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  • Neos Therapeutics Presents Data at ASCP Annual Meeting for Investigational XR-ODT for Treatment of ADHD
    Dallas/Fort Worth, TX (June 24, 2015) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a pharmaceutical company with three late-stage innovative, extended-release (“XR”) product candidates for the treatment of attention deficit hyperactivity disorder (“ADHD”), today announced the presentation of new data at the American Society of Clinical Psychopharmacology Annual Meeting (“ASCP”) in Miami, Florida. The results from two clinical trials of the Company’s methylphenidate XR orally disintegrating tablet (“ODT”) drug candidate, Cotempla XR-ODT™ (formerly NT-0102), and one clinical trial of its amphetamine XR-ODT drug candidate, NT-0202, were presented. The data confirm that both formulations have a concentration-time profile that is consistent with once daily dosing, and that they maintain their extended-release properties in the presence of a high fat meal and varying concentrations of alcohol. Tolerability data were also presented.

    “These studies offer valuable insights into Neos’ two extended-release orally disintegrating tablet drug candidates for ADHD, and demonstrate a pharmacokinetic profile similar to a marketed capsule product,” said Ann Childress M.D., University of Nevada School of Medicine and President, Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada. “The breadth of XR-ODT candidate data presented at ASCP reinforce that these formulations appear to provide a pharmacokinetic profile consistent with once daily dosing, maintain their extended-release properties in the presence of a high-fat meal and alcohol and are generally well-tolerated.”

    Up to 54% of pediatric patients and 40% of adult patients in the general population are reported to have difficulty swallowing tablets and capsules, which may result in skipped doses or discontinuance of their medication altogether. Cotempla XR-ODT™ and NT-0202 disintegrate in the mouth without water and provide a pharmacokinetic (“PK”) profile that is consistent with once-daily dosing.

    “We are pleased that the results of the studies presented at ASCP suggest that Cotempla XR-ODT™ can be dosed with or without food and has a similar pharmacokinetic profile to a marketed methylphenidate capsule product,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “We are also encouraged to see that the modified-release properties of NT-0202 are maintained in the presence of alcohol. We believe that this is the first public presentation of data from a study on the effects of alcohol on the PK parameters of an extended-release amphetamine formulation.”

    In January 2015, Neos announced the submission of a New Drug Application (“NDA”) for Cotempla XR-ODT™ to the U.S. Food and Drug Administration (“FDA”). The NDA was accepted for filing by the FDA on March 10, 2015, and has a Prescription Drug User Fee Act (“PDUFA”) goal date of November 9, 2015. If approved, the Company believes Cotempla XR-ODT™ will be the first methylphenidate extended-release orally disintegrating tablet for the treatment of ADHD, potentially providing patients the combination of two key drug delivery attributes – an extended-release profile which allows for once-daily dosing and an ODT dosage form which disintegrates in the mouth without water – in one formulation.

    Three Key Data Presentations at ASCP

    Title: Pharmacokinetics of Novel Methylphenidate Extended-Release Oral Disintegrating Tablets for ADHD

    Date: 6/23/2015; Session Time: 11:15:00 AM to 1:00:00 PM; Poster Board # 18

    In a Phase 1 study of healthy adults comparing the oral bioavailability and absorption of methylphenidate XR-ODT™ 60 mg to a reference marketed product, Metadate CD® (methylphenidate HCL extended-release capsules) 60 mg, the PK profile of methylphenidate XR ODT was generally similar to that of Metadate CD; however MPH XR-ODT had a 25% higher Cmax.

    27% of adult volunteers receiving methylphenidate XR-ODT reported an adverse event (“AE”) compared to 30% of patients receiving Metadate CD®, with no AEs leading to discontinuation of the study drug. The most common AE was nausea, which was similar in the two treatment groups.

    Title: No Food Effect for a Novel Oral Disintegrating Tablet Formulation of Extended-Release Methylphenidate for the Treatment of ADHD

    Date: 6/24/2015; Session Time: 12:00:00 PM to 2:00:00 PM; Poster Board # 1

    A Phase 1 study of Cotempla XR-ODT™ 60 mg in healthy adults determined a standard FDA high-fat meal did not significantly alter the rate of oral absorption or the extent of exposure to methylphenidate XR-ODT, suggesting that this formulation can be taken with or without food. Similar mean maximum plasma concentrations (Cmax) and overall exposure (AUC0-inf, AUC0-last) were observed in both fed and fasted patients. Time to peak plasma concentration (Tmax) was similar under both conditions.

    58% of adult volunteers reported an AE, with similar incidence across the fed and fasted groups. The most common AEs were anxiety and nausea.

    Title: The Controlled-Release Properties and Exposure Levels of a Novel Orally Disintegrating Tablet Formulation of Amphetamine for Treatment of ADHD are Maintained in the Presence of Alcohol

    Date: 6/24/2015; Session Time: 12:00:00 PM to 2:00:00 PM; Poster Board # 2

    A Phase 1 study of NT-0202 (amphetamine XR-ODT) 30 mg found varying concentrations of alcohol (0% to 40% ethanol) did not significantly alter the rate, extent of absorption or exposure of the active drug in healthy fasted adult volunteers.

    66% of adult volunteers reported an AE, with no AEs leading to discontinuation of NT-0202. The most common AEs were catheter site inflammation, headache, nausea and intoxication.

    About XR-ODT Technology
    Stimulant medications such as methylphenidate and amphetamine are the standard of care for treating ADHD, and XR formulations of these medications allow for once-daily dosing. However, recent data suggest that a significant percentage of children in the general population are unable to easily swallow solid dosage forms, and many remain uncomfortable doing so through adolescence. ODTs differ from traditional tablets and capsules in that they are designed to disintegrate on the tongue, rather than being swallowed whole.

    About ADHD
    According to the National Institute of Mental Health, ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and hyperactivity (over-activity).

    About Neos Therapeutics

    Neos Therapeutics, Inc. is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platform. The Company is initially focusing on ADHD and has developed three branded product candidates that are XR medications in patient-friendly ODT or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.


    Special Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the federal securities laws and these statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in this press release include, but are not limited to, statements about the PDUFA date for Cotempla XR-ODT™ and PK profile, extended-release properties and tolerability of our product candidates, including Cotempla XR-ODT™ and NT-0202. We caution you that the foregoing may not be the only the forward-looking statements made in this press release. You should not rely upon forward-looking statements as predictions of future events. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to differ materially from what is expressed in or indicated by the forward-looking statement.

    CONTACTS:
    Thomas P. McDonnell, Chief Commercial Officer
    Neos Therapeutics
    (484) 477-6729
    tmcdonnell@neostx.com

    Richard I. Eisenstadt, Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    June 24, 2015

  • Neos Therapeutics Announces Appointment of Paul Edick and John Schmid to its Board of Directors
    Dallas/Fort Worth, TX (June 11, 2015) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a pharmaceutical company with three late-stage extended-release (“XR”) product candidates currently in development for the treatment of attention deficit hyperactivity disorder (“ADHD”), today announced the appointment of Messrs. Paul Edick and John Schmid to its Board of Directors.

    “It is with great pleasure that we welcome both Paul and John to our Board of Directors. Their extensive experience in industry-specific business and product development, strategic planning, and leadership, coupled with their financial expertise, will be extremely valuable to Neos as the Company continues to progress towards commercialization of its proprietary products,” commented Alan Heller, Chairman of the Board, Neos Therapeutics.

    Mr. Edick is currently the Managing Partner of 3G Advisors, LLC, a consultancy to the pharmaceutical, healthcare and investor communities. From July 2010 until November 2014, Mr. Edick was the Chief Executive Officer of Durata Therapeutics, which was acquired by Actavis plc in November 2014. Prior to that, Mr. Edick was Chief Executive Officer of Ganic Pharmaceuticals from 2008 to 2010, Chief Executive Officer of MedPointe Healthcare Inc. from 2006 to 2008, and President of Pharmaceutical Operations at MedPointe from 2002 to 2006. From 1994 to 2002, Mr. Edick worked in a series of leadership positions at G. D. Searle and its acquirer, Pharmacia Corporation. Mr. Edick currently serves on the boards of directors of NewLink Genetics Inc. and Circassia Ltd. Mr. Edick holds a B.A. in Psychology from Hamilton College in Clinton, New York.

    Mr. Schmid served as Chief Financial Officer of Auspex Pharmaceuticals, Inc., from September 2013 until its sale to Teva Pharmaceuticals, Inc. in June 2015. Prior to that, he co-founded Trius Therapeutics, Inc., where he served as Chief Financial Officer from June 2004 until its merger with Cubist Pharmaceuticals, Inc. in September 2013. Mr. Schmid also served as Chief Financial Officer at GeneFormatics, Inc. from 1998 to 2003 and as Chief Financial Officer at Endonetics, Inc. from 1995 to 1998. He currently serves as chairman of the board of directors of Speak, Inc. Mr. Schmid holds a B.A. in Economics from Wesleyan University and an M.B.A. from the University of San Diego.

    About Neos Therapeutics

    Neos Therapeutics, Inc. is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platform. The Company is initially focusing on ADHD and has developed three branded product candidates that are extended-release (XR) medications in patient-friendly, orally disintegrating tablets (ODT) or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.

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

    Richard I. Eisenstadt, Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    June 11, 2015

  • Neos Therapeutics Announces Trade Name Cotempla XR-ODT™ for its Methylphenidate Extended-Release Orally Disintegrating Tablets
    Dallas/Fort Worth, TX (May 20, 2015) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a pharmaceutical company with three late-stage extended-release (“XR”) product candidates for the treatment of attention deficit hyperactivity disorder (“ADHD”) currently in development, today announced that the U.S. Food and Drug Administration (“FDA”) has provisionally accepted the trade name Cotempla XR-ODT™ for its methylphenidate extended-release orally disintegrating tablets (“ODT”).

    Cotempla XR-ODT™ may be the first XR-ODT for the treatment of ADHD. The Cotempla XR-ODT™ formulation quickly disintegrates in the mouth, and in a pivotal clinical trial of children with ADHD, was shown to have a statistically significant improvement versus placebo with respect to attention and behavior, with onset-of-effect observed within one hour and a12-hour duration. Cotempla XR-ODT™ combines two key drug delivery attributes into one formulation, an extended-release profile which allows for once daily dosing and an ODT dosage form which can facilitate administration and ingestion.

    It has been reported that up to 54% of pediatric patients have difficulty swallowing tablets and capsules. For many of these patients, swallowing difficulties can persist into adolescence and adulthood, with 40% of the adult population reporting pill-swallowing difficulties which may result in skipping doses or discontinuing their medication altogether. Cotempla XR-ODT™ disintegrates in the mouth without water and thus may provide a more patient- and caregiver-friendly once-daily dosage form for these patients.

    Neos submitted a 505(b)(2) NDA for Cotempla XR-ODT™ in January of this year. The NDA was accepted for a standard 10-month review by the FDA on March 10, 2015.



    About Neos Therapeutics

    Neos Therapeutics, Inc.is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platform. The Company is initially focusing on ADHD and has developed three branded product candidates that are XR medications in patient-friendly, ODT or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®, an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.


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

    Richard I. Eisenstadt, Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    May 20, 2015

  • Neos Therapeutics, Inc. Appoints Thomas P. McDonnell as Chief Commercial Officer
    Dallas/Fort Worth, TX (April 28, 2015) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a pharmaceutical company with a late-stage pipeline of innovative extended-release (“XR”) product candidates for the treatment of Attention-Deficit Hyperactivity Disorder (“ADHD”), today announced the appointment of Thomas P. McDonnell, to the role of Chief Commercial Officer, effective immediately.

    Prior to joining Neos, Mr. McDonnell spent 10 years with Shire (NASDAQ: SHPG), most recently as Vice President of US Marketing in the Neuroscience Business Unit from December 2013 to March 2015. In this role, he led the US Product Strategy Team responsible for the commercialization of Vyvanse and Intuniv into the ADHD market. From August 2012 to November 2013, he was Vice President, General Manager of Adult Psychiatry and led the product strategy team for all commercial and clinical development of Vyvanse in Major Depressive Disorder and Binge Eating Disorder. Previously, he held several commercial and marketing positions at Shire, including Senior Director, General Manager for Equasym XL, Senior Director of Marketing for Intuniv, Director of Marketing for Vyvanse, and Senior Product Manager for Adderall XR.

    Before joining Shire, Mr. McDonnell held various sales, sales management and marketing positions at Abbott Laboratories and Knoll Pharmaceuticals from 1997 to 2005. He received his B.A. in Marketing from Muhlenberg College.

    “I am very excited to welcome Tom to the Neos team. His wealth of experience in commercializing and marketing innovative therapeutic products for the treatment of ADHD, combined with his strong leadership and strategic planning skills, strengthen the management team at a key time in our development as a company,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Neos. “We look forward to his contributions as we prepare for the potential launches of our methylphenidate XR-ODT, NT-0102, amphetamine XR-ODT, NT-0202, and amphetamine XR Liquid Suspension, NT-0201, ADHD medications based on Neos’ patented XR-ODT or XR Liquid Suspension technology.”


    About Neos Therapeutics

    Neos Therapeutics, Inc. is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platform. The Company is initially focusing on ADHD with three branded product candidates which are extended-release, or XR, medications in patient-friendly, oral disintegrating tablets or liquid suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex® an XR liquid suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.



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

    Richard I. Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    April 28, 2015

  • Neos Therapeutics Completes $20.6 Million Financing to Further Advance its Late-Stage ADHD Product Pipeline
    Dallas/Fort Worth, TX (February 25, 2015) – Neos Therapeutics, Inc. (“Neos” or “the Company”), a specialty pharmaceutical company with a late-stage pipeline of innovative extended-release (“XR”) products for Attention-Deficit Hyperactivity Disorder (“ADHD”), today announced that it has completed an oversubscribed round of financing, raising a total of $20.6 million. The financing included investments by Presidio Partners, Crabtree Partners, CAC LLC, Delaware Street Capital, Burrill Life Sciences Capital Fund III and Essex Capital Corporation, as well as other investors.

    With the successful completion of this financing and the recent submission of a New Drug Application (NDA) for its methylphenidate XR-ODT drug candidate, NT-0102, an ADHD medication based on Neos’ patented XR-ODT technology, the company is well positioned for growth.

    Proceeds from this financing will support the Company’s efforts during the FDA review of NT-0102 as well as the submission of NDAs for two additional ADHD drug candidates, an amphetamine XR-ODT and an amphetamine XR-Liquid Suspension.

    Stimulant medications such as methylphenidate and amphetamine are effective in ameliorating the symptoms of ADHD, and extended-release formulations of these medications allow for once-daily dosing. However, recent data suggest that a significant percentage of children are unable to easily swallow solid dosage forms, and many remain uncomfortable doing so through adolescence. Neos’ XR-ODT and XR-Liquid product candidates are designed to provide patient-friendly dosage forms for those who have difficulty swallowing or do not like to swallow intact tablets or capsules and may benefit from extended-release formulations.

    “We are grateful to our investors for their continued confidence and support of the Company and our management team,” commented Vipin K. Garg, Ph.D., President and CEO of Neos. “This places the Company in an excellent financial position as we prepare to transition to a commercial enterprise during the next six to twelve months.”



    About Neos Therapeutics

    Neos Therapeutics, Inc. is a fully integrated specialty pharmaceutical company. The Company is initially focusing on ADHD with three proprietary products in late-stage development that provide patient-friendly dosage forms incorporating controlled and extended release oral disintegrating tablets (ODTs) and liquid suspensions. In addition, Neos manufactures and markets a generic of Tussionex® (hydrocodone and chlorpheniramine) extended-release oral suspension for the treatment of cough and upper respiratory symptoms of a cold. The Company’s products are developed and manufactured using its proprietary and patented ion resin technology. For more information, visit www.neostx.com.


    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
    Neos Therapeutics
    (919) 434-6643
    vgarg@neostx.com

    Richard I. Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    February 25, 2015

  • Neos Therapeutics Announces Submission of a New Drug Application for its Methylphenidate Extended Release Oral Disintegrating Tablet (XR-ODT) for the Treatment of ADHD
    Dallas-Fort Worth, TX (January 12, 2015) – Neos Therapeutics, Inc. ("Neos"), a specialty pharmaceutical company with a late-stage pipeline of innovative extended release (“XR”) products for Attention-Deficit Hyperactivity Disorder (“ADHD”), announced today that it has submitted a New Drug Application (NDA) for its methylphenidate XR-ODT drug candidate, NT-0102, an ADHD medication based on its patented XR-ODT technology.

    Orally disintegrating tablets (“ODTs”) differ from traditional tablets and capsules in that they are designed to quickly disintegrate on the tongue, rather than being swallowed whole. XR-ODTs provide a patient-friendly dosage form for those who have difficulty swallowing or do not like to swallow intact tablets or capsules and benefit from extended release formulations. NT-0102 is an extended release ODT formulation of methylphenidate that may be the first XR-ODT for the treatment of ADHD. The Neos XR-ODT formulation quickly disintegrates in the mouth without water, and has been shown to control ADHD symptoms through twelve hours post-dose in a pivotal clinical trial.

    The pivotal clinical trial was a multicenter, randomized, double-blind, placebo-controlled laboratory classroom study in children (ages 6-12) with ADHD. NT-0102 met all primary and secondary efficacy endpoints, showing statistically significant improvement versus placebo on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Scale (p<0.0001) and the Permanent Product Measure of Performance (PERMP) scale (p<0.0001). The SKAMP is a validated rating scale that measures classroom manifestations of inattention, hyperactivity, and impulsivity; the PERMP is a five-page math test that provides an objective assessment of effortful performance in the classroom. No serious adverse events were reported during the study and the adverse event profile was consistent with the drug’s mechanism of action.

    “The submission of the NDA for NT-0102 is a major milestone for Neos Therapeutics, and we look forward to working closely with the FDA during the review period," stated Vipin K. Garg, Ph.D., President and CEO of Neos. Dr. Garg further stated that “Neos is poised to submit additional NDAs for its ADHD pipeline drug candidates in 2015.”

    “ADHD is a condition that can result in significant academic and social impairment for patients. The burden on family members and caregivers can be enormous. The submission of NT-0102 NDA to the FDA brings us one step closer to having an easy to administer treatment option for those patients with ADHD who prefer not to swallow tablets or capsules,” noted Dr. Ann Childress (Center for Psychiatry and Behavioral Medicine, La Vegas, NV), lead investigator for the study.



    About Neos Therapeutics

    Neos Therapeutics, Inc. is a fully integrated specialty pharmaceutical company. The Company is initially focusing on ADHD with three proprietary products in late-stage development that provide patient-friendly dosage forms incorporating controlled and extended release oral disintegrating tablets (ODTs) and liquid suspensions. In addition, Neos manufactures and markets a generic of Tussionex® (hydrocodone and chlorpheniramine) extended-release oral suspension for the treatment of cough and upper respiratory symptoms of a cold. The Company’s products are developed and manufactured using its proprietary and patented ion resin technology. For more information, visit www.neostx.com.


    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
    Neos Therapeutics
    (919) 434-6643
    vgarg@neostx.com

    Richard I. Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    January 12, 2015

  • Neos Therapeutics Announces Issuance of Key Patent Covering its Extended Release Oral Disintegrating Tablet (XR-ODT) Platform Technology

    Dallas-Fort Worth, TX (October 8, 2014) – Neos Therapeutics, Inc. ("Neos"), a specialty pharmaceutical company with a portfolio of novel and proprietary oral drug delivery technologies as well as a late-stage pipeline of innovative extended release ("XR") products for Attention Deficit Hyperactivity Disorder ("ADHD"), announced today that is has been granted a key patent (US Patent No. 8,840,924) covering its XR-oral disintegrating tablet ("ODT") technology, known as Rapidly Disintegrating Ionic Masking™ (RDIM™).

    RDIM™ utilizes an orally disintegrating, controlled release, taste-masked pharmaceutical composition that can withstand compression forces associated with standard tableting technology, allowing for a drug to be incorporated into the ODT dosage form using ion resin technology. This technology not only provides extended release or controlled release properties, it can also mask the unpleasant taste of the drugs.

    ODTs are tablets that disintegrate quickly when placed on the tongue and thus facilitate ingestion of a tablet. By combining the ODT dosage form with controlled release properties, Neos' XR-ODT formulations can benefit those patients who have difficulty swallowing intact tablets and capsules and who require extended release products. XR-ODTs are easily transported, can be taken without liquid and provide convenient and easy to administer dosage form for patients and caregivers.

    "This XR-ODT technology is embedded in two near-term products that Neos is developing. NT-0102 is an XR-ODT of Methylphenidate and NT-0202 is an XR-ODT of Amphetamine. Methylphenidate and Amphetamine are two of the most prescribed compounds for the treatment of ADHD. The application of XR-ODT technology to ADHD was obvious as the medications for ADHD need to be administered effectively and last all day long," stated Vipin K. Garg, Ph.D., President and CEO of Neos.

    "This patent further strengthens Neos' intellectual property position and further protects our proprietary product candidates," said Mark Tengler, Chief Technology Officer of Neos. "We believe that our XR-ODT technology will have a broad applicability in multiple therapeutic areas."

    About Neos Therapeutics
    Neos Therapeutics, Inc. is a fully integrated specialty pharmaceutical company. The Company is initially focusing on ADHD with three proprietary products in late-stage development that provide patient-friendly dosage forms incorporating controlled and extended release oral disintegrating tablets (ODT) and liquid suspensions. In addition, Neos manufactures and markets a Generic of Tussionex®, for the treatment of cough and cold. The Company’s products are developed and manufactured using its proprietary and patented ion resin technology. For more information, visit www.neostx.com.

    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
    Neos Therapeutics
    (919) 434-6643
    vgarg@neostx.com

    Richard I. Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    October 8, 2014

  • Neos Therapeutics, Inc. Announces Settlement of Pending Patent Litigation Concerning its Amphetamine Polistirex XR-ODT (NT-0202) with Shire LLC

    Dallas-Fort Worth, TX (September 9, 2014) – Neos Therapeutics, Inc. ("Neos"), a specialty pharmaceutical company with a portfolio of novel and proprietary oral drug delivery technologies as well as a late-stage pipeline of innovative extended release ("XR") products for Attention Deficit Hyperactivity Disorder ("ADHD"), announced today that is has settled all pending litigation with Shire LLC ("Shire") in connection with Neos' amphetamine polistirex orally disintegrating tablet known as NT-0202 for the treatment of ADHD. NT-0202 is positioned to be the first-ever, extended release orally disintegrating tablet ("XR-ODT") dosage form of amphetamine for the treatment of ADHD.

    The litigation involved a patent infringement lawsuit brought by Shire under the Hatch-Waxman Act framework stemming from Neos's filing of its New Drug Application under section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act for NT-0202 with the United States Food and Drug Administration ("FDA"). On April 11, 2013, Shire filed suit against Neos asserting that Neos infringed U.S. Patent No. RE 42,096 and U.S. Patent No. 41,148 (collectively, the "Patents").

    The parties have entered into a License Agreement which provides Neos with a license to the Patents and U.S. Patent No. 6,913,768, to make, market and sell NT-0202. Neos will pay Shire a royalty from the sales of NT-0202 until the expiration of the patents

    Vipin K. Garg, Ph.D., President and CEO of Neos, stated, "We are very pleased to have reached this settlement with Shire. Neos will continue to pursue FDA approval of NT-0202 without further risk of delay due to this litigation."

    About Neos Therapeutics

    Neos Therapeutics, Inc. is a fully integrated specialty pharmaceutical company. The Company is initially focusing on ADHD with three proprietary products in late-stage development that provide patient-friendly dosage forms incorporating controlled and extended release oral disintegrating tablets (ODT) and liquid suspensions. In addition, Neos manufactures and markets a Generic of Tussionex®, for the treatment of cough and cold. The Company's products are developed and manufactured using its proprietary and patented ion resin technology. For more information, visit www.neostx.com.


    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
    Neos Therapeutics
    (919) 434-6643
    vgarg@neostx.com

    Richard I. Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    September 9, 2014

  • Neos Therapeutics Acquires all Commercialization and Profit Rights to Generic Tussionex® (Extended Release Hydrocodone Polistirex/Chlorpheniramine Polistirex) from Chiesi USA and Coating Place, Inc.

    Dallas/Fort Worth, TX (September 8, 2014) - Neos Therapeutics, Inc. ( "Neos"), a specialty pharmaceutical company with a portfolio of novel and proprietary oral drug delivery technologies as well as a late-stage pipeline of innovative extended release (“XR”) products for Attention Deficit Hyperactivity Disorder (“ADHD”), announced today the completion of the acquisition of all of the commercialization and profit rights to its Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Suspension Product from its collaboration partners Chiesi USA, Inc., and Coating Place, Inc.

    The antitussive/antihistamine combination product is a generic equivalent of the product currently sold under the Tussionex® brand name. The product is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children six years of age and older. According to Symphony Health Solutions, a third-party provider of prescription data, there were approximately 2.5 million total prescriptions of Tussionex® and related generic products in 2013.

    "We are pleased to acquire the full rights to this product as we believe that there is a significant opportunity to expand our sales given the demand within the market. Antitussives are among the most commonly prescribed medications for the treatment of coughs and colds," said Dr. Vipin K. Garg, President and CEO of Neos. "Establishing a commercial presence is a natural progression for Neos as its late-stage ADHD pipeline moves forward in the approval process," he added.

    This transaction is in alignment with our strategy to focus our growth of the company in the hospital and related specialty markets," said Ken McBean, President of Chiesi USA. "We are pleased that Neos, our manufacturing partner for the product, will now have the opportunity to also market this product.”

    "We are committed to continuing our relationship with Neos as its exclusive supplier of the drug resin complexes used in the suspension" added Tim Breunig, CEO of Coating Place, Inc.


    About Neos Therapeutics

    Neos Therapeutics, Inc. is a fully integrated specialty pharmaceutical company. The Company is initially focusing on ADHD with three proprietary products in late-stage development that provide patient-friendly dosage forms incorporating controlled and extended release oral disintegrating tablets (ODT) and liquid suspensions. In addition, Neos manufactures and markets a Generic of Tussionex®, for the treatment of cough and cold. The Company’s products are developed and manufactured using its proprietary and patented ion resin technology. For more information, visit www.neostx.com.

    About Chiesi USA, Inc.

    Chiesi USA, Inc., headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. Chiesi USA, Inc. is a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A. For more information, visit www.chiesiusa.com.


    About Chiesi Farmaceutici S.p.A.

    Chiesi Farmaceutici is a research-focused international group, with more than 75 years of experience headquartered in Parma (Italy). Chiesi researches, develops and commercializes innovative pharmaceutical solutions in the respiratory therapeutics and specialist medicine areas. In 2013, Chiesi achieved sales of over 1.2 billion Euros, constituting double digit growth over 2012. Its R&D centers in Parma (Italy), Paris (France), Rockville (USA), Chippenham (UK) and the R&D team of the newly-acquired Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. The Chiesi Group employs approximately 3900 people, 480 of whom are dedicated to R&D activities. For more information, please visit www.chiesi.com.


    About Coating Place, Inc.

    Coating Place is an innovative pharmaceutical company specializing in Wurster fluid bed technology focused on drug delivery system development and contract manufacturing.  We provide our customers with modified & extended release bulk active products through cutting-edge development, unique manufacturing capabilities and integrated quality philosophy. CPI's extended release drug-resin API’s are developed using our patented DRC Technology combined with our trade secret linear scale-able Wurster manufacturing process. For more information, please visit www.coatingplace.com.

    Tussionex® is a registered trademark of the UCB Group of companies.

    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
    Neos Therapeutics
    (919) 434-6643
    vgarg@neostx.com

    Richard Eisenstadt, MBA
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389
    reisenstadt@neostx.com
    September 8, 2014

  • 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, Inc. Announces the Appointment of Richard I. Eisenstadt as Chief Financial Officer


    Dallas/Fort Worth, TX (May 22, 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 the appointment of Richard I. Eisenstadt to the role of Chief Financial Officer, effective immediately.

    Mr. Eisenstadt has over twenty-five years of finance leadership experience in the healthcare, life sciences and emerging technology industries. Before joining Neos Therapeutics, he served as Chief Financial Officer of ArborGen Inc., a leader in the development and commercialization of technologies that improve the productivity of trees. Prior to ArborGen, Mr. Eisenstadt was Vice President of Finance and Chief Financial Officer of Tranzyme Pharma (NASDAQ: TZYM), a drug discovery and development company, where he raised over $100 million in both private and public equity and debt financings, including an initial public offering of the company’s stock in April 2011.

    Neos Therapeutics’ President and Chief Executive Officer, Vipin Garg, stated, "I am excited to welcome Rich to the Neos team. He brings an extensive track record of finance and business experience and a broad understanding of funding and managing growth companies. Rich will work closely with the organization and financial community to ensure funding of our existing pipeline, and expansion of 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, Mr. Eisenstadt served as Director of Finance at Cogent Neuroscience, and held financial leadership positions at Nimbus CD International and Genicom Corporation.

    Mr. Eisenstadt received his MBA from James Madison University and his BA in Economics from the University of North Carolina at Chapel Hill. He was the recipient of the Triangle Business Journal CFO of the Year award in 2011.


    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. Chief Executive Officer (919) 434-6643 vgarg@neostx.com
    Richard Eisenstadt, MBA
    Chief Financial Officer
    (972) 408-1389
    reisenstadt@neostx.com
    May 22, 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