Fibromyalgia related Press Releases

Pierre Fabre Médicament is Granted Authorisation in Australia to Market the Milnacipran JONCIA® to Treat Fibromyalgia

Mon, 21 Nov 2011 09:21:01 -0500

CASTRES, France, November 21, 2011 /PRNewswire/ --

The Therapeutic Goods Administration (TGA), Australia's regulatory body for therapeutic products, granted Pierre Fabre Médicament's milnacipran market authorisation for the treatment of fibromyalgia ("for the management of fibromyalgia").

Discovered by Pierre Fabre Médicament, milnacipran has been developed for this purpose in collaboration with Cypress Bioscience (taken over by Royalty Pharma) and Forest Laboratories. Milnacipran is a mixed serotonin-norepinephrine reuptake inhibitor.

Pierre Fabre Médicament granted the rights for North America for the treatment of fibromyalgia to Cypress Bioscience (Royalty Pharma) and Forest Laboratories who have been marketing it since 2009 under the name Savella^® (authorisation granted by the FDA in January 2009).

The TGA's decision makes Pierre Fabre Médicament the first pharmaceutical laboratory to offer a medicine in Australia to treat fibromyalgia, a disease suffered by between 2 and 4% of the local population.

Following on from the authorisation granted in the United States, this approval from Australia confirms the potential for the international development of milnacipran.

"The approval of milnacipran by the TGA is doubly encouraging for Pierre Fabre Médicament: it highlights the expertise of our research into conditions affecting the central nervous system, and also confirms our potential for international development" explains Frédéric Duchesne, Managing Director of Pierre Fabre Médicament, adding that "milnacipran is to be marketed in Australia in the form of a strategic partnership".

The TGA's approval of JONCIA^® is based on an application outlining three pivotal phase III clinical studies, each one lasting three months and conducted in the United States and Europe. In these studies, involving more than 3,000 patients affected by fibromyalgia, the milnacipran, administered in doses of 100 mg and 200 mg milnacipran, demonstrated a clinically significant reduction in pain as well as the alleviation of symptoms during self-evaluation (by the patient him/herself). The clinical development of milnacipran in fibromyalgia is based on the assessment of a number of 'responsive' patients, that is to say patients that demonstrated a clinically significant and simultaneous improvement with regards to these two assessment criteria. Furthermore these studies highlighted a significant improvement in terms of fatigue and sleep.

Long-term phase III studies have confirmed that the effects of milnacipran are maintained beyond the first six months of treatment.

Furthermore, milnacipran was generally well tolerated, most of the undesirable effects being weak to moderate in terms of severity. The balance between the benefits and risks of JONCIA^® has been judged to be positive by the TGA.

About fibromyalgia:

Fibromyalgia affects between 2% and 3% of the population, most of whom are women (80%). Identified by the WHO in 1992, it presents itself as a syndrome combining debilitating pain, chronic fatigue and sleep problems. Many experts, including rheumatologists, pain specialists and psychiatrists, are continuing to work on the condition to try and pinpoint its causes, mechanisms and treatment. A multidimensional and multidisciplinary approach to the disease is currently recommended, combining treatment with drugs, physical rehabilitation, therapeutic patient education and if necessary, psychotherapeutic treatment.

About the Pierre Fabre group:

The Pierre Fabre Laboratories, the second largest independent pharmaceutical group in France, achieved a turnover of 1.86 billion Euros in 2010, with international sales accounting for more than 50%. Their activities cover all aspects of healthcare, from ethical medicines and over-the-counter drugs (OTC) to derma-cosmetics.

The Pierre Fabre Laboratories have some 10,000 employees, 1,300 of whom are dedicated to R&D. In 2010, the company allocated 22% of its drug sales to R&D, focusing on three main areas : oncology, the central nervous system and dermatology.

With brands including Avène, A-Derma, Ducray, Elgydium, Eludril, Klorane or René Furterer, the Pierre Fabre Laboratories are France's market leader when it comes to cosmetics, hair care, oral products and dermatological products sold in pharmacies. Avène is the leading dermo-cosmetics brand sold in France, and one of the biggest in Europe.

To find out more, go to http://www.pierre-fabre.com

SOURCE Laboratoires Pierre Fabre

The Fibromyalgia Drug Market Will Experience Minimal Growth over the Next Decade, Increasing from Nearly $1.6 Billion in 2

Thu, 29 Sep 2011 09:21:08 -0400

In 2010, Eli Lilly/Boehringer Ingelheim’s Cymbalta Supplanted Pfizer’s Lyrica as the Market- and Patient-Share Leader in the U.S. Fibromyalgia Market, According to Findings from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to the generic erosion of two key agents—Eli Lilly/Boehringer Ingelheim’s Cymbalta (duloxetine) and Pfizer’s Lyrica (pregabalin)—the fibromyalgia drug market will experience minimal growth over the next decade, increasing from nearly $1.6 billion in 2010 to less than $1.8 billion in 2020 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

The findings from the Pharmacor topic entitled Fibromyalgia reveal that, through 2020, an expanding drug-treated population and, to a lesser extent, the uptake of Forest Laboratories/Cypress Bioscience's Savella (milnacipran), Johnson & Johnson/Grünenthal’s Nucynta ER (tapentadol ER) and Pfizer’s controlled-release formulation of Lyrica (pregabalin CR), will help to offset sales lost to the generic erosion of Cymbalta and Lyrica. Additionally, as awareness and acceptance of fibromyalgia among physicians and the general population increases, the diagnosed and drug-treated population will grow by 1.7 million from 2010 to 2020.

In 2010, Cymbalta unseated Lyrica as the U.S. patient- and market-share leader. According to interviewed experts, Lyrica’s side effects, in particular its CNS side effects and weight gain side effect have significantly curbed the use of this agent in the fibromyalgia population.

The findings also reveal that the U.S. accounted for nearly 80 percent of major-market fibromyalgia sales in 2010, and in 2020 the U.S. will account for two-thirds of worldwide sales for the indication. The majority of U.S. sales continue to be driven by the leading fibromyalgia-approved therapies—Cymbalta, Lyrica and Savella. In Europe and Japan, market expansion will be constrained by a dearth of approved therapies, lower diagnosis rates and less widespread recognition of the disorder.

Because fibromyalgia is a difficult condition to treat—its symptoms vary widely from patient to patient and can include pain, depression, fatigue and sleep dysfunction—significant unmet need remains for effective treatments.

“Even the leading, FDA-approved drugs for fibromyalgia have limited efficacy and tolerability,” said Decision Resources Analyst Andrea Buurma. “As a result, ample opportunity remains in this patient population for therapies that can demonstrate efficacy while also offering acceptable safety profiles.”

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

CONTACT:

Decision Resources
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

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TONIX Pharmaceuticals Presents Findings on the Effects of Bedtime Very Low Dose (VLD) Cyclobenzaprine (CBP) on Symptoms an

Thu, 16 Jun 2011 11:20:42 -0400

Presented at the Associated Professional Sleep Societies, June 2011 25^th Anniversary Meeting in Minneapolis, MN

NEW YORK--(BUSINESS WIRE)-- TONIX Pharmaceuticals, a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system, including Fibromyalgia Syndrome (FM) and Post-traumatic Stress Disorder (PTSD), presented sleep EEG (electroencephalogram) findings from a clinical study in which patients with FM were treated with very low dosage (VLD) cyclobenzaprine (CBP) at bedtime. The VLD CBP treated patients showed a decrease in pain, fatigue, tenderness and depressive symptoms and reported fewer of the side effects often associated with daytime CBP at higher doses. In the new findings, VLD CBP treatment improved sleep efficiency and increased the number of nights with reduced rates of EEG Cyclic Alternating Pattern (CAP) sleep types CAP_A2 + CAP_A3, which are associated with sleep instability and previously were shown to be elevated in FM patients. The findings were the subject of a poster presentation at the Associated Professional Sleep Societies 2011 Anniversary Meeting in Minneapolis, MN.

Dr. Harvey Moldofsky, President and Medical Director, Centre for Sleep and Chronobiology, Toronto, Canada, and lead author of the study, commented, “This study showed that a low dose of cyclobenzaprine taken at bedtime improves the widespread pain and tenderness in patients with fibromyalgia. It also provides a novel algorithm that identifies reductions in a specific EEG pattern of sleep instability that correlate with improvements in the nonrestorative sleep symptoms of fatigue and disturbed mood.”

“These new findings suggest that our technology for bedtime treatment of fibromyalgia with very low dose cyclobenzaprine confers benefits that have been associated with restful or restorative sleep,” stated President Seth Lederman, M.D., Chairman and President of TONIX.

About the Study

The study was a randomized, double-blind, placebo-controlled, dose-escalating parallel-design study in 36 patients with FM conducted at two Canadian sites. The study was analyzed with regard to efficacy, safety and tolerability as well as EEG and other parameters assessed during sleep. VLD CBP treated subjects showed significant improvements over eight weeks in pain, fatigue, tenderness, the Hospital Anxiety and Depression Scale (HAD), and sleep efficiency. In addition, VLD CBP was well tolerated, with no adverse events or discontinuations due to adverse events. The sleep EEG data were analyzed for the types of CAP: CAP_A1 (associated with sleep stability) and CAP_A2 + CAP_A3 (usually associated with sleep instability). VLD CBP treatment increased EEG sleep nights with normalized CAP_A2+A3, or CAP_A2+A3(Norm) ≤ 33%. Increased nights of CAP_A2+A3(Norm) ≤ 33% correlated with improvement in fatigue, total HAD score, HAD depression subscore, and self-rated and clinician-rated change in fatigue. In VLD CBP treated subjects, the correlation of increased nights of CAP_A2+A3(Norm) ≤ 33% with improvement with FM symptoms is consistent with the hypothesized effects of restorative sleep. The symptomatic benefit may relate to VLD CBP decreasing arousal or alarm signals during sleep. CAP_A2+A3(Norm) rate may provide a novel biomarker for assessing treatment effects on nonrestorative sleep and associated subjective somatic and mood symptoms in FM. The full abstract can be found at www.sleepmeeting.org (# 0690).

About TONIX Pharmaceuticals

TONIX Pharmaceuticals is developing new treatments for challenging disorders of the central nervous system. The Company’s most advanced program targets fibromyalgia syndrome based on bedtime treatment with very low dosage cyclobenzaprine. Cyclobenzaprine in higher doses is the active ingredient of U.S. FDA approved muscle relaxants. Based on this foundation, the Company is building a deep and diverse pipeline of high-value medications for other syndromes, disorders and diseases, including post-traumatic stress disorder. For more information, please visit www.tonixpharma.com.

CONTACT:

TONIX Pharmaceuticals
Susan Oliver, 212-980-9155 ext. 104
Susan.Oliver@tonixpharma.com

KEYWORDS: United States North America Canada Minnesota New York

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical

MEDIA:

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U.S. Fibromyalgia Patients Currently Taking an Approved Therapy are More Likely to Request a Discontinuation of Their Trea

Wed, 30 Mar 2011 10:20:43 -0400

EXTON, Penn.--(BUSINESS WIRE)-- Data from a recent report from BioTrends Research Group suggest that U.S. fibromyalgia patients who are currently taking one of the three agents approved for the treatment of fibromyalgia – Eli Lilly’s Cymbalta, Pfizer’s Lyrica, and Forest Laboratories/Cypress Biosciences’ Savella – may have higher expectations for their treatment than patients taking off-label therapies. Approximately 40% of surveyed patients taking an approved therapy indicate they are “very unlikely” to ask their doctor to switch their therapy in the next year, compared with more than half of surveyed patients taking an off-label treatment.

“These data suggest that patients currently taking an approved therapy are not well-established on their current treatments, creating a higher risk of drug switching in these patients” said CNS analyst Andrea Buurma. “This indicates there is a significant opportunity for emerging novel agents.”

Surveyed patients express they are most likely to request a switch to an agent that offers improvement over their current therapy in treating pain, fatigue, and/or sleep problems. “More than two-thirds of patients indicated they would be somewhat or very likely to switch to an emerging agent that offers improvement in these areas” Ms. Buurma said.

PatientTrends™: Fibromyalgia is a yearly report that investigates patients’ attitudes, perceptions and behavior regarding their disease, with a focus on the patient’s path to diagnosis and their perception of their interaction with their physician. The report looks at what drives patients’ satisfaction with their current fibromyalgia treatment and identifies which drug attributes are most likely to prompt a patient to request a switch to an emerging treatment. This report is based on a survey fielded in January and February of 2011 with 500 U.S. patients diagnosed with fibromyalgia.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC (www.bio-trends.com) provides syndicated market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends’ publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com. BioTrends Research Group, LLC is a Decision Resources, Inc. company.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

CONTACT:

BioTrends Research Group, LLC
Sharon Funk, 404-223-2963
sfunk@bio-trends.com
or
Decision Resources, Inc.
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Health Biotechnology Genetics Medical Devices Pharmaceutical Other Health Research Science General Health

MEDIA:

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TONIX Pharmaceuticals to Present at the OneMedForum San Francisco 2011 on January 11 and at the Biotech Showcase™ on Janua

Tue, 04 Jan 2011 10:23:23 -0500

NEW YORK--(BUSINESS WIRE)-- TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty pharmaceutical company focused on central nervous system (CNS) disorders, announced today the Company will present at the OneMedForum San Francisco 2011 at 10:15 am PT on January 11, 2011, at the Sir Francis Drake Hotel in San Francisco. TONIX also will present at the Biotech Showcase™, co-produced by Demy-Colton Life Science Advisors and the EBD Group, at 3:45 pm PT on January 12, 2011, at the Parc 55 Wyndham San Francisco Hotel. TONIX President Seth Lederman, M.D., will provide an update on the Company’s R&D programs, including its lead clinical-stage program in fibromyalgia syndrome.

About TONIX Pharmaceuticals

TONIX Pharmaceuticals is developing new treatments for challenging disorders of the central nervous system. The Company’s most advanced program targets fibromyalgia syndrome based on very low dosage cyclobenzaprine, an active pharmaceutical ingredient used in higher doses in approved therapeutics in the U.S. Based on this foundation, the Company is building a deep and diverse pipeline of high-value medications for other syndromes, disorders and diseases, including post-traumatic stress disorder. For more information, please visit www.tonixpharma.com.

CONTACT:

TONIX Pharmaceuticals
Susan Oliver, 212-980-9155 ext. 104
Susan.Oliver@tonixpharma.com
or
For Media:
Burns McClellan on behalf of TONIX
Justin Jackson, 212-213-0006
jjackson@burnsmc.com

KEYWORDS: United States North America California New York

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical Research Science

MEDIA:

Meda Acquires Exclusive Rights to flupirtine for fibromyalgia, a Potential USD Billion Indication

Fri, 07 May 2010 07:19:12 -0400

STOCKHOLM--(BUSINESS WIRE)-- Meda (STO:MEDAA) has acquired exclusive US, Canadian and Japanese rights for the use of flupirtine to treat fibromyalgia from Adeona Pharmaceuticals. As part of the agreement, Meda is taking over full responsibility for development and commercialization of the compound. Flupirtine is currently in phase II development for the patented indication fibromyalgia.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. Fibromyalgia affects an estimated 2-4% of the population worldwide, including an estimated 4 million patients in the United States.

There are presently three products approved for this indication in the US – Lyrica, Cymbalta and Savella. Meda estimates the US market for fibromyalgia to be near 1 billion USD at launch of flupirtine. Flupirtine is differentiated from these products in that it employs a unique mode of action.

“We are very pleased to collaborate with Adeona in the development of flupirtine for fibromyalgia, a therapeutic area with a large unmet medical need. Flupirtine has the potential to have better efficacy and safety than current treatments. Additionally, flupirtine has displayed good tolerability during all the years it has been used for the treatment of acute and chronic pain”, says Anders Lönner, CEO Meda.

Meda also believes flupirtine’s neuroprotective properties can be leveraged to treat new indications outside of pain and fibromyalgia, resulting in robust product lifecycle opportunities.

Under the agreement with Adeona, Meda will make an up-front payment of 2,5 MUSD. In addition, Meda will make a milestone payments of 5 MUSD upon the Food and Drug Administration’s (FDA’s) acceptance of the New Drug Application (NDA), and 10 MUSD upon NDA Approval by the FDA. Meda will also pay single digit royalties to Adeona.

MEDA AB (publ) is a leading international specialty pharma company. Meda’s products are sold in 120 countries worldwide and the company is represented by its own organizations in 50 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more, visit www.meda.se.

This information was brought to you by Cision http://www.cisionwire.com

CONTACT:

Meda
Anders Larnholt, Vice President Corporate Development & IR
Ph: +46 709-458 878

KEYWORDS: United States Europe North America Sweden

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

MEDIA:

European CHMP Adopts Negative Opinion on Eli Lilly, Boehringer Ingelheim's Cymbalta for the Treatment of Fibromyalgia

Calisha Myers — Fri, 24 Oct 2008 09:42:40 -0400

European CHMP Adopts Negative Opinion on Eli Lilly, Boehringer Ingelheim's Cymbalta for the Treatment of Fibromyalgia

INDIANAPOLIS, Oct. 24 /PRNewswire-FirstCall/ -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on a Cymbalta® (duloxetine hydrochloride) application for the treatment of fibromyalgia.

"Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMP's opinion," said James Russell, M.D., global medical director for duloxetine, Eli Lilly and Company. "We remain confident in the duloxetine data."

No medication has been approved in Europe for the treatment of fibromyalgia, a disease characterized by chronic widespread pain.

The CHMP received data on the use of duloxetine in the treatment of fibromyalgia in 1,411 patients in four placebo-controlled studies and 350 patients in one open-label safety study, a total of 1,761 patients in five clinical trials.(1,2,3,4,5)

The cause of fibromyalgia remains unknown;(6) however, scientists believe it may be related to some combination of genetic disposition(7) and subsequent changes in pain processing in the brain.(6) The disorder, which has a worldwide prevalence ranging from 0.5 percent to 5.0 percent of the population,(8) has a high impact on quality of life. In addition to chronic widespread musculoskeletal pain, many fibromyalgia patients experience other symptoms such as tenderness, fatigue, sleep disturbance, anxiety and depression.(1,9)

In Europe, duloxetine has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), major depressive episodes, generalised anxiety disorder (GAD) and stress urinary incontinence (SUI). Duloxetine was approved in the United States for the management of fibromyalgia in June 2008 by the U.S. Food and Drug Administration (FDA).

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. For more information please visit www.lilly.co.uk.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and almost 38,900 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit www.boehringer-ingelheim.com.

Duloxetine for major depressive episodes, diabetic peripheral neuropathic pain and generalised anxiety disorder is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Germany, Greece, Italy and Spain. In Germany, Lilly and Boehringer Ingelheim market duloxetine for major depressive episodes under the brand name Cymbalta, and market the product for diabetic peripheral neuropathic pain as Ariclaim®. In Greece, Italy and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim markets the product as Xeristar®. In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine is co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lilly under the brand name Yentreve®.

(1) Russell, IJ, et al. Efficacy and Safety of Duloxetine for Treatment of Fibromyalgia in Patients With or Without Major Depressive Disorder: Results From A Six-Month, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Trial, Pain. 2008.

(2) Arnold, L, et al. A Randomized, Double-Blind, Placebo Controlled Trial of Duloxetine in the Treatment of Women with Fibromyalgia With or Without Major Depressive Disorder. Pain. 2005; 119 (1-3): 5-15

(3) Arnold, L, et al. A Double-Blind, Multicenter Trial Comparing Duloxetine with Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder. Arthritis Rheum 2004; 50(9):2974-84.

(4) Chappell, AS, et al. Duloxetine 60-120 mg Versus Placebo in the Treatment of Fibromyalgia Syndrome. Poster presented at the American College of Rheumatology Annual Meeting; Nov 2007, Boston, MA.

(5) Chappell, AS, et al. A 1-Year Safety and Efficacy Study of Duloxetine in Patients with Fibromyalgia. Poster presented at European League Against Rheumatism Annual Meeting; Jun 2008, Paris, France.

(6) Leventhal, LJ. Management of Fibromyalgia. Annals of Internal Medicine. 1999; 131: 850-858.

(7) Arnold, L, et al. Family Study of Fibromyalgia. Arthritis & Rheumatism. 2004; 50(3): 944-952.

(8) White, et al. Classification, Epidemiology, and Natural History of Fibromyalgia. Current Pain and Headache Reports 2001; 5:3320-329

(9) Epstein, SA, et al. Psychiatric Disorders in Patients with Fibromyalgia. Psychosomatics. 1999; 40(1):59

(10) Rao, SG, et al. Understanding the Fibromyalgia Syndrome. Psychopharmacology Bulletin. 2007: 4:24-67

(11) Carville, SF, et al. EULAR Evidence-based Recommendations for the Management of Fibromyalgia Syndrome. Ann Rheum Dis. Republished 2008: 67: 536-541.

Source: Eli Lilly and Company

Forest Laboratories, Cypress Bioscience Fibromyalgia Drug Delayed at FDA

Calisha Myers — Mon, 20 Oct 2008 11:52:09 -0400

Forest Laboratories, Cypress Bioscience Fibromyalgia Drug Delayed at FDA

NEW YORK and SAN DIEGO, Oct. 20 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX - News) and Cypress Bioscience, Inc. (Nasdaq: CYPB - News; the "Companies") today announced that the U.S. Food and Drug Administration (FDA) has advised the Companies that it was not able to take final action by the scheduled Prescription Drug User Fee Act action date of October 18, 2008, on their New Drug Application for milnacipran, a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia. The FDA has not requested any additional information from the Companies but did indicate that a clinical data question related to the NDA submission required confirmation. The FDA indicated that their assessment could be completed in a matter of weeks, but could not confirm specific timing. The FDA could not provide further information as to the reason for the delay. The Companies continue to plan for a first quarter 2009 product launch meeting.

About Forest Laboratories

Forest Laboratories (NYSE: FRX - News) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

About Cypress Bioscience

Cypress Bioscience, Inc. is developing therapeutics and personalized medicine services, to facilitate improved and individualized patient care. Cypress' goal is to address the evolving needs of specialist physicians and their patients by identifying unmet medical needs in the areas of pain, rheumatology, and physical medicine and rehabilitation, including challenging disorders such as fibromyalgia and rheumatoid arthritis. We intend to use this approach to improve patient care and create a unique partnership with physicians.

For more information about Cypress, please visit the Company's website at www.cypressbio.com.

This press release, as well as Cypress' SEC filings and website at www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of milnacipran to treat fibromyalgia syndrome, that the FDA review may be completed in a matter of weeks and that Cypress continues to plan for a first quarter 2009 product launch meeting for milnacipran. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress' Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, milnacipran may not ever receive marketing approval from the FDA and even if it does, that the FDA review may take longer than weeks to complete, that the FDA may request additional information from Cypress and that the milnacipran launch may be delayed such that it may not occur in the first quarter of 2009.

Source: Forest Laboratories, Inc.; Cypress Bioscience, Inc.

JAZZ PHARMACEUTICALS, INC. ANNOUNCES FINAL PATIENT HAS COMPLETED PHASE III CLINICAL TRIAL OF SODIUM OXYBATE TO TREAT FIBROMYALGI

Maureen Martino — Thu, 11 Sep 2008 12:09:39 -0400

JAZZ PHARMACEUTICALS, INC. ANNOUNCES FINAL PATIENT HAS COMPLETED PHASE III CLINICAL TRIAL OF SODIUM OXYBATE TO TREAT FIBROMYALGIA

PALO ALTO, Calif., Sept. 11 -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the final patient has completed participation in the first Phase III pivotal clinical trial of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.

The JZP-6 Phase III clinical trial program includes two randomized, double blind, placebo-controlled studies. The first study enrolled 550 fibromyalgia patients at 65 centers in the U.S. The second Phase III study is enrolling patients at sites in the U.S. and Europe. The primary endpoint for both studies is the change from baseline in pain based on the pain visual analog scale, which the U.S. Food and Drug Administration (FDA) and the European Medicines Agency have indicated is the appropriate primary endpoint.

"Completion of the final patient's participation in this trial is a key milestone in the JZP-6 program," said Samuel Saks, M.D., Chief Executive Officer. "The trial results remain blinded to the company, investigators, and patients. We will remain blinded as we conduct analysis of the extensive data set generated by this study. We anticipate releasing primary efficacy and safety data from the first Phase III clinical trial on schedule in the fourth quarter of this year, and we continue to plan for submission of a New Drug Application to the FDA by the end of 2009."

"We appreciate the dedication of the patients, clinical investigators and Jazz Pharmaceuticals employees who are taking part in this important program," Dr. Saks continued.

The JZP-6 clinical program also includes an open-label continuation trial to provide long-term safety data. Enrollment in this trial is ongoing, and the trial is open to patients who complete either of the two pivotal Phase III trials.

Sodium oxybate is the active ingredient in Xyrem(R), a Jazz Pharmaceuticals product approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy. Sodium oxybate has not been approved for the treatment of fibromyalgia.

About Fibromyalgia

Fibromyalgia is a chronic pain syndrome defined by widespread pain lasting at least three months. According to the American College of Rheumatology, between two and four percent of the U.S. population suffers from fibromyalgia. Fibromyalgia is believed to be a central nervous system condition. In addition to pain, fibromyalgia patients often suffer from a combination of muscle stiffness, fatigue, disturbed sleep, restless legs syndrome and impaired memory and concentration. Although physicians do not understand the cause of fibromyalgia, it may be triggered by physical trauma, emotional stress or infection. The criteria established by the American College of Rheumatology for the classification of fibromyalgia require the application of pressure at 18 different points on the body and measurement of pain induced by such pressure. If at least 11 of the 18 points are painful and have been painful for three months, the patient is diagnosed with fibromyalgia.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see http://www.JazzPharmaceuticals.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, statements related to the continued development of Jazz Pharmaceuticals' JZP-6 product candidate for the treatment of fibromyalgia and the timing of the release of clinical study results and the submission of a New Drug Application to the FDA. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the clinical trials of Jazz Pharmaceuticals' JZP-6 product candidate, including the risk that clinical trial results may require Jazz Pharmaceuticals to discontinue its development, risks related to our reliance on third parties to conduct the clinical trials for our product candidates, and risks that regulatory filings may not be made, or may be delayed, and that products may not be approved for marketing by regulatory authorities. These and other risk factors are discussed under "Risk Factors" in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August 8, 2008. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

PRESS RELEASE: Milnacipran Demonstrated Significant Improvement in Pain and the Core Symptoms of Fibromyalgia Syndrome

Maureen Martino — Thu, 08 Nov 2007 12:35:46 -0500

Milnacipran Demonstrated Significant Improvement in Pain and the Core Symptoms of Fibromyalgia Syndrome, Data Show

NEW YORK, Nov. 8Â -- Total daily dosages of milnacipran 100 mg and 200 mg demonstrated statistically significant and clinically meaningful improvements in both pain and other core symptoms associated with fibromyalgia syndrome (FMS), according to Phase III data presented this week at the 2007 American College of Rheumatology meeting in Boston, MA. The therapeutic effects of milnacipran among responders in a six-month study were sustained for up to one year in a double-blind extension trial.

(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

Although widespread chronic pain is the defining characteristic of FMS, it typically occurs as part of a broader spectrum of symptoms, including fatigue, cognitive dysfunction, and reduced physical function. Milnacipran is the first treatment studied for fibromyalgia whose effectiveness has been evaluated utilizing a composite responder approach which requires, on a patient-by- patient basis, concurrent improvements across multiple FMS domains. As such, composite responder analyses represent a more stringent assessment of therapeutic effect than the evaluation of individual symptoms.

To be considered a responder for the composite "pain of fibromyalgia" endpoint, each patient had to demonstrate concurrent and clinically meaningful improvements in two validated measures: pain and global impression of disease status. In addition to meeting those criteria, responders for the composite "treatment of the fibromyalgia syndrome" endpoint also had to demonstrate improvement in a third validated measure: physical function. The results of two Phase III trials showed that milnacipran demonstrated improvement compared to placebo in treating both the pain of fibromyalgia, as well as the broader syndrome of fibromyalgia. Furthermore, data from a six-month extension study showed that the therapeutic effects of milnacipran were sustained for up to one year of therapy.

"Because patients with fibromyalgia experience a wide array of symptoms that can overlap with other conditions, diagnosis and treatment can be complicated. Currently, many doctors are using multiple medications to treat the various symptoms of fibromyalgia," said Daniel J. Clauw, MD, lead investigator, Chronic Pain and Fatigue Research Center, University of Michigan. "There is a real unmet need for a therapy that not only relieves pain but addresses the functional and physical aspects of the illness that can have a significant impact on a patient's quality of life."

Study Methodology

In two double-blind, placebo-controlled, pivotal Phase III studies (Study MLN-MD-02 and Study FMS-031), the two parallel, primary efficacy assessments consisted of composite responder analyses for the treatment of both fibromyalgia syndrome and the pain of fibromyalgia. Pain composite responders were defined as individuals who achieved both a greater than or equal to 30% reduction in pain compared to baseline as measured by a visual analog scale recorded daily on an electronic patient experience diary, and who rated themselves as "very much improved" or "much improved" on a Patient Global Impression of Change (PGIC) scale. Fibromyalgia syndrome composite responders needed to satisfy the pain composite criteria as well as demonstrate at least a 6-point improvement in their SF-36 physical component summary (SF-36 PCS) score.

In Study MLN-MD-02, 1196 patients were randomized to receive either milnacipran 100 mg/day (n=399), 200 mg/day (n=396) or placebo (n=401) over a three-month period, 67.7% of whom completed the trial.

In Study FMS-031, 888 patients were randomized to receive either milnacipran 100 mg/day (n=224), 200 mg/day (n=441) or placebo (n=223) for six- months, 63.6% of whom completed three-months of treatment, and 57.6% of whom completed the full six-months of double-blind treatment. Results were assessed for all patients at both the three- and six-month visits.

Patients who completed the full six-months of treatment in Study FMS-031 were eligible to enroll in a multi-center, dose-blinded, extension study designed to evaluate durability of response up to one year. A total of 449 patients were either maintained at 200 mg/day (n=209) or re-randomized to 100 mg/day (n=48) or 200 mg/day (n=192) for an additional six months. Efficacy assessments included change in pain, as measured using a paper visual analog scale, and multidimensional symptomatic improvements, as measured using the Fibromyalgia Impact Questionnaire and PGIC.

Data Highlights

Results reported below are based on observed cases, which include only patients who were evaluable at the landmark visit. In study MLN-MD-02, there were 713 evaluable patients for the fibromyalgia syndrome and pain analyses (n=236 for 100 mg, n=215 for 200 mg, and n=262 for placebo).

In study FMS-031, at the three-month visit there were 549 evaluable patients for the syndrome analysis (n=134 for 100 mg, n=259 for 200 mg, and n=156 for placebo), and 553 evaluable patients for the pain analysis (n=135 for 100 mg, n=260 for 200 mg, and n=158 for placebo). At the six-month visit there were 488 evaluable patients for the fibromyalgia syndrome analysis (n=120 for 100 mg, n=229 for 200 mg, and n=139 for placebo), and 491 evaluable patients for the fibromyalgia pain analysis (n=121 for 100 mg, n=230 for 200 mg, and n=140 for placebo).

Composite responder rates for fibromyalgia syndrome (pain, PGIC, and SF-36 PCS)

Â Â Â -- A statistically significant number of patients treated with milnacipran
Â Â Â Â Â Â during Study MLN-MD-02 met the composite syndrome responder criteria
Â Â Â Â Â Â (25% and 26% for the milnacipran 100 mg and 200 mg groups,
Â Â Â Â Â Â respectively) compared to patients treated with placebo (13%).
Â Â Â -- A statistically significant number of patients treated with milnacipran
Â Â Â Â Â Â during Study FMS-031 also met the composite syndrome responder criteria
Â Â Â Â Â Â at three months (33% and 33% for the milnacipran 100 mg and 200 mg
Â Â Â Â Â Â groups, respectively) compared to patients treated with placebo (17%).
Â Â Â Â Â Â Statistically significant differences were also observed at the six-
Â Â Â Â Â Â month visit: 33% and 32% of patients met responder criteria for the
Â Â Â Â Â Â milnacipran 100 mg and 200 mg groups, respectively, compared to 19% of
Â Â Â Â Â Â patients in the placebo group.

Â Â Â Composite responder rates for fibromyalgia pain (pain and PGIC)
Â Â Â -- A statistically significant number of patients treated with milnacipran
Â Â Â Â Â Â during Study MLN-MD-02 met the composite pain responder criteria (39%
Â Â Â Â Â Â and 46% in the milnacipran 100 mg and 200 mg groups, respectively)
Â Â Â Â Â Â compared to patients treated with placebo (25%).
Â Â Â -- A statistically significant number of patients treated with milnacipran
Â Â Â Â Â Â during Study FMS-031 also met the composite pain responder criteria at
Â Â Â Â Â Â three months (45% and 45% in the milnacipran 100 mg and 200 mg groups,
Â Â Â Â Â Â respectively) compared to patients treated with placebo (27%).
Â Â Â Â Â Â Statistically significant differences were also observed at the six-
Â Â Â Â Â Â month visit: 44% and 45% of patients met the composite pain responder
Â Â Â Â Â Â criteria in the milnacipran 100 mg and 200 mg groups, respectively,
Â Â Â Â Â Â compared to 28% of patients in placebo group.
Tolerability

Milnacipran was generally well-tolerated, with the majority of adverse events (AEs) reported being mild to moderate in nature.

Â Â Â -- The most common treatment emergent AEs during the placebo-controlled
Â Â Â Â Â Â clinical trials included nausea (37% vs. 20% placebo), headache (18%
Â Â Â Â Â Â vs. 14% placebo), constipation (16% vs. 4% placebo), hot flushes (12%
Â Â Â Â Â Â vs. 2% placebo), hyperhidrosis (9% vs. 2 % placebo), vomiting (7% vs.
Â Â Â Â Â Â 2%), palpitations (7% vs. 2%), heart rate increase (6% vs. 1% placebo),
Â Â Â Â Â Â dry mouth (5% vs. 2%) and hypertension (5% vs. 2%).
Â Â Â -- Milnacipran did not cause weight gain.
Development Plans

On September 28, 2005, Forest and Cypress reported that preliminary top- line results from Study FMS-031 did not achieve statistical significance. Subsequently, the Food and Drug Administration (FDA) revised its guidelines for approval of FMS therapies and agreed to allow the Companies to re-assess the data based on an updated analysis approach, which included a change from LOCF (last observation carried forward) to BOCF (baseline observation carried forward) analysis as well as other changes in the use of primary endpoints for efficacy evaluation. Using the revised analyses, a daily dose of 200 mg milnacipran produced statistically significant differences compared to placebo for both the fibromyalgia syndrome and pain of fibromyalgia composite endpoints. Also, compared to placebo, a daily dose of 100 mg milnacipran produced a statistically significant difference on the fibromyalgia syndrome composite endpoint and trended toward significance on the pain of fibromyalgia composite endpoint (p= .056). These data will be included as part of the New Drug Application (NDA) for milnacipran for the treatment of FMS, planned for submission around the end of 2007.

The Companies will review these data and the status of the milnacipran development timeline during an investor call on Thursday, November 8, 10:00 - 11:00 AM ET. To participate in the call, please use the following URL: http://phx.corporate-ir.net/phoenix.zhtml?p=irol- eventDetails&c=83198&eventID=1686016. (Due to the length of the link, please copy and paste into your browser.)

The webcast can also be accessed from both the Forest and Cypress corporate websites: www.cypressbio.com or www.frx.com.

About Milnacipran

Milnacipran is a unique dual-reuptake inhibitor, which preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for the treatment of depression in over 32 countries, with real-world commercial experience outside the U.S. spanning more than 10 years and 20 million patient-months. Milnacipran is being developed for fibromyalgia in the United States market jointly by Forest and its licensor, Cypress Biosciences, Inc. Milnacipran was originally developed by and is sold outside of the U.S. by Pierre Fabre Medicament.

About Fibromyalgia

FMS is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. According to the American College of Rheumatology, FMS is estimated to affect over six million people in the United States. FMS is most often diagnosed in the primary care setting and, in addition, is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this syndrome, there are limited treatment options specifically approved for FMS in the United States or elsewhere, and the addressable patient population is not yet well established.

About Cypress

Cypress is committed to being an innovator and leader in providing products for the treatment of patients with Fibromyalgia Syndrome. As part of its business development strategy, the company evaluates a number of Proof of Concept stage opportunities that leverage its repurposing experience and innovative approach to clinical trial design and regulatory strategy, and intend to continue to do this on an ongoing basis. The company continues to evaluate various other potential strategic transactions, including the potential acquisition of products, product candidates, technologies and companies.

For more information about Cypress, please visit Cypress' website at www.cypressbio.com.

This press release, as well as Cypress' SEC filings and website at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of milnacipran to treat fibromyalgia syndrome and our planned NDA filing for milnacipran. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress' Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that more detailed analysis of the trial results may not be favorable or may lead to different conclusions; the FDA may not accept our first Phase III clinical trial as one of the two pivotal trials required for NDA approval, that upon further reflection that we may determine not to submit an NDA around the end of 2007 and even if we do submit the NDA, that it may not be accepted or not approved by the FDA, that we may not be able to protect our milnacipran patent portfolio and that milnacipran may never be approved as a drug by the FDA.

About Forest Laboratories and Its Products

Forest Laboratories (www.frx.com) is a US-based pharmaceutical company dedicated to identifying, developing and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; and Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, Benicar HCT(R)* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, and AZOR(TM)* (amlodipine and olmesartan medoxomil) a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.

*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.

Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in the Forest Laboratories' SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2007, and on Form 10-Q for the period ended June 30, 2007.