Symptom Advice .com » release source

Medivir: Medivir’s Cold Sore Treatment Xerese™ Now Launched in the United States

Symptom Advice — Mon, 14 Mar 2011 02:17:10 +0000

Press Release Source: Medivir on Tuesday March 1, 2011, 1:15 am EST

HUDDINGE, Sweden–(BUSINESS WIRE)– Regulatory News:

Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces that the Company’s commercialization partner, Meda AB, has launched Medivir’s unique cold sore treatment Xerese™ in the United States.

Xerese™ is the first topical combination product of five per cent acyclovir and one per cent hydrocortisone in a unique cream vehicle for the treatment of recurrent herpes simplex labialis. Xerese™ was granted FDA marketing approval [1] and based on strong clinical data, Xerese™ was given a label, which differentiates it from other topical cold sore products currently on the market.[2] Xerese™ will be sold in the U.S. as a prescription medicine.

Medivir estimates that the U.S. market for cold sore products is valued at USD 230 million (EUR 168 million) and with Meda’s strong commercial presence and deep understanding of U.S. market dynamics, combined with Xerese’s™ differentiated profile, it is anticipated that Xerese™ will be a successful entrant to the cold sore treatment market. Medivir granted Meda the exclusive rights to market, sell and distribute Xerese™ in the United States, Canada and Mexico for the treatment of cold sores (herpes labialis) in February 2010. In addition to funding the commercial development of Xerese™ and up-front and pre-launch milestones totaling USD 5 million, Medivir will also receive double-digit royalties on sales.

Ron Long, CEO of Medivir, commented: “We are delighted that Xerese™ has been launched on the U.S. market today. Our partner Meda has a strong commercial presence in the US and has demonstrated great success in marketing products in the U.S., specifically in dermatology. We very much look forward to the further launches of Xerese™ by our partner Meda in Canada and Mexico and also the launch later this year in Europe by our partner GlaxoSmithKline.”

About Xerese™ (Xerclear® in Europe)

Xerese™ is the first and only cold sore treatment that demonstrated greater efficacy vs. 5% acyclovir in the same cream vehicle (with early treatment), reduced the likelihood of progression to ulceration with early treatment [3] and combines an antiviral and an anti-inflammatory.

Xerese™ also provided faster healing time vs. vehicle placebo (mean time to skin normalization was approximately 1.6 days shorter) [4], 50% greater reduction in cumulative lesion area with Xerese™ vs. vehicle placebo and greater relief of symptoms, such as tenderness vs. vehicle placebo [3],[4].

About cold sores

Recurrent herpes labialis (cold sores) is a common infection that affects one-third of the population in the Western world resulting in around 600 million episodes per year with 57 million people having 3 or more episodes per year. The great majority of cases are caused by herpes simplex virus type 1 (HSV-1). unlike most viruses, the cold sore virus is not completely eliminated by the body’s immune response. instead it establishes a chronic, latent and life-long infection in sensory ganglia. at a later date, the virus may be reactivated and travel back to the skin – often around the mouth and nose – to trigger a clinical episode of recurrent herpes labialis. The virus is reactivated by factors like sunlight and stress.

Products based on antiviral substances such as aciclovir, penciclovir, famciclovir and valaciclovir are the most commonly used treatment options. The market for topical treatment of herpes infections in the USA and Europe is estimated at USD 230 million and USD 170 million, respectively.

[1] US Food and Drug Administration, 31/07/2009. accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist

[2] US Food and Drug Administration, 5/12/2010.

accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf

[3] Hull CM, Harmenberg J, Arlander E, et al. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial [published online ahead of print September 17, 2010].

[4] Xerese™ (package insert). Somerset, NJ:Meda Pharmaceuticals inc.; 2010

About Medivir

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is TMC435, a protease inhibitor which has recently entered phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals.

Medivir is also marketing its first product, the unique cold sore product Xerese™/Xerclear® which has recently been launched on the US market. Xerese™/Xerclear®, which has been approved in both the US and Europe. is partnered with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia and with Meda AB in North America, Canada and Mexico. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.

for more information about Medivir, please visit the Company’s website: medivir.com.

This information was brought to you by Cision cisionwire.com

Kraft Philadelphia® Cooking Creme Fights Chicken Fatigue

Symptom Advice — Sat, 05 Mar 2011 19:17:20 +0000

Press Release Source: Kraft Foods On Wednesday March 2, 2011, 11:06 am EST

GLENVIEW, Ill., March 2, 2011 /PRNewswire/ — Its insidious symptoms can crop up in kitchens at any time – boredom with current repertoire of chicken recipes, hearing cries of “chicken AGAIN?” from the family, and even fantasizing about other (tastier) dishes. The diagnosis: chicken fatigue. The cure? New Philadelphia® Cooking Creme, a spoonable, easy-to-blend creme that can be effortlessly stirred into skillets, casseroles and pasta. Seasoned with delicious combinations of savory herbs, cheeses and spices, Philadelphia Cooking Creme replaces bland ingredients such as condensed soup or sour cream to create rich and creamy chicken dishes that will “wow” the whole family.

“Chicken has always been an American dinnertime favorite because it’s a budget-friendly, lean protein,” says Howard Friedman, Senior Vice President of Marketing, Cheese and Dairy at Kraft Foods. “However, American mothers tell us they often fall into a rut cooking the same, routine chicken recipes night after night. with its smooth texture and distinctive flavors, Philadelphia Cooking Creme aims to cure chicken fatigue by transforming everyday chicken recipes into chef-inspired fare.”

Available in four delicious varieties – Italian Cheese & Herb, Savory Garlic, Original and Santa Fe Blend, Philadelphia Cooking Creme makes cooking with Philly easier than ever, offering a dollop-able, creamy consistency that’s simple to measure, mix and melt in all of your favorite dishes, ranging from chicken and rice skillets to zesty enchiladas.

“Philadelphia Cooking Creme is not only a quick and easy dinner solution, but is packed with the flavors needed to bring a delicious restaurant experience direct to your table,” says Todd English, James Beard award-winning chef and TV personality.

Philadelphia Cooking Creme is packaged in rectangular, easy-to-open 10-ounce tubs and can be found in the cream cheese section at leading grocery stores nationwide in early 2011. for more information, visit cookphilly.com.

ABOUT KRAFT FOODS

Northfield, Ill.-based Kraft Foods Inc. (NYSE:KFT – News) is a global snacks powerhouse with an unrivaled portfolio of brands people love. Proudly marketing delicious biscuits, confectionery, beverages, cheese, grocery products and convenient meals in approximately 170 countries, Kraft Foods had 2010 revenue of $49.2 billion, more than half of which was earned outside North America. eleven of the company’s iconic brands — including Cadbury, Jacobs, Kraft, LU, Maxwell House, Milka, Nabisco, Oreo, Oscar Mayer, Philadelphia and Trident — generate revenue of more than $1 billion annually, and 40 have been loved for more than a century. A leader in innovation, marketing, health & wellness and sustainability, Kraft Foods is a member of the Dow Jones Industrial Average, Standard & Poor’s 500, Dow Jones Sustainability Index and Ethibel Sustainability Index. For more information, visit kraftfoodscompany.com and facebook.com/kraftfoodscorporate.

Pharmaxis Launches ARIDOL® (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness

Symptom Advice — Sat, 26 Feb 2011 04:51:10 +0000

Press Release Source: Pharmaxis, Inc. On Wednesday February 23, 2011, 4:20 pm EST

EXTON, Pa., Feb. 23, 2011 /PRNewswire/ — Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for chronic respiratory and immune disorders, announced today the commercial launch of ARIDOL® (mannitol inhalation powder) Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades and the company’s first product launch in the U.S. ARIDOL is used to assess bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma. ARIDOL should not be used as a stand alone test to assess asthma or as a screening test for asthma, but as part of a physician’s overall assessment of asthma. ARIDOL can be ordered directly from Pharmaxis and is available to pulmonary function labs and physicians’ offices by calling Pharmaxis Customer Service at 1-888-416-1828.

“ARIDOL is an important advancement in bronchial challenge testing – the first in 20 years – and a significant addition to the tools available to help in an overall assessment of asthma,” said Stephen Beckman, President, Pharmaxis, Inc. ”We are excited to provide patients and the medical community with an effective, accurate and reproducible test that can be conducted in the convenience of a pulmonary function lab or physician’s office.”

ARIDOL is a single-use, indirect test that is easy-to-administer, requires minimal preparation time and a 15% reduction in lung function from baseline for a positive test. ARIDOL was approved by the U.S. Food and Drug Administration (FDA) on October 5, 2010, and demonstrated safety and efficacy in two Phase III clinical trials.

“The ARIDOL Bronchial Challenge Test takes only about 20 minutes to administer for a positive test and requires a 15% reduction in FEV[1]. Previous options may take up to 40 minutes to implement and require a 20% reduction in FEV[1],” said Bradley Chipps, MD, Capital Allergy and Respiratory Disease Center, Sacramento, CA. “The ARIDOL Bronchial Challenge Test offers health care professionals another tool to help with a disease that is often hard to definitively diagnose.”

“PHARMAXIS is committed to bringing our therapeutic advances for respiratory and immune diseases to patients throughout the world. The U.S. launch of ARIDOL highlights this commitment and our focus on helping physicians and patients world-wide affected by respiratory illnesses,” added mr. Beckman.

How ARIDOL Works

The ARIDOL test requires patients to inhale increasing doses of dry powder mannitol from a simple, hand-held device, which causes airways to narrow and contract when airway inflammation is present. the doses are contained in capsules that are administered at one-minute intervals until a positive response is achieved or until all the capsules have been inhaled, indicating a negative result. A positive response is indicated when there is a 15% reduction in lung function from baseline compared to a 20% fall required by a methacholine challenge test.(1) the lower the dose required to cause bronchoconstriction, the more severe the bronchial hyperresponsiveness.

Other Bronchial Challenge Tests

Unlike other bronchial challenge tests, ARIDOL is a single-use test that requires less preparation time and eliminates reconstitution, use of a nebulizer to administer, clean-up and sterilization. A positive ARIDOL test is complete in approximately 20 minutes, compared to an average of 45 minutes for a methacholine test.(2) a methacholine test requires additional equipment to administer and a designated testing room with ventilation.(1) Tests that use exercise to assess bronchial hyperreponsiveness require special equipment and conditions, and may not be appropriate for patients with physical limitations.

Safety/Efficacy Profile

The safety and efficacy of ARIDOL as a bronchial challenge test were verified in two global Phase III clinical trials, which assessed the effectiveness of the ARIDOL bronchial challenge test in non-asthmatic patients with symptoms suggestive of asthma and clinically diagnosed asthmatic patients six years of age and older. Approved for use in 19 countries, ARIDOL has been used by more than 44,000 patients, and is marketed in Australia, major European countries and Korea. ARIDOL is included in official international guidelines for the clinical assessment of asthma. Organizations and guidelines endorsing ARIDOL include: the International Olympic Committee Medical Commission’s Independent Panel on Asthma, the U.S. Asthma Management Guidelines, the Global Initiative for Asthma (GINA) Report on Global Strategy for Asthma Management and Prevention, the World Anti-Doping Agency and the Australian Asthma Management Handbook. ARIDOL is the only dry powder bronchial challenge test approved for use in the U.S.

Indication

Mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.

ARIDOL is not a stand alone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician’s overall assessment of asthma.

Important Safety Information

WARNING: RISK OF SEVERE BRONCHOSPASM

Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. If severe bronchospasm occurs it should be treated immediately by administration of a short acting inhaled beta-agonist. because of the potential for severe bronchoconstriction, bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV[1]

EpiCept Reports Positive Results from EpiCept™ NP-1 Trial in Patients with Chemotherapy-Induced Peripheral Neuropathy

Symptom Advice — Mon, 07 Feb 2011 23:34:13 +0000

Press Release Source: EpiCept Corporation on Monday February 7, 2011, 12:01 am EST
TARRYTOWN, N.Y.–(BUSINESS WIRE)– Regulatory News:

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced positive results from a Phase IIb trial evaluating the efficacy and safety of EpiCept™ NP-1 (NP-1) in chemotherapy-induced peripheral neuropathy (CPN). EpiCept NP-1 is a topical analgesic cream containing two FDA-approved drugs, amitriptyline and ketamine, in development for the relief of pain from various peripheral neuropathies.

the multi-center, double-blind, randomized, placebo-controlled study was conducted by the National Cancer Institute (NCI)-funded Community Clinical Oncology Program. More than 460 cancer survivors suffering from painful CPN were enrolled in the six-week study. the results of the trial in the intent to treat (ITT) population demonstrated that the change in average daily neuropathy intensity scores in the NP-1 group achieved a statistically significant reduction in CPN intensity versus placebo (p

Colonoscopy Prep App from WellApps Released for iPhone and Android Smartphones

Symptom Advice — Sat, 22 Jan 2011 12:17:10 +0000

Press Release Source: WellApps, LLC On Monday January 10, 2011, 6:18 am EST
UPPER SADDLE RIVER, N.J., Jan. 10, 2011 /PRNewswire/ — WellApps, LLC, developer of GI Monitor for Crohn’s and Ulcerative Colitis, announced today the release of Colonoscopy Prep Assistant. during the portion of colonoscopy preparation when a patient ingests a liquid laxative, Colonoscopy Prep Assistant tracks the number of glasses completed and time between glasses, notifying the patient when it’s time to drink their next glass. The app is available for free in iTunes and the Android Market.

As an Ulcerative Colitis patient, Brett Shamosh, Co-Founder & CEO of WellApps, LLC, is at a higher risk for colon cancer and undergoes an annual colonoscopy for screening. during a recent colonoscopy prep, he was instructed by his doctor to drink 8 glasses of a liquid laxative every 10-15 minutes for 2 hours. Said mr. Shamosh, “I used a notepad to tally the number of drinks and a stopwatch to keep track of time. then I decided that there should be an app for that.” The app is currently intended for liquid laxative preps, but WellApps is enhancing the app to support all specific colonoscopy preparation methods suggested by providers. Edward Shin, MD, Co-Founder of WellApps, adds, “I have no doubt that providers will begin to prescribe apps for colonoscopy and other procedure preparations. Apps can guide the patient through their specific prep as if a nurse was there with them.”

Procedure preparation apps can offer significant benefits to patients and providers. Arun Swaminath, Associate Director of the IBD Center at Columbia University Medical Center, says “Thorough bowel preparation allows me to identify the smallest polyps or cancers. In addition, good prep shortens the procedure’s duration, making it safer for patients. Strict adherence to prep instructions allows for the highest quality colonoscopy.” Procedure preparation apps also provide unique opportunities to Pharmaceutical companies looking to enhance their products. Bill Jennings, CEO of good Health Media, says “Pharma is always trying to collect feedback from patients. with apps like these, they can get real-time survey information right after the prep is completed, while suggestions for improvement are fresh in the mind of the patient.”

Inspired by an ongoing battle with Ulcerative Colitis, 35-year old Brett Shamosh, a digital media executive from Bergen County, NJ, decided to use the booming smartphone app market to help fellow IBD (Inflammatory Bowel Disease) patients. He created GI Monitor, currently the #1 mobile symptom tracking app for Crohn’s and Ulcerative Colitis. Since then, he started WellApps, LLC to develop and distribute symptom tracking applications for patients with chronic illnesses. Shamosh says, “We know that apps can help make procedure preps more effective and prevent do-overs. The release of this particular app also serves as a great reminder that IBD patients are at a higher risk of colon cancer and should get screened regularly, as directed by their doctor.”

Colonoscopy Prep Assistant is free to patients and is currently available at wellapps.com.

About WellApps, LLC:

WellApps develops and distributes symptom tracking applications for patients with chronic illnesses. The data collected is compiled into easy-to-read reports for physicians, resulting in optimal patient treatment and reduced periods of active disease. Patients can also access interactive charts to see correlations between symptoms and understand how compliance to medication affects their well-being.

This press release was issued through 24-7PressRelease.com. For further information, visit 24-7pressrelease.com.

Sinovac Receives SFDA Approval to Commence Clinical Trials for Inactivated Enterovirus Type 71 Vaccine

Symptom Advice — Tue, 18 Jan 2011 14:34:18 +0000

Press Release Source: Sinovac Biotech Ltd. on Tuesday December 28, 2010, 8:35 am EST
BEIJING, Dec. 28, 2010 /PRNewswire-Asia/ — Sinovac Biotech Ltd. (Nasdaq:SVA – News), a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD). according to the approval document, Sinovac is required to conduct each phase of the human clinical trials in accordance with SFDA requirements, to conduct studies to assess safety and immunogenicity in the phase I and II clinical trials, and to conduct efficacy study in the phase III clinical trial. Sinovac filed in late December 2009 with the SFDA the application to commence human clinical trials for its inactivated EV71 vaccine.

Dr. Weidong Yin, Chairman, President & CEO, stated, “We are very pleased to advance our near term vaccine development pipeline with the approval from the SFDA to commence clinical trials for our internally developed EV 71 vaccine. Currently, there is no vaccine available worldwide for this disease. We had no precedent to go by during the development, so we had to start with the basic research on this vaccine. moreover, our R&D people has successfully completed pre-clinical research and made significant breakthroughs during the development. We will move forward with our research and development of vaccines with the objective to supply high quality vaccine products to children worldwide as soon as possible and to contribute to the prevention and control of HFMD.”

As previously announced, the Company began preclinical research in 2008 for its independently developed EV 71 vaccine. The animal model, built by researchers at Sydney University, showed cross protection and demonstrated that the vaccine is effective in animals. in addition, Sinovac has already filed five patent applications covering the EV 71 vaccine.

About EV 71

Enterovirus 71, or EV 71, causes Hand, Foot, and Mouth Disease (or HFMD). more than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease. however, there has been an increase in severe HFMD cases reported associated with neurological symptoms caused by EV 71. a number of outbreaks of EV 71 HFMD in the Asia-Pacific region have been reported since 1997. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. no specific treatment for this enterovirus infection and no vaccine are currently available.

HFMD has become a very serious problem in China, some other Asian countries and other areas in recent years given that no vaccine and specific treatment is currently available to protect against this disease. EV 71 has evolved into a severe health threat to children as a growing number of HFMD cases have been reported in parts of Asia, including mainland China, Hong Kong, Singapore, South Korea, and Taiwan. according to the Chinese Ministry of Health’s data available for the period from January 1 to November 30, 2010, the disease caused 876 deaths in China and over 1.73 million HFMD infection cases during the 2010 eleven-month period, as reported by health authorities, as compared to 353 fatalities in China and over 1.15 million reported HFMD infectious cases for the entire year of 2009. HFMD is common among infants and children, as most of the recently reported cases have occurred in children under five years of age.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases including hepatitis a, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza. in 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, PANFLU.1, and has received orders from the Chinese Central Government pursuant to the government stockpiling program. The Company is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against Hand, Foot & Mouth Disease), Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps and rubella. its wholly owned subsidiary, Tangshan Yian, is focusing on the research, development, manufacturing and commercialization of animal vaccines and has completed the field trials for an independently developed inactivated animal rabies vaccine, which is anticipated to be launched into market in 2011.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. a number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

PTC Therapeutics Completes Enrollment of Phase 3 Trial of Ataluren in Patients with Cystic Fibrosis

Symptom Advice — Sun, 26 Dec 2010 13:00:24 +0000

Press Release Source: PTC Therapeutics, Inc. On Tuesday December 21, 2010, 8:00 am EST
SOUTH PLAINFIELD, N.J., Dec. 21, 2010 /PRNewswire/ — PTC Therapeutics, Inc. announced today that it has completed enrollment of a Phase 3 clinical trial of ataluren, an investigational new drug, in patients with nonsense mutation cystic fibrosis (nmCF).

(Logo: photos.prnewswire.com/prnh/20010919/PTCLOGO )

The 48-week study is designed to determine whether ataluren can improve lung function in patients with nmCF. The trial has enrolled 238 patients at 36 sites in North America, Europe and Israel. Patients who complete the treatment phase of the Phase 3 trial are eligible to participate in a 48-week, open-label extension study, which has begun enrolling patients.

“The enrollment of this trial represents an important step forward in our efforts to develop disease-modifying treatments that advance the standard of care in CF and improve quality of life for CF patients,” stated Michael Konstan, MD, Chairman, Department of Pediatrics at Rainbow Babies and Children’s Hospital in Cleveland, Ohio. Dr. Eitan Kerem, Head, Department of Pediatrics and CF Center, Hadasash University Hospital, Jerusalem, Israel added, “Despite significant advances in the 21 years since the identification of the disease-causing gene, cystic fibrosis remains a debilitating and life-threatening disorder and available therapies focus only on alleviating symptoms. Ataluren couples a patient’s genetic diagnosis with a mutation-specific therapeutic approach designed to address the underlying cause of the disease.”

Ataluren is a protein restoration therapy designed to enable the formation of full-length, functional cystic fibrosis transmembrane regulator (CFTR) protein in patients with cystic fibrosis due to a nonsense mutation. CFTR is a critical protein lacking in CF patients. Nonsense mutations are categorized as Class I mutations that result in little or no production of the CFTR protein. CF patients with Class I mutations typically experience more severe disease symptoms than those with lower-risk genotypes, including a greater than twofold increased risk of death, a higher probability of end-stage lung disease and a higher prevalence of pancreatic insufficiency. A simple genetic test can determine if a patient’s disease is caused by a nonsense mutation.

“We are pleased to have completed enrollment of our second pivotal clinical trial of ataluren in patients with a nonsense mutation genetic disorder. This is a tremendous achievement and a testament to the commitment of clinical trial patients and their families, as well as study investigators and trial site staff,” stated Stuart Peltz, Ph.D., president and CEO of PTC Therapeutics. ”PTC is committed to improving the quality of life of patients with serious and life-threatening diseases through our innovative scientific approach to the discovery of novel treatments.”

PHASE 3 STUDY DESIGN

The primary objective of the registration-directed, double-blind, placebo-controlled study is to determine whether ataluren can improve lung function in patients with nmCF, as measured by forced expiratory volume in 1 second (FEV1). Additional secondary endpoints are evaluating other aspects of patient function, drug activity, and safety. The 48-week trial enrolled 238 patients, ages six years and older, at multiple sites in North America, Europe, and Israel. Patients were randomly assigned to one of two treatment arms: ataluren (10 mg/kg morning, 10 mg/kg midday, 20 mg/kg evening) or placebo (morning, midday, evening).

ABOUT ATALUREN

An investigational new drug discovered by PTC Therapeutics, ataluren is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. A nonsense mutation is an alteration in the genetic code that prematurely halts the synthesis of an essential protein. The resulting disorder is determined by which protein cannot be expressed in its entirety and is no longer functional, such as the CFTR protein in nonsense mutation cystic fibrosis.

The development of ataluren has been supported by grants from Cystic Fibrosis Foundation Therapeutics Inc. (the nonprofit affiliate of the Cystic Fibrosis Foundation); FDA’s Office of Orphan Products Development; Muscular Dystrophy Association; National Center for Research Resources; National Heart, Lung, and Blood Institute; and Parent Project Muscular Dystrophy.

The FDA and the European Commission have granted ataluren Orphan Drug status for the treatment of nonsense mutation cystic fibrosis and nonsense mutation Duchenne and Becker muscular dystrophy. The FDA has also granted ataluren Subpart E designation for expedited development, evaluation, and marketing for CF and dystrophinopathy and Fast Track designation for the development of treatment for nonsense mutation dystrophinopathy.

COLLABORATION WITH GENZYME

PTC Therapeutics has an exclusive collaboration with Genzyme Corporation for the development and commercialization of ataluren. PTC Therapeutics will commercialize ataluren in the United States and Canada, while Genzyme will commercialize the product in other regions of the world.

ABOUT CYSTIC FIBROSIS (CF)

CF is a life-threatening genetic disorder that causes serious lung infections and digestive complications. The predicted median age of survival for a person with CF is about 37 years. According to the Cystic Fibrosis Foundation, CF affects approximately 30,000 adults and children in the United States and nearly 70,000 people worldwide. Genetic testing is required to confirm a complete diagnosis and to determine if a patient’s disease is caused by a nonsense mutation. It is estimated that nonsense mutations are the cause of CF in about 10 percent of patients in the United States and Europe and over 50 percent of patients in Israel. Available treatments for CF are designed to alleviate symptoms rather than correct the underlying cause of the disease. Based on the current standard of care, the treatment burden for CF patients is high and, on average, adults with CF take 7 daily therapies. More information regarding CF is available through the Cystic Fibrosis Foundation (cff.org).

ABOUT PTC THERAPEUTICS, INC.

PTC is a biopharmaceutical company focused on the discovery, development and commercialization of orally administered small-molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing of protein production and are of central importance to proper cellular function. PTC’s internally discovered pipeline addresses multiple therapeutic areas, including rare genetic disorders, oncology, and infectious diseases. PTC has developed proprietary technologies that it applies in its drug discovery activities and is the basis for collaborations with leading biopharmaceutical companies. For more information, visit the company’s web site at ptcbio.com.

Reportlinker Adds Prostate Cancer – Germany Drug Forecasts and Treatment Analysis to 2020

Symptom Advice — Thu, 02 Dec 2010 18:00:15 +0000

Press Release Source: Reportlinker on Tuesday November 23, 2010, 1:46 pm EST
NEW YORK, Nov. 23, 2010 /PRNewswire/ — Reportlinker.com announces that a new market research report is available in its catalogue:

Prostate Cancer – Germany Drug Forecasts and Treatment Analysis to 2020

reportlinker.com/p0332251/Prostate-Cancer—Germany-Drug-Forecasts-and-Treatment-Analysis-to-2020.html

Prostate Cancer – Germany Drug Forecasts and Treatment Analysis to 2020

Summary

GlobalData’s pharmaceutical report, “Prostate Cancer – Germany Drug Forecasts and Treatment Analysis to 2020″. The report is an essential source of information and analysis on the German prostate cancer therapeutics market. The report provides comprehensive information on prostate cancer, highlighting the treatment guidelines. It identifies and analyzes the key trends shaping and driving the German prostate cancer therapeutics market, and analyzes the treatment usage patterns. The report also provides insights into the competitive landscape and the emerging players expected to significantly alter the positions of the existing market leaders. The report provides valuable insights into the pipeline products within the global prostate cancer sector. It quantifies the unmet need in the German prostate cancer therapeutics market, highlighting the opportunity for future players.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

The scope of the report includes:

- An overview of prostate cancer which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.

- Annualized German prostate cancer therapeutics market revenue, annual cost of therapy and treatment usage patterns data (for hormone therapy and hormone resistant or refractory therapy) from 2001 to 2009, forecast for 11 years to 2020.

- Insightful review of the key industry drivers, restraints and challenges and predicted impact of key events.

- Competitor assessment including drug launch analysis and drug sales forecasts.

- Product profiles covering efficiency, safety, clinical study details, annual cost, regulatory approvals, LCM (Life Cycle Management) activities and drug sales forecast.

- Analysis of unmet need in the market and target product profiles including opportunity for target products.

- Technology trends analytic framework to assess the strength of the pipeline.

- Pipeline analysis data providing a split across different phases, mechanisms of action being developed and emerging trends. The key classes of mechanism of action include EGFR inhibitors, VEGF inhibitors, tyrosine kinase inhibitor, angiogenesis inhibitors and others.

- An overview of the most promising drugs including clinical study details, efficacy, safety, collaboration agreements, marketing rights and launch analysis.

- Analysis of the current and future market competition in the German Prostate Cancer therapeutics market. Company profiles including business description, financial overview and SWOT analysis. Key future market players covered include Sanofi-aventis, Pfizer, inc., AstraZeneca PLC, Bristol-Myers Squibb, Medivation, Takeda Pharmaceuticals and Dendreon Corporation.

- Analysis of licensing agreements during 2004-2010 in the prostate cancer therapeutics market. Merger and Acquisition (M&A analysis) which includes M&A deals by size and geography.

- Strategic assessment of the market through market impact analysis, future market scenario and company analysis.

- Direct quotes from key opinion leaders (KOL) or physicians in the prostate cancer therapeutics market in Germany.

Reasons to buy

The report will enhance your decision making capability. It will allow you to:

- Develop business strategies and perform superior market quantification analysis by

- Understanding the trends shaping and driving the German prostate cancer therapeutics market.

- Understanding the treatment preferences of physicians for each disease state and across treatment flow.

- Accessing market sizing forecasts and quantified growth opportunities in the German prostate cancer therapeutics market up to 2020.

- Quantifying the patient population in the German to better design product pricing and launch plans.

- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape by

- Performing benchmarking analysis and growth opportunities against currently marketed products.

- Identifying market entry points based on safety, efficacy, and pricing parameters.

- Assessing competitiveness of products in the market by understanding the strengths and weaknesses of current competition.

- Develop and design your in-licensing and out-licensing strategies by

- taking a comprehensive look at the disease pipeline and identifying the most promising paradigm-shifting products.

- Assessing the strength of pipeline based on first-in-class, me-too and generic products and their lifecycle management.

- Track drug sales in the German prostate cancer therapeutics market from 2001 to 2020.

- Identify the emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for consolidation, investments and strategic partnerships.

- What’s the next big thing in the German prostate cancer therapeutics market landscape? Identify, understand and capitalize.

1 Table of contents 4

1.1 List of Tables 7

1.2 List of Figures 8

2 Disease Overview 10

2.1.1 TNM (Tumor, Nodes, Metastasis) Staging system 10

2.1.2 Jewett-Whitmore system 11

2.4.1 Localized or Locally Advanced Prostate Cancer 12

2.4.2 Metastatic Prostate Cancer 13

2.5.1 Digital Rectal Examination 13

2.5.2 Prostate Specific Antigen Test 13

2.5.3 Transrectal Ultrasound 14

2.5.4 Prostate Biopsy 14

2.7.1 Watchful Waiting 15

2.7.2 Radiation therapy 15

2.7.4 Hormone therapy 17

2.7.5 Chemotherapy Options 18

2.7.6 other Treatments being Studied 19

2.8 Treatment Guidelines 19

3 Market Characterization 20

3.1.2 Drivers and Barriers 26

3.1.3 Impact on the Market 28

3.1.6 Pricing & Reimbursements 39

4 Competitor Assessment 40

4.1 Strategic Competitor Assessment 40

4.1.2 Benchmarking 40

4.1.3 Current Competitor Assessment 44

4.2 Launch Analysis and Sales Forecasts 45

4.3 Product Profiles 46

4.3.1 Taxotere (docetaxel) 47

4.3.2 Casodex (Bicalutamide) 50

4.3.3 Zoladex (Goserelin) 55

4.3.4 Eligard (leuprolide acetate) 57

4.3.5 Firmagon (degarelix) 62

4.3.6 Novantrone (Mitoxantrone hydrochloride) 64

4.3.7 Emcyt (estramustine) 66

4.3.8 Trelstar (triptorelin) 68

4.3.10 Delestrogen 71

4.3.12 Estrace tablet 73

4.3.16 Sales Forecast for Trelstar, Decapeptyl, Gonapeptyl, Flutamide, Estradiol 76

5 Pipeline Assessment 77

5.2 Pipeline Analysis by Phase of Development 78

5.3 Pipeline by Mechanism of Action 79

5.4 Strategic Pipeline Assessment 80

5.4.1 Technology Trends Analytical Framework 80

5.5 Trends in Prostate Cancer Pipeline 81

5.5.1 more Clarity on the Origin of Prostate Cancer will help in Identifying novel Targets for Prostate Cancer Drugs 81

5.5.2 Molecules with novel Mechanism of Action Strengthening Prostate Cancer Pipeline 81

5.5.3 Failure of Key Molecules to Achieve Positive Results in Phase III Development 81

5.6 Partners in Research and Development 82

5.6.1 Licensing Agreements by Phase of Development 82

5.6.2 Licensing Agreements by Geography 85

5.6.3 Licensing Agreements: Technology Licensing Agreements in Prostate Cancer 85

5.7 most Promising Drugs’ Profiles 86

5.7.1 Provenge (sipuleucel-T) 87

5.7.2 Jevtana (cabazitaxel) 90

5.7.3 Aflibercept (VEGF Trap) 91

5.7.5 Abiraterone Acetate (CB7630) 96

5.7.6 Zibotentan (ZD4054) 98

5.7.7 Sprycel (dasatinib) 100

5.8 Prostate Cancer Pipeline – Pre-clinical Phase 105

5.9 Prostate Cancer Pipeline – Phase I 106

5.10 Prostate Cancer Pipeline – Phase II 108

5.11 Prostate Cancer Pipeline – Phase III 115

5.12 Key Takeaway 116

6 Unmet need and Target Product Profile 117

6.1 Unmet need 119

6.1.1 Hormone-independent Metastatic Prostate Cancer Therapy 119

6.1.2 Hormone-dependent Metastatic Prostate Cancer Therapy 120

6.2 Opportunity for Target Product 121

6.3 Target Product Profile 123

6.3.1 Ideal Characteristics 123

6.3.2 Target Product Description 124

7 Strategic Assessment 125

7.1 Key Events Impacting the Future Market 125

7.2 Market Impact Analysis 126

7.3 Future Market Scenario 126

7.4 Company Analysis 127

7.4.1 Market Leadership 127

7.4.2 Future Players in the Market 128

8 Company Profiles 129

8.1 Sanofi-aventis 129

8.1.1 Business Description 129

8.1.2 Financial Overview 131

8.1.3 SWOT Analysis 131

8.1.4 Oncology Focus 136

8.2 Pfizer inc. 136

8.2.1 Business Description 136

8.2.2 Financial Overview 137

8.2.3 SWOT Analysis 138

8.2.4 Oncology Focus 144

8.3.1 Business Description 145

8.3.2 Financial Overview 147

8.3.3 SWOT Analysis 147

8.3.4 Oncology Focus 151

8.4 Bristol-Myers Squibb 152

8.4.1 Business Description 152

8.4.2 Financial Overview 153

8.4.3 SWOT Analysis 154

8.4.4 Oncology Focus 159

8.5.1 Business Description 160

8.5.2 SWOT Analysis 161

8.5.3 Oncology Focus 164

8.6 Takeda Pharmaceuticals 164

8.6.1 Business Description 164

8.6.2 SWOT Analysis 165

8.7 Dendreon Corporation 166

8.7.1 Business Description 166

8.7.2 SWOT Analysis 167

8.8 Johnson and Johnson 170

8.8.1 Business Description 170

8.8.2 SWOT Analysis 171

8.8.3 Oncology Focus 178

8.9 Auron Healthcare GmbH 179

8.9.1 Business Description 179

8.10 Oncogenex Pharmaceuticals, inc. 179

8.10.1 Business Description 179

8.11.1 Business Description 179

8.12 GTx, inc. 180

8.12.1 Business Description 180

8.13 GlaxoSmithKline plc. 180

8.13.1 Business Description 180

8.13.2 Financial Overview 181

8.13.3 SWOT Analysis 181

8.13.4 Oncology Focus 187

9.1 Key Highlights 189

9.2 Key Deals’ Analysis 190

9.2.1 Johnson & Johnson Acquires Cougar Biotechnology 190

9.2.2 Endo Pharmaceuticals Acquires Indevus Pharmaceuticals 190

9.2.3 Tolmar Holding Acquires QLT USA from QLT 191

9.2.4 Biomarin Pharmaceutical to acquire Lead therapeutics 191

9.2.5 Isis Pharmaceuticals Reacquires Rights to Cancer Drug from Eli Lilly & co. 191

9.2.6 Quest PharmaTech Acquires Late-stage Immunotherapeutic Antibody Pipeline from Paladin Labs 191

9.2.7 VaxOnco Acquires Rights to Onyvax-P Cell Vaccine from Onyvax 191

9.2.8 GPC Biotech Merges with Agennix 191

9.2.9 Eli Lilly Acquires ImClone 192

9.2.10 BBM Holdings Acquires YM BioSciences 192

9.2.11 Sagent Pharmaceuticals Acquires Injectable Generic Drug Applications of Spectrum Pharmaceuticals 192

9.3 M&A Deals by Geography 193

9.4 M&A Deals by Deal Size 193

10 Expert Opinion 194

11.1 Market Definitions 195

11.2 Abbreviations 195

11.3 Research Methodology 197

11.3.2 Secondary Research 198

11.3.3 Forecasting 198

11.3.4 Primary Research 201

11.3.5 Expert Panel validation 201

11.3.6 Contact us 201

11.3.7 Disclaimer 201

1.1 List of Tables

Table 1: Prostate Cancer Therapeutics Market, Global, Staging of the Prostate Cancer, 2010 11

Table 2: Prostate Cancer, Global, Age Related PSA Levels (ng/ml), 2010 14

Table 3: Prostate Cancer Therapeutics Market, Germany, Sales Value ($m), 2001-2009 20

Table 4: Prostate Cancer Therapeutics Market, Germany, Annual Cost of Therapy ($), 2001-2009 22

Table 5: Prostate Cancer Therapeutics Market, Germany, Patient Volume (’000s), 2001-2009 23

Table 6: Prostate Cancer Therapeutics Market, Germany, Treatment Usage Patterns (’000s), 2001-2009 24

Table 7: Prostate Cancer Therapeutics Market, Germany, Sales Value ($m), 2009-2020 29

Table 8: Prostate Cancer Therapeutics Market, Germany, Annual Cost of Therapy ($), 2009-2020 30

Table 9: Prostate Cancer Therapeutics Market, Germany, Patient Volume (’000s), 2009-2020 31

Table 10: Prostate Cancer Therapeutics Market, Germany, Treatment Usage Patterns (’000s), 2009-2020 32

Table 11: Prostate Cancer Therapeutics Market, Germany, Hormone-refractory Prostate Cancer Drug Sales ($m), 2001-2010 36

Table 12: Prostate Cancer Therapeutics Market, Germany, Hormone-refractory Prostate Cancer Drug Sales ($m), 2011-2020 36

Table 13: Prostate Cancer Therapeutics Market, Germany, Hormone-dependent Prostate Cancer Drug Sales ($m), 2001-2010 38

Table 14: Prostate Cancer, Germany, Hormone-dependent Prostate Cancer Drug Sales ($m), 2011-2020 38

Table 15: Prostate Cancer, Global, Clinical Endpoints for Benchmarking, 2010 41

Table 16: Prostate Cancer, Global, Chemotherapy, Safety Profile of Standard Care Treatment, 2010 42

Table 17: Prostate Cancer, Global, Hormone Therapy, Safety Profile of Standard Care Treatment, 2010 43

Table 18: Prostate Cancer, Germany, Benchmarking Major Marketed Products, 2010 46

Table 19: Prostate Cancer, Global, Casodex, Incidence of Adverse Effects, 2010 51

Table 20: Prostate Cancer, Global, Eligard, Effect on PSA Level, 2010 58

Table 21: Prostate Cancer, Global, Eligard, Incidence of Adverse Effects, 2010 59

Table 22: Prostate Cancer, Global, Eligard, Regulatory Approval by Region 60

Table 23: Prostate Cancer, Global, Licensing Agreements, 2009-2010 84

Table 24: Prostate Cancer, Global, Technology Licensing Agreements Description, 2010 86

Table 25: Prostate Cancer, Global, most Promising Drugs under Clinical Development, 2010 86

Table 26: Prostate Cancer, Global, Pre-clinical Phase Pipeline, August 2010 105

Table 27: Prostate Cancer, Global, Phase I Pipeline, August 2010 106

Table 28: Prostate Cancer, Global, Phase II Pipeline, August 2010 108

Table 29: Prostate Cancer, Global, Phase III Pipeline, August 2010 115

Table 30: Prostate Cancer, Global, Characteristics of Ideal Drug which Satisfies the Unmet Needs of the Market, 2010 123

Table 31: Prostate Cancer, Global, Description of Ideal Drug which Satisfies the Unmet Needs of the Market, 2010 124

Table 32: Prostate Cancer, Johnson & Johnson, Oncology Late Stage Pipeline by Indication, 2010 178

Table 33: Prostate Cancer, Global, Auron Healthcare, Key Pipeline Products, 2010 179

Table 34: Prostate Cancer, Global, M&A Deals by Geography, 2010 189

1.2 List of Figures

Figure 1: Prostate Cancer Therapeutics Market, Global, Treatment Guidelines, 2010 19

Figure 2: Prostate Cancer Therapeutics Market, Germany, Sales Value ($m), 2001-2009 20

Figure 3: Prostate Cancer Therapeutics Market, Germany, Annual Cost of Therapy ($), 2001-2009 21

Figure 4: Prostate Cancer Therapeutics Market, Germany, Patient Volume (’000s), 2001-2009 23

Figure 5: Prostate Cancer Therapeutics Market, Germany, Treatment Usage Patterns (’000s), 2001-2009 24

Figure 6: Prostate Cancer Therapeutics Market, Germany, Market Drivers and Restraints, 2009 26

Figure 7: Prostate Cancer Therapeutics Market, Germany, Historical Events Impact on the Market, 2010 28

Figure 8: Prostate Cancer Therapeutics Market, Germany, Sales Value ($m), 2009-2020 29

Figure 9: Prostate Cancer Therapeutics Market, Germany, Annual Cost of Therapy ($), 2009-2020 30

Figure 10: Prostate Cancer Therapeutics Market, Germany, Patient Volume (’000s), 2009-2020 31

Figure 11: Prostate Cancer Therapeutics Market, Germany, Treatment Usage Patterns (’000s), 2009-2020 32

Figure 12: Prostate Cancer Therapeutics Market, Germany, Future Market Drivers and Restraints, 2009-2020 34

Figure 13: Prostate Cancer Therapeutics Market, Germany, Hormone-refractory Prostate Cancer Drug Sales ($m), 2001-2020 35

Figure 14: Prostate Cancer Therapeutics Market, Germany, Hormone-dependent Prostate Cancer Drug Sales ($m), 2001-2020 37

Figure 15: Prostate Cancer, Global, Strategic Competitor Assessment of Major Marketed Drugs, Chemotherapy Drugs, 2010 44

Figure 16: Prostate Cancer, Global, Strategic Competitor Assessment of Major Marketed Drugs, Hormone Therapy Drugs, 2010 45

Figure 17: Prostate Cancer Therapeutics Market, Germany, Sales Forecast by Therapies, 2001-2020 46

Figure 18: Prostate Cancer, Global, Taxotere, Chemical Structure 48

Figure 19: Prostate Cancer, Global, Taxotere, LCM Activities, 2004-2010 49

Figure 20: Prostate Cancer, Germany, Taxotere, Sales ($m), 2004-2020 50

Figure 21: Prostate Cancer, Global, Casodex, Chemical Structure 51

Figure 22: Prostate Cancer, Global, Casodex, LCM Activities, 2004-2010 54

Figure 23: Prostate Cancer, Germany, Casodex, Sales ($m), 2001-2020 55

Figure 24: Prostate Cancer, Global, Zoladex, Chemical Structure 56

Figure 25: Prostate Cancer, Germany, Zoladex, Sales Forecast ($m), 2001-2020 57

Figure 26: Prostate Cancer, Global, Eligard , Chemical Structure 58

Figure 27: Prostate Cancer, Germany, Leuprolide (Eligard), Sales Forecast ($m), 2001-2020 61

Figure 28: Prostate Cancer, Global, Firmagon, Chemical Structure 62

Figure 29: Prostate Cancer, Germany, Firmagon, Sales Forecast ($m), 2008-2020 64

Figure 30: Prostate Cancer, Global, Novatrone, Chemical Structure 64

Figure 31: Prostate Cancer, Germany, Mitoxantrone, Sales Forecast ($m), 2001-2020 66

Figure 32: Prostate Cancer, Global, Emcyt, Chemical Structure 67

Figure 33: Prostate Cancer, Germany, Estramustine, Sales Forecast ($m), 2001-2020 67

Figure 34: Prostate Cancer, Global, Trelstar, Chemical Structure 68

Figure 35: Prostate Cancer, Global, Eulexin, Chemical Structure 69

Figure 36: Prostate Cancer, Global, Delestrogen, Chemical Structure 71

Figure 37: Prostate Cancer, Global, Gynodiol, Chemical Structure 72

Figure 38: Prostate Cancer, Global, Estrace, Chemical Structure 73

Figure 39: Prostate Cancer, Global, Tace, Chemical Structure 74

Figure 40: Prostate Cancer, Global, Nilandrone, Chemical Structure 74

Figure 41: Prostate Cancer, Global, Premarin, Chemical Structure 75

Figure 42: Prostate Cancer, Germany, Combined sales of Trelstar, Decapeptyl, Gonapeptyl, Flutamide, Estradiol, Sales Forecast ($m), 2001-2020 76

Figure 43: Prostate Cancer, Global, Clinical Trials by Therapy, 2010 77

Figure 44: Prostate Cancer, Global, Clinical Trials by Phase of Development, 2010 78

Figure 45: Prostate Cancer, Global, Pipeline by Mechanism of Action, 2010 79

Figure 46: Prostate Cancer, Global, Technology Trends Analytic Framework of Pipeline Drugs, 2010 80

Figure 47: Prostate Cancer, Global, Technology Trends Description of Pipeline Drugs, 2010 81

Figure 48: Prostate Cancer, Global, Licensing Agreements by Phase of Development, 2009-2010 82

Figure 49: Prostate Cancer, Global, Licensing Agreements by Geography, 2010 85

Figure 50: Prostate Cancer, Germany, Provenge, Sales Forecast ($m), 2009-2020 89

Figure 51: Prostate Cancer, Germany, Jevtana, Sales Forecast ($m), 2001-2020 91

Figure 52: Prostate Cancer, Global, Aflibercept, Chemical Structure 92

Figure 53: Prostate Cancer, Germany, Aflibercept, Sales Forecast ($m), 2009-2020 93

Figure 54: Prostate Cancer, Germany, Ipilimumab , Sales Forecast ($m), 2009-2020 95

Figure 55: Prostate Cancer, Global, Abiraterone, Chemical Structure 96

Figure 56: Prostate Cancer, Germany, Abiraterone, Sales Forecast ($m), 2009-2020 98

Figure 57: Prostate Cancer, Global, Zibotentan, Chemical Structure 99

Figure 58: Prostate Cancer, Germany, Zibotentan , Sales Forecast ($m), 2009-2020 100

Figure 59: Prostate Cancer, Germany, Sprycel , Sales Forecast ($m), 2009-2020 102

Figure 60: Prostate Cancer, Global, MDV3100, Chemical Structure 103

Figure 61: Prostate Cancer, Germany, MDV3100 , Sales Forecast ($m), 2009-2020 104

Figure 62: Prostate Cancer, Global, Median Overall Survival for Hormone-independent Metastatic Prostate Cancer Patients, 2010 117

Figure 63: Prostate Cancer, Global, Median Overall Survival for Hormone-dependent Metastatic Prostate Cancer Patients, 2010 118

Figure 64: Prostate Cancer, Global, Hormone-dependent Metastatic Prostate Cancer Patients Achieving Castrate Level Testosterone Level in 28-30 Days (%), 2010 118

Figure 65: Prostate Cancer, Germany, Prostate Cancer, Opportunity and Unmet need, 2010 119

Figure 66: Prostate Cancer, Germany, Hormone-independent Metastatic Prostate Cancer, Opportunity and Unmet need, 2010 122

Figure 67: Prostate Cancer, Germany, Hormone-dependent Metastatic Prostate Cancer, Opportunity and Unmet need, 2010 123

Figure 68: Prostate Cancer, Global, Key Events Impacting the Future Market 125

Figure 69: Prostate Cancer, Germany, Implications for Future Market Competition, 2010 126

Figure 70: Prostate Cancer, Global, Future Players in the Market, 2010 128

Figure 71:Prostate Cancer, Sanofi-aventis, Major Pharmaceutical Drugs 2010 129

Figure 72: Prostate Cancer, Sanofi-aventis Pasteur, Diseases under each Vaccination Area 2010 130

Figure 73: Prostate Cancer, Global, Sanofi-aventis, SWOT Analysis, 2010 131

Figure 74: Prostate Cancer, Sanofi-aventis, Therapeutic Segment Share of Pipeline 2010 136

Figure 75: Prostate Cancer, Global, Pfizer, SWOT Analysis 2010 138

Figure 76: Prostate Cancer, Pfizer, Distribution of Pipeline by Phase, 2010 144

Figure 77: Prostate Cancer, Pfizer, Therapeutic Segment Share of Pipeline 2010 145

Figure 78: Prostate Cancer, Astrazeneca, Key Products Portfolio 2010 146

Figure 79: Prostate Cancer, Global, AstraZeneca, SWOT Analysis 2010 147

Figure 80: Prostate Cancer, AstraZeneca, Oncology Products for different Cancers 2010 151

Figure 81: Prostate Cancer, AstraZeneca, Distribution of Pipeline, by Phase, 2010 151

Figure 82: Prostate Cancer, AstraZeneca, Therapeutic Segment Share of Pipeline 2010 152

Figure 83: Prostate Cancer, Bristol-Myers Squibb, Key Products Portfolio 2010 153

Figure 84: Prostate Cancer, Global, Company Bristol-Myers Squibb, SWOT Analysis, 2010 154

Figure 85: Prostate Cancer, Bristol-Myers Squibb, Distribution of Pipeline by Phase, 2010 159

Figure 86: Prostate Cancer, Bristol-Myers Squibb, Therapeutic Segment Share of Pipeline 2010 160

Figure 87: Prostate Cancer, Global, Medivation, SWOT Analysis 2010 161

Figure 88: Prostate Cancer, Global, Takeda Pahrmaceuticals, SWOT Analysis 2010 165

Figure 89: Prostate Cancer, Global, Dendreon Corporation, SWOT Analysis 2010 167

Figure 90: Prostate Cancer, Global, Johnson and Johnson, SWOT Analysis 2010 172

Figure 91: Prostate Cancer, Johnson & Johnson, Late Stage Pipeline by Therapy Area, 2010 178

Figure 92: Prostate Cancer, Global, GlaxoSmithKline, SWOT Analysis 2010 181

Figure 93: Prostate Cancer, GlaxoSmithKline, Distribution of Pipeline by Phase, 2010 187

Figure 94: Prostate Cancer, GlaxoSmithKline, Therapeutic Segment Share of Pipeline 2010 188

Figure 95: Prostate Cancer, Global, M&A Deals by Geography of Target Companies, 2010 193

Figure 96: Prostate Cancer, Global, M&A Deals by Deal Size, 2010 193

Figure 97: Prostate Cancer, Germany, Key Data Inputs from KOL Interviews, July 2010 194

Figure 98: GlobalData Market Forecasting Model 200

Companies mentioned

Pfizer inc.

Takeda Pharmaceuticals

Auron Healthcare GmbH

Oncogenex Pharmaceuticals, inc.

GTx, inc.

To order this report:

Drug and Medication Industry: Prostate Cancer – Germany Drug Forecasts and Treatment Analysis to 2020

Drug and Medication Business News

More Market Research Report

Check our Company Profile, SWOT and Revenue Analysis!

Intl: +1 805-652-2626

Reportlinker Adds Antipsychotic Drugs: Technologies and Global Markets

Symptom Advice — Sat, 28 Aug 2010 11:36:13 +0000

Press Release Source: Reportlinker on Tuesday August 10, 2010, 10:00 am EDT
NEW YORK, Aug. 10 /PRNewswire/ — Reportlinker.com announces that a new market research report is available in its catalogue:

Antipsychotic Drugs: Technologies and Global Markets

reportlinker.com/p0236244/Antipsychotic-Drugs-Technologies-and-Global-Markets.html

The total worldwide market for antipsychotic drugs is expected to reach $19.6 billion in 2010. with continued market penetration into new diseases and price increases for currently marketed antipsychotics, this market is expected to grow to a high of $20.8 billion in 2011 and then hit a low of $14.4 billion in 2013, before resuming growth again to $14.8 billion in worldwide sales for 2014. this represents a total compound annual growth rate (CAGR) of -4.6%.

Most atypical antipsychotics will lose patent exclusivity through the study period, resulting in a compound annual growth rate (CAGR) of -3.7%. this market will be worth an estimated $18.5 billion by the end of 2010, but decrease to $14.5 billion in 2014.

Antipsychotic drug sales are expected to remain strong in long-acting injectable (depot) formulations. Long-acting injectables are forecast to record a 16.6% compound annual growth rate (CAGR) during this time period, increasing from $1.5 billion in 2009 to $3.2 billion in 2014.

Chapter- 1: INTRODUCTION — Complimentary

STUDY GOALS AND OBJECTIVES 1

REASONS FOR DOING THIS STUDY 2

INFORMATION SOURCES 4

AUTHOR’S CREDENTIALS 4

RELATED BCC WORK CREDENTIALS 4

BCC ONLINE SERVICES 4

SUMMARY TABLE THE WORLDWIDE MARKET FOR ANTIPSYCHOTIC DRUGS, THROUGH 2014 ($, MILLIONS) 7

SUMMARY FIGURE THE WORLDWIDE MARKET FOR ANTIPSYCHOTIC DRUGS, 2010–2014 ($, MILLIONS) 7

DEFINITION OF AN ANTIPSYCHOTIC DRUG 8

HISTORY OF ANTIPSYCHOTIC DRUGS 9

TYPES OF ANTIPSYCHOTICS ON THE MARKET 10

TYPICAL ANTIPSYCHOTICS 10

Typical Antipsychotics (Continued) 11

TABLE 1 CLASSES OF TYPICAL ANTIPSYCHOTICS ON THE MARKET AND THEIR SIDE EFFECTS 12

ATYPICAL ANTIPSYCHOTICS 13

TABLE 2 CURRENTLY APPROVED ATYPICAL ANTIPSYCHOTICS ON THE MARKET 14

TABLE 2 (CONTINUED) 15

TABLE 3 FEATURES OF TYPICAL VERSUS ATYPICAL ANTIPSYCHOTICS 15

TABLE 4 COST OF SELECTED ATYPICAL AND TYPICAL ANTIPSYCHOTIC DRUGS ($) 16

RECEPTOR TARGETS OF ANTIPSYCHOTIC DRUGS 16

SIDE EFFECTS OF ANTIPSYCHOTICS 20

NEUROLOGIC SIDE EFFECTS (EXTRAPYRAMIDAL SYMPTOMS) 21

ANTICHOLINERGIC SIDE EFFECTS 22

CARDIOVASCULAR SIDE EFFECTS 22

METABOLIC SIDE EFFECTS 23

OTHER SIDE EFFECTS 24

TABLE 5 COMPARISON OF SIDE EFFECT PROFILES OF ANTIPSYCHOTICS ON THE MARKET 25

ANTIPSYCHOTICS IN CLINICAL DEVELOPMENT 25

TABLE 6 ANTIPSYCHOTICS IN CLINICAL TRIALS, ORDERED BY PHASE 26

TABLE 6 (CONTINUED) 27

TABLE 7 NUMBER OF ANTIPSYCHOTICS IN CLINICAL TRIALS, BY PHASE (NUMBER/%) 27

FIGURE 1 ANTIPSYCHOTICS IN CLINICAL TRIALS BY PRIMARY RECEPTOR TARGET 28

TABLE 8 COMPANIES WITH MORE THAN ONE ANTIPSYCHOTICS IN CLINICAL TRIALS OR ON THE MARKET* 29

Chapter-4: TECHNOLOGY OVERVIEW

TECHNOLOGY OVERVIEW 30

TABLE 9 SALES OF ATYPICAL ANTIPSYCHOTICS BY FORMULATION, THROUGH 2014 ($, MILLIONS) 31

TABLE 10 ADMINISTRATION PROFILES OF LONG-ACTING ATYPICAL ANTIPSYCHOTICS 31

Chapter-5: PATENT EVALUATION

PATENT LENGTHS AND MARKET EXCLUSIVITY 32

TABLE 11 PATENT EXPIRATION DATES FOR ANTIPSYCHOTICS ON THE MARKET OR IN PHASE III DEVELOPMENT 33

TABLE 12 SALES OF ANTIPSYCHOTICS POTENTIALLY FACING GENERIC COMPETITION BY THE END OF 2014 ($ MILLIONS) 34

Chapter-6: ANTIPSYCHOTICS ON THE MARKET AND IN DEVELOPMENT

TABLE 13 GLOBAL MARKET FOR ANTIPSYCHOTICS BY INDIVIDUAL DRUG, THROUGH 2014 ($ MILLIONS) 35

TABLE 13 (CONTINUED) 36

TABLE 14 GLOBAL MARKET FOR ANTIPSYCHOTIC DRUGS BY MECHANISM OF ACTION, THROUGH 2014 ($ MILLIONS) 37

DOPAMINERGIC ANTIPSYCHOTICS IN DEVELOPMENT 37

DOPAMINE D2/SEROTONIN 5-HT2A RECEPTOR ANTAGONISTS 37

TABLE 15 MARKET FOR D2/5-HT2A ANTAGONISTS BY REGION, THROUGH 2014 ($ MILLIONS) 38

Serdolect (Sertindole) 38

Serdolect … (Continued) 39

Solian (Amisulpride) 40

Lonasen (Blonanserin) 40

Lullan (Perospirone) 41

Saphris/Sycrest (Asenapine, ORG 5222, SCH 900274) 41

Saphris/Sycrest (Continued) 42

Risperdal (Risperidone) 43

Risperdal Consta (Risperidone) 44

Risperdal Consta… (Continued) 45

Clozaril/Leponex (Clozapine) 46

Seroquel IR and XR (Quetiapine) 47

Seroquel IR and XR…(Continued) 48

Zyprexa (Olanzapine) 49

Zyprexa…(Continued) 50

Zyprexa Relprevv/Zypadhera (Olanzapine Pamoate) 51

Fanapt (Iloperidone) 51

Fanapt…(Continued) 52

AZ-004 (Staccato Loxapine) 53

TABLE 16 PROFILE OF AZ-004 VERSUS OTHER ANTIPSYCHOTICS FOR TREATING AGITATION 54

TABLE 17 AZ-004/STACCATO LOXAPINE STUDIES 55

Lurasidone (SM-13496) 56

TABLE 18 LURASIDONE STUDY RESULTS 57

Geodon/Zeldox (Ziprasidone) 58

Invega (Paliperidone) 59

TABLE 19 INVEGA COMPARED TO RISPERDAL 60

Invega Sustenna (Paliperidone Palmitate) 60

Zicronapine (Lu 31-130) 61

DOPAMINE D2 RECEPTOR PARTIAL AGONISTS 63

TABLE 20 MARKET FOR D2 PARTIAL AGONISTS BY REGION, THROUGH 2014 ($ MILLIONS) 64

Abilify (Aripiprazole, OPC-14597) 65

Aripiprazole Depot 66

Cariprazine (RGH-188, MP-214) 67

Cariprazine…(Continued) 68

ALKS 9070 (Long-acting Aripiprazole) 71

Bifeprunox (DU-127,090) 71

SEROTONERGIC ANTIPSYCHOTICS IN DEVELOPMENT 72

TABLE 21 SELECTED SEROTONIN RECEPTOR SUBTYPES AND ANTIPSYCHOTIC DRUGS BINDING TO THESE SITES 73

Pimavanserin (ACP-103) 74

Pimavanserin…(Continued) 75

TABLE 22 PIMAVANSERIN PHASE II ADJUNCTIVE SCHIZOPHRENIA EFFICACY RESULTS 76

5-HT6 RECEPTOR AGONISTS AND ANTAGONISTS 77

PF-5212365 (SAM-531) 78

Eplivanserin (SR46349B) 78

GLUTAMATERGIC ANTIPSYCHOTICS IN DEVELOPMENT 79

LY2140023 (Continued) 80

Glutamatergic Modulators in Preclinical Testing 82

GLYCINE TRANSPORT INHIBITORS 82

SCH 900435 (Org 25935) 82

OTHER ANTIPSYCHOTICS IN DEVELOPMENT 84

Talnetant (SB-223412) 87

Osanetant (SR-142801) 87

Licarbazepine (LIC477D) 88

Corlux (Mifepristone, RU-486, C-1073) 89

Corlux …(Continued) 90

SCH 900636 (ORG 34517) 91

Chapter-7: DISEASE APPLICATIONS

SYMPTOMS OF SCHIZOPHRENIA 94

TREATMENT OF SCHIZOPHRENIA 95

Treatment of Schizophrenia (Continued) 96

TESTS OF SCHIZOPHRENIA DRUG EFFECTIVENESS 97

Positive and Negative Syndrome Scale (PANSS) 97

Brief Psychiatric Rating Scale (BPRS) 97

Clinical Global Impression scale (CGI) 97

Scale for the Assessment of Positive Symptoms/Negative Symptoms (SAPS/SANS) 98

CATIE Phase 1 Results 99

TABLE 23 CATIE PHASE 1 ALL-CAUSE STUDY DISCONTINUATIONS 99

CATIE Phase 2 Results 100

CATIE Phase 3 Results 100

The Lancet Second-generation vs First-Generation Antipsychotics Meta-analysis 102

Young Mania Rating Scale 104

Montgomery-Asberg Depression Rating Scale 104

Hamilton Depression Rating Scale 104

MAJOR STUDIES USING ANTIPSYCHOTICS IN BIPOLAR DISORDER 105

MARKET OPPORTUNITY 106

TABLE 24 LIST OF APPROVED BIPOLAR I DISORDER USES FOR ATYPICAL ANTIPSYCHOTICS 107

MAJOR DEPRESSIVE DISORDER 108

MARKET OPPORTUNITY 109

OTHER ON- AND OFF-LABEL USES OF ANTIPSYCHOTICS 110

ANXIETY SPECTRUM DISORDERS 110

ALZHEIMER’S AND PARKINSON’S DISEASES 111

MARKET OPPORTUNITY 111

Market Opportunity (Continued) 112

Chapter-8: MAJOR COMPANIES AND MARKET SHARE

TABLE 25 FORECASTED SALES AND MARKET SHARE OF COMPANIES WITH ANTIPYSCHOTICS ON THE MARKET, 2014 ($ MILLIONS/%) 113

ACADIA PHARMACEUTICALS 114

ADDEX PHARMACEUTICALS 115

ALEXZA PHARMACEUTICALS 116

AstraZeneca – U.S. Headquarters 118

BRISTOL-MYERS SQUIBB 120

CYRENAIC PHARMACEUTICALS 121

DAINIPPON SUMITOMO PHARMA 122

FABRE-KRAMER PHARMACEUTICALS 123

JOHNSON AND JOHNSON 125

MITSUBISHI TANABE PHARMA 127

NPS PHARMACEUTICALS 130

OTSUKA PHARMACEUTICAL CO. 132

Pfizer (Continued) 133

TITAN PHARMACEUTICALS 134

VANDA PHARMACEUTICALS 135

Chapter-9: INTERNATIONAL ASPECTS AND REGULATORY ISSUES

TABLE 26 GLOBAL FORECAST FOR ANTIPSYCHOTICS MARKET BY REGION, THROUGH 2014 ($ MILLIONS) 136

MARKET BY REGION (CONTINUED) 137

The FDA Modernization Act of 1997 138

Fast-track Status 139

Special Protocol Assessments 140

New Surveillance and Safety Requirements 140

Approvable Letters 140

Consumer Confidence 141

Other Health Care Changes 142

New Drug Approvals and Innovation 142

Drug Reimbursement and Reference Pricing 143

Relocation of R&D 144

New Drug Approvals 145

Regulatory Climate 145

Relationship Between Academia and Industry 146

Chapter-10: FUTURE DIRECTIONS

THE ROLE OF BIOMARKERS AND PHARMACOGENOMICS 147

COMBINATION THERAPIES 147

THE EFFECT OF GENERIC ANTIPSYCHOTICS ON PRICE 148

THE EFFECT OF GENERIC …(CONTINUED) 149

To order this report:

Drug and Medication Industry: Antipsychotic Drugs: Technologies and Global Markets

Drug and Medication Business News

More Market Research Report

Check our Company Profile, SWOT and Revenue Analysis!

Intl: +1 805-652-2626