ADHD related Press Releases

Supernus Pharmaceuticals Raises $42 Million to Prepare for Launch of Product Candidates in Epilepsy and Develop Pipeline i

Fri, 06 Jan 2012 09:20:52 -0500

Two Transactions in December Bring Total Raised in Non-Dilutive Financing to More Than $165 Million

ROCKVILLE, Md.--(BUSINESS WIRE)-- Supernus Pharmaceuticals, Inc. today announced that in December 2011 it closed two transactions through which it raised $42 million. The sale of its TCD Royalty Subsidiary, which was established in April 2008 to securitize royalties that were generated by Sanctura XR® and Oracea®, generated $27 million, while the second transaction, the issuance of venture debt, generated $15 million. Proceeds from the transactions will be used to prepare for the commercial launch of its two lead product candidates in epilepsy and to further the development of its pipeline designed to treat central nervous system (CNS) diseases.

"We have been able to raise more than $165 million through a series of five non-dilutive financing transactions that have enabled us to progress two epilepsy product candidates into NDA stage and two other product candidates in the ADHD area into Phase II. Since its inception six years ago, and despite the continued challenging financing environment, Supernus has developed a broad and diversified portfolio of product candidates that provides us with multiple opportunities to achieve our goal of becoming a leading CNS specialty pharmaceutical company,” said Jack Khattar, President and Chief Executive Officer.

About Supernus

Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The company’s extensive expertise in product development has been built over the past 20 years: initially as a stand alone development organization, then as a U.S. subsidiary of Shire plc and, upon its acquisition of substantially all the assets of Shire Laboratories Inc. in late 2005, as Supernus Pharmaceuticals. The company is developing several product candidates in neurology and psychiatry to address large market opportunities in epilepsy and ADHD including ADHD patients with impulsive aggression. These product candidates include SPN-538 (extended-release topiramate) and SPN-804 (extended-release oxcarbazepine) for epilepsy, SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.

Supernus’ proprietary technologies have been used in the following approved and marketed products: Carbatrol®, Equetro®, Adderall XR®, Sanctura XR®, Oracea® and Intuniv®.

Supernus and the Supernus Pharmaceuticals logo are registered trademarks of Supernus Pharmaceuticals, Inc. in the United States. All other trademarks are the property of their respective owners.

CONTACT:

Supernus Pharmaceuticals, Inc.
Jack Khattar, 301-838-2591
President & CEO
www.supernus.com

KEYWORDS: United States North America Maryland

INDUSTRY KEYWORDS: Health Biotechnology Mental Health Pharmaceutical Other Health Research Science

MEDIA:

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Shire Announces Strategic Partnership for ADHD Medicines in Japan With Shionogi & Co., Ltd.

Fri, 18 Nov 2011 04:21:06 -0500

Shionogi and Shire to jointly develop and commercialize ADHD medicines in Japan

NYON, Switzerland and PHILADELPHIA, November 18, 2011 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has entered into an agreement with Shionogi & Co. Ltd. of Japan to co-develop and co-commercialize certain of Shire's Attention Deficit Hyperactivity Disorder (ADHD) medicines in Japan. Shionogi will pay a one time fee and share costs with Shire in exchange for rights to jointly co-develop and co-commercialize the products upon approval for the Japanese market. Specific terms of the agreement are not being disclosed.

Shire is a recognized leader in the area of ADHD treatment and support, with a portfolio of medicines and resources to help ADHD patients and their families. Shionogi & Co., Ltd. is one of the leading Japanese pharmaceutical companies with an expertise in developing medicines for the central nervous system, among other therapeutic areas. Working together with the Shionogi team, Shire believes the path to regulatory approval, market development and commercialization for ADHD medicines will be more effective and efficient.

"Providing support for ADHD patients, their families and the medical community who treat these patients is at the heart of our approach at Shire, and this agreement with Shionogi underscores our commitment to helping patients diagnosed with ADHD," said Mike Yasick, Senior Vice President of Shire's ADHD business. "We look forward to working with the Shionogi team on efforts to enhance awareness in Japan about the impact undiagnosed and untreated ADHD can have on our societies, and the value that new treatment options can deliver for ADHD patients."

Senior Vice President of Shire's International Specialty Pharma business, Gian Piero Reverberi added, "Our agreement with Shionogi further demonstrates Shire's commitment to enabling greater patient access to Shire's growing portfolio of specialist therapeutics around the globe and specifically to the Japanese market."

ABOUT ADHD

Attention deficit hyperactivity disorder (ADHD) is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.^[^1]

Globally, ADHD is one of the most common childhood psychiatric disorders.^[^{2, 1]} In Japan, the prevalence of ADHD is almost 8%^[^4] or in excess of one million school aged children. The Japanese ADHD market is one of the world's most rapidly growing ADHD markets.^[^3]

The specific etiology of ADHD is unknown, and there is no single diagnostic test for this disorder.^[^2] Adequate diagnosis requires the use of medical and special psychological, educational, and social resources, utilizing diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR^®) or International Classification of Diseases, 10th revision (ICD-10).^[^1,2]

Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms.^[^2] Standard treatments include educational approaches, psychological therapies that may include behavioral modification, and/or medication.^[^2]

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

SHIONOGI & CO. LTD.

Shionogi & Co., Ltd. (Shionogi) are an Osaka based Japanese pharmaceutical company. Shionogi's policy is to strive constantly to provide medicine of the best possible kind essential for the protection of the health of the people. Shionogi's mission, based on this policy, is to deliver pharmaceuticals that offer the greatest possible level of satisfaction to patients, their families, and healthcare providers and that improve quality of life for patients and their families. Global revenues are derived from diverse therapeutic areas including Anti infectives, Cardiovascular, Respiratory & Allergy, CNS & Pain.

For further information on Shionogi please visit the company's website: http://www.shionogi.co.jp/index_e.html

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision (DSM-IV-TR ®). Washington, DC: American Psychiatric Association; 2000:85-93.
Pliszka S and the AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
Source IMS data 2^nd Quarter 2011
ADHD-Related Behavior Among Non-Referred Children: Parents' Ratings o f DSM-III-R Symptoms,Yasuko Kanbayashi, MD,Yojiro Nakata, MA,Kazuko Fujii, BSoc,Michiko Kita, MD.National Institute of Mental Health, National Center of Neurology and Psychiatry, Japan Kayo Wada, MA, Saitama College of Health

Notes to editors

For further information please contact:

    Investor
    Relations       Eric Rojas (erojas@shire.com)            +1-781-482-0999
                    Sarah Elton-Farr (seltonfarr@shire.com)  +44-1256-894-157
    Media           Jessica Mann (jmann@shire.com)           +44-1256-894-280
                    Matthew Cabrey (mcabrey@shire.com)       +1-484-595-8248
 
                    Nicole Barraud (nbarraud@shire.com)
                                                             +41-22-419-4056

SOURCE Shire plc

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD

Kay Nguyen — Tue, 16 Jun 2009 11:49:07 -0400

For Immediate Release: June 15, 2009

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD

There may be an association between the use of stimulant medications for attention-deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children, according to a study published in the American Journal of Psychiatry. But the U.S. Food and Drug Administration says that, because of the study's limitations, parents should not stop a child's stimulant medication based on the study. The FDA recommends that parents should discuss concerns about the use of these medications with the prescribing health care professional.

The FDA can not conclude that the data in the study affect the overall risk-benefit profile of stimulant medications used to treat ADHD in children.

The study's limitations include:

--a significant time lag between the dates when the deaths occurred and collection of the data;
--the difference in circumstance of death may have accounted for a difference in family or caregiver recall of information relating to medication use at the time of death;
--sudden unexplained death in a child would be more likely to trigger a post-mortem inquiry into the cause of death than death due to blunt force trauma as a result of a motor vehicle collision; and
--there was a low frequency of stimulant use reported in both the study group and the control group.

The FDA and the National Institute of Mental Health provided funds for the study, authored by Madelyn S. Gould, Ph.D. of Columbia University.

"The FDA continues to review drug safety information for stimulant medications used to treat ADHD so that we can give health care professionals and families the most up-to-date drug safety information available," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

In the study, the investigators compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, most likely due to sudden cardiac disturbance, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. According to the study report, out of 564 healthy children who died suddenly, 10 were reported to be taking a stimulant medication at the time of death. Out of 564 healthy children who died in a motor vehicle accident, two were reported to be taking a stimulant medication at the time of death.

More information about the study can be found in the FDA Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD).

The FDA recommends that physicians follow the current prescribing information (labeling) for these products, which recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their health care professional to develop a treatment plan that includes a careful health history for cardiovascular disease in the child and his or her family. This includes performing a physical exam with special focus on the cardiovascular system and consideration of further tests such as a screening electrocardiogram and echocardiogram, if the history or examination suggests underlying risk for or the presence of heart disease.

The FDA will continue to review all available information on the potential risks of stimulant medications in children. In addition, the FDA is co-sponsoring a large study, in partnership with the Agency for Healthcare Research and Quality, which is evaluating the potential for increased risk of heart attack, stroke or other cardiovascular problems associated with stimulant medication use in children. Findings from this study are expected later in 2009.

Patients and caregivers should refer to the information contained in the Medication Guides for these products.

PRESS RELEASE: AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

Maureen Martino — Mon, 12 Nov 2007 11:45:10 -0500

AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Researchers supported by the Agency for Healthcare Research and Quality and the U.S. Food and Drug Administration will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD, to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a seven-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data.

"This study highlights one of AHRQ's most important missions: Â to collect and analyze, scientific evidence that will help patients, policymakers, and clinicians make the best possible decisions," said AHRQ Director Carolyn M. Clancy, M.D. "This partnership with the FDA is a great way to move closer to answering important clinical questions that affect children and adults who have ADHD."

"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," said Gerald Dal Pan, M.D., director of FDA's Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question."

The study will be coordinated by Vanderbilt University researchers on contract through AHRQ's Effective Health Care program. Data analysis will be performed by researchers at Vanderbilt, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. The analysis will include all drugs currently marketed for treating ADHD. The study will analyze the risks of all the drugs as a whole, and risks of the drugs grouped by class.

The analysis will take about two years to complete. Results are expected to be important not only to patients, their families and health care providers, but also to government insurance programs. Medicaid, Medicare, and the State Children's Health Insurance Program provide reimbursement for drugs prescribed for ADHD. This information could also be used to inform product labeling, which is used by health care providers when making treatment decisions.

ADHD is a behavioral disorder that, in many patients, causes hyperactivity, and may have a significant impact on school performance and social functioning. According to the National Institute of Mental Health, ADHD affects approximately 3 percent to 5 percent of school-age children and about 4 percent of adults.

Use of ADHD drugs has increased in recent years among children and adults. A recent AHRQ analysis of medication expenditures found three ADHD drugsâ€”Concerta, Strattera, and Adderallâ€”ranked among the top five drugs prescribed for children ages 17 years and younger. About $1.3 billion was spent on those drugs in 2004, the study estimated.Â Adult use is also believed to be increasing.

In May 2006, based on a review of anecdotal reports of heart attack, stroke and sudden death among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. Drug manufacturers have created patient Medication Guides for individual products to help patients understand risks.
FDA and AHRQ recommend that individuals using or being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current health status, particularly for cardiovascular and psychiatric problems, including assessment for a family history of such problems.

For more information:

National Institute of Mental Healthâ€”ADHD page
www.nimh.nih.gov/healthinformation/adhdmenu.cfm

FDA Newsâ€”ADHD Medications and Cardiovascular, Psychiatric Adverse Events
www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

AHRQ's Effective Health Care Program
www.effectivehealthcare.ahrq.gov

FDA STATEMENT: AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

Maureen Martino — Tue, 18 Sep 2007 11:04:53 -0400

AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications