Mylan Inc. (NASDAQ MYL) announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the Presidents Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

Mylans product represents the firstever fixeddose combination of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate and now provides Matrix with numerous Tenofovir combination product opportunities. This new drug adds to the Matrix portfolio of important treatments for HIV/AIDS. The product may be used for either first or secondline treatment in adults. People use secondline therapies if and when they develop resistance to initially prescribed treatments.

Mylan President Heather Bresch said “This product represents yet another important advance in our continuing fight against the global epidemic of HIV/AIDS. By combining three antiretroviral (ARV) products into a oncedaily dose, we can dramatically improve the quality of care for people living with HIV/AIDS in emerging markets. Lower pill burden also increases the likelihood that patients adhere to treatment. This innovation also adds another affordable option to our large and rapidly growing portfolio of lifesustaining ARV products.”

The FDAs tentative approval under PEPFAR means that Matrixs product meets all of the agencys manufacturing quality, safety and efficacy standards. Although existing patents or exclusivity prevent its marketing in the U.S., the product will be eligible for purchase outside the U.S. in many developing countries.

Matrixs wide range of ARV products includes active pharmaceutical ingredients and first and secondline finished doses. The companys emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries who are receiving treatment depend on Matrix ARV products.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industrys broadest and highest quality product portfolios supported by a robust product pipeline; operates the worlds third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies.

Biogen Idec (NASDAQ BIIB) today announced data results from the CHAMPIONS (Controlled HighRisk AVONEX® (interferon beta1a) Multiple Sclerosis (MS) Prevention Study In Ongoing Neurologic Surveillance) study, an open label followup to CHAMPS (Controlled High Risk Subjects AVONEX MS Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. The CHAMPIONS tenyear follow up showed that patients treated immediately after their first episode had significantly less chance of experiencing a second attack versus those patients with delayed treatment. These results at ten years also indicate that 80 percent of patients taking AVONEX were below an expanded disability status scale (EDSS) score of three. These data were presented as a poster at the Annual American Academy of Neurology (AAN) meeting.

“There is a consensus among physicians that early initiation of effective therapy beginning shortly after symptom onset may be required to alter the long term course of MS, but until now there has been little evidence to support this hypothesis,” said Dr. R. Philip Kinkel, director of the multiple sclerosis center, Beth Israel Deaconess Medical Center in Boston, MA and lead investigator of CHAMPIONS. “This data confirms that treatment of high risk patients beginning shortly after symptomonset reduces relapse rates and may reduce disease progression for up to 10 years. This may translate into an ability to remain active and enjoy daily activities that otherwise might be lost without treatment.”

The CHAMPIONS open label followup study was designed to determine longterm clinical outcomes and the tenyear follow up included 155 patients from 24 of the 50 Phase III CHAMPS study sites. Key findings include

40 percent reduction in conversion to CDMS in patients treated immediately upon diagnosis of CIS versus those that were delayed by a median of 30 months (original placebo randomization arm)

91 percent of patients had an EDSS less than 4.0 after 10 years;

80 percent of patients on AVONEX had an EDSS of less than 3; and

the annualized relapse rate for patients with up to 10 years of care was only 0.25, suggesting a relapse rate of only one relapse every four years

“The CHAMPIONS study adds to the longterm followup data available and supports the benefits of starting early and staying on treatment with AVONEX,” said Thorsten Eickenhorst, M.D., vice president of global medical affairs, Biogen Idec. “This followup study conducted in MS patients who received early treatment reinforces the clinical effectiveness of AVONEX in patients who experience their first clinical MS episode.”

About AVONEX

AVONEX is the number one most prescribed treatment for relapsing forms of MS worldwide, with approximately 135,000 patients on therapy. It was launched in the U.S. in 1996 and in Europe in 1997 for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX has been proven effective in clinical trials for up to three years. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS; this use was approved in Europe in 2002 and in the U.S. in 2003.

The most common side effects associated with AVONEX multiple sclerosis treatment are flulike symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain, and asthenia.

AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idecs significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis.

Source Biogen Idec

Shire plc (LSE SHP, NASDAQ SHPGY), the global specialty biopharmaceutical company, reported that it has completed its submission of a New Drug Application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the U.S. Food and Drug Administration (FDA). The Company also announced positive results from the final two Phase III studies of velaglucerase alfa, with both studies reaching all of their primary and secondary endpoints.

“The submission of the NDA for velaglucerase alfa, earlier than previously announced, is an important milestone for Shire, bringing us another step closer to providing a new treatment option for patients with Type 1 Gaucher disease,” said Sylvie Gregoire, President of Shire Human Genetic Therapies. “We are also pleased to report that the data from our final two Phase III trials met our expectations by reaching all of their primary and secondary endpoints, demonstrating consistency with the results recently reported from the first Phase III trial. In addition, we are ontrack to submit our European filing for velaglucerase alfa by the end of 2009.”

Shires velaglucerase alfa program included the largest and most comprehensive set of Phase III clinical trials conducted to date for Gaucher disease. Over 100 patients at 24 sites in 10 countries around the world have participated in the clinical studies.

“I am impressed by the series of clinical trials that were designed to evaluate velaglucerase alfa at multiple doses and in different patient groups,” said Dr. Christine Eng, Professor of Molecular and Human Genetics, Baylor College of Medicine. “The inclusion of children, who are often the sickest patients, is especially useful. I believe velaglucerase alfa will be an important new treatment option for Type 1 Gaucher disease and I am pleased that there is a mechanism in place for physicians to access this therapy for their patients.”

Velaglucerase alfa is made using Shires proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and has a human glycosylation pattern.

Phase III Studies Overview and Results

All three Phase III studies of velaglucerase alfa demonstrated positive results. The product was generally welltolerated in both treatment naive and previously treated Gaucher patients. The three studies included Study 032, which studied velaglucerase alfa in naive patients; Study 039, which was a headtohead study of velaglucerase alfa and imiglucerase; and Study 034, which was a switch study from imiglucerase to velaglucerase alfa.

As reported on August 3, 2009, Study 032 in naive patients met its primary endpoint which evaluated change in hemoglobin concentrations from baseline.

Study 039 was a 9month, randomized, doubleblind efficacy study in 34 treatment naive patients aged two years and older that compared velaglucerase alfa to imiglucerase. Patients were eligible to participate in the study if they presented with diseaserelated anemia and had at least one of the following clinical manifestations of Gaucher disease thrombocytopenia, moderate splenomegaly or a readily palpable enlarged liver. Patients were randomized to receive either velaglucerase alfa or imiglucerase at 60 U/ kg every other week. The primary endpoint was the comparison of increases in hemoglobin concentrations between the velaglucerase alfa and imiglucerase groups. Secondary endpoints were comparisons of increases in platelet counts, decreases in organ volumes, and surrogate markers of Gaucher disease.

In this study of enzyme replacement naive patients, velaglucerase alfa demonstrated robust clinical efficacy that was comparable to imiglucerase in all endpoints.

Study 034 was a 12month switch study in 40 clinically stable Type 1 Gaucher patients aged two years and older who had been receiving treatment with imiglucerase at doses ranging between 15 U/kg and 60 U/kg every other week for a minimum of 30 consecutive months. This study assessed the safety of patients switched from imiglucerase to velaglucerase alfa administered at the same number of units as their imiglucerase dose. In this study, hemoglobin concentrations, platelet counts, and organ volumes were sustained through 12months of velaglucerase alfa treatment, and the therapy was generally welltolerated.

In all three studies, most adverse events were mild to moderate in intensity. Most of the drugrelated adverse events were reported in association with velaglucerase alfa infusions, all of which resolved without sequelae.

The development of antibodies to velaglucerase alfa was rare in all three studies, occurring in approximately 1% of patients treated.

The specific data from all three trials will be presented at future scientific meetings.

Background on Gaucher disease

Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme betaglucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside, primarily in macrophages. In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs. The accumulation of glucocerebrosidase in the liver and spleen leads to organomegaly. Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises. Deposits in the bone marrow and splenic sequestration lead to clinically significant anemia and thrombocytopenia.

Gaucher disease is the most prevalent lysosomal storage disorder, with an incidence of about 1 in 20,000 live births. Gaucher disease has classically been categorized into 3 clinical types. Type 1 is the most common; it is distinguished from Type 2 and Type 3 by the lack of central nervous system involvement. Type 1 Gaucher disease is characterized by variability in signs, symptoms, severity, and progression.

Velaglucerase alfa supplements or replaces betaglucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.

Shire plc

Shires strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shires inlicensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively smallscale sales forces will deliver strong results.

“Safe Harbor” Statement Under The Private Securities Litigation Reform Act of 1995

Statements included herein that are not historical facts are forwardlooking statements. Such forwardlooking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Companys results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Companys Specialty Pharmaceutical and Human Genetic Therapies products, including (without limitation) velaglucerase alfa, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Companys products; the Companys ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Companys products; the Companys ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Companys ability to obtain and maintain government and other thirdparty reimbursement for its products; and other risks and uncertainties detailed from time to time in the Companys filings with the Securities and Exchange Commission.

Source Shire Plc

Deep in Africas Kalahari Desert lies the “Devils claw,” a plant that may hold the key to effective treatments for arthritis, tendonitis and other illnesses that affect millions each year. Unfortunately, years of drought have pushed the Devils claw toward extinction, so scientists are scrambling to devise new ways to produce the valuable medicinal chemicals of the Devils claw and other rare plants.

One group of scientists reported a major advance toward that goal here today at the 238th National Meeting of the American Chemical Society (ACS). They described the first successful method of producing the active ingredients in Devils claw ingredients that have made the Devils claw a sensation in alternative medicine in Europe. Their technique may eventually lead to the development of “biofactories” that could produce huge quantities of rare plant extracts quickly and at little cost.

Milen I. Georgiev, Ph.D., who delivered the report, pointed out that for thousands of years, native populations in Southern Africa have used the Devils claw as a remedy for a huge number of ailments, including fever, diarrhea and blood diseases. Today, there are dozens of medicinal and herbal products around the world that are based on chemicals derived from the Devils claw.

In particular, studies suggest that two chemicals the socalled iridoid glycosides harpagoside and harpagide may have beneficial effects in the treatment of degenerative rheumatoid arthritis, osteoarthritis, tendonitis, and other conditions, Georgiev said.

“In Germany, 57 pharmaceutical products based on Devils claw, marketed by 46 different companies, have cumulative sales volumes alone worth more than $40 million.” Georgiev noted. In the United States, Devils claw extracts are in phase II clinical trials for the treatment of hip and knee arthritis. Other promising uses are not far behind. But while the demand for these beneficial compounds is increasing, the supply of natural Devils claw is dwindling.

“The Devils Claw faces significant problems with its natural renewal, especially low rainfall,” Georgiev notes. “These problems are driving efforts to find alternative ways to produce high value compounds from the plant, independent of geographical and climatic factors,” he says.

Currently, more than 25 percent of all prescribed medicines used in industrialized countries are derived either directly or indirectly from plants, many of which are rare and sometimes endangered. “Hairy root,” an infectious plant disease caused by the soil bacteria Agrobacterium rhizogenes, is at the core of a promising new technique that could one day lead to “biofactories” that produce medicines derived from rare plants in huge quantities at a low cost. Georgiev notes that hairy roots are a big improvement over traditional, greenhousebased plant culturing.

“The transformed root cultures possess fast growth rates, genetic and biochemical stability and the capacity for synthesis of plant metabolites. It should be also mentioned that the amount of active metabolites in naturally grown plants in greenhouses significantly vary seasonally,” notes Georgiev. Hairy root biofactories, on the other hand, could produce consistently high levels of plant metabolites year round.

Georgiev and his team are the first to induce hairy root cultures of Devils claw. They took the roots of the Devils claw and infected them with the A. rhizogenes soil bacteria a natural genetic engineer to create a system of hairy roots to produce the plants key medicinal chemicals. Their studies demonstrated stable growth and high production of both iridoid glycosides harpagoside and harpagide. Previous studies were only capable of producing one of these two compounds.

Georgiev notes that there is a long way to go before hairy root biofactories become commercialized, but he hopes to make the technology ready for use within a few years.

“Our target aim is to develop such technology, so we are paying attention not only to fundamental scientific tasks, but also to those related to some of the technological problems associated with hairy root biofactories,” Georgiev said. “It is the desire of each scientist is to see the fruits of his work. In the current case, we hope to be able to develop costeffective laboratory technology for production of these pharmaceuticallyimportant metabolites within the next five years.”

Source
Michael Bernstein

QuatRx Pharmaceuticals Company, a privatelyheld biopharmaceutical company, announced positive topline efficacy results from the first of two patient cohorts in its second pivotal Phase 3 trial of the investigational compound, Ophena(TM) (ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). The Company has also successfully completed two long term safety extension studies from its first pivotal Phase 3 studies. QuatRx intends to use these results in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in early 2010 seeking approval for Ophena(TM), a new SERM (selective estrogen receptor modulator) for the treatment of the symptoms of vulvovaginal atrophy. Ophena(TM) is the only nonestrogen therapy currently in latestage development for the treatment of vaginal symptoms associated with menopause.

“We are delighted with the progress in our Phase 3 program of Ophena(TM), which provides further evidence of the potential of Ophena(TM) as a firstinclass nonestrogen drug for the treatment of vaginal atrophy, a highly prevalent and symptomatic condition” said Robert L. Zerbe, M.D., Chief Executive Officer of QuatRx. “These new efficacy data confirm results seen in our first phase 3 pivotal study and are an important milestone towards our planned NDA submission.”

This second Phase 3 study of Ophena(TM) is a randomized, doubleblind, placebocontrolled trial of 919 patients with vulvovaginal atrophy conducted at 116 sites in the United States. Patients were stratified into two cohorts based on their most bothersome moderate to severe vaginal atrophy symptom either vaginal dryness or dyspareunia (sexual pain). The results announced focus on the cohort of 314 patients from this study identifying vaginal dryness as their most bothersome symptom. The positive efficacy results in this cohort, achieved in all four coprimary endpoints, confirm the results seen in the first pivotal Phase 3 trial of Ophena(TM). The results also demonstrate that Ophena(TM) was welltolerated. A second cohort of the study, consisting of 605 patients with the most bothersome moderate to severe vaginal atrophy symptom of dyspareunia, is fully enrolled and will report out in late summer of this year.

The latest results showed statistically significant changes from baseline to week 12 compared to placebo in four coprimary endpoints the percentages of both parabasal cells and superficial cells in the vaginal maturation index, changes in vaginal pH (all p

Rep. Charles Rangel, DN.Y., says the House Ways and Means Committee may seek to raise money for health reform by imposing a $37 billion tax on drugmakers advertisements, Bloomberg reports “As lawmakers seek ways to pay for a healthcare overhaul, one thing thats not off the table is you can pick up $37 billion knocking out the deduction for advertising for prescription drugs,” Rangel said. The idea is among several proposals by Democratic legislators to raise reform money (Donmoyer, 6/16).

Rangels plan for taxing drugmakers, meanwhile, would pay for only a small piece of the bill, and the congressman said he expects to know whether that and other proposals are still on the table by Friday, CQ Politics reports. Speaking about the prescription drug ads, Rangel told CQ, “I go to the doctor and say, Did you ever think about ordering this for me? If he says no, I dont like him, because they promised me on TV that I [would] have no problems at all” (Rubin, 6/16).

CongressDaily “House Democrats are considering options such as raising the payroll tax that funds Medicare and slapping a new “surtax” on wealthier households to help pay for a $1 trillionplus healthcare overhaul bill, according to a document obtained by CongressDaily. Lawmakers and aides cautioned that no decisions have been made, but the options distributed to Ways and Means Democrats provide a glimpse of the possible directions that chamber is headed in as it seeks $600 billion in new tax revenues to fund the bill. Every one of House Ways and Means Chairman Charles Rangels proposed options is controversial, and runs the risk of angering interest groups ranging from the small business lobby to the moribund newspaper industry” (Cohn, 6/17).

Rangel also is proposing cuts to private plans operating in Medicare Advantage, Reuters reports “Companies, including Humana Inc and UnitedHealth Group Inc would be impacted by these cuts.” Rangel added that he too was examining cutting the “depth” of the insurance subsidy for lowerincome people (Dixon, 6/16).

“Almost 30 key lawmakers helping draft landmark healthcare legislation have financial holdings in the industry, totaling nearly $11 million worth of personal investments in a sector that could be dramatically reshaped by this summers debate,” The Washington Post reports. The list of members includes “Congresss most powerful leaders and a bipartisan collection of lawmakers in key committee posts.” For example, Senate Majority Leader Harry Reid, DNev., “has at least $50,000 invested in a healthcare index” (fund), and Sen. Judd Gregg, RNH, “a senior member of the health committee, has between $254,000 and $560,000 worth of stock holdings in major healthcare companies, including BristolMyers Squibb and Merck.” The data was part of a “release of financial disclosure forms for the House and Senate” on Friday.

“While no congressional rules bar members from holding financial stakes in industries they regulate, some ethics experts suggest that it often creates the appearance of a conflict of interest, particularly if there is a chance that the legislation could result in a personal financial boost.” But at “nearly 20%” of the national economy, “many legal experts say the healthcare industry is so predominant that it is impossible for lawmakers to avoid financial ties to that sector, suggesting that the best antidote is a clear disclosure system that makes every lawmakers finances publicly available.”

The 22member Senate Health, Education, Labor and Pensions Committee, which will consider a “liberalleaning proposal that includes the creation of a public plan” on Tuesday, includes “at least eight senators with financial interests in the health care industry worth a minimum of $600,000 and potentially worth as much as $1.9 million” (Kane, 6/13).

The New York Times adds that “Rep. Dave Camp of Michigan, the senior Republican on the Ways and Means Committee, one of three panels in the House with jurisdiction over health care, reported at least tens of thousands of dollars in healthrelated interests, including the medical technology giant Medtronic, the drug maker Wyeth and the insurance company Aetna.” But neither Sen. Max Baucus, DMont., and Sen. Charles. Grassley, RIowa, who are “expected to unveil a bipartisan plan” later in the week, have major healthrelated holdings. NancyAnn DeParle, President Barack Omabas chief health care advisor, earned “more than $2 million from 2008 to this year” while serving “on the boards of health companies and as director of a privateequity firm with health investments” (Calmes, 6/13).

The AP reports that the wife of Sen. Chris Dodd, DConn., “sits on the boards of four health care companies,” and received more than $200,000 in fees and stock options last year. Sen. Dodd is filling in for the ailing Sen. Edward Kennedy, DMass., as the “lawmaker in charge of writing the Senates bill” for the HELP Committee (Margasak and Theimer, 6/13).

Proteolix, Inc. announced data from ongoing Phase 2 and Phase 1b clinical trials of carfilzomib for the treatment of multiple myeloma at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany. Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors being developed by Proteolix for the treatment of hematologic malignancies and solid tumors.

Relapsed Multiple Myeloma Patients Achieve Responses with SingleAgent Carfilzomib

Keith Stewart, M.B., Ch.B., Professor, Division of Hematology/Oncology at the Mayo Clinic, Arizona presented positive data from an ongoing Phase 2 clinical trial of singleagent carfilzomib in relapsed multiple myeloma patients. Patients in the study have relapsed after receiving one to three prior therapies and are stratified according to prior exposure to bortezomib.

A total of 31 patients have been enrolled in the Phase 2 clinical trial to date, of which 45 percent had no prior bortezomib experience and 55 percent relapsed following bortezomib treatment. In both arms, substantial response rates were achieved and sustained. Bortezomibnaive patients achieved an overall response rate of 57 percent with a median duration of response of 8.5 months. The median time to progression in this cohort has not been reached.

Among patients with prior bortezomib exposure, 18 percent achieved partial responses and the median duration of response has not yet been reached in this population. The median time to progression for patients in this cohort was 8.9 months. Ten additional patients achieved stable disease.

“Carfilzomib monotherapy achieves durable responses in relapsed multiple myeloma patients regardless of their prior exposure to bortezomib, and notably, a number of patients remain progression free after twelve cycles,” said Dr. Stewart. “Further, carfilzomib has been generally well tolerated, and the compounds selectivity appears to avoid the offtarget effects, such as peripheral neuropathy, associated with currently available proteasome inhibitors.”

Adverse events were generally mild and manageable and carfilzomib has been well tolerated for up to one year. Of 31 patients treated, 29 percent have received 12 full cycles of treatment.

These data were reported by Dr. Stewart in an oral presentation, titled “# 0474 Safety and Efficacy Update of PX171004, an Openlabel Phase II Trial of Carfilzomib in Relapsed Multiple Myeloma,” on Saturday, June 6, 2009.

Carfilzomib Combination with Lenalidomide is WellTolerated; Achieves Responses in Heavily Pretreated Patients at Low Doses

Positive preliminary data from an ongoing Phase 1b doseescalating trial of carfilzomib in combination with lenalidomide and lowdose dexamethasone in relapsed and refractory patients was presented by Michael Wang, M.D., of the University of Texas MD Anderson Cancer Center on Sunday, June 7, 2009. The Phase 1b clinical trial is designed to evaluate safety and to establish a maximumtolerated dose of carfilzomib in combination with lenalidomide and dexamethasone administered on a 28day treatment cycle. Lenalidomide in combination with dexamethasone is currently indicated for use in patients with multiple myeloma who have had at least one prior therapy.

To date, the combination of carfilzomib and lenalidomide was well tolerated in heavily pretreated patients and adverse events were manageable. The most common adverse events reported include anemia and fatigue. No cases of peripheral neuropathy, a common adverse event associated with approved proteasome inhibitors, have been reported. A maximumtolerated dose has not yet been established and doseescalation in this trial continues.

Sixtyone percent of the 18 patients evaluable for efficacy achieved very good partial, partial or minor responses. Responses occurred in the first 28day cycle of treatment at doses well below the maximumtolerated dose for either lenalidomide or carfilzomib alone. Initial responses improved with continued therapy. Potent inhibition of the proteasome has been observed and the lenalidomide/dexamethasone combination does not appear to interfere with carfilzomibs activity.

“Results observed to date in our Phase 1b combination study of carfilzomib are very promising,” said Michael Kauffman, M.D., Ph.D., Chief Medical Officer of Proteolix. “We believe that carfilzomib in combination with lenalidomide and dexamethasone should provide superior activity to lenalidomide and dexamethasone alone. In addition, the lack of overlapping toxicities and absence of peripheral neuropathy may allow for longterm dosing and ultimately, sustained clinical benefit.”

Dr. Wang presented interim data from the Phase 1b clinical trial during the Novel Therapeutics and Drug Resistance session in an oral talk, titled “#1070 PX171006 Phase IB Multicenter Dose Escalation Study of Carfilzomib (CFZ) plus Lenalidomide (LEN) and Low Dose Dexamethasone (LODEX) in Relapsed and Refractory Multiple Myeloma (MM) Preliminary Results.”

About Multiple Myeloma

According to the American Cancer Society, in 2009, approximately 20,500 new cases of multiple myeloma will be diagnosed in the United States. Newly diagnosed patients have treatment options that include combination chemotherapeutic agents and stem cell transplantation. While many patients respond to treatment, most eventually relapse and require subsequent treatment. Few patients are ultimately cured of their disease. In spite of advances in the treatment of multiple myeloma, this year alone, approximately 10,500 patients are expected to die of the disease.

About Carfilzomib

Carfilzomib is the first in a new class of selective, irreversible proteasome inhibitors. Carfilzomib produces specific and sustained inhibition of the proteasome, leading to apoptosis in cancer cells with minimal offtarget effects. In Phase 1 and Phase 2 clinical trials, carfilzomib has demonstrated singleagent activity in hematologic malignancies and solid tumors, including multiple myeloma, Waldenstroms macroglobulinemia, mantle cell lymphoma and renal cell carcinoma.

Proteolix is conducting a comprehensive clinical development program evaluating carfilzomib for the treatment of multiple myeloma, including an ongoing accelerated approval study in heavily pretreated relapsed/refractory patients and a Phase 2 clinical trial in relapsed patients stratified by prior treatment with bortezomib. Both Phase 2 clinical trials are being conducted by Proteolix in collaboration with the Multiple Myeloma Research Consortium (MMRC). A Phase Ib clinical trial of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma is also ongoing. In addition, Proteolix is conducting a singleagent Phase 2 clinical trial of carfilzomib in patients with recurrent or advanced solid tumors.

About Proteolix

Founded in December 2003, Proteolix, Inc. is a privatelyheld biotechnology company, headquartered in South San Francisco, dedicated to discovering, developing and commercializing novel therapeutics that target protein degradation pathways for cancer and autoimmune diseases. Proteolixs lead product, carfilzomib, is the first in a new class of selective, irreversible proteasome inhibitors. Proteolix is also developing a pipeline of novel proteasome inhibitors, including a selective, oral proteasome inhibitor and a selective immunoproteasome inhibitor.

As projected, Eli Lilly and Company (NYSE LLY) has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA). Lillys resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia.

Lilly originally submitted the sNDA in the second quarter of 2008 but withdrew the application in November 2008 following discussions with the FDA primarily about statistical methodology and study design. At that time, Lilly said it expected to resubmit the application in the first half of 2009.

“The additional chronic osteoarthritis pain and chronic low back pain data were not available at the time of the initial submission,” said John Hayes, M.D., a Lilly Research Laboratories vice president. “We believe including these new data in the updated sNDA package will provide a broader clinical basis for the FDA to review the application.”

According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. (i) Chronic pain persists beyond acute pain or beyond the expected time for an injury to heal.(ii) Chronic pain disorders affect millions of Americans and can be a major cause of work absenteeism, underemployment and unemployment.

About Cymbalta

Based on preclinical studies, Cymbalta is a potent reuptake inhibitor of serotonin and norepinephrine. Although the exact way that Cymbalta works in people is unknown, it is believed to be related to an increase in the activity of serotonin and norepinephrine, which are two naturally occurring substances in the brain and spinal cord.

Cymbalta is approved in the United States for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+). Cymbalta is not approved for use in pediatric patients.

Important Safety Information

Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.

Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine), or have uncontrolled glaucoma. Patients should speak with their doctor about any medical conditions they may have including kidney problems, glaucoma, or diabetes. Patients should talk to their doctor if they have itching, right upper belly pain, dark urine, yellow skin or eyes, or unexplained flulike symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported. They should also talk to their doctor about alcohol consumption. Patients should tell their doctor about all their medicines, including those for migraine to avoid a potentially lifethreatening condition. Symptoms may include high fever, confusion, and stiff muscles. Taking Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase bleeding risk. Patients should consult with their doctor before stopping Cymbalta or changing the dose and if they are pregnant or nursing.

Patients taking Cymbalta may experience dizziness or fainting upon standing. The most common side effects of Cymbalta include nausea, dry mouth, sleepiness and constipation. This is not a complete list of side effects.

If patients have any questions, they should talk to their doctor before taking Cymbalta.

About Eli Lilly and Company

Lilly, a leading innovationdriven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers through medicines and information for some of the worlds most urgent medical needs.

This press release contains forwardlooking statements about the potential of Cymbalta for the management of chronic pain, and reflects Lillys current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will receive regulatory approval for chronic pain, or that it will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lillys filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forwardlooking statements.

References

(i) International Association for the Study of Pain.

(ii) American Pain Society. “Pain Control in the Primary Care Setting.” 200615.

Bayer Healthcare Pharmaceuticals Inc. announced that several studies evaluating the use of Leukine(R) (sargramostim) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting.

“We are excited to see that several studies of Leukine have been accepted at ASCO,” said Pam Cyrus, MD, vice president, Medical Affairs, Oncology, Bayer HealthCare Pharmaceuticals.

Leukine data highlights include the following

ChemotherapyInduced Neutropenia

Budget impact analysis of sargramostim use in patients with chemotherapyinduced neutropenia

Lead investigator M. Duh, Analysis Group, Inc., Boston, MA

Abstract e20596, Publication only

Melanoma

Immunological effects and clinical outcomes in patients with highrisk melanoma given adjuvant therapy with granulocytemacrophage colony stimulating factor (GMCSF, sargramostim)

Lead investigator Lynn Spitler, Northern California Melanoma Center, Saint Marys Medical Center, San Francisco, CA

Abstract e20004, Publication only

Follicular Lymphoma

Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission Phase III clinical trial results

Lead investigator S. J. Schuster, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA

Abstract 2, Plenary Presentation, Sunday, May 31, 100 PM to 400 PM, Level 2, West Hall D2

Neuroblastoma

A phase III randomized trial of the chimeric antiGD2 antibody ch14.18 with GMCSF and IL2 as immunotherapy following dose intensive chemotherapy for highrisk neuroblastoma Childrens Oncology Group (COG) study ANBL0032

Lead investigator A. L. Yu, Childrens Oncology Group

Abstract 10067z, Oral Presentation, Tuesday, June 2, 800 AM to 1045 AM, Level 3, W304E

About Leukine(R)

Leukine(R) (sargramostim) is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults (older than 55) with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and lifethreatening infections and infections resulting in death. Leukine also has been approved in the U.S. for use in four additional indications myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation and bone marrow transplantation failure or engraftment delay. Leukine is available in two formulations, both of which are suitable for IV infusion and subcutaneous injection

Liquid 500 mcg/mL sterile solution in multiuse vial

Lyophilized powder 250 mcg in singleuse vial ready for sterile reconstitution

Among its indications, Leukine is the only myeloid growth factor approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with AML.

Important Safety Considerations

Leukine is contraindicated in patients with excessive leukemic blasts in bone marrow or peripheral blood (10 percent), in patients with known hypersensitivity to GMCSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy. Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious or anaphylactic reactions occur, Leukine therapy should immediately be discontinued and appropriate therapy initiated. Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates or CHF; respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome, pleural and or/pericardial effusion, supraventricular tachycardia, sequestration of granulocytes in the pulmonary circulation and dyspnea have been reported in patients after Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration. Adverse events occurring in 10 percent of AML patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were fever, skin reactions, metabolic disturbances, nausea, vomiting, weightloss, edema, and anorexia. If ANC 20,000 cells/mm3 or if platelet counts 500,000 mm3, Leukine administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed. Leukine therapy should be discontinued if disease progression is detected during treatment.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the worlds leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units Womens Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The companys aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forwardlooking Statements

This news release contains forwardlooking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20F). The company assumes no liability whatsoever to update these forwardlooking statements or to conform them to future events or developments.