One Busy Week for AbbVie: Hepatitis C, Fibroids, Alzheimer’s & Parkinson’s, and Generic Criticism
It was only yesterday that Chicago’s AbbVie announced new data for its Mavyret (glecaprevir/pibrentasvir) for hepatitis C. At the same time, the company announced a deal with the Medicines Patent Pool (MPP) to increase access to the drug in 99 low- and middle-income countries (LMICs) and territories. That’s a royalty-free license that lets generic drug makers develop and produce an inexpensive version of Mavyret for distribution in markets like Vietnam, South Africa, Pakistan and Egypt.
Today, AbbVie had even more announcements. First, in cooperation with Neurocrine Biosciences, the companies presented additional data from two replicate pivotal Phase III clinical trials for elagolix in women with uterine fibroids. The results were presented at the 47th American Association of Gynecologic Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology in Las Vegas, NV.
In the sixth month of the six-month treatment period, elagolix at 300 mg twice daily in combination with estradiol 1.0 mg/ norethindrone acetate 0.5 mg add-back hormonal therapy reduced heavy menstrual bleeding linked to uterine fibroids compared to placebo.
“Many women in the United States suffer from uterine fibroids, yet symptoms often go unresolved and can have significant impact on day-to-day activities,” stated William D. Schlaff, chair, Department of Obstetrics & Gynecology, Thomas Jefferson University. “These findings provide objective data demonstrating the potential value of elagolix as a future treatment for women with uterine fibroids.”
The second announcement was that AbbVie and Mission Therapeutics, based in Cambridge, England, inked a collaboration deal to develop specific deubiquitylating enzymes (DUBs) to treat Alzheimer’s and Parkinson’s diseases.
Both diseases involve the accumulation of misfolded, toxic proteins in the brain. These misfolded proteins are believed to be behind the impaired function and nerve cell death in both diseases. DUBs regulate the degradation of these proteins, so their abnormal functioning is implicated in these diseases. There are more than 100 different DUBs in human beings.
“There is an urgent need for new treatments that will make a positive impact on the lives of patients with Alzheimer’s and Parkinson’s disease,” stated James B. Summer, vice president, Neuroscience Discovery Research, AbbVie. “Mission’s scientists have developed impressive early research toward the understanding of these diseases. Together, we will work to advance this early science and develop meaningful therapies.”
And in news related to the story about the deal with Medicines Patent Pool, apparently this particular deal has come under some criticism for limiting the availability of the drug compared to similar licensing deals other companies have signed.
Criticism of MPP isn’t new. The organization was founded in 2010 by UNITAID, a United Nations-based initiative with the goal of using innovative financing to increase access to HIV, tuberculosis and malaria drugs in developing countries.
Back in 2015, Merck & Co. shared intellectual property (IP) rights with MPP for HIV drugs, but critics argued it was “a false solution to a real problem.”
Merck and MPP inked a licensing deal for pediatric formulations of raltegravir. It allowed drug companies to make generic versions of the drug and not pay royalties to Merck—this is a very similar deal to the one AbbVie signed with MPP for Mavyret.
In 2015, Othoman Mellouk, an IP expert with the In, argued that the agreement looked more like a publicity stunt that won’t deliver improved access to drugs where they’re most needed.
Another critic, Tahir Amin, director of U.S.-based I-MAK, indicated the problem, at least with retroviral drugs for children, isn’t patents, but lack of return on investment. “By controlling the competition to restricted licensed countries, the originator companies achieve their objectives. The patent pool is merely cementing the pharmaceutical company’s strategy of market segmentation which will in the long term be a detriment to the growth of generics, especially in India, supply chains and more importantly access,” he told SciDev.Netin 2015.
Gilead Sciences had also come under criticism for its 2011 agreement with MPP for its HIV drugs.
Lauren Ulrich, currently an associate with law firm Troutman Sanders in Atlanta, wrote a lengthy analysis of MPP and similar patent pools in the Emory International Law Review. In it, Ulrich noted, “The MPP’s licensing strategy is flexible to attract the maximum number of patent holders to the pool, meaning that licensing terms are variable and subject to negotiation.”
However, Ulrich went on, MPP has at least four principles that guide all MPP licenses. First, the licenses’ terms and conditions should be made available to the public and they must be non-exclusive. Second, they must be limited to low- and middle-income countries, excluding developed countries. Third, “generic manufacturers must put in place mechanisms to provide quality assurance for the generic products to accommodate the concerns of patent holders whose medicines they will be producing.” And fourth, the royalties the patent holders receive under the licensing deals should be adjusted based on the recipient country’s disease burn and ability to pay.