SAN DIEGO, Calif.–(BUSINESS WIRE)–Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today reported results from the final five-year follow-up analysis of the international, multicenter, Phase III VISTA1 trial. The analysis assessed overall survival (OS) after treatment with VELCADE (bortezomib) in combination with melphalan and prednisone (VcMP) versus melphalan and prednisone (MP) alone, in patients with previously untreated multiple myeloma (MM) at a median follow-up of 60.1 months. The data were presented by Professor Jesús F. San Miguel, M.D., Ph.D., Hospital Clìnico Universitario de Salamanca, Salamanca, Spain, during an oral session at the 53rd annual meeting of the American Society of Hematology (ASH), held December 10-13, 2011 in San Diego, California. These long-term OS data were also the basis of the recent FDA-approved label update for VELCADE.

“Elderly patients with multiple myeloma strive for upfront therapy that will extend their lives”

“This VELCADE-based therapy resulted in an impressive 13.3-month increase in the median overall survival after five years of follow-up,” said San Miguel. “These data confirm that starting previously untreated multiple myeloma patients with the VELCADE based combination (VcMP) provided a significant survival advantage over MP, a recognized standard of care, that could not be regained despite the substantial use of novel agent based salvage therapies including VELCADE.”

The VISTA trial was conducted in 682 previously untreated MM patients ineligible for high-dose therapy, and compared VcMP versus MP treatment alone. The primary endpoint of the study was time-to-disease progression, and secondary end points for the study were: OS, progression free survival (PFS), response rates and safety. After a median follow-up of 60.1 months, median OS was 56.4 versus 43.1 months for patients randomized to VcMP and MP, respectively – a significant survival advantage of 13.3 months for the VcMP arm (p=0.0004). an exploratory analysis of the incidence rate of secondary primary malignancies (SPM) reported an exposure-adjusted incidence rate of 1.66 SPM per 100-patient-years for VcMP, and 1.30 SPM for MP alone.

“Elderly patients with multiple myeloma strive for upfront therapy that will extend their lives,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “Today’s VELCADE data confirmed the sustained clinical benefits, including overall survival and complete response, that VELCADE provided in patients with previously untreated MM.”

Continued overall Survival Benefit After 5 Years’ Follow-Up with Bortezomib-Melphalan-Prednisone (VcMP) Versus Melphalan-Prednisone (MP) in Patients with Previously Untreated Multiple Myeloma, and no Increased Risk of Second Primary Malignancies: Final Results of the Phase 3 VISTA Trial (Abstract #476)

The updated results showed:

• After a median follow-up of 60.1 months, median OS was 56.4 months in the VcMP arm compared to 43.1 months in the MP arm (HR 0.695, p=0.0004), reflecting a 13.3-month OS advantage
• among patients who received subsequent therapies, OS was significantly longer in patients who received VcMP upfront compared to those who received MP (median 55.7 vs. 46.4 months; HR 0.745, p=0.0162)
• Time to next treatment (median 27.0 vs. 19.2 months; HR 0.557, p<0.0001) and treatment-free interval (median 16.6 vs. 8.3 months, HR 0.573, p<0.0001) were longer with VcMP versus MP
• The exposure-adjusted incidence rate of 1.66 SPM per 100-patient-years for VcMP, and 1.30 SPM for MP alone

Patients were randomized (1:1) to receive nine 6-week cycles of VcMP (N=344; bortezomib 1.3 mg/m2, days 1, 4, 8, 11, 22, 25, 29, and 32, cycles 1–4, days 1, 8, 22, and 29, cycles 5–9; melphalan 9 mg/m2 days 1–4, prednisone 60 mg/m2, days 1–4, all cycles) or MP (N=338) alone. Patients were followed at least every 12 weeks for survival and subsequent therapy use. Data on SPM were collected by surveying all study sites to capture information for 655 (96 percent) patients.

Maintenance therapy with bortezomib plus thalidomide (VT) or bortezomib plus prednisone (VP) after induction with bortezomib, melphalan and prednisone (VcMP) or bortezomib, thalidomide and prednisone (VTP) in elderly untreated myeloma patients included in the GEM2005MAS65 Spanish randomized trial. (Abstract #477)

This Phase III trial in 260 elderly patients, with a median age of 73 years, was conducted by the Spanish Myeloma Group PETHEMA/GEM. The patients remained on maintenance therapy for up to three years. one third of the patients were over the age of 75. The updated results, presented by María-Victoria Mateos, M.D., Hospital Universitario de Salamanca, Salamanca, Spain showed:

• Maintenance therapy with VT or VP resulted in an increase in immunofixation-negative complete response (CR) rates from 24 percent after induction to 42 percent, after a median of 20 months of maintenance therapy
• At a median follow-up of 46 months, median PFS was 39 months for patients receiving VT maintenance and 32 months for patients receiving VP maintenance (p=0.1)
• Median OS for the VP arm was 60 months; median OS for the VT arm has not yet been reached at a median follow-up of 46 months since first randomization
• Most common grade ?3 adverse events in the maintenance phase were;
  • VT: Peripheral neuropathy (9 percent), GI symptoms (4 percent), asthenia and cardiac events (each 2 percent), neutropenia (1 percent)
  • VP: Peripheral neuropathy (3 percent), GI symptoms (0 percent), asthenia (0 percent), cardiac events (1 percent), neutropenia (0 percent)

Patients were randomized to receive six cycles of VMP or VTP as induction therapy followed by randomization to maintenance. Maintenance therapy included VELCADE 1.3 mg/m2 on day 1, 4, 8, 11 every three months for both arms, plus either thalidomide 50 mg daily for VT or prednisone 50 mg every other day for VP for up to three years.

About VELCADE

VELCADE is co-developed by Millennium and Janssen Pharmaceutical Companies of Johnson & Johnson. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen Pharmaceutical Companies of Johnson & Johnson are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 300,000 patients worldwide.

Important Safety Information

VELCADE® (bortezomib) is approved for the treatment of patients with multiple myeloma. VELCADE is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.

Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. Women should be advised not to take VELCADE while pregnant or breast-feeding. Patients with diabetes may require close monitoring and adjustment of their medication.

VELCADE can cause serious side effects, including:

• Lowering the levels of blood cells, which could result in a higher risk for infections or bleeding.
• Nausea, vomiting, diarrhea and constipation.
• Nerve problems, which can be severe including muscle weakness, tingling, burning, pain, or loss of feeling in the hands and feet.
• a drop in blood pressure resulting in dizziness, light headedness or fainting.
• Heart rhythm problems and heart failure including worsening of existing conditions. Symptoms may include chest pressure or pain, palpitations, swelling of the ankles or feet, or shortness of breath.
• Lung disorders, some of which have been fatal. Symptoms include cough, shortness of breath, wheezing or difficulty breathing.
• Liver failure including a yellow discoloration of the eyes and skin.
• Tumor Lysis Syndrome and Reversible Posterior Leukoencephalopathy Syndrome have been reported.

Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, insomnia and headache.

Additional information and full prescribing information is available at VELCADE.com.

Please see the full prescribing information for VELCADE including warnings and precautions.

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

Editor’s Note: This press release is also available under the Media section of the Company’s website at: millennium.com/InTheNews.aspx.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, inc. was acquired by Takeda Pharmaceutical Company ltd. in May, 2008. The Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, millennium.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. as the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, takeda.com.

1 (VELCADE as Initial Standard Therapy in Multiple Myeloma)

Photos/Multimedia Gallery Available: businesswire.com/cgi-bin/mmg.cgi?eid=50102746&lang=en

June 06, 2011 03:57 PM Eastern Daylight Time 

– Data show overall response rates of 55 percent; 37 percent in VELCADE refractory patients –

2011 ASCO Annual Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Millennium: the Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today reported results from two studies of VELCADE® (bortezomib) for Injection based combinations in patients with relapsed or refractory multiple myeloma (MM). the first study investigated the safety and efficacy of VELCADE in combination with LY2127399, a human monoclonal antibody. the second study assessed the safety and efficacy of VELCADE in combination with panobinostat. These data were presented at the annual meeting of the American Society of Clinical Oncology, held June 3 through 7 in Chicago, Illinois.

“These two studies provide encouraging evidence of VELCADE’s utility as a backbone for novel combinations”

“These two studies provide encouraging evidence of VELCADE’s utility as a backbone for novel combinations,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “We are especially pleased to see activity from VELCADE based combinations in these heavily pre-treated patient populations, including those who were refractory to VELCADE.”

Phase I study of LY2127399, a human anti-BAFF antibody, and bortezomib in patients with previously treated multiple myeloma

the primary objective of this Phase I study in 20 patients was to identify an efficacious dose of LY2127399 with VELCADE. Sixty-five percent of patients had received prior treatment with VELCADE. the results, which were presented by Noopur Raje, M.D., Massachusetts General Hospital, showed:

• the median number of cycles completed was 5, and no dose-limiting toxicities (DLTs) were observed
• the 100 mg dose of LY was selected for further study with VELCADE
• the most common grade 3/4 adverse events were thrombocytopenia (15 percent), neutropenia (10 percent), diarrhea (10 percent) and neuropathy (10 percent)
• Overall response rate (ORR) was 55 percent
• Ten percent of patients achieved a complete response (CR), 15 percent of patients achieved a very good partial response (VGPR) and 30 percent of patients achieved a partial response (PR)
• the median duration of response was 9.7 months

VELCADE was given at 1.3 mg/m2 IV on days 1, 4, 8, and 11 q21d and LY at 1, 10, 30, 100, or 300 mg IV (30 min) on day 1 in Cycles 1 – 3, and every other cycle thereafter. Corticosteroids were not allowed. Response was assessed per IMWG criteria and adverse events per CTCAE v3.0. Pharmacokinetics (PK) were assessed, and pharmacodynamic studies included B-cell immunophenotyping and serum markers of bone turnover. (Abstract #8012)

A phase Ib study of oral panobinostat and IV bortezomib in relapsed and refractory multiple myeloma

this Phase Ib study of 62 relapsed or relapsed and refractory multiple myeloma patients assessed the safety and efficacy of VELCADE in combination with panobinostat. Forty-five percent of patients had received prior treatment with VELCADE, and 31 percent were refractory to VELCADE. the results, which were presented by Jesus San Miguel, M.D., Ph.D., Hospital Universitario de Salamanca, showed:

• Maximum tolerated dose was established as 20 mg of panobinostat plus 1.3 mg/m2 of VELCADE
• the most common grade 3/4 adverse events were thrombocytopenia (79 percent), neutropenia (55 percent) and leukopenia (30 percent)
• across all dosing cohorts, ORR was 55 percent
• among VELCADE-refractory patients, ORR was 42 percent

this phase Ib study of relapsed or relapsed and refractory multiple myeloma completed enrollment (N=62) in Dec 2010 with 47 patients in the dose escalation phase and 15 patients in the dose expansion phase. in the dose escalation phase panobinostat was dosed orally 3 times/week (wk) in combination with VELCADE (IV Days 1, 4, 8, 11) in 21-day cycles (C). Dexamethasone was added for suboptimal response from C2 onwards. MTD was determined to be 20 mg panobinostat and 1.3 mg/m2 VELCADE. in the expansion phase, 15 patients received the MTD of panobinostat and VELCADE, with a modified panobinostat schedule (2 weeks on, 1 week off) and dexamethasone introduced for all patients at C2. this is identical to the dose and schedule in the ongoing phase II and III PANORAMA trials. (Abstract #8075)

About Millennium

Millennium: the Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, inc. was acquired by Takeda Pharmaceutical Company Ltd. in may, 2008. the Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, millennium.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. as the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, takeda.com.

About VELCADE

VELCADE is co-developed by Millennium and Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 230,000 patients worldwide.

Indications and important Safety Information (Patient)

What is VELCADE® (bortezomib) used for?

VELCADE is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of patients with mantle cell lymphoma (a cancer of lymph nodes) who have already received other treatments.

How is VELCADE administered?

VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. it is administered as an injection into your vein (IV) by a health care professional.

Who Should not Receive VELCADE?

Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. you should not receive VELCADE if you are:

• allergic to bortezomib, boron or mannitol
• pregnant or plan to become pregnant
• breastfeeding. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment.

the effects of VELCADE in children have not been evaluated.

What are the Possible Side Effects of VELCADE?

VELCADE can cause serious side effects including:

• Neutropenia (low levels of neutrophils, a type of white blood cell) and Thrombocytopenia (low levels of platelets). VELCADE can cause low levels of white blood cells (infection fighting cells) and/or platelets (clot-forming cells). you will have regular blood tests to check your cell counts during your treatment with VELCADE. if the number of these cells is very low, your doctor may change the dose and/or schedule of VELCADE. if your white blood cells become low, you can be at higher risk for infections. tell your doctor if you develop a fever or believe you have an infection. if platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion. There have been cases of bleeding in the stomach, bowels and brain during treatment with VELCADE.
• Gastrointestinal Problems. VELCADE treatment can cause nausea, vomiting, diarrhea, and constipation. if your symptoms are severe, your doctor may recommend IV fluids and/or medications.
• Peripheral neuropathy. VELCADE can cause damage to the nerves, a condition called peripheral neuropathy. you may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of VELCADE or stop it altogether.
• Low blood pressure. VELCADE can cause a drop in blood pressure. tell your doctor if you have low blood pressure, feel dizzy or feel as though you might faint. if you are taking drugs that lower blood pressure, your medications might need to be adjusted. if you are not drinking enough liquids, your doctor may need to administer IV fluids.

• Heart problems. VELCADE treatment can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.
• Lung Disorders. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. tell your doctor if you experience any cough, shortness of breath, wheezing or difficulty breathing.
• Liver disease. if you have liver problems, it can be harder for your body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease. in patients with moderate or severe liver disease, VELCADE should be started at a lower dose. Additional dose adjustments may be made based on your tolerance of the drug.
• Tumor Lysis Syndrome (TLS). TLS can occur with cancer treatments and your doctor will be monitoring blood and urine for any signs of this syndrome. if you develop TLS, your doctor will take appropriate steps to treat it.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS). There have been reports of a rare, reversible condition involving the brain called RPLS in patients treated with VELCADE. Patients with RPLS can have seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems. VELCADE treatment should be stopped in cases of RPLS.

the most common side effects seen in patients receiving VELCADE include: thrombocytopenia, neutropenia, nausea, peripheral neuropathy, neuralgia (nerve pain), pyrexia (high temperature), diarrhea, anemia, leukopenia (low levels of white blood cells), decreased appetite, fatigue, constipation, vomiting, dehydration, dyspnea (difficulty breathing), cough, asthenia (low energy), insomnia (trouble sleeping), peripheral edema (swelling of the limbs), and headache.

What other information should you discuss with your doctor?

you should also tell your doctor if you:

• have kidney disease. if you are on dialysis, your doctor will administer VELCADE after the dialysis procedure.
• are taking medication for diabetes. VELCADE can affect your blood glucose levels. Your doctor may require close monitoring of your blood glucose levels and change the dose of your diabetes medicine while you are being treated with VELCADE.
• have liver disease.
• are using medicines like ketoconazole (an anti-fungal) and ritonavir (an anti-viral), which will require close monitoring during treatment with VELCADE.
• are using any other medications (including over the counter drugs), herbal or dietary supplements, or holistic treatments.
• develop a rash of any type while receiving VELCADE.

the side effects of VELCADE may impair your ability to drive or operate machinery.

These are not all of the possible side effects with VELCADE. it is important to always contact your doctor if you experience any side effects while on VELCADE. if you have any questions about VELCADE, contact your doctor. Additional information and full prescribing information is available at VELCADE.com.

Please see the full prescribing information for VELCADE including warnings and precautions.

for more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

Editors’ Note: this press release is also available under the Media section of the Company’s website at: millennium.com/InTheNews.aspx.

March 01, 2011 07:54 AM Eastern Time 

– Top line results expected in fourth quarter 2011 –

BEDMINSTER, N.J.–(BUSINESS WIRE)–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”

“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.

Posted on 09/08/2010 in Pharmaceutical Company Product News

Shire has published data from a phase IIIb study of its attention deficit hyperactivity disorder (ADHD) drug Vyvanse, demonstrating its efficacy among adult patients.Results published in the medical journal Behavioral and Brain Functions showed that patients using the once-daily Vyvanse Capsule CII treatment benefited from improved attention spans between two and 14 hours after administering.it has previously been proven to offer similar benefits among children aged between six and 12 in previous clinical studies.Dr Matthew Brams, study author and clinical assistant professor of psychiatry at Baylor College of Medicine, said this illustrates the drug’s benefits for ADHD sufferers wishing to manage their symptoms during a working day.He added: “Because ADHD symptoms may extend into the evening for many adults, the availability of treatments that provide symptom improvement throughout the day is important.”Earlier this month, the company published phase III trial data for the hereditary angioedema Firazyr, illustrating its efficacy when compared to placebo.

Other news stories from 09/08/2010

Read more in the Zenopa News Archive

How this news is generated