professional marketing program 2011

Professional Marketing Program July 2011

Culturelle Probiotics For Kids - Key Insights

• Physicians are a primary influencer in the use and selection of probiotics.

• Pediatricians see an average of 1500 patients in a 3 month period; discuss OTC probiotics with approx. 6% of them. Over 70% are for children <13yrs

• Overall, more pediatricians recommend Culturelle to their patients than any other brand.

• Recommendations are driven by awareness and sample availability.

• Focus on professional market where Brand is strongest, which is Pediatricians.

• Research shows Culturelle is leader with this segment and there’s significant opportunity for growth.

Culturelle Probiotics for Kids - Objectives

• Recommend Culturelle whenever you prescribe an antibiotic because, only Culturelle contains Lactobacillus GG, proven to prevent and shorten the duration of pediatric diarrhea associated concomitant antibiotic use and/or infection.

– Use strong clinical data to focus message on AAD and differentiate Culturelle

– Raise awareness and educate HCPs about the superior benefits of LGG to support differentiation of Culturelle.

• Continue to build pediatric HCP awareness and recommendations for Culturelle as an effective adjunct in the treatment of pediatric patients with infectious or antibiotic associated diarrhea.

• Maintain #1 pediatrician recommended status.

• Increase the number of pediatricians receiving samples and recommending Culturelle by 15%.

Culturelle Probiotics for Kids Campaign• Tier 1-

– Increase our sampling program by targeting physicians and nurses through direct mail campaign

– Maintain our sampling program to the current 5,600 HCP’s that have requested samples

• Tier 2– Increase awareness of LGG through clinical education in

direct mail marketing, Online Nurse Resource Program, clinical tradeshows and journal advertising

• Tier 3 (Under Review)– Increase awareness of LGG clinical research by

developing an Advisory Panel of Key Opinion Leaders– Develop print and video enduring material from our

Advisory Panel

Existing Sample Program

• 3 H&W Sample drops to existing database of approximately 5,600 HCP offices (all non Pediatric offices)

• Drop 1 scheduled for April 2011 and includes 56 individual samples of Culturelle H&W, Doctor Letter and 90 sheet coupon pad

• Drops 2 and 3 scheduled for July and Sept to include 90 sheet coupon pads only

Pediatric Acquisition Mailer

• Designed to increase our existing database by targeting 11,000 High Prescribing Pediatricians and Pediatric Nurses, July 2011

• Each custom box includes – Kids stick sample– 2-page Clinical Visual Aid– Invitation to Nurse to join Culturelle Pediatric

Nurse Support Program– Sample fax back sign-up– Online sample sign-up

Culturelle Pediatric Clinical Visual Aid Page 1

Culturelle Pediatric Clinical Visual Aid Page 2

Pediatric Sample Program

• Pediatric Sample drops to our existing list of 4,500 and any additional new names acquired in the Acquisition Mailing, forecasting approximately 1,100 new names

• Pediatric drop will include box of 36 individual Kids Sticks, Doctor Letter, Clinical Detailing Sheet and 30 sheet coupon pad

• Pediatric drops schedule is July, Oct, Nov 2011

Online Pediatric Nurse Support Program Objectives

•To better understand pediatric nurses’ knowledge, attitudes, and practices regarding Probiotics and Culturelle in pediatric patients

•Acquire names and profiling data to build recommender profiles, confirm nurses are a significant business building opportunity, and help grow nurse recommendations for Culturelle.

•Assess pediatric nurses’ reactions to a sales presentation Clinical for Culturelle for Kids.

Online Pediatric Nurse Support Program Description

• The nurse acquisition program is designed to increase customer involvement and feedback regarding Culturelle through clinical education and market research.

• Through the Pediatric Acquisition Mailer, pediatric nurses are invited to review basic LGG data and the Culturelle message online.

• Nurse responders who complete the approximately 20 minute study will be enrolled in the Culturelle Nurse database and patient counseling tips related to treating Pediatric AAD and general probiotic and LGG clinical education.

• Live on July 14, 2011; http://www.surveywriter.net/in/survey/survey919/1113.asp

http://www.surveywriter.net/in/survey/survey919/1113.asp

Welcome and thank you for joining the Culturelle Pediatric Nurse Support Program. We appreciate your time and are pleased you’ve chosen to join us to learn more about how Culturelle Probiotics for Kids can benefit

your pediatric patients. In the next few minutes, you will learn how Culturelle is different from other probiotics and how it can help those pediatric patients on antibiotic therapy experience better outcomes. Then we’d like to ask you about

your reaction to this information. Afterward, you’ll be enrolled in the Culturelle Pediatric Nurse Support Program and receive ongoing

information relevant to your practice and special offers. Please enter the passcode you were provided on your invitation into the space below, and click the button to

begin!

1{A175F65We are sodarkgreendarkgreen3FalseFalseENDM_sw4cClick Here to Start

Culturelle Kids Journal Ad Schedule

October, November and December 2011• American Academy of Pediatrics• Consultant for Pediatricians• Contemporary Pediatrics• Infectious Disease in Children• Pediatric News

Culturelle Kids Journal Ad

LGG Clinical Outreach

• LGG Outreach mailed to 11,000 High-Prescribing Pediatricians in late August and includes 4 page clinical brochure to reinforce the Culturelle clinical message, reduce risk of AAD, by highlighting specific, relevant properties of LGG ad associated clinical support/studies

• Additional, will include self-mailer, online sample sign-up, and faxback to request samples

LGG Outreach Clinical Brochure

• Brochure completion date - Aug• Mail drop date forecasted - September

Culturelle Kids Tradeshow Schedule

• National Association of Pediatric Nurse Practitioners March

23

• Yale Workshop April 8

• ASCP Mid-Year Conf May 17-19

• American Association for Pediatrics Oct. 15-17

National Association of Pediatric Nurse Practitioners Conference April 2011• Introduced Brainstrong, answered many questions on

Culturelle and renewed loyalty to Amerifit products.

• Booth extremely busy, over 300 sample sign-up

• Brainstrong was very well accepted. Most of the audience, without exception, said this is a good thing for the kids. Lots of people tried the gummy’s and we got a total of 2 negatives! Everyone else said they were good and kids would like them.

• Culturelle, Offices want samples and coupons, All offices want patient information on LGG aimed at parents.

National Association of Pediatric Nurse Practitioners Conference April 2011 Exhibit Booth

National Association of Pediatric Nurse Practitioners Conference April 2011 Brainstrong Kids Sell Sheet

Scientific Discussion with Culturelle the Advisory Symposium (Under Planning and Review)

• The Advisory Panel will include LGG research investigators and are experts in the fields of probiotic use in Pediatric and Infectious Disease research

• The Culturelle® Advisory Board is designed to educate pediatricians on benefits of probiotics, specifically LGG, the different strains of probiotics, mechanism of action and ongoing research

• To educate internal teams on current LGG research and provide insights

into future research, barriers to success and opportunities for development .

• Counsel Amerifit and Martek Executive Management, Marketing and Sales, Medical Affairs Scientific Affairs and Regulatory teams

• To further extend our Pediatric campaign and recommending LGG concurrent to prescribing an antibiotic by developing enduring material from event

Advisory Panel Objectives

• Build brand awareness

• Educate healthcare professionals on the benefits of LGG and mechanism of action of probiotics

• Increases acceptance among HCP’s in recommending LGG for patients

• To further extend our Pediatric campaign and recommending LGG concurrent to prescribing an antibiotic by developing enduring material from event

Advisory Symposium Enduring Material 2012• Create a monograph with outcomes from the live

meeting o Monograph is a supplementary resource for pediatricians to extend knowledge about probiotics and benefits of Culturelle

• The event will be video recorded and utilized in online and print enduring education and training.

Culturelle Campaign Schedule• Pediatric Acquisition Mailer July 2011• Nurse Online Survey July 2011• Non Ped Sample Drop June, July, Sept 2011• Ped Sample Drop 1, 2, 3 July, Oct, Nov 2011 • Pediatric LGG Outreach Aug 2011• Journal Ads Oct, Nov, Dec 2011• Conferences April, Oct. 2011• Advisory Panel Nov 2011

LGG Clinical Trials – Snydman, VRE

• Probiotic Lactobacillus GG to Eliminate Vancomycin Resistant Enterococcal (VRE) Colonization, Phase I

– Tuft New England Medical Center– Principal Investigator, David Snydman, MD, FACP

• Chief, Division of Geographic Medicine and Infectious Diseases and Hospital Epidemiologist

• Professor of Medicine, Tufts School of Medicine• Study Dates: March Ongoing

– The primary comparison will be VRE elimination rates among those patients that receive LGG compared to those that receive placebo. The primary endpoint will be the proportion of patients with VRE at one week after cessation of administration of study medication or placebo. The investigators assume that the placebo group will have very little spontaneous elimination of VRE and that the LGG group will be more likely to have eliminated VRE colonization at the end of one week.

What is VRE?• Enterococci are a group bacteria that commonly live in the gut, but can

cause infection in other areas of the body. They can be resistant to several antibiotics, but in the past, physicians could rely on the drug vancomycin to effectively treat enterococcal infections.

• In recent decades, however, some enterococci have become resistant to vancomycin. The two main species that cause problems are vancomycin-resistant Enterococcus faecium and vancomycin-resistant Enterococcus faecalis, with E. faecium being the most common.

• Vancomycin resistance is acquired when a sensitive Enterococcus acquires a special piece of DNA called a plasmid. The new strain is called vancomycin-resistant enterococci (VRE).

• One concern is that VRE appears able to transfer vancomycin resistance to unrelated bacteria such as MRSA (methicillin-resistant Staphylococcus aureus). In addition, VRE organisms are usually resistant to more than one antibiotic.

• VRE can also be spread from person to person and are an increasing problem in hospitals and chronic-care facilities. Approximately 30% of all enterococcal infections are now caused by vancomycin-resistant strains (VRE).

http://www.medicinenet.com/script/main/art.asp?articlekey=20162

http://www.medicinenet.com/script/main/art.asp?articlekey=84499

LGG Clinical Trials-Hibberd, Healthy Adult• Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in

Healthy Volunteers, Phase I– Principal Investigator: Patricia L. Hibberd, MD, PhD– Chief, Division of Global Health, Mass General Hospital for

Children– Consultant, Infectious Disease Unit, Mass General Hosp– Additional study location: Tufts Medical Center– Study Dates: Dec 2009-July 2012

• This study is a single site, Phase I, masked, randomized study to evaluate the safety and tolerability of twice daily dosing of LGG (Lactobacillus GG ATCC 53103) in normal healthy adult volunteers. Study drug capsules (1x10^10 LGG/capsule or placebo) will be taken by mouth twice a day with cow's milk or soy milk on an outpatient basis. Volunteers will have study visits at baseline, 1 month, 3 months, 6 months, 7 months, and 12 months where they will be asked about any medical problems that have come up since the last study visit, have vital signs taken, review current medication use, and review any signs of potential adverse events. Blood and urine samples will also be collected at these visits, as well as throat and stool samples.

LGG Clinical Trials-Hibberd Healthy Adults• The goal is to assess the safety and tolerability of LGG when

administered to healthy adult volunteers twice a day. Assessment of safety will be determined by vital sign measurements, physical examinations, clinical laboratory tests, and from the incidence and severity of adverse events that occur during study participation.

• Additionally, the study will assess whether LGG colonizes the throat and/or gastrointestinal tract of healthy adult volunteers and assess the effect of LGG on the bacteria that normally live in the throat and GI tract by using culture-independent techniques.

• Volunteers enrolled in this study will also be invited to participate in a companion genetic study that will investigate the host immune response to the bacteria in LGG.

• Cornerstone study in LGG safety and efficacy to permit further research• This will be the longest study purely on the safety of LGG in healthy

adults.

LGG Clinical Trials-Shien Lo, Healthy Adults

• Effect of Lactobacillus GG Probiotic on Health Adults, Phase I– Principal Investigator, Tze Shien Lo, MD

• Internal Medicine, Infectious Disease, Fargo VA Medical Center

• Associate Professor of Medicine, University of North Dakota

• Completion Date: Feb 2010 – Sept 2011

• Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the risk of other infections, develop into more serious forms of disease, and lead to premature discontinuation of the needed antibiotic. The purpose of this study is to examine the safety and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of diarrhea associated with antibiotic use.

Yindra, Kirsten

Rose, CT.gov indicates this study is recruiting but in the text is has the completion date as Feb 2011, please advise.

LGG Clinical Trials-Bajaj, Liver Disease• Probiotic Lactobacillus GG (LGG) in Patients With Minimal Hepatic

Encephalopathy– Principal Investigator, Jasmohan Bajaj, MC MSc– Associate Prof of Medicine, Division of Gastroentoerology,

Hepatology and Nutrition, Virginia Commonwealth University– Completion Date: Oct 2009 – Nov 2012

LGG Clinical Trials-Bajaj, Liver Disease• Development of complementary and alternative medicine approaches to liver disease is a priority area at NCCAM. Minimal hepatic encephalopathy (MHE) is a significant complication of cirrhosis which can result in poor quality of life, impaired cognition and difficulty in driving motor vehicles with a high traffic accident risk. MHE is estimated to affect one half of the 5.5 million cirrhotics in the U.S. Despite these negative outcomes, there is no consensus on treatment of MHE. Currently available therapies for MHE act on intestinal flora but are limited by adverse effects (i.e. lactulose-induced diarrhea), which negatively impact adherence. Probiotic bacterial supplements, which also act on intestinal flora, are an emerging therapy for MHE. Our group has performed a pilot, randomized trial which demonstrated a significantly higher rate of MHE reversal with excellent adherence in patients randomized to probiotic yogurt compared to no therapy. This proposal intends to define Lactobacillus GG (LGG) as a biologically-based alternative therapy for MHE with special focus on metabolic and stool bacteriologic changes.

• The hypothesis of this Phase I proposal is: LGG will be safe and efficacious for the treatment of minimal hepatic encephalopathy compared to placebo in a randomized, double-blind trial.

Clinical Trials Key Insights

• Tufts, Dr. Snydman: Probiotic Lactobacillus GG to Eliminate Vancomycin Resistant Enterococcal (VRE) Colonization-one of the rising costly nosocomial infections

• Mass Gen & Tufts, Dr. Hibberd: Safety of Lactobacillus GG in Healthy Adult and Elderly Volunteers (2 separate studies). NIH requested studies to validate safety in healthy volunteers prior to use in disease states.• Healthy adults-placebo controlled (18-50yrs old)• Healthy Elderly-open label (65-80yrs old)

• Mass Gen, Dr. Hibberd: LGG in elderly getting inactivated flu vaccine–starting fall 2011

• Mass Gen, Dr. Hibberd: LGG in elderly getting live flu vaccine–starting summer 2012

• University of North Dakota, Dr. Shien Lo: Effect of Lactobacillus GG on AAD in Adults—would be beneficial if we can demonstrate some + results in adults.

• Virginia Commonwealth Univ, Dr. Bajaj: Effect of Lactobacillus GG in Patients With Minimal Hepatic Encephalopathy—would demonstrate another systemic effect if + and at the least will demonstrate safety in a “ill” population.

Brainstrong Prenatal Market Insights• Prenatal vitamin category is an atypical market.

• -Big, complicated market with players in Rx Generic, Rx Branded, and OTC. Over 200+ competitors

• -Category is fragmented with no clear category leader.

Generics have large slice of pie-No clear divisions between premium/everyday/value brands as in a natural market.-Small US pharma companies have strong presence, but medium-sized European and Asiancompanies have bought into market for reasons other than prenatal vitamins.

Brainstrong Prenatal OBGYN Research Findings• Cost plays a factor in this decision

– Physicians report monthly copays of $20 to $50 per month for prescription prenatals

• OTCs are a less expensive alternative• Physicians report that all of the “major” prescription prenatal vitamins

are sampled to their office– Samples of prenatal vitamins are very important to OB/GYNs– Samples provide an opportunity for the patient to test tolerability

before filling prescription– Patients are usually provided with several brands of samples and

asked to decide for themselves• Use of OTC, as an alternative to high insurance copays

– Copays reported to be $20-$50 per month– For patients without insurance coverage or poor coverage

• Most OB/GYNs voice positive reactions– Positive reactions

• Price of $19.99 per month is often cited• Plant-based DHA seen as a positive; no “fishy smell”• High dose of DHA (350 mg)• Easier to recommend an OTC than write a prescription

Brainstrong Prenatal Market Objectives• Break the traditional “knee jerk” habit of writing a

prescription for a prenatal vitamin by offering Brainstrong as a better alternative for both OB/Gyns and pharmacists.

• Leverage Brainstrong OTC status as a way to provide patients with optimum benefits at a competitive price.

• Focus most resources on OB/GYN’s as the primary audience

• Create awareness and encourage recommendations of Brainstrong Prenatal among OBGYN’s, Nurse Midwives and Pharmacists, to gain a foothold with this growing market.

Brainstrong Prenatal Campaign• OBGYN Brainstrong Introduction Mailer to 7200 high-

prescribers-July

• Coupon Fulfillment Mailer, estimated 5,600 Responders from the Intro Mailer, 4 drops Sept-Dec

• Pharmacist Mailer Intro, 4 page brochure sent to 42,000 Retail Chain Pharmacy’s – Aug 2011

• Pharmacist Coupon Mailer-40 sheet coupon pads mailed by request only to 3,000 Retail Pharmacy chains-Oct 2011

• Journal Ad and Tradeshow

Brainstrong Prenatal Introduction• OBGYN Brainstrong Introduction Mailer to 7200 high-

prescribers-July– Custom dimensional mailer to include

• Retail box Brainstrong Prenatal• Clinical Vis Aid• Doctor Letter• 90 Sheet Coupon Pad• Online sign-up and Faxback for Coupons

Brainstrong Prenatal Clinical Vis Aid Page 1

Brainstrong Prenatal Clinical Vis Aid Page 2

Brainstrong Prenatal Medical Marketing Coupon

Brainstrong Prenatal Pharmacy Introduction

• Brainstrong Prenatal Introduction, 4-page brochure mailed to 42,000 C-Chain Retail Pharmacies- August 2011– CVS, K-Mart, Kroger, Rite Aid, Target, Walgreens, Wal-

Mart

Front Page Pharmacist Letter Back Page Complete Brainstrong Product Line

Brainstrong Prenatal Pharmacy Introduction

Inside pages

Brainstrong Prenatal Journal Ad

Brainstrong Prenatal Journal Ad Schedule

• Contemporary OBGYN June, July, Sept

• OBG Management June, July, Aug

• OBGYN News June, July, Aug, Sept, Oct

• American J for Nurse Practitioners: Women’s Health Care Edition Oct

• J of Midwifery & Women’s Health July, Sept

Brainstrong Prenatal TradeshowAmerican College of Obstetricians and Gynecologist May 2011

• We successfully introduced BrainStrong to OB/GYNs, answered questions about BrainStrong and distributed product samples. In addition, we informally questioned physicians about their prenatal vitamin prescribing habits to gauge their reaction to and potential usage of BrainStrong. Overall their reaction was extremely positive!

• The message, “the complete OTC vitamin with 350mg of DHA that has everything you need in a PNV at a competitive price,’ was on target with MDs.

• Price was a big issue. Almost universally the first question asked was

“how much does it cost?” When told $19.99 for a 30-day supply all were impressed, and usually stated that it was a lot less than current co-pays.

Brainstrong Prenatal ACOG Exhibit Booth

Brainstrong Prenatal Tradeshow Sell Sheet

Brainstrong Prenatal 2011Campaign Schedule• Journal Ad -- OB/GYN midwife June-Oct

2011 • ACOG May 2011 • OB/GYN Intro Mlr Patient Coupon Pad July 2011• Coupon pad fulfillment Aug-Nov 2011• Pharmacy Introduction Aug 2011• Pharmacy Coupon Drop Oct 2011

professional marketing program 2011

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