TEL AVIV, Israel and
RICHMOND, Calif., Nov. 13, 2019 /PRNewswire/ -- RDD Pharma,
Ltd. ("RDD"), a company focused on orphan and innovative therapies
for gastrointestinal disorders entered into a non-binding letter of
intent ("LOI") to acquire Naia Rare Diseases ("Naia"), a
biopharmaceutical company developing drugs for Short Bowel Syndrome
("SBS") and other rare gastrointestinal diseases. Closing of
the transaction is anticipated to occur after the consummation of
the proposed merger of RDD and Innovate Biopharmaceuticals, Inc.
(Nasdaq: INNT) which will form a combined company (the "INNT
Merger") intended to be named 9 Meters Biopharma, Inc. In exchange,
Naia will receive a combination of cash and shares in 9 Meters
Biopharma subject to closing of the INNT Merger. Pursuant to the
terms of the LOI, the combined company would acquire all of the
outstanding capital stock of privately-held Naia.
"Combining the pipelines of RDD, Innovate and Naia Rare Diseases
into 9 Meters Biopharma would create a next generation
gastroenterology company focused on developing treatments for unmet
needs in specialty, rare and orphan indications. From Naia's drug
candidates to the first-ever Phase 3 registration trial in celiac
disease, we expect multiple value creating inflection points over
the next 24 months," said John
Temperato, the current CEO of RDD and named CEO of 9
Meters Biopharma. 9 Meters will be poised to realize these
inflection points behind a highly seasoned management team
especially adept at in-licensing, developing and commercializing
multi-billion dollar assets in gastroenterology, along with
prominent healthcare-dedicated institutional investors, led by
Orbimed Advisors, LLC.
Through the transaction, the combined company will acquire
Naia's investigational therapeutic, NB-1001, a long-acting
glucagon-like peptide-1 (GLP-1) receptor agonist that combines
exenatide with a proprietary extended half-life technology for the
treatment of SBS. Long-acting NB-1001 extends the half-life of
GLP-1 and allows for up to once-per-month dosing, considerably
increasing administration convenience with a potentially improved
safety profile versus other GLP-1 agonists secondary to lower
overall exposure and dose required. The proposed agreement includes
a glucagon-like peptide 2 (GLP-2) analogue with improved serum
half-life compared with short-acting versions, which the company
intends to progress through a clinical and regulatory pathway in an
undisclosed orphan and rare gastrointestinal indication.
NB-1001 has demonstrated efficacy and an extended half-life up
to 30 days in a 70-patient clinical study1 and received
orphan drug designation by the U.S. Food and Drug Administration.
The companies, along with Cedars-Sinai Medical Center, plan to
initiate a clinical program in SBS in 2020, with the goal of
developing a safer, more efficacious and convenient therapy.
"People living with Short Bowel Syndrome have unique, unmet
motility needs and NB-1001 is one of the only compounds in
development to directly address this by potentially allowing for
elimination of parenteral nutrition and an improvement in quality
of life," said Mark Pimentel, MD,
FRCPC, executive director of the Medically Associated Science and
Technology (MAST) program at Cedars-Sinai. The patent rights
covering the use of NB-1001 are owned by Cedars-Sinai Medical
Center and are exclusively licensed by Cedars-Sinai to Naia.
H. Daniel Perez, M.D.,
co-founder, chairman and CEO of Naia Rare Diseases, said, "The
potential behind the combination of these companies is powerful. We
believe the high-caliber, experienced team will advance our
exciting pipeline, as they share our commitment of bringing
innovative new medicines to patients suffering from SBS and other
debilitating gastrointestinal rare diseases with few options."
About Short Bowel Syndrome
According to the National
Institute of Diabetes, and Digestive and Kidney Diseases (NIDDK),
SBS is a rare syndrome of problems related to poor absorption of
nutrients as a result of at least half of the small intestine being
removed and sometimes all or part of the large intestine;
significant damage to the small intestine; or poor motility, or
movement inside of the intestines.2 The incidence
of SBS is poorly known but estimated at about 5 to 10 patients per
year per million population. In adults, the incidence of SBS
requiring at-home parenteral nutrition is estimated at two adult
patients per year per million population.3 The only
approved pharmacologic therapies for SBS include trophic factors,
such as short-acting daily injectable GLP-2 analogues, which may
not be appropriate for all patient types.
About the Transaction
Pursuant to the LOI, the
combined company will acquire all of the outstanding capital stock
of Naia in exchange for an undisclosed amount of cash and equity.
The Naia acquisition would be expected to close after the merger of
RDD and Innovate to create 9 Meters Biopharma, Inc. Closing is
subject to the negotiation of a definitive agreement, customary
legal and regulatory clearances and procedures. The corporate
headquarters for the combined company will be located in
Raleigh, North Carolina.
Wyrick Robbins Yates & Ponton
LLP and Shibolet & Co. are serving as legal counsel to RDD, and
Dorsey and Whitney LLP is serving as legal counsel to Naia.
About Naia Rare Diseases
Naia Rare Diseases is a
development stage biopharmaceutical company developing novel drugs
for rare gastrointestinal disorders. The company is pursuing three
development programs including NB 1001 for Adult SBS, NB 1001 for
pediatric SBS and NB 1002, a GLP-2 agonist, for an undisclosed
orphan gastrointestinal indication. Naia Rare Diseases has been
funded by an international syndicate of private investors, and was
founded by Naia Limited, a company focused on building new biotech
companies using de-risked clinical stage assets. For more
information, please visit www.naiapharma.com.
About RDD Pharma
RDD Pharma, Ltd. ("RDD"), is a
privately held biopharmaceutical company focused on orphan and
innovative therapies for gastrointestinal disorders. The company
has two clinical stage products which serve significant unmet
needs. RDD-0315 is currently in Phase 2 development for the
treatment of fecal incontinence in spinal cord injury patients.
RDD-0315 has received Orphan Drug status in the E.U. and Fast Track
designation in the U.S. RDD-1609 is being developed for the
treatment of Pruritus Ani. For more information, please visit
www.rddpharma.com.
About Innovate Biopharmaceuticals, Inc.
Innovate is a
clinical stage biotechnology company focused on developing novel
therapeutics for autoimmune and inflammatory diseases. Innovate's
lead drug candidate, larazotide acetate, has a mechanism of action
that renormalizes the dysfunctional intestinal barrier by
decreasing intestinal permeability and reducing antigen
trafficking, such as gliadin fragments in celiac disease, and
bacterial toxins and immunogenic antigens in NASH. In celiac disease, larazotide is the
first-ever drug to enter Phase 3 registration trials. Larazotide
has been exposed to nearly 600 subjects in clinical trials
demonstrating a favorable safety profile comparable to placebo for
long-term chronic administration. Larazotide has received Fast
Track designation from the FDA for celiac disease. For more
information, please visit www.innovatebiopharma.com.
Forward-Looking Statements
This press release includes
forward-looking statements based upon Naia's and RDD's current
expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements
about the structure, timing and completion of the proposed
transactionr; expectations regarding the ownership structure of the
combined company; the future operations of the combined company;
the nature, strategy and focus of the combined company; the
development and commercial potential and potential benefits of any
product candidates of the combined company; anticipated preclinical
and clinical drug development activities and related timelines,
including the expected timing for data and other clinical and
preclinical results; the company having sufficient resources to
advance its pipeline; and other statements that are not historical
fact. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation: (i) the risk that the conditions to
the closing of the proposed transaction are not satisfied; (ii) the
ability of RDD and Naia to enter into a definitive agreement, (iii)
uncertainties as to the timing of the consummation of the proposed
transaction and the ability of the parties to consummate the
proposed transaction; (iv) risks related to integration of the
companies; (v) risks related to the failure or delay in obtaining
required approvals from any governmental or quasi-governmental
entity necessary to consummate the proposed transaction; (vi)
potential unexpected costs, charges or expenses resulting from the
transaction; (vii) potential adverse reactions or changes to
business relationships resulting from the announcement or
completion of the proposed transaction; (viii) the uncertainties
associated with the clinical development and regulatory approval of
product candidates; (ix) risks related to the inability of the
combined company to obtain sufficient additional capital to
continue to advance these product candidates and its preclinical
programs; (x) uncertainties in obtaining successful clinical
results for product candidates and unexpected costs that may result
therefrom; (xi) risks related to the failure to realize any value
from product candidates and preclinical programs being developed
and anticipated to be developed in light of inherent risks and
difficulties involved in successfully bringing product candidates
to market; and (xii) risks associated with the possible failure to
realize certain anticipated benefits of the proposed transaction,
including with respect to future financial and operating results.
Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties. You should not place undue
reliance on these forward-looking statements, which are made only
as of the date hereof or as of the dates indicated in the
forward-looking statements. Innovate expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statements are based.
Contact:
RDD Pharma, Ltd.
Susan Forman
Media Contact
Tel: +1-212-825-3210
Email: susanformandgi@gmail.com
www.rddpharma.com
Naia Rare Diseases
H. Daniel Perez, MD
Chief Executive Officer
Mark Bagnall
Chief Financial Officer
Email: dperez@naiapharma.com
Email: mbagnall@naiapharma.com
www.naiapharma.com
References:
- Data presented at the 71st American Diabetes
Association conference (2011)
- NIH Health Information – Short Bowel Syndrome
- Amiot A, Messing B, Corcos O, Panis Y, Joly F. Determinants of
home parenteral nutrition dependence and survival of 268 patients
with non-malignant short bowel syndrome. Clin Nutr
2013;32(3):368—74.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/rdd-pharma-enters-into-non-binding-letter-of-intent-to-acquire-naia-rare-diseases-strengthening-gastroenterology-orphan-disease-pipeline-300957044.html
SOURCE RDD Pharma
