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Speaker Program Supported by DARA BioSciences Inc., Leaders in Oncology Supportive Care The Benefits of Soltamox ® (tamoxifen citrate) Oral Solution in.

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Presentation on theme: "Speaker Program Supported by DARA BioSciences Inc., Leaders in Oncology Supportive Care The Benefits of Soltamox ® (tamoxifen citrate) Oral Solution in."— Presentation transcript:

1 Speaker Program Supported by DARA BioSciences Inc., Leaders in Oncology Supportive Care The Benefits of Soltamox ® (tamoxifen citrate) Oral Solution in Breast Cancer Patients

2 2 Agenda Breast Cancer and the use of tamoxifen citrate Soltamox ® (tamoxifen citrate) oral solution Improving Patient Outcomes

3 3 DISCLAIMERS This program was developed by DARA BioSciences Inc. and I presenting on behalf of DARA BioSciences Inc. I have received compensation from DARA BioSciences Inc. to make this presentation. The information I am presenting is consistent with the full prescribing information for Soltamox® (tamoxifen citrate) oral solution as required under applicable Food and Drug regulations. Copies of the full prescribing information for Soltamox ® (tamoxifen citrate) oral solution are available at this presentation and at www.Soltamox.com.

4 4 Breast Cancer US Prevalence * –2.6M women with a history of breast cancer –~290K new cases each year 230K invasive and 58K in-situ Tamoxifen citrate ** –Used to t reat estrogen receptor + breast cancer (~80% all cases), to reduce the risk of recurrence –Prevention in high-risk patients –Used in up to 40% of patients (~1.8 M Rx written per year) –Treatment period up to 5 years * American Cancer Society - Facts and Figures 2011-2012; ** Tamoxifen citrate US Package Insert; Symphony Rx data 2012

5 5 Adjuvant Endocrine Therapy NCCN Guidelines (BINV-J) NCCN Treatment Guidelines Version 3. 2013 (AI = Aromatase Inhibitor) Pre-menopausalTamoxifen 5 yrs Pre- menopausal Post- menopausal Consider tamoxifen +5 yrs or No further endocrine treat. Aromatase inhibitor 5 yrs AI to complete 5 yrs or up to 5 yrs AI Post- menopausal AI contra- indicated Tamoxifen 4.5-6 yrs AI 5 yrs or Tamoxifen 2- 3 yrs or AI 2-3 yrs Tamoxifen 5 yrs or consider tamoxifen up to 10 yrs AI 5 yrs or consider tamoxifen for +5 yrs Tamoxifen to complete 5 yrs

6 6 Tamoxifen Efficacy - DCIS* NSABP B-24 Trial –Double-blind, randomized, placebo-controlled trial –1,804 women randomized to tamoxifen 20mg/day or placebo (in addition to lumpectomy and radiation) –For the primary endpoint, the incidence of invasive breast cancer was reduced by 43% among women assigned to tamoxifen –44 cases tamoxifen vs. 74 cases placebo; p=0.004 *DCIS = Ductal Carcinoma in Situ; NSABP B-24 Trial (Tamoxifen citrate Package Insert)

7 7 Tamoxifen - Breast Cancer Prevention Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer* –Defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model *Tamoxifen citrate Package Insert

8 8 Tamoxifen Efficacy in High Risk Women NSABP P-1 Trial –Double-blind, randomized, placebo controlled trial –13,388 women at least 35 yrs, randomized to tamoxifen 20mg/day or placebo for 5 yrs –After a median follow-up of 4.2 years, the incidence of invasive breast cancer was reduced by 44% –86 cases tamoxifen vs. 156 cases placebo; p<0.00001 NSABP P-1 trial; Tamoxifen citrate Package Insert

9 9 Soltamox ® (tamoxifen citrate) Oral Solution Launched in the US, Nov. 2012 – Bioequivalent to tamoxifen tablets – Same indications as tamoxifen tablets With free Co-pay assistance, same low monthly cost ($10) as generic tablets Recommended dosage –Tamoxifen 20-40mg per day –20mg Soltamox = 10 mL Measuring cup supplied Soltamox (tamoxifen citrate) oral solution Package Insert

10 10 Offering Patients a Choice = Preference

11 11 One pharmacokinetic study has been performed in healthy perimenopausal and postmenopausal female subjects to evaluate the bioavailability of Soltamox® in comparison with the commercially available tamoxifen citrate tablets under fasting condition and also to determine the drug absorption from Soltamox® under fed conditions. The rate and extent of absorption of Soltamox® was found to be comparable to that of tamoxifen citrate tablets under fasting condition as shown in the table. Soltamox (tamoxifen citrate) oral solution Package Insert Parameter Soltamox liquid (n=30) Mean (SD) Tamoxifen Citrate tablet (n=33) Mean (SD) AUC (ng.hr/mL)4131.57 (1499.45)4105.61 (1431.90) AUCT (ng.hr/mL)3108.82 (847.38)3229.47 (900.86) Cmax (ng/mL)53.38 (14.03)55.94 (13.63) Tmax (hour) a 4.5 (2.13-8.00)4.5 (3.0-8.0) t½ (hour)255.70 (69.58)227.43 (58.88) Soltamox ® Bioequivalent to Tamoxifen Tablets

12 12 Soltamox ® The Same Indications as tamoxifen citrate Metastatic Breast Cancer Tamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men. Adjuvant Treatment of Breast Cancer Tamoxifen citrate is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. Tamoxifen citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial. Tamoxifen citrate reduces the occurrence of contra lateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer. Ductal Carcinoma in Situ (DCIS) In women with DCIS, following breast surgery and radiation, tamoxifen citrate is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the Prescribing Information). The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy. Reduction in Breast Cancer Incidence in High Risk Women Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. (see BOXED WARNING at the beginning of the Prescribing Information). Tamoxifen citrate is indicated only for high-risk women. "High risk" is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer = 1.67%, as calculated by the Gail Model. Dosage and administration For patients with breast cancer, the recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening). A 20 mg dose of SOLTAMOX™ is administered as 10 mL (equivalent to 2 teaspoons) of the oral solution (Please see the Full Prescribing Information for complete dosage instructions.) Please see full Prescribing Information and complete Black Box Warning contained within your presentation folder. Soltamox (tamoxifen citrate) oral solution Package Insert

13 13 Serious and life-threatening events associated with tamoxifen medications such as Soltamox (tamoxifen citrate) in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer. Soltamox ® (tamoxifen citrate) oral solution The Same Important Safety Information Soltamox (tamoxifen citrate) oral solution Package Insert

14 14 In Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events were associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer. Soltamox ® (tamoxifen citrate) oral solution The Same Black Box Warning Soltamox (tamoxifen citrate) oral solution Package Insert

15 15 Improving Patient Outcomes Important considerations: –Patient preference –Long term adherence

16 16 Preference – The Importance of Offering Patients a Choice Some patients prefer a liquid to tablets/pills –Psychological factors, anxiety Can address/identify underlying pathologies –Age related swallowing difficulties –Co-existing conditions (e.g. neurological, acid-reflux) –Effect of other medications (e.g. that cause dry mouth, have anticholinergic or CNS-depressing effects) Consistent with good practices

17 17 Consistent with Good Practices “The 8 Rights of Medication Administration” 1.Right Patient 2.Right Medication 3.Right Dose 4.Right Route – check the order and appropriateness of the route ordered – confirm that the patient can take or receive the medication by the ordered route 5.Right Time 6.Right Documentation 7.Right Reason 8.Right Response *Nursing Center.com May 27, 2011 Lisa Bonsall, MSN, RN, CRNPLisa Bonsall, MSN, RN, CRNP

18 18 Good Administration Practices CMS* policies and procedures require the correct route, to ensure that the method of administration is the appropriate one for that particular medication and patient Standards for Medicines Management** recommend that dosage, method of administration, route and timing be considered during the administration of medicines *CMS Guidance on Medication Administration, Hospital Appendix A P.10 (2011) **Standards for Medicines Management NMC pg.6 (UK)

19 19 Underlying Pathologies CONDITIONS e.g. Neurological disorders incl. stroke Structural lesions Connective tissue diseases Iatrogenic causes MEDICATIONS e.g. Cause dry mouth Anticholinergic or antimuscarinic effects Certain antipsychotic and neuroleptics Depress the CNS

20 20 Age Related - 40% patients on tamoxifen >65yrs Patient Gender Female = 99.9% Male = 0.1% 20 Source: Catalina Retail Pharmacy data base (N = 27,315 pts.) Approx. 40% >65yrs

21 21 Improving Patient Outcomes - Better Long Term Adherence “We’re doing well with women taking endocrine therapy, but there’s work to do. If guidelines begin to shift so that some women at high risk of breast cancer recurring need 10 years of endocrine therapy, then the number of women who persist with treatment will likely worsen. We need better ways of supporting women through this therapy ” Christopher Friese. Assistant Professor, University of Michigan School of Nursing* Lead study author, Adjuvant endocrine therapy initiation and persistence in a diverse sample of patients with breast cancer. Breast Cancer Res Treat. 2013 Friese C et al Apr;138(3):931-9. doi: 10.1007/s10549-013-2499-9Breast Cancer Res Treat.

22 22 Adherence – University of Michigan Study (2013) Study of 743 women eligible for endocrine therapy (tamoxifen or aromatase inhibitors) Women surveyed in Detroit and Los Angeles Reported to SEER (Surveillance, Epidemiology and End Results) registry – 11 % never initiated therapy – 15% stopped early Breast Cancer Res Treat.Breast Cancer Res Treat. 2013 Friese C et al Apr;138(3):931-9. doi: 10.1007/s10549-013-2499-9 26%

23 23 University of Michigan Study The most common reason patients discontinue or never start therapy is side effects –menopause-like symptoms, joint pain Women who expressed more worry about cancer recurring were more likely to complete their endocrine therapy. Women who reported receiving less information about endocrine therapy were less likely to begin taking it. Breast Cancer Res Treat.Breast Cancer Res Treat. 2013 Friese C et al Apr;138(3):931-9. doi: 10.1007/s10549-013-2499-9

24 24 Murphy et al Adherence to adjuvant hormonal therapy among breast cancer survivors in Clinical practice: a systematic review. Breast Cancer Research Treat Pub. Online 12 June 2012 Murphy C et al. Breast Cancer Research and Treatment 2012 Tamoxifen Adherence A Systematic Review of 30 Studies At the end of 5 years treatment: Adherence: 41% - 72% Discontinuation: 31% - 73%

25 25 McCowan C et al. Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer British Journal of Cancer (2008) 99, 1763–1768. doi:10.1038/sj.bjc.6604758 www.bjcancer.com Published online 4 November 2008 McCowan et al. British Journal Cancer, 2008 Tamoxifen Adherence “Patients who are prescribed adjuvant tamoxifen… have a lower risk of death” “Cumulative non-persistence with tamoxifen therapy occurs in nearly half of patients….”

26 26 Of 961 women ≥65 years prescribed tamoxifen, 49% discontinued treatment before 5 years. Cynthia Owusu et al. Predictors of Tamoxifen Discontinuation among Older Women with Estrogen Receptor–Positive Breast Cancer. Journal of Clinical Oncology. Volume 26 Number 4 549-555, February 1 2008 Tamoxifen Discontinuation Women ≥ 65 yrs

27 27 US Tamoxifen Prescribers Believe Patients Have Adherence Issues Patient adherence (Percentage of tamoxifen prescribers) 4% 51% 42% 3% never miss a dose rarely miss a dose sometimes miss a dose frequently miss a dose My patients on Tamoxifen… 55% Yes 45% No On average, respondents believe that 15% of their breast cancer patients stop taking their Tamoxifen prior to the prescribed duration Patients with issues taking medication long-term as prescribed (Percentage of tamoxifen prescribers) US Market Research (on-line) Gelclair and Soltamox; Conducted Jan 2013 N=103

28 28 Reason Why Patients Stop Taking Tamoxifen Reasons patients stop taking Tamoxifen tablet therapy early Percentage of writers 34%17%9% Too expensive/can’t afford to pay for prescription Lack of understanding regarding importance 16% 10% 12% Patient feels better and stops taking medication 12% 24% 25% 15% Multiple conditions/pills - forget to take Drug side effects 8% 51%11% 6% Lack of follow-up by primary care provider 3% 4% Have difficulty swallowing in general 5% Have difficulty swallowing tablets as a result of chemotherapy or radiation therapy 4% 2% Other Not rankedRanked 2Ranked 3Ranked 1 US On-line Market Research among oncologists and oncology nurses; Jan 2013 (N=103)

29 29 Possible Ways to Improve Long Term Adherence to Tamoxifen Educate pts. regarding the importance of long term tamoxifen therapy Educate pts. regarding the management of tamoxifen side effects Monitor pt. adherence Assess pts. ability to swallow Offer pts. a choice of a liquid vs. a tablet –Patients who have a say in their “choice” of medicine may be more compliant on a daily basis

30 30 Do you prefer a liquid medication or pills? How do you take your tablets? Do you use applesauce or crush them? Do you think taking a liquid form of tamoxifen will help you take your therapy over the long term? Simple Questions Do you take your tamoxifen tablets every day? Do you find it difficult to swallow certain things?

31 31 Summary - Patients Who May Benefit From Soltamox Tamoxifen Patients who prefer a liquid vs. a pill Patients who have underlying “pathology” (e.g., cancer treatment, co-existing disease, concomitant meds, physical or psychological issues) Patients with tablet adherence issues who may benefit from a change Offering patients a choice between a pill and a solution may support long term adherence.

32 32 Conclusions Tamoxifen has proven efficacy, yet treatment remains sub-optimal due to poor adherence Two dose forms (tablets, liquid) are now available –Soltamox has the same indications and is bioequivalent to tamoxifen citrate tablets Offering patients a choice may improve adherence Patients who have a say in their “choice” of medicine may be more compliant on a daily basis

33 33 Discussion Topics To what extent do your breast cancer patients have adherence issues with tamoxifen? –Main reasons? –Impact on treatment outcomes? –Ways to monitor? –Ways to address? Does it make sense to offer patients a choice between tablets and liquid tamoxifen? Do you see a role for Soltamox in certain populations? –Patient types? –How to keep Soltamox top-of-mind?


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