Manufacturing
Partners
Contact Neos

Neos News & Events

  • Neos Therapeutics Announces Positive Phase 3 Study Results for its Methylphenidate Extended-Release (XR) Oral Disintegrating Tablet (ODT) in ADHD Patients

    Dallas/Fort Worth, TX (July 15, 2014) - Neos Therapeutics, Inc. ( "Neos" or "the Company"), a highly differentiated oral drug delivery company with a portfolio of proprietary technologies and a late-stage pipeline of innovative controlled release (CR) products for ADHD, announced today that it has completed a positive Phase 3 study for its methylphenidate XR-ODT drug candidate, NT-0102, in children with ADHD.

    The trial was a multicenter, randomized, double-blind, placebo-controlled laboratory classroom study in 87 children with a diagnosis of ADHD. NT-0102 met primary and secondary efficacy endpoints, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale, through 12 hours post-dose. No serious adverse events were reported during the study and the adverse event profile was consistent with the drug’s mechanism of action.

    “ADHD is a condition that causes significant distress for patients and caregivers. Although, there are a number of effective long-acting medications currently on the market, most formulations consist of tablets or capsules that can be difficult for children to swallow. The positive data from this study is exciting. Hopefully, soon we will have a once-daily oral disintegrating tablet option that is easy to administer to patients,” said Dr. Ann Childress (Center for Psychiatry and Behavioral Medicine, La Vegas, NV), lead investigator for the study.

    "We are very pleased to have worked with Dr. Childress on this study. Having a potential treatment option for those who cannot swallow other dosage forms is important, especially in a chronic disorder like ADHD, in which children may struggle to take their medication or develop pill fatigue,” noted Dr. Carolyn Sikes, Vice President of Clinical Development at Neos.

    Stimulant medications, such as methylphenidate, have been available for the treatment of ADHD for decades. Extended-release formulations of these medications allow for once-daily dosing, however recent data suggest that a significant percentage of children and adolescents struggle to ingest tablets or capsules. An XR-ODT formulation, which does not require swallowing an intact tablet or capsule and can be dosed once daily, may offer a practical alternative.

    Dr. Vipin Garg, President and CEO of Neos, added that “We are delighted with these robust clinical results, as this data validates our XR-ODT technology. We believe that our methylphenidate and amphetamine XR-ODT formulations could provide a patient-friendly dosage form for both children and adults with ADHD. We are looking forward to filing the NDA for our NT-0102 drug candidate in the near future."

    About ADHD

    Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurobehavioral disorder characterized by excessive levels of inattention and/or hyperactivity/impulsivity for an individual’s age and level of development, which causes significant functional and social impairment. The disorder begins in childhood and up to 9.5% of children (ages 4-17) have received a diagnosis of ADHD (about 5.4 million school-aged children). For up to 50% of these individuals, the condition or symptoms of the condition persist into adulthood.


    About Neos Therapeutics

    Neos Therapeutics, Inc. is a specialty pharmaceutical company focused on the development and manufacture of FDA approved drug products that utilize the Company’s proprietary and patented delivery technologies. The Neos drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or oral disintegrating tablet (ODT) dosage forms. By utilizing APIs that are already FDA-approved, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more information, visit www.neostx.com.

    Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, an affiliate of Neos Therapeutics, Inc., and Rapidly Disintegrating Ionic MaskingTM and RDIMTM are trademarks of Neos Therapeutics, Inc.

    This press release contains certain forward-looking statements that include projections and may also include words such as may, will, expects, believes, anticipates, plans, estimates, seeks, could, intends, and other similar expressions. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.

    CONTACTS
    Vipin K. Garg, Ph.D.
    President and CEO
    (919) 434-6643
    vgarg@neostx.com

    Richard Eisenstadt, MBA
    Chief Financial Officer
    (972) 408-1389
    reisenstadt@neostx.com
    July 15, 2014

  • Neos Therapeutics Announces Issuance of New Patent Covering Composition of Matter for Company’s Novel ADHD Products
    US Patent No. 8,709,491 will Provide Protection Until 2032

    Dallas/Fort Worth, TX (May 15, 2014) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a highly differentiated oral drug delivery company with a portfolio of proprietary technologies and a late-stage pipeline of innovative controlled release (CR) products for ADHD, announced today that it has been granted a patent covering its novel amphetamine ADHD products.

    Neos has developed an extended release (XR) amphetamine oral disintegrating tablet (ODT) and an extended release amphetamine liquid suspension both of which are expected to be filed for FDA approval in the next 12-15 months. We are pleased with the grant of this patent as it will provide protection for our amphetamine XR-ODT and amphetamine XR-suspension until June 2032,  said Vipin K. Garg, Ph.D., Chief Executive Officer of Neos. We have begun to assess our options to commercialize these products in anticipation of FDA approval. 

    The Neos patent portfolio continues to grow as we continue to develop and utilize our platform drug delivery technologies, stated Mark Tengler, Chief Technology Officer of Neos. Extended release and patient-friendly dosage forms are essential in the treatments of ADHD, and our technologies may provide this advantage. 

    About Neos Therapeutics

    Neos Therapeutics Inc.,is a specialty pharmaceutical company focused on the development and manufacture of FDA approved drug products that utilize the Company’s proprietary and patented delivery technologies. The Neos drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or orally is integrating tablet (ODT) dosage forms. By utilizing APIs that are already FDA-approved, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more
    information, visit www.neostx.com.

    Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, an affiliate of Neos Therapeutics, Inc., and Rapidly Disintegrating Ionic Masking!" and RDIM!" are trademarks of Neos Therapeutics, Inc.

    This press release contains certain forward-looking statements  that include projections and may also include words such as may , will , expects , believes , anticipates , plans , estimates , seeks , could , intends , and other similar expressions. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.

    CONTACT
    Vipin K. Garg, Ph.D.
    Chief Executive Officer
    (919) 434-6643
    vgarg@neostx.com
    May 15, 2014

  • Neos Therapeutics Announces $20 Million Loan Facility and Updated Total of $18 Million for its Additional Series C Financing

    Dallas/Fort Worth, TX (April 23, 2014) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a highly differentiated oral drug delivery company with an exciting portfolio of proprietary technologies and a late-stage pipeline of innovative controlled release (CR) products for ADHD, announced today that it has entered into a $20 million loan facility with Hercules Technology Growth Capital, Inc. (NYSE:HTGC). The Company also reported that the total amount raised in the recent additional Series C financing increased to $18 million from the $15.5 million previously announced on March 4, 2014.

    The funds will support the Company’s efforts to obtain FDA approval of its three ADHD products, to expand the use of the proprietary controlled release technologies in the development of additional CR orally disintegrating tablet and CR liquid products, and to refinance its existing debt facility.

    “We are pleased to be a financial partner for Neos,” said Chad Norman, Managing Director at Hercules. “With its novel drug delivery technology and late-stage ADHD drug candidates, Neos offers a portfolio of attractive products in a well-established, growing market.”

    About Neos Therapeutics

    Neos Therapeutics Inc.
    , is a specialty pharmaceutical company focused on the development and manufacture of FDA approved drug products that utilize the Company’s proprietary and patented delivery technologies. The Neos drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are already FDA-approved, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more information, visit www.neostx.com.

    Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, an affiliate of Neos Therapeutics, Inc., and Rapidly Disintegrating Ionic Masking™ and RDIM™ are trademarks of Neos Therapeutics, Inc.

    About Hercules Technology Growth Capital, Inc.

    Hercules Technology Growth Capital, Inc. (NYSE:HTGC) is a leading specialty finance company focused on providing senior secured loans to venture capital-backed companies in technology-related markets, including technology, biotechnology, life science, and energy and renewable technology industries, at all stages of development. Since inception (December 2003), Hercules has committed more than $4.0 billion to over 260 companies and is a lender of choice for entrepreneurs and venture capital firms seeking growth capital financing. For more information please visit www.htgc.com, or call 650-289-3060.

    This press release contains certain “forward-looking statements” that include projections and may also include words such as “may”, “will”, “expects”, “believes”, “anticipates”, “plans”, “estimates”, “seeks”, “could”, “intends”, and other similar expressions. These forwardlooking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.

    CONTACT
    Vipin K. Garg, Ph.D.
    Chief Executive Officer
    (919) 434-6643
    vgarg@neostx.com

    Victor Miller
    Vice President, Finance
    (847) 597-1991
    vmiller@neostx.com
    April 23, 2014

  • Neos Therapeutics Completes $15.5 Million Additional Series C Financing

    Dallas/Fort Worth, TX., March 4, 2014 (BUSINESS WIRE) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a highly differentiated oral drug delivery company with an exciting portfolio of proprietary technologies and a late-stage pipeline of innovative controlled release (CR) products for ADHD, announced today that it has completed an oversubscribed round of private financing, raising a total of $15.5 million. Investors participating in the financing included, Burrill Life Sciences Capital Fund III, CAC LLC, CMEA Capital, Crabtree Partners and Delaware Street Capital.

    With the successful completion of this financing as well as the recent commercialization of a generic of Tussionex®, an extended release cough cold product developed utilizing the Neos technology and manufactured by Neos, the company is well positioned for growth.

    The funds will support the Company’s efforts to obtain FDA approval of its existing product pipeline, and create an opportunity to expand the use of the proprietary controlled release technologies to develop additional CR orally disintegrating tablet and CR liquid products.

    “We are very pleased that Neos’ progress has allowed us to attract strong support from our investors,” stated Vipin K. Garg, Ph.D., Chief Executive Officer of Neos. "This places the Company in an excellent financial position to execute our strategy of bringing novel products based on the Neos proprietary technologies to market. These technologies are currently being utilized to develop three ADHD products, which will advance significantly in the next 12-15 months.”

    About Neos Therapeutics

    Neos Therapeutics Inc., is a specialty pharmaceutical company focused on the development and manufacture of FDA approved drug products that utilize the Company’s proprietary delivery technologies. The Neos drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are already FDA-approved, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more information, visit www.neostx.com.

    Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, an affiliate of Neos Therapeutics, Inc., and Rapidly Disintegrating Ionic Masking™ and RDIM™ are trademarks of Neos Therapeutics, Inc.

    This press release contains certain “forward-looking statements” that include projections and may also include words such as “may”, “will”, “expects”, “believes”, “anticipates”, “plans”, “estimates”, “seeks”, “could”, “intends”, and other similar expressions. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.

    CONTACT
    Vipin K. Garg, Ph.D.
    Chief Executive Officer
    (919) 434-6643
    vgarg@neostx.com
    March 4, 2014

  • Neos Therapeutics, Inc. Announces the Appointment of Vipin K. Garg, Ph.D. as Chief Executive Officer and Board Director

    Grand Prairie TX., October 22, 2013 (BUSINESS WIRE) – Neos Therapeutics, Inc. (Neos), a highly differentiated oral drug delivery company with an exciting portfolio of proprietary technologies and a pipeline of innovative controlled release (CR) products, announced today the appointment of Vipin K. Garg, Ph.D. to the role of Chief Executive Officer, effective immediately. Dr. Garg succeeds Neos Interim Chief Executive Officer, Alan Heller, who will continue serving as Chairman of the Neos Board of Directors. Dr. Garg will also serve as a member of the Neos Board of Directors.

    Dr. Garg has over twenty-five years of experience within the biotechnology and pharmaceutical industries in both technical and management positions. He has a proven track record of building and managing both private and publicly traded companies. Before joining Neos Therapeutics, he served as President and Chief Executive Officer of Tranzyme Pharma (NASDAQ: TZYM), where he led the company’s initial public offering in 2011 and its merger with Ocera Therapeutics (NASDAQ: OCRX), Inc. in July, 2013.

    Neos Therapeutics’ Chairman, Al Heller, stated, “I am excited to welcome Vipin to the Neos team. He brings to us a wealth of strategic, scientific and industry experience. Vipin will work closely with the organization to obtain FDA approval of our existing pipeline, and expand the use of our proprietary controlled release technologies to create additional CR orally disintegrating tablets and CR liquids to bring to market.”

    Prior to joining Tranzyme, Dr. Garg served as Chief Operating Officer of Apex Bioscience, Inc. (now Curacyte AG of Munich, Germany), and held senior management positions at DNX Bio-Therapeutics, Inc. until its acquisition by Baxter Healthcare Corporation, Sunovion Pharmaceuticals, Inc. (formerly known as Sepracor Inc., now a subsidiary of Dainippon Sumitomo Pharma), and Bio-Response Inc. (acquired by Baxter Healthcare Corporation).

    Dr. Garg received his Ph.D. in Biochemistry in 1982 from the University of Adelaide, Australia, and his M.S. from New Delhi, India in 1978. He was a member of the U.S. Presidential Mission to India led by President Bill Clinton in March, 2000. He is a past board member of the North Carolina Biotechnology Center and currently serves on the Executive Committee of CED (formerly the Council for Entrepreneurial Development). He was the recipient of the Ernst & Young Entrepreneur of the Year 2009 Award, Carolinas Region.

    "I am delighted to join Neos Therapeutics," said Dr. Garg. "Neos has developed proprietary controlled release technologies. These technologies are being utilized to develop a pipeline of novel ADHD products which will advance significantly in the next 12-18 months. Building on the approval of a generic of Tussionex®, an extended release cough cold product developed utilizing the Neos technology and manufactured exclusively by Neos, the company is well positioned for growth. I look forward to working with the Neos team to expand the pipeline to additional opportunities including prescription, over-the-counter and veterinary products in a wide range of therapeutic areas.“

    About Neos Therapeutics

    Neos Therapeutics Inc. is a specialty pharmaceutical company focused on the development, manufacture and sale of FDA approved drug products that utilize the company’s proprietary delivery technologies. The Neos drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are FDA-approved and known to be safe and effective, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more information, visit www.neostx.com.

    Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, an affiliate of Neos Therapeutics, Inc., and Rapidly Disintegrating Ionic Masking™ and RDIM™ are trademarks of Neos Therapeutics, Inc.

    This press release contains certain “forward-looking statements” that include projections and may also include words such as “may”, “will”, “expects”, “believes”, “anticipates”, “plans”, “estimates”, “seeks”, “could”, “intends”, and other similar expressions. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.

    Contact: Neos Therapeutics, Inc.
    Ellen Hoffing, 847-597-1980
    Co-President & COO
    ehoffing@neostx.com
    October 22, 2013

  • FDA Approves Cornerstone Therapeutics’ ANDA for Generic Tussionex® Pennkinetic® Product. Neos Therapeutics developed the drug product formulation using its proprietary formulation technology and will be the exclusive manufacturer.

    U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product. The antitussive/antihistamine combination product is a generic equivalent for the product currently sold under the Tussionex® Pennkinetic® brand name.

    CRTX 067 was developed through a collaboration including Cornerstone, Coating Place, Inc. and Neos Therapeutics, LP, a subsidiary of Neos Therapeutics, Inc. Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies the active pharmaceutical ingredients (APIs), including a patent-protected version of hydrocodone polistirex. Neos developed the CRTX 067 drug product formulation using its proprietary formulation technology, Dynamic Time Release Suspension® (DTRS®), and Neos will be the exclusive manufacturer of the approved drug product.
    July 2, 2012