Pullan Consulting
Biotech Business Development Consulting
www.pullanconsulting.com and www.lindapullan.com
email: lpullan@msn.com 805-558-0361
Issue #27
Pullan's Pieces
Commentary on Science & Business of Drug Development
For Business Development & Others
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A strong case for genotyping in patient treatment with warfarin, still not ready for wide use?
Warfarin is a commonly prescribed anticoagulant but is hard to dose, with a narrow therapeutic index leading to risks of GI bleeds and intracranial hemorrhages. If DNA typing were performed for every patient before they were prescribed warfarin, an estimated 85,000 serious bleeding events and 17,000 strokes could be avoided annually, saving over $1 billion in healthcare spending. Together the polymorphism in the metabolizing enzyme cytochrome p450 CYP2C9 and the warfarin target, vitamin K epoxide reductase subunit VKORC1, can explain up to 45% of warfarin response variability. Adding the currently used physiologic variables (body mass, gender and age) accounts for 70% of the variability in drug response. (A. LaSala et al, Connecticut Medicine 72, 399). Multiple tests are now commercially available.
Opponents to more widespread use of pharmacogenomic warfarin testing are waiting for hard evidence of the benefits. “There’s good evidence that two SNPs on CYP2C9 and several on VKORC1 affect warfarin metabolism. This we know well,” said Amir Jaffer, MD, Associate Professor of Medicine at the University of Miami’s Leonard M. Miller School of Medicine and Service Chief of Medicine at Miami Hospital. “What we don’t know well is if testing translates into evidence of improved clinical outcomes.” http://www.aacc.org/publications/cln/2008/July/dailies/Pages/mon_daily1.aspx
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4th tiers in drug insurance payments –patients paying a percentage of the costs of expensive drugs
In the recent past, most insurance plans covered prescription drugs in three "tiers," requiring flat co-payments ranging from $5 or $10 for generics, to several times that for brand-name drugs not "preferred" by the insurer. But that appears to be changing, with Medicare Part D plans, the stand-alone prescription drug plans set up by Congress in 2003, leading the way. Now, 86% of such plans have a "fourth tier" requiring higher cost-sharing — up to 33% — for more expensive drugs, according to the Kaiser Family Foundation. About 10% of commercial plans now also have a specialty-drug tier, with higher cost-sharing for the most expensive drugs given to fewer patients. What is in the highest tier varies. For example, Regence BlueShield and Premera Blue Cross offer plans requiring patients to pay 50 percent of top-tier drugs' costs. But Tykerb, for advanced breast cancer, is a “preferred” drug getting a lower tier at Premera but not at Regence. (Carol Ostrom, Seattle Times, August 17, 2008, http://seattletimes.nwsource.com/html/health/2008119250_drugs17m.html ).
These stories of high costs to patients and variability in cost decisions will only increase the political pressure for healthcare reform.
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VC-backed firms may become eligible for SBIR grants
Small biotech businesses that are majority-backed by venture capital will be eligible for a portion of Small Business Innovation Research (SBIR) grants under a bill reported out of the Senate Committee on Small Business. The bill reauthorizes the SBIR program for 14 years. Under a Senate compromise on the renewal for the SBIR program, small companies that are majority-owned by venture capital firms would once again be eligible for Small Business Innovation Research awards.
The SBIR program requires federal agencies to set aside 2.5% of their outside R&D budgets for small businesses (less than 500 employees and owned 51% by individuals). The current SBIR phase I grant submissions are due November 3rd. http://grants.nih.gov/grants/Funding/sbir.htm Firms with a 50% stake by VCs are ineligible.
The new proposed legislation would allow the National Institutes of Health to award up to 18% of its SBIR dollars to VC-owned firms. The other 10 agencies that participate in the SBIR program could award up to 8% of their SBIR dollars to VC-backed companies. There are those that think that diverting SBIR money to VC-backed firms reduces the amount available to seed-stage businesses that find it hard to get VC funding. The increase in funding per grant at each level is also criticized as reducing the number of grants available. http://www.bio.org/news/newsitem.asp?id=2008_0730_01
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UK cancer care continues to be scary
The charity Myeloma UK found a quarter of myeloma specialists did not tell patients about new treatments, such as lenalidomide (Revlimid), that may be difficult to obtain on the NHS. The myeloma treatment Revlimid obtained its UK license in June 2007, but can be hard to get covered because NHS watchdog body the National Institution for health and Clinical Excellence (Nice) is not expected to make a decision on whether it should receive NHS funding until sometime in 2009. http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/cancer-patients-not-told-about-new-treatments-909009.html
The National Institute for Health and Clinical Excellence (NICE) has ruled against the NHS providing 4 kidney cancer drugs: Bevacizumab (Avastin), sorafenib (Nexavar), sunitinib (Sutent) and temsirolimus (Torisel). Following a preliminary review, NICE has ruled that although these drugs are clinically effective, they are not good value for money for the NHS. http://www.ecancermedicalscience.com/news-insider-news.asp?itemId=256
A study of treatments for rare cancers found that where you live in the UK continues to make a difference in access to cancer medicines. 96% of patients living in Mid Essex had their requests for cancer drugs approved, while 0% in neighboring South West Essex had theirs approved. http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/unequal-access-to-drugs-leaves-patients-to-die-890288.html
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Pullan Consulting
Linda M. Pullan, Ph.D.
Biotech Business Development
www.pullanconsulting.com and www.lindapullan.com
e-mail: lpullan@msn.com
805-558-0361
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