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Aries Pharmaceuticals and Olympus Initiate Co-Promotion of Eleview™ at the American College of Gastroenterology’s World Congress

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SAN DIEGO (October 13, 2017)Aries Pharmaceuticals, Inc. (Aries), a specialty pharmaceutical company commercializing best-in-class gastroenterology products utilized in endoscopy and for the treatment of select gastrointestinal diseases, today announced it will initiate with Olympus the co-promotion of Eleview™ at the American College of Gastroenterology’s (ACG) World Congress in Orlando, Fla. Eleview is an FDA 510(k) cleared, ready-to-use submucosal injection composition that provides an immediate and long-lasting cushion for GI endoscopic resections of polyps, adenomas, early stage cancers, and other lesions in the gastrointestinal (GI) tract. Aries is the U.S. distribution arm of Aries Ltd., a wholly owned subsidiary of Cosmo Pharmaceuticals N.V., who developed Eleview.

Aries Pharmaceuticals, Inc. enters co-promotion agreement in the U.S. with Olympus for Eleview™, a ready-to-use submucosal injection composition that provides an immediate and long-lasting cushion for GI endoscopic resections of polyps, adenomas, and other lesions.

Eleview, designed for easy and safe resection, increases visibility of target lesion margins and lowers the risk of perforation. It is appropriate for challenging polyps, regardless of size, location, or type and the immediate, long-lasting cushion can hold for up to 45 minutes. Eleview improves margin visualization and helps decrease the risk of gastrointestinal perforation and damage to the external muscular layer, which can lead to gastrointestinal perforation. Furthermore, it may decrease the time needed to resect a lesion while reducing both reinjections required and piecemeal excisions, as compared to saline.

“We are very happy to be initiating this co-promotion with our colleagues at Olympus,” said Tom Joyce, President and Chief Executive Officer of Aries. “Olympus is a global leader in endoscopy, and our joint promotion will be a significant boost for the commercial success of Eleview.”

“This innovative injection agent is a complement to our EndoTherapy portfolio and will further assist physicians during endoscopic procedures and when performing gastrointestinal resections,” said Kurt Heine, Group Vice President of the Endoscopy Division at Olympus America, Inc. “Better visibility of lesions, along with increased efficiency, can bring us closer to our goal of improving quality of care, reducing healthcare costs and enhancing patient satisfaction.”

Aries and Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, will work together to promote and sell Eleview to end-user customers and will each sell Eleview through their existing distribution networks. This combined effort will leverage both companies’ established salesforce and distribution networks to address the endoscopy market in an efficient and cost-effective manner.

To learn more about Eleview or to place an order, please call 1-888-ARIES-08 (1-888-274-3708).

About Aries Pharmaceuticals, Inc.

Aries Pharmaceuticals, Inc. (Aries) is a specialty pharmaceutical company commercializing best-in-class gastroenterology products for the United States market with a focus on products utilized in endoscopy and for the treatment of select gastrointestinal diseases. The company’s initial portfolio of four products, three of which are still in development, are licensed from Cosmo Pharmaceuticals N.V. to Aries Ltd. Aries is the US distribution arm of Aries Ltd., a wholly owned subsidiary of Cosmo Pharmaceuticals N.V. For further information on Aries, please visit the company’s website: www.ariespharma.com. Developed by Cosmo Pharmaceuticals, Eleview™ has been 510(k) cleared by the FDA as a class II medical device and is the only commercially available medical device for this indication. Additional product information is available at EleviewUS.com.

About Olympus Medical Systems Group

Olympus Medical Systems Group, a division of global technology leader Olympus, develops solutions for healthcare professionals that help improve clinical outcomes, reduce overall costs and enhance quality of life for their patients. By enabling less invasive procedures, innovative diagnostic and therapeutic endoscopy, and early stage lung cancer evaluation and treatments, Olympus is transforming the future of healthcare. For more information visit Olympus at www.medical.olympusamerica.com.

Media Contacts:

Deborah Hernandez
FKH
Vice President
617-417-6359
Deborah.Hernandez@fkhealth.com

FDA accepts New Drug Application for Methylene Blue MMX™ and sets PDUFA Date for May 21, 2018

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SAN DIEGO – October 16, 2017Aries Pharmaceuticals, Inc. (Aries), a specialty pharmaceutical
company commercializing best-in-class gastroenterology products, today announced that the U.S. Food
and Drug Administration (FDA) has set a PDUFA date of May 21st, 2018, for its decision on the New Drug
Application (NDA) for Methylene Blue MMX™ (MB MMX). A Phase III clinical trial studied Methylene
Blue MMX™ for the detection and visualization of pre-cancerous and cancerous lesions in people
undergoing screening and surveillance colonoscopies. MB MMX was developed by
Cosmo Pharmaceuticals,  N.V and upon FDA approval, Aries will be the sole distributor of MB MMX in the United States.

“We are excited that the FDA has accepted the NDA submission, and our team is focused on preparing
for the anticipated approval of MB MMX in the U.S.,” Aries CEO Tom Joyce stated. He added, “this
milestone marks another positive step towards bringing innovative drugs to the GI community and
strengthens the Aries gastrointestinal franchise.” In May of this year, Aries launched Eleview™, a
novel ready-to-use submucosal injectable that forms an immediate and long-lasting cushion beneath
lesions undergoing removal during colonoscopy.

MB MMX™ is a first-in-class drug candidate based on Cosmo Pharmaceuticals’ proprietary MMX delivery
technology. This formulation allows methylene blue to aid in the detection and visualization of
adenomas during colonoscopy. In the Phase III clinical trial, MB MMX met its primary endpoint
(p-value: 0.009), identifying 17.71% more patients with adenomas or carcinomas than HDWL (High
Definition White Light) colonoscopy which is currently the most advanced standard of care. Adenomas
were found in 56.3% of all subjects when using MB MMX, in contrast to 47.8% found with HDWL. The
NDA is expected to demonstrate that MB MMX increases the Adenoma Detection Rate (ADR) beyond the
current standard of care in endoscopic procedures. Results of the Phase III trial are expected to
be published next year.

“Increases in ADR have important clinical relevance,” stated Michael B. Wallace MD, MPH, (Mayo
Clinic Florida) and a primary investigator on the Phase III trial. He added that, “we know that for
each 1% increase in ADR, a 3% decline in the incidence of interval cancer and a 5% decline in the
incidence of fatal colorectal cancer (CRC) should be expected. MB MMX has the potential to provide
gastroenterologists with a significant new means to improve their ADR and potentially help reduce
colorectal cancer rates in the United States.”

About Colonoscopies and Colorectal Cancer
Colonoscopies are used for the early detection and prevention of colorectal cancer, one of the
leading causes of cancer deaths in the United States.1 The detection and removal of precancerous
and cancerous lesions as a part of colorectal cancer screening colonoscopies are key to colorectal
cancer prevention.2 In fact, the U.S. Multi-Society Task Force of Colorectal Cancer has identified
that the Adenoma Detection Rate (ADR) is an important quality measure3,4 and an independent
predictor of the risk and interval cancer after screening colonoscopy.5 In a prospective study of
individuals who underwent screening colonoscopy within a National Colorectal Cancer Screening
Program, increased ADR was associated with a reduced risk of interval colorectal cancer and death.2

About MB MMX™
MB MMX is a novel application of methylene blue dye. MMX technology allows for the delivery of
methylene blue along the entire length of the colon, with the objective to enable endoscopists to
better detect and visualize pre-cancerous and cancerous lesions. MB MMX is formulated as a tablet
that provides sustained dye contact with the mucosal wall as it travels through the colon, allowing
the time needed to ensure its absorption in the cells lining the colon wall, thus enhancing
contrast between abnormal areas and surrounding healthy cells before an endoscopy procedure is
initiated.

About Eleview™
Eleview submucosal injectable composition is intended for use in gastrointestinal endoscopic
procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal
mucosal lesions, prior to excision with a snare or endoscopic device. Developed by Cosmo
Pharmaceuticals, Eleview has been 510(k) cleared by the FDA as a class ll medical device and is the
only commercially available medical device for this indication. Additional product information at
EleviewUS.com.

About Aries Pharmaceuticals, Inc.

Aries Pharmaceuticals, Inc. (Aries) is a specialty pharmaceutical company commercializing
best-in-class gastroenterology products for the United States market with a focus on products
utilized in endoscopy and for the treatment of specific gastrointestinal diseases. The company’s
initial portfolio of four products, three of which are still in development, are licensed from
Cosmo Pharmaceuticals N.V. to Aries Ltd. Aries is the US distribution arm of Aries Ltd., a wholly
owned subsidiary of Cosmo Pharmaceuticals N.V. For further information on Aries, please visit the
company’s website: www.ariespharma.com

References

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Deborah Hernandez
Feinstein Kean Healthcare
deborah.hernandez@fkhealth.com
617-761-6731

1-LUM17230
1 U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2014 Incidence and
Mortality Web- based Report. Atlanta (GA): Department of Health and Human Services, Centers for
Disease Control and Prevention, and National Cancer Institute; 2017
2 Kaminski MF, Wieszczy P, Rupinski M, et al. Increased Rate of Adenoma Detection Associates With
Reduced Risk of Colorectal Cancer and Death. Gastroenterology. 2017;153(1):98-105.
3 Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: Recommendations for
physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer.
Gastrointestinal endoscopy. 2017;86(1):18-33.
4 Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointestinal
endoscopy. 2015;81(1):31-53.
5 Kaminski MF, Regula J, Kraszewska E, et al. Quality Indicators for Colonoscopy and the Risk of
Interval Cancer.
New England Journal of Medicine. 2010;362(19):1795-1803.

Aries Pharmaceuticals, Inc. Launches Eleview™ for use in Gastrointestinal Endoscopic Procedures

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Novel Development in Submucosal Injection Agents Elevates Lesions to Facilitate Removal

SAN DIEGO – May 2nd, 2017 – Aries Pharmaceuticals, Inc. (Aries) today announced the launch and commercial availability of its first product, Eleview™, a novel, ready to use, submucosal injectable composition for use in the easy and safe endoscopic removal of polyps, adenomas, and early stage cancers, and other lesions in the gastrointestinal (GI) tract. Eleview was developed by Cosmo Pharmaceuticals, N.V. (SIX: COPN) (Cosmo). Aries is the sole distributor of Eleview in the United States.

Eleview offers important benefits for gastroenterologists. Upon injection, the product forms an immediate cushion of optimal shape, height, and duration. The inclusion of methylene blue, a contrast dye, improves visibility of the lesion. By providing an immediate and long-lasting cushion beneath the polyp and improving the visibility of the lesion, Eleview may help achieve a complete and safe removal of the lesion. When compared to saline, one of the most commonly used agents, Eleview has demonstrated better cushion-forming ability and a duration of lift of up to 45 minutes. As a ready to use, sterile, premixed composition, it is a convenient option for clinicians.

“Eleview offers a meaningful advancement designed specifically to help endoscopists improve their procedural capabilities for an easy and safe removal of polyps and lesions throughout the GI tract. This is important because effective removal of precancerous polyps in the colon is a critical component of colon cancer prevention.” noted David Kriesel, Executive Director of Medical Affairs. “Eleview’s duration of polyp lift, along with the contrast provided by methylene blue, helps physicians visualize the margins of the lesion, an important aspect of achieving a complete resection with a potential for lower risk of complications.”

“We are excited to announce the commercial availability of Eleview. Improving patient outcomes during colorectal cancer screening and surveillance colonoscopies is a key area of focus for our product portfolio,” Aries CEO Tom Joyce stated. “We look forward to supporting gastroenterologists in their mission to lower the incidence of colorectal cancer, which is the second most common yet preventable cancer in the United States. Our products are designed to make a significant difference within endoscopy and select gastroenterology conditions.”

As part of the company’s launch readiness efforts, Aries made a significant investment in the training of a U.S. based salesforce, including completion of the American Society for Gastrointestinal Endoscopy (ASGE) training for sales and marketing representatives. The training, which included both didactic learning as well as a hands-on component that introduced participants to basic and advanced endoscopic techniques, will enable Aries representatives to better partner with clinicians to support positive patient outcomes. Following successful completion of this training, all Aries participants receive ASGE Recognized Industry Associates (ARIA) designation.

Aries Presence at DDW

Aries will be at Digestive Disease Week (DDW) in Chicago, May 6-9th introducing Eleview™ to the gastroenterology community.  The company will be exhibiting at Booth #2526 during DDW and hosting nine product breakout sessions throughout the conference. Cosmo, the parent company, plans to announce the outcome of Eleview’s clinical trial on May 8th. The results of the trial will be presented by Dr. Douglas Rex at DDW on May 8th.

About Eleview™

Eleview submucosal injectable composition is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Developed by Cosmo, Eleview has been 510(k) cleared by the FDA.  Please see important safety information below and additional product information at EleviewUS.com. Eleview is available now for order at 888-ARIES-08.

Important Safety Information 

WARNINGS AND PRECAUTIONS

  • The safety of Eleview™ has not been established in pregnant or lactating women, or in children under 18 years of age.
  • The endoscopist injecting Eleview™ must be experienced in the injection technique.

CONTRAINDICTIONS 

Patients with known sensitivity to any of the components contained in Eleview™.

ADVERSE REACTIONS 

  • Rarely, local bleeding and/or inflammatory reaction could occur which may or may not be associated with Eleview™. 
  • Please see Instructions for Use for complete Important Safety Information.

About Aries Pharmaceuticals, Inc.

Aries Pharmaceuticals, Inc. (Aries) is a specialty pharmaceutical company commercializing best-in-class gastroenterology products for the United States market with a focus on products utilized in endoscopy and for the treatment of specific gastrointestinal diseases.  The company’s initial portfolio of four products, three of which are still in development, are licensed from Cosmo Pharmaceuticals N.V. to Aries Limited. Aries Inc., is the US distribution arm of Aries Ltd., a wholly owned subsidiary of Cosmo Pharmaceuticals N.V. For further information on Aries, please visit the company’s website:  www.ariespharma.com

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Mike Walther
Aries Pharmaceuticals, Inc.
mwalther@aries-pharma.com

Deborah Hernandez
Feinstein Kean Healthcare
deborah.hernandez@fkhealth.com

617-761-6731

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