Fremont, CA, August 22, 2008-- ARYx Therapeutics Inc., a biopharmaceutical company, today announced the results of a Phase 2b clinical trial testing the safety and efficacy of its prokinetic agent, ATI-7505, in patients with chronic idiopathic constipation. The clinical trial, conducted by Procter and Gamble Pharmaceuticals (P&G), was designed to enroll 400 patients evaluating four doses of the agent compared to placebo. As announced last month, the study was terminated early after only 214 patients had been enrolled, as a result of the termination of the collaboration between ARYx and P&G.
"In spite of the early termination of the study, ATI-7505 achieved statistical significance at the study's primary endpoint in the 80 mg twice daily dose. In addition, all doses tested demonstrated a clinically meaningful increase in spontaneous bowel movements over baseline compared to placebo after one week of treatment," said Dr. Paul Goddard, Chief Executive Officer and Chairman of ARYx. "From a tolerability perspective, ATI-7505 improved patients' ability to experience spontaneous bowel movements with virtually no reports of diarrhea or nausea from the patients in this trial."
The clinical trial was a Phase 2b, randomized, placebo-controlled study of ATI-7505 in patients with chronic idiopathic constipation conducted at 42 trial sites in 5 countries. Patients were treated for 4 weeks and the primary efficacy endpoint was the improvement in the total number of spontaneous bowel movements (SBM) during the first 7 days after randomization compared to placebo. Patients were randomized to either placebo or doses of ATI-7505 of 20 mg twice a day (bid), 40 mg bid, 80 mg bid, or 120 mg bid. Randomization was balanced amongst all treatment arms. SBM was defined as a bowel movement occurring without the need for a laxative or enema within the preceding 24 hours. Safety assessments were conducted on every patient enrolled.
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Shelton, CT, August 5, 2008 -- Cara Therapeutics, Inc. today announced completion of a Phase I clinical trial for its second-generation, peripherally acting kappa opioid agonist, CR845, under development for thetreatment of acute and chronic pain. The drug candidate was safe and well-tolerated after intravenous infusion, and resulted in plasma levels of CR845 expected to be associated with clinical analgesic activity. In addition, CR845 infusion triggered a quantitative endocrine biomarker of peripheral kappa opioid receptor activation at the lowest dose tested.
The Phase Ia single-center clinical trial evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of CR845 in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female volunteers. CR845 was shown to be safe at all doses investigated, with no reports of serious side effects or adverse central nervous system activity. Linear, dose-proportional increases in systemic exposure to CR845 were observed. Low doses of CR845 resulted in plasma levels at or above the plasma levels of drug expected to be associated with clinical analgesic efficacy.
The Company plans to advance its intravenous formulation of CR845 into Phase II trials later in 2008. Based on the demonstrated safety, tolerability, and bioactivity of this formulation in Phase I, Cara will continue to develop its oral formulation of CR845 for advancement into Phase I.
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Shelton, CT, July 24, 2008 -- Cara Therapeutics, Inc. announced today that it had closed on $12.3 million of additional funding to its original $24 million Series C financing which was completed in 2007. The round was led by new investor, Devon Park Bioventures, and included participation by Connecticut Innovations. Previous investors participating in the round included; Ascent Biomedical Ventures, Mitsubishi International Corporation and Wistar Morris. In conjunction with the financing, Dr. Christopher Moller, General Partner at Devon Park Bioventures, will join Cara's Board of Directors. The additional funds will be used primarily for further clinical development of both intravenous and oral formulations of Cara's second generation peripherally-selective kappa opioid agonist, CR845.
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Shelton, CT, July 22, 2008 -- Cara Therapeutics, Inc. announced today that The United States Patent and Trademark Office has issued U.S. Patent No. 7,402,564 entitled "Synthetic Peptide Amides" under its Accelerated Examination Program. The application was filed on November 12, 2007 and covers Cara's second generation, peripherally-selective kappa opioid receptor agonist compounds. These compounds include CR845, currently completing a Phase I clinical trial and in development for injectable and oral delivery for the treatment of acute and chronic pain of visceral, inflammatory and neuropathic origin, and for the treatment of pruritis (itch), a common disorder associated with several diseases and conditions.
In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in reducing pain of inflammatory, neuropathic and visceral origin. The analgesic and anti-inflammatory effects of CR845 lasted for up to 18 hours after a single dose. CR845 was active after intravenous, subcutaneous, or oral administration. Preclinical studies also indicate that CR845 possesses anti-itch properties. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus), impair breathing or elicit signs of addiction in animal models. CR845 is currently completing Phase Ia studies.
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Sunnyvale, CA, June 24, 2008 -- Spinal Kinetics, a leader and innovator in advanced generation artificial disc technology, today announced that it has successfully completed patient enrollment in it’s M6-C artificial cervical disc U.S. Feasibility Study.
The Feasibility Trial results will be used to gain FDA clearance to initiate a broader U.S. pivotal trial to study the safety and efficacy of the M6-C artificial cervical disc in a larger population of patients with degenerative disc disease of the cervical spine. “Overall we were extremely pleased with the intra-operative performance of the M6 cervical disc, as well as the simplicity and ease of implanting the device during the study,” states Thomas Dimmig, MD, Principal Study Investigator from Triangle Orthopedic Associates in Durham, NC. “The natural design characteristics of this artificial disc may provide added clinical benefit for our disc replacement patients by more accurately replicating the biomechanical motion of the natural disc we remove. We will be closely assessing our patient outcomes to gain further insight to the benefits of this unique design.” Founded in 2003, Spinal Kinetics is a privately-held medical device company focused on partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine.
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Raynham, MA, November 13, 2007 -- DePuy Spine, Inc., in partnership with Johnson & Johnson Development Corporation (JJDC), today announced that they will provide $5 million in Series C equity financing to Biomerix Corporation, a medical technology company developing novel devices in orthopedic, endovascular, and neurovascular medicine. The investment will be used to advance the company’s development programs including development of a new annulus repair implant following lumbar discectomy.
The annular implant utilizes a novel, proprietary biomaterial, the Biomerix Reticulated Matrix, a biocompatible, biodurable polyurethane scaffold which has been shown to support tissue growth in animals and may reduce the risk of recurrent disc herniation and continued degeneration of the affected disc.
Approximately 300,000 discectomy procedures are performed in the United States and up to 10 percent of patients require additional surgeries to correct reherniation. During a discectomy, the surgeon removes the portion of the spinal disc that is herniated and protruding into the spinal canal.
“We continue to invest in new technologies that have the potential to dramatically improve patient outcomes in spinal interventions,” said Gary P. Fischetti, President, DePuy Spine. “Biomerix has an innovative technology that we believe can make a real difference for spine surgeons and their patients and we look forward to our continued collaboration with them.”
“We are pleased with the support we received from DePuy Spine and JJDC. This will enable us to take our product development efforts to the next level with a partner committed to innovation that improves outcomes,” said Steven Hochberg, Chief Executive Officer, Biomerix.
DePuy Spine, a Johnson & Johnson company, has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies.
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Fremont, CA, November 7, 2007 -- ARYx Therapeutics Inc., announced today
that it has priced its initial public offering of 5,000,000 shares of its common stock at a price of $10.00 per share. All shares are being offered by ARYx Therapeutics. In addition, ARYx Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares to cover over-allotments, if any. ARYx Therapeutics common stock will trade on the NASDAQ Global Market under the symbol "ARYX."
The underwriters of this offering are Morgan Stanley & Co. Incorporated acting as sole book runner and lead manager, and CIBC World Markets Corp., Jefferies & Company, Inc. and Leerink Swann LLC, Inc. acting as co-managers.
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Fremont, CA, August 30, 2007 -- ARYx Therapeutics Inc., announced today that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission for a proposed initial public offering of shares of its common stock. All of the shares in the proposed offering will be sold by ARYx Therapeutics.
The underwriters of the offering will be Morgan Stanley & Co. Incorporated acting as sole book runner and lead manager and CIBC World Markets Corp., Jefferies & Company, Inc. and Leerink Swann & Co., Inc. acting as co-managers. The number of shares to be offered and the price range for the offering have not yet been determined.
The offering will be made only by means of a prospectus. When available, a copy of the preliminary prospectus relating to the offering may be obtained from Morgan Stanley & Co. Incorporated by emailing prospectus@morganstanley.com or by contacting the prospectus department at 180 Varick Street, New York, NY 10014 Attn: Prospectus Department.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
ARYx Therapeutics is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates designed to eliminate known safety issues associated with well-established, commercially successful drugs. ARYx uses its
RetroMetabolic Drug Design™ technology to design structurally unique molecules that retain the efficacy of these original drugs but are metabolized through a potentially safer pathway to avoid specific adverse side effects associated with these compounds. ARYx currently has three products in Phase 2 clinical trials: ATI-7505 for the treatment of various gastrointestinal disorders, ATI-5923 for the treatment of patients at risk for the formation of dangerous blood clots, and ATI-2042 for the treatment of atrial fibrillation.
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Tarrytown, NY, November 28, 2006 -- Cara Therapeutics, Inc. announced today that it had closed on $19 million of its Series C financing. New investors participating in the round include MVM Life Science Partners and Alta Biopharma Partners, as well as previous investors Ascent Biomedical Ventures. In conjunction with the financing, Dr. Stephen Reeders, Managing Partner of MVM Life Science Partners, and Ed Hurwitz, Director of Alta Partners, will join Cara's Board of Directors. Dr. Stephen Reeders commented "Over the last twenty years there has been little innovation in treating pain. There is a big gap in the choices available to clinicians between moderately efficacious OTC analgesics and centrally accting opiates with serious side effects. We believe that Cara Therapeutics is developing novel drugs to fill this gap."
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Cincinnati, OH, and Fremont, CA, July 11, 2006 -- Procter & Gamble Pharmaceuticals Inc., a division of The Procter & Gamble Company (NYSE: PG) and ARYx Therapeutics Inc., a private drug discovery and development company, today announced a strategic alliance under which P&G will develop and commercialize ARYx's novel drug, ATI-7505, for the treatment of gastrointestinal disorders such as gastrointestinal reflux disease (GERD) and gastroparesis (delayed emptying of the stomach).
Under the terms of the agreement, which remains subject to clearance under the Hart-Scott-Rodino Improvements Act, ARYx will grant P&G rights to the worldwide development and commercialization of ATI-7505 in exchange for a $25 million upfront fee, milestone payments, and royalties on product sales. In addition, ARYx has an option to co-develop and co-promote ATI-7505. In total, payments could reach $435 million over the life of the project, including $250 million that could be earned prior to commercialization. These payments are contigent upon the successful completion of specified development, regulatory, and commericialization goals. ARYx will receive royalties, with the rate escalating upon the achievement of varying sales targets. No other financial terms of the agreement were disclosed.
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Fremont, CA, February 7, 2006 -- ARYx Therapeutics Inc., a private drug discovery and development company, announced today that it has completed a $30.4 million Series E financing led by Ascent Biomedical Ventures. The Company plans to use the funds to continue developing its three clinical programs, ATI-2042, ATI-7505 and ATI-5923 through to proof of concept Phase 2 data. The Company expects to seek partnerships for each of its products upon successful proof of concept.
In addition to Ascent Biomedical Ventures, the Company's existing investors, including MPM Capitol, Nomura Phase4 Ventures, OrbiMed, Merlin BioMed, JAFCO Life Science Invesments, Scottish Widows Investment Partnership, Montreux Equity Partners and Novel Bioventures, participated in the fundraising.
ARYx anticipates that through the application of its proprietary retrometabolic chemistry approach, the Company can address and resolve safety issues associated with well-established and commercially successful drugs. Based on this approach, ARYx has advanced three products into human clinical trials. ATI-7505, a treatment for gastroesophageal reflux disease (GERD) and gastroparesis, and ATI-2042, a treatment for atrial fibrillation, are both in Phase 2. ATI-5923 is an oral anti-coagulant therapy currently in Phase 1 clinical testing.
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Tarrytown, NY, January 5th, 2006 -- Cara Therapeutics, Inc. announced today that it had entered into a worldwide licensing agreement with ALZA Corporation, a Johnson & Johnson company, for Cara's novel peripherally-acting pain drug candidate, CR665. Cara has successfully completed a Phase 1a clinical trial with an intravenous formulation of CR665 and the collaboration will focus on further clinical development of this formulation, as well as the development of additional formulations of this compound incorporating ALZA technologies. "We believe that ALZA's and Johnson & Johnson's proven expertise in drug development and marketing in the analgesia and anti-inflammatory sector will provide an optimum path for the worldwide clinical development and commercialization of CR665," stated Dr. Derek Chalmers, Cara's President and CEO.
Under the terms of the agreement, Cara received an upfront payment and will be eligible to receive pre-determined clinical and regulatory milestone payments. Cara is also eligible to receive royalties on sales of all marketed products incorporating the compound, as well as an option to co-promote intravenous products in the U.S. Cara will be supported by J&J and ALZA for further development of CR665 -- including an IV formulation for post-operative and nursing home applications, and formulations that would allow outpatient and primary care pain treatments in large indications such as rheumatoid arthritis and inflammatory bowel syndrome.
The Company also announced that it had closed $4.7 million of Series B funding in December 2005. Ascent Biomedical Ventures participated in the round along with existing individual investors. The Series B funding will be used to advance internal development programs for additional pain and inflammation drug candidates.
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New York, NY, February 3, 2005 -- Biomerix Corporation announced today that it received 510(k) clearance from the U.S. FDA for its first device, the Biomerix Vascular Occlusion Device (VOD). The VOD is based on the Company's novel, proprietary biomaterial, the Biomerix Reticulated Matrix, a biocompatible, biodurable polyurethane scaffold which has been demonstrated to support tissue ingrowth in preclinical studies. Biomerix is a medical technology company developing novel devices for endovascular, neurovascular, and orthopedic medicine. Founded in late 2001, Biomerix is currently developing four products addressing an aggregate worldwide market opportunity of approximately $2 billion.
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