Biotechnology Brands

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Pfizer submits NDA for Sutent for treating gastrointestinal stromal tumors, metastatic renal cell carcinoma; receives fast track status

Pfizer Inc. submitted a New Drug Application to the Food and Drug Administration for Sutent (sunitinib malate) and was granted fast track status.

The company is hoping Sutent will be approved to treat malignant gastrointestinal stromal tumors and metastatic renal cell carcinoma in patients whose tumors will not respond to or tolerate the usual therapies. Pfizer said the drug "may provide significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists."

More than 2,000 patients have already received the drug. It works to halt the formation of blood vessels as well as tumor activity by stopping the blood supply to tumor cells and directly attacking them. It is one of the first in a class of drugs that selectively targets several protein receptors, or receptor tyrosine kinases. Researchers believe that inhibition of these receptors will starve tumors of the blood and nutrients they need and kill the cancer cells that make up the tumors.

In a Phase III study, Sutent was shown to more than double survival and significantly reduce tumor growth and spread when compared with Onyx Pharmaceuticals Inc. and Bayer AG's sorafenib. The drugs were administered to patients with gastrointestinal stromal tumors who were resistant to Novartis AG's Gleevec (imatinib mesylate).

Sutent is also being investigated as a monotherapy or adjuvant treatment for breast, lung, prostate and colorectal cancers.

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Boehringer will not proceed with Phase III studies for NS2330 in Alzheimer's disease, Parkinson's disease

Three Phase II trials of NeuroSearch A/S and Boehringer Ingelheim GmbH's NS2330 did not meet efficacy guidelines to proceed with Phase III development for the treatment of Alzheimer's disease and Parkinson's disease.

Boehringer, which is responsible for financing NS2330's development, will stop all development of the drug for AD based on the results of a 14-week, Phase II, proof-of-concept trial that involved 430 patients with mild to moderate forms of the disease.

The drug's development as a treatment for Parkinson's disease is still being discussed, but a Phase III trial will not take place at this time. This decision was made based on data from two 14-week, Phase II, proof-of-concept trials that involved 515 patients with advanced or early stage PD.

Preclinical safety testing for NS2330 has been completed and the results are satisfactory, NeuroSearch said. Based on this, and the drug's mechanism of action, the companies are looking to possibly develop NS2330 for additional indications.

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CMS revises previous estimate, projects lower costs for new Medicare drug benefit

The Centers for Medicare & Medicaid Services projected that the amount the government pays for each beneficiary for the new Medicare drug benefit will be approximately 14 percent less than previously expected.

Thus, beneficiaries will pay average premiums of $32.20 per month, approximately $5 less than the previous estimate of an average of $37.37.

The bids received from various providers allowed the calculation of this new per-person amount, but the number of bids and from whom has not been disclosed, The Wall Street Journal reported. Actual premiums will vary based on geographic region and different plans. Based on the newest projections, companies may adjust or withdraw their bids.

"We are far enough along to see that robust competition is translating into lower costs," CMS Administrator Dr. Mark McClellan told Reuters.

Insurance consultant John Gorman, a former Medicare official, told The New York Times that companies are keeping premiums low to "secure market share in the first year of the program," even if this means lower profits.

The government will protect insurers against large losses in their Medicare drug business in 2006 and 2007, but "I don't think that will last for long. You will see more realistic pricing--higher premiums--in 2008," Gorman explained.

According to the new calculation, the government is now expected to pay $94.08 per beneficiary each month, down from the previous projection of $109.18. Prior to this new estimate, total federal costs for the drug benefit were projected to reach approximately $37.4 billion in 2006 and approximately $724 billion during its first 10 years, The Journal added.

CMS will approve bids from the providers beginning next month, and enrollment into the various drug benefit plans will start in November.

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Study shows Enbrel improves quality of life in patients with ankylosing spondylitis

Amgen Inc. and Wyeth's Enbrel (etanercept) significantly improved health-related quality of life (HRQOL) in study patients with ankylosing spondylitis, or arthritis of the spine.

For this investigation, patients with ankylosing spondylitis were compared with members (n=2,474) of the general U.S. population, including Americans who had other medical conditions. They were assessed using the Short-Form 36 (SF-36), which is used to evaluate HRQOL.

Of the patients with ankylosing spondylitis, 40 were randomized to receive Enbrel or placebo for 16 weeks in a U.S. study, while 129 patients from a multinational sample first received placebo but were later treated with Enbrel during a 48-week, open-label extension trial.

At baseline, the patients with ankylosing spondylitis had lower scores on the SF-36 than the general U.S. population and the respondents with other medical conditions. The differences were especially evident on the physical domains.

At week 16, the U.S. patients treated with Enbrel showed increases in all eight scales of the SF-36. The differences in improvement from baseline in the U.S. patients were more significant on the scales of physical functioning, role physical, bodily pain and social functioning for those who received Enbrel compared with those who received placebo.

At week 48, the global sample of patients who received Enbrel showed statistically significant improvements of more than five points on all SF-36 scales; the greatest effects were again seen in the more physical scales, especially on the role physical scale.

"[T]herapy with [Enbrel] is associated with significant improvements in HRQOL, indicating that decrements due to [ankylosing spondylitis] may be at least partly reversible," the researchers summarized.

The complete study is published in the Aug. 15 issue of the journal Arthritis Care & Research.

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Researchers conduct systematic review of studies using cholinesterase inhibitors to treat patients with Alzheimer's disease

A review appearing in the Aug. 6 issue of the British Medical Journal explored scientific evidence for the clinical use of Eisai Inc. and Pfizer Inc.'s Aricept (donepezil hydrochloride), Novartis AG's Exelon (rivastigmine tartrate) and Johnson & Johnson's Reminyl (galantamine hydrobromide) for the treatment of Alzheimer's disease. The researchers concluded that recommendations for using cholinesterase inhibitors do not appear to be based on evidence.

A team of researchers in Germany performed a search using Medline, Embase and the Cochrane Database of Systematic Reviews and the terms "donepezil," "rivastigmine" and "galantamine."

Included in the review were all papers presenting original data of randomized, double-blind, placebo-controlled trials of these agents in patients with Alzheimer's disease. The research team excluded trials that did not examine clinical outcomes and those that focused on vascular dementia. They did not include head-to-head comparisons of these drugs, since their goal was "to explore the scientific evidence for the clinical benefits claimed for cholinesterase inhibitors and not to compare the benefits of the various cholinesterase inhibitors with each other."

Of the 412 studies identified, 22 studies met the inclusion criteria. In these 22 studies, the duration of treatment ranged from six weeks to three years and the number of patients per study ranged from 27 to 978.

Based on their review, the authors concluded that the methodological quality of the trials identified was poor. They observed flaws such as failure to correct for multiplicity, missing intention to treat analyses and mishandling of incomplete data. They also noted that the benefits measured on rating scales were minimal.

"Because of flawed methods and small clinical benefits, the scientific basis for recommendations of cholinesterase inhibitors for the treatment of Alzheimer's disease is questionable," the authors wrote.

They also noted that "[c]linicians often argue that cholinesterase inhibitors have an effect in a subgroup of only 10 percent to 20 percent of patients with Alzheimer's disease. As this subgroup cannot be identified in advance, they conclude that all patients with Alzheimer's disease should be treated."

In response to this view, the authors offered the following comments: "Firstly, this observation could also be due to a placebo effect. Secondly, if there are subgroups of patients who benefit, research should focus on the definition of responders. Thirdly, if the efficacy of the drugs is tested at the level of individual patients, clear reassessment procedures are needed for clinical practice."

Biotechnology Brands

Bayer Q2 net income rises but earnings fail to meet expectations

Bayer AG reported a nearly two-fold increase in second-quarter net income as its material science and health care divisions posted strong sales growth. The firm's second-quarter net income rose to approximately $491.2 million, or approximately $0.68 per share, compared with approximately $177.8 million, or approximately $0.24 per share, in the previous-year period.

Earnings before interest and tax and before special items were approximately $1.03 billion, less than the approximately $1.07 billion forecast by analysts polled by Reuters.

Net sales increased from approximately $7.17 billion in the second quarter of 2004 to approximately $8.53 billion in the same period this year.

While the material science division's net sales grew nearly 31 percent in local currency, the health care division achieved an 18.1 percent local-currency gain in net sales to approximately $2.87 billion; second-quarter sales of biologic hemophilia treatment Kogenate rose more than $50 million to approximately $210.5 million.

In addition, Bayer said it now expects full-year sales of more than approximately $31.45 billion and underlying earnings before interest and tax to increase by approximately 40 percent, up from a previous guidance of 20 percent; the health care group's full-year underlying earnings before interest and tax are expected to be "at least 10 percent higher than in 2004."

Including one-time, noncash income of approximately $242 million and excluding additional litigation-related expenses, the firm said it expects to take net special charges of between approximately $121 million and approximately $181.5 million.

Bayer shares closed at $36.82, down $0.93, or 2.5 percent, in heavy trading on the New York Stock Exchange.

Biotechnology Brands

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The Securities and Exchange Commission

The Securities and Exchange Commission is investigating whether medical researchers accept money to reveal information about drug studies to investment firms, The Seattle Times reported. A Times investigation found at least 26 cases in which doctors divulged confidential and critical information about their research to Wall Street brokerages or hedge funds. Typically, doctors receive $300 to $500 per hour to talk to Wall Street firms, while hedge funds and mutual funds pay up to $1 million a year to "matchmaker" firms to set up interviews. Responding to the Times report, Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee, asked the SEC and the Justice Department to investigate. Buying or selling confidential information to assist in investment decisions violates insider-trading laws and, according to Grassley, "[s]elling drug secrets violates a trust that is fundamental to the integrity of both scientific research and our financial markets."

Biotechnology Brands

Biotechnology Brands
CytRx Corp.

CytRx Corp. received a written explanation from the Food and Drug Administration explaining the reasons for the clinical hold placed on the company's Phase II trial for arimoclomol, an oral drug candidate for the treatment of amyotrophic lateral sclerosis. In July, CytRx received verbal notification from the FDA that a planned Phase II trial to investigate arimoclomol was placed on hold pending receipt and review of additional information. In order for the FDA to lift the hold, CytRx must submit existing clinical information on its related drug candidate, bimoclomol, which has been tested more extensively for safety in humans. The company must also add specific clinical tests to be administered to patients in the study.

Biotechnology Brands

Biotechnology Brands
BioSante Pharmaceuticals Inc.

BioSante Pharmaceuticals Inc. exercised an option for an exclusive license to three patents covering triple hormone contraception technology from Wake Forest University Health Sciences and Cedars-Sinai Medical Center. The technology is a novel combination of estrogens and progestins with androgens such as testosterone, BioSante said. "The testosterone component of the triple hormone contraceptive formulation may help restore sexual desire and activity to women taking traditional oral contraceptives who have experienced this side effect," the firm added. Under the agreement, BioSante will make an up-front payment, regulatory milestone payments, maintenance payments and royalty payments if a product that uses the technology is approved and marketed.

Biotechnology Brands

Biotechnology Brands
Corautus Genetics Inc.

Corautus Genetics Inc. entered into agreements with Caritas St. Elizabeth's Medical Center of Boston (CSEMC), possibly leading to Corautus administering clinical trials to evaluate the safety and efficacy of the firm's vascular endothelial growth factor-2 (VEGF-2) for the treatment of diabetic neuropathy. Under the agreements, Corautus will provide VEGF-2 for evaluation in the 64-patient, Phase I trial for diabetic neuropathy currently being conducted at CSEMC. If Phase I trial data are promising, the company has the exclusive right to develop and commercialize VEGF-2 for the treatment of diabetic neuropathy.

Biotechnology Brands