The Breast International Group (BIG) in collaboration with Roche announced that women with HER2 positive early breast cancer continue to benefit from Herceptin (trastuzumab) several years after treatment completion and as a result enjoy a longer life disease free. The patients were treated for one year with Herceptin and followed up for four years. These data from the HERA study were presented at the Primary Therapy in Early Breast Cancer conference in St. Gallen, Switzerland.

The HERA (HERceptin Adjuvant) study showed that women treated with Herceptin had a 25% reduction in the risk of their cancer coming back compared to women who did not receive Herceptin, and after four years of medical observation on average, almost 90% of the Herceptin-treated women were still alive. In addition to the significant treatment benefit, this analysis confirmed the long-term safety profile of Herceptin, with good cardiac safety and tolerability maintained throughout the four-year follow-up period.

“These data are extremely important for the treatment of breast cancer” commented Dr Martine Piccart, lead investigator of the HERA study and Chair of BIG. “HERA is the first of the four large Herceptin studies in early HER2 positive breast cancer to substantiate the long-term benefit derived from one year of treatment”.

“These important long-term results from the HERA trial reinforce that women with this aggressive type of cancer have the best chance of cure with Herceptin”, said William M. Burns, CEO of Roche’s Pharmaceuticals Division.

Historically, HER2 positive breast cancer has been associated with a poor prognosis, but the first analysis of the HERA trial, released in 2005, established unprecedented benefits in terms of lowering the risk of cancer returning (disease-free survival). “It is rewarding to see that women with HER- 2 positive early breast cancer can be confident about their future with Herceptin as the foundation of their treatment” said Dr Luca Gianni from the Istituto Nazionale Tumori Milano, Italy, lead investigator of the HERA study.

To date, four large studies HERA, NSABP B-31, NCCTG N9831 and BCIRG 006 have consistently demonstrated that Herceptin prolongs survival in women with HER2 positive early breast cancer.

About the HERA study

HERA is a large international phase III study conducted as collaboration between BIG and Roche. The study, with over 5000 patients enrolled, is assessing the benefits of adjuvant Herceptin treatment in women with HER2 positive early breast cancer. The primary endpoint is disease-free survival (DFS), the secondary endpoint is overall survival (OS) and cardiac safety.

Previously, with 2 years of median follow up, the HERA study demonstrated that one year of treatment with Herceptin given at three-weekly intervals after the completion of adjuvant chemotherapy and/or radiotherapy achieved a highly significant improvement in DFS versus the observation group (no Herceptin), reducing the relative risk of relapse by 36% (hazard ratio [HR]: 0.64; 95% confidence interval [CI]: 0.54, 0.76; p=0.0001).1 Herceptin also reduced the risk of death by 34% compared to observation (HR: 0.66; 95% CI: 0.47, 0.91; p=0.0115). Upon publication of these unprecedented results in 2005, more than 50% of the patients in the observation arm opted to receive Herceptin (‘crossed-over’ to Herceptin treatment).

The focus of the current analysis was to evaluate the efficacy and safety of one year of Herceptin treatment versus no Herceptin at a median of four years follow-up after entry onto the study. The results of the analysis including all women involved in the trial (intent to treat, ITT) showed a 25% reduction in risk of cancer recurrence for women receiving Herceptin compared to those on observation (no Herceptin) (HR 0.76; p=0.0001). At four years of follow-up, nearly 79% of women receiving Herceptin remained cancer-free, a significant increase compared to 73% of women in the observation arm. With regard to safety, it was shown that the incidence of severe cardiac dysfunction associated with adjuvant Herceptin-based therapy was low (0.8%). These results confirm the benefit and safety of one year of Herceptin treatment in women with HER2 positive tumors despite the substantive crossover of patients from the observation group to active treatment. The present analysis also suggests that women who crossed over derived benefit from Herceptin even if they started Herceptin therapy late after completion of adjuvant chemotherapy.

The HERA study is ongoing and final results are expected in 2011.

About breast cancer

Breast cancer is the most common cancer among women worldwide.2 Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually.3

In HER2 positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2 positivity’ and affects approximately 20-25% of women with breast cancer.

About Herceptin

Herceptin is a humanised antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumour. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (metastatic) HER2 positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2 positive breast cancer.

Herceptin received approval for use in the European Union for advanced (metastatic) HER2 positive breast cancer in 2000, and for early (adjuvant) HER2 positive breast cancer in 2006. In the advanced (metastatic) setting, Herceptin is approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In the early (adjuvant) setting, Herceptin is approved for use following standard (adjuvant) chemotherapy.

Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat nearly 600,000 women with HER2 positive breast cancer worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2008 sales by the Pharmaceuticals Division totaled 36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com.

All trademarks used or mentioned in this release are legally protected.

About BIG

The Breast International Group (BIG) is an international non-profit organisation for academic breast cancer research groups from around the world, based in Brussels, Belgium. Created by leading European opinion leaders in 1996, BIG now constitutes a network of 44 groups based in Europe, Canada, Latin America, and the Asia-Pacific region. These research entities are tied to approximately 3000 specialised hospitals and research centres worldwide. BIG also collaborates with the U.S. National Cancer Institute (NCI) and North American collaborative groups, with BIG and the North Americans together representing an impressive integrating force in the breast cancer research arena. To make significant scientific advances in breast cancer research, reduce the wasteful duplication of effort, and optimally serve those affected by the disease, large-scale cooperation is crucial. Therefore BIG facilitates breast cancer research at international level, by stimulating cooperation between its members and other academic networks, and collaborating with, but working independently from, the pharmaceutical industry.

References

(1) Smith I, Procter M, Gelber RD, et al., Lancet 2007; 369:29-36 1

(2) World Health Organization, http://www.who.int/cancer/detection/breastcancer/en

(3) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. 2004

Roche
http://www.roche.com

View drug information on Herceptin.

The conference is offered through the support of the Oncology Nursing Foundation Public Education Grant and the Pittsburgh Susan G. Komen Public Education Grant.

WHEN: 9 a.m. to 2 p.m., Saturday, March 21
WHERE: Gilda’s Club
2816 Smallman St.
Pittsburgh, PA 15222

R.S.V.P.: The conference is free and open to women living with advanced breast cancer. Each attendee is welcome to bring a guest.

To register, call (412) 383-8839 or e-mail mros@pitt.edu.

For over 30 years, post-operative radiotherapy was the standard treatment for glioblastoma, but offered only modest survival benefits to patients. The average life-expectancy of patients with glioblastoma was 9-12 months.

In 2004, after many disappointing attempts with drug therapy, the large international phase III EORTC-NCIC trial finally showed some promising results in this difficult setting where use of combined treatment with radiotherapy and temozolomide reduced the risk of dying from glioblastoma by 37% (HR for death 0.63, CI 0.53-0.75) compared with radiotherapy alone. At 2 years, 27% of patients receiving temozolomide in combination with radiotherapy (TMZ/RT) were alive, compared with just 10% of patients being treated with radiotherapy (RT) alone. However, whether this survival benefit would persist over time was unknown.

In this study, Roger Stupp and colleagues report the long-term 5-year outcomes of patients involved in the original EORTC-NCIC trial. The authors also examined whether clinical factors and the molecular profile of the tumours would identify patients with particularly good survival or response to chemotherapy.

Findings showed that at 3 years, 16% of patients receiving TMZ/RT were alive compared with only 4% of patients having RT alone. At 4 years, overall survival data after combined treatment were 12.1% compared with 3% for RT alone and at 5 years, 9.8% vs 1.9%, respectively. Importantly, improvement in survival was seen across all clinical prognostic subgroups, even in patients considered to have a poor diagnosis-such as more elderly patients or patients whose tumour could not be removed.

In exploratory analyses, overall survival data were best in patients being treated with TMZ/RT whose tumours carried an inactivated MGMT gene (0-6-methylguanine-DNA methyltransferase). Almost half of these patients were alive after 2 years and they also showed a persistent survival advantage at 3, 4, and 5 years. The authors suggest that testing tumours for the methylation status of the MGMT gene would allow the selection of patients most likely to benefit from this treatment.

Despite this improvement-with a substantial proportion of patients surviving for several years after treatment with TMZ/RT-most still died. The authors noted no difference in the pattern of recurrence between patients treated with RT alone or TMZ/RT, and caution that upfront combined therapy may be effective in reducing tumour bulk and aggressiveness, but it does not truly modify the natural behaviour of the disease, and thus is unlikely to lead to a cure.

*The EORTC-NCIC (European Organisation for Research and Treatment of Cancer and the National Cancer Institute of Canada Clinical Trials Group) trial was a randomised trial in which standard post-operative radiotherapy and standard post-operative radiotherapy combined with temozolomide followed by up to six cycles of temozolomide were compared in 573 patients with newly diagnosed glioblastoma.

TEMODAL is a chemotherapy agent approved in the EU for treatment of patients with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy, and for patients with malignant gliomas, such as GBM or anaplastic astrocytoma (AA), showing recurrence or progression after standard therapy. In the US, TEMODAR is approved for the treatment of adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment, as well as for refractory AA, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

“TEMODAR is a well recognized, effective treatment for patients with newly diagnosed GBM. The newly approved IV formulation of TEMODAR provides patients with an important alternative method of administration, and the European TEMODAL sachet presentation offers flexibility and a convenient alternative form of packaging,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “These two new options recognize Schering-Plough’s commitment to providing effective treatments in a variety of presentations for specific patient needs and patient convenience.”

About Malignant Gliomas

The worldwide incidence rate of primary malignant brain and central nervous system tumors, using the world standard population, is 3.7 per 100,000 person in males and 2.6 per 100,000 person in females(1). The most common type of primary malignant brain tumors are gliomas, with AA and GBM being the most common and among the most serious types.

About temozolomide

In addition to the new presentations, TEMODAL (temozolomide), a cytotoxic agent, is currently approved in oral form as 5mg, 20mg, 100mg, 140mg, 180mg and 250mg capsules in Europe. Cytotoxic agents are designed to impact the replication of cells that divide rapidly, such as those in tumors.

TEMODAL was initially approved in the EU in 1999 for the treatment of patients with malignant glioma, such as GBM or AA, showing recurrence or progression after standard therapy. In June 2005, TEMODAL received marketing approval in the EU for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy and subsequently as monotherapy treatment. The TEMODAL IV formulation approved by the EU Commission was developed for cancer patients who are unable to take TEMODAL Capsules and has shown bioequivalence to the oral product. The sachet packaging presentation for TEMODAL Capsules was created to provide greater patient convenience and flexibility.

TEMODAR capsules (temozolomide) received accelerated approval from the US Food and Drug Administration (FDA) for adult patients with refractory AA in 1999 and full approval in March 2005 for refractory AA, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine, and for the treatment of newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment.

Important Information Regarding US Labeling for TEMODAR and TEMODAR Intravenous Formulation

TEMODAR(R) (temozolomide) is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. TEMODAR is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

TEMODAR(R) is contraindicated in patients who have a history of hypersensitivity (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis and Stevens-Johnson syndrome) to any of its components, or to DTIC.

Patients treated with TEMODAR(R) Capsules may experience myelosuppression including prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome. In some cases, exposure to concomitant medications associated with aplastic anemia including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim complicates assessment. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have also been observed.

Prophylaxis against Pneumocystis carinii pneumonia is required for all patients receiving concomitant TEMODAR(R) and radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. However, all patients receiving temozolomide, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen.

TEMODAR(R) can cause fetal harm when administered to a pregnant woman. In nursing women, a decision should be made whether to discontinue nursing or to discontinue TEMODAR(R), taking into account the importance of the drug to the mother. The safety and effectiveness of TEMODAR(R) in children have not been established.

As bioequivalence between TEMODAR Capsules and TEMODAR for Injection has been established only when TEMODAR for Injection was given over 90 minutes, infusion over a shorter or longer period of time may result in suboptimal dosing. Additionally, the possibility of an increase in infusion related adverse reactions cannot be ruled out.

TEMODAR(R) Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes.

Caution should be exercised when administered to those with severe hepatic or renal impairment.

In newly diagnosed patients with glioblastoma multiforme, the adverse event profile was similar in patients <65 years of age and those greater than or equal to 65 years.

In newly diagnosed glioblastoma multiforme the most common adverse reactions in clinical studies in the Concomitant Phase (Radiotherapy + TEMODAR(R)) and the Maintenance Phase (TEMODAR(R) alone), respectively, were alopecia 69%, 55%; fatigue 54%, 61%; nausea 36%, 49%; vomiting 20%, 29%; anorexia 19%, 27%; headache 19%, 23%; rash 19%, 13%; constipation 18%, 22%; with the following important adverse events also reported: convulsions 6%, 11% and thrombocytopenia 4%; 8%. Of these adverse events, those grade greater than or equal to 3 in clinical studies in the Concomitant Phase (Radiotherapy + TEMODAR) and the Maintenance Phase (TEMODAR alone), respectively, were fatigue 7%, 9%; nausea 1%, 1%; vomiting <1%, 2%; anorexia 1%, 1%; headache 2%, 4%; constipation 1%, 0%; convulsions 3%, 3%; thrombocytopenia 3%, 4%.

In the newly diagnosed GBM population, when laboratory abnormalities and adverse events were combined, Grade 3 or 4 neutropenia occurred in 8% and Grade 3 or 4 platelet abnormalities including thrombocytopenic events occurred in 14% of patients treated with temozolomide.

Most common adverse reactions in the trial in AA patients overall and Grade 3/4, respectively, were: nausea 53%, 10%; vomiting 42%, 6%; headache 41%, 6%; fatigue 34%, 4%; constipation 33%, 1%; convulsions 23%, 5%; with the following important adverse events also reported: hemiparesis 18%, 6%; asthenia 13%, 6%.

Adverse hematologic effects (Grade 3 to 4) in the AA trial in adults were lymphopenia (55%); platelets (19%); neutrophils (14%); WBC (11%); and hemoglobin (4%).

7% and 9.5% of patients over age 70 experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients less than or equal to age 70, 7% and 5.5% experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively.

Adverse reactions reported from intravenous formulation studies that were not reported in TEMODAR capsule studies were: pain, irritation, pruritus, warmth, swelling, and erythema at infusion site as well as the following adverse reactions: petechiae and hematoma.

About Schering Plough

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to TEMODAL and the potential market for TEMODAL. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Item 1A. “Risk Factors” in the 2008 10-K, filed February 27, 2009.

Also Included In: Neurology / Neuroscience; Regulatory Affairs / Drug Approvals; Clinical Trials / Drug Trials

“We are very pleased with these results. ProLindac was well tolerated in an absolute sense and relative to commercially-available platinum therapies. We saw significant DACH platinum activity and efficacy in patients at the highest dose levels which is very encouraging given that this study involved monotherapy in a heavily pretreated patient population that typically only respond to an aggressive drug combination,” commented Dr. David Nowotnik, Access’ Senior Vice President R&D. “The DACH platinum activity level seen benchmarked favorably with published studies of monotherapy oxaliplatin in similar but less heavily pre-treated patient populations. Having achieved the recommended dose for future combination studies, we look forward to moving ahead in the clinic ourselves and with our regional partners.”

This 26 patient Phase 2 study explored 3 different dose levels and 2 dosing regimens of ProLindac as a monotherapy treatment for advanced ovarian cancer, to provide data on the monotherapy anticanceractivity and safety of ProLindac. Of patients eligible for evaluation according to standard RECIST criteria, clinically-meaningful disease stabilization was achieved in 42% of all patients, and 66% of all patients in the higher dose groups. Sustained and significant reductions in Ca-125, the established specific serum marker for ovarian cancer, were also observed in several patients.

“We are delighted that the results from this study support our belief that ProLindac is an active platinum agent with a favorable side effect profile,” stated Jeffrey B. Davis, Access’ President & CEO. “These data provide us with a strong incentive to continue the clinical development of ProLindac. As previously announced, we are currently planning a number of combination trials, looking at combining ProLindac with other cancer agents, such as taxol and gemcitabine, in multiple solid tumor indications including colorectal and ovarian.”

Access has previously announced that it has licensed ProLindac to Jiangsu Aosaikang Pharmaceutical Co., Ltd. (“ASK”) for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both of these partners will be conducting Phase 2 combination studies with ProLindac in specific tumor types at their expense based on these results. Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories.

About ProLindac(TM):

ProLindac is a novel DACH platinum prodrug which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. Access believes that ProLindac’s unique molecular design potentially could eliminate some of the toxic side effects seen in the currently marketed DACH platinum, Eloxatin, which has sales in excess of $2 billion.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access’ products include ProLindac(TM), currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard(TM) for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix(R), a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; Prodrax(R), a non-toxic prodrug which is activated in the hypoxic zones of solid tumors to kill cancer cells; Alchemix, a chemotherapeutic agent that combines multiple modes of action to overcome drug resistance. Access is also developing Phenylbutyrate (“PB”), an HDAC inhibitor and differentiating agent currently a Phase 2 clinical candidate. Access recently announced the acquisition of MacroChem Corporation. This acquisition provides Access with three additional late-stage product candidates. Pexiganan, a novel topical anti-infective for the treatment of diabetic foot infection, has already completed two Phase 3 trials. EcoNail is a topically applied econazole lacquer based on Access’ proprietary SEPA polymer technology, for the treatment of onychomycosis, a condition commonly known as nail fungus. Thiarabine is a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. For additional information on Access Pharmaceuticals, please visit our website at http://www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access’ plans to continue and initiate clinical trials, the value of its products in the market, its ability to achieve clinical and commercial success and its ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

Also Included In: Women’s Health / Gynecology; Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry

A copy of the presentation will be available on the company’s corporate website at http://www.lexpharma.com.

About ENETS

The ENETS conference is a medical conference focused on diagnosis and treatment of neuroendocrine tumors including carcinoid. The meeting brings together leading neuroendocrine tumor experts from around the world in such fields as oncology, pathology, radiology, nuclear medicine, endocrinology, surgery and gastroenterology. The 2009 ENETS conference runs from March 5-7 in Granada, Spain.

About Carcinoid Syndrome and LX1032

Carcinoid syndrome is a chronic condition that is the result of metastatic neuroendocrine tumors that usually originate from the gastrointestinal tract. These tumors secrete large amounts of serotonin, which can cause a variety of symptoms including severe diarrhea and abdominal discomfort. LX1032 acts to reduce serotonin production by inhibiting tryptophan hydroxylase (TPH), a key enzyme in the synthesis of serotonin.

LX1032 is being developed in a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.

About Lexicon

Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by the company’s research team. The company has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit http://www.lexpharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX1032 and the potential therapeutic and commercial potential of LX1032. This press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct clinical development of LX1032 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Factors Affecting Forward-Looking Statements” and “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Dr Paul Ashton, President and CEO of pSivida Corp. said, “We are very pleased to be progressing BrachySil™ as a potential new treatment for pancreatic cancer, a devastating disease for patients and their families.”

The dose ranging study, conducted in the UK at Guy’s and St Thomas’ NHS Foundation Trust, London and University Hospital, Birmingham is designed to assess the safety of escalating radiation doses of the BrachySil™ device. Patient survival and tumor response are secondary end points.

This dose ranging study follows a safety study of BrachySil in patients with inoperable pancreatic cancer. This first study had shown BrachySil in combination with standard chemotherapy (gemcitabine) was well tolerated with no clinically significant adverse events related to the device. The data also showed disease control in 82% of patients and an overall median survival of people in the study of 309 days. BrachySil™ was also found to be easily deliverable by endoscopic ultrasound. This was presented at ASCO (American Society of Clinical Oncology)-GI.

Pancreatic cancer is the fourth most frequent cause of cancer death, and at least 80% of patients present with inoperable locally advanced or metastatic disease. The median survival for these patients following diagnosis is typically less than 178 days with standard chemotherapy. Accordingly, there is significant clinical and market demand for more effective therapies.

About pSivida Corp.

pSivida is a world leader in the development of miniaturized, injectable, drug delivery systems for the eye. pSivida has two products approved by the Food and Drug Administration (FDA): Retisert® to treat uveitis and Vitrasert® for treating AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has one product in fully recruited Phase III clinical trials: Iluvien™, which delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), formerly known as Medidur FA for DME. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.

pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida completed an initial safety and efficacy clinical trial of BrachySil for the treatment of pancreatic cancer and has commenced a dose-ranging clinical trial.

pSivida’s intellectual property portfolio consists of 45 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.

Safe Harbor Statements Under The Private Securities Litigation Reform Act Of 1995

Various statements made in this release are forward-looking and involve a number of risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the forward-looking statements: maintaining key collaboration agreements with Alimera and Pfizer; uncertainties regarding the achievement of milestones and other contingent contractual payment events; failure to prove safety and efficacy of Iluvien or BrachySil; inability to raise capital; continued losses and lack of profitability; inability to derive revenue from Retisert; termination of license agreements; inability to pay any registration penalties; inability to develop or obtain regulatory approval for new products; inability to protect intellectual property or infringement of others’ intellectual property; inability to obtain partners to develop and market products; competition; risks and costs of international business operations; manufacturing problems; insufficient third-party reimbursement for products; failure to retain key personnel; product liability; failure to comply with laws; failure to achieve and maintain effective internal control over financial reporting; impairment of intangibles; volatility of stock price; possible dilution through exercise of outstanding warrants and stock options or future stock issuances; possible influence by Pfizer; and other factors that may be described in our filings with the Securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. We do not undertake to publicly update or revise our forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied in such statements will not be realized .

Previous studies have shown that younger breast cancer patients consistently have poorer outcomes than patients who develop the disease later in life, which can translate into lower rates of overall survival. While the reason for this is not known, it is suggested that breast cancer in younger patients is more biologically aggressive.

Researchers from the University of Texas M.D. Anderson Cancer Center in Houston sought to determine which form of breast cancer treatment breast-conserving therapy, mastectomy alone or mastectomy with adjuvant radiation better benefits younger women with either Stage I or Stage II breast cancer.

A total of 652 young women with breast cancer from 1973 to 2006 were studied, with 197 of the patients having received breast-conserving therapy, 237 having received a mastectomy and 234 having received mastectomy with adjuvant radiation. The study authors confirmed that younger breast cancer patients do have relatively high locoregional recurrence rates, but that patients with Stage II disease achieved the best locoregional control rates with mastectomy plus adjuvant radiation therapy. Patients with Stage I disease had similar outcomes with breast-conserving therapy and mastectomy, but adding chemotherapy to either treatment was beneficial.

“Locoregional recurrence after optimal breast cancer treatment in young women remains a significant problem,” Beth Beadle, M.D., Ph.D., a resident at M. D. Anderson and lead author of the study, said. “Our study hopefully will help radiation oncologists plan therapies for younger breast cancer patients, who have inferior outcomes compared to older patients, and generate new interest in prospective studies to evaluate the best treatment strategies for these young women.”

ASTRO is the largest radiation oncology society in the world, with more than 10,000 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to improving patient care through education, clinical practice, advancement of science and advocacy. For more information on radiation therapy, visit http://www.rtanswers.org. To learn more about ASTRO, visit http://www.astro.org.

“The study is significant because ILC can often be difficult to detect mammographically and is often not palpable at clinical examination. BSGI offers improved detection of this form of breast cancer that impacts approximately 10 percent of new breast cancer patients every year,” said Dr. Rachel Brem, Director of Breast Imaging and Intervention at George Washington University Medical Center in Washington, D.C., and Vice Chair of the Department of Radiology.

Brem and her colleagues conducted a retrospective multi-center study of women with biopsy-proven ILC. All patients had undergone mammography and BSGI, and the imaging findings were classified as positive or negative for invasive lobular carcinoma by experienced breast imagers. Ultrasound and MRI results, if performed, were included for analysis. The sensitivity of mammography, ultrasound, MRI and BSGI was determined for each modality and compared. Twenty-six women, ages 46 to 82 (mean age of 62.8), with 28 biopsy proven pure ILC, mean size of 22.3mm (2mm – 90mm), were included.

The study concludes that BSGI had the greatest sensitivity for the detection of ILC with a sensitivity of 93 percent. Mammography, ultrasound and MRI demonstrated sensitivities of 79 percent, 68 percent and 83 percent, respectively.

With BSGI, the patient receives a pharmaceutical tracing agent that is absorbed by all the cells in the body. Due to their increased rate of metabolic activity, cancerous cells in the breast absorb a greater amount of the tracing agent than normal, healthy cells and generally appear as “hot spots” on the BSGI image. The Dilon 6800 Gamma Camera is a high-resolution, compact gamma camera, optimized to perform BSGI. The camera provides a manageable four to 16 images versus up to thousands of images with breast MRI.

“BSGI is a physiologic, rather than an anatomic, approach to breast cancer diagnosis. It is likely that the molecular imaging obtained with BSGI is the reason it has the greatest sensitivity for the detection of invasive lobular cancer,” said Dr. Brem. “In our study, the sensitivity of BSGI for detecting ILC was greater than MRI. In fact it is known that MRI can be limited in the detection of ILC. In addition, the cost of BSGI is significantly less than a breast MRI.”

The complete study can be found in The American Journal of Roentgenology, Invasive Lobular Carcinoma: Detection with Mammography, Sonography, MRI, and Breast-Specific Gamma Imaging, AJR: 192, February 2009; Pages 379 – 383.

About Dilon Technologies

Dilon Technologies Inc. is bringing innovative new medical imaging products to market. Dilon’s cornerstone product, the Dilon 6800, is a high-resolution, compact field-of-view gamma camera, optimized to perform BSGI, a molecular breast imaging procedure which images the metabolic activity of breast lesions through radiotracer uptake. Many leading medical centers around the country are now offering BSGI to their patients, including: Cornell University Medical Center, New York; George Washington University Medical Center, Washington, D.C.; and The Rose, Houston. For more information on Dilon Technologies please visit http://www.dilon.com.

Dilon Technologies Inc.
http://www.dilon.com

The primary objective of the study is to assess the efficacy of MORAb-009 as combination therapy with the current standard of care as determined by progression-free survival in patients with locally advanced malignant pleural mesothelioma. Secondary objectives include safety and anti-tumor activity of MORAb-009 as determined by objective response rate. The patient population includes individuals with locally advanced malignant pleural mesothelioma who have not received any prior treatment for their disease. Morphotek expects to enroll up to 86 patients in this clinical study, which is being conducted at clinical centers globally.

“We are excited to have initiated this Phase II study of MORAb-009 in mesothelioma in cooperation with leading physician-scientists,” stated Martin D. Phillips, M.D., Chief Medical Officer at Morphotek. “Mesothelioma has a generally poor prognosis, so we hope that MORAb-009 will one day provide a benefit and hope to mesothelioma cancer patients.”

MORAb-009 is a monoclonal antibody that blocks the function of mesothelin, a cell surface protein on mesothelioma, pancreatic and a subset of other types of tumor cells that can allow these cells to attach, metastasize and grow. Mesothelin has been demonstrated by several independent studies to be expressed on virtually all mesothelioma tumors. Preclinical data support the theory that MORAb-009 achieves its pharmacological effect by two mechanisms: first, by blocking mesothelin’s ability to interact with its target and second, by stimulating the patient’s immune system to attack the tumor by specifically destroying those cells bound by MORAb-009. The Phase II clinical trial is supported by safety data and clinical observations from a recently completed Phase I trial of MORAb-009 in patients with mesothelin-bearing tumors, including pancreatic, mesothelioma and ovarian cancers as well as data derived from preclinical models.

Mesothelioma develops in the chest outside the lungs, usually growing asymptomatically before it is discovered. It is especially common in people who have been exposed to asbestos, such as ship yard workers and pipefitters. Each year, an estimated 2,500 to 3,000 people are diagnosed with mesothelioma in the United States. It accounts for more than 2,500 deaths in the United States. It accounts for approximately 43,000 deaths worldwide each year.

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About Morphotek

Morphotek, Inc., a subsidiary of Eisai Corporation of North America, is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit http://www.morphotek.com/.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery. For more information about Eisai, please visit http://www.eisai.com/.

Main Category: Asbestos / Mesothelioma
Also Included In: Clinical Trials / Drug Trials; Cancer / Oncology