ASTRAZENECA PRESENTS SATURN STUDY RESULTS AT AHA ANNUAL SCIENTIFIC SESSIONS
Date : 17th November 2011
AstraZeneca has presented at the American Heart Association Annual Scientific Sessions in Orlando, Florida, the full results from the SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN) study, which demonstrated that aggressive treatment with a statin can lower LDL-C (“bad” cholesterol) to an average of 70 mg/dL or less, increase HDL-C ("good" cholesterol) to an average of approximately 50 mg/dL, and reduce plaque in the arteries of the heart.
Treatment with CRESTOR (rosuvastatin) or atorvastatin for two years resulted in statistically significant regression in the primary efficacy measure, change from baseline in percent atheroma volume (PAV) in a =40 mm segment of the targeted coronary artery as assessed by intravascular ultrasound (IVUS). CRESTOR 40mg demonstrated a numerically greater reduction versus atorvastatin 80mg, but the difference between the two did not reach statistical significance (-1.22% vs. -0.99%; p=0.17).
For the secondary efficacy measure of normalized total atheroma volume (TAV), CRESTOR demonstrated a statistically significant reduction compared with atorvastatin (-6.39 mm3 vs. -4.42 mm3; p=0.01).
SATURN also demonstrated statistically significant differences between CRESTOR and atorvastatin in a pre-specified analysis of lipid parameters.
CRESTOR resulted in significantly lower LDL-C levels compared to atorvastatin (62.6 vs. 70.2 mg/dL, p<0.001). Significantly more patients taking CRESTOR achieved an LDL-C <70 mg/dL than those taking atorvastatin (72.1% vs. 56.1%, p<0.001). CRESTOR resulted in significantly higher HDL-C levels compared to atorvastatin (50.4 vs. 48.6 mg/dL, p=0.01). CRESTOR resulted in significantly lower total cholesterol levels compared to atorvastatin (139.4 vs. 144.1 mg/dL, p=0.006)
“These results are good news for patients with cardiovascular disease and provide further support of what we already know about CRESTOR,” said Howard Hutchinson, chief medical officer, AstraZeneca. “CRESTOR consistently and significantly lowers LDL-C, increases HDL-C and helps patients get to target LDL-C of less than 70 mg/dL. In addition, SATURN once again shows us that CRESTOR helps to reduce plaque build-up in the arteries.”
The safety and tolerability of both statins used in SATURN were in line with previous studies. Additional analyses from the SATURN study will be published in due course.
Atherosclerosis is the progressive buildup of plaque — made of cholesterol, fatty material and other substances— in the inner walls of the arteries. Elevated cholesterol and other risk factors can contribute to the disease process, which for many progresses silently, with no apparent signs or symptoms. Atherosclerosis can begin in early adulthood and continue to progress for the rest of a person’s life.
SATURN is a 104-week, randomized, double-blind, parallel group, multi-centre phase III b study of approximately 1,000 patients comparing the effects of treatment with rosuvastatin 40 mg and atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound (IVUS) in patients with coronary artery disease. The primary objective is to compare the effects of rosuvastatin with atorvastatin on the change in percent atheroma volume (PAV) of a coronary artery following 2 years of treatment. Secondary objectives include determining whether statin treatment is associated with regression of PAV, the effect of rosuvastatin and atorvastatin on total atheroma volume (TAV), lipids and lipoproteins, and safety and tolerability.
The SATURN study is part of AstraZeneca’s GALAXY Programme, a large, comprehensive, long-term and evolving global research initiative designed to address important unanswered questions in statin research and to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes. Currently, more than 67,000 patients have been recruited from 57 countries worldwide to participate in the GALAXY Programme’s robust clinical trials.
CRESTOR has now received regulatory approvals in over 109 countries. Worldwide, doctors have written nearly 330 million prescriptions for CRESTOR. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with that of other marketed statins.
INNOCOLL INKS PACT WITH MERUS LABS FOR DISTRIBUTION OF COLLAGUARD IN CANADA
Date : 17th November 2011
Innocoll Inc., a biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products, has entered into a license and distribution agreement with Merus Labs Inc. in Canada for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.
Dr Michael Myers, president and CEO stated, “We are pleased to announce the expansion of our partnership with Merus to include CollaGUARD and we look forward to the successful launch of the product in Canada.”
Ali Moghaddam, vice president at Merus Labs added, “Adhesions occur after most surgical procedures, and are of major clinical, social and economic concern. The addition of CollaGUARD to our portfolio means that millions of patients at risk of adhesion will have a clinically proven superior solution. We look forward applying for Health Canada approval and working with our key opinion leaders to launch this important product. CollGUARD will add significant scale to our women’s health portfolio.”
CollaGUARD is a transparent bioresorbable film of 100 per cent type I collagen developed using Innocoll’s proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and anti-adhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically.
CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain.
Merus is a specialty pharmaceutical company engaged in the acquisition and licensing of pharmaceutical products.
ALMIRALL INKS PACT WITH BIOFOCUS TO FIND NEW HIT COMPOUNDS AGAINST KEY TARGETS
Date : 17th November 2011
Spain-based Almirall SA and integrated drug discovery partner, BioFocus, has signed a collaboration agreement to find new hit compounds against key targets of interest to Almirall. These compounds will be used to support projects aimed at the treatment of respiratory and inflammatory conditions.
Under the terms of the collaboration, BioFocus will apply its screening technologies and compound collections to an undisclosed number of Almirall projects.
“We have been impressed by the depth of the BioFocus technology platforms, the size, content and diversity of the available compound decks and the obvious strength and experience of the scientists that will be engaged on our projects working on respiratory and inflammatory conditions,” said Dr Bertil Lindmark, CSO, executive director R&D of Almirall.
“We are delighted to form a drug discovery alliance with one of Europe’s leading research-based pharmaceutical companies,” added Dr Kate Hilyard, VP Biological Sciences, BioFocus.
Almirall is an international pharmaceutical company based on innovation and committed to health. It researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.
BioFocus provides integrated drug discovery that delivers pre-clinical drug candidates in all therapeutic areas with strong capability in neurodegenerative diseases, inflammatory diseases and with a growing track record of delivering candidates against rare and neglected diseases.
LUPIN'S JAPANESE SUBSIDIARY ACQUIRES I'ROM PHARMACEUTICAL
Date : 17th November 2011
Lupin acquires 100 per cent stake in I'rom Pharmaceuticals Co Ltd through its Japanese subsidiary Kyowa Pharmaceutical Industry Co Ltd from I'rom Holdings Co Ltd, an integrated Japanese healthcare provider. In a separate development, Kyowa has entered into a strategic alliance involving comprehensive operational support to be provided by I'rom Holdings site management organization subsidiary I'rom Co, Ltd for clinical studies conducted by Kyowa for the Japanese market. I'rom is known as the pioneer of the site management organization business in Japan, and the alliance seeks to utilize I'rom's expertise to support Kyowa.
Established in 1947, I'rom Pharmaceutical Co (IP) is a specialty injectables company headquartered in Tokyo. For the fiscal year ended March 2011, IP recorded sales revenues of JPY 5,361 million. IP has a significant presence in the DPC hospitals within Japan. Injectable products enjoy a significant usage in the DPC hospital segment, and generic injectable penetration is slated to grow significantly in future. There are currently over 1,400 DPC hospitals in Japan, covering over 35 per cent of all hospital beds nationwide, and a market size of USD11 billion.
Vinod Dhawan, president – Asia Pacific, Middle East, Africa and Latin America at Lupin, said, “Japan is a growth market of strategic focus for Lupin. IP's strong presence in the DPC hospital segment in Japan, through its line of injectable products, is an ideal fit with our existing oral business portfolio in Japan. The acquisition will not only strengthen our presence in the Japanese market but would also provide for a stronger growth footprint in this priority market.”
Ray Tsunoda, president and representative director of Kyowa, said, The acquisition will allow Kyowa and IP to leverage their strengths and competencies to create meaningful synergies that would augment Lupin's growth in the Japanese generics market. The success which Kyowa has experienced after becoming a part of the Lupin family will certainly be shared by IP.”
Toshinori Mori, representative director and chairman of I'rom Holdings Co, said, “In light of the success of Indian generic pharmaceutical companies across the world, going further it should be in the best interest of IP to pursue its ambitious growth strategies as a member of Lupin, one of the largest pharmaceutical companies in India. Meanwhile, IH continue to focus its management resources on reinforcement of clinical trial service business for major pharmaceutical companies including the Lupin group.”
“Our strategic alliance with Kyowa is an important stepping stone in our pursuit of providing comprehensive clinical trial services including BE studies to innovator and generic companies using I'rom's clinical sites infrastructure to become a leading site management organization in the Asia Pacific region.
EMA GRANTS ORPHAN DESIGNATION FOR AMT'S HAEMOPHILIA B GENE THERAPY
Date : 17th November 2011
he European Medicines Agency (EMA) has granted orphan designation for Amsterdam Molecular Therapeutics' (AMT), a leader in the field of human gene therapy, gene therapy programme for the treatment of haemophilia B.
Orphan designation in the European Union provides several benefits including 10 years of market exclusivity from product launch and access to the central authorization procedure.
AMT’s haemophilia B programme, which consists of an adeno-associated viral (AAV) vector containing the human factor IX gene, is being investigated in a Phase I/II study conducted by St. Jude’s Children’s Research Hospital (Memphis, USA) and University College London (UK). Promising data from an initial 6 patients shows that gene therapy administration resulted in a reduced need for protein replacement treatment, the standard care for haemophilia patients. AMT is preparing for additional clinical development work to establish safety, tolerability and proof-of-concept with a factor IX gene therapy produced using its proprietary AAV production system.
“Orphan designation is an important milestone for our haemophilia B gene therapy programme and will provide additional support to our negotiations as we seek potential licensing partners,” said Jörn Aldag, CEO of AMT. “A successful gene therapy for haemophilia could dramatically change not only the lives of patients but also the current haemophilia market that is dominated by protein replacement therapies.”
AMT is a world leader in the development of human gene based therapies. The company has a product pipeline of gene therapy products in development for haemophilia B, acute intermittent porphyria, Parkinson’s disease and SanfilippoB.
INNOCOLL INKS PACT WITH MERUS LABS FOR DISTRIBUTION OF COLLAGUARD IN CANADA
Date : 17th November 2011
Innocoll Inc., a biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products, has entered into a license and distribution agreement with Merus Labs Inc. in Canada for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.
Dr Michael Myers, president and CEO stated, “We are pleased to announce the expansion of our partnership with Merus to include CollaGUARD and we look forward to the successful launch of the product in Canada.”
Ali Moghaddam, vice president at Merus Labs added, “Adhesions occur after most surgical procedures, and are of major clinical, social and economic concern. The addition of CollaGUARD to our portfolio means that millions of patients at risk of adhesion will have a clinically proven superior solution. We look forward applying for Health Canada approval and working with our key opinion leaders to launch this important product. CollGUARD will add significant scale to our women’s health portfolio.”
CollaGUARD is a transparent bioresorbable film of 100 per cent type I collagen developed using Innocoll’s proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and anti-adhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically.
CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain.
Merus is a specialty pharmaceutical company engaged in the acquisition and licensing of pharmaceutical products.
AVI BIOPHARMA ENTERS COLLABORATION TO DEVELOP TWO ADDITIONAL EXON-SKIPPING PRODUCTS FOR DMD
Date : 17th November 2011
RNA-based therapeutics developer, AVI BioPharma, Inc., enters collaboration for the development of two additional exon-skipping drugs, one for exon 45 and one for exon 50, to support AVI's broad-based development programme for the treatment of DMD.
AVI's collaboration with Children's National Medical Center in Washington, D.C. and the Carolinas Medical Center (CMC) will support certain IND-enabling activities for an exon 45-skipping therapeutic.
The collaboration with the National Institutes of Health (NIH) will support IND-enabling activities for an exon 50-skipping therapeutic and will be supported through in-kind research conducted either by the Therapeutics for Rare and Neglected Diseases (TRND) programme or by contract research organizations. AVI is currently conducting a phase IIb trial of eteplirsen, its exon 51-skipping therapeutic candidate for the treatment of DMD.
"The initiation of these additional programs, with the financial support of, and in collaboration with, leading institutions, is a validation of AVI's exon-skipping drug platform and will help to accelerate the development of our DMD programme," said Chris Garabedian, president and CEO of AVI BioPharma. "These collaborations will lay the foundation for AVI's pan exon strategy for the development of therapeutics to treat a majority of the DMD population."
The collaboration with Children's National and CMC will be funded primarily through two grants, one from the US Department of Defense's (DoD) Congressionally Directed Medical Research Program to Children's National and the other from the National Institute of Neurological Disorders and Stroke to CMC. This funding is intended to pursue the most promising treatments for DMD. The collaboration will support a series of GLP toxicology studies for an exon 45-skipping drug candidate based on AVI's phosphorodiamidate morpholino oligomer (PMO) chemistry. The details of the research plan associated with this collaboration, as well as the details of the funding from the NIH and the DoD, will be finalized by the parties over the next few months.
"Children's National is committed to finding an effective treatment for Duchenne muscular dystrophy patients," said Eric Hoffman, PhD, Director of the Center for Genetic Medicine Research at Children's National Medical Center. "Working with partners like AVI and their PMO-based exon-skipping therapeutics may accelerate the clinical development of a specific exon 45-skipping therapeutic that could improve the care and quality of life for more boys with this disease."
Dr Qi Long Lu, director of the McColl-Lockwood Laboratory at Carolinas Medical Center, added, "A strong pre-clinical GLP toxicology package is a critical part of a robust drug development program. Our collaboration with AVI is designed to help support the IND-enabling work necessary to advance AVI's exon-skipping drug candidates into the clinic."
The TRND programme is a new initiative by NIH designed to assist in the development of new drugs for rare and neglected diseases. To develop new medicines, TRND establishes partnerships with leading academic, government, biopharmaceutical and patient advocacy groups to focus on the discovery, optimization and pre-clinical testing of new drugs. AVI was selected for the award through a national competitive process. Definitive details of the collaboration will be finalized upon execution of a Cooperative Research and Development Agreement (CRADA) between the two parties.
"TRND collaborates with researchers and companies with an aim of helping companies like AVI advance TRND's mission of accelerating the development of therapeutics for rare diseases like DMD," said John McKew, PhD, Chief of TRND's Therapeutic Development Branch. "TRND selected AVI because its innovative platform technology has the potential to move forward into later stage clinical trials in this disease for which there is little or no therapy."
SUDARSHAN SUKHANI OF TECHNICALTRENDS.COM ONE CAN SELL SUN PHARMA
Date : 17th November 2011
Sukhani told CNBC-TV18, "Sun Pharma not only fell yesterday, it’s been falling for the last three days. Normally after three days of decline the stock should recover. I don’t see that happening today for most of the market. If Sun Pharma were to break today then what we are seeing is a breakdown from a narrow trading range. It was already in a range, it did not participate in Dr Reddy’s, Cipla rally, so once it breaks a range we are looking at a fairly decent downside."
He further added, "Sun Pharma is something that we are selling because of an anticipated correction, it’s not in a bear market. There is a difference because when you are selling corrections you need to take profits and get out."
ADVAXIS LICENSES ANTIGEN FOR BREAST CANCER FROM UNIVERSITY OF PENNSYLVANIA
Date : 17th November 2011
Advaxis, Inc., a biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases, has licensed from the University of Pennsylvania, the use of antigen ISG15 in Advaxis’ Lm-LLO based immunotherapies. This intellectual property resulted from research conducted in Dr Yvonne Paterson’s laboratory that demonstrated ISG15 was an effective immunological target for the treatment of breast cancer in animal models.
“Targeting ISG15 may represent a therapeutic approach suitable for a population of patients with advanced breast cancer for whom few approved treatments currently exist. The research conducted by Dr Paterson and colleagues, as well as research conducted at other institutions, suggests that this antigen may have utility in treating other tumour types as well. ISG15 is Advaxis’ first proprietary antigen,” said Dr John Rothman, executive vice president, Science & Operations.
ISG15 is a novel protein associated with numerous cancers. Recently published data demonstrate that Advaxis’ Lm-LLO immunotherapy reduced primary and metastatic breast tumours in an animal model when directed against ISG15. “The Ubiquitin-like Protein, ISG15, is a Novel Tumour-Associated Antigen for Cancer Immunotherapy,” (Wood, LM, Pan, ZK, Seavey, MM, Muthukumaran, G, and Paterson, Y 2011, Cancer Immunol Immunother).
PROFIBRIX PHASE II TRIAL WITH FIBROCAPS MEETS PRIMARY ENDPOINT
Date : 17th November 2011
ProFibrix BV, a leader in the development of innovative products for haemostasis, has announced that its multi-centre phase II clinical trial with Fibrocaps in liver resection surgery resulted in a highly statistically significant 50 per cent reduction in mean time to haemostasis (TTH) compared to active control.
A total of 56 patients were enrolled in the company’s Dutch prospective, randomized, controlled, multi-centre phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The study results show that Fibrocaps has a very good safety profile along with rapid haemostatic activity that succeeds in significantly reducing mean time to haemostasis, the primary end point of the phase II trial.
Professor Dr R J Porte from the University Medical Centre Groningen, the Lead Investigator of the study, said: “We’re very pleased with the excellent performance of Fibrocaps in this phase II study. I have no doubt that the substantial reduction in mean time to haemostasis we report for Fibrocaps is clinically very meaningful, and demonstrates the strength of this unique dry powder formulation of fibrinogen and thrombin.”
Jan Öhrström, CEO of ProFibrix said: “Our clinical data constitute the strongest result ever reported for fibrin sealants in a phase II study in this indication. These positive results ensure that we remain on track to initiate a pivotal phase III trial in H1 2012, and target a BLA filing in 2013. In the coming months we expect to report on the results of the phase II trial we are running in parallel in the US. Altogether we believe that the positive outcome of the European and US studies should allow us to generate strong support from investors as we continue developing Fibrocaps and its line extensions.”
Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and haemostats: it is ready for immediate use, and is stable at room temperature.
The phase II clinical trial of Fibrocaps (FC-002 NL) was a prospective, randomized (2:1), single-blind, controlled study in 56 subjects undergoing liver resection surgery. The Dutch study was conducted at 5 sites, which included major medical centres in the Netherlands. Fibrocaps was considered to have a very good safety profile, with no adverse events attributed to Fibrocaps, which is consistent with the previously conducted Phase II study. The primary efficacy endpoint of the study was an intent-to-treat analysis of the mean TTH of Fibrocaps versus active control. The TTH means were 2.2 min for Fibrocaps (n=39) and 4.4 min for control (n=17) (p=0.004).
ProFibrix conducted the Fibrocaps phase II study in the Netherlands under a Clinical Trial Application (CTA) as required by the Dutch Central Committee on Research involving Human Subjects (CCMO).
ProFibrix leverages its expertise in fibrinogen technology to develop and bring to market innovative products for the haemostasis and regenerative medicine markets.
