MELBOURNE, March 30 (UPI) — Officials of the Australian drug maker Biota Holdings ltd. said a Phase II clinical trial of an antiviral treated colds in people with asthma.

Peter Cook, chief executive officer of Biota, said the successful completion of the Phase II trial delivered a major milestone in the development of BTA798, or vapendavir, for the treatment of naturally acquired human rhinovirus — the predominant cause of the common cold — infection in asthmatics.

Drug treatment resulted in a statistically significant reduction in cold symptoms compared to a placebo, Cook said.

Cook said the next phase is to design appropriate Phase III studies.

The Phase II multicenter, randomized, double-blind, placebo-controlled study in asthmatic adults with symptomatic, naturally acquired human rhinovirus infection was conducted over two consecutive seasons in 48 centers in the United States. Subjects received either 400 milligrams of BTA798 or placebo twice daily for six days.

“This trial not only represents a valuable step in the successful delivery of one of Biota’s key programs but it is also a unique accomplishment in the field of antiviral development,” Cook said in a statement. “While the clinical link between human rhinovirus infection and loss of asthma control is now widely accepted, Biota is the first company to evaluate the use of an anti-viral to treat the infection in asthmatics. This has the potential to be of considerable benefit to sufferers through better control of their asthma.”

Press Release Source: Physiotherapy Associates on Wednesday March 9, 2011, 10:52 am EST

EXTON, Pa., March 9, 2011 /PRNewswire/ — Physiotherapy Associates, the nation’s foremost provider of outpatient rehabilitation services, will celebrate Multiple Sclerosis Awareness Week in more than 600 of its clinical facilities across the U.S. from March 14-20, 2011, celebrations within Physiotherapy Associates’ clinics include open houses, clinician presentations, patient support groups, physician talks, and more events focused on raising the awareness around the disease. more than 3,100 employees of Physiotherapy Associates will show their support for people living with MS during the week by wearing orange, the signature color of the National Multiple Sclerosis Society.

“I am excited to wear orange the week of March 14th to show our company’s support of the National Multiple Sclerosis Society’s efforts to help people living with MS,” said Dan Connors, Chief Executive Officer, Physiotherapy Associates. “This week represents an opportunity for our clinics to open their doors to people who want to learn more about the disease and potential outpatient treatments.”

Physiotherapy Associates offers an MS Specialty Program in all of its 600 locations which includes physical therapy services and health and wellness programs designed to reduce or alleviate the symptoms of multiple sclerosis for the more than 400,000 people living in the United States with MS. with a shared vision of a world free of MS, Physiotherapy Associates has named the National Multiple Sclerosis Society as its national community service partner. the community service efforts involve Physiotherapy Associates’ 3,100 employees in local activities to achieve this vision.

With more than 600 clinics in 32 states, Physiotherapy Associates’ clinics are convenient to people with MS who need physical/occupational therapy, custom orthotics or custom-fabricated prosthetic devices.

Physiotherapy Associates’ COO Pete Grabaskas, PT, stated, “We know physical therapy is an integral part of helping people with MS overcome pain, fatigue and muscle spasticity. Our clinicians practice one-on-one care and are well-qualified to help people with MS improve their daily functions. All year long, people living with MS receive the care they need and the outcomes they deserve from our clinicians, no matter where they live.”

With a national team which includes fourteen clinic teams to date participating in various MS events such as Walk MS and Bike MS, Physiotherapy Associates’ associates continue to build on the community service partnership with the National MS Society formed earlier this year. “Our clinic team members are helping to raise awareness for people living with MS with their local efforts in MS community activities,” said Janna King, Physiotherapy Associates’ Senior Vice President and General Counsel. she added, “From California to Pennsylvania, from Indiana to Florida, we see engagement from our clinic directors, front office staff, and everyone in between. we look forward to promoting this initiative throughout 2011 and beyond.”

About Physiotherapy Associates

Physiotherapy Associates is the nation’s foremost provider of outpatient rehabilitation services. Physiotherapy Associates employs an industry-leading team of physical therapists and healthcare practitioners who are dedicated to high-quality patient care. the company provides physical therapy, industrial rehabilitation and orthotics and prosthetics services to millions of patients each year across the United States. with more than 600 clinics, Physiotherapy Associates is national in scope, local in care. For more information, visit physiocorp.com, follow us on Twitter (@physiocorp) or become a Physio fan on Facebook.

About the National Multiple Sclerosis Society

For more information on MS and the research and service programs supported by the Society, visit nationalMSsociety.org

February 14, 2011 09:00 AM Eastern Time 

EWING, N.J.–(BUSINESS WIRE)–Antares Pharma, Inc. (NYSE Amex: AIS) today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol® Gel for overactive bladder (OAB).

“We are pleased to have received the waiver for the NDA filing fee for the Anturol NDA. this waiver represents a significant accomplishment for the Company and helps maintain our strong cash position”

The waiver, requested by Antares in accordance with section 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, is granted to a small business for the first human drug application that it submits to the FDA for review. To be considered for the waiver, a company must demonstrate it meets the size restrictions established by the Small Business Administration (SBA), which the SBA confirmed for Antares on January 14, 2011. The FDA will typically provide notice of acceptance of the NDA within 60 days of receipt of the waiver.

“We are pleased to have received the waiver for the NDA filing fee for the Anturol NDA. this waiver represents a significant accomplishment for the Company and helps maintain our strong cash position,” said Paul K. Wotton Ph.D., President and Chief Executive Officer.

About Overactive Bladder

OAB, also called urge incontinence, is a condition marked by a sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when the smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage. OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). According to published reports it is estimated that more than 30 million Americans have OAB, and while it can happen at any age is more prevalent among older individuals. it is more common than both diabetes and asthma. According to IMS the annual OAB prescription market in the United States is valued at approximately $2.0 billion.

About Anturol®

Anturol is oxybutynin gel based on the ATD Gel technology platform which is a clear, odorless, hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. The ATD technology is also used in Elestrin®, an FDA approved product for hormone replacement therapy in postmenopausal women. it has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. by delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. These side effects account for a significant level of patient non-compliance among existing oral OAB treatments.

About Antares Pharma

Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. The Company’s subcutaneous and intramuscular injection technology platforms include VIBEXTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the Company’s lead product candidate is Anturol®, an oxybutynin ATD™ gel that has completed Phase 3 studies for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.

— Company to Expand ALKS 33 Clinical Program into Treatment-Resistant Depression —

— Alkermes Presents Positive Data from Phase 4 Study of VIVITROL® in Healthcare Professionals with Opioid Dependence —

WALTHAM, Mass.–(BUSINESS WIRE)–Alkermes, inc. (NASDAQ: ALKS) will provide an overview of upcoming milestones for its commercial products, late-stage product candidates and emerging clinical candidates from the company’s proprietary pipeline on Monday, January 10, 2011, at the 29th Annual JPMorgan Healthcare Conference in San Francisco. Highlights include the expansion of the ALKS 33 clinical program into treatment-resistant depression (TRD) and the presentation of interim data from the VIVITROL® (naltrexone for extended-release injectable suspension) phase 4 study in healthcare professionals with opioid dependence.

“we will discuss the details of these major milestones in our webcast presentation at the conference.”

“We are very much looking forward to 2011 as we expect major developments in virtually all of our late-stage clinical and commercial programs,” commented Richard Pops, Chief Executive Officer of Alkermes. “We will discuss the details of these major milestones in our webcast presentation at the conference.”

Alkermes 2011 Milestones

During the year, Alkermes expects:

Program Highlights to be Presented at JPMorgan Conference

• Expansion of the ALKS 33 clinical program into TRD: Alkermes will announce that ALKS 33, in combination with buprenorphine, is being studied for TRD. TRD, which is also known as refractory depression, refers to depressive episodes that are not adequately controlled by standard antidepressant therapy. Depression is a serious and chronic disease that affects more than 20 million American adults each year1 and finding the right treatment can be difficult for many patients. Approximately half of depressed patients have an inadequate response to monotherapy2 and as many as 20% have chronic depression despite multiple interventions.3 ALKS 33 and buprenorphine have established activity at the Mu receptor, although buprenorphine is a partial agonist while ALKS 33 is an antagonist. The net effect of this combination may attenuate buprenorphine’s Mu agonist effects. Blockade activity from the combination of ALKS 33 and buprenorphine at Kappa opioid receptors may affect neurochemical changes associated with depression. Preclinical research has demonstrated that Kappa blockade has antidepressant effects in behavioral models of depression. The company plans to file an Investigational new Drug application (IND) in mid-calendar year 2011 and initiate a phase 1/2 trial by the end of calendar year 2011.The expansion of the ALKS 33 clinical program into TRD follows the recent announcement of phase 2 data for ALKS 33 for the treatment of alcohol dependence. this phase 2 study was designed to assess the safety, tolerability, pharmacokinetics and efficacy of daily oral administration of three different dose levels of ALKS 33 compared to placebo in approximately 400 alcohol dependent patients. The phase 2 study showed that ALKS 33 was generally well tolerated and characterized by its potential for daily dosing, non-hepatic metabolism, extended pharmacologic benefit in the event of missed doses and pharmacologic activity in reducing heavy drinking behavior. ALKS 33 is also in clinical development for the treatment of binge eating disorder and as a combination therapy with buprenorphine for the treatment of cocaine addiction.

• Positive phase 4 data for VIVITROL in the treatment of healthcare professionals with opioid dependence: Alkermes will present interim data from an ongoing, multicenter, open-label, two-year, phase 4 study of VIVITROL. this study is designed to evaluate the safety and efficacy of VIVITROL in the treatment of 38 healthcare professionals with a history of opioid dependence who are enrolled in an extended outpatient treatment program that includes psychosocial support, such as counseling. At the time of the interim analysis, of the 38 patients who initiated VIVITROL treatment, approximately 70% of subjects persisted with VIVITROL treatment for at least six months, all of whom had opioid-free screens for the full six-month period.according to the 2009 U.S. National Survey on Drug use and Health, an estimated 1.6 million people aged 18 or older were dependent on pain relievers or heroin.4 Physicians display higher rates of prescription drug abuse and dependence than the general population, including misuse of prescription opioids.5 Physician impairment is a major public health issue, as it affects not only these individuals but also their patients, colleagues and families.

Webcast

a live webcast of the JPMorgan presentation will begin on Monday, January 10, 2011, at 11:00 a.m. ET (8:00 a.m. PT). The webcast will be available on the investor relations section of the company’s website at alkermes.com. To ensure a timely connection to the webcast, it is recommended that users register 15 minutes prior to the scheduled webcast. this webcast will be archived for 14 days.

About VIVITROL

VIVITROL (naltrexone for extended-release injectable suspension) 380 mg/vial is the first and only once-monthly, extended-release injectable medication for the treatment of alcohol dependence and opioid dependence. The proprietary Medisorb® drug delivery technology in VIVITROL enables the medication to be gradually released into the body at a controlled rate over a one-month time period. The VIVITROL clinical development program was funded in part with a Small Business Innovation Research Program grant from the National Institute of Drug Abuse (NIDA). For a copy of the VIVITROL full prescribing information, please visit vivitrol.com or call 1-800-VIVITROL (1-800-848-4876). Please see below for important safety information, including boxed warning.

VIVITROL IMPORTANT SAFETY INFORMATION

VIVITROL is contraindicated in patients with acute hepatitis or liver failure, patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opioid withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, and in patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose or any other components of the diluent.

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

VIVITROL is administered as an intramuscular (IM) gluteal injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using one of the customized needles provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for IM administration. VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including in some cases surgical intervention.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis. Opioid-dependent patients including those being treated for alcohol dependence, must be opioid-free for a minimum of 7-10 days before VIVITROL treatment. Attempts to overcome opioid blockade due to VIVITROL may result in a fatal overdose. After opioid detoxification, patients are likely to have reduced tolerance to opioids. use of lower doses of opioids after VIVITROL is discontinued, at the end of a dosing interval or after missing a dose could result in life threatening opioid intoxication. Alcohol- and opioid-dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. as with any IM injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder. In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.

The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders. The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients include hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

About Alkermes

Alkermes, inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients’ lives. Alkermes developed, manufactures and commercializes VIVITROL® for alcohol and opioid dependence and manufactures RISPERDAL® CONSTA® for schizophrenia and bipolar I disorder. Alkermes’ robust pipeline includes extended-release injectable and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Massachusetts, Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio. For more information, please visit Alkermes’ website at alkermes.com.

Note Regarding Forward-Looking Statements

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to: statements concerning the sales growth of VIVITROL, the timing and success of development activities for the company’s programs, including BYDUREON, VIVITROL, ALKS 33, ALKS 37 and ALKS 9070 and the potential therapeutic value of Alkermes’ products. although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees. The company’s business is subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: whether the development activities discussed in this press release will be completed on time or at all; potential changes in cost, scope and duration of the clinical trials; whether the company’s product candidates will demonstrate sufficient efficacy and safety; whether advancement of the company’s partnered product candidates will be delayed due to actions or decisions by its partners with regard to development and regulatory strategy, timing and funding which are out of its control; the outcome of clinical and preclinical work the company and its partners are pursuing; decisions by the FDA and foreign regulatory authorities regarding the company’s products, including the timeline for review of, and the outcome of regulatory action relating to, BYDUREON; and the company’s ability to manufacture its products on a commercial scale, economically or in sufficient quantities; the company’s ability to commercialize VIVITROL successfully in the U.S.; and whether the company’s products may be precluded from commercialization by proprietary rights of third parties. For further information with respect to factors that could cause the company’s actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof, and the company disclaims any intention or responsibility for updating predictions or financial expectations contained in this release.

VIVITROL® is a trademark of Alkermes, inc. RISPERDAL® CONSTA® is a trademark of Janssen-Cilag group of companies. BYDUREON™ is a trademark of Amylin Pharmaceuticals, inc. VICTOZA® is a trademark of NovoNordisk.

1 Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun; 62 (6): 617-27.

2 Bauer M, Whybrow PC, Angst J, et al. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 1: Acute and continuation treatment of major depressive disorder. World J Biol Psychiatry, 2002; 3:5–43.

3 Paykel ES. Epidemiology of refractory depression. In: Nolen WA, Zohar J, Roose SP, et al, editors. Refractory depression: current strategies and future directions. new York: Wiley; 1994:3–18.

4 SAMHSA, Office of Applied Studies, National Survey on Drug use and Health, 2009.

5 Hughes PH, Brandenburg N, Baldwin DC, et al. Prevalence of substance use among US physicians. JAMA, 1992;267:2333–9.

The new genetic approach could make the PSA screening test for prostate cancer more accurate. (CBC)

Scientists have taken a first step toward improving problematic PSA tests for prostate cancer, by mixing in some genetic information that might help tell which men really need a biopsy.

The widely used blood tests measure a protein named PSA that only sometimes signals prostate cancer is brewing. a patient’s PSA level can be high for other reasons, but doctors order a biopsy to check for a tumour whenever PSA reaches a certain level.

Now scientists have discovered a set of genetic variants that show those cutoffs may be skewed for some men because their normal PSA level is naturally much higher than the average that PSA testing was based on.

That means “you end up biopsying a lot of prostates that did not need any biopsy,” said Dr. Kari Stefansson, chief executive officer of deCODE Genetics in Iceland.

His team reported the findings Wednesday in the journal Science Translational Medicine.

Stefansson said he plans to develop a test for those genetic markers, perhaps later next year, in hopes that doctors could use the information to customize how they read and react to their patient’s PSA test results.

This genetic approach makes sense but “I don’t think that this test is ready for prime time” without more research to confirm the findings, cautioned Dr. Otis Brawley, chief medical officer of the American Cancer Society, who wasn’t part of the study.

“It’s important, but it’s a small step in the long road ahead” for better prostate cancer detection, he said.

Finding deadly cancers

Making a PSA test more accurate solves only part of the problem, Brawley stressed. Screening often detects small prostate tumors that will prove too slow-growing to be deadly, but there’s no sure way to tell in advance who needs aggressive therapy.

“What we desperately need is some type of test … that tells us, this is the kind of prostate cancer that kills versus the kind of cancer that doesn’t kill,” he said.

More than 190,000 cases of prostate cancer will be diagnosed this year in U.S. men, and it will kill about 27,000. but routine screening is highly controversial: while most men over 50 have had at least one PSA test, many major medical groups don’t recommend them over fears they may do more harm than good.

The cancer society, for instance, advises that men be told of the pros and cons of the test and decide for themselves.

Among the problems: more than a third of men with PSA levels of 10 or more have no evidence of prostate cancer at biopsy, and many doctors order a tumour check at levels lower than that, around four. Conversely, some men with very low PSA levels wind up with cancer.

Stefansson’s team discovered a set of genetic variants that alters how much PSA, or prostate specific antigen, men naturally produce.

The team reported that men who bear any of three of those variants had PSA levels about 40 per cent higher than average men. When they examined the records of nearly 4,000 men in Iceland and Britain who underwent prostate biopsies, those high-PSA producers were more likely to have had an unnecessary biopsy.

Conversely, men with a fourth variant had PSA levels about 40 per cent lower than average.

Roughly five per cent of men fall into each category, Stefansson said.

What does that mean? if a doctor usually orders a biopsy for a PSA of four, a high-PSA producer might not need one until reaching almost six, Stefansson said. but a low-PSA producer might need one sooner.

The Canadian Cancer Society suggests men over 50 should talk to their doctor about getting tested for prostate cancer. it also suggests that if you are over 40 and have a higher risk of developing the disease, you should talk to your doctor about getting tested.

But for healthy men with no symptoms of the disease, the Canadian society notes there are no recommended screening tests.

EWING, N.J.–(BUSINESS WIRE)–Antares Pharma, inc. (NYSE Amex: AIS) today announced the filing of a new Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Anturol® Gel in patients with overactive bladder (OAB).

“the NDA submission for Anturol represents a significant accomplishment for the Company in 2010. the dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement”

the NDA submission was supported by a Phase 3 clinical trial, which demonstrated a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily). the trial was conducted under a Special Protocol Assessment (SPA) with the FDA. in addition, an Open Label Extension study, evaluating long-term safety has been successfully completed.

“The NDA submission for Anturol represents a significant accomplishment for the Company in 2010. the dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement,” said Paul K. Wotton Ph.D., President and Chief Executive Officer.

Anturol Phase 3 Trial

the NDA submission, subject to acceptance by FDA, was supported by a Phase 3 trial conducted under a Special Protocol Assessment (SPA) with FDA. the trial was a double blind, randomized, parallel placebo-controlled multi-center study that evaluated the efficacy and safety of Anturol in 600 subjects with overactive bladder. the primary objective of the study was to demonstrate that daily treatment of 56mg or 84mg dose of oxybutynin applied in the ATDTM Gel technology for 12 weeks was superior to placebo for the relief of OAB symptoms. the study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily, p=0.028 and 0.033 respectively).

Secondary end points included changes from baseline in average daily urinary frequency, void volume, patient perceptions, as well as safety and tolerability including skin irritation. although not the basis for approval, the 84 mg dose provided highly statistically significant results for the secondary end points of urinary frequency and volume while the 56 mg dose did not reach statistical significance. Additionally, Anturol which uses the proprietary ATD Gel technology was well tolerated in the study. No serious adverse events related to the treatment were reported. Anticholinergic side effects such as dry mouth and constipation were low and no CNS side effects were seen compared to placebo. Treatment-related adverse events that resulted in study discontinuation during the double-blind period were low and similar for both the treatment and placebo groups.

About Overactive Bladder

OAB, also called urge incontinence, is a condition marked by a sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when the smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage. OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). According to published reports it is estimated that more than 30 million Americans have OAB, and while it can happen at any age is more prevalent among older individuals. It is more common than both diabetes and asthma. According to IMS the annual OAB prescription market in the United States is valued at approximately $2.0 billion.

About Anturol®

Anturol is oxybutynin gel based on the ATD Gel technology platform which is a clear, odorless, hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. the ATD technology is also used in Elestrin®, an FDA approved product for hormone replacement therapy in postmenopausal women. It has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. by delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. these side effects account for a significant level of patient non-compliance among existing oral OAB treatments.

About Antares Pharma

Antares Pharma focuses on self-injection pharmaceutical products and topical gel-based medicines. the Company’s subcutaneous and intramuscular injection technology platforms include VIBEXTM disposable pressure-assisted auto injectors, ValeoTM/VisionTM reusable needle-free injectors, and disposable multi-use pen injectors. in the injector area, Antares Pharma has a multi-product deal with Teva Pharmaceutical Industries, Ltd that includes Tev-Tropin® human growth hormone and a partnership with Ferring Pharmaceuticals. in the gel-based area, the Company’s lead product candidate is Anturol®, an oxybutynin ATD™ gel that has completed Phase 3 studies for the treatment of OAB (overactive bladder). Antares also has a partnership with BioSante that includes LibiGel® (transdermal testosterone gel) in Phase 3 clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin® (estradiol gel) indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the U.S. Antares Pharma has corporate headquarters in Ewing, new Jersey, with subsidiaries performing research, development and product commercialization activities in Minneapolis, Minnesota and Muttenz, Switzerland.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements related to the potential success or failure of the Anturol NDA and the impact of Phase 3 trials on the NDA. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. these risks and uncertainties include, among others, difficulties or delays in the initiation, progress, or completion of product development, clinical trials, difficulties or delays in the progress or completion of Anturol’s product development or in the success of the NDA and whether or not the Company’s application for marketing approval is accepted for review or at all by the FDA or any other regulatory authority. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. the Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

CAMBRIDGE, MASS.–(BUSINESS WIRE)–

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that it has completed the submission of a new Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex’s investigational treatment for people with hepatitis C. The NDA submission is supported by results from three Phase 3 studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before but did not achieve a sustained viral response (SVR, or viral cure). The submission includes a request for Priority Review, which would reduce the FDA’s review time from 10 months to six months. The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment.

“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. “We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”

Highlights of the Telaprevir Phase 3 Data Included in the Submission

all Phase 3 studies met their primary endpoints and results below are from the treatment arms where telaprevir was started immediately in combination with pegylated-interferon and ribavirin for the first 12 weeks of treatment.

in people with hepatitis C who were new to treatment (treatment-naïve):

• Up to 75% achieved a viral cure with telaprevir-based combination therapy, compared to 44% of people who received pegylated-interferon and ribavirin alone;
• A majority (58% in ADVANCE and 65% in ILLUMINATE) were eligible to reduce their treatment time by half – from 48 weeks to 24 weeks; and
• Data showed there was no benefit to extending total treatment from 24 weeks to 48 weeks in people whose virus was undetectable at weeks 4 and 12 with telaprevir-based therapy.

in the three major subgroups of people with hepatitis C who had not achieved a viral cure with a prior course of treatment (treatment-experienced):

• 83% of prior relapsers, 59% of prior partial responders and 29% of prior null responders achieved a viral cure with telaprevir-based combination therapy compared to 24%, 15%, and 5% of people in these subgroups, respectively, who received pegylated-interferon and ribavirin alone. these results were achieved with a simultaneous start of all three drugs for the first 12 weeks followed by pegylated-interferon and ribavirin alone for an additional 36 weeks.

The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment arm were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.

More Effective Therapies Needed to Improve Viral Cure Rates

Hepatitis C is a serious disease, typically without symptoms, which affects up to 3.9 million people in the United States. Hepatitis C can lead to scarring of the liver (cirrhosis), resulting in liver failure, liver cancer and the need for liver transplantation. Approved medicines for people with genotype 1 hepatitis C are given for a year, and less than half of people treated with these therapies achieve a viral cure.4,5,6 Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. to date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.

“In our trials, starting patients with 12 weeks of telaprevir-based combination therapy significantly improved viral cure rates compared to treatment with currently approved medicines, even in groups of people considered the most difficult to treat,” said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. “We’re also encouraged by telaprevir data that showed most patients new to therapy were able to achieve high viral cure rates and reduce their total treatment time by half.”

Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America and Tibotec has rights in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.

Vertex was granted fast Track designation by the FDA for telaprevir in 2005. in mid-2010, as part of the fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete.

Data from Phase 3 Studies in all Major Patient Types, Including the most Difficult-to-Treat

The Phase 3 studies evaluated people with genotype 1 hepatitis C who were new to treatment as well as those who had previously received treatment but did not achieve a cure, including people who have traditionally responded poorly to approved medicines. in Phase 3 studies, telaprevir was given to people three times a day in combination with pegylated-interferon and ribavirin for the first 12 weeks of therapy followed by either 12 weeks or 36 weeks of Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) alone for a total treatment time of either 24 weeks or 48 weeks. The ability to shorten treatment time from 48 weeks to 24 weeks for people new to treatment was based on their response to therapy at weeks 4 and 12. People who did not achieve a viral cure with a prior course of therapy received a total of 48 weeks of treatment. in October 2010, Vertex announced the start of a Phase 3 study to evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen.

ADVANCE: Pivotal study in 1,095 people who were new to treatment

The primary endpoint of ADVANCE was SVR, defined as the proportion of people who had undetectable viral load (HCV RNA) both at the end of treatment and 24 weeks after the end of treatment. The secondary endpoint was to evaluate the safety of telaprevir when dosed in combination with pegylated-interferon and ribavirin. ADVANCE also evaluated the ability to reduce total treatment time by half – from 48 weeks to 24 weeks, which was guided by a patient’s response to therapy (undetectable viral load at weeks 4 and 12).

ILLUMINATE: Supplemental study in 540 people to evaluate shorter treatment durations in people who were new to treatment

The primary endpoint of the study was SVR in two telaprevir-based treatment arms of people whose virus was undetectable at week 4 and week 12 of treatment (eRVR, extended rapid viral response). these patients were randomized to either 24 weeks or 48 weeks of total therapy. ILLUMINATE was designed to evaluate whether there was any benefit to extending therapy from 24 weeks to 48 weeks in people who met these criteria. There was no control arm of pegylated-interferon and ribavirin alone in the study.

in both the ADVANCE and ILLUMINATE studies, telaprevir-based combination therapy also resulted in improved SVR rates in various subgroups of people with characteristics known to limit response to approved medicines such as race/ethnicity or stage of liver fibrosis. Data from these studies were presented in November 2010 at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

REALIZE: Pivotal study in 662 people who did not achieve a viral cure with previous therapy

The primary endpoint of the study was SVR in each of the two telaprevir treatment arms compared to the control arm, and for the three subgroups of people included in the study. REALIZE is the only Phase 3 study to date of a direct-acting antiviral medicine to include all three major subgroups of people with hepatitis C who did not achieve a viral cure with a previous course of therapy:

• Relapser: defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period;
• Partial Responder: defined as a person who achieved at least a 2 log10 (100 times) reduction in viral load (HCV RNA) at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy; and
• Null Responder: defined as a person who experienced a less than 2 log10 drop in viral load at week 12 of a prior course of therapy.

in REALIZE, people received 48 weeks of total therapy, which included 12 weeks of telaprevir combined with pegylated-interferon and ribavirin. one of the telaprevir treatment arms was designed to evaluate, for the first time, whether viral cure rates could be further improved by starting pegylated-interferon and ribavirin alone for the first four weeks of treatment (delayed start) compared to a simultaneous start of telaprevir in combination with these medicines. There was no clinical benefit observed with the telaprevir delayed-start treatment arm in any of the subgroups of patients compared to the simultaneous-start arm. Final results from REALIZE, including safety and efficacy data, will be presented at an upcoming medical meeting.

Safety and Tolerability Information for ADVANCE, ILLUMINATE and REALIZE

The safety and tolerability results of telaprevir-based combination regimens were consistent across the Phase 3 studies. The most common adverse events (AEs) were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia with the majority being mild or moderate in severity. Rash and anemia occurred more frequently in the telaprevir treatment arms compared to the control arms.

Rash was primarily characterized as eczema-like, manageable and resolved upon stopping telaprevir. More than 90% of rash was mild to moderate and was primarily managed with the use of topical corticosteroids and antihistamines. Anemia was primarily managed by reducing the dose of ribavirin. Erythropoiesis-stimulating agents (ESAs) were used in only 1% of people in the Phase 2 and Phase 3 studies. Discontinuation of all drugs due to either rash or anemia during the telaprevir/placebo treatment phase was 1% to 3% in the telaprevir treatment arms.

About Hepatitis C

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.2 Up to 3.9 million people in the United States have chronic hepatitis C and 75% of those infected are unaware of their infection.3 The majority of people with hepatitis C were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.11 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.2 though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.2

Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR, 4,5,6 or viral cure.1 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8,9,10,11 in the United States, hepatitis C is the leading cause of liver transplantations and is reported to contribute to 4,600 to 12,000 deaths annually.8 by 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11

Additional resources for media are available at: investors.vrtx.com/press.cfm.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company’s strategy is to commercialize its products both independently and in collaboration with other pharmaceutical companies. Vertex’s product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, epilepsy, cancer and pain.

Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

Lexiva is a registered trademark of the GlaxoSmithKline group of companies.

PEGASYS® and COPEGUS® are a registered trademarks of Hoffman-La Roche.

References:

1Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.

2 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. available at: cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed may 25, 2010.

3 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed may 25, 2010.

4 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.

5 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.

6 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.

7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).

8 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.

9 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.

10 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.

11 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. natap.org/2009/HCV/051809_01.htm. Updated may 2009. This report was commissioned by Vertex Pharmaceuticals, inc.

12 Picchio G, et al. Discrepancies between definitions of null response to treatment with peginterferon alfa-2a and ribavirin: Implications for new HCV drug development. [poster 289]. in: Program and Abstracts of the 2010 International Liver Conference by the European Association for the Study of Liver Disease. . Athens, Greece: April 2010.

13 United States Food and Drug Administration. Chronic hepatitis C virus infection: developing direct-acting antiviral agents for treatment. federalregister.gov/articles/2010/09/14/2010-22806/draft-guidance-for-industry-on-chronic-hepatitis-c-virus-infection-developing-directacting-antiviral. Updated September 14, 2010. Accessed September 14, 2010.

Special Note regarding Forward-looking Statements

this press release contains forward-looking statements, including statements regarding (i) the potential that the FDA’s review time for the telaprevir NDA will be reduced from 10 months to six months; (ii) Vertex’s commitment to working closely with the FDA to make telaprevir available as quickly as possible; (iii) Vertex being encouraged by telaprevir data that showed most patients new to therapy were able to achieve high viral cure rates and reduce their total treatment time by half and (iv) the expectation that final results from REALIZE will be presented at an upcoming medical meeting. while the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that Vertex could experience unforeseen delays in obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based therapy and the other risks listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex’s website at vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

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