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Regenicin - Several FDA and Clinical Trial Catalysts Pending

publication date: Jan 14, 2011
Regenicin (RGIN) - Mike Havrilla's Stock Notes 
 
References include SEC 10-K Filing on 1/13/11 and press release / media coverage for $RGIN Regenicin, Lonza, and PermaDerm…
http://www.nasdaq.com/asp/quotes_sec.asp?symbol=RGIN&selected=RGIN
 
This is a highly speculative regenerative medicine play that is developing a patient-derived engineered skin substitute known as PermaDerm with several FDA, clinical trial catalysts pending as outlined in the recent SEC 10-K filing on 1/13/11…most notably the Company plans to file for Humanitarian Device Exemption (HDE) for potential early (i.e. prior to full FDA approval) marketing under designation as a Pediatric Humanitarian Use Device (HUD)…also plans to conduct clinical trial (United States Army Institute of Surgical Research at Fort Sam Houston and at a second site to be determined) in adults to support full FDA approval (PMA filing)
 
$RGIN Regenicin – Clinical Regulatory Catalyst Calendar Entries (2) for PermaDerm (patient-derived, bio-engineered skin substitute)…
 
1.) Pending Pivotal (Medical Device) Clinical Trial to Support PMA Filing
 
Expects to begin pivotal study in early 2011 (1Q11 estimate) in up to 40 adult burn victims at US Army Institute Surgical Research (Fort Sam Houston) to support PMA submission for full FDA clearance, study and FDA approval process is expected to take two years, partnered with Lonza including Dept. of Defense funding support
 
2.) FDA New Filing (Humanitarian Device Exemption or HDE)
 
SEC 10-K filing on 1/13/11 outlines plans to file for Humanitarian Device Exemption (HDE) for potential early (i.e. prior to full FDA approval) marketing under designation as a Pediatric Humanitarian Use Device (HUD) based on use in over 150 pediatric burn victims, estimate for potential HDE filing during 1Q11 w/ expected 75-day review period
 
Background info on Humanitarian Use Device (HUD) / Humanitarian Device Exemption (HDE) Applicatons => HUD is a program enacted by legislation that creates an alternative pathway for obtaining market approval for medical devices that may help people with rare diseases or conditions. HUD is defined as a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.” To obtain approval for an HUD, a humanitarian device exemption (HDE) application is submitted to FDA, which is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. The HDE must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. An approved HDE authorizes marketing of the HUD that may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The FDA will approve or deny HDE applications within 75 days from the date of receipt. In addition, a 30-day filing period starting at the filing date, will be used by FDA to determine completeness of the filing for a full review and the review time for amendments, supplements and additional reports is 75 days.
 
$RGIN Notes from SEC 10-K filing on 1/13/11 and related news / media articles…
 
- 83.4 million (M) shares of common stock outstanding as of 1/6/11
 
- partnership w/ Lonza Group, which was recently awarded $18M to develop / commercialize PermaDerm for treatment of severe burns
 
- PermaDerm is a patient-derived, engineered skin substitute that has been used in over 150 pediatric burn victims (through Investigation Device Exemption or IDE clearance by FDA) that has the ability to expand / grow a small sample of a patient’s skin by up to 100X in 30 days to form skin that grows w/ the patient and is not rejected by the immune system, as compared to skin grafts that are harvested from the patient or derived from pigs (porcine) or human cadavers that represent much longer, riskier, and more complex methods of treating burn victims. PermaDerm is a combination of cultured epithelium with a collagen-fibroblast implant that produces a skin substitute that contains both epidermal and dermal components, which has demonstrated the ability to generate a functional skin layer.
 
- Plans to initial clinical trial to support PMA filing for use in adults that will involve up to 40 patients, both male and female, between the ages of 18 and 40, who suffer third-degree burns.  These trials and future trials will take place at the United States Army Institute of Surgical Research at Fort Sam Houston and at a second site to be determined. Unrestricted sales of PermaDerm will require approval of either a PMA or PDP after data for safety and efficacy are collected from a multi-center study. Design of the multi-center study is being discussed with the FDA.  Based on the proposed design, the study is estimated to require enrollment and treatment of not more than 40 patients, and follow-up for one year.  Enrollment and treatment are expected to require one year.  After collection of data and submission to FDA, one year is planned for FDA’s review and decision.  Therefore, we plan that performance of the multi-center study and a decision from FDA will require two years.
 
- $RGIN has commenced preparation of the HDE application and expects to file it with the FDA early this year.  FDA is permitted 75 days to respond to HDE applications.  After approval of the HDE, sales of the HUD can begin.  HDEs are reviewed as PMAs that are not required to demonstrate statistical significant evidence of efficacy.  Each hospital that uses the HUD must activate study protocol (which must be reviewed and approved by a local Institutional Review Board (IRB) to monitor risks and possible adverse reactions.  We will develop a standard study protocol, and act as liaison to activate the protocol at each hospital.
 
- Early marketing can begin under designation of PermaDerm as a Pediatric Humanitarian Use Device (HUD) or biological product, which $RGIN will seek to obtain.  Notwithstanding the historical classification of skin substitutes as “medical devices”, early discussions with the FDA provide some indication that the product, PermaDerm, may be classified otherwise.  In such an event, the product will face a different regulatory process and time frame.
 
=> Cultured skin substitutes that contain both cells and biomedical polymers have historically been categorized as Class III medical devices by FDA.  This classification requires that multi-center studies be performed to verify the safety and efficacy of the device.  Multi-center studies usually occur at the Phase III level of assessment.  The format for data collection in a Phase III study may follow either a Pre-Market Approval (PMA), or Product Development Protocol (PDP). It is most probable that the products for wound care will follow the PDP format because it is believed to provide greater flexibility for modification of clinical protocols during the performance of the study.  Before full marketing of PermaDerm can proceed, either a PMA or PDP approval must be obtained from FDA. During Phase III-level multi-center studies, HUD marketing of PermaDerm can begin.  Marketing of PermaDerm under HUD designation will facilitate clinical experience with the product, and expedite full market penetration after completion of a PMA or PDP. 
 
- Department of Defense Provides Funding to Lonza to Move Therapeutic Candidate PermaDerm into the First Clinical Trials for Adults (11/22/10)…
http://finance.yahoo.com/news/Department-of-Defense-prnews-117132258.html?x=0&.v=1
 
-  The U.S. Department of Defense recently awarded more than $18M in funding to a unit of Lonza Group, Ltd. for the development and commercialization of the therapeutic candidate, PermaDerm for the treatment of severe burns among U.S. troops and civilians.  The funding was announced at a conference celebrating advancements in regenerative medicine on November 9th in Walkersville, MD.
- Regenicin, Inc. (OTC Bulletin Board:RGIN.ob - News), has an agreement with Lonza pursuant to which Regenicin has been charged to obtain FDA approval for the commercial sale of PermaDerm.  The funding will assist Regenicin and Lonza in advancing the clinical trials to be conducted in connection with the FDA approval process.  Regenicin was a presenter at the conference at which the funding was awarded.
 
- $RGIN paid Lonza $3M for the exclusive license and assistance to seek approval from the FDA for the commercial sale of PermaDerm™ in the U.S., and later for approval in foreign jurisdictions for commercial sale of PermaDerm™ throughout the world. In conjunction with Lonza, we intend to create and implement a strategy to conduct human clinical trials and to assemble and present the relevant information and data in order to obtain the necessary approvals for PermaDerm™ and possible related products.
 
- The HUD designation had already been received by Cutanogen and, upon completion of the Lonza Transaction, will be transferred to $RGIN as part of a licensing agreement with the University of Cincinnati, which will allow immediate manufacture and sale of PermaDerm for treatment of catastrophic burns in children.  Subsequent to the transfer of the HUD designation, a Humanitarian Device Exemption (HDE) application must be submitted to specify the protocol for clinical use of the HUD. 
 
- Communication with FDA has designated PermaDerm in the B2 category for Health Care Finance Administration (HCFA) reimbursement. Category B: Non-experimental/investigational 2. It is expected that this categorization will identify the conditions and limitations for reimbursement of costs for this kind of medical device, and for this kind of medical indication. However, because the treating hospitals or physicians will be the customers, reimbursement issues will be their primary responsibility. Nonetheless, for markets to grow as rapidly as possible, $RGIN will expect to assist customers with reimbursement information.
 
- At present, it is not known whether the B2 categorization will apply to the HUD designation. $RGIN plans to investigate the most expeditious and effective mechanisms for cost recovery and reimbursement for its products. Determination of reimbursement mechanisms will be an immediate priority upon activation of corporate management after funding. It is planned that $RGIN will contract the services of a consultant to facilitate clarification of reimbursement issues. It is expected that these issues will be resolved before the simultaneous initiation of HUD sales and the multi-center study of PermaDerm.
 
- $RGIN is currently being financed through a Private Placement Memorandum (PPM) (as of 10/28/10) to sell up to 6M shares of stock @$0.75 w/ 623,400 shares sold through 1/6/11 for gross proceeds of $467,550…$RGIN incurred a net loss of $935,250 for the year ended September 30, 2010 w/ a very low cash balance of $4,564 as of 9/30/10 that is reason for sale of stock through PPM to fund the Company
 
- Operating activities used $346,617 in cash for the year ended September 30, 2010 while investing activities used $3,007,500 during the year ended September 30, 2010 as a result of the Lonza Transaction and the purchase of trademarks from KJR-10 Corp. Financing activities provided $3,358,681 for the year ended September 30, 2010 and consisted of $2,502,025 in proceeds from the sale of common stock less expenses of $369,133, $900,000 from the issuance of notes, $318,789 from advances from related parties, and $7,000 from officer advances.
 
- On August 16, 2010, $RGIN sold 4,035,524 shares of our common stock as part of a Securities Purchase Agreement with certain accredited investors (the “Purchasers”) pursuant to the closing of our Private Placement Offering (the “Offering”). We received aggregate gross proceeds from the Purchasers of $2,502,025 from the sale of the common stock. Expenses related to the Offering totaled $369,133.  The proceeds from the Offering were used to finance the Lonza Transaction.
 
- Below is a summary of agreement w/ Lonza / Cutanogen related to PermaDerm and related patents…
 
The agreement with Lonza also provides that, upon Lonza obtaining FDA approval for commercial sale of PermaDerm we will pay Lonza an additional $2 million to buy its subsidiary, Cutanogen Corporation, (which controls certain exclusive patent licenses underlying the product), and that Lonza will then serve as our exclusive manufacturer and distributor for the product and will share in our product revenue. We currently do not own any rights to PermaDerm
 
In the first stage of the Lonza Transaction, we received, in exchange for the payment of $3 million, an exclusive license to use certain proprietary “Know-How” necessary to develop and seek the approval (“FDA Approval”) by the FDA for the commercial sale of PermaDerm, relating to manufacturing, testing, facilities, and media formulations, and Lonza agreed to provide us with certain related assistance and support.
 
The Lonza Transaction contemplates that, upon receipt of the FDA Approval, in the second stage of the transaction, $RGIN will execute a Stock Purchase Agreement pursuant to which we will purchase all of the outstanding stock of Cutanogen Corporation (“Cutanogen”) from Lonza for an additional purchase price of $2 million. Cutanogen holds certain exclusive licenses (the “Cutanogen Licenses”) to patent rights (“Patent Rights”) owned by The Regents of the University of California and the University of Cincinnati and the Shriners Hospital for Children related to the commercialization of PermaDerm.
In the second stage of the Lonza Transaction, it also is anticipated that we will sign a Manufacturing Agreement and a Distribution Agreement with Lonza, pursuant to which we will appoint Lonza as our exclusive manufacturer and distribution agent for PermaDerm and Lonza will share in our product revenue.  Because Lonza will retain such exclusive manufacturing and distribution rights, we believe that maintaining a good working relationship with Lonza will be critical for the success of our business. 
    
The Lonza Agreement also provides for the payment by us to Lonza of expenses related to the Know-How, expenses related to the prosecution and maintenance of the Patent Rights and certain payments due under a Settlement Agreement and Release with Cambrex Bioscience Walkersville, Inc and the former shareholders of Cutanogen Corporation.  Cutanogen will also be responsible for certain payments respecting the Patent Rights and for other expenses.
 
$RGIN / Lonza / PermaDerm media mentions and articles…
 
 
WALKERSVILLE, MD.  Lonza Walkersvville, Inc. a subsidiary of Lonza AG, a Swiss based life science company and one of the world’s leading cell therapy manufacturers recently hosted, on November 9, 2010, a conference celebrating the latest advancements in regenerative medicine.  More than one hundred people and organizations attended the event in Walkersville, MD to reinforce their commitment to developing and delivering new cellular treatments to the patients who need them.
Presenters and participants emphasized the importance of nurturing public-private partnerships to support the development and delivery of new therapies for the treatment of U.S. troops and civilians.
In attendance was The U.S. Department of Defense Office of Technology Transition, the Armed Forces Institute of Regenerative Medicine, as well as members of Congress, U.S. Armed Forces personnel, scientists, firefighters, and surgeons on the frontlines of treating burns and wounds in the U.S.
Dr. Craig Eagle, who serves on Regenicin’s Board of Directors, presented at the conference. “I was very moved by the solidarity and commitment of all parties, to seek out, develop and deliver new treatments for disease and catastrophic injuries,” says Eagle.
Regenicin, Inc. is a development stage biotechnology company which has recently contracted with Lonza Walkersville to market PermaDerm should Lonza Walkersville win federal regulatory approval.  Lonza Walkersville announced around the time of the conference that Lonza Walkersville received a $1.5 million grant and a $16.9 million contract to develop and commercialize its PermaDerm product.
PermaDerm is aimed at both military and civilian burn victims with severe burns over at least 50 percent of their bodies.
According to Regenecin, Inc.’s website, “PermaDerm™ is being developed to be the only tissue-engineered skin prepared from autologous (patient’s own) skin cells consisting of both epidermal and dermal layers. A small harvested section of the patient’s own skin can be grown to graft an area one hundred times its size in as little as thirty days.
These living, self-to-self skin graft tissue are intended to form permanent skin tissue that will not be rejected by the immune system of the patient, a critical possibility in porcine or cadaver skin grafts used today.
The technology has been clinically tested in over 150 pediatric, catastrophic burn patients. Currently Regenicin is working with its contract manufacturer to prepare for pre-market approval of PermaDerm™ from the FDA.
PermaDerm™ is being designed to save lives, reduce healthcare costs by decreasing the patient’s stay in the Critical Care Unit and reduce the need for additional surgeries. An insurance company procedural code has been approved for reimbursement of costs to hospitals. The American Medical Association has assigned CPT (Current Procedural Terminology) code for cultured skin substitutes under the dermal substitute category which enables insurance companies to process and hospitals to be reimbursed for cultured skin substitutes once approved by the FDA.”
 
2.) Firm Gets Defense Deal for Skin Substitute
Swiss Biotech Group Gets $18 Million is U.S. Funding to Develop Skin Substitute Grown from Patient's Own Cells
http://www.cbsnews.com/stories/2010/11/11/tech/main7046601.shtml
 
(AP)  The Swiss biotechnology company Lonza Group Ltd. is announcing more than $18 million in U.S. defense funding to develop a skin substitute grown from the patient's own cells.
Spokeswoman Melanie Disa said Thursday that Lonza's Walkersville unit received a $1.5 million grant and a $16.9 million contract to develop and commercialize its PermaDerm product.
PermaDerm is aimed at both military and civilian burn victims with severe burns over at least 50 percent of their bodies.
Lonza recently licensed worldwide marketing rights to Regenicin (re-GEN'-ih-sin) Inc. of Little Falls, N.J., provided PermaDerm wins federal regulatory approval.
Disa says clinical trials should begin in early 2011 at Fort Sam Houston, Texas, and another site yet to be determined.
 
3.) Department of Defense Provides Funding to Lonza to Move Therapeutic Candidate PermaDerm™ into the First Clinical Trials for Adults
http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201011220800PR_NEWS_USPRX____NY05900&feedID=600&press_symbol=11138857
 
NEW YORK, Nov. 22, 2010 /PRNewswire-FirstCall/ -- The U.S. Department of Defense recently awarded more than $18 million in funding to a unit of Lonza Group, Ltd. for the development and commercialization of the therapeutic candidate, PermaDerm™ for the treatment of severe burns among U.S. troops and civilians.  The funding was announced at a conference celebrating advancements in regenerative medicine on November 9th in Walkersville, MD.
Regenicin, Inc. (OTC Bulletin Board: RGIN), has an agreement with Lonza pursuant to which Regenicin has been charged to obtain FDA approval for the commercial sale of PermaDerm.  The funding will assist Regenicin and Lonza in advancing the clinical trials to be conducted in connection with the FDA approval process.  Regenicin was a presenter at the conference at which the funding was awarded.
PermaDerm™, an engineered skin substitute grown from a patient's own skin cells, has already been used to treat more than 150 pediatric, catastrophic burn victims through an Investigation Device Exemption issued by U.S. Food and Drug Administration (FDA).  This is PermaDerm's first clinical trial to be conducted on adults, a major milestone for achieving pre-market approval by the FDA.
The initial trial will contain 10 patients, both male and female, between the ages of 18 and 40, who suffer third-degree burns.  These trials and future trials will take place at the United States Army Institute of Surgical Research at Fort Sam Houston and at a second site to be determined.
The protocol, agreed to by the FDA, required that an initial group of patients be treated and assessed by a DSMB prior to enrolling the full complement of patients in each forty (40) patient group.