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Barr Announces Favorable Ruling in Yasmin Patent Challenge

Tuesday, March 4, 2008

"We are delighted that Judge Sheridan has invalidated the patent on Yasmin," said Bruce L. Downey, Barr's Chairman and CEO. "We are currently reviewing the opinion in the case and evaluating all of our options. Clearly, this is a positive development for the Company and we are evaluating what the potential impact could be on our earnings guidance for 2008."

Yasmin provides an oral contraceptive regimen consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $572 million for the twelve months ended December 2007, based on IMS sales data.

Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Yasmin product with the U.S. Food & Drug Administration (FDA) in January 2005, and received notification of the application's acceptance for filing in February 2005. Following receipt of the notice from the FDA, Barr notified Berlex, the New Drug Application (NDA) holder, and Schering AG, the patent owner. In April 2005, Schering AG and Berlex filed a patent infringement suit against Barr in the U.S. District for the District of New Jersey. In June 2006, Bayer AG acquired Schering AG. In November 2007, the patent infringement case was heard in front of Judge Sheridan.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 26 proprietary products in the U.S. and approximately 1,025 products globally outside of the U.S. For more information, visit www.barrlabs.com.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment in the markets where we operate; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (such as PLIVA d.d.) and products we acquire and implementing our new SAP enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through our PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our significantly increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed in our SEC filings, including in our Transition Report on Form 10-K/T for the six months ended December 31, 2006.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.

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Dendreon Publishes Manuscript on CD54 as a Surrogate Marker of Antigen Presenting Cell Activation

The manuscript describes and supports the use of CD54 as a surrogate marker of antigen presenting cell activation (APC) activation and validates its utility as a potency measure of PROVENGE(R) (sipuleucel-T). In particular, it describes how Dendreon researchers used CD54 and the upregulation of its expression on antigen presenting cells (APC) as a means by which human APC activation could be assessed and most importantly, how such measurements could be used to determine the potency of PROVENGE before its administration to patients with prostate cancer. The assessment of product potency is a key release measure required by the U.S. Food and Drug Administration (FDA).

The upregulation of CD54 has been used as part of the potency assay for PROVENGE since the initiation of the PROVENGE clinical development program. Data correlating CD54 upregulation to overall survival in patients from two Phase 3 trials, D9901 and D9902A have been presented at recent scientific meetings and at the FDA Cell Tissue and Gene Therapy Advisory Committee Meeting on March 29, 2007.

About Active Cellular Immunotherapy with PROVENGE

PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In clinical studies, patients typically received three doses of PROVENGE over a one-month period as a complete course of therapy.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.

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Mayo Researchers Look for Explanation Behind High Incidence of Diabetes Among Asian Indians

Friday, February 29, 2008

ROCHESTER, Minn. — The incidence of type 2 diabetes is rising, especially in urbanized parts of the world where sedentary lifestyles and obesity abound. In addition to weight and inactivity, race puts some people at increased risk for developing type 2 diabetes. The incidence of diabetes is rapidly increasing globally, and Asian Indians have the highest prevalence. An estimated 32 million Asian Indians have been diagnosed with this condition, and some experts expect this number to double over the next 30 years. In a study published in the March issue of Diabetes, Mayo researchers examined whether Asian Indians have observable differences in the way their cells convert nutrient fuel to available energy and whether these differences may increase the risk for diabetes.

"We know that Asian Indians are highly susceptible to this condition, and they often acquire the disease at an earlier age and at lower body mass index than people of European origin," explains Mayo endocrinologist K. Sreekumaran Nair, M.D., Ph.D., the study's lead researcher. "The question we asked is whether any metabolic differences between Asian Indians and Americans of Northern European origin can explain the higher incidence of diabetes in Indians."

Once known as adult-onset or non-insulin-dependent diabetes, type 2 diabetes is a chronic condition that affects the way the body utilizes sugar (glucose). People with type 2 diabetes don't produce enough insulin — a hormone that regulates the absorption of sugar into cells — and their cells resist the effects of insulin (insulin-resistant). While death rates due to heart attack, stroke and even cancer are decreasing, deaths related to diabetes are increasing. Type 2 diabetes is the leading cause of cardiovascular deaths, kidney failure, blindness, sexual dysfunction and many other chronic complications.

Mayo researchers studied 13 diabetic Indians, 13 nondiabetic Indians, and 13 nondiabetic northeast Americans of European descent who were matched for gender, age and body mass to Indian study participants. Study participants were fed the same diet and underwent tests for insulin resistance and muscle biopsy to see whether differences occurred at the cellular level among the different study subject groups.

The study yielded a number of interesting findings. Researchers observed that the Indian subjects, irrespective of their diabetic status, had a greater degree of insulin resistance than the American subjects of Northern European origin, even though the study subjects were not obese, a condition commonly associated with insulin resistance. Earlier research has established that people with insulin resistance typically have poorly functioning muscle mitochondria. Mitochondria are the part of cells responsible for converting energy from nutrients to ATP (adenosine triphosphate), the chemical form of cellular energy that the body uses for almost all functions.

"Our study showed that the Indian diabetic and nondiabetic subjects with insulin resistance actually had mitochondrial function that was higher than those observed in the Northern European American subjects," says Dr. Nair.

Dr. Nair hypothesizes that key to understanding this difference may lie in an examination of how populations adapt as they become more urbanized. Urban societies typically move away from lifestyles that involve a higher level of physical activity and diets dominated by low-calorie foods.

"The higher capacity to produce ATP that the Indian subjects displayed may have been an adaptive advantage for the generations that preceded them, when energy content of their diet was lower. But today, this trait may be a disadvantage given the higher energy content of their current diets," explains Dr. Nair.

Dr. Nair and his team are hopeful that the information gained from this study will have a substantial impact on understanding the cause of the global epidemic in diabetes.

"Our findings have potential to help determine the energy requirements of different populations and what role this plays in the onset of diabetes" says Dr. Nair.

Other authors of this article are: Maureen Bigelow; Yan Asmann, Ph.D.; Lisa Chow; Jill Coenen-Schimke; Katherine Klaus; ZengKui Guo, Ph.D.; Raghavakaimal Sreekumar; and Brian Irving, Ph.D.

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New Study of Targeted Therapies for Breast Cancer Establishes Model for Global Clinical Trials

Friday, February 29, 2008

Two targeted medications designed to treat an aggressive form of breast cancer are being tested in a new study involving 8,000 participants in 50 countries across six continents — a clinical trial that investigators hope will provide a new model for global cancer research. This trial, dubbed ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization study), will be one of the first global initiatives in which two large, academic breast cancer research networks covering different parts of the world have jointly developed a study in which all care and data collection are standardized, regardless of where patients are treated. The networks are The Breast Cancer Intergroup of North America (TBCI), based in the United States, and the Breast International Group (BIG) in Brussels, Belgium. TBCI consists of six National Cancer Institute (NCI)-funded clinical trials cooperative groups. NCI is part of the National Institutes of Health.

ALTTO is designed to answer the most pressing questions regarding use of two widely used cancer agents: whether one agent is more effective, which agent is safer for patients, and what benefit will be derived by taking the drugs separately, in tandem order, or together? The trial is a randomized, Phase III study, which is considered a gold standard method for proving drug effectiveness.

The two agents tested in ALTTO are drugs designed to treat HER2-positive tumors, which is a particularly aggressive form of cancer that affects approximately 20 percent to 25 percent of breast cancer patients. Both agents, trastuzumab (Herceptin) and lapatinib (Tykerb), have already been approved by the U.S. Food and Drug Administration for use for treatment of HER2-positive breast cancer. ALTTO will provide the first head-to-head comparison of trastuzumab and lapatinib in the earliest, most treatable stages of cancer. It will also be one of the first large-scale studies to evaluate lapatinib's effectiveness in treating early breast cancer.

HER2-positive breast cancer is caused by an excess of HER2 genes or by over-production of its protein, the HER2 cell surface receptor. Trastuzumab consists of large antibodies that once injected into patients, latch on to the portion of the HER2 protein that sits on the outer surface of the cancer cell whereas lapatinib acts by entering a cancer cell and binding to the part of the HER2 protein that lies beneath the surface of the cell.

The trial is unusual in that it has two different designs depending on whether patients with stage I or stage II breast cancer have already been treated with chemotherapy. The study thus will compare four different regimens of targeted therapy administered over a 52-week period. Patients will be randomized to receive either trastuzumab or lapatinib alone, or trastuzumab followed by lapatinib, or the two treatments in combination.

"There have been major improvements in the management of patients with early breast cancer in the last few years, so this new study builds on this knowledge and sets an example of the new era: good science, good worldwide collaboration," said Edith Perez, M.D., an oncologist in the North Central Cancer Treatment Group (NCCTG) at Mayo Clinic in Jacksonville, Fla., who will lead the study for TBCI. "It may be that using two treatments that work in different ways against HER2-positive breast cancer offers a complementary strategy that is more powerful than either drug alone."

ALTTO will be one of the first trials of its scope in which translational research — taking science from bench to bedside — plays a critical role, investigators say. In ALTTO, biological material will be collected from thousands of patients in order to determine a tumor profile that responds best to the drugs — information that could lead to individualized patient care and, possibly, to development of next generation agents.

"The difference between this study and many that came before it is that the collection of biological materials occurs as the trial is being conducted, not as an afterthought. While there are exceptions, not many companies or organizations have been willing to invest in that kind of research before," said Martine J. Piccart, M.D., Ph.D., professor of oncology at the Université Libre de Bruxelles, Belgium, and lead investigator for BIG, which she founded in 1996. "Now we have the chance to optimize therapy with powerful drugs in order to provide the best treatment possible for each of our patients."

Perez and Piccart led the development team of the ALTTO trial and will act as the study's co-principal investigators. On behalf of BIG and TBCI, these two lead investigators have been working toward collaborative clinical studies for a number of years. The ALTTO study, they say, represents a new paradigm that blends the high standards of both systems in order to test the latest breast cancer treatments as efficiently as possible in thousands of women worldwide.

"The NCI greatly appreciates the work that Mayo Clinic, TBCI and BIG are doing to help advance our understanding of the complex mechanisms that underlie different types of breast cancer," said Jo Anne Zujewski, M.D., a senior investigator in the clinical investigations branch at NCI. "We hope that this model of international collaboration is one which we can build upon in the future."

Lapatinib, in combination with the chemotherapy drug capecitabine, was approved by the U.S. Food and Drug Administration in March 2007 for the treatment of advanced or metastatic HER2-positive breast cancer in patients who had received prior therapy with three agents — an anthracycline, a taxane and Herceptin. GlaxoSmithKline is providing the study drug, as well as additional financial support for the ALTTO trial. All drugs carry potential side effects, and more information of side effects for lapatinib and trastuzumab can be found in the Q&A at http://www.cancer.gov/newscenter/pressreleases/ALTTOQandA. NCI and GSK also provided comment and input on the design of the study.

NCCTG will act as the treatment base for ALTTO in North America. BIG is a network of 41 non-U.S. research groups from around the world. Its Brussels-based BrEAST Data Center is providing centralized data management for the global study (including the United States). The other members of TBCI include the Eastern Cooperative Oncology Group (ECOG), the Cancer and Leukemia Group B (CALGB), the Southwest Oncology Group (SWOG), and the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG).

To date, more than 300 centers around the world have enrolled patients into ALTTO. Full enrollment is expected to involve about 500 centers in the United States and more than 800 centers in Europe and the rest of the world. A complete listing of ALTTO participating sites can be found by searching for ALTTO at http://clinicaltrials.gov.

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FDA Accepts for Review Ovation's Two NDA Submissions for Sabril

February 28, 2008

WILMINGTON, N.C., February 28, 2008 /PRNewswire-FirstCall/ -- PPD, Inc. today confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, has been accepted for filing by the U.S. Food and Drug Administration. PPD partnered with Takeda to develop the compound.

Under PPD's agreement with Takeda, the FDA's acceptance of the NDA filing triggers a $15 million milestone payment to PPD. This milestone payment was included in PPD's previously issued 2008 financial guidance.

"We are pleased to partner with Takeda, one of the leading pharmaceutical companies in the area of diabetes," said Fred Eshelman, PPD's chief executive officer. "We are also delighted that this important regulatory milestone has been achieved as a result of close cooperation between Takeda and our company."

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 30 countries and more than 10,200 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at http://www.ppdi.com.

Except for historical information, all of the statements, expectations and assumptions contained in this news release, including expectations and assumptions about the alogliptin NDA filing with the FDA, subsequent milestone payments for regulatory approvals for alogliptin, if any, the continued development and commercialization of this drug candidate and the value of this collaboration with Takeda, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause results to differ materially include the following: risks associated with the development and commercialization of drugs, including obtaining regulatory approvals; risks associated with and dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; continued success in sales growth; loss of large contracts; increased cancellation rates; economic conditions and outsourcing trends in the pharmaceutical, biotechnology, medical device, academic and government industry segments; competition within the outsourcing industry; the ability to attract and retain key personnel; risks associated with acquisitions and investments, such as impairments; risks that we may not continue our dividend policy; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.

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