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Replies to #7245 on Biotech Values
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10nisman

02/01/05 10:58 PM

#7246 RE: aslan2772 #7245

Medicare prescription benefit to cover Viagra
Drug prescribed only when medically necessary
Tuesday, February 1, 2005 Posted: 12:04 PM EST (1704 GMT)

WASHINGTON (AP) -- Sexual performance drugs like Viagra will be covered by Medicare's new prescription benefit beginning next year, along with medications for other conditions like high blood pressure and heart disease, Health and Human Services officials said Tuesday.

And like those other drugs, prescriptions for Viagra will be tightly controlled. The law, which takes effect January 1 at a cost of more than $500 billion over a decade, says Viagra can be prescribed only when medically necessary, and in limited quantities.

"The law says if it's an (Food and Drug Administration)-approved drug and it is medically necessary, it has to be covered," said Gary Karr, spokesman for the Centers for Medicare and Medicaid Services, which administers the health insurance program for older Americans.

Since it was approved by the FDA in 1998, about 16 million men have tried Viagra, according to Pfizer, which makes the drug.

President Bush two years ago signed into law the new voluntary drug benefit, which is expected to cover the drug expenses of 11 million low-income older and disabled people. The government contends the program also could cut drug costs in half for most seniors.

Medicare issued final rules last month for the prescription program, for which low-income people begin registering in June. Other recipients are to sign up in November. The Los Angeles Times first reported Medicare's coverage of sexual performance drugs.

Conservatives say the law opens the door to precisely the kind of big government bureaucracy that they -- and Bush -- campaigned against.

There was never a discussion of what drugs would be covered during Congress's all-night debates on the issue, one analyst pointed out.

"You cannot have a universal entitlement like this without extreme micromanagement," said Robert E. Moffit, a health care analyst at the Heritage Foundation.

"Members of Congress, frankly, are not competent to make these decisions. Is Congress going to start writing prescriptions?" he added. "Micromanagement will institutionalize incompetence."

The signature component of last year's Medicare law, the prescription drug benefit, will vary widely in its impact on the 29 million older and disabled Americans that the Congressional Budget Office projects will enroll, the study said. The CBO said the average savings will be 37 percent in 2006.


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bladerunner1717

02/01/05 11:08 PM

#7247 RE: aslan2772 #7245

Could someone with more scientific expertise that I have--I have none--explain a little bit more of what this means.

Spectrum Pharmaceuticals Licenses RenaZorb(TM) From Altair Nanotechnologies
Monday January 31, 8:50 am ET
* RenaZorb(TM) second-generation lanthanum-based phosphate binders which utilize Altair's proprietary lanthanum nanomaterial technology have the potential to address a multi-billion dollar market opportunity for the treatment of hyperphosphatemia in patients with chronic kidney disease and end-stage renal disease


IRVINE, Calif., Jan. 31 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) announced today that it has acquired worldwide exclusive rights to RenaZorb(TM) (two second-generation lanthanum-based phosphate binding agents) from Altair Nanotechnologies, Inc. (Nasdaq: ALTI - News). These novel non-aluminum, non-calcium phosphate binders which utilize Altair's proprietary lanthanum nanomaterial technology have the potential to treat hyperphosphatemia, i.e., high phosphorus levels in blood, in patients with end-stage renal disease (ESRD) and chronic kidney disease (CKD), with potentially as little as one tablet per meal while currently approved therapies require as many as several tablets per meal. There are an estimated 340,000 ESRD patients in the U.S. who are on kidney dialysis, and the market for phosphate binding agents was in excess of $600 million in 2004. According to the National Kidney Foundation, the number of ESRD patients in the U.S. is expected to double over the next decade. In addition, there are an estimated 8.4 million CKD patients, representing a potential multi-billion dollar market opportunity, who are candidates for phosphate binder therapy under the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines, issued in 2003.
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Under the terms of the agreement, Spectrum acquired an exclusive worldwide license to develop and commercialize RenaZorb(TM) for all human therapeutic and diagnostic uses. Spectrum will pay to Altair an upfront payment of 100,000 shares of restricted Spectrum common stock and will make an equity investment of $200,000 for 38,314 shares of Altair common stock. In addition, Altair is eligible to receive payments upon achievement of a clinical development and certain regulatory and sales milestones, in addition to royalties on potential net sales. Additional financial details were not disclosed.

"This in-licensing of RenaZorb is an important step in our continued effort to build an extensive and well-diversified portfolio of drug product candidates that span all stages of development and address significant unmet medical needs," stated Rajesh Shrotriya, M.D., Chairman of the Board, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We are extremely pleased to establish this alliance with Altair. We look forward to advancing RenaZorb(TM) into clinical trials, and pursuing the appropriate regulatory strategy to maximize its potential."

"We are delighted to have the opportunity to work with the Altair team and look forward to developing and commercializing RenaZorb," stated Luigi Lenaz, M.D., of Spectrum Pharmaceuticals, Inc. "We believe there is a significant unmet medical need for the treatment of hyperphosphatemia, a condition that leads to significant bone disorders and cardiovascular disease, and is associated with a significantly higher death risk in patients with chronic and end-stage kidney disease. According to K/DOQI Guidelines, fewer than 30 percent of dialysis patients are able to achieve and maintain serum phosphorus levels in the optimal range, despite dietary phosphorus restriction and treatment with currently marketed phosphate binders. As a non-aluminum, non-calcium phosphate binder, RenaZorb has the potential to become one of the preferred first-line treatment options for hyperphosphatemia under the new K/DOQI Guidelines because it has the potential to significantly improve patient compliance by lowering the daily pill burden to the lowest-in-class dosage, namely one tablet per meal, and smaller-sized tablets, in addition to a potentially more favorable safety and efficacy profile."

"We are delighted to have a collaborator for the first of our Life Sciences initiatives, RenaZorb, with the drug development, regulatory and commercialization expertise of Spectrum's management," stated Alan J. Gotcher, Ph. D., Chief Executive Officer of Altair Nanotechnologies, Inc. "We look forward to working with Spectrum to enhance and expedite the development of this promising compound."

"RenaZorb represents a new generation of high performance phosphate binding drugs that have significant promise in terms of dose and compliance," stated Dr. Ravi Thadhani, M.D., M.P.H. Department of Medicine and Renal Unit, Massachusetts General Hospital, Boston, MA. "The partnership between Altair and Spectrum is an excellent complementary marriage of leaders in their respective fields."

http://biz.yahoo.com/prnews/050131/lam041_1.html


Bladerunner


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DewDiligence

02/01/05 11:36 PM

#7252 RE: aslan2772 #7245

>>My point is only that TrpRS is not likely to be membrane permeable, and thus not a good choice for elution from a device if its target is intracellular.<<

OK, I see. So we agree that drugs which have intracellular targets and are membrane permeable may be candidates for elution from a device. Is that right?
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mskatiescarletohara

02/02/05 3:13 PM

#7288 RE: aslan2772 #7245

Aslan/Dew--TrpRS therapy.

Perhaps Cheresh and his colleagues have determined blocking/inhibiting RAF1 is the route for delivering genes. If it works in cancerous tumors, it very well could work on blood vessels in the eye.

http://www.signaling-gateway.org/update/updates/200208/nrc870.html

David Cheresh and colleagues have destroyed tumors using a strategy of gene-delivery that blocks the endothelial signaling pathways required for new blood-vessel formation.

Although many drugs have been developed to interfere with tumour angiogenesis, it has been difficult to find ones that specifically target tumour blood vessels without affecting normal tissues. David Cheresh and colleagues have developed a gene-delivery strategy to block endothelial signalling pathways that are required for new blood-vessel formation, and report that this approach can be used to destroy established and metastatic tumours.


The angiogenic epithelium expresses several surface molecules that are potential therapeutic targets. One of these, the integrin alphavbeta3, is a particularly good candidate because it is involved in cancer-cell invasion and has also been shown to mediate virus internalization — meaning it could mediate entry of other ligands into vascular endothelial cells. Cheresh and colleagues report in Science that a cationic polymerized lipid-based nanoparticle (NP) coupled to a small, organic integrin alphavbeta3 ligand can be used to deliver therapeutic genes to angiogenic blood vessels. But what genes are best for stopping blood-vessel growth?

The angiogenic factors basic fibroblast growth factor (bFGF) and vascular endothelial growth factor (VEGF) signal through a RAF1-mediated pathway, and blocking this pathway induces endothelial-cell apoptosis. A mutant form of Raf1 that fails to bind ATP (ATP µ -Raf) has been shown to block endothelial-cell Raf1 activity and inhibit angiogenesis in vivo. The authors coupled this mutant gene to alphavbeta3–NP, creating alphavbeta3–NP/Raf(-). When mice bearing established M21-L melanomas received a single injection of alphavbeta3–NP/Raf(-), the vector specifically targeted tumour blood vessels, where it induced apoptosis within 24 hours. By 72 hours, concentric rings of apoptotic tumour cells were observed around each apoptotic vessel, and the tumours began to necrose.

Consequently, treated mice displayed rapid tumour regression — in four out of six mice the tumours completely disappeared, and the other two showed a 95% reduction in tumour mass and a 75% suppression of blood-vessel density. Tumour regression was sustained for over 250 days. M21-L cells do not express alphavbeta3, indicating that the tumour regressed as a result of anti-angiogenic effects, rather than due to a direct effect on the cancer cells themselves.

But is this therapy effective against metastases? The authors injected mice with CT-26 colon adenocarcinoma cells, which led to the formation of lung or liver metastases, and 10 days later injected alphavbeta3–NP/Raf(-). Mice treated with control vector developed extensive lung and liver metastases, whereas treatment with alphavbeta3–NP/Raf(-) caused a regression and disappearance of these tumours. NPs are less immunogenic than viral vectors, so this molecule should be safer than other cancer gene-therapy approaches, and can also be used to deliver other types of therapeutic genes to blood vessels.

Kristine Novak
References

1. Hood, J. D. et al. Tumor regression by targeted gene delivery to the neovasculature. Science 296, 2404 – 2407 (2002) / PubMed /
2. Hood, J. D. & Cheresh, D. A. Role of integrins in cell invasion and migration. Nature Rev. Cancer 2, 91 – 100 (2002) / Article /