstetrics in Rome in October. A spokeswoman said Bayer was in talks with the Food and Drug Administration over a possible filing also in the U.S.
Mr. Paulos, in reference to the likelihood of Bayer’s patch being approved in the United States, stated that, “hormonal contraceptives are a large blip on the FDA’s radar screen, and one can only hope that the FDA has learned from Bayer’s past questionable conduct in reporting and sharing information with regulators, and requires that Bayer accurately and truthfully report all safety data and appropriately label their products to sufficiently warn consumers and prescribers.”
The transparent patch, which Bayer says could generate annual sales of 250-500 million euros ($325-$650 million), is applied once a week either to the abdomen, buttocks or outer upper arm, where it delivers a steady dose of hormones through the skin.
If successful, Bayer’s product would offer an alternative to J&J’s Ortho Evra birth control patch, which is approved in North America and Europe. U.S. drug advisers have, however, recommended that the label of Ortho Evra patch be simplified to better explain the risk of blood clots.
“It’s interesting that Bayer would chose to enter into the alternative delivery market considering that patches and rings have come under fire for their inability to deliver hormones in a consistent fashion,” claims Paulos. “Recent studies have shown that products like Merck’s NuvaRing and the Ortho Era patch are susceptible to damage or instability issues, and have also been shown to deliver uneven quantities of hormones throughout their life-cycle, all of which can lead to safety and tolerability issues. The most recent science suggests that these patch and ring products are even more dangerous than the majority of their oral delivery competitors.”
Bayer is one of the largest competitors in the $8 billion global market for hormonal birth-control pills, vying for dominance against companies like J&J, Teva’s Barr Pharmaceuticals and Ireland-based Warner Chilcott.
While Bayer is busy introducing this latest non-oral contraceptive product, it has also been quietly settling cases related to its main oral contraceptive brand Yasmin. To date, Bayer has agreed to pay a combined $400 million to settle almost one third of nearly 6,000 legal claims in the U.S. that Yasmin and Yaz caused blood clots.
More information on contraceptive litigation.
Reported on by E.J. Jaskiewicz, based upon original reporting by Ludwig Berger of Reuters.