Arch Therapeutics Announces Plans for Upcoming Activities

CAMBRIDGE, MA, Aug 06, 2013 (Marketwired via COMTEX) -- Arch Therapeutics, Inc. (otcqb:ARTH) ("Arch" or the "Company"), a life science company and developer of AC5(TM), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to provide a brief review of proposed future activities.

Arch Therapeutics CEO Dr. Terrence Norchi states, "We are thrilled to be moving ahead with the development of our core technology. We envision the potential future customers in the marketplace for AC5(TM) and related products will include surgeons and other doctors, government agencies, hospital and operating room management, ambulances and trauma specialists. These market segments, even taken separately, present meaningful opportunities for the Company."

According to a 2012 report produced by MedMarket Diligence, LLC, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the U.S. We estimate that 20-25% of those surgeries are performed laparoscopically. Additionally, there are many minor procedures and operations that may not be included in those figures. Those surgeries and other procedures could benefit from sealants and hemostatic agents, as surgical and trauma patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluid.

As a result of this demand, use of hemostatic agents and sealants is increasing. According to MedMarket Diligence, the market for these products achieved approximately $3.4 billion in 2010 worldwide sales and is projected to reach $4.5 billion in 2013 and surpass $6.5 billion in 2017. Over two-thirds of those sales are for hemostats. The growth rate for sealants is even higher than that for hemostats due to a general lack of available products and potentially larger unmet need.

The results of early data from preclinical tests have shown that AC5(TM) achieves hemostasis quickly and effectively. From a commercialization perspective, improvements in relevant synthetic manufacturing techniques in the past several years have reduced complexity and decreased materials cost. Further, AC5 will be made of naturally occurring ingredients that are not sourced from humans or other animals, but do exist in humans in their natural state. This type of ingredient is categorized as "generally recognized as safe," or "GRAS," by the U.S. Food and Drug Administration ("FDA"). Although the FDA and other regulatory authorities or related bodies will finally determine the classification of AC5(TM), the Company believes it meets the criteria for a medical device.

In furtherance of its stated long-term business goals, the Company reiterated plans to focus on the following activities during the remainder of calendar year 2013 and calendar year 2014:

-- further developing and securing intellectual property rights; and 

-- engaging a large scale manufacturing partner to produce cGMP product for clinical trials;

-- participating in EU and, subsequently, U.S. regulatory meetings; 

-- preparing for initial clinical trials, including developing clinical trial protocols; 

-- conducting formal biocompatibility studies;

-- commencing human clinical trials.


Company CEO Dr. Terrence Norchi further comments, "We believe that AC5(TM) will meet increasing demands, with anticipated market entry for use in laparoscopic, as well as open surgery. While open surgery represents the more established market for hemostatic agents, approximately one-quarter of surgeries are laparoscopic, and that number is growing. Many of the hemostasis products currently available do not possess certain features and handling characteristics that are ideal for the laparoscopic setting. Further, there seems to be increased pressure to perform more complex surgeries at reduced costs, including conducting operations in less expensive outpatient settings. We believe that the novel features and differentiating characteristics of our technology platform, starting with AC5(TM), will address the need for highly improved hemostatic and sealant products."

Additional details regarding Arch Therapeutics, Inc., its business, agreements and related matters are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission ("SEC"), and are available at the SEC's website at www.sec.gov. For more information, visit our website at www.archtherapeutics.com.



About Arch Therapeutics, Inc. (otcqb:ARTH) Arch Therapeutics, Inc. (otcqb:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch's goal is to develop and commercialize products based on our innovative technology platform that make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate known as AC5(TM) is being designed to elegantly achieve hemostasis in minimally invasive and open surgical procedures. Find out more at www.archtherapeutics.com.

Medicines Co. wraps $240M deal to buy ProFibrix following PhIII success

The Medicines Company has swooped in to buy out the Dutch biotech ProFibrix, chipping in $90 million in cash on top of a $10 million option anted up in June as Phase III data on a lead surgical therapy loomed. And the buyer has agreed to pay up to $140 million more for a set of unspecified milestones.

The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.

The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, commented ProFibrix CEO Jan Ohrstrom. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.

"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.

"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."

The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.

US FDA clears Abyrx's absorbable haemostatic bone putty for clinical use

Abyrx, Inc., a privately-held therapeutic device company, has received the United States Food and Drug Administration (FDA) clearance for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the state.

AHBP is provided ready-to-use (without requiring mixing or warming) and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery. Abyrx will offer AHBP in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to improve efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.

AHBP complements Abyrx’s existing surgical hemostat product offerings which currently include Hemasorb and Hemasorb Apply. With this new product, Abyrx is executing its strategy of vertically integrating within the surgical hemostasis marketplace.

Commenting on Abyrx’s portfolio approach to the marketplace, John J Pacifico, the Company’s president and chief executive officer, stated, “Our team is committed to providing the most comprehensive bone hemostat product line in the operating room. AHBP and other products under development complement our Hemasorb products and will provide surgeons with more options to treat their patients and help enable hospitals to reduce costs.”

Richard Kronenthal, Ph.D., Abyrx’s chief scientific officer, offered his thoughts about the developmental challenge and the potential of the AHBP technology platform, “Our technical team evaluated dozens of subtle chemical and processing variables to specifically meet the surgical performance requirements of AHBP. Indeed, we continue to enjoy the challenge of further innovation by drawing on this new technology platform and our knowledge of the surgeon’s important needs.”

Abyrx’s surgical hemostat products are used by cardiothoracic, craniomaxillofacial, spine, orthopaedic, neurological, and trauma surgeons. The Company estimates that over 3.5 million patients undergoing surgical procedures each year could benefit from the intraoperative use of its products.

Court Enters Order Under Which Vascular Solutions Will Cease Manufacture, Sales and Distribution of R-Band

SOMERSET, N.J., May 21, 2013 /PRNewswire/ -- Terumo Medical Corporation (Terumo), today announced that it was pleased with the U.S. District Court for the District of New Jersey's Order approving an agreement of the parties under which Vascular Solutions Inc. will cease further manufacture, sales, and distribution of its R-Band™ Radial Hemostasis Device, pending litigation of Terumo's claims.

In February, Terumo filed a patent infringement lawsuit alleging that the R Band™ Radial Hemostasis Device infringes on U.S. patent and trademark rights held by Terumo Medical Corporation for its proprietary TR Band™ Radial Compression Device. The R-Band is distributed in the U.S. by Vascular Solutions and manufactured by Lepu Medical Technology. Terumo sought an injunction against further sales of the infringing product.

"Terumo is extremely gratified with the Court's Order. We are thankful for the opportunity to successfully defend our TR Band™ device, which is a critical part of our transradial solutions portfolio," said James Rushworth, President, Terumo Interventional Systems and Onset Medical Corporation. "As a market leader, Terumo is committed to doing what is right for our business and, when appropriate, we will vigorously protect our investments, assets and intellectual property."

Terumo's market-leading TR Band™ Radial Compression Device is used to achieve patent hemostasis immediately following a transradial access diagnostic and intervention in the treatment of cardiac and vascular disease. The clear band is placed around the patient's wrist to effectively stop access-point bleeding. The TR Band™ features dual compression balloons that maintain precise pressure on the radial artery to ensure blood return without compromising local nerve structure. Transradial access interventions have been shown to significantly reduce bleeding complications by up to 75 percent when compared to femoral (through the groin) interventions.

Cohera Medical Completes Enrollment of Sylys™ Surgical Sealant Clinical Trial

PITTSBURGH, May 30, 2013 -- /PRNewswire/ -- Cohera Medical, Inc.^®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the completion of enrollment of its clinical trial for Sylys, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures.

Currently underway in Europe, the study is evaluating the safety of Sylys on the reduction of anastomotic leakage following bowel repair. The study included patients enrolled at two sites in the Netherlands.

"We are excited to conclude enrollment in this significant safety trial for Sylys, which has the potential to help reduce anastamotic leakage following colorectal procedures," said Dr. Consten of the Meander Medical Center, Amersfoort.  "We look forward to following the enrolled patients and reporting the findings of this study." 

"Cohera appreciates the fast enrollment by both Dr. Bemelman, at AMC Hospital and Dr. Consten at the Meander Medical Center" said Chad Coberly, JD, VP of Clinical, Regulatory and Legal Affairs of Cohera Medical.  "We also greatly appreciate the assistance of the team at Factory CRO, in the Netherlands, to help us reach our timeline objectives on this important first in human study.

Anastomotic leaks, on average, occur in 3 – 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 – 4B market.

"Enrollment completion of this study is monumental for Cohera Medical, as this is our second class III product in humans," said Patrick Daly, President and Chief Executive Officer of Cohera Medical.  "It is an indication of the remarkable surgeons we work with, who recognize the value of this sealant, and its ability to enhance standard closure techniques, supporting the healing process and reducing post-operative complications."

Read more here: http://www.sacbee.com/2013/05/30/5457988/cohera-medical-completes-enrollment.html#storylink=cpy

Chinese Starch Medicals Perclot Patent Claims Denied - Impact for Cryolife predicted

Recently denied claims for China based Perclot manufacturer Starch Medical have seen Starch re-file a dramatically reduced set of claims revised patent application published May 16, 2013 (see HERE). 
The original 2009 filing which includes "Inventors" Ji Xin (James Ji), previously Chinese Distributor of Medafor's Arista, has now dropped Jianping Chen (Jane Chen) as an "Inventor".

 Of more critical importance the patent has now shrunk in respect of claims made. Currently claims 1-53 have now been cancelled and it seems likely this patent is less than secure.

The EU search indicates denial regarding incorrect claims and scope of the claims regarding novelty, and inventive steps. Comments such as "the skilled person knows....this method does not support an inventive step" amongst others is available in the embedded document below.

  European Search Report Starch Medical PCT_US2009000227

In the meantime it will be interesting to see the reaction from Cryolife Shareholders who, having been subjected to the Medafor - Cryolife debacle, may now have serious due diligence queries of executives. The millions spent already on the CRY-Starch marriage may be a concern, but continued investments highlighted in the last quarterly report by executives such as Ashley Lee who announced Q1 2013 the intention of (after initial denial of the Perclot IDE) re-filing the IDE with the FDA in May. Ashley also stated further investment in Perclot with "a 320 patient study, randomized 1:1 with a 30-day follow up over across several medical specialties". CEO Steve Anderson commented when questioned about Perclot manufacturing "I think we’ve already spent the money that we’re going to spend to build out our manufacturing facility that frankly is up and ready to go".

RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age

PARSIPPANY, NJ--(Marketwired - May 9, 2013) -  The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for RECOTHROM®, Thrombin topical (Recombinant) to include use in pediatric patients, following completion of a post-approval pediatric clinical trial commitment. RECOTHROM is a recombinant topical thrombin now indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adult and pediatric populations greater than or equal to one month of age. RECOTHROM provides patients greater than one month of age an alternative to bovine or human plasma derived thrombin. 

"Pediatric patients, in various surgical settings, have an increased chance of repeat surgeries. RECOTHROM has been studied in pediatric patients and shown to have a low rate of immunogenicity, and offers an important tool for use in this patient population," said Kevin N. Foster, MD, MBA, FACS, Chief, Burn Services, The Arizona Burn Center at Maricopa Medical Center.

The recent FDA approval is based, in part, on data from a completed Phase 4, open-label, single-group safety and immunogenicity study. This study was conducted in 30 pediatric patients greater than one month of age undergoing synchronous burn wound excision and skin grafting. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults. Safety and efficacy has not been established in neonates.

"Our purpose is to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world," said Brent Furse, Senior Vice President and Chief Customer Officer of The Medicines Company. "There are several hundred leading hospitals in the United States that conduct thousands of surgical procedures in pediatric patients each year. We believe the expanded pediatric indication for RECOTHROM provides an opportunity to make this topical hemostat available to a broader range of surgical patients."

About The Medicines CompanyThe Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.

ProFibrix Completes Patient Enrolment in Pivotal Phase III with FibrocapsTM and Reports Positive Feedback from Surgical Community

Company remains on track for 2013 filings in US and Europe

LEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)-- ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced that the company has completed enrolment of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) on schedule.
FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in surgical patients with mild to moderate surgical bleeding. Participating surgeons enrolled a total of 718 patients in only 10 months. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within four surgical indications, and to confirm the overall safety results from the Phase II Fibrocaps trials. Final study results are expected to be announced in the summer of 2013.
Jan Öhrström, Chief Executive Officer of ProFibrix said: “As enrolment neared completion, we found that participating surgeons repeatedly asked us to allow them to include even more patients, because they find Fibrocaps easy to use and working well in their specific surgical procedures. Based on the very positive response from the surgical community throughout our Phase III trial, we are confident that Fibrocaps will be able to rapidly capture a substantial share of the topical hemostat market, which is currently at US$ 1 billion and growing. With our regulatory filings in the U.S. and EU on track for 2013, we expect to launch Fibrocaps in 2014.”
About Fibrocaps
Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical fibrin sealant, which is being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid fibrin sealants and hemostats: it is ready for immediate use, and is stable at room temperature.
About the FINISH-3 trial
FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control in 718 subjects undergoing spinal (n=183), liver (n=180), vascular (n=174) and soft tissue surgery (n=181). The study was conducted at 65 sites across Europe and the U.S.
For more details on the study, please go to http://clinicaltrials.gov.

ProFibrix Phase III Trial with FibrocapsTM (FINISH-3) Passes Important Safety Milestone & Almost Completes Enrolment

LEIDEN, The Netherlands & SEATTLE -- 

ProFibrix B.V., the leader in next generation hemostatics, today announced that the Data Monitoring Committee (DMC) of the FINISH-3 trial of Fibrocaps unanimously recommended the study to continue as designed. The DMC is an independent expert panel overseeing patient safety of this pivotal trial in spine, liver, vascular and soft tissue surgery. At its final meeting, the DMC reviewed data from the first 403 subjects enrolled in the trial, and found no safety concerns.

To date, less than 9 months after the first subject was enrolled, over 85% of the 672 subjects necessary to complete enrolment have already been recruited into the study. Two of the four surgical indications, spinal and soft tissue surgery, completed enrolling. Full enrolment is expected to be completed in April 2013 and final results from the study are anticipated in June 2013.

Jan Öhrström, Chief Executive Officer of ProFibrix said: “The positive review by the DMC bodes well for our filings with U.S. and EU authorities in the fall of 2013. Furthermore, the strong support of the investigators involved in FINISH-3 has resulted in an amazing speed of enrolment. This strengthens our belief that Fibrocaps has the hallmarks to capture a significant part of the fast growing USD 1 billion topical hemostat market.”

About Fibrocaps

Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.

About the FINISH-3 trial

FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control for the treatment of mild to moderate bleeding in 672 subjects undergoing spinal, liver, vascular and soft tissue surgery (n=168 in each indication), conducted at 65 sites across Europe and the U.S.

MDCO, Bristol-Myers Squibb begin global alliance for Recothrom

The global license and two-year collaboration signed between the Medicines Company (MDCO) and Bristol-Myers Squibb (BMS) for Recothrom, a recombinant thrombin approved by the US Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures has become effective. The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions. Glenn Sblendorio, president and chief financial officer of The Medicines Company, said, "We look forward to the start of our global license and collaboration for Recothrom. We believe that completing this deal is another step to establish The Medicines Company as a leader in acute and intensive care medicine globally." Recothrom is a surgical hemostat that is applied topically to stop bleeding during surgery. Its active ingredient is recombinant human thrombin (rThrombin) and the product is indicated as an aid to hemostasis whenever control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. Recothrom is part of a class of surgical hemostats commonly referred to as "active" hemostats. Other classes of surgical hemostats include mechanical hemostats, flowable hemostats and fibrin sealants. Recothrom was approved in the United States in January 2008 and in Canada in December 2010. The Medicines Company provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide.