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
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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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