pharmaceuticals

Getting Cheap Car Insurance Using an Online Quote Service

2008-09-23T09:44:00.001-07:00

Thinking about remewing you car insurance? If you are, perhaps you should consider sourcing for cheap car insurance quotes online. I will explain the benefits of doing so a little bit later. Quickly, let’s first look at the traditional method of selecting car insurance.

Before the days of the World Wide Web, buying car insurance was a tedious and cumbersome process. To begin with, you needed to seach through the yellow pages to find a list of insurance companies. And from this list, you then had to then contact each one of them and go over the same basic criteria, such as driver and car details. This was typically done over the phone or sometimes by fax.

Once the insurance companies had your details, they would then send or call you with the quote, this could be sometime later. Only then could you start comparing the actual prices and choose the insurance company that offered the best car insurance deal for your needs.

Ringing around for car insurance quotes is just too time consuming, people don’t have the time these days. Just imagine having to contact over eighty different car insurance suppliers to get quotes… how long would that take! Because of time constaints most people actually just contacted two or three companies, and made do with the best quote from those two or three. The end result was that they missed the opportunity to capitalise on the best car insurance deals in the market.

I am happy to say, all this has now changed.As the Internet has evolved, many interactive websites are now available to automatically provide car insurance quotes. These websites have a wide network of car insurance suppliers in their database, and they are able to provide quotations in a few seconds with just a few simple clicks. You can save a lot of time and effort by using an online quotation service which saves you from having to contact the individual insurance companies yourself. From a single point of contact, you can now source up to eighty individual quotations, all at the same time. The end result is that you get all the policy details and price in a matter of minutes.

The fact is, car insurance companies really prefer that you request car insurance quotations online. Online quotations lead to tremendous cost savings for the car suppliers due to reduced administrative and labor costs. There is no need for call centers to deal with telephone quotes. Discounts are often available as insurance companies often pass on their savings. These discounts encourage consumers to request quotations online whenever possible. The whole buying process is streamlined, much quicker, and hassle free.

Finally, when visiting a insurance car quotes webbsite, remember to prepare the necessary information required beforehand. The basic information that is usually required will be your name, contact details, age, driving record, and make and model of your car. Just enter the required details when prompted, and you will immediately receive the best quotes available.

Source : mylittleautoshop.com

Ground Zero Pharmaceuticals Announces Expansion Of Regulatory Consulting Services To South Africa

2007-10-12T02:42:00.000-07:00

The advent of biosimilar drugs, new combinations of old ingredients and clinical trial failures in Phase 3 have required new emphasis on "doing it right, the first time." Better use of resources, carefully selected outsource partners and wise allocation of funding lead to fewer failed products in late stages and more success with the FDA review process.

In 2007 GZP added its first South African clients while dramatically increasing the number of Australian and US firms and programs that it represents to the FDA, for mid-discovery through full-scale clinical development and approval.

Several INDs that GZP created and submitted in 2006 received a first-cycle clearance to proceed with clinical trials. A number of pre-IND and end of Phase 2 meetings with the FDA led to successful acceleration of drug and biologic development programs for our clients. Special Protocol Assessments (SPAs) for Phase 3 programs have been submitted and successfully negotiated with the Agency, as well as Orphan Drug and Fast Track status requests. The firm is under contract for two electronic (eCTD) BLAs and three eCTD NDAs and expects additional such programs to be initiated in 2008.

According to Evan Siegel, Ph.D., President and Chief Executive Officer, "The additional resources, combined with zero turnover of our people, allow us to preserve continuity with our long-term clients and to offer the same level of expertise, commitment and rapid turnaround to our new clients. We continue to enjoy the privilege of working with new additions to drug and biologic pipelines while bringing our more than 400 aggregate years' experience in medical product development to bear on the programs of firms new to our partnership. We believe more than ever that bringing regulatory excellence to the table at the beginning of a program, combined with efficient and knowledgeable project management and technical expertise in all disciplines, can launch or re-launch a product into the FDA arena in a highly effective manner."

With GZP's wholly owned Australian subsidiary, Ground Zero Pharmaceuticals Pty Ltd. reaching its first anniversary, Dr. Sandra Webb, Executive Director, is optimistic about the growth in Australia stating, "More and more small biotech companies with early stage development products are realizing the value of collecting only necessary and sufficient data from the outset for timely discussions with the FDA at the key strategic points in their development plans."

In related developments, GZP has augmented its staff in the Regulatory, Project Management, and scientific areas to further improve its efficiency in handling the increased workload attendant to the growth of both its client base and new programs. Evan Siegel, Ph.D., President and Chief Executive Officer has been regularly lecturing as an Adjunct Professor at the University of Queensland in Brisbane, Australia and will be delivering several lectures at the University of Pretoria in South Africa this month. We expect that this will create new opportunities for client training in the coming years.

Therapeutic areas covered by GZP's services include cancers of both hard and soft tissues, AIDS, antiinfectives and antivirals, medical imaging, dermatological disorders such as psoriasis, acne, rosacea, erythema and herpes, anti-inflammatory/analgesics for rheumatoid arthritis, osteoarthritis and SLE, vaccines, coagulation disorders, wound healing, cardiovascular conditions, emergency plasma volume expansion, gastrointestinal disorders, hematological illness, and serious neurological disorders such as Stroke, Peripheral Arterial Occlusion, Parkinson's disease, and Alzheimer's disease.

Based in Irvine, a major center of biotechnology innovation in Southern California, Ground Zero Pharmaceuticals, Inc. is a regulatory affairs and product development consulting firm providing strategic and tactical support to the pharmaceutical, biologics, biotechnology and medical device industries. Some of its service portfolio includes regulatory representation and submissions (paper and electronic), preclinical planning, clinical consulting, biostatistics, chemistry, manufacturing and controls consulting, and medical writing. The GZP core team is located internationally, throughout the US, Canada, Australia and Europe.

For further information please contact Ms. Tisha Templeton, Vice President of Finance and Operations, Ground Zero Pharmaceuticals, Inc., +1-949-419-6136, fax, +1-949-852-3655, ttempleton@groundzerous.com.

Source: Ground Zero Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. Announces Eight Abstracts on Ferumoxytol to Be Presented at Upcoming American Society of Nephrology Meeting

2007-10-12T02:38:00.000-07:00

AMAG Pharmaceuticals, Inc. Announces Eight Abstracts on Ferumoxytol to Be Presented at Upcoming American Society of Nephrology Meeting

(Nanowerk News) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today announced that eight abstracts on ferumoxtytol, its lead product candidate, have been accepted for presentation at the American Society of Nephrology (ASN) meeting to be held in San Francisco, CA, November 1-5, 2007.
At the ASN meeting, results will be presented on ferumoxytol, the Company’s lead product candidate, which has been studied for use in the treatment of iron deficiency anemia in chronic kidney disease (CKD) patients. The results will include new data evaluating the safety and efficacy of ferumoxytol in CKD patients on hemodialysis, updated data evaluating the safety and efficacy of ferumoxytol in non-dialysis CKD patients, a preclinical biodistribution study, a plasma pharmacokinetic profile of ferumoxytol and a pharmacoeconomic profile comparing the use of ferumoxytol to oral iron. Full abstracts are available on the ASN website at www.asn-online.org.
“We are very excited to share additional data on ferumoxytol at the ASN meeting this year,” stated Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG Pharmaceuticals. “We are focused on bringing this new therapy to all CKD patients and remain on track to file our NDA for ferumoxytol as an intravenous iron replacement therapeutic in CKD patients during the fourth calendar quarter of this year.”
The following abstracts will be presented as posters at this year’s ASN meeting:
# R. Provenzano, et al. “Intravenous Ferumoxytol as Two IV Push Doses of 510 mg for Iron Replacement in Hemodialysis Patients”, Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0858b).
# R. Provenzano, et al. “Comparison of Two Regimens of Ferumoxytol for Treating Iron Deficiency Anemia in Hemodialysis Patients”, Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0859b).
# J. Lewis, et al. “Biodistribution of 59Fe-Labeled Ferumoxytol into Red Blood Cells Following Intravenous (IV) Administration in Rats”, Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0848).
# A. Singh, et al. “Safety of Ferumoxytol as Intravenous (IV) Iron Therapy for Iron Deficiency Anemia”, Friday, November 2, 2007, 10:00 am - 12:00 pm PT (Poster F-P0857).
# W.K. Bolton, et al. “Ferumoxytol as an IV Iron Replacement Therapy: Efficacy Results from Two Phase III Studies in Subjects with Chronic Kidney Disease (CKD)”, November 4, 2007, 10:00 am -12:00 pm PT (Poster SU-P0798).
# A. Besarab, et al. “Ferumoxytol as an Intravenous Iron Replacement Therapy: Safety Results from Two Phase III Studies in Subjects with Chronic Kidney Disease (CKD)”, Sunday, November 4, 2007, 10:00 am - 12:00 pm PT (Poster SU-P0805).
# B. Spinowitz, et al. “Achievement of Target Hemoglobin with Ferumoxytol versus Oral Iron in Anemic CKD Patients”, Sunday, November 4, 2007, 10:00 am - 12:00 pm PT (Poster SU-P01031).
# A. Pai, et al. “Plasma Pharmacokinetic (PK) Profile of Ferumoxytol in Healthy Subjects”, Sunday, November 4, 2007, 10:00 am - 12:00 pm PT (Poster SU-P01032).
About Ferumoxytol
Ferumoxytol, the Company’s lead product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease patients.
The Company plans to file an NDA for marketing approval of ferumoxytol with the U.S. Food and Drug Administration during the fourth calendar quarter of 2007. The Company has previously released data on all four planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. For further information about AMAG Pharmaceuticals please refer to http://www.amagpharma.com.
Combidex®, the Company’s other product under development, is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with MRI to aid in the differentiation of cancerous from normal lymph nodes. In March 2005, the Company received an approvable letter from the FDA with respect to Combidex, subject to certain conditions.
Forward-Looking Statements
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements of our intent to bring ferumoxytol to CKD patients and that we are on track and plan to file an NDA for ferumoxytol with the FDA during the fourth calendar quarter of 2007, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to successfully complete the development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to deficiencies in the design or oversight by us of these trials, the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, inadequate performance by third-party service providers, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) the possibility that we may not be able to obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or we may not obtain such approvals in a timely manner; (3) the fact that we have limited sales and marketing expertise; (4) uncertainties relating to our patents and proprietary rights; and (5) other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

RSS feed for China-AsiaStocks.com:

2007-10-12T02:37:00.000-07:00

RSS feed for China-AsiaStocks.com:

InvestorIdeas.com and China-AsiaStocks.com, its investor and industry portal focused on the China-Asia sector, announce China-based pharmaceutical company, Benda Pharmaceutical, Inc. (OTCBB: BPMA), as a new showcase company. Benda is involved in the production of both conventional and Traditional Chinese Medicines and most notably is responsible for the production of Gendicine®, the world’s first commercialized gene therapy medicine for the treatment of cancer.

China, a nation that is facing escalating cancer rates, heart disease and an aging population, is currently exploring options for significantly reforming its health system in an effort to provide improved access to affordable health treatment and services. The Country’s healthcare challenges have been driving growth in its pharmaceutical and biotech market, leading many to believe that China has the potential to become the world’s fifth largest drug market by 2010.

Benda Pharmaceutical owns and operates five plants combining to produce more than thirty medicines and medicine ingredients, including the addition of the gene therapy cancer medicine, Gendicine®, acquired through its purchase of SiBiono Genetech Corp, the developers of this promising treatment.

According to the Company, Gendicine®, supplemented by radiotherapy, chemotherapy or heat treatment, raises treatment efficacy to 3x that of all other tumor treatment methods. In clinical trials for 135 patients affected by head and neck tumors, 64% had their tumors eliminated after one month of Gendicine® treatment, marking a 340% increase in efficacy relative to traditional treatments.

Benda Pharmaceutical is working to build their presence within the fast growing Chinese market and forecasts that Gendicine® will generate $20.8 million in revenue in 2008 up from estimates of $12 million for 2007. In total, the Company anticipates revenues to reach $40.7 million in 2007 and progressing upwards to $76.2 million in 2008.

For Additional Information Visit: http://www.investorideas.com/co/bpma/

Benda Pharmaceutical Inc. is a Showcase Company on InvestorIdeas.com. Compensation is disclosed in disclaimer below.

About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing covering over thirty industry sectors and global markets including China, India, Middle East and Australia. China-AsiaStocks.com is an investor portal within InvestorIdeas.com covering news and market info, as well as a growing directory of stocks in the sector.

InvestorIdeas.com Disclaimer: www.InvestorIdeas.com/About/Disclaimer.asp. Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. Benda Pharmaceutical, Inc. (OTCBB: BPMA) $4000USD per month.

Indian pharmaceuticals – Targeting the poor sweetens the profits pill

2007-10-12T02:36:00.000-07:00

Indian pharmaceuticals – Targeting the poor sweetens the profits pill

Ethical Corporation, 11 October 2007 - Indian pharma multinational Dr Reddy's chief executive G V Prasad says that patient needs and shareholder value go hand-in-hand “Our vision for the next five years is to ensure that no patient goes without treatment because one is not able to afford it.” A statement from a healthcare charity organisation? No, it is from the head of a pharmaceutical company.

Meet G V Prasad, chief executive of Dr Reddy's Laboratories, a $1.6 billion Indian multinational that has operations in more than 100 countries. It is India's most profitable pharmaceutical company.

Prasad believes it is possible for a pharmaceutical company to model itself around sustainability. Making medicines accessible, affordable and developed to satisfy unmet patient needs does not necessarily conflict with shareholder interests, he says.

Cancer treatment is an area where Dr Reddy's is making drugs more accessible. The company this year launched its own, generic, version of Roche's blockbuster drug Rituximab, which sells at half the price of the original. Reditux, as Dr Reddy's version of the drug is known, is used to treat non-Hodgkin's lymphoma, a type of cancer that attacks white blood cells. The company plans to market Reditux in all markets including the US and Europe.

At $600 per vial, the price of Reditux is still steep for many in India, where about 40,000 patients have been diagnosed with non-Hodgkin's lymphoma. To make it accessible for the poor, the company has launched a project called Sparsh – which translates as “touch” – where it sets aside a certain volume of production to be freely distributed to those who cannot afford it. All a patient needs is a recommendation from a doctor to receive free medication.

Cardiovascular diseases are another area where Dr Reddy's wants to make treatments cheaper. Through its Little Red Heart Pills project, it is developing a combination pill – combining five ingredients into one pill – for secondary prevention of heart attacks. Aside from slashing production costs, a single pill will increase “patient compliance” as individuals will not have to remember to take five different tablets. The cost of the pills? One rupee (2.5 US cents) each.

Dr Reddy's hopes to launch the heart disease drug later this year, making it available in developed and developing markets. Prasad says: “We have spent considerable resources to develop this medicine even though it cannot be patented. However, it supports our sustainability thinking and business model of offering affordable drugs for the masses.”

The company has collaborated with the University of Auckland, New Zealand, for trials, partially funded by the Health Research Council of New Zealand. New Zealand's high commissioner to India, Graeme Waters, says: “This project has the possibility of revolutionising an important aspect of healthcare in both developing and developed countries.”

Price advantage

As heart disease rates rise, investment in developing a cheaper cardiovascular treatment makes business sense for the company. A low-cost drug would mean competitive advantage in this growing market. The World Health Organisation projects that cardiovascular diseases will kill almost 20 million people a year worldwide by 2015. India alone reports 2.8 million deaths a year from cardiovascular ailments. Cheaper drugs could save many of these lives.

Developing generics and active pharmaceutical ingredients (APIs) can help find lower-cost alternative drugs. Few companies invest in these initiatives because patent protection is not available for such products. However, Dr Reddy's believes these drugs are strategic to its gaining cost-competitiveness in the marketplace – the company can profit by selling high volumes. Dr Reddy's has built up a wide portfolio of APIs – one of the largest in the world – backed by a global team of 1,700 staff.

Apart from generics and APIs, the company has an impressive performance on the research and development front. In 2005-06, the company spent $52 million (9% of sales) on R&D, making it the largest spender in India.

Developing affordable drugs is the most effective way for Dr Reddy's to enhance its reputation. But community investment can help. The company's flagship initiative is an employee volunteering programme with child development agency Naandi. As India's largest non-governmental organisation, with an annual budget of $30 million and 200 full-time professionals, Naandi operates in more than 20,000 villages, providing free mid-day meals, tuition and healthcare for state school children, who are often underprivileged.

Naandi chief executive Manoj Kumar says Dr Reddy's leadership has displayed a “consistent commitment to addressing larger social concerns such as child development, education, drinking water and livelihood generation for rural youth and tribal farmers”. This, he says, differentiates the company from many other large Indian firms. The company is one of the few in the country to produce an annual sustainability report following Global Reporting Initiative guidelines.

Prasad says: “Investment in social initiatives is not huge. We spend about 2% of profits. It's a little cost to us, but it makes a big impact on society.”

Dr Reddy's at a glance

* Second largest pharmaceutical company in India.
* Fourth largest branded generics player in Germany.
* 11th largest finished dosage player in India.
* 18th largest pharmaceutical company in Russia.
* Among the largest API players in India and the US.
* Among the top five in the US in terms of ANDA and DMF pipeline.
* Among the largest players in the custom pharmaceutical services segment.
* North America (44% of Dr Reddy's sales) is the company's largest market followed by Europe 23% and India 14%.
* The first Asia-Pacific company outside Japan to list on the New York Stock Exchange.

Elekta: FINDING HOPE FOR AUTISM - NEW BRAIN RESEARCH TECH...

2007-10-12T02:34:00.001-07:00

Elekta: FINDING HOPE FOR AUTISM - NEW BRAIN RESEARCH TECH...

FINDING HOPE FOR AUTISM - NEW BRAIN RESEARCH TECHNOLOGY CENTRE OPENED BY HRH PRINCESS ANNE

PRESS RELEASE Stockholm, Sweden, October 12, 2007

The Oxford Neurodevelopmental Magnetoencephalography (MEG) Centre, featuring advanced new Elekta Neuromag® technology for the investigation of autism, has been officially opened today at the University Department of Psychiatry, Warneford Hospital, in Oxford, United Kingdom by HRH Princess Anne, The Princess Royal.

The Centre is the world's first purpose-built facility specialising in the study and research of autism and other neurodevelopmental disorders, and utilizes state-of-the-art MEG technology from Elekta. The new Centre offers an important resource for a wide community of clinicians and neuroscientists studying both normal and abnormal brain development and function.

Elekta is the world leader in advanced non-invasive technology for diagnosing and treating brain disorders with unparalleled experience in the development of magnetoencephalography (MEG) systems.

With its Elekta Neuromag MEG system, the Centre will enable the non-invasive registering of nerve cell activity in the brain in real time. The uniquely sensitive Elekta MEG technology will allow doctors and researchers to measure the intensity of extremely weak magnetic fields generated by electrical activity in the brain. This diagnostic tool increases the ability to understand and to improve treatment of functional disorders, such as autism spectrum disorders (ASD).

"The brain is the most complex structure in the human body", explains Professor Anthony Bailey at The University of Oxford's Department of Psychiatry. "In the investigation and treatment of brain disorders, whether it is tumors, neurodegenerative diseases or functional disorders, it is of utmost importance to gather as much information as possible about the individual patient's brain."

The missing piece of the puzzle

"Until now, we have not had a good enough tool to combine information about temporal and spatial localization of relevant functional centers in the brain. Using MEG technology, we can determine the function of different parts of the brain for each specific patient in the current stage of his or her development. This information can give us an important piece of the puzzle for diagnosing and plan treatment for patients with brain disorders or related diseases," says Professor Bailey.

"MEG technology is considered as one of the most exciting developments in neuroscience today. This new MEG center is step furhter in that progress", says David Miles at Elekta Ltd, Managing Director, Business Unit UK

Higher sensitivity for better results

Elekta Neuromag with 306 MEG-channel sensor array offers a higher density than any other system on the market. With better overall coverage of the brain, the system is able to register a greater degree of brain activity then other MEG systems.

Elekta is currently also focusing on research programs for non-invasively locating epileptogenic zones, since MEG has proven useful for locating these zones in relation to other functionally important areas of the brain. It is believed that MEG technology increasingly will be used to localize functional targets prior to non-invasive radiosurgery as well as conventional neurosurgery, which is an increasingly common alternative for patients with drug-resistant focal epilepsy.

Ongoing research and development in other areas include cerebrovascular disease and mild brain trauma; psychiatric disorders, such as schizophrenia and depression; learning disorders, such as dyslexia; as well as normal cognitive functions underlying memory and language.

******

For further information, please contact:

Elekta Ltd, UK: David Miles, Business Unit Manager UK, Elekta Ltd. Tel: +44 771 4159871 (mobile), e-mail: david.miles@elekta.com MEG Inquiries: Michael Enwall, Product Marketing Director, MEG +46708166660 (mobile), e-mail: michael enwall@elekta.com Investor inquiries: Peter Ejemyr, Group VP Corporate Communications, Elekta AB Tel: +46 733 611 000 (mobile), e-mail: peter.ejemyr@elekta.com

About Elekta

Elekta is an international medical technology group, providing oncologists, radiation therapists, neurosurgeons and many other medical specialists with state of the art tools to fight serious disease.

Elekta provides advanced clinical solutions, comprehensive management and information systems as well as services for improved cancer care and management of brain disorders.

Elekta's systems and solutions are used in over 4,500 hospitals around the world. Clinical information management solutions include, among others, Leksell Gamma Knife® for non-invasive treatment of brain disorders, Elekta Axesse and Elekta Synergy® for stereotactic and image guided radiation therapy and radiosurgery and the MOSAIQ suite of software for image-enabled EMR and efficient management of clinical and patient data.

With over 2,000 employees globally, the corporate headquarter is located in Stockholm, Sweden and the company is listed on the Nordic Exchange under the ticker EKTAb. More information about Elekta can be found at www.elekta.com.

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Peregrine Pharmaceuticals Doses First Patient in Clinical Trial of Bavituximab in HCV Patients Co-Infected With HIV

2007-10-12T02:34:00.000-07:00

Peregrine Pharmaceuticals Doses First Patient in Clinical Trial of Bavituximab in HCV Patients Co-Infected With HIV

New Trial in Important Patient Subgroup Will Assess Safety and Anti-Viral

Activity -

TUSTIN, Calif., Oct. 10 /PRNewswire-FirstCall/ — Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted therapies for the treatment of cancer and hepatitis C virus infection (HCV), today announced that the first patient has been dosed in a clinical trial designed to evaluate the safety and pharmacokinetics of bavituximab in patients co-infected with HCV and the human immunodeficiency virus (HIV). The multi-center trial is being conducted initially at Saint Michael’s Medical Center in Newark, NJ under the guidance of Dr. Stephen Smith, director of the Peter Ho Memorial Clinic, the largest HIV/AIDS treatment facility in the state.

“We are delighted that patient treatment has begun in this important clinical trial that was designed to evaluate an extended bavituximab treatment schedule in an important HCV patient population,” said Steven W. King, president and CEO of Peregrine. “We believe that bavituximab has the potential to act on both HCV and HIV infections, and this trial gives us our first opportunity to assess the drug’s anti-viral activity in this underserved group of patients.”

This open-label, dose escalation study will be conducted in approximately 24 patients chronically infected with HCV and HIV. Patient cohorts will receive ascending dose levels of bavituximab weekly for up to eight weeks. HCV and HIV viral titers and other biomarkers will be evaluated, although they are not formal study endpoints.

In the United States alone, an estimated 300,000 individuals are co-infected with HCV and HIV, representing up to 30% of all HIV-infected patients. Co-infected patients have been shown to have a lower response to current HCV treatment regimens and the adverse effects of these regimens can be especially problematic for some HIV patients.

Bavituximab is a monoclonal antibody in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses, including both HCV and HIV. Bavituximab helps stimulate the body’s immune defenses to destroy both the virus particles and the infected cells. Since bavituximab’s PS target comes from the host and not the virus, bavituximab may be less susceptible to the development of anti-viral resistance. Peregrine has completed two bavituximab Phase l monotherapy clinical trials in patients with chronic HCV infection. In these trials, the drug appeared safe and well tolerated with encouraging signs of anti-viral activity.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection in the U.S. and India with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the results from the co-infected HCV/HIV clinical trial will not be consistent with the results from the Company’s prior HCV clinical trials and the risk that bavituximab will not be as effective as the current standard of care for co-infected patients. It is important to note that the Company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2007 and the quarterly report on Form 10-Q for the quarter ended July 31, 2007. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

Contacts:

GendeLLindheim BioCom Partners

Investors Media

info@peregrineinc.com Barbara Lindheim

(800) 987-8256 (212) 918-4650

MAP Pharmaceuticals Raises $60 Million In IPO

2007-10-12T02:30:00.000-07:00

MAP Pharmaceuticals Raises $60 Million In IPO
Tuesday, October 09, 2007 5:00:00 AM PDT | VentureDeal Staff
MOUNTAIN VIEW, CA -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) publicly traded it shares for the first time, raising $60 million in gross proceeds from its IPO.

MAP is developing its proprietary Tempo Inhaler platform, a pressurized metered-dose inhaler (pMDI) that's designed to help deliver respiratory and systemic drug therapies via the pulmonary tract.

The company's investors included the D.E. Shaw Group, Perseus, LLC, Pequot Ventures, Skyline Ventures and Bay City Capital.

Female Hair Loss Caused by Pharmaceuticals and Treatments

2007-10-12T02:23:00.002-07:00

Female Hair Loss Caused by Pharmaceuticals and Treatments

Hair loss is devastating no matter what the reason, but when one’s medication is the culprit - it may be even more difficult to understand. This is often a real concern for anyone who is diagnosed with cancer, as chemotherapy and radiation treatments are the most common cause of this type of hair loss. However, this type of hair loss also affects patients with thyroid disease and young girls who are taking birth control. Though hair loss cased by medicine can affect anyone with a serious illness, it is more prevalent in women and children. breast cancer gifts The reasons for this are that female breast cancer and Leukemia are the two most common types of cancer and both are treated with the use of chemotherapy and radiation. Women are at the greatest risk because they are also more susceptible to thyroid disease. breast cancer gifts In addition, a woman may lose her hair from a strong form of birth control. As you can see, women have a higher risk of receiving one of the many harsh medicines that cause hair loss. Among the medicines known to cause hair loss, chemotherapy is probably the best known. breast cancer gifts This treatment is used to fight the late stages of cancer and can cause a drop in red blood cells, hair loss, and a weakened immune system. This type of medicine is often used in the treatment of Leukemia and breast cancer, the two most common forms of cancer. Radiation treatments and radio active medicines are the next most common medicines known to cause hair loss. These treatments are used in cancer and thyroid patients and target a certain area of the body with a large amount of radiation (meant to kill harmful cells). buy soma online Due to the extreme amount of radiation, hair loss is almost inevitable when using these types of treatments. If you or someone you know isolates themselves from society because of their hair loss, contact a counsellor and become part of a support group. buy propecia While losing one’s hair due to the medicine they are on may be devastating, it is important to remember that this is only a temporary stage of your life.

News/ general information

2007-10-12T02:23:00.001-07:00

I am in the middle of a longish post on another case/ drug situation which involves reading multiple documents. So, for regular visitors, here is a snippet of news in the pharma world:

a) US Biogenerics -- not an easy sail:

Not all is well with the generics groups in the US on the biogenerics front. Specifically, a provision of that legislation providing brand name sponsors with additional exclusivity periods for certain product improvements, such as new indications and structural modifications, has been questioned by the generics industry. A similar two-tier exclusivity paradigm is currently in place for drug products approved under the FDC Act, where innovators can obtain 5-year new chemical entity exclusivity and 3-year exclusivity for certain product improvements.

Generics want lowering of the 12-year exclusivity period in S. 1695 in exchange for providing a period of “new use” exclusivitywhile Innovator companies want to stick with the 12-year period agreed to under S. 1695.

Here is the link for the Bill:

As is normal in the US discussion, hectic lobbying is going on from both sides. For e.g. some House Members have sent a letter to the Chairman of the House Energy and Commerce Committee and the Senate HELP Committee.
Link:

b) Europe: Biosimilars

On the other side of the Atlantic, the EMEA is moving ahead with steps in this regard.

It recently released a paper answering some questions on biosimilar products.
Link:

c) Roche recalls Viracept [Nelfinavir]:
Roche has recalled its ARV drug Viracept in countries outside the

United States

Canada

, and

Japan

due to contamination with a harmful substance.
Roche has said that patients who may have been exposed will be closely monitored while more information on the harmful potential of the contaminant is gathered.
The European Medicines Agency (EMEA) has recommended to the European Commission that Viracept’s marketing authorisation be suspended.

News- Viracept Europe & Novartis's bad luck

2007-10-12T02:22:00.002-07:00

I had mentioned briefly Viracept's contamination at Roche's facility.

Now, Reuters' reports the following:
' BRUSSELS, Aug 7 (Reuters) - The European Commission has suspended Swiss drug maker Roche's licence to market the HIV drug Viracept in the European Union, it said on Tuesday.
"The suspension is due to the contamination of certain lots of Viracept with ethyl mesilate, a genotoxic substance," the EU executive said in a statement.'
For those of you who want to read the news item, please click here.

As you may remember, the Chennai High Court in Novartis' Gleevec case had said that Novartis could, if it wanted, go to the Dispute Settlment Body at Geneva and argue that India's patent law [specifically, S. 3d] was not in line with its TRIPs commitment.
For such an effort, it would have been necessary for Novartis to get support from its government [Swiss Govt.].
News is now coming in that Swiss Govt. wont come in the picture. Specifically,
“The Swiss government never gets involved in any judicial pronouncements of other countries. We accept any case which is settled in India. It is a normal litigation in which one party happens to be a company while other is a country,”
Statement by Doris Leuthard, Federal Councilor, Department of Economic Affairs of the Swiss Confederation.
Complete details in Business Standard's web article here.

ARV drugs - news update

2007-10-12T02:22:00.001-07:00

The following news items come via good friend and IP advocate - Tahir Amin from I-Mak:

1) Atazanavir [Reyataz (R)]:
I had previously mentioned Atazanavir's Indian patent application related news, here.
It is now clear that the abandoned application was for the base/ product, which was filed in India in 1997. The marketed composition contains the sulfate salt of Atazanavir. Further, with S.3(d) in the picture, salt forms are not patentable in India.
So, patent applications [if any] for the sulfate salt are not a concern.
This is good news for Indian patients as well drug makers.

2) Heat Stable Lopinavir + Ritonavir [Kaletra (R)]:
US:
Tahir also updates us that Abbott has abandoned at least one critical patent application for heat stable Lopinavir + Ritonavir formulation at the US PTO [Application no. 10/650,178; published as US2005048112]. It is an open question as to whether there are other applications that cover the same in US.

India:
I-Mak has submitted pre-grant opposition to the Indian patent application for heat stable Lopinavir + Ritonavir.

Europe:
I-Mak has submitted comments/ observations on the European patent application as well.

3) Nevirapine [Viramune (R)]:
I-Mak has also opposed the patent application for the hemi-hydrate form of Nevirapine at the Indian Patent Office.

4) Tenofovir [Viread (R)]:
I had earlier posted on Tenofovir's US patent problems, here.
In India, Gilead had made a very interesting move.
It had got a whole bunch of generic companies to sign in a license agreement, before it was even granted an Indian patent for the product. Post signing, the application went in for heavy duty oppositions filed by NGOs. The only market player who did not sign was Cipla, who is opposing the patent application.
As of date, there is no granted product patent in India.

Now, I-Mak informs us that Gilead does not have a product patent even in critical ARV markets such as South Africa, Namibia and [possibly] all of the ARIPO countries too.

Canada issues compulsory license for Aids Drugs to be exported to Rwanda

2007-10-12T02:21:00.000-07:00

The Federal Commissioner of Patents issued today a compulsory licence for ApoTriavir under Canada's Access to Medicines Regime Program (CAMR) allowing Apotex to proceed with manufacturing of the product. This drug, a triple combination AIDS therapy [lamivudine 150mg/nevirapine 200mg/ zidovudine 300mg tablets], was the first product to be approved by Health Canada under the provisions of the CAMR. The CAMR was designed to help developing countries that have little or no pharmaceutical manufacturing capacity in their fight against HIV/AIDS, tuberculosis, malaria and other diseases.

But Apotex insisted that the delay in getting a licence – more than a year after the antitretroviral had been approved by Health Canada in August 2006 – proved the system was not working. Further, Apotex pointed out that GlaxoSmithKline and Shire – which between them own eight patents covered by the licence – had not opposed its application, but had chosen not to grant voluntary licences, “requiring Apotex to navigate the complexities of the CAMR”. Boehringer Ingelheim was also not prepared to freely grant a licence.

Additional information here:

Apotex’ press release.

Cipla and HIV drugs- Uganda

2007-10-12T02:20:00.000-07:00

ipla- the leader in generic and affordable HIV drugs has opened a factory to make HIV drugs in Uganda in collaboration with Ugandan drug importing company Quality Chemicals in Kampala, Uganda's capital. The plant will also produce anti-malaria medication.

The drugs produced in this factory will be available by Jan, 2008. The aim will be to make drugs more accessible and affordable to the estimated 300,000 Ugandans living with HIV/AIDS who need the drugs for their survival.

The Famciclovir [Famvir (R)] story

2007-10-12T02:19:00.000-07:00

Teva had filed a P.IV ANDA for Famciclovir [Novartis' Famvir (R), drug for treating herpes] and had been fighting the case in the Dist. of New Jersey. It was the first P.IV ANDA filer and had the 180 day exclusivity. The patent in question was US5246937.

On Sep. 7^th it started shipping the product [an at-risk launch] to which Novartis filed an Emergency Motion for an Injunction Pending Appeal with the Federal Circuit. The Federal Circuit temporarily enjoined TEVA from selling its generic famciclovir product. Post the injunction order, both parties filed briefs elucidating their positions.

On Sep. 28^th , the Federal Circuit denied Novartis' emergency motion for an injunction pending its appeal of a September 5, 2007 District Court preliminary injunction ruling in favor of Teva, allowing Teva to resume sales of its generic Famciclovir Tablets.

TEVA press release here:

News article here.

Interestingly, the present commercial sale by Teva was triggered due to the expiry of the 30 month stay period. The original patent infringement case’ trial date has not even set as yet.

BIG Pharma pays HEFTY fines

2007-10-12T02:18:00.001-07:00

I had earlier reported that Sanofi had paid a huge fine, now, its the turn of Bristol Myers Squibb to bay a US $500mn + fine, to end a probe into the firm's drug pricing practices that began a number of years ago.

The US DoJ concluded on Friday that the company and a wholly-owned subsidiary called Apothecon had used incentive schemes to encourage doctors and wholesalers to stockpile their drugs and so help Bristol-Myers achieve its sales targets.

Read the BBC story here.

This is after the 2006 debacle, when the Securities and Exchange Commission announced that BMS would pay $750 million which would be distributed to compensate shareholders injured by fraudulent earnings management at Bristol-Myers Squibb Company.

No one is BIG pharma is clean; Pfizer has been in the dock for Gabapentin [Neurontin (R)] and paid $34.7 million for human growth hormone [Genotropin (R)] while AstraZeneca paid $355 million for Zoladex.

Table showing fines paid by Big Pharma in recent years [from BrandweekNRX]:

Company	Fines and settlements (Mn US $)
Schering-Plough	1280
Bristol Myers Squibb	1265
Takeda-Abbott	875
Serono	704
GlaxoSmithKline	563
Pfizer	514
Abbot	482
AstraZeneca	355
Bayer	271
Eli Lilly	36

The rot also includes the pharmaceutical benefits managers. In 2006, Medco, the second-largest PBM firm, had to pay $155 million to settle a host of fraud claims while in 2005 Caremark paid $137.5 million in penalties. Not to forget, Omnicare who agreed to pay at least $102 million to settle Medicaid fraud charges in 42 states.

Updated: Glaxo and Teva settle Rosiglitazone [Avandia (R)]

2007-10-12T02:18:00.000-07:00

Updated:

It seems that both, Innovators and generics are increasingly coming close to settlements.

Earlier Teva has settled with Wyeth for Venlafaxine [Effexor (R)] and possibly may now settle on Pantoprazole [Protonix (R)], while Ranbaxy earlier settled with Glaxo on Valacyclovir [Valtrex (R)] and on Valsartan [Diovan (R)] with Novartis.

News is now coming that Teva and Glaxo have settled thier dispute on Rosiglitazone.

--------

Teva as well as Dr. Reddy's had filed P.IV ANDAs for Rosiglitazone [Avandia (R)]. But, Glaxo and Teva have now announced a settlement of their dispute for Rosiglitazone [Avandia (R)] as well as Avandamet and Avandaryl. The terms, which were kept confidential, will allow TEVA to sell generic versions of three Glaxo diabetes drugs in the United States beginning in first quarter of 2012.

Avandia is Rosiglitazone maleate,
Avandamet combines Rosiglitazone maleate with Metformin hydrochloride and
Avandaryl combines Rosiglitazone maleate with Glimepiride.

The dispute was for US patents 5002953 and 5741803. The ‘953 patent on rosiglitazone, the active ingredient in Avandia, expires in March 2012. Glaxo accused Teva of infringing the 2012 patent on the compound, as well as a second patent [‘803] for a method of using the compound to treat diabetes, which is to expire in 2015.

Glaxo had filed a complaint at the District Court of New Jersey on May 11, 2007 [docket number: 1:07-cv-02238]. The trial on the case was earlier scheduled to begin in August in federal court in Camden, New Jersey.

Interestingly, the Motley Fool has a unique perspective on this settlement. It says:

‘…deal allows Teva to start marketing generic forms of Avandia and its related combination products in the first quarter of 2012. This seems like a safe compromise for Teva, because rather than risk losing in the courts and having to possibility wait until 2015, it now gets to safely launch at a compromise date.’

But the fate of DRL and its P.IV/ 180 day exclusivity is still in the balance as there is no information on whether it too has settled the dispute. DRL has, in the past, gone in for settlements as well as authorized generic partner as well.

Reuters post, here.

TEVA press release, here.

Olanzapine [Zyprex (R)] - Supreme Court rejects generic drug makers' bid

2007-10-12T02:17:00.002-07:00

The U.S. Supreme Court approved a December 2006 Federal Circuit decision upholding Eli Lilly's patent [US5229382] on Zyprexa as valid and infringed, rejecting appeals by Teva and Dr. Reddy's to offer generic versions.

The Supreme Court made no comment in turning away the appeal.

Bloomberg' news story here.

Levetiracetam [Keppra(R)] -- Settlement

2007-10-12T02:17:00.001-07:00

UCB has announced a settlement agreement for its product, Levetiracetam [Keppra(R)] with Mylan [including its subsidiary Mylan Pharmaceuticals Inc.], Dr. Reddy's Laboratories and Cobalt Pharmaceuticals to settle pending patent infringement lawsuits over its patent - US4,943,639, in the U.S. District Court for the Northern District of Georgia. The normal expiry for this patent is July 14, 2008.

Mylan had a first to file ANDA position on this product. Interestingly, the press reports state:
'This settlement of the lawsuits in a mutually beneficial manner was achieved following a mediation process at the encouragement of the Court and will enable the parties to focus their efforts on the conduct of their respective businesses.'

Pursuant to the settlement terms disclosed, Mylan has the right to market the 250mg, 500mg and 750mg strengths of Levetiracetam Tablets in the United States on Nov. 1, 2008, provided that UCB obtains pediatric exclusivity for Keppra and Mylan's abbreviated new drug application (ANDA) obtains final approval from the Food and Drug Administration (FDA). If granted, pediatric exclusivity relating to the '639 patent would extend to Jan. 14, 2009.

Mylan's entry into the market could come sooner than Nov. 1, 2008, if the FDA does not grant UCB pediatric exclusivity.

The parties have agreed to maintain as confidential, the remaining terms of the Mylan settlement agreement and those with Dr. Reddy's and Cobalt.

The settlement arrangements are subject to mandated review by the US anti trust authorities.

News reports here:
Reuters
CNN Money
ABN Newswire
RTT News

Up-coming generics

2007-10-12T02:16:00.001-07:00

Sun Caraco will launch chewable Cetirizine Hydrochloride [generic version of chewable Zyrtec (R)] post December 25th, 2007 once the patent expires. It has received tentative FDA approval and will receive the final approval, in all likelihood, at the time of Innovator patent expiry.

Teva will launch generic Valacyclovir in December 2009. Final approval for Teva is expected in December 2009, after GlaxoSmithKline's patent on the drug expires. Ranbaxy had earlier filed a P. IV ANDA alleging that the product patent was invalid/ not infringed. But it later settled and will start selling generic Valacyclovir in late 2009.
Ranbaxy has ~~tentative~~ final approval and Mylan Laboratories Inc. has ~~received~~ tentative approval for generic Valtrex.

Teva has also announced final approval for Risedronate tablets [generic version of Actonel® 5 mg, 30 mg and 35 mg]. Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of Delaware. A trial was held in November, 2006 but a decision has not yet been reached. In connection with the pending patent litigation, Teva agreed to provide 30 days advance notice to Procter & Gamble of any launch activities and has not yet provided such notice.... which means a generic launch is not anywhere close... :-(

Forbes reports that FDA has approved the first generic versions of Novartis AG's epilepsy drug Oxcarbazepine [Trileptal (R)]. The approvals are to Roxane Laboratories Inc, Glenmark Pharmaceuticals Ltd and Sun Pharmaceutical Industries Ltd.

Additional news articles on Oxcarbazepine approvals here:

Sun pharma;

Reuters.

Roxane has now announced launch of its generic oxcarbazepine drug.

More on Ramipril [Altace (R)] approvals and exclusivity

2007-10-12T02:15:00.000-07:00

I had earlier remarked on Ramipril and the possibility that Lupin may not get 180 day exclusivity, in view of Cobalt's launch, here. There have been developments since then. FDA has now called in for views on this issue and has opened a separate docket on the 180 day exclusivity issue in this case.

The generic companies [including Lupin] have asked the FDA to grant immediate final approvals to their tentatively approved ANDAs.

Details:

Lupin has submitted a letter to FDA on 03/Oct. and is asking for approval for its Ramipril ANDA. This letter has an excellent summary of the entire matter and I recommend reading it to understand the finer aspects.

Lupin asks FDA to:

a) conclude that Cobalt is no longer entitled to 180-day exclusivity or alternatively

b) permit it to amend its earlier P.IV certification [for the ‘722] patent

c) recognize an exception to the usual certification practice for the meritorious second applicant, particularly where the first applicant frustrates the intent of the statute.

In either alternative, Lupin asks FDA to give immediate approval to its ANDA.

Nowhere does Lupin argue or state that it is entitled to enter to the preclusion of other generic players. It also does not suggest that any agreement to settle patent litigation or failure to market by ANDA filer would extinguish the 180-day exclusivity.

Another letter of the same date, was submitted Hyman, Phelps & McNamara, P.C. submitted a letter on behalf of a company that has a tentatively approved ANDA for ramipril capsules.

The letter asks FDA to:

a) determine that Cobalt’s ANDA does not contain a P.IV certification but rather deem it as a P.III certification;

b) therefore Cobalt is no longer entitled to 180 day exclusivity;

c) Once the Federal Circuit issues its mandate in the Lupin/ King litigation, the FDA should remove the ‘722 patent from the Orange Book and grant final approval to all ANDAs that already have tentative approvals.

Innovators opening facilities in India

2007-10-12T02:14:00.001-07:00

Regardless of the Novartis circus about IP protection in India, other companies are moving on with expanding facilities in India.

Eli Lilly expands its India operations.
Similarly, Wyeth is also expanding its research operations, in collaborations with GVK [one of India's leading contract research players].

Personally, I am not so clear on why Innovator companies would think that China is a better IP protection location compared to India... but that is another debate.

Esomeprazole - Europe

2007-10-12T02:13:00.000-07:00

A European patent [EP0773940] covering a manufacturing process for AstraZeneca's top-selling stomach acid drug- Esomeprazole [Nexium(R)] has been upheld in an amended form, the European Patent Office said on Tuesday. The amended patent would protect its manufacturing process until 2015. Astra also has other patents and data exclusivity through 2010 in major European markets

Related Reuters report.

Astra news release, here.

Earlier in DEC/2006, AstraZeneca announced that the European Patent Office (EPO) had ruled that the European patent covering the drug substance (EP0652872) was rejected, following an appeal from the German generic manufacturer Ratiopharm. The original patent expiry for the substance patent was 2014.

AstraZeneca cannot appeal the loss of the substance patent. Patent covered approx. 17 EU countries, including U.K., Germany, France and Netherlands. Astra still retains protection for the substance patent in those countries where it received patents through national offices.

US situation:
AstraZeneca is engaged in a patent infringement lawsuit related to Nexium® in the District of New Jersey (#3:05-cv-05553-JAP-TJB) against a number of defendants, including Ranbaxy, Ivax, Zenith, and Teva.

Simulated Moving Bed Technologies for Producing High Purity Biochemicals and Pharmaceuticals

2007-10-12T02:12:00.001-07:00

Simulated Moving Bed Technologies for Producing High Purity Biochemicals and Pharmaceuticals

Thursday, October 11, 11:30 a.m.
Room 207 Koffolt Labs, 140 W. 19th Avenue

Reception before the Seminar in Room 336 Koffolt Labs, at 11:00 a.m.

Nien-Hwa Linda Wang
Professor
School of Chemical Engineering
Purdue University

Abstract:
Batch adsorption and chromatography processes are highly selective separation techniques. They have been widely used for the analysis of complex mixtures and the purification of chemicals, biochemicals, and pharmaceuticals. A continuous adsorption process (or "Simulated Moving Bed" process) can have significantly higher yield, higher purity, higher throughput, and lower solvent consumption than batch chromatography. SMB processes have been used for the production of hydrocarbons since 1970's, high-fructose corn syrup purification since 1980's, and chiral pharmaceuticals since 1990's. SMB, however, has never been used for large-scale purification of proteins or biochemicals from complex mixtures. There have been three major barriers: (1) the lack of an efficient design method to isolate a protein with high purity and high yield from a mixture of three or more components; (2) the lack of SMB equipment for multi-component separation; and (3) the lack of an effective method to control the identity of a batch in an SMB process. In this talk, the fundamental principles of SMB will be introduced, followed by the new technologies developed at Purdue for overcoming the major barriers. The applications of the new technologies in developing a tandem SMB for insulin purification and a five-zone SMB for biofuel production will be presented.

Bio:
Dr. Nien-Hwa Linda Wang is a Professor of Chemical Engineering at Purdue University. She has been teaching and doing research at Purdue since 1980. She obtained her BS in Chemical Engineering from National Taiwan University in 1971, her MS in Chemical Engineering from the University of Wyoming in 1973, and her PhD in Chemical Engineering from the University of Minnesota in 1978. She is a Fellow of the American Institute of Medical and Biological Engineering. She was a Director of the Separations Division, American Institute of Chemical Engineers (2001-2004) and a Director of the International Adsorption Society (2001-2007). She has also served as a consultant to NIH, NSF, Oak Ridge National Laboratories, and fourteen chemical, food, and pharmaceutical companies.
She is internationally known for her research contributions in adsorption, ion exchange, multi-component chromatography, and simulated moving bed technologies. She has more than 100 technical publications, two patents, and more than 200 invited lectures and presentations at national and international meetings. She has developed several important chromatography and simulated moving bed technologies that are applicable to the design of a wide range of adsorption and ion exchange separations. These technologies include VERSE (a comprehensive simulation package for chromatography based on a detailed rate model), the Standing Wave Design method for simulated moving beds, and new Versatile Simulated Moving Bed Equipment. Her current research is focused on developing new adsorption processes for protein purification, chiral separation, and the production of biofuels.

Cipla and HIV drugs- Uganda

2007-10-12T02:12:00.000-07:00

Cipla- the leader in generic and affordable HIV drugs has opened a factory to make HIV drugs in Uganda in collaboration with Ugandan drug importing company Quality Chemicals in Kampala, Uganda's capital. The plant will also produce anti-malaria medication.

The drugs produced in this factory will be available by Jan, 2008. The aim will be to make drugs more accessible and affordable to the estimated 300,000 Ugandans living with HIV/AIDS who need the drugs for their survival.

Lupin takes majority stake in Japan's Kyowa

2007-10-12T02:11:00.000-07:00

News channels here are reporting that Indian pharmaceutical company Lupin has purchased a majority stake [80%] in Japan's Kyowa Pharmaceutical Industry.

It was already into a strategic alliance with Kyowa since about two years ago to market finished formulations in Japan. Kyowa is one of top ten generic drug makers of Japan had reported sales of US $63 mn for the year ended March 2007. It is likely that Lupin may acquire the balance stake of 20% soon, as well.

Rediff/ Business Standard discussing this news, here.

It is an interesting move, coming on heels of other generic companies which are already present in the Japanese market [Ranbaxy/ Strides Arcolab]. Similarly, Zydus Cadila had acquired Nippon Pharmaceuticals in April 2007.

The Japanese pharmaceutical market is worth approx. US $ 60 bn.

Concorde Capital Completes Darnitsa Pharmaceuticals Private Placement

2007-10-12T02:09:00.000-07:00

Concorde Capital Completes Darnitsa Pharmaceuticals Private Placement

Darnitsa Pharmaceuticals, one of Ukraine´s largest pharmaceutical
producers, through its holding company Nord Star Pharmashare (Denmark)
has successfully placed a 10% equity stake among foreign investors for
USD 48 m, giving Darnitsa a total MCap of USD 560 m.
Shares of Nord Star Pharmashare were sold in the form of global
depositary receipts (GDR) issued by The Bank of New York and began
trading on the Frankfurt stock exchange on October 5. The price per
GDR corresponding to one share was USD 8.7 at the placement. In all, 5
555 550 depositary receipts were placed on the exchange.
Concorde Capital acted as sole financial advisor and book runner
of the placement.
Darnitsa is the first Ukrainian pharmaceutical company to list on
an international exchange.
Concorde Capital CEO Igor Mazepa had this to say about the deal,
"the strong interest the placement received from foreign investors,
led the management to increase its placement stake to 20%, which is
likely to be purchased by strategic investors, and will have a
positive impact on Darnitsa´s development strategy."
The company intends to use the placement proceeds to enlarge its
production and complete its transition to full compliance with GMP
(Global Manufacturing Practice). According to Aleksey Troinikov, Head
of Darnitsa´s Auditing Committee, "Darnitsa´s strategic plans include
launching an asthma drug production unit by the end of 2009, as well
as the construction and launch of biotechnological medicine production
(R-DNA insulin, human growth hormone, and anticancer vaccines) by late
2010".
For Editors
Darnitsa Pharmaceuticals was the first company in Ukraine to
launch production in compliance with GMP and ISO 9001:2000. The
company has been operating for over 70 years in the domestic market,
and over the last few years it has been the leader of Ukrainian
pharmaceutical industry. Darnitsa is the largest pharmaceutical
company in terms of output with over a 26% share of total
pharmaceutical production in Ukraine.
Concorde Capital (www.concorde.com.ua) is a full service
investment bank operating on the Ukrainian, Russian and CIS financial
markets. In 2007, Concorde Capital´s analytical team was named the Top
Analytical Team covering Ukraine by Thomson Extel´s Pan European
Survey. Concorde´s role in the sale of Elektron Bank to Austria´s
Volksbank International earned the company the Adam Smith Institute´s
"Best Ukrainian M&A deal of 2007" award. Concorde Capital has
attracted over USD 1 bln for leading Ukrainian companies over the last
two years.

Venlafaxine - India

2007-10-12T00:52:00.000-07:00

Venlafaxine - India

Friends,
I return to Venlafaxine after quite some days. :-)

Wyeth has an Indian process patent [IN187337] for [possibly] the extended release capsule formulation.
Details:
"A process for preparing an encapsulated extended release formulation of venlafaxine hydrochloride.

Application number: 507/CAL/1997
Patentee: WYETH"

This patent has the following US granted patents as family members:
US6274171 / US6403120/ US6419958
All the above three are Orange Book listed patents, there other pending/ abandoned applications as well.