NEW YORK
and HERTFORDSHIRE, England
and PITTSBURGH, April 18, 2019 /PRNewswire/ -- Non-profit
drug developer, TB Alliance, and pharmaceutical company, Mylan
N.V. (NASDAQ: MYL), today announced a global collaboration to make
the experimental drug pretomanid accessible for use in two
investigational drug regimens for pulmonary tuberculosis (TB).
TB, a bacterial infection transmitted through the air, is a
challenging disease to treat, often requiring treatment through a
combination of antibiotics. It also is the leading cause of death
among people with HIV/AIDS2 and accounts for more than 1
in 4 fatalities from antimicrobial resistance annually.3
TB occurs in every part of the world. In 2017, the largest number
of new TB cases occurred in the Southeast
Asia and Western Pacific regions, followed by the African
region. There is a growing resistance to available drugs, which
means the disease is becoming deadlier and more difficult to treat.
There were 558,000 cases of drug resistant TB in
2017.1
Multidrug resistant- (MDR) and extensively drug resistant- (XDR)
TB are forms of the disease caused by bacteria that do not respond
to first-line anti-TB drugs. Current treatments, therefore, consist
of combinations of many different drugs, which may need to be taken
for up to two years. Patients may take as many as 20 pills a day,
resulting in numerous side-effects and often creating a significant
economic burden.4 Drug sensitive- (DS) TB treatment,
which consists of treatment with up to four drugs daily for six to
nine months, has traditionally fared better with a global treatment
success rate of approximately 82%; however, rising rates of
resistance are complicating treatment and necessitating different
options.1
"The TB drug pipeline is showing significant promise as we
progress in our goal to provide transformative benefit to people
with TB," said Mel Spigelman,
President and CEO of TB Alliance. "We are determined to take steps
now to ensure that pretomanid, if approved, will be able to reach
patients in need as part of an appropriate treatment regimen."
Mylan CEO Heather Bresch added,
"For more than a decade, Mylan has led the charge in accelerating
access to high quality and affordable antiretrovirals for people
living with HIV all over the world. We look forward to
collaborating with TB Alliance to bring that same level of
commitment and innovation to the millions of people suffering from
tuberculosis, many of whom also have HIV. The drug regimens under
development represent an important step in transforming the TB
treatment landscape."
Advancing Treatment for Patients
Pretomanid is a new chemical entity and a member of a class of
compounds known as nitroimidazooxazines. TB Alliance began
preclinical development of pretomanid in 2002, and it has since
studied pretomanid in 20 clinical trials alone or in combination
with other anti-TB drugs. Pretomanid has been administered in a
clinical trial setting to more than 1,200 people in 14
countries.
The two pretomanid-based regimens under development include:
- For XDR-TB and MDR-TB that is treatment-intolerant or
non-responsive: All oral, six- to nine-month treatment regimen
consisting of bedaquiline, pretomanid and linezolid ("BPaL"
regimen)
- For DS-TB and MDR-TB: All oral, four- and six-month treatments,
respectively, consisting of bedaquiline, pretomanid, moxifloxacin
and pyrazinamide ("BPaMZ" regimen)
TB Alliance is currently advancing the development of pretomanid
in three ongoing late-stage clinical trials. The Nix-TB and ZeNix
trials are evaluating the BPaL regimen for treatment of XDR-TB and
related highly resistant forms of TB, while the SimpliciTB trial is
evaluating the BPaMZ regimen for the treatment of DS-TB in four
months and MDR-TB in six months.
The BPaL regimen has been studied in the ongoing Phase 3 Nix-TB
trial, an open-label, single arm trial. Nix-TB participants with
XDR-TB and treatment-intolerant or non-responsive MDR-TB were
treated with bedaquiline, pretomanid and linezolid over six months,
extended to nine months in some cases, with the intent to cure. In
interim results from the first 75 participants presented at the
2018 Union World Conference on Lung Health, 89% of the trial
participants had a favorable outcome with their clinical infection
resolved and sputum cultures negative for TB after six months of
treatment and six months of post-treatment
follow-up.5
The BPaMZ regimen is being studied in the ongoing late-stage
SimpliciTB clinical trial, initiated in 2018, for the treatment of
both DS- and MDR-TB. The BPaMZ regimen was previously evaluated in
TB Alliance's Phase 2b study called
NC-005, in which people with MDR-TB who were treated with the BPaMZ
regimen cleared TB bacteria from their lungs up to three times
faster than drug-sensitive TB patients treated with the standard
first-line treatment (HRZE).6
A Global Commitment
The collaboration between Mylan and TB Alliance includes a
global license from TB Alliance to Mylan for pretomanid for use in
the following regimens:
- As part of the BPaL regimen, TB Alliance has granted a license
to Mylan to manufacture and commercialize pretomanid, pending
regulatory approval, for XDR-TB and treatment-intolerant or
non-responsive MDR-TB. The BPaL regimen includes bedaquiline, which
is exclusively manufactured and marketed by the Janssen
Pharmaceutical Companies of Johnson & Johnson (Janssen) outside of DS-TB, and
linezolid, which is available from multiple manufacturers,
including Mylan. A New Drug Application for pretomanid as part of
the BPaL regimen is currently under Priority Review by the U.S.
Food and Drug Administration.7 In addition, a marketing
authorization application for pretomanid as part of the BPaL
regimen is under review by the European Medicines Agency. Janssen
will retain the exclusive rights to market bedaquiline including as
part of any combination therapy for the treatment of MDR-TB for the
term of its patents.
- As part of the BPaMZ regimen, TB Alliance has licensed
pretomanid to Mylan for DS- and MDR-TB, and has granted a
sublicense for bedaquiline to Mylan, for its development and
commercialization for use in DS-TB only, under its license
agreement with Janssen Pharmaceutica N.V., one of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Janssen has
granted its consent to this sublicense. If the BPaMZ regimen is
proven successful in the SimpliciTB trial, Mylan will seek
regulatory approval of pretomanid as part of the BPaMZ regimen in
DS-TB and MDR-TB as well as bedaquiline as part of the regimen in
DS-TB. As with the BPaL regimen, Janssen will retain the exclusive
rights to market bedaquiline as part of the combination therapy for
the treatment of MDR-TB for the term of its patents.
Under the terms of the agreements comprising the collaboration
and pending regulatory approvals, Mylan anticipates being the first
company with the license to commercialize pretomanid for use in
these regimens in certain low- and middle-income countries, where
the vast majority of the global TB burden is located. The license
agreement for pretomanid for the aforementioned countries will be
non-exclusive, reflecting the commitment by TB Alliance and Mylan
to ensure affordable and sustainable access to new TB treatments
from multiple sources. Mylan has an exclusive license agreement for
commercializing pretomanid for use in the BPaL and BPaMZ regimens
in high-income markets.
Moving forward, TB Alliance and Mylan will work together to
support antimicrobial stewardship and ensure that upon
introduction, pretomanid is accessible to those who need it in the
appropriate treatment regimen, pending regulatory approval and the
issuance of new treatment guidelines by the World Health
Organization.
About TB Alliance
TB Alliance is a not-for-profit organization dedicated to
finding faster-acting and affordable drug regimens to fight TB.
Through innovative science and with partners around the globe, we
aim to ensure equitable access to faster, better TB cures that will
advance global health and prosperity. TB Alliance operates with
support from Australia's
Department of Foreign Affairs and Trade, Bill & Melinda Gates
Foundation, Germany's Federal
Ministry of Education and Research through KfW, Global Health
Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council
(United Kingdom), National
Institute of Allergy and Infectious Disease, Netherlands Ministry
of Foreign Affairs, United Kingdom Department for International
Development, UK Department of Health, and the United States Agency
for International Development.
About Mylan
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 more than 40% of people
being treated for HIV/AIDS globally 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 approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
Forward-looking statements
This press release includes statements that constitute
"forward-looking statements," including with regard to statements
that: TB Alliance and Mylan announced a global collaboration
to make the experimental drug pretomanid accessible for use in two
investigational drug regimens for pulmonary TB; the drug regimens
under development represent an important step in transforming the
TB treatment landscape; if the BPaMZ regimen is proven
successful in the SimpliciTB trial, Mylan will seek regulatory
approval of pretomanid as part of the BPaMZ regimen in DS-TB and
MDR-TB as well as bedaquiline as part of the regimen in DS-TB;
under the terms of the agreements comprising the collaboration and
pending regulatory approvals, Mylan anticipates being the first
company with the license to commercialize pretomanid for use in
these regimens in certain low- and middle-income countries, where
the vast majority of the global TB burden is located; and moving
forward, TB Alliance and Mylan will work together to support
antimicrobial stewardship and ensure that upon introduction,
pretomanid is accessible to those who need it in the appropriate
treatment regimen, pending regulatory approval and the issuance of
new treatment guidelines by the World Health Organization. These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Because
forward-looking statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such statements. Factors that
could cause or contribute to such differences include, but are not
limited to any changes in, interruptions to, or difficulties with
Mylan's or its partners' ability to develop, manufacture, and
commercialize products; the effect of any changes in Mylan's or its
partners' customer and supplier relationships and customer
purchasing patterns; other changes in third-party relationships;
the impact of competition; changes in the economic and financial
conditions of the businesses of Mylan or its partners; the scope,
timing, and outcome of any ongoing legal proceedings and the impact
of any such proceedings on Mylan's or its partners' business; any
regulatory, legal, or other impediments to Mylan's or its partners'
ability to bring products to market; actions and decisions of
healthcare and pharmaceutical regulators, and changes in healthcare
and pharmaceutical laws and regulations, in the United
States and abroad; Mylan's and its partners' ability to
protect intellectual property and preserve intellectual property
rights; risks associated with international operations; other
uncertainties and matters beyond the control of management; and the
other risks detailed in Mylan's filings with the Securities and
Exchange Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
1 World Health Organization:
http://www.who.int/tb/publications/global_report/en/
2 UNAIDS:
http://www.unaids.org/en/topic/tuberculosis
3 Review on Antimicrobial Resistance:
https://amr-review.org/
4 MSF: https://www.msf.org/tuberculosis
5 The 49th Union World Conference on Lung
Health:
https://thehague.worldlunghealth.org/2018/10/encouraging-drug-resistant-tb-treatment-results/
6 Conference on Retroactive and Opportunistic
Infections, 2017:
http://www.croiconference.org/sessions/efficacy-bedaquiline-pretomanid-moxifloxacin-pza-bpamz-against-ds-mdr-tb
7 TB Alliance:
https://www.tballiance.org/news/pretomanid-enters-FDA-review
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