Based on clinical trials, we know a fair amount about drugs on the market. But how much don’t we know?

It’s been a long-running controversy, and has come to a head in recent years after a string of drug-safety scandals. There are efforts to get drugmakers to disclose more trial results, such as a rule requiring them to register trials and provide results on clinicaltrials.gov. But today’s WSJ Science Journal column presents some recent stats that bring the issue into sharp relief.

Some highlights:

• Last month, analysts led by an expert at the University of California in San Francisco checked 164 clinical trials testing 33 different drugs submitted for FDA approval from 2001 to 2002. One in four had yet to be published. Almost all of the unpublished findings made the drug in question look bad.
• In September, some UCSF folks reviewed 900 FDA filings involving 90 new drugs. More than half of the clinical trials were still unpublished 5 years after the drugs had been approved.
• Earlier this year, doctors at the University of Washington reported in the journal Oncology that only one in five cancer clinical trials ever is disclosed.
• Earlier this fall, researchers at the State University of New York reviewed 1,835 clinical research articles from four leading otolaryngology journals and reported that a third of them failed to mention any side effects at all.

For a taste of the controversies that come up, take a look at some of our past posts about a negative study of Pfizer’s Neurontin, unpublished negative studies of depression, and of course, the brouhaha early this year after Merck and Schering-Plough delay in releasing findings about cholesterol-drug Vytorin that turned out to be unflattering. Those results were published ultimately in the New England Journal of Medicine in April.

Source: The Wall Street Journal

Popularity: 12% [?]

SHANGHAI — Shanghai-based Hutchison MediPharma Limited said yesterday that it recently entered into an agreement with US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) on jointly developing new-type targeted cancer new drugs, further expanding their partnership.

Under the agreement, both sides will jointly develop a new target in oncology. Hutchison MediPharma will take primary responsibility in the discovery phase activities of identifying and selecting clinical candidates for the R&D around the world. In return, it will get an up-front payment, potential fees like R&D millstone payments and also royalties on the global sales revenue of any drugs that are fruits of the cooperation.

In fact, both side inked a similar cooperative contract on August 20, 2008 on developing specified targets in oncology and inflammation. The Shanghai company successfully completed staged responsibility of the cooperation with its advanced drug R&D platforms, talents and strong technical investment. Thus, Lilly decides to extent the cooperation and will pay more money to the Shanghai partner.

Hutchison MediPharma is engaged in R&D of new drugs and is under the wing of Hutchison China MediTech Limited (Chi-Med).

Source: Trading Markets

Popularity: 10% [?]

Debiopharm Group and Aurigene Discovery Technologies signed an exclusive worldwide license agreement, excluding the territories of Japan and the rest of Asia, to develop and commercialize Debio 0617, an inhibitor of an undisclosed oncology pathway. Utilizing its fragment-based drug delivery technology platform, Aurigene has generated potent leads against the target. Under the terms of the agreement, Debiopharm will pay Aurigene an upfront fee, as well as further payments according to predefined discovery, development, and sales milestones.

“We are very excited to continue our collaboration with Aurigene. Their business model offers a one-stop solution for structure-guided drug design, lead optimization, and preclinical work. The Debio 0617 project aims at developing inhibitors targeting a key oncology pathway, which plays essential roles in various solid tumors and hematological malignancies,” said Rolland-Yves Mauvernay, president and founder of Debiopharm Group.

Source: GEN News

Popularity: 14% [?]

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA - News) today announced that Merck & Co., Inc. has extended its research collaboration with Idera for an additional year. The Company and Merck entered into an exclusive license and research collaboration agreement to research, develop and commercialize vaccine products containing the Company’s investigational agonist compounds targeting Toll-like Receptors (TLR) 7, 8, and 9 in the fields of oncology, infectious diseases and Alzheimer’s disease in December 2006. As part of the agreement, the two companies engaged in a two-year research collaboration to generate novel agonists targeting TLR7 and TLR8 incorporating both Merck and Idera chemistry for use in the licensed fields.

“Our two-year research collaboration with Merck scientists has been very productive and has created several novel agonists of TLR7 and TLR8 for potential use in vaccine products,” said Sudhir Agrawal, D.Phil., Chief Executive Officer and Chief Scientific Officer, Idera Pharmaceuticals. “We are looking forward to a productive third year of the collaboration to fully capitalize on the accomplishments from the first two years.”

“Our close working relationship with Idera continues to yield progress,” said Dennis Zaller, Ph.D., Executive Director of External Basic Research, Merck Research Laboratories. “The extension of this research collaboration underscores our commitment to further evaluating these novel vaccine adjuvants.”

About Idera Pharmaceuticals, Inc.

Idera Pharmaceuticals develops drug candidates to treat infectious diseases, autoimmune diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. Our proprietary drug candidates are designed to modulate specific Toll-like Receptors, which are a family of immune system receptors that direct immune system responses. Our pioneering DNA and RNA chemistry expertise enables us to create drug candidates for internal development and generates opportunities for multiple collaborative alliances. For more information, visit www.iderapharma.com.

Idera Forward Looking Statements

This press release contains forward-looking statements concerning Idera Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “should,” “could,” “will,” “may,” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause the Company’s actual results to differ materially from those indicated by such forward-looking statements, including whether results obtained in early clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future clinical trials or warrant additional trials; whether products based on the Company’s technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company’s products receive approval, they will be successfully distributed and marketed; whether the Company’s collaborations with Novartis, Merck & Co., Inc. and Merck KGaA will be successful; whether the patents and patent applications owned or licensed by the Company will protect the Company’s technology and prevent others from infringing it; whether the Company’s cash resources will be sufficient to fund the its operations; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed on November 6, 2008, which important factors are incorporated herein by reference. The Company disclaims any intention or obligation to update any forward-looking statements.

Source: Idera Pharmaceuticals, Inc.

Popularity: 20% [?]

Merck Serono, the division for innovative pharmaceuticals of Merck KGaA, Darmstadt, Germany, today held a cornerstone ceremony at the Merck Serono Biotech Center (MSBC), its production site in Corsier-sur-Vevey, Switzerland, to mark the expansion of the site. The expansion will enable the production of greater quantities of Erbitux® (cetuximab), in order to meet growing patient needs, as well as the production of potential future treatments in autoimmune and inflammatory diseases currently under clinical development. Erbitux, Merck Serono’s monoclonal antibody for the targeted treatment of colorectal and head and neck cancers, is currently available in around 70 countries.

“The expansion of the Merck Serono Biotech Center embodies our company’s primary commitment to bringing therapeutic innovations to patients with serious unmet medical needs,” said Elmar Schnee, General Partner and Member of the Executive Board of Merck KGaA and President of Merck Serono. “This investment will cement our company’s position as a leader in biotechnology, while contributing to the local economy with the creation of more than 200 new jobs, and its construction will create business opportunities for local companies.”

Hanns-Eberhard Erle, Executive Vice President Technical Operations of Merck Serono added: “This expansion underscores our commitment to excellence at all levels and will serve as a catalyst towards our goal of becoming a responsible world leader in providing specialist therapies. Through efficient manufacturing processes to scale up the production and the use of state-of-the-art technologies, the Merck Serono Biotech Center will continue to be one of the top centers of excellence for biotechnology in the world.”

Two new dedicated production suites with 120,000 liters of bioreactor capacity, plus a state-of-the-art wastewater treatment station and a logistic center will be added to the existing facilities by the end of 2010. After inspection by worldwide health authorities, including the EMEA and Swissmedic, the production of Erbitux is expected to start at the MSBC in 2012.

Inaugurated in April 1999, the MSBC currently manufactures the active ingredient for Merck Serono’s leading multiple sclerosis treatment Rebif® (interferon beta-1a) for the global market, as well as various therapeutic proteins for the ongoing clinical trials in development at Merck Serono. The two existing production suites are currently operated by 250 qualified employees including laboratory personnel, engineers and biologists. Merck Serono uses state-of-the-art technology and implements environmental management programs to reduce waste and energy consumption. Accordingly, the MSBC has been operating under ISO 14001:2004 certification, the international standard for environmental excellence, since 2005.

Powered by 25 production sites and 5,000 employees across four continents, Merck Serono today manufactures and distributes an extensive portfolio of biotechnological and pharmaceutical drugs including Rebif®, Saizen®, Serostim®, Gonal-f®, Glucophage®, ConCor® and Euthyrox®. In Switzerland, Merck Serono operates three sites in the Vaud Canton: Corsier-sur-Vevey (manufacturing of active ingredients), Aubonne (manufacturing of active ingredients, fill and finish, packaging) and Coinsins (packaging and logistics).

About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Euthyrox®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).

With an annual R&D expenditure of around EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck
Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 32,458 employees in 59 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit http://www.merckserono.net or http://www.merck.de

SOURCE: Merck Serono International S A

Popularity: 36% [?]

Lpath, Inc. (LPTN) and Merck Serono, a division of Merck KGaA, Darmstadt, Germany, have entered into a worldwide alliance to develop and commercialize ASONEP, Lpath’s Phase 1 monoclonal antibody that is being evaluated for the treatment of cancer.

Generated via Lpath’s proprietary ImmuneY2(TM) drug-discovery engine, ASONEP is a humanized monoclonal antibody that neutralizes S1P, a bioactive lipid that stimulates tumor-cell migration, invasion, and survival, and also promotes angiogenesis, i.e., growth of new blood vessels. S1P has also been highly correlated with the development of drug resistance in various cancer types.

Under the terms of the agreement, Merck Serono will provide Lpath up to $23 million of upfront payments and R&D funding to support Lpath’s completion of the Phase 1 clinical trial. If Merck Serono accepts the responsibility to develop ASONEP beyond Phase 1, it will pay Lpath an additional $28 million and will fund all continuing development activities. Further payments will be made on achievement of development, regulatory, and sales milestones that could total up to $422 million should ASONEP be approved in multiple indications.

As part of the alliance, Lpath licensed to Merck Serono exclusive, worldwide rights to develop and commercialize ASONEP across all indications, and Lpath will receive royalties on commercial sales of the product.

Lpath has retained full ownership and control of its other leading drug candidates and underlying development technology, including iSONEP(TM) (Lpath’s ocular formulation of the anti-S1P antibody) and Lpathomab(TM) (an antibody against LPA, a key bioactive lipid). Further, Lpath plans to expand its pipeline of first-in-class monoclonal antibodies against bioactive lipids using its patented ImmuneY2 drug-discovery platform.

“This alliance is a promising strategic fit for Merck Serono’s business model and culture,” said Vincent Aurentz, executive vice president portfolio development and member of the Merck Serono executive board. “ASONEP is an innovative drug candidate and the first monoclonal antibody targeting a bioactive lipid to be tested in clinical trials. We believe that S1P, the bioactive-lipid target of ASONEP, plays an important role in cancer.”

Scott Pancoast, president and chief executive officer of Lpath, commented: “Merck Serono, which has distinguished itself as an outstanding developer and marketer of innovative drugs in key therapeutic areas, is an ideal partner for ASONEP and for Lpath. We expect this alliance to further validate the importance of bioactive-lipid-targeted therapeutics and extend Lpath’s leadership position in this exciting new field.”

About ASONEP

ASONEP is a unique humanized antibody that binds to and inhibits S1P, a bioactive lipid that has multiple effects on cells, including cell proliferation, migration, and survival. S1P, which is up-regulated in tumor cells, also promotes tumor and endothelial-cell growth, angiogenesis, and inflammation, and, importantly, it prevents apoptosis (cell death). S1P is associated with several pathologies, including cancer, ocular disorders, autoimmune disease, and inflammatory- and fibrosis-related disorders. Further, S1P has been highly correlated with drug resistance across a wide array of tumor types, as well as with increased mortality of patients with many different types of cancer.

By inhibiting S1P activity, ASONEP may be able to increase survival in cancer patients, not only via its anti-angiogenic and anti-tumorigenic effects, but also via its ability to help patients overcome drug resistance.

ASONEP is the systemic version of sonepcizumab, which is the humanized version of Sphingomab(TM).

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)), endocrine and cardiometabolic disorders (Glucophage(R), Concor(R), Saizen(R), Serostim(R)), as well as psoriasis (Raptiva(R)).

With an annual R&D investment of around EUR 1 billion (~$1.5 billion), Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility, and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

For more information, please visit http://www.merckserono.net or http://www.merck.de.

About Merck KgaA

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 32,458 employees in 59 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

About Lpath

Lpath, Inc., headquartered in San Diego, California, is the category leader in bioactive-lipid-targeted therapeutics, an emerging field of medical science whereby bioactive signaling lipids are targeted for treating important human diseases. ASONEP(TM), an antibody against S1P, is currently in Phase 1 clinical trials for the treatment of cancer and also holds promise against multiple sclerosis and various other disorders. A second product candidate, iSONEP(TM) (the ocular formulation of the S1P antibody), has demonstrated superior results in various preclinical AMD and retinopathy models and has received FDA authorization to begin Phase 1 clinical trials. Lpath’s third product candidate, Lpathomab(TM), is an antibody against LPA, a key bioactive lipid that has been long recognized as a valid disease target (fibrosis, cancer, neuropathic pain). The company’s unique ability to generate novel antibodies against bioactive lipids is based on its ImmuneY2(TM) drug-discovery engine, which the company is leveraging as a means to expand its pipeline. For more information, visit www.Lpath.com.

SOURCE: Lpath, Inc.

Popularity: 34% [?]

Wyeth shares rose 7.4 percent on Tuesday after reporting that the company will narrow its early-stage research to focus on more severe disease segments, specialised care, and the company’s biotech-pharmaceutical franchise. The drugmaker indicated that compounds currently in late-stage testing will not be affected by the changes.

Therapeutic areas will be nearly halved from the current 14, with greater emphasis on oncology, inflammation, neuroscience, vaccines, metabolic diseases and muscular-skeletal disorders, according to Evan Loh, Wyeth’s vice president of medical therapeutics. The number of diseases the company is developing drugs for will be cut from 55 to 27. “It didn’t really make sense for us to try to be successful in all of those different diseases and therapeutic areas. We needed to have more focus,” Loh remarked, adding that the company will target treatments “where we can clearly define what the unmet need is” and launch new products more quickly.

Specifically, the company will place less emphasis on primary-care medications and cease conducting discovery work on women’s health. Wyeth will continue R&D for conditions that disproportionately affect women, such as breast cancer and osteoporosis. “Our message is that women’s health needs are much broader than hormone therapy and contraceptive therapy,” Loh commented.

The changes are the latest part of Wyeth’s “Project Impact” plan, which aims to make the company more efficient at introducing pharmaceuticals onto the market. The initiative is also a response to the stricter stance adopted by regulatory agencies over drug approvals, particularly regarding treatments that are similar to those currently on the market. According to Mikael Dolsten, Wyeth’s head of R&D, “it will be harder for ‘me too’ or even ‘me better’” medicines in the future. He added: “I think as an industry we need to stop complaining [about regulatory standards]. I think we want to engage in a much more constructive dialogue.”

Regarding the impact on jobs, Wyeth spokesperson Michael Lampe stated that “this is not a cost-reduction effort at all; the dollars spent and number of personnel won’t change.” However, the company indicated that some scientists will lose their positions because their expertise is not transferable to other areas. The drugmaker specified that larger teams of researchers will be working together on similar diseases.

Source: FirstWord

Popularity: 32% [?]

A September 25, 2008 memo by Martin Mackay, Pfizer’s (PFE) president for Global Research and Development, confirms that Pfizer will not develop any more drugs that target cholesterol as the culprit in causing heart disease. In fact, Pfizer will exit drug development for cardiovascular disease altogether.

Pfizer’s exit from statin development indicates the cholesterol craze has reached the end of its cycle trend. Profits have declined as more statins go off patent, and patients switch to much cheaper generics, or forgo statins altogether in order to take “essential” medications.

This means that high cholesterol as an indicator of heart disease was nothing more than a marketing strategy for big pharma to make a ton of money and should be viewed like any other product trend. Bone health and frailty (osteoporosis) is another trend Pfizer is exiting for the same reasons.

Pfizer’s “higher priority areas” for drug development are Alzheimer’s disease, diabetes, inflammation/immunology, oncology, pain, and psychoses (schizophrenia). Medicines for pain and inflammation could be big blockbusters if they have the ability to target the specific area needing treatment rather than affecting the entire body.

At this point in time, pharmaceutical stocks should be viewed like a utility company. In the next few years, the real leaps in health care will not emanate from a drug company’s R&D lab but instead come from the physics department. Think magnetism, light waves, sound waves, and other forces.

*All of Pfizer’s patents related to Lipitor expire in 2011.

Source: Seeking Alpha

Popularity: 28% [?]

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced positive incremental data from its ongoing Phase 2 clinical trial of picoplatin in combination with docetaxel and prednisone as first-line therapy for metastatic hormone-refractory prostate cancer (HRPC). The expanded and updated results continued to show that picoplatin can be safely administered with full-dose docetaxel and prednisone, the standard treatment for HRPC, with no neurotoxicity observed. In addition, reductions of prostate specific antigen levels (PSA) of at least 50 percent were achieved in 78 percent of evaluable patients. Normalized PSA levels were achieved in 26 percent of patients.

“These data are very encouraging as they suggest that picoplatin can be safely administered with full doses of docetaxel as first-line therapy in the treatment of hormone-refractory prostate cancer,” said E. David Crawford, M.D., professor of surgery and radiation oncology, and head of the Section of Urologic Oncology at the University of Colorado Denver and associate director of the University of Colorado Comprehensive Cancer Center in Denver. Dr. Crawford also is a member of Poniard’s Clinical Advisory Board. “I believe these early Phase 2 results may potentially support a Phase 3 trial. A therapy with an improved safety and efficacy profile would be important for patients with advanced prostate cancer, who have a very poor prognosis and few effective treatment options.”

The data were presented in a poster session (abstract # 211/poster #211) during the 20th EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer” in Geneva, Switzerland. Picoplatin, the Company’s lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations for the treatment of multiple solid tumor indications.

Phase 2 HRPC Trial Design and Preliminary Results

In the ongoing Phase 2 trial, the efficacy and safety of intravenous picoplatin (120 mg/m squared) administered every three weeks (21 days) in combination with full-dose docetaxel (75 mg/m squared) with daily prednisone (5 mg) as a first-line treatment are being evaluated in 30 patients with metastatic HRPC who have not received prior chemotherapy. PSA response (defined as a PSA reduction of at least 50 percent from baseline) is the primary endpoint; secondary endpoints include safety, response rate, time to progression and overall survival. The trial completed enrollment in December 2007.

Results presented at the Symposium showed a PSA response of at least 50 percent in 78 percent of the 27 evaluable patients and also showed that the combination of picoplatin and full-dose docetaxel can be safely administered. Manageable and reversible neutropenia were the main hematologic toxicities. In contrast to picoplatin monotherapy, thrombocytopenia was less severe and less frequent in combination with docetaxel. To date, no neurotoxicity has been observed in this study. These findings confirm and extend earlier Phase 2 results presented at the 44th Annual Meeting of the American Society of Clinical Oncology in May and results from the Phase 1 trial presented earlier this year.

“We are encouraged by the PSA decreases observed with picoplatin in combination with docetaxel to date and with the finding that picoplatin continues to be well tolerated in this Phase 2 proof-of-concept trial,” said Robert De Jager, M.D., chief medical officer of Poniard. “Additional data from this ongoing study may support the advancement of picoplatin into a Phase 3 clinical trial for HRPC. Our growing body of safety and efficacy data also supports the potential for additional uses of picoplatin as a combination therapy in the treatment of non-small cell lung and ovarian cancers where platinum and taxane combinations are currently used.”

About Picoplatin

Picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and is designed to overcome platinum resistance associated with chemotherapy in solid tumors. It is being studied in multiple cancer indications, combinations and formulations. Picoplatin has been evaluated in more than 750 patients and has demonstrated anti-tumor activity in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs.

In addition to the ongoing Phase 2 clinical trial in HRPC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registration trial currently is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. Picoplatin is also being evaluated in a Phase 2 clinical trial in patients with metastatic colorectal cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. The oral formulation of picoplatin has the same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by any regulatory authority for use in humans.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. For additional information please visit http://www.poniard.com.

This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, timing and results of clinical trials and the potential safety and efficacy of its products in development. The Company’s actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company’s research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of required regulatory approvals; the market’s acceptance of the Company’s proposed products; the Company’s anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company’s ability to preserve and protect intellectual property rights; the Company’s dependence on third-party manufacturers and suppliers; the Company’s lack of sales and marketing experience; the Company’s ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007 and its Quarterly Report on Form 10-Q for the period ended June 30, 2008. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.

SOURCE Poniard Pharmaceuticals, Inc.

Popularity: 26% [?]

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. SEROQUEL XR is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.

Bipolar disorder, also known as manic depressive illness, is a serious psychiatric condition that consists of recurring episodes of depression and mania. Approximately eight million American adults may be affected by bipolar disorder.

“When people think about bipolar disorder it is important to remember how debilitating the depressive episodes of the disease can be. In fact, in the long term, patients with bipolar disorder experience depressive symptoms three times longer than manic symptoms” said Dr. Trisha Suppes, Professor of Psychiatry and Behavioral Sciences, Stanford University Medical Center and VA Palo Alto Health Care System. “With the approval of SEROQUEL XR for the treatment of bipolar depression and mania, we have a once-daily treatment that has been proven to help control the depressive and manic symptoms of bipolar disorder”

About bipolar disorder
Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterised by one or more manic or mixed episodes, often with one or more episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode. Patients with bipolar I disorder experience depressive symptoms – approximately three times longer than manic symptoms. Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania. Bipolar disorder is typically managed through a treatment strategy with several phases – including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient; the maintenance treatment phase aims to reduce the risk of recurrence of future episodes.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com

Source: WebWire

Popularity: 31% [?]