Nanotherapeutics

Your Biopharmaceutical Development and Manufacturing Partner

Nanotherapeutics Receives NIAID Contract as Part of a Multiple Award Pool for Task Orders Valued at Up to $159.4 Million

ALACHUA, FL, September 20, 2016 (BUSINESSWIRE) - Nanotherapeutics, Inc., a contract development and manufacturing organization (CDMO), announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the company a contract for advanced biologics manufacturing services as part of a multiple award IDIQ (Indefinite Delivery/Indefinite Quantity) pool. The contract has a maximum ceiling of $159.4 million and a performance period of up to 10 years.

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Former Gates Foundation and Baxter Executive Peter H. Khoury, Ph.D. Joins Nanotherapeutics as Chief Commercial Officer

ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, Inc., a contract development and manufacturing organization (CDMO), announced today that Peter Khoury, Ph.D. has joined the Company as Senior Vice President and Chief Commercial Officer, effective August 1, 2016.

“We are delighted to welcome Peter, a highly seasoned executive with proven sales and marketing skills, as our Chief Commercial Officer,” stated James M. Matthew, President, Chief Executive Officer and Chief Financial Officer of Nanotherapeutics, Inc. “Having worked in the healthcare and life sciences industries for more than 20 years with several of the largest, most influential and respected global organizations, Peter’s expertise and relationships make him a perfect fit for Nanotherapeutics. In this new position, Peter’s experience will be invaluable as we execute on our strategic plan, including an emphasis on commercial full-scale manufacturing, which is expected to significantly increase our customer base and revenue stream going forward.”

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Nanotherapeutics Closes Sale-Leaseback Financing with Senior Housing Properties Trust for the Company’s New Advanced Development and Manufacturing Facility in Alachua, FL

ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, an integrated biopharmaceutical company with a focus on advanced development and manufacturing, today announced the closing of a sale-leaseback transaction with Senior Housing Properties Trust, or SNH, for the company’s new Advanced Development and Manufacturing Facility in Alachua, FL. The transaction, under which Nanotherapeutics sold the property for $45 million and entered into a 15-year lease, provides the company with long term financing for the 183,000 square foot, state-of-the-art, multi-purpose-multi-product, Biosafety Level-3 capable facility.

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Nanotherapeutics CEO is Guest Panelist at FBR’s Health Series Conference

ALACHUA, FL April 22, 2016. On April 20, FBR hosted a thematic conference featuring 16 guest speakers in four panels to discuss key topics related to infections and diseases, and provided investors a rare opportunity to interact with Robin Robinson, Ph.D., who was most recently the director of the Biomedical Advanced Research and Development Authority (BARDA).   

On the “BARDA Funding Opportunities for Biotech Companies” panel were Dr. Garrett Nichols, CMO of Chimerix; Dr. Jim Talton, CEO of Nanotherapeutics; Stan Erck, CEO of Novavax; and Kelly Childress Lange, partner at East End Group. The main takeaways from the panel were the origins of BARDA and what its role could be in the future for biotech companies. BARDA is meant to fill the gap between early-stage research funded by the NIH and NIAID and later-stage research done by biotech companies. While BARDA was originally funded for 10 years with $5.6 billion, funding now is done by yearly appropriations, meaning it can fluctuate from year to year. However, we note that when an emerging threat presents itself, Congress has typically stepped up to the plate to provide funding. An important aspect going forward could be the award of priority review vouchers for diseases on the Department of Homeland Security’s material threat list, which could then be sold.

Governor Scott Highlights Recent Job Growth at Nanotherapeutics, Inc.

ALACHUA, Fla. – Today, Governor Rick Scott highlighted recent job growth at Nanotherapeutics, Inc., a biopharmaceutical company. In 2013, Governor Scott announced that Nanotherapeutics would be expanding to create 150 new jobs at their new manufacturing facility with a capital investment of $122 million. Since the announcement, the company has already created 75 new jobs and invested $250 million into the local community. Nanotherapeutics currently employs more than 120 Floridians. 

Governor Scott said, “I am proud to recognize Nanotherapeutics for their continued growth and the creation of 75 new jobs. By cutting taxes more than 55 times since 2010, including permanently eliminating the sales tax on manufacturing machinery and equipment, we have helped create a business-friendly environment so manufacturers like Nanotherapeutics can create more job for our families. I also appreciate all of Nanotherapeutics’ work with our nation’s military and their continued efforts to hire veterans so our heroes can build successful careers in Florida.”  

Nanotherapeutics is an integrated biopharmaceutical company with a focus on development and manufacturing. The company produces medical counter measures to combat chemical, biological, radiological and nuclear attacks as well as naturally occurring disease outbreaks. Nanotherapeutics will integrate into a new state-of-the-art facility that can provide the military’s national security requirements for Medical Counter Measures. Nearly 1,000 biotech, pharmaceutical and medical devices companies are located around the state, making Florida’s life science industry one of the best in the country.

Weaver Gaines, Chairman of Nanotherapeutics said, “By August, with the commencement of operations of the Advanced Development and Manufacturing facility in Alachua, we will embark on a dynamic opportunity to become a world class contract development and manufacturing company, serving not only our country’s servicemen and women, but also commercial companies that need our highly specialized abilities.  We have worked closely with the Department of Defense to build a state of the art capability here in Florida, employing a highly skilled labor force that speaks volumes about our state and region. We are extremely grateful for the support we have received from the State of Florida and our local leadership."

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Nanotherapeutics to host interactive mini-symposium about Monoclonal Antibody Technology

On March 21st, 2016, Nanotherapeutics will host an interactive mini-symposium devoted to the use of Monoclonal Antibody Technology for Development of Medical Countermeasures.  Specific emphasis will be on the development of monoclonal antibodies against Botulinum Neurotoxins, as part of the Advanced Development and Manufacturing of Antibody Technologies (ADAMANT) concept.  This meeting will take place at the Nanotherapeutics-Maryland office located at 8490 Progress Drive, Suite 150, Frederick, MD 21701.  The meeting will begin at 10:00 a.m. and will conclude at 1:00 p.m.

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Zika Virus: Medical Countermeasure Development Challenges has published in PLOS!

Reports of high rates of primary microcephaly and Guillain–Barré syndrome associated with Zika virus infection in French Polynesia and Brazil have raised concerns that the virus circulating in these regions is a rapidly developing neuropathic, teratogenic, emerging infectious public health threat. There are no licensed medical countermeasures (vaccines, therapies or preventive drugs) available for Zika virus infection and disease. The Pan American Health Organization (PAHO) predicts that Zika virus will continue to spread and eventually reach all countries and territories in the Americas with endemic Aedes mosquitoes. This paper reviews the status of the Zika virus outbreak, including medical countermeasure options, with a focus on how the epidemiology, insect vectors, neuropathology, virology and immunology inform options and strategies available for medical countermeasure development and deployment.

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Zika Response News

Nanotherapeutics Grants Worldwide Rights to Amend Surgical, Inc. for NanoFUSE® DBM

ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, Inc., an integrated biopharmaceutical company with a focus on advanced development and manufacturing, today announced that the Company has granted an exclusive worldwide license to its proprietary bone void filler product, NanoFUSE® DBM (demineralized bone matrix), to Alachua, FL-based Amend Surgical, Inc. Financial terms of the transaction were not disclosed, however, under the license agreement, Nanotherapeutics will become a minority shareholder in Amend Surgical.

 

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XOMA's divests biodefense program to Nanotherapeutics, Inc.

BERKELEY, Calif., Nov. 5, 2015 -- XOMA Corporation (XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has agreed to sell its biologics manufacturing facilities, equipment, and associated real estate to Agenus Inc. (AGEN). The transaction is expected to close in December 2015. In conjunction with the transaction, Agenus will offer employment to a select team of XOMA employees currently operating the facilities and may provide small-scale manufacturing services for XOMA in the future.

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Takeda and Nanotherapeutics Announce Agreement to Expand Takeda’s Commercialization and Technology Access Rights in Support of Influenza and Other Vaccine Programs

ALACHUA, Fla. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (Takeda) (TOKYO: 4502) and Nanotherapeutics, Inc., announced an agreement providing Takeda with expanded commercialization and technology access rights related to Nanotherapeutics’ Vero cell technology platform – a cell culture-based platform for vaccine production which Nanotherapeutics acquired from Baxalta, formerly Baxter International’s BioScience division. Financial terms of the agreement were not disclosed.

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Nanotherapeutics Awarded BARDA Fill-Finish Manufacturing Network Task Orders to Develop Two FDA Drug Shortage Products

ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, Inc., a global manufacturer of biodefense and infectious disease products, announced today that it has received two new Task Orders from The United States Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) Fill-Finish Manufacturing Network’s (FFMN) Pilot Production program, for the Center for Drug Evaluation and Research (CDER) pathway regulated products.

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How BARDA Is Helping Speed Up Drug Development/Manufacture

An unusual federal government agency, the Biomedical Advanced Research and Development Authority (BARDA), is providing funding and technical expertise to more than 85 pharmaceutical and biotech companies and 25 academic organizations.

The goal is to accelerate the late-stage development and manufacture of vaccines, drugs, diagnostics, and medical devices that could prove vital to protecting public health during an anthrax outbreak, a bioterrorist nuclear event, pandemic H7N9 (avian flu) epidemic, or an emerging infectious disease that is antibiotic-resistant.

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Nanotherapeutics Closes Final Round of Financing for Completion of New Advanced Development and Manufacturing Facility

Nanotherapeutics, Inc., an integrated biopharmaceutical company with a focus on advanced development and manufacturing, announced today that it has secured a $28.5 million debt financing from White Oak Global Advisors, LLC. The funds will support the completion of the Company’s 180,000 sq. ft. flexible biologics manufacturing facility located in Alachua.

The NANO-ADM (Advanced Development and Manufacturing) facility, as it is known, will expand Nanotherapeutics’ core competencies in the development and cGMP manufacture of preclinical and clinical stage biopharmaceutical products. The Company provides a full range of drug development services and intends to further capitalize on its capabilities through partnerships with government and established companies, as well as continuing to fund the development of its internal pipeline.

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Nanotherapeutics Receives Expanded 510(K) Marketing Clearance from the FDA for NanoFUSE® DBM

Nanotherapeutics, Inc., a company focused on advanced development and manufacturing, today announced that the Company’s proprietary bone void filler product, NanoFUSE® DBM (demineralized bone matrix), has received expanded 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for use in spinal fusion surgery. Specifically, NanoFUSE® DBM has been cleared for use with autograft (transplanted bone from a patient’s own body) as a bone graft extender in the posterolateral spine.

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Baxter to Divest Vero Cell Vaccines Platform to Nanotherapeutics

Baxter International Inc. (BAX) today announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed.

The Vero cell platform is an advanced, cell-based technology for vaccines production. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus.

In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer Inc.

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Manufacturing Issues Crucial to Combating Ebola

A key challenge in testing and developing new therapies to combat the Ebola virus involves producing sufficient quantities of candidate treatments to conduct clinical trials and then to facilitate commercial scale-up for any product demonstrating effectiveness. Clinical trials are being launched for several promising Ebola therapies and vaccines, and successful results will require massive efforts to produce the millions of doses needed to treat and prevent further spread of the virus. 

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Pharmathene and Nanotherapeutics Form Strategic Alliance To Advance Biodefense Programs

PharmAthene, Inc. (NYSE MKT: PIP) and Nanotherapeutics, Inc., a privately-held biopharmaceutical company, announced today that they have formed a Strategic Alliance to advance the development of certain medical countermeasures for the U.S. biodefense market. Under the Alliance Agreement, each company will contribute its specific expertise and resources with the objective of advancing biodefense products to be agreed to under individual product plans.

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Ohio Doctor Leads Cervical Cancer Study of Promising Drug

An Akron physician is leading a national clinical trial with the goal of improving survival rates for cervical cancer patients worldwide.

Dr. Charles Kunos, medical director of radiation oncology at Summa Akron City Hospital, is heading a National Cancer Institute study to determine whether a compound called Triapine results in a better chance for a cure when combined with the traditional treatments of chemotherapy and radiation.

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