Brand Name for Denosumab

Prolia

• Brand name for denosumab

• Fully human antibody for osteo
• Patents expire between 2017 and 2023

• Competitors were bisphos

• Slowed osteo, increase BMD
• 40-50% reduction in verteb fract
• Minor gastro side effects, long-term issues
• Low compliance after 1st year (barriers to entry)

• No immediate visible benefits
• Gastro effects
• Patient- not Physician-admin

• Fosamax

• Industry leader
• Big success
• Launched Feb 2008
• Lost patent
• Oral, once weekly dose

• Actonel

• Top selling biph in 2010
• Patent expires May 2012
• Taken weekly

• Boniva

• Patent expires Mar 2012
• Daily dose

• Reclast

• Only drug for POST-menopaus osteo
• Specially infused once every 2 years, not oral
• Second-line therapy

• Evista

• Mimicked estrogen to increase thickness
• Also handled breast cancer
• Clots and strokes side-effects
• Patent expires end of 2012
• Daily

• Forteo

• Increased bone growth, first of its kind
• Cancer side effect
• Administered to severe cases
• Daily

• Denosumab

• First biologic product for osteo
• Blocked a protein known to decay bones
• Administered by pro
• Study 216 (FREEDOM)

• Reduced vert fract by 68%
• Reduced nonvert fract by 20%
• Hip fract by 40%

• Study 234 (STAND)

• Compare denos to Fosamax

• Superior BMD production

• Study 141 (DECIDE)

• Compare denos to Fosamax on cust satis

• Preferred six-month injection to weekly

• Already FDA approved
• Only RANK ligand inhibitor
• Large trained sales force to reach physicians, expand global
• $825/injection
• Launched Mid 2010
• Initial sales slow
• Analysts expect only new osteo product for 5 years
• Buy and bill from physicians (tough for them to manage)

Providers

• Physicians, able to measure BMD
• Did not carry drugs in inventory

Patients

• Fosamax: picked up at pharmacy
• Prolia: schedule separate appt for injection
• 50% not receiving therapy
• 30.7 mill w/ osteo (estimate)
• 15.5 were diagnosed (estimate)
• Only a portion of 15.5 received treatment
• 40% receiving treatment continued to see declining BMD

Payers

• Most important source: Medicare Part D
• Out-of-pocket primary concern for patients
• Most osteo fell under Medicare Part D

Metastases (spreading of cancer)

• 70% of patients with advanced breast/prostate cancer developed bone metast
• Metastates can cause SREs
• Survival declined w/ SRes
• Leading competitors

• Zometa

• Leading player
• Didn’t cure cancer, but reduced SREs
• Infused every 3-4 weeks
• Long setup time
• Reduced SRE risk by 30-40%
• Patent ended 2013
• $840/dose

Xgeva

• Injection every 4 weeks
• Studies showed X superior to Zomet in delaying SRE
• FDA approved in Nov 2010
• $1,650/month
• Launched trials for prostate/breast cancer (unmet markets)
• Delayed onset of metastatic cancer (analyst believe big sale)
• Little competition
• No other new product for 5 years

Bone Metastases - Providers

• Administered by oncologists
• Comfortable managing inventories and “buy and bill”
• Off-label use common
• Pharma comps could not encourage off-label use
• Cancer patients

Bone Metastases – Patients

• Cancer patients very involved
• Very aggressive
• Stopped treatment if not successful and just did pain meds
• Cancer treatment very expensive

Growth Potential

• Few blockbuster pharma products declined
• Endorsed by CEO
• Analyst predict $2-5bill in rev for denos

1. Taking market share (Prolia)

1. Fosamax still industry leader (take while to gain share, awareness)
2. Initial slow sales
3. Buy and bill for physicians (tough to manage, therefore not as likely)
4. First RANK inhibitor, biological osteo drug
5. Only new osteo product for 5 years
6. Superior vert fracture and BMD production results to Fosamax

1. Untreated osteo

1. Reduces new verteb fractures by almost 30% of leader in industry in study, that is visible
2. Reduces hip fractures by 40% in study, visible
3. Only taken twice as opposed to weekly or daily
4. Administered by pro
5. Mild adverse effects when compared to placebo in study

1. Taking market share (Xgeva)

1. Similar administration
2. X superior to Z in delaying SRE per study
3. Little other competition
4. But almost $9000 more expensive
5. Only fully biologic treatment, therefore less side effects

1. Patients not treated

1. 70% of US cancer pop
2. If marketing done properly, knowledge advanced between bone metastases and cancer, more patients will be active in X
3. Setup time could be shorter than long one for nurses for Z
4. Superior breast and bone cancer trial performance of X to Z
5. Performed trial for use as a prevention drug, the first of it’s kind

1. Prostate metastases

1. X superior to Z in delaying SRE in trial
2. Also trialed prevention with success vs placebo, lengthened survival and first occurrence time
3. No similar product for 5 years

1. Breast metastases

1. X superior to Z in delaying SRE in trial
2. Study about prevention won’t be completed by release, but could show similar results for Prostate
3. Oncologists prescribe off-label if they think it will help and fairly common
4. Amgen can’t market though, politicians heavily monitor