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FDA Grants Cosmo Pharmaceuticals both QIDP and Fast Track Designations for Aemcolo (Rifamycin SV MMX®) for Travelers’ Diarrhea

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Upon FDA Approval, Aries Pharmaceuticals, Inc. to Lead U.S. Commercial Efforts

 

DUBLIN – October 30, 2017 Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that the U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo (Rifamycin SV MMX®) for the treatment of patients with travelers’ diarrhea. Aries Pharmaceuticals, Inc., Cosmo’s U.S. subsidiary based in San Diego, California, will lead the commercial sales and marketing for Aemcolo in the U.S.

“There have not been any new chemical entities approved to treat colonic infections in years, so resistance to current available drugs is a serious issue. The QIDP and Fast Track designations highlight the importance of treating colonic infections with new chemical entities and Aemcolo’s potential to address this unmet medical need,” said Alessandro Della Chà, Chief Executive Officer of Cosmo Pharmaceuticals. “We look forward to productive interactions with the FDA as we work to bring Aemcolo to patients.”

“We are pleased with the FDA’s decision to Fast Track Aemcolo and provide those who suffer from travelers’ diarrhea with a potentially new treatment option,” said Tom Joyce, CEO of Aries Pharmaceuticals. “Travelers’ diarrhea can be highly disruptive and cause significant discomfort for patients, and in some cases, it can progress to more serious conditions if not treated effectively. Aemcolo has the potential to be an excellent fit with our portfolio of novel products that address high unmet needs for physicians and patients in diagnosing and treating gastrointestinal disorders.”

If approved, Aemcolo will be eligible for an additional five years of market exclusivity based on the QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. With Fast Track designation, Aemcolo is now eligible for priority review. Fast Track is a process the FDA designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need. The program’s purpose is to get important new drugs to the patient earlier.

Phase III clinical trials of Aemcolo in travelers’ diarrhea have been completed in the U.S. and EU. The Phase III program demonstrated Aemcolo’s superiority as compared to placebo (p-value= 0.0008) and its non-inferiority as compared to Ciprofloxacin.

New Drug and Marketing Authorization Applications are currently being prepared for submission to the FDA and European Medicines Agency, respectively.

Earlier this year, Aries launched Eleview™, a Cosmo-developed novel, ready-to-use submucosal injectable that forms an immediate and long-lasting cushion beneath lesions undergoing removal during colonoscopy. Cosmo and Aries also recently announced that the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of May 21, 2018 for Methylene Blue MMX®, being studied for the detection and visualization of pre-cancerous and cancerous lesions in people undergoing screening and surveillance colonoscopies.

About Aemcolo
Aemcolo is a pharmaceutical product candidate employing rifamycin SV engineered with Cosmo Pharmaceuticals’ MMX® technology. Aemcolo is a broad spectrum, semi-synthetic, orally administered, minimally absorbed antibiotic which can be used for the treatment of bacterial infections of the colon such as travelers’ diarrhea. The application of MMX technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Aemcolo tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus abating its systemic absorption in the small intestine.

 

About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal Disorders and Endoscopic Procedures. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company has developed a medical device for polyp and adenoma excision and is has completed clinical trials of Methylene Blue MMX®, a diagnostic drug for the detection of colon cancer as well as new chemical entities that are being developed by the associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo’s MMX products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Santarus/Salix/Valeant and in the Rest of the World to Ferring as Cortiment®. Cosmo’s proprietary MMX technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.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.

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Media Contacts:
Cosmo Pharmaceuticals N.V.
John Manieri, Head of Investor Relations
Tel: +353 (1) 8170 370
jmanieri@cosmopharma.com

Aries Pharmaceuticals, Inc.
Deborah Hernandez
FKH
Vice President
617.417.6359
Deborah.Hernandez@fkhealth.com

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

 

This press release does not constitute an “offer of securities to the public” within the meaning of Directive 2003/71/EC of the European Union (the “Prospectus Directive”) of the securities referred to in it (the “Securities”) in any member state of the European Economic Area (the “EEA”). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.

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, 2017 – Aries 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 U.S. 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 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

Aries Pharmaceuticals, Inc. Shares Positive Results for Clinical Study of Eleview™ at Digestive Disease Week Annual Meeting

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Novel Development in Submucosal Injection Agents Elevates Lesions to Facilitate Removal

SAN DIEGO – May 18, 2017 – Aries Pharmaceuticals, Inc. (Aries), a specialty pharmaceutical company commercializing best-in-class gastroenterology products, shared positive results of the first Eleview™ clinical trial in humans at the annual Digestive Disease Week (DDW) conference in Chicago, Illinois earlier this month. Eleview is a novel, ready to use, methylene blue containing, 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.
The product, which is packaged as a set of five 10 mL single use, sterile ampoules with a luer lock closure that can easily be connected to a suitable syringe, was also unveiled for the first time. The “Twist and Go” ampoules enable endoscopists to quickly access Eleview when needed without having to wait for compounding and eliminate product waste should a lesion not be identified during the procedure. Eleview is administered through an endoscope via a normal, commercially available endoscopic injection needle.
The goals of the study were to assess the comparative effectiveness and safety of Eleview versus standard saline plus methylene blue (saline admixture) in patients undergoing Endoscopic Mucosal Resection (EMR) of colonic lesions ≥20 mm. While not powered for statistical significance, several efficacy endpoints did demonstrate significance and all others trended positively for Eleview.

Study Results
Data presented at the meeting positively demonstrated both efficacy and safety for Eleview when compared to saline plus methylene blue.
The three primary efficacy endpoints were all positive for the Eleview arm of the study:

  • The mean total injected volume of Eleview needed per procedure for lesion removal was 16.1 mL (range of 3-41 mL) compared to the saline plus methylene blue arm which had a mean total injected volume of 31.6 mL (range of 4-248 mL). In the comparator arm, 49.2% more saline admixture was required than Eleview. Statistical significance (P<0.001) was achieved for this endpoint.
  • The mean total injected volume per lesion was also less for Eleview with 0.53 mL per mm of lesion (range of 0.09-1.75 mL/mm) compared to saline admixture which needed a volume of 0.92 mL per mm (range of 0.2-4.96 mL/mm) and represents 42.4% more volume per mm needed of saline admixture than of Eleview. Statistical significance (P<0.001) was also achieved for this endpoint.
  • Time to resect the lesion was notably lower for the Eleview arm of the study having a mean time of 19.15 minutes (range of 1-100 minutes) while the comparator arm required 35.5% longer with a mean of 29.7 minutes (range of 2-687 minutes) (p=0.326).

Secondary efficacy endpoints also demonstrated relative improvement for the Eleview arm of the study:

  • Injected volume needed to provide initial lift per lesion with Eleview had a mean of 10.4 mL compared to saline plus methylene blue which had a mean of 15.3 mL (p<0.001).
  • Less re-injections were necessary when using Eleview (1.05) than the comparator arm (1.79) (p=0.159).
  • When Eleview was used, the lesions were removed in fewer number of pieces (11.9%; p<0.052).
  • 58% more en bloc (removal in one piece) resections were possible with Eleview (p<0.125).
  • The Sydney Resection Quotient (calculated by dividing the lesion size by the total number of resections (pieces) required to remove the lesion) was 28.8% higher in the Eleview arm (p<0.044).

The safety data is interim given that some patients have not yet reached their 60-day post-procedure follow-up exam. To date, no substantial differences in the number of complications between Eleview and the comparator saline admixture arm were seen. The study results so far suggest that Eleview is at least as safe as the comparator saline in terms of procedural complications.
“The results of this study helped to demonstrate clear procedural advantages over saline and that’s great news for patients and clinicians — and potentially also the healthcare system,” noted David Kriesel, Executive Director of Medical Affairs. “A key differentiator for Eleview is the fact that it’s premixed and ready-to-use. Unlike the current standard of care of saline admixed with methylene blue and/or other components, Eleview’s convenient ready-mixed packaging can save procedure time by not having to order the admixture to be compounded either before or during the procedure. We’re excited to now offer the product in the United States, and look forward to working with endoscopists to increase access nationwide.”
The study helps to reinforce the benefits Eleview presents for gastroenterologists and patients. 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 helps endoscopists achieve a complete and safe removal of the lesion. When compared to saline, one of the most commonly used agents and used as the comparator arm with the addition of methylene blue in the above study, Eleview demonstrated better cushion-forming ability and a duration of lift of up to 45 minutes. In addition to potential time savings gained from the premixed formulation and a more rapid lesion removal, costs savings may also be seen if there are shortened procedural times, which could also positively impact patient sedation time, endoscopy suite utilization, and personnel costs per procedure. Additional studies are being considered to confirm these assumptions.


About the Study
This first-in-human study was a randomized, double blind, multicenter clinical trial with parallel arms with sites in the United States and Europe. 211 patients were included in the primary analysis. The mean lesion size in the Eleview arm was 31.64 mm. In the comparator saline arm, the mean lesion size was 32.31 mm. The data set was presented at Digested Disease Week (DDW) on May 8, 2017 by one of the principal investigators, Dr. Douglas Rex from Indiana University Hospital, Indianapolis, Indiana. Additional principal investigators include: Mike Wallace from Mayo Clinic, Jacksonville, Florida; Prateek Sharma, University of Kansas Medical Center, Kansas City, Kansas; Alessandro Repici, Humanitas Research Hospital, Milan, Italy; and Pradeep Bhandari, Solent Center for Digestive Diseases, Portsmouth, United Kingdom. The clinical trial was sponsored by Cosmo Pharmaceuticals, N.V. (SIX: COPN) (Cosmo), the developer of Eleview.
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 as a class ll medical device and is the only commercially available medical device for this indication. 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.

CONTRAINDICATIONS
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 Ltd. Aries is the U.S. 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: https://www.ariespharma.com/

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Mike Walther
Aries Pharmaceuticals, Inc.
mwalther@aries-pharma.com
858-202-6138

Deborah Hernandez
Feinstein Kean Healthcare
deborah.hernandez@fkhealth.com
617-761-6731
1-ELE17084

 

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 U.S. 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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hr@aries-pharma.com

News 03
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hr@aries-pharma.com