DEERFIELD, IL and BRIDGEWATER, NJ — (MARKET WIRE) — 11/14/11 — Horizon Pharma, Inc. (NASDAQ: HZNP) and Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved the use of the sanofi-aventis Canada Inc. manufacturing site in Laval, Quebec to manufacture DUEXIS?, (ibuprofen/famotidine) a proprietary single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg). DUEXIS was approved by the FDA in April 2011. Sanofi will serve as the primary commercial manufacturer for DUEXIS in the United States.

"The approval of the Sanofi Laval manufacturing site provides Horizon with an experienced commercial manufacturer as we move forward with the launch of DUEXIS," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. "We look forward to making DUEXIS available in the next few weeks to patients who suffer from osteoarthritis and rheumatoid arthritis and who may be at risk for upper gastrointestinal ulcers stemming from ibuprofen use."

about DUEXIS DUEXIS, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

Important safety information

Risk of Serious Cardiovascular and Gastrointestinal Events

See full Prescribing Information for complete boxed warning

Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.

DUEXIS should not be given to patients who have experienced asthma, urticaria or allergic reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylaxis with NSAIDs has been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. DUEXIS is contraindicated in patients in late stages of pregnancy as premature closure of the ductus arteriosus in the fetus may occur. DUEXIS should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Cross sensitivity with other H2-receptor antagonists has been observed.

when active and clinically significant bleeding from any source occurs in patients receiving DUEXIS, the treatment should be withdrawn.

NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Monitor blood pressure closely during treatment with DUEXIS.

Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure.

Long-term administration of NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, has resulted in renal papillary necrosis and other renal injury. Use DUEXIS with caution in patients at risk (e.g., the elderly; those with renal impairment, heart failure or liver impairment and those taking diuretics or ACE inhibitors).

Hepatic injury ranging from transaminase elevations to liver failure can occur. if clinical signs and symptoms consistent with liver disease develop, if abnormal liver tests persist or worsen or if systemic manifestations occur, DUEXIS should be discontinued immediately.

Anaphylaxis may occur in patients with the aspirin triad or in patients without prior exposure to DUEXIS. if an anaphylactoid reaction occurs, DUEXIS should be discontinued immediately.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be fatal, can occur. Discontinue DUEXIS if rash or other signs of local skin reaction occur. Nursing mothers should use DUEXIS with caution, as it is not known if ibuprofen is excreted in human milk, and famotidine is excreted in human milk.

The most common adverse reactions (

November 07, 2011 07:33 AM Eastern Time 

CAMBRIDGE, Mass.–(EON: Enhanced Online News)–Dyax Corp. (NASDAQ: DYAX) announced today that two oral and two poster presentations featuring KALBITOR® (ecallantide) data in hereditary angioedema (HAE) were presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting held November 3-8, at the Hynes Convention Center in Boston, MA. three of the presentations featured results from patients enrolled in DX-88/19, an open-label continuation study of ecallantide for the treatment of acute HAE attacks, and the fourth highlighted integrated results from 2 double-blind, placebo-controlled studies of ecallantide for treatment of acute HAE attacks, the EDEMA3® and EDEMA4® studies. KALBITOR® is indicated for the treatment of acute attacks of HAE in patients 16 years of age and older.

“Data from our clinical studies in HAE continue to support the use of KALBITOR in treating acute attacks, with a consistent and significant treatment effect demonstrated regardless of attack location”

Andrew MacGinnitie, MD, PhD, Assistant Professor of Pediatrics at Harvard Medical School and attending physician at Children’s Hospital Boston, delivered the oral presentation titled “DX-88/19: Final Results from the Open-Label Continuation Study of Ecallantide for Acute Attacks of Hereditary Angioedema.” Commenting on the DX-88/19 study, Dr. MacGinnitie stated, “The data presented at ACAAI demonstrate that ecallantide remains effective for acute HAE attacks across multiple treatment episodes while drug related adverse events did not appear to increase upon repeat dosing.” He continued, “These findings confirm the safety and efficacy of ecallantide and further support its use as a treatment for this rare and potentially serious condition.”

“Data from our clinical studies in HAE continue to support the use of KALBITOR in treating acute attacks, with a consistent and significant treatment effect demonstrated regardless of attack location,” commented Gustav Christensen, President and Chief Executive Officer at Dyax Corp. “Dyax is highly committed to helping HAE patients and healthcare providers learn about this disease by providing educational and awareness programs and ensuring access to KALBITOR therapy.”

Complete List of Presentations on KALBITOR® at ACAAI 2011

• DX-88/19: Final Results from the Open-Label Continuation Study of Ecallantide for Acute Attacks of Hereditary Angioedema – Andrew J. MacGinnitie, MD, PhD, Children’s Hospital Boston, Boston, MA – Oral Abstract 31 presented on Sunday, November 6, 2:30-2:45 p.m. EST
• Rebound and Relapse of Acute Attacks of Hereditary Angioedema Following Ecallantide Treatment – Jonathan a. Bernstein, MD, University of Cincinnati, Cincinnati, OH – Oral Abstract 8 presented on Sunday, November 6, 2:45-3:00 p.m. EST

Poster Presentations

• Ecallantide Administration as 2 vs. 3 Injections for Hereditary Angioedema: Results from the DX-88/19 Study – Daniel F. Soteres, MD, MPH, Asthma & Allergy Associates, P.C., Colorado Springs, CO – Poster P335 presented on Saturday, November 5, 12:30-1:30p.m. EST and Sunday, November 6, 12:00-1:00p.m. EST
• Efficacy of Ecallantide for the Treatment of Acute Attacks by Primary Attack Location in DX-88/19 (Continuation)—the Open-Label Extension Study – Timothy J. Craig, DO, Pennsylvania State University, Hershey, PA – Poster P336 presented on Saturday, November 5, 12:30-1:30p.m. EST and Sunday, November 6, 12:00-1:00p.m. EST

About KALBITOR® (ecallantide)

KALBITOR is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. KALBITOR, which was discovered and developed by Dyax, is the first subcutaneous treatment available in the U.S. for treating acute HAE attacks.

Important KALBITOR Safety Information

Anaphylaxis has been reported after administration of KALBITOR. because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. KALBITOR should not be administered to patients with known clinical hypersensitivity to KALBITOR.

As part of product approval, Dyax has implemented a Risk Evaluation and Mitigation Strategy (REMS) program. the goal of the REMS is to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms.

for more information about KALBITOR, including full prescribing information, visit KALBITOR.com.

KALBITOR Development HAE Program

the approval of KALBITOR is based on the results of two placebo-controlled Phase 3 clinical studies, known as EDEMA3® and EDEMA4®. Patients having an attack of HAE, at any anatomic location, with at least one moderate or severe symptom, were treated with 30 mg subcutaneous KALBITOR or placebo. because patients could participate in both trials, a total of 143 unique patients participated. there were 64 patients with abdominal attacks, 55 with peripheral attacks, and 24 with laryngeal attacks. In both trials, the effects of KALBITOR were evaluated using the Mean Symptom Complex Severity (MSCS) score and the Treatment Outcome Score (TOS), two HAE-specific patient-reported outcome endpoints developed by Dyax. these measures evaluated the severity of attack symptoms at all anatomical locations (MSCS score) and response to therapy (TOS). In the EDEMA4 trial at 4 hours, patients treated with KALBITOR demonstrated a greater decrease from baseline in the mean MSCS than placebo (-0.8 vs. -0.4; p = 0.010) and a greater mean TOS (53 vs. 8, p = 0.003). In the EDEMA4 trial at 24 hours, patients treated with KALBITOR also demonstrated a greater decrease from baseline in the mean MSCS than placebo (-1.5 vs. -1.1; p = 0.04) and a greater mean TOS (89 vs. 55, p = 0.03). the results in the EDEMA3 trial were consistent with the EDEMA4 trial results.

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical studies, 10 patients (3.9%) experienced anaphylaxis. for the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (2.7%) experienced anaphylaxis. Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension. these reactions occurred within the first hour after dosing.

the most common adverse reactions occurring in greater-than or equal to 3% of KALBITOR-treated patients and greater than placebo were headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.

KALBITOR Access®

Patients and healthcare providers can contact KALBITOR Access® to receive information and work with program staff to research patient insurance coverage for KALBITOR. KALBITOR Access is designed as a one-stop point of contact for information about KALBITOR. the program is staffed with dedicated insurance specialists and nurse case managers who will help coordinate patient treatment and access to KALBITOR. Patients and healthcare providers can call 1-888-4KALBITOR (1-888-452-5248) for information and to utilize these services or visit KALBITOR.com.

About HAE

Hereditary angioedema (HAE) is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, gastrointestinal tract, genitalia, and larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. HAE is estimated to affect 1 in 10,000 to 1 in 50,000 individuals. Learn more at HAEHope.com.

About Dyax

Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel biotherapeutics for unmet medical needs. the Company’s lead product, ecallantide, has been approved under the brand name KALBITOR® in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

Dyax is commercializing KALBITOR in the United States independently, and establishing strategic partnerships to develop and commercialize ecallantide for the treatment of HAE in key regions worldwide. Currently, Dyax has partnership agreements for regions including Europe, Japan, Russia, the Middle East, Israel, North Africa, Australia, New Zealand, Latin America (excluding Mexico), the Caribbean, Taiwan, Singapore and South Korea. the company is also exploring other potential indications for ecallantide, either alone or through partnerships, including drug-induced angioedema.

Ecallantide and other compounds in Dyax’s pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly through the Licensing and Funded Research Program (LFRP), which has approximately 75 revenue generating licenses and collaborations for therapeutic discovery, as well as for affinity separations, diagnostic imaging, and research reagents. the success of the Company’s LFRP royalty portfolio is illustrated by the program’s advanced licensee pipeline that includes 17 candidates in clinical development. Of those candidates, four are in Phase 3 clinical trials, four are in Phase 2 and nine are in Phase 1.

Dyax Disclaimer

this press release contains forward-looking statements, including statements regarding the prospects for therapeutic benefits and treatment advantages of KALBITOR for HAE. Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. the statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. important factors which may affect the prospects for therapeutic benefits and treatment advantages of KALBITOR for HAE include the risks that: others may develop technologies or products superior to KALBITOR or that are on the market before KALBITOR; KALBITOR may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, marketing, sales and distribution of KALBITOR; and other risk factors described or referred to in Item 1A, “Risk Factors” in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. these statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.

Dyax, the Dyax logo, KALBITOR and KALBITOR Access are registered trademarks of Dyax Corp. EDEMA3 and EDEMA4 are registered service marks of Dyax Corp.

Market adoption of Meridian Bioscience’s (NASDAQ:VIVO) new molecular diagnostic testing platform illumigene will go a long way toward determining the company’s future.

Cincinnati-area Meridian is betting big on the technology, hoping it’ll help rescue the diagnostic testing company from its recent struggles. the company has reported declining year-over-year earnings in several recent quarters and twice in the last few months downwardly revised its full-year earnings outlook for 2011.

Meridian’s illumigene platform provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the use of expensive instrumentation. It represents Meridian’s first foray into molecular diagnostics, a means of analyzing the makeup of an organism at the genetic level.

AdvertisementMolecular diagnostic tests tend to offer better sensitivity and specificity than their antibody-based counterparts, said Zarak Khurshid, a senior research analyst with Wedbush Securities. “the world appears to be moving in the direction of molecular tests,” he said.

So for Meridian to stay at the cutting edge of its industry and build the best products it can, the company’s push into molecular diagnostics must succeed.

“Illumigene is critically important to Meridian’s future — the reason being that the diagnostic space is fiercely competitive,” Khurshid said.

Thus far, Meridian has just one illumigene test on the market, for C. difficile, a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. CEO Jack Kraeutler said in July that Meridian expects to begin selling a second illumigene test, for Group B Streptococcus, to international markets before the end of the year.

Kraeutler said at the time that the company had achieved 500 “placements” of the test, with 90 percent of those in the U.S. Those sales contributed $6 million in revenue in 2011. (Kraeutler didn’t return calls for this article.)

That performance is a little better than Khurshid had expected, though he warned the true test of the illumigene platform will be whether it can help Meridian regain market share it’s lost to competitors like Cepheid, Becton Dickinson and Thermo Fisher Scientific.

Cepheid, in particular, has bruised Meridian with a molecular C. difficile test that came on the market in 2009. Khurshid estimates that the Cepheid test has taken a 10 percent bite out of Meridian’s market share in each of the last two years.

If Meridian is going to succeed, it needs to turn that around quickly — and that’s among the company’s biggest looming challenges.

“the jury is still out as to whether illumigene will allow Meridian to take back some of its lost market share and whether they can develop additional tests on that platform to build a meaningful, high-growth franchise in molecular diagnostics,” Khurshid said.

Stocks on watch: IPXL, UPI, SAASImpax Laboratories, Inc. (Public, NASDAQ:IPXL). last Market Price: 27.52, Change: +0.01, % Change: (0.04%). Shares trade in the range of 27.41 – 27.80 dollars. it has a market capitalization of 1.79B dollars and has 65.07M outstanding shares. the company has a beta of 0.56, indicating, the stock to be less volatile than the market. as per the most recent quarterly report, the net income per share (EPS) is 3.85; P/E of 7.16. it operates in Healthcare sector and belongs to Biotechnology and Drugs industry. the organization is a technology-based, specialty pharmaceutical company. the company has a 52 week high of $ 28.06 and a 52 week low of $ 7.20. Average volumes of shares traded daily are 753,445.00. Volume traded in the last session was at 580,738.00, 0.77 times the average volume. Impax Laboratories (IPXL) announced that it will collaborate with Banner Pharmacaps Inc. with respect to the supply and commercialization of two softgel capsule products. Uroplasty, Inc. (Public, NASDAQ:UPI). last Market Price: 7.01, Change: -0.54, % Change: (-7.15%). Shares trade in the range of 6.95 – 7.60 dollars. it has a market capitalization of 144.65M dollars and has 20.63M outstanding shares. the company has a beta of 1.53, indicating, the stock to be more volatile than the market. as per the most recent quarterly report, the net income per share (EPS) is -0.22. it operates in Healthcare sector and belongs to Medical Equipment and Supplies industry. the organization is a medical device company that develops, manufactures and markets products for the treatment of voiding dysfunctions. the company has a 52 week high of $ 7.96 and a 52 week low of $ 2.85. Average volumes of shares traded daily are 106,870.00. Volume traded in the last session was at 313,067.00, 2.93 times the average volume. Uroplasty (UPI) announced that NHIC will cover posterior tibial nerve stimulation using Uroplasty’s Urgent PC Neuromodulation System for the treatment of overactive bladder and associated symptoms, effective May 22, 2011. inContact, Inc. (Public, NASDAQ:SAAS). last Market Price: 3.34, Change: -0.03, % Change: (-0.89%). Shares trade in the range of 3.34 – 3.57 dollars. it has a market capitalization of 119.31M dollars and has 35.72M outstanding shares. the company has a beta of 0.94, indicating, the stock to be less volatile than the market. as per the most recent quarterly report, the net income per share (EPS) is -0.03. it operates in Technology sector and belongs to Software and Programming industry. the organization is a provider of cloud computing (also referred to as software as a service or (SaaS)) contact center services and network connectivity. the company has a 52 week high of $ 3.75 and a 52 week low of $ 2.12. Average volumes of shares traded daily are 65,638.00. Volume traded in the last session was at 49,552.00, 0.75 times the average volume. inContact (SAAS) announced that an expanding U.S. based outsourcer has selected the inContact solution to better serve its growing energy industry clientele.

Press Release Source: Repros Therapeutics Inc. On Wednesday March 16, 2011, 9:30 am EDT

THE WOODLANDS, Texas, March 16, 2011 (GLOBE NEWSWIRE) — Repros Therapeutics Inc.(R) (Nasdaq:RPRX – News)today announced it has commenced dosing the 6 mg cohort in the Company’s low dose study of Proellex(R) following a safety review of data from women that have completed 8 weeks of treatment at a 3 mg dose. No signals of liver toxicity were detected to date in the 3 mg group. Increased levels of drug activity were detected in this second cohort. the Company previously noted that it has observed signals of clinically relevant activity at even the lowest dose, 1 mg.

Proellex is an oral therapy in development for the treatment of uterine fibroids and endometriosis. Large Phase III clinical studies exhibited severe liver toxicity in a small percentage of subjects that were exposed to a 50 mg dose. As a result of these observations, the program was placed on full clinical hold until the phenomenon could be better understood. After an analysis of all the subjects that had been exposed to Proellex, Repros petitioned the FDA to allow the Company to conduct a low dose trial to assess impact on the liver and signals of efficacy. in the summer of 2010 the FDA moved Proellex to partial hold status to allow for the low dose study.

the trial is enrolling up to 12 subjects per cohort. there are five cohorts; 1, 3, 6, 9 and 12 mg administered per day over the dosing period. the next higher dose cohort is not allowed to commence until the Chairman of the outside drug safety monitoring board, a hepatologist, reviews the liver safety data from a minimum of 8 subjects from the current cohort that were dosed for a minimum of 8 weeks.

One of the first signals of efficacy for Proellex is induction of amenorrhea. this has profound effects on symptoms of both uterine fibroids and endometriosis. the 3 mg cohort has 10 women currently on study with 8 women reaching at least the 8 week dosing point. Of those 8 women, 7 have appeared to cease menstruating based on their daily diaries. in the final analysis of the 1 mg group 5 out of 11 women stopped menstruating while taking the drug.

this clearly dose dependent effect, coupled with the efficacy signals observed at the 1 mg dose leads the Company to believe that one or more doses being studied in the low dose trial will warrant further study. These low doses are expected to possess a significant safety margin as compared to the 50 mg dose previously studied, while still being able to provide clinical benefit for a significant percentage of women suffering from uterine fibroids or endometriosis.

the Company plans to issue similar releases as each new cohort commences dosing. Repros believes the study can be completed during the fourth quarter of 2011.

About Repros Therapeutics Inc.

Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

the Repros Therapeutics Inc. logo is available at globenewswire.com/newsroom/prs/?pkgid=7738

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros’ ability to have the partial hold on Proellex(R) lifted, the reliability of preliminary data and interim results, whether a safe and effective dose for Proellex can be determined, and such other risks which are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please visit the Company’s website at reprosrx.com.

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the randomization of the last patient in REPLACE, its Phase 3 registration study of NPSP558, a bioengineered form of human parathyroid hormone. REPLACE is a double-blind, placebo-controlled study evaluating the use of NPSP558 as hormone replacement therapy in adult patients with hypoparathyroidism. A total of 135 patients were randomized in this study.

“This is an important milestone in our NPSP558 pivotal study in hypoparathyroidism and we look forward to reporting top line results by the end of this year,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “There are currently no approved treatments for hypoparathyroidism, a disease that can cause serious bone, muscular and neurological symptoms. Current treatment approaches are palliative and can lead to long-term health risks. As a replica of natural parathyroid hormone 1-84, NPSP558 has the potential to address this unmet need by treating the underlying cause of the disorder rather than just managing the symptoms.”

NPS believes positive results from REPLACE will enable it to file for U.S. marketing approval in 2012 for NPSP558 in hypoparathyroidism.

About the REPLACE Study

REPLACE is a randomized, double-blind, dose escalating, placebo-controlled Phase 3 registration study to investigate the use of NPSP558 for the treatment of adults with hypoparathyroidism at more than 30 sites in North America and Europe.

The study consists of an average 10-week screening and stabilization period followed by a 24-week treatment period marked by randomization (2:1) to 50µg once daily NPSP558 or placebo. Following randomization, patients undergo staged reductions in calcium and vitamin D supplementation, while maintaining stabilized serum calcium. if needed, step-wise up-titration of study drug (NPSP558 or placebo) to a dose of 75 µg and then if necessary to 100 µg in patients over a six to eight week period will be performed. Patients will continue on their final dose through week 24. A follow-up period without study drug will last from week 24 to week 28.

The primary efficacy endpoint of REPLACE is to demonstrate by Week 24 at least a 50 percent reduction from baseline of oral calcium supplementation and active vitamin D metabolite/analog therapy and a total serum calcium concentration that is normalized or maintained compared to baseline (=7.5 mg/dL).

About Hypoparathyroidism

Hypoparathyroidism is a rare disorder in which the body produces insufficient levels of parathyroid hormone, the principal regulator of calcium and phosphorus. When the body has too little parathyroid hormone, blood calcium levels drop and phosphorus levels increase, which can cause muscular and neurological symptoms, as well as bone impairments. There is no approved treatment for hypoparathyroidism. it is one of the few remaining hormone deficiency syndromes in which replacement therapy using the native hormone is not clinically available. Hypoparathyroidism is currently managed with large doses of oral calcium and vitamin D supplementation to raise the calcium levels in the blood and reduce the severity of symptoms. Over time, calcium may build up in the body and result in serious health risks, including calcifications in the kidneys, heart or brain.

NPS has estimated that approximately 60,000 to 65,000 patients suffer from hypoparathyroidism in the U.S.

About NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection)

NPSP558, a bioengineered replica of human parathyroid hormone 1-84, is being evaluated in a Phase 3 registration study, known as REPLACE, as the first hormone replacement therapy for the underlying cause of hypoparathyroidism. because it mimics the action of natural parathyroid hormone, NPSP558 has the potential to treat hypoparathyroidism and offer a more physiological treatment outcome than what is available with existing treatments.

Results from an investigator-initiated Phase 2 open-label proof-of-concept study demonstrated that NPSP558 potentially can be used as a therapeutic agent in hypoparathyroidism effectively and safely. The study showed that NPSP558 treatment in hypoparathyroidism significantly reduces supplemental calcium and 1,25-dihydroxyvitamin D requirements while maintaining serum calcium levels. Data were published in January 2010 in the international peer-reviewed journal Osteoporosis International.

NPS has received orphan drug status for NPSP558 for the treatment of hypoparathyroidism. The company’s partner Nycomed markets PTH (1-84) ex-US as Preotact® for the treatment of osteoporosis in post-menopausal women at high risk of fractures.

About NPS Pharmaceuticals

NPS Pharmaceuticals is an outsourcing-based development company focused on bringing biopharmaceuticals to patients with rare disorders and few, if any, therapeutic options. The company is advancing two Phase 3 registration programs, GATTEX® (teduglutide) in short bowel syndrome (SBS) and NPSP558 (parathyroid hormone (1-84) [rDNA origin] injection) in hypoparathyroidism. NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, Kyowa Hakko Kirin, Nycomed, and Ortho-McNeil Pharmaceutical.

“NPS”, “NPS Pharmaceuticals”, and “GATTEX” are the company’s registered trademarks. all other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. these statements are based on the company’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to the company’s business include, but are not limited to, the risks associated with any failure by the company to successfully complete its preclinical and clinical studies within the projected time frames or not at all, the risk of not gaining marketing approvals for GATTEX, the risks associated with the company’s strategy, as well as other risk factors described in the company’s periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. all information in this press release is as of the date of this release and NPS undertakes no duty to update this information.

Business Wirebusinesswire.com/

Last updated on: 01/03/2011 14:00:03

Press Release Source: Immunomedics, Inc. On Friday January 21, 2011, 10:00 am EST

SAN FRANCISCO, Jan. 21, 2011 (GLOBE NEWSWIRE) — Immunomedics, Inc. (Nasdaq:IMMU – News), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that repeated therapy cycles of its proprietary antibody, clivatuzumab tetraxetan, labeled with yttrium-90 (Y-90) plus low-dose gemcitabine at 200 mg/m2, extended median overall survival (OS) to 11.8 months, more than double the 5.4 months OS in patients treated with a single cycle. Increased Y-90 doses also improved responses; patients receiving a dose of 12 mCi/m2 or higher once a week for 3 weeks reporting a median OS of 8.0 months versus 6.0 months at doses of 9 mCi/m2 or less, once a week for 3 weeks.

These encouraging results were updated at the 2011 Gastrointestinal Cancers Symposium, which is co-sponsored by the American Gastroenterological Association Institute, the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

At the Symposium, results from 50 evaluable patients were reported. The overall disease control rate for all dose groups, including those that received gemcitabine at greater than 200 mg/m2, was 60%, with 7 patients (14%) reporting a partial response by RECIST criteria (i.e., responses showing decreases in tumor size of more than 30% by CT and the absence of new lesions) and 23 patients (46%) with disease stabilization. Metabolic imaging with PET and the biomarker, CA19-9, both provided supportive evidence of anti-tumor activity.

Commenting on these encouraging results, Dr. Allyson Ocean of the new York Presbyterian Hospital, Weill Medical College of Cornell University, new York, NY, stated, “This is the first time we are reporting survival benefits with this antibody, which are significant in pancreatic cancer. Shrinkage of primary tumors in patients with advanced, inoperable pancreatic cancer is extremely rare. Equally important are improvements in quality-of-life, particularly in the reduction of pain, we have witnessed in our patients.”

to date, more than 70 patients with locally advanced or metastatic pancreatic cancer have been treated with the regimen involving Y-90-labeled clivatuzumab tetraxetan administered once a week for 3 weeks, in combination with gemcitabine. Treatments were well tolerated, including 16 patients retreated with 1-3 additional cycles, with few non-hematologic side effects. In spite of higher cumulative Y-90 doses, hematologic suppression was transient and occurred without major infections or bleeding events.

The open-label study is continuing with new patients enrolled to receive Y-90-labeled clivatuzumab tetraxetan at 12 mCi/m2 once a week for 3 weeks, and gemcitabine at higher doses, including the standard-of-care dose of 1000 mg/m2.

“We are pleased that clivatuzumab tetraxetan continues to produce encouraging results in this difficult-to-treat disease, and we look forward to evaluating this compound in randomized clinical trials,” remarked Cynthia L. Sullivan, President and CEO of Immunomedics. “We plan to complete this dose-escalation study shortly and to seek regulatory advice on protocols designed to determine response rates and overall survival for the future development of this agent,” added Ms. Sullivan.

The multicenter study includes physicians and staff from new York (New York Presbyterian Hospital, Weill Medical College of Cornell University), Delaware (Helen F. Graham Cancer Center at Christiana Care, Newark), Indiana (Goshen Center for Cancer Care), Florida (University of Miami Sylvester Comprehensive Cancer Center; Florida International University Herbert Wertheim College of Medicine, Miami), Ohio (Ohio State University College of Medicine, Columbus) and new Jersey (Garden State Cancer Center, Belleville; Immunomedics, Inc., Morris Plains).

About Clivatuzumab

Clivatuzumab or hPAM4 is a humanized monoclonal antibody targeting a mucin antigen expressed in most pancreatic cancers, but not pancreatitis, normal pancreas or most other normal tissues. Preclinical studies in mice with human pancreatic cancer xenografts given the murine version of Y-90 PAM4 demonstrated favorable tumor responses, which could be further improved when given in combination with gemcitabine. a prior Phase I single dose-escalation study of Y-90 clivatuzumab tetraxetan in treatment-relapsed pancreatic cancer patients has also produced encouraging results, with evidence of objective responses. The radiolabeled humanized antibody is currently in a Phase I/II fractionated dose-escalation study in combination with gemcitabine for the treatment of patients with newly diagnosed, untreated, stage III or stage IV cancer of the pancreas.

About Pancreatic Cancer

According to the American Cancer Society, pancreatic cancer is the fourth leading cause of cancer death in the United States. In 2010, an estimated 43,140 Americans were diagnosed with the disease, and about 36,800 patients died from it. it is often called a silent disease because it is difficult to detect and symptoms do not usually appear until the cancer has grown and often spread beyond the pancreas for quite some time. Pancreatic cancer is difficult to diagnose because there are no symptoms in the early stages and because, when symptoms appear, they can be confused with other diseases.

The treatment options depend on stage and location of the cancer, age, and general health of the patient. Potentially curative surgeries are performed when the cancer has started in the head of the pancreas (near the bile duct), which can allow earlier detection when bile duct blockage produces jaundice. Palliative surgery is a type of surgery chosen when the tumor is too widespread and is done to relieve the symptoms or complications caused by the cancer. if the cancer has not spread beyond the pancreas, therapy can be successful, but it is rare to find pancreatic cancer in the early stages. In later stages, various forms of chemotherapy or combinations of radiation and chemotherapy are given to try to control the disease, and ultimately therapy strives to comfort the patient and reduce pain.

About Immunomedics

Immunomedics is a new Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. we have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. we also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. we believe that our portfolio of intellectual property, which includes approximately 154 patents issued in the United States and more than 375 other patents issued worldwide, protects our product candidates and technologies. For additional information on us, please visit our website at immunomedics.com. The information on our website does not, however, form a part of this press release.

This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C -Six-month review date of May 23, 2011 set by FDA-

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the new Drug Application (NDA) for telaprevir and granted the company’s request for six-month Priority Review. Telaprevir is Vertex’s lead medicine in development for people with genotype 1 chronic hepatitis C. the FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. a target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA’s approval decision, which is four months earlier than the standard review time of 10 months.

Additionally, Vertex today announced the completion of a new Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.

In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.

“Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment,” said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. “We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C.”

Data to Support the Telaprevir Submissions

The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). in these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. the majority of these people were able to complete their course of treatment at six months – half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. 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 regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.

Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission.

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.

Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir 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.

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.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1 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,2,3,4 or viral cure.5 if treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10

Hepatitis C in the United States

Up to 3.9 million people in the United States have chronic hepatitis C and 75 percent of them are unaware of their infection.11 the majority of people with hepatitis C in the U.S. were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the U.S. and is reported to contribute to 4,600 to 12,000 deaths annually.7 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.10

Hepatitis C in Canada

Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected.12 three provinces account for 80 percent of hepatitis C infections in Canada: Ontario (42 percent), British Columbia (22 percent) and Quebec (16 percent).13 each year up to 5,000 people are newly infected with hepatitis C and in 2007 alone, nearly 8,000 people were infected.12, 13 in 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.14 by 2022, the number of hepatitis C-related deaths is expected to increase by one-third.15

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

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

Special Note regarding Forward-looking Statements

This press release contains forward-looking statements, including statements regarding (i) the FDA’s target review date for the telaprevir NDA, (ii) Priority Review in Canada allowing for faster review of new Drug Submissions, typically shortening the review time to approximately six to nine months and (iii) Vertex working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C. 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.

Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

About Vertex in Canada

In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the potential launch of telaprevir in Canada.

For more information and to view Vertex’s press releases, please visit vrtx.com.

Initiative announced on “The Oprah Winfrey Show” today

DEERFIELD, Ill.–(BUSINESS WIRE)–According to the American Heart Association, one in three U.S. adults has high blood pressure, making hypertension among the leading conditions that can be controlled or managed through early detection. Walgreens (NYSE: WAG)(NASDAQ: WAG) is now offering free blood pressure testing through Sunday at all Walgreens pharmacies and Take Care Clinics nationwide, as announced on “The Oprah Winfrey Show” today.

“It’s extremely important for people to know their numbers when it comes to blood pressure, because often times there may not be symptoms that alert you to a problem”

“It’s extremely important for people to know their numbers when it comes to blood pressure, because often times there may not be symptoms that alert you to a problem,” said Richard Ashworth, Walgreens vice president of pharmacy operations. “Hypertension is one of the most prevalent chronic conditions in our country today, and by offering free blood pressure testing at our more than 7,600 locations, we hope these services and interaction with our health care service providers encourage more people to make blood pressure monitoring a practice in managing their overall health.”

Blood pressure testing is available to adults ages 18 and over at all Walgreens pharmacies and Take Care Clinics today through Sunday, Jan. 16, during regular pharmacy and clinic hours. each test includes a free consultation from a Walgreens pharmacist or Take Care Clinic nurse practitioner. the free blood pressure tests are not being done for diagnostic or treatment purposes and recipients are encouraged to report results to their primary care provider.

For more information or to find the nearest participating location, visit walgreens.com/findastore.

More than 76 million people in the U.S. age 20 and older have high blood pressure, American Heart Association statistics show. of those, the association says about 22 percent are unaware of their condition, 69 percent are receiving treatment and only 45 percent have their blood pressure controlled.

About Walgreens

Walgreens (walgreens.com) is the nation’s largest drugstore chain with fiscal 2010 sales of $67 billion. the company operates 7,655 drugstores in all 50 states, the District of Columbia and Puerto Rico. each day, Walgreens provides nearly 6 million customers the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice in communities across America. Walgreens scope of pharmacy services includes retail, specialty, infusion, medical facility and mail service, along with pharmacy benefit solutions and respiratory services. These services improve health outcomes and lower costs for payers including employers, managed care organizations, health systems, pharmacy benefit managers and the public sector. Take Care Health Systems is a Walgreens subsidiary that is the largest and most comprehensive manager of worksite health centers and in-store convenient care clinics, with more than 700 locations throughout the country.

— 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.