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MSF calls on J&J, Otsuka, TB Alliance to remove barriers blocking generic production of bedaquiline & delamanid

Laxmi Yadav, Mumbai
Thursday, November 10, 2022, 08:00 Hrs  [IST]

With newer tuberculosis (TB) drugs- bedaquiline and delamanid going off patent in 2023, Médecins Sans Frontières (MSF) has called on Johnson & Johnson, Otsuka, and TB Alliance to remove additional barriers blocking generic manufacturers from entering the market.
The two newer TB medicines going off patent next year present a critical opportunity to increase access to shorter, safer and better treatment for people with drug-resistant forms of the disease (DR-TB). Once additional barriers are removed, more manufacturers can enter the market and bring prices down, stated global medical non-governmental organisation in a report.
The report – DR-TB Drugs Under the Microscope, 8th edition – surveyed the pricing and patent landscape of DR-TB medicines for adults and children and found that extremely high prices are still being charged for newer TB drugs; a key factor hampering treatment scale-up. With DR-TB cases increasing for the first time in years, MSF called on pharmaceutical corporations and other drug developers to immediately dismantle the barriers blocking generic manufacturers from entering the market, so that production of these drugs can be scaled up, leading to increased access to affordable, safer, and more effective medicines for people who need them.
Currently, bedaquiline and delamanid are still patented medicines for which the originator pharmaceutical corporations, Johnson & Johnson (J&J) and Otsuka respectively, have a global monopoly blocking price-lowering competition among generic manufacturers.
According to research that estimates the cost of production plus a profit, delamanid is a shocking 13-18 times more expensive than it could be; ranging from USD 1,250 to USD 1,700 for a 6-month treatment course, when it could be priced at USD 96. Bedaquiline is almost three times more expensive than it could be, at USD 270 for a 6-month treatment course, when it could be USD 102.
With the patents on bedaquiline and delamanid expiring in 2023, generic manufacturers could enter the market and lower prices. However, barriers may prevent this, including secondary patents that extend the term of the monopoly for J&J and Otsuka in several countries; and opaque and restrictive licenses that undermine competition, such as the restrictive voluntary license between J&J and the not-for-profit organisation TB Alliance. In addition, generic manufacturers require samples of the originator product (i.e. delamanid or bedaquiline) in order to conduct the studies necessary to bring quality-assured generic medicines to market. However, pharmaceutical corporations generally do not make their products available for such studies. The World Health Organization (WHO) should address this additional barrier to entry by establishing a process for obtaining the necessary samples, stated the medical NGO.
"In our Mumbai clinic, we are receiving increasing numbers of patients with TB with complex resistance who are in need of bedaquiline and delamanid to form an effective treatment regimen,” said Dr Mabel Morales, medical coordinator for MSF in India.
“There is an urgent need for delamanid to be more widely available for patients for whom an effective regimen cannot otherwise be formulated. The high price of delamanid is not only limiting our capacity to treat more patients but is also limiting the efforts of national TB programmes to scale up the treatment,” stated Dr Morales.
In addition to bedaquiline and delamanid, pretomanid remains an important component of DR-TB treatment regimens, including in the new BPaLM regimen evaluated in MSF’s TB PRACTECAL clinical trial and recommended by WHO in May 2022. However, the current lowest global price for this regimen is out of reach at around USD 700 for a six-month course, with pretomanid alone accounting for nearly half the cost at USD 336. Given the significant public funding that the TB Alliance received for the development of pretomanid, this is unacceptable, especially considering that research estimates it could be produced and sold at profit for USD 210, much less than its current price. MSF has contended that in total, the price of a complete DR-TB treatment course should be no more than USD 500 per person.
“Bedaquiline, delamanid, and pretomanid are game-changing TB drugs that could help save many more lives, so everyone with DR-TB should be able to access them,” said Christophe Perrin, TB advocacy pharmacist with MSF’s Access Campaign. “Drug corporations should not put their profits over people’s lives. It’s time for all three newer TB drugs to be affordable,” stated Perrin.
Additionally, the limited number of children being diagnosed and treated for DR-TB means that manufacturers may not consider the paediatric TB market viable, even though children affected by DR-TB can now be treated with complete regimens made up of medicines in child-friendly formulations. Governments need to urgently step up efforts to diagnose and treat more children with DR-TB, and pool their needs and procurement across countries to help secure sustainable supply. There needs to be more competition among generic and originator companies to bring prices of newer medicines, bedaquiline and delamanid, down after patents expire, stated MSF.


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