TO: HELENA SALES, POC SPECALISTS, INTERNATIONAL DISTRIBUTORS FROM: HELENA HEMOSTASIS/POINT OF CARE SUBJECT: ROUND-UP DATE: 11/10/2010

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1 TO: HELENA SALES, POC SPECALISTS, INTERNATIONAL DISTRIBUTORS FROM: HELENA HEMOSTASIS/POINT OF CARE SUBJECT: ROUND-UP DATE: 11/10/2010 General News It has been a while since the last issue but every time this Roundup gets started there is much more information on the pharmaceutical, study, testing and new diagnostic systems that needs to be added. The Pharmaceutical industry has been very busy developing a strong pipeline of products for the anti-coagulation and anti-platelet markets. This would appear to be an increasing recognition in the major role of Hemostasis in the daily lives of all of us. In general some portion of Hemostasis is involved or responsible for upwards of 70% of deaths in developed populations. This means either bleeding or clotting issues. As we all know there are two major pathways in the hemostatic mechanism. Primary Hemostasis involves the vascular system and Platelets which generally occurs in the first five minutes and thus forms the primary closure of a wound or the plug in a vessel. Malfunctions here cause both clotting and bleeding. The influx of new and supposedly better drugs to control Platelets is evidenced by the fact that worldwide the anti-platelet drug market is currently over $ 3 Billion (USD) and growing. Secondary Hemostsasis being the process of utilizing the plasma coagulation factors to form a firm clot in either a wound or within a vessel. The two current products (Warfarin & Heparin) have been around for over 50 years. The projected market for just one of the proposed replacements for warfarin is in excess of $ 1.2 billion (USD. This means that there will be a lot of activity in the Hemostasis marketplace and therefore a lot of recognition that newer monitoring techniques need to be developed or expanded. Product Notes With the above markets in mind Helena Hemostasis/POC is working diligently to not only develop new products but refine current products and show their usefulness in today s healthcare market. To this end we are in the process of wrapping up the initial FDA clinical trials and preparing for submission of the Cascade Abrazo. Helena is shooting for a submission prior to the end of the year. For those of you not familiar with the Cascade Abrazo this will be a hand held POC coagulation analyzer with a color touch screen menu, integrated bar code reader, communication capabilities to a variety of devices such as a PC, LIS or HIS system, capable of operating on battery for extended periods of time or while plugged in. The system will use essentially the same test cards as the current Cascade POC with additional tests beyond those presently on the CPOC. The screen provides simplified pictorial direction for the operator while the system also records and stores QC, operator ID, patient ID, and other demographic information.

2 Article Reviews Some interesting articles are attached. In this issue we will separate the categories and try to summarize the work that is ongoing. In order to keep pages to a minimum in some cases only the abstract or discussion page is included. The total articles are being sent to Helena Technical services and if the entire article is desired they can be requested from TS. There is still going to be a lot of reading as the topic of Homeostasis is becoming a topic of increased awareness. General notes There is an increasing awareness of Hemostasis in the news and research areas as noted by the first set of articles. Many revolve around Platelets but other coagulation factors also come into play. The first article of note concerns trauma patients and a very inexpensive drug that may be used to reduce bleeding in these patients. TXA is an anti-fibrinolytic drug that reduces the effect of plasmin in destroying a clot and increases the effectiveness of the clotting system. The next in the series describes what can happen by exposure to auto exhaust. The thickening of arteries creates cardiac issues but we also know that nitric oxide is in auto exhaust and that can inhibit platelet function. While looking at Platelets there is a note that states Platelets can reproduce which goes along with studies ongoing in the US as well as several international sites on using stem cells to produce platelets. There is also a note concerning how platelets being used in prophylactic transfusionsmay reduce bleeding in certain patients. Of interest is an article from Chicago concerning undefined bleeding and may be problematic for females. Of interest here is that 32% of patients had inherited platelet issues and 21% had acquired platelet disorders. Other deficiencies noted were vonwillbrand disease and factor deficiencies. All the more reasons for institutions to perform Platelet studies, vwd studies, and factor assays. Hemostasis is not a small time issue. The next article also highlights vwd in patients being treated with Ventricular Assist Devices(VAD) and bleeding issues. VAD s are increasingly being used as staging for patients prior to heart transplants an increasing occurrence. The next series lists a variety of disease states where clotting is now being recognized as an issue. These include Alzheimer s Disease, Sleep disorders, Inflammatory Bowel disease(ibd), clotting in Cancer patients, drugs to treat nausea, vomiting, and antipsychotics, Lupus, and last nut not least the recreational use of cocaine. As we illustrate in Hemostasis seminars, Hemostasis is involved in over 70% of all deaths not directly related to instant trauma. Helena is Hemostasis both in the laboratory and at the Point of Service or Point of Care. New Anti-thrombotic Advances The activity in this area has real ticked up substantially in the last several months. This section has several articles on LMWH s and the competition there. The majority of the competition is in relation to warfarin competitors. The drug that has been a standard for 50 years is under a lot of pressure. What this means for Helena is that while in the next Page 2

3 five years our traditional PT testing volume will decrease the opportunity for our newer and more specific assays at POC will see surge in activity. The first two here are concerning Lovenox and competition. First there is a generic version approved by the FDA from Sandoz. This is on top of six generic versions including one from Sanofi in Europe. Helena is currently evaluating a method for LMWH cards and the Cascade Abrazo. One of the other competitors to Lovenox in fondaparinux. It has been shown to be superior Lovenox with reduced bleeding rates but it has an excess of catheter clotting in patients undergoing PCI. This situation appears to be resolved by adding UFH at the same time. This will be interesting to follow. The next major topic is warfarin. Items that have been known to the laboratory for years are just now making headlines such as garlic along with other herbal supplements( gingko, fish oil, cranberry, glucosamine, ginseng, and green tea) reduce or increase the effectiveness of warfarin. Several articles here also point out issues with antibiotics that can even lead to death by bleeding. This has pushed into several studies looking at personalized prescriptions and alternative courses of treatment. The truly major news is that there are now a number of alternatives coming available. These include oral factor Xa inhibitors and direct thrombin inhibitors. Direct Thrombin Inhibitors: Pradaxa ( dabigatran, Boehringer Ingelheim) set for FDA approval 10/19/10 Xa inhibitors include: apixaban(pfizer/bristol-myers Squibb), Xarelto (rivaroxaban, Bayer), Edoxaban( Daiichi- Sankyo), betrixaban(portola, Merck) Pradaxa will be the first oral competitor to be approved. It supposedly holds the advantage that there is no required diet and supposedly there will be no need for monitoring. We have heard this before with a number of pharmaceutical preparations only to find the monitoring is really necessary (example-plavix). There is an article attached however that raises the issues of incompatibilities with other drugs and herbals These new drugs may be slow in catching on but Helena will be there with testing systems for each of the competitors. The cost will be an issue in the US as projected cost will be at $ 8.00 to $ per day for the drug. These cost issues will be very interesting to follow as the market for warfarin is estimated at $ 300 million per year and Bayer projects its drug Xarelto and others could reach $ 15 Billion. The articles are there for background on each of the new competitors. There are several studies also on Angiomax as a DTI. Helena is currently wrapping up studies on our DTM card and Cascade Abrazo. Helena is positioned to help the physician, hospital and patient when using these new therapies. Platelet s and Plateletworks, Plavix, and new Competitors Not to be outdone the interest in Platelets is also booming. The interest in genetics is looking at clotting issues due to overactive Platelets and other factors as well. There is now a distinct segment that is beginning to push for personalized medicine including looking at Platelets before starting therapy. Not only are there genetic Page 3

4 factors but in looking at Plavix low responders we know that with age, high BMI, insulin dependent diabetes along with P450 metabolism, smoking status and ACS there is a lower response to Plavix. The articles describe PPI inhibition of Plavix, calcium channel blockers, high rate of turnover (many times seen in patients on chemotherapy and bone marrow stimulation) and inflammation. One sentence stands out Platelet reactivity is superior to genetic testing and could be used to overcome genetic resistance. Plateletworks is platelet function or reactivity. There are also several articles discussing the doubling of the Plavix dose to achieve better results. Also a note on issues due to patients failing to get prescriptions after hospitalization. Last but not least is an announcement of Eli Lilly recommending Accumterics to the physicians through an alliance with Accumetrics. The physicians and their office staff are being pushed and that push will relate to hospital testing as well. Physician leads need to be followed up quickly and appropriately. There are now a number of competitors to Plavix in studies and being a pproved by the FDA. Effient(prasugrel, Eli Lilly) is already on the market. Brillinta(ticagrelor, Astrazeneca, cangrelor(medicines Company) and elinogrel(portola Pharmacueticals) are all in studies and being published. There are a number of articles describing these new drugs and their comparison to Plavix with advantages attached. There are also several notes on a new class of anti-platelet drug attached. This one is atopaxar(e5555, Esai) and it targets thrombin induced platelet activation. When you think of Cardiology and CVOR trying to see which one works, then the market for Plateletworks expands dramatically. There are other approaches coming also as seen in the notice of a new temperature dependent antiplatelet drug for use in the CVOR. Again Helena is positioned well to help the physician, hospital and patient with better care by monitoring the effectiveness of anti-platelet therapy with Plateletworks. News in the world ofaspirin Last but not least is some news in the world of a very old drug Aspirin. First is an article of a possible new competitor from the British health food segment. Fruitflow is being touted as being able to inhibit platelets without any of the side effects of aspirin. This product is a tomato-extract which has started studies and looks promising. Also from Europe comes a new Pollypill with aspirin, a statin, and two anti-hypertensives agents all in one pill package. Trials have already started and appear to be expanding. Also there is interest in studying aspirin for extending life and aspirin in reducing recurrence risk fir breast cancer survivors. For an old and well studied drug there is still new life and Helena has the mechanisms to help in those studies. Stay tuned for new product releases and new lines from Helena Laboratories Hemostasis/POC! Page 4

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