Nuovo Biologics, LLC

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Company Milestones

 

 

May 15, 2013
Nuovo Biologics, LLC Reports Data on Canine Distemper Disease Pilot Study

May 15, Davie, FL., In response to an outbreak of distemper in the Dallas Metroplex, and the surrounding areas, Nuovo Biologics has been working with Dr. Stephanie Polley to treat dogs with our investigational antiviral drug PVX. The distemper outbreak had led to the euthanasia of many animals and Nuovo's initial pilot project treated some forty-eight dogs so far. Forty two dogs have recovered, and several more are still undergoing treatment, and they are expected to survive.  There was a significant reduction of disease symptoms, as well as reduction of viral loads as determined by PCR testing (a blood test designed to identify a virus and determine its level).   Fourteen dogs were treated for distemper before Nuovo's drug was made available. The animals were treated with antibiotics and fluids for the most part. Less than 50% of those dogs survived. "I don't believe that many of these dogs would be alive today were it not for this new treatment", Dr. Polley states. All the dogs that recovered were either put up for adoption or returned to their owners. According to Dr. Jay Yourist, CEO of Nuovo Biologics, the results of the study support further testing.
November 2, 2012
FDA Center For Veterinary Medicine and Nuovo Biologics, LLC Schedule Meeting to Discuss Protocols.

DAVIE, FL., November 2, 2012 – Nuovo Biologics, LLC has announced that on November 14, 2012 they will meet with the Office of New Animal Drug Evaluation (ONADE) Oncology team at the FDA Center of Veterinary Medicine in Rockville, MD.  The purpose of this advisory meeting is to reach agreement on the key aspects of protocols for two clinical studies to support approval of a Conditional New Animal Drug Application (CNADA).  The product is being evaluated as a potential treatment for canine oral stage II & III malignant melanoma.  Nuovo's melanoma clinical research collaborators, Drs. Bruce Smith and R. Curt Bird, from Auburn University, College of Veterinary Medicine and Auburn University's Research Initiative in Cancer (AURIC) will be joining Nuovo Biologics CEO, Dr. Jay Yourist in this meeting.

While preparing for this meeting, Dr. Yourist stated, "We are on schedule and this will be a significant milestone in bringing our new drug to market. We expect that the discussion with FDA will pave the way for protocol concurrence and initiation of the planned clinical studies". Both the dose characterization and reasonable expectation of efficacy study will be carried out at the College of Veterinary Medicine at Auburn University.

Nuovo Biologics, LLC is a Florida based biopharmaceutical company that is pursing innovative health products and technologies.

For additional information contact:
Stuart Rose 786-619-1642
September 6, 2012
Robert G. Savage, Former Worldwide Chairman, Johnson & Johnson's Pharmaceuticals Group, Joins Board of Nuovo Biologics, LLC
PR Newswire

MIAMI, September 6, 2012 – Nuovo Biologics, LLC announced that Robert G. Savage has joined its Board. Mr. Savage served as Group Vice President and President – General Therapeutics & Inflammation Business of Pharmacia Corporation from 2002 until its acquisition by Pfizer, Inc. in 2003. From 1996 through 2001, Mr. Savage served Johnson & Johnson in a variety of roles, most recently as Worldwide Chairman of Johnson and Johnson's Pharmaceutical Group. From 1985 to 1996 he served Roche Holding AG in a variety of senior marketing, business development and operations positions, most recently as Vice President – Marketing, Hoffman-La Roche, Inc. He is currently a director of EpiCept Corporation and The Medicines Company. Mr. Savage was a member of the Board of Directors of Noven Pharmaceuticals, Inc. from 2004 until 2009 when the company was sold to Hisamitsu Pharmaceuticals Company. Mr. Savage has been the President of Strategic Imagery LLC, a pharmaceutical consultancy, since 2003.

Donald A. Denkhaus, Chairman of the Board of Nuovo Biologics, stated "We are exceptionally fortunate to have a pharmaceutical executive with such a wealth of experience join our Board. Bob's leadership, strategic vision and marketing experience will help move our company to the next level".

Dr. Jay Yourist, CEO, said "Nuovo's first drug in the U.S. will be a broad spectrum antiviral to treat companion animals. Ultimately, approval for human uses for our drugs will be sought. We are particularly pleased that Bob is joining our Board, especially in light of his past responsibility of developing and launching several antiviral and anti-bacterial drugs including Rocephin (ceftriaxone) and Tamiflu (oseltamivir) while he was at Roche and Levaquin (levofloxacin) while he was at Johnson & Johnson." Tamiflu is currently a leading antiviral drug with billions in sales globally since its launch.

Nuovo Biologics, LLC is a Florida based biopharmaceutical company that is pursing innovative health products and technologies.
July 20, 2012
Dr. Jay Yourist, Nuovo Biologics CEO To Speak At The World Animal Health Congress 2012

Dr. Jay Yourist, the President and CEO of Nuovo Biologics, LLC, a biopharmaceutical company headquartered in Davie, Florida has been invited to speak at this year's World Animal Health Congress.

This year's event, sponsored by Terrapinn, will be a two-day forum and parallel exhibition featuring senior-level speakers from pharma, biotech, diagnostics, and government and will be held in Kansas City, MO, November 27 – 28 2012.

Dr. Yourist will speak on building a new animal product research and development paradigm through partnerships and collaborations. This is the Nuovo Biologics development model and Dr. Yourist will address, amongst other things, the challenges in decentralizing drug development between multiple parties.

About Terrapinn
Terrapinn is a business media company. Its products are trade exhibitions, conferences, training solutions, electronic and print publications. Terrapinn owns a portfolio of business to business brands.

The company was established in Sydney, Australia in 1987 and now operates throughout the world from a network of offices in Sydney, Singapore, Johannesburg, New York, Dubai and London. The organization consists of approximately 400 staff and is led by an experienced management team headquartered in London.

About the World Animal Health Congress
The World Animal Health Congress is a senior-level business to business conference for animal drug companies seeking the best business strategies to maximize returns. It is a place where innovation is showcased, learning is done and new business contacts are made. By uniting senior-level animal health executives from big pharma together with CEOs and CSOs from leading small to mid-size pharma and biotechs, World Animal Health Congress USA provides an unrivalled platform to expose the most pressing business challenges of the industry.  Discussing everything from regulatory compliance to delivering veterinary drugs to the market, it is the perfect opportunity to identify and approach new business prospects (www.terrapinn.com/animalhealth).

 
May 3, 2012
Auburn University Scientists to Test Anti-Tumor Properties of New Drug

The Auburn University College of Veterinary Medicine and Nuovo Biologics, a biotechnology company, have announced a collaborative research agreement to study a new anti-cancer drug which also has antiviral properties. Scientists with the Auburn University Research Initiative in Cancer at the College of Veterinary Medicine will be working with Nuovo Biologics to examine the anti-tumor properties of this new drug. These studies will look at the drug from the perspective of its interactions with cells, as well as in clinical trials in dogs with malignant melanoma, a form of skin cancer. Preliminary studies have shown that the drug appears to be safe, with no side effects and active against a wide variety of viruses.

"This agreement exemplifies how Auburn University scientists, working with biotech and pharmaceutical industries, can provide expertise to move exciting new discoveries from the laboratory into the clinic," said AURIC director Bruce Smith.

The Auburn University Research Initiative in Cancer, or AURIC, embodies the "One Medicine" concept which links human, animal and environmental health and where discoveries in one species advance health in all species. For more information on the initiative, go to auricoonline.org.

Nuovo Biologics, LLC is a Florida-based animal health company dedicated to the development of drugs, biologics and supplements to enhance animal health and wellness.

Contact: Tara Lanier, 334-844-3698, tara.lanier@auburn.edu

March 5, 2012
AMERICAN ASSOCIATION OF FELINE PRACTITIONERS (AAFP)
2011 AAFP RESEARCH AWARD


Dr. Les Mandelker, DVM of the Community Veterinary Hospital in Largo, FL has been awarded a 2011 AAFP Research Award for a Pilot Study for PANAVIRA™ for the Treatment of Feline Viral Upper Respiratory Disease.

Dr. Lester Mandelker, DVM with Dr. Jay Yourist, PhD, CEO of Nuovo Biologics, and Co-Principal Investigator will conduct this study and present their research findings at the AAFP Annual Meeting at the conclusion of the study.

The study will be conducted at rescue facilities due to the large number of animals in these facilities with Feline Viral Upper Respiratory Disease. Feline URI is perhaps the most frustrating feline illness facing shelter veterinarians, breeders, and rescue organizations. Many cats are silent carriers of the viruses that cause URI. Shelter cats are predisposed to such infections because of their proximity to multiple felines, as opposed to the limited contact in a private household.

Nuovo Biologics, the sponsor of PANAVIRA™, is testing this drug which is a new broad-spectrum antiviral for nonfood animals.
January 2, 2012
Nuovo Biologics Leases Space - Davie, Fl - Nuovo Biologics, LLC has entered into a lease agreement for 5600 square feet facility in Davie, Florida. The site will have 1700 square feet of sterile manufacturing space, 1100 square feet of cGLP laboratory space, 1200 square feet of cGMP air conditioned warehouse space with the remainder for office and common areas. The Company expects to move into the office and laboratory portion by February 15th, 2012 and have the manufacturing area completed by early in the second quarter of 2012. The custom designed facility will allow Nuovo Biologics to manufacture PANAVIRA™ its signature product, to meet FDA regulations for future studies and clinical trials.

Nuovo Biologics plans to conduct in vitro and laboratory animal research relative to the company's two Investigational New Animal Drug (INAD) numbers and future applications. The Company's long range business plan calls for production under the strictest supervision to meet all FDA regulations. Dr. Neil Ross, Vice President for Product Operations was responsible for the location selection and space design. Dr Ross said, "We are reviewing all the newest technology to allow us to produce PANAVIRA™ in accordance with the FDA's requirements and which will allow us the ability to meet our present and future production needs." The facility will have the capacity and resources for contract manufacture of similar water based sterile pharmaceutical products for veterinary use.

Nuovo Biologics, LLC is a Florida based animal health company dedicated to the development of drugs, biologics and supplements to enhance animal health and wellness.
December 14, 2011
The FDA Center for Veterinary Medicine (CVM) under the Animal Drug User Fee Act (ADUFA), has again granted Nuovo Biologics an extension of the Waiver Sponsor Fees. The current waiver is for FY 2012.

The FDA's decision to grant the fee waiver is based on the assessment that Nuovo Biologics, LLC is pursuing innovative animal drug products and technology in the development on Panavira™ (See Original Waiver of March 9, 2010).
July 27, 2011
Nuovo Biologics, LLC, has received a Minor Use Minor Species Designation (MUMS) for the treatment of local disease in stage II and stage lll oral malignant melanoma in dogs from the U.S. Food and Drug Administration for its drug PanaviraTM.

In a statement released by the company, Dr. Jay Yourist, CEO of Nuovo Biologics, said "This is a pivotal step in a process to bring Panavira TM to market. It is significant in that the designation qualifies Panavira for seven years of exclusive marketing rights relative to the intended use. We are excited about the prospects of beginning our clinical trials."

Under section 573(c)(1) of the Federal Food, Drug, and Cosmetic Act, this marketing exclusivity begins with the date of approval or conditional approval of PanaviraTM for the designated intended use.

PANAVIRA™ is a novel peptide the company believes will prove effective against canine malignant melanoma, along with a host of other viral-related animal diseases. The company has filed several patent applications regarding its PanaviraTM product.
July 20, 2011
The Federal Drug Administration, Center for Veterinary Medicine, has opened a second file for Nuovo Biologics. This Investigational New Animal Drug (INAD) number allows Nuovo Biologics to begin clinical studies for Canine Malignant Melanoma. This INAD is the second granted to Nuovo Biologics. The first INAD was for a broad spectrum antiviral for all non consumable animals.

Nuovo Biologics has been assembling a network of small animal veterinarians in preparation for research and development and for clinical studies. Clinical studies, primarily for respiratory disease caused by viral infections and for canine malignant melanoma have already begun. If you are a veterinarian interested in becoming part of our network,click here.
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July 7, 2011
Nuovo Biologics represented by Dr. Jay Yourist, Mr. Stuart Rose and joined by Dr. Steve Reed met with our Review Team at the FDA Center for Veterinary Medicine to discuss the Clinical Research Strategy for NADA approvals for Viral Respiratory Claims for all non-consumable animals.
July 7, 2011
Dr. Steve Reed, one of Nuovo Biologics research collaborators at Rood & Riddle Equine Hospital, Kentucky, lectured at the FDA Staff College. Dr. Reed delivered three one hour lectures on Equine Neurological Diseases.
June 27, 2011
Colorado State University holds a webinar on the recent Ogden, UT EHV-1 (Equine Herpes-1) outbreak in which Dr. Yourist and other Nuovo Biologics Team members were invited to participate.
June 15-18, 2011
Dr. Yourist attends ACVIM (American College of Veterinary Internal Medicine) conference in Denver, CO. Dr. Yourist and Dr. Reed meet with Colorado State University experts regarding the recent Ogden, UT Equine Herpes Virus-1. Continuing discussions were also held to collaborate with the equine viral infectious disease experts at Colorado State University College of Veterinary Medicine.
May 25, 2011
Initial treatment results for treatment of a ten week old German Shepard named "Trooper" diagnosed PCR positive for Distemper from an outbreak in Miami-Dade County was PCR negative for the Distemper virus after 10 weeks of treatment with PANAVIRA™.
May 16-18, 2011
Dr. Yourist, Mr. Greg Carney (Corporate COO), and Mr. Dan White, (Corporate Counsel) meet in Denver, CO with Mr. Gary Connell and Dr. Richard Stern from Sheridan Ross to initiate discussions on a patent portfolio strategy. Dr. Yourist and Mr. Carney also meet with Dr. Paul Lunn, the Department Head of Clinical Sciences at the James L. Voss Veterinary Teaching Hospital College of Veterinary Medicine of Colorado State University, to discuss a possible research collaboration regarding equine herpes virus.
May 8, 2011
Nuovo Biologics selects Gary Connell of Sheridan Ross, P.A., as new IP counsel to expand our patent portfolio and guide our patent strategy.
April 20, 2011
Dr. Yourist and Mr. Stuart Rose, the Nuovo Biologics Vice President for Business Development, meet with American Equine Insurance Group regarding Equine Health programs and other opportunities. American Insurance Company had agreed to reimburse treatment of a "Dressage" horse diagnosed with Equine Herpes Virus-5 (EHV-5) as a pilot study.
April 19-20, 2011
Dr. Yourist and Mr. Rose meet with Drs. Horohov, Chambers and Church at the University of Kentucky to finalize their research collaboration agreements. Meetings were also held with Dr. Steve Reed, of the Rood & Riddle Equine Hospital to discuss including plans for the upcoming FDA meeting and for the equine pharmacokinetic studies.
April 14, 2011
The Minor Use Designation Request was submitted to the FDA CVM Office for Minor Use Minor Species for Canine Malignant Melanoma grade two and grade three.
March 31, 2011
Nuovo Biologics, LLC closes its $1 million Angel Investor round. The majority of this round consisted of a group of strategic investors from Pittsburgh consisting of primarily physicians, and pharmaceutical industry professionals. The group selected Jeffery Fischer, PharR to sit on the Nuovo Biologics Board.
March 25-26, 2011
The Nuovo Biologics Technical Team completes two days of meetings to discuss and complete a research and manufacturing plan for a time frame through the end of the year. Dr. Jay Yourist, Nuovo CEO, says "it's time to develop a comprehensive plan, given the initial research we've done and the support commitments we've received from collaborators and investors".
February 23, 2011 - Palm Beach International Horse Jumping Competition
Mr. Greg Carney, COO and Mr. Stuart Rose, VP for Business Development attend the Palm Beach International Horse Jumping Competition to meet with various representatives of the equine insurance industry.
January 25, 2011 - Dr. Yourist visits with U.S. Department of Agriculture
Washington, D.C. - Nuovo Biologics CEO along with Stuart Rose, Vice President of Business Development met with seven Senior Managers of the U.S. Department of Agriculture. The agenda included a presentation on Panavira™ and its potential uses by Dr. Yourist and a discussion of possible opportunities for working with the USDA.
January 24, 2011 - Nuovo Biologics meets with FDA Center for Veterinary Medicine
Rockville, MD - The pre-NADA (New Animal Drug Application) Conference was convened with the FDA Center for Veterinary Medicine staff on January 24th.  The meeting focused on our three phased clinical research strategy to complete the proposed New Animal Drug Applications.  Discussions centered on Phase One studies including the proposed pilot malignant melanoma study to meet the Conditional New Animal Drug Application regulatory requirements, as well as product manufacturing requirements, and requisite safety studies. Nuovo Biologics, in conjunction with Auburn University, School of Veterinary Medicine, will initiate clinical trials this spring.
January 15, 2011
Orlando, Florida - The Members of Nuovo Biologics, LLC assembled for their annual Members meeting and to elect their Board of Directors. The Directors include company CEO Dr. Jay E.Yourist, company COO/CFO Gregory Carney, founding member Dr. Kent Miller, and investor Donald Denkhaus, who was selected as Chairman. Jeffery Fisher, of Pittsburgh, PA, representing a group of angel investors, was also selected to serve on the board.

Both Mr. Denkhaus and Mr. Fisher bring to the company a wealth of experience in the pharmaceutical and corporate world. After his election as Chairman, Mr. Denkhaus said; "I am delighted to accept this opportunity to help guide this company. We have an impressive array of talent, experience, and willingness to undertake the task ahead of us."

Nuovo Biologics, LLC is a new animal health product research and development company dedicated to innovative, safe and efficacious products such as drugs, biological and supplements that best support and maximize animal health. Nuovo Biologics, LLC provides, through its network, information sharing, training and education for clinical research and new product development among all animal industry stakeholders.
October 6, 2010
Nuovo Biologics was assigned an Investigational New Animal Drug (INAD) number for PANAVIRA™ for its proposed use as a broad spectrum antiviral drug in non-consumable animals (dogs, cats, horses and birds). For more information please visit Our Products.
October 5, 2010
The United States Patent Office issued Patent # USSN 7,807,635 for PANAVIRA™ mechanisms of action and related disease indications.
August 26, 2010
The FDA Center for Veterinary Medicine (CVM) under the Animal Drug User Fee Act (ADUFA), granted Nuovo Biologics an extension of the Waiver Sponsor Fees for FY 2011.( See March 9, 2010).
April 14, 2010 - Florida Agriculture Commissioner Sends Letter of Support
Florida's Commissioner of Agriculture and Consumer Services has sent a letter of support for bringing Panavira to market. After a review by his staff, Commissioner Charles Bronson wrote to Nuovo Biologics CEO, Dr. Jay Yourist, expressing his support for the project. Florida Department of Agriculture is the Department of Health for animals and, as such, works to eliminate potential deadly viral epidemics, not only to protect the state's animal industry but to keep viruses from possibly being transmitted to humans.
Nuovo Biologics welcomes the support of the industry.
 
 
 
 
March 09, 2010
Nuovo Biologics was granted a waiver fee for FY 2010 from FDA Center for Veterinary Medicine (CVM) under the Animal Drug User Fee Act (ADUFA) based on the assessment that our firm is pursuing innovative animal drug products and technology.
In the letter granting the fee waiver, the FDA is quoted as saying there are virtually no antiviral drugs market for animal use.
Nuovo Biologics reapplied for the Waiver Extension for FY 2011 and an extension was granted on August 26, 2010 (see August 26, 2010). The waiver represents a significant milestone in efforts to bring 'Panavira' to market.