News Release Detail
Otsuka and Mylan Announce License Agreement to Commercialize Delamanid (Deltyba™) for Multidrug-Resistant Tuberculosis (MDR-TB) in High-Burden Countries
Under the terms of the agreement, Mylan has been granted an exclusive license by Otsuka to prioritize access to Deltyba™ in
Mylan is anticipated to further exercise exclusive commercial rights and registration responsibilities in additional countries, including many other high MDR-TB burden countries where Otsuka does not have a commercial presence. The agreement announced today also allows both companies to enter into discussions and feasibility studies for a technology transfer plan, enabling Mylan to manufacture and distribute Deltyba™ for these markets in the future.
"Otsuka is a global leader in TB research and development and Mylan is a recognized leader in the provision of high-quality medicines for infectious diseases in many developing countries," said
Deltyba™ is one of two anti-tuberculosis medicines recently approved, after more than 40 years of treatment with the same agents. It is registered in the
The efficacy of Deltyba™ was studied in a large, randomised, placebo-controlled phase 2 trial that included a 2-month treatment period and a 1-month follow-up of 481 MDR-TB patients (Trial 204), with 213 patients continuing to a 6-month open-label treatment trial (Trial 208), and concluding with a 24-month follow-up study of 421 out of the originally randomized 481 patients (Trial 116). Adding 100 mg Deltyba™ twice daily to a WHO-recommended OBR was associated with a statistically significant 53% increase (p=0.008) in the percentage of patients achieving SCC at 2 months (64/141, 45.4%) compared to those with placebo added (37/125, 29.6%).2 The reported mortality rate was lower in patients receiving Deltyba™ for at least 6 months (2/192 (1.0%) compared with those receiving Deltyba™ for 2 months or no Deltyba™ (19/229 (8.3%); p < 0.001).
Clinical trial results demonstrated that Deltyba™ is well tolerated with adverse events evenly distributed in the Deltyba™ and placebo treatment groups with the exception of QT prolongation. Electrocardiogram QT prolongation was reported in 9.9% (16/161) of patients receiving Deltyba™ as 100 mg twice daily compared to 3.8% (6/160) of patients receiving placebo plus OBR. This was not accompanied by any clinical symptoms such as syncope or arrhythmias.2
Publication of results of the phase 3 study to confirm the safety and efficacy of Deltyba™ is expected in 2018, and a paediatric investigational programme is underway.
About TB & MDR-TB
Tuberculosis (TB), an airborne infectious disease, is among the top causes of death in the world and is the leading infectious disease killer. Drug resistance poses a real challenge to fighting and treating TB. Globally in 2015, nearly half a million people developed MDR-TB, an infection resistant to at least isoniazid and rifampicin, the two most commonly used first-line TB drugs.1 Mycobacterial MDR strains with additional resistance to at least one fluoroquinolone drug and a second-line injectable agent are defined as extensively drug-resistant (XDR). Secondary or acquired resistance has its roots in inappropriate treatment.
Resistance to anti-tuberculosis drugs worsens the prognosis for a successful treatment outcome. The treatment of MDR-TB combines at least five drugs - active or presumed active against the resistant strain - for an extended period of up to 20 months or more depending on patient response. The anti-TB drug combinations are chosen depending on the patterns of resistance from drug susceptibility testing and tolerance.
TB is the leading killer of HIV-positive people: about 35% of HIV deaths were due to TB in 2015. That year, there were an estimated 1.2 million new cases of TB amongst people who were HIV-positive, 71% of whom were living in
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.
This press release includes statements that constitute "forward-looking statements," including with regard to Mylan further exercising exclusive commercial rights and registration responsibilities in additional countries, Mylan manufacturing and distributing Deltyba™ for other markets in the future and that a pre-approval access program in
2Gler MT, et al. Delamanid for multidrug-resistant pulmonary tuberculosis.
3Skripconoka V, et al. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis.
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