Otsuka Ties Up With Mylan To Advance MDR-TB Drug In India?
Executive Summary
Otsuka, which has been under fire over delayed access to delamanid in India, appears to have allied with Mylan, which has now secured a key clearance for the novel multidrug-resistant TB therapy in the country.
Mylan appears to have made significant progress towards bringing Otsuka Pharmaceutical Co. Ltd.’s novel treatment for multidrug-resistant tuberculosis (MDR-TB), delamanid, to India after a key local expert panel cleared the product, subject to certain conditions.
Otsuka has, over the recent past, faced flak from pro-health groups in India, over the alleged delay in bringing the patented drug to India – a hotbed of TB accounting for close to a quarter of the world’s cases of the infectious disease.
While specifics around the scope of the Otsuka-Mylan alliance for delamanid are not immediately clear, a Subject Expert Committee (SEC), which advises the Indian drugs regulator on trial-related permissions, has now recommended for approval of delamanid in the conditional access program through India’s Revised National Tuberculosis Control Program (RNTCP).
“Based on the examination of the data on global clinical trials conducted and approval by the EU and Japan for this drug, and risk benefit analysis, the committee recommended for waiver of local clinical trial as this drug is required as an unmet need in emergency for the treatment of MDR/XDR-TB in adults,” the SEC (antimicrobial and antiviral) said at its meeting on June 14.
The committee has recommended that Mylan Laboratories Ltd. submit the “data of monitoring” after three years for further review by the office of the Drugs Controller General of India (DCGI).
The SEC go-ahead for delamanid is significant given that in early June, India stipulated pivotal tweaks to its existing three-tier review process for clinical trial-related clearances. Under the new approach, in general, once global clinical trial (GCT) proposals are accepted or rejected by the SEC, no further approval of the Technical Committee or Apex Committee will be required, though reviews are possible in certain circumstances. The existing three-layered system required recommendations of the SECs to be vetted by the Technical Review Committee and then cleared by the Apex Committee. It is, however, not immediately clear whether Mylan needs additional clearances in India for delamanid.
Both Mylan and Otsuka did not immediately respond to requests for comments on their alliance aimed at bringing delamanid to India or other specifics around aspects such as pricing and supply discussions with the Indian government.
Expanding Access
Last year Otsuka had struck an agreement with the Stop TB Partnership's Global Drug Facility (GDF) to improve international access to Deltyba (delamanid). The deal facilitated access to the product through the GDF (a United Nations-based mechanism) at a single flat price in more than 100 eligible low-and middle-income countries, where it had not been available for procurement.
Otsuka had, at the time, indicated that additional efforts were proposed to expand access to delamanid. It said that the GDF pact "is only the first step in assuring wider, equitable access to delamanid," and that it would work to further scale up use "in a rational way that supports larger efforts to combat antimicrobial resistance." The Japanese company had also added that registrations and access strategies were being pursued in certain high-burden countries such as South Africa, Russia, India and China that do not purchase through the GDF. (Also see "South East Asia Steps Up Fight Against TB" - Pink Sheet, 20 Mar, 2017.)
Pressure Building Up
Otsuka has been under significant pressure from pro-health groups in India, which claim that despite a patent on delamanid in India for several years, MDR TB patients in India have been unable to access the drug in the country. These groups had urged the Indian government to step in and direct the company to register delamanid without delay.
“Otsuka has denied us access to the new anti TB drug delamanid for a really long time. If the pharmaceutical corporation does not make the drug available in the country, the ministry of health should proceed to find generic suppliers for government use. Doing so will save many thousands of lives,” Paul Lhungdim of The Delhi Network of Positive People, said earlier this year.
In April agency reports said that Otsuka had had an initial meeting pertaining to delamanid with the Drugs Controller General of India (DCGI) in late 2016 and a follow-up meeting with the regulator had been scheduled to “discuss next steps”. Initial talks with the Indian government included providing around 400 courses of delamanid at select treatment centers after approval under a conditional access program, these reports said. (Also see "Latest WHO Essential Medicines List: New Drugs And A New Way Of Tackling Antibiotic Resistance" - Pink Sheet, 6 Jun, 2017.)
Similar efforts were implemented for Janssen Pharmaceutical Cos.’s Sirturo (bedaquiline), which along with delamanid, are the first drugs in decades with potential to dramatically improve MDR-TB treatment outcomes. (Also see "J&J’s Stoffels On Actelion’s ‘Exquisite’ Researchers, India TB R&D Plans" - Scrip, 14 Feb, 2017.)Janssen had earlier donated 600 courses of Sirturo to India’s RNTCP for use as part of a conditional access program. About the same number of patients were also expected to get free access to the drug through six public hospitals and institutes of national importance. (Also see "Indian Teen’s Fight For Lifesaving TB Drug Highlights Access Issues" - Pink Sheet, 16 Jan, 2017.)