- Collaboration will evaluate Radius’
investigational drug, RAD1901, in combination with Novartis
investigational CDK4/6 inhibitor LEE011 for the treatment of breast
cancer
Radius Health, Inc. (Nasdaq:RDUS) today announced that it has
entered into a worldwide clinical collaboration with Novartis
Pharmaceuticals (NYSE:NVS) to evaluate the safety and efficacy of
combining investigational agent RAD1901, a novel oral selective
estrogen receptor degrader (SERD), with investigational agent
LEE011 (ribociclib)*, a cyclin-dependent kinase (CDK) 4/6
inhibitor. Preclinical studies of RAD1901 have shown consistent and
robust single agent anti-tumor activity in multiple wild type and
ESR1-mutant breast cancer models and tumor regression when combined
with targeted agents such as CDK 4/6 inhibitors in pre-clinical
models. The parties also intend to conduct pre-clinical studies to
evaluate the effects of RAD1901 in combination with BYL719
(alpelisib), an investigational phosphoinositide 3-kinase (PI3K)
inhibitor, with the goal of initiating future clinical trials.
“We are pleased to begin work with Novartis to explore the
potential clinical benefits of RAD1901 in combination with these
promising investigational agents for breast cancer, the second most
common cancer in the world and the most prevalent cancer in women,”
said Robert Ward, President and Chief Executive Officer of Radius
Health. “This collaboration will evaluate the potential of
combination therapies to generate improved clinical results, as
compared to single agents alone, and to address the needs of these
underserved patient populations.”
Under the agreement, Radius and Novartis will each contribute
resources and supply compound material necessary for the studies to
be conducted under the collaboration and will share third party
out-of-pocket research and development expenses. The agreement is
non-exclusive and each party will solely own all rights to any
invention or discovery solely related to its respective product
and/or compound. The parties will jointly own all data and
inventions related to the combination use of investigational drug
RAD1901 with investigational drugs LEE011, BYL719 or another
compound arising under the collaboration.
*LEE011 was developed by the Novartis Institutes for BioMedical
Research in collaboration with Astex Pharmaceuticals
About Radius
Radius is a science-driven biopharmaceutical company that is
committed to developing innovative therapeutics in the areas of
osteoporosis, oncology and endocrine diseases. Radius' lead product
candidate, the investigational drug abaloparatide for subcutaneous
injection, has completed Phase 3 development for potential use in
the reduction of fracture risk in postmenopausal women with
osteoporosis. The Radius clinical pipeline also includes an
investigational abaloparatide transdermal patch for potential use
in osteoporosis and the investigational drug RAD1901 for potential
use in hormone-driven, or hormone-resistant, metastatic breast
cancer, and vasomotor symptoms in postmenopausal women. Radius’
preclinical pipeline includes RAD140, a non-steroidal, selective
androgen receptor modulator (SARM) under investigation for
potential applications in oncology. For more information, please
visit www.radiuspharm.com.
About Abaloparatide
Abaloparatide is an investigational therapy for the potential
treatment of women with postmenopausal osteoporosis who are at an
increased risk for a fracture. Abaloparatide is a novel synthetic
peptide analog of the PTH receptor binding domain of parathyroid
hormone-related protein (PTHrP), a naturally occurring
bone-building hormone that has the ability to increase bone mineral
density by stimulating new bone formation. Abaloparatide was
designed to have a unique mechanism of action with the goal of
stimulating bone formation, increasing bone mineral density,
restoring bone microarchitecture and augmenting bone strength.
Abaloparatide has completed Phase 3 development for potential
use as a daily self-administered injection (abaloparatide-SC). In
the fourth quarter of 2015, Radius’ Marketing Authorisation
Application (MAA) for abaloparatide-SC for the treatment of
patients with postmenopausal osteoporosis was validated and is
currently undergoing regulatory review by the European Medicines
Agency (EMA). Radius plans to submit a New Drug Application (NDA)
for abaloparatide-SC to the US Food and Drug Administration at the
end of the first quarter of 2016.
Radius is also developing abaloparatide-transdermal
(abaloparatide-TD) based on 3M's patented Microstructured
Transdermal System technology for potential use as a short
wear-time transdermal patch.
About RAD1901
RAD1901 is a selective estrogen receptor
down-regulator/degrader, or SERD, which at high doses has potential
for use as an oral non-steroidal treatment for hormone-driven, or
hormone-resistant, metastatic breast cancer. RAD1901 is currently
being investigated in postmenopausal women with advanced estrogen
receptor positive (ER+), HER2-negative breast cancer, the most
common form of the disease. The compound has the potential for use
as a single agent or in combination with other therapies to
overcome endocrine resistance in metastatic breast cancer.
RAD1901 is also being evaluated in a Phase 2b study at low doses
for potential relief of the frequency and severity of moderate to
severe hot flashes in postmenopausal women with vasomotor symptoms.
Additional information on the clinical trial program of RAD1901 is
available on www.clinicaltrials.gov.
About RAD140
RAD140 is a non-steroidal selective androgen receptor modulator,
or SARM, that is currently in preclinical development as a
potential treatment for breast cancer. RAD140 resulted from an
internal drug discovery program focused on the androgen receptor
pathway, which is highly expressed in many breast cancers. Due to
its receptor and tissue selectivity, potent oral activity and long
half-life, RAD140 could have clinical potential in the treatment of
breast cancer or other conditions where androgen modulation may
play a role.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do
not relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding the results of prior studies of RAD1901, the potential
uses for RAD1901, the potential clinical benefits of combination
therapies compared to single agent therapies generally and to the
combination of RAD1901 with Novartis’s investigational compounds,
the potential studies that may be conducted under the
collaboration, and the timing and progress of regulatory
submissions for abaloparatide-SC in Europe and the United
States.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: we have no product revenues; our need for additional
funding, which may not be available; we are not currently
profitable and may never become profitable; risks related to
raising additional capital; our limited operating history;
quarterly fluctuation in our financial results; failure of the
financial institutions in which we hold our cash and cash
equivalents; market, interest, and credit risk; our dependence on
the success of abaloparatide-SC, and our inability to ensure that
abaloparatide-SC will obtain regulatory approval or be successfully
commercialized; risks related to clinical trials, including having
most of our products in early stage clinical trials and uncertainty
that results will support our product candidate claims; the risk
that adverse side effects will be identified during the development
of our product candidates; product candidates for which we obtain
marketing approval, if any, could be subject to restrictions or
withdrawal from the market and we may be subject to penalties;
failure to achieve market acceptance of our product candidates;
risks related to the use of our limited resources on particular
product candidates and not others; delays in enrollment of patients
in our clinical trials, which could delay or prevent regulatory
approvals; the dependence of our drug development program upon
third-parties who are outside of our control; the risk that a
regulatory or government official will determine that third-parties
with a financial interest in the outcome of the Phase 3 study of
abaloparatide-SC affected the reliability of the data from the
study; our reliance on third parties to formulate and manufacture
our product candidates; failure to establish additional
collaborations; our lack of experience selling, marketing and
distributing products and our lack of internal capability to do so;
failure to compete successfully against other drug companies;
developments by competitors may render our products or technologies
obsolete or non-competitive; risks related to the fact that our
drugs may sell for inadequate prices or patients may be unable to
obtain adequate reimbursement; the effects of product liability
lawsuits on commercialization of our products; failure to comply
with obligations of our intellectual property licenses; failure to
protect our intellectual property or failure to secure necessary
intellectual property related to abaloparatide-SC,
abaloparatide-TD, RAD1901 and/or RAD140; our or our licensors'
inability to obtain and maintain patent protection for technology
and products; risks related to our compliance with patent
application and maintenance requirements; failure to protect the
confidentiality of our trade secrets; risks related to our
infringement of third parties' rights or the costs of defending
against infringement by third parties; claims of wrongful
disclosure or use of trade secrets by employees' former employers;
risks associated with intellectual property litigation, including
expending substantial resources and distracting personnel from
their normal responsibilities; risks associated with healthcare
reform; our failure to comply with healthcare laws and regulations;
our exposure to claims associated with the use of hazardous
materials and chemicals; as we become involved in drug
commercialization, risk related to our inability to successfully
manage our growth and expanded operations; risks relating to
business combinations and acquisitions; our reliance on key
executive officers and advisors; our inability to hire additional
qualified personnel; volatility in the price of our common stock;
capital appreciation is the only source of gain for our common
stock; risks related to the costs and compliance initiatives
associated with operating as a public company; our directors,
executive officers and principal stockholders have substantial
influence over us and could delay or prevent a change in control;
future sales and issuances of our common stock could depress the
price of our common stock; risks related to securities or industry
analysts ceasing to publish research about us or publishing
inaccurate or unfavorable information about us, which could cause
the price of our common stock to decline; provisions in our charter
documents and Delaware law that could discourage takeover attempts;
and our ability to use our net operating loss carryforwards and
certain other tax attributes may be limited. These and other
important factors discussed under the caption "Risk Factors" in our
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission, or SEC, on November 5, 2015, and our other
reports filed with the SEC could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this press release.
Radius Health
Media Contact:
Alice L. Pomponio
Email: apomponio@radiuspharm.com
Phone: 617-551-4099
Investor Relations Contact:
Barbara Ryan
Email: bryan@radiuspharm.com
Phone: 203-274-2825
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