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

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

1 The Benefits of Soltamox® (tamoxifen citrate) Oral Solution in Breast Cancer Patients
Speaker Program Supported by DARA BioSciences Inc., Leaders in Oncology Supportive Care Open with informal audience survey. Sample questions: Who in the room is directly involved in the diagnosis and treatment of women with breast cancer? Are you: A medical oncologist? A radiation oncologist? An oncology/radiology nurse or NP/PA? None of the above? Who in the room is involved in diagnosing and managing swallowing difficulties in breast cancer patients? Do you believe swallowing difficulties are a potential issue among your breast cancer patients? Lastly, who actively seeks to understand if your patients have some degree of swallowing difficulty, via use of a simple assessment tool or probing/counseling?

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

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

4 Breast Cancer US Prevalence* Tamoxifen citrate**
2.6M women with a history of breast cancer ~290K new cases each year 230K invasive and 58K in-situ Tamoxifen citrate** Used to treat 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 Tamoxifen widely used in treating hormone receptor-positive breast cancer Also used to prevent breast cancer in high-risk patients Tamoxifen a chronic treatment: patients on therapy many years * American Cancer Society - Facts and Figures ; ** Tamoxifen citrate US Package Insert; Symphony Rx data 2012

5 Adjuvant Endocrine Therapy NCCN Guidelines (BINV-J)
Pre-menopausal Tamoxifen 5 yrs 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 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 NCCN Treatment Guidelines Version (AI = Aromatase Inhibitor)

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 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 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< NSABP P-1 trial; Tamoxifen citrate Package Insert

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 For patients with breast cancer, the recommended daily dose of tamoxifen is mg. Dosages greater than 20mg 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. Soltamox (tamoxifen citrate) oral solution Package Insert

10 Offering Patients a Choice = Preference

11 Soltamox® Bioequivalent to Tamoxifen Tablets
Parameter Soltamox liquid (n=30) Mean (SD) Tamoxifen Citrate tablet (n=33) AUC (ng.hr/mL) ( ) ( ) AUCT (ng.hr/mL) (847.38) (900.86) Cmax (ng/mL) 53.38 (14.03) 55.94 (13.63) Tmax (hour) a 4.5 ( ) 4.5 ( ) t½ (hour) (69.58) (58.88) 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

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 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 Soltamox® (tamoxifen citrate) oral solution The Same Important Safety Information
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 Package Insert

14 Soltamox® (tamoxifen citrate) oral solution The Same Black Box Warning
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 Package Insert

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

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 Consistent with Good Practices “The 8 Rights of Medication Administration”
Right Patient Right Medication Right Dose 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 Right Time Right Documentation Right Reason Right Response *Nursing Center.com May 27, 2011 Lisa Bonsall, MSN, RN, CRNP

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

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 Friese C et al Apr;138(3): doi: /s

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 26% Breast Cancer Res Treat Friese C et al Apr;138(3): doi: /s

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 Friese C et al Apr;138(3): doi: /s

24 Tamoxifen Adherence A Systematic Review of 30 Studies
At the end of 5 years treatment: Adherence: 41% - 72% Discontinuation: 31% - 73% Murphy C et al. Breast Cancer Research and Treatment 2012 Prevalence of adherence ranged from 41% to 72% and discontinuation (i.e., non-persistence) ranged from 31% to 73%, measured at the end of 5 yrs of treatment. Extremes of age (older or younger), increasing out-of- pocket costs, follow-up care with a general practitioner (vs. oncologist), higher CYP2D6 activity, switching from one form of therapy to another, and treatment side effects were negatively associated with adherence and/or persistence. 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 24

25 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….” Full quotes: “Patients who are prescribed adjuvant tamoxifen in the community have a lower risk of death, with increased duration of use further reducing the risk.” “Cumulative non-persistence with tamoxifen therapy occurs in nearly half of patients prescribed tamoxifen. Conversely, in those who continue to take tamoxifen adherence is generally high, but there is a significant proportion of women with low adherence who are at greater risk of death.” McCowan et al. British Journal Cancer, 2008 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: /sj.bjc Published online 4 November 2008 25

26 Tamoxifen Discontinuation Women ≥ 65 yrs
Of 961 women ≥65 years who were prescribed tamoxifen, 49% discontinued tamoxifen before the completion of 5 years. 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 , February 26

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

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

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 Simple Questions Do you prefer a liquid medication or pills?
Do you find it difficult to swallow certain things? Do you take your tamoxifen tablets every day? 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?

31 Summary - Patients Who May Benefit From Soltamox
Tamoxifen Patients who prefer a liquid vs. a pill Offering patients a choice between a pill and a solution may support long term adherence. 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

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 Difficulty swallowing occurs in the general population but is under-diagnosed Breast cancer patients are at increased risk of swallowing difficulties Simple assessment tools (e.g., EAT-10) and proactive counseling can identify affected breast cancer patients A variety of options exist to help manage the issue, including substitution of solid/tablet medications with liquid (Soltamox, tamoxifen citrate)

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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