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Business Plan Teriparatide
Transcript of Business Plan Teriparatide
Estimated population above 50 years old has highr risk of osteoporosis
Facts about the market
Only 3500-4000 patients are being treated from osteoporosis
Osteoporosis is underdiagnosed
Osteoporosis affects 55% of Americans aged 50 and above. Of these, approximately 80% are women.One in three women and one in 12 men over the age of 50 worldwide are estimated to have osteoporosis.
Zolendronate 4mg,5mg ,Novartis(Zometa,Aclasta)
-Currently a market brand Forsteo
-Other Brand Dose:An infusion once yearly for osteoporosis of the 5 mg(Aclasta),An infusion every 3 weeks of the 4 mg (Zometa) for bone complications of cancer.
-Side effects can include fatigue, anemia, muscle aches, fever,Flu-like symptoms are commonly experienced after the first zoledronate infusion.
-Must be avoided for patients with
hypocalcemia and kidney disease patients.
Allendronate 70 mg, MSD(Fosamax)
-Alendronate has been linked in long-term users to the development of
low-impact femoral fractures
Osteonecrosis of the Jaw
deterioration of the Temporomandibular Joint (TMJ) may occur while on this drug, if dental work of any kind is carried out
-The drug is unusual in that it both increases deposition of new bone by osteoblasts and reduces the resorption of bone by osteoclasts. It is therefore promoted as a
"dual action bone agent" (DABA).
- Servier released a Direct Healthcare Professional Communication which stated that important new restrictions for the use of Protelos are now in place, as randomised trials have shown an increased risk of
-The drug is
not FDA approved
-FDA issued a communication warning of the possibility of severe and sometimes incapacitating bone, joint and muscle pain.
-Treat PM osteoporosis,Paget's disease of the bone, bone metastasis , multiple myeloma, and other conditions involving fragile, breakable bone.
-Adverse events:Osteonecrosis of the jaw ,Unusual fractures with long term use.
-Occupy about major
of the osteoporosis market.
-Teriparatide is the first, and to date the only FDA approved agent for the treatment of osteoporosis that
stimulates new bone formation.
-Adverse events:Teriparatide has a theoretical risk of osteosarcoma, which was found in rat studies but not confirmed in humans
-Dose:20 μg per day subcutaneous injection in the thigh or abdomen
- Indicated for prevention of skeletal-related events in patients with bone metastasis from solid tumors
-On 13 June 2013, the US FDA approved denosumab for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where resection would result in significant morbidity.
Denosumab 60 mg (Prolia)
-Non formulary product in HMC.
in discharge pharmacy and
in Al Amal Hospital.
-Price is 1370 QR
- Dosing is one 60 mg subcutaneous injection every six months.
-Indicated for treatment of postmenopausal osteoporosis, and for the treatment of bone loss in patients undergoing hormone ablation for prostate cancer.
The product in question
-Approved by the FDA for new born formation
-Strong head to head trials against the bisphosphonates,showing superior efficacy and similar safety data.
-Dosing is twice yearly.
-More data is needed to establish the long term safety.
-It's a new class so it will take a lot of time and effort to establish the product.
-Untapped potential for growth in the osteoporosis market.
-Pricing is expensive.
-High market share of bisphosphonates.
-Little understanding of the disease risks which explains the low number of patients treated.
High prevelance of vitamin D defeicency
-Representing about 50% of the business.
-15 senior consultants.
- KOL lectures
-Representing about 30% of the business.
-10 Senior consultants.
-More concerned with surgical procedures.
Our first and main priority as it represents about major patients of the osteoporosis market
-Represent about 15% of the business.
-Represents less than 5% of the business,Mainly with postmenopausal osteoporosis while the rest is referral to the main departments.
-Fast hospital penetration within two months.
-Maximizing the gain from our marketing resources,By pre-planning our activities the year before.
-Tailoring our message for each department.
-Create an osteoporosis membership,gathering all the Drs concerned with osteoporosis
-Aclasta is the Market leader with
42% Market share
,Followed by protelos with about
,Then comes Fosavance with about
25%(Total year 2012).
-Represents very little number of units but with high value,So its critical to grow in the private market.
-Al Ahli Hospital:
With 5 Ortho Drs,1 Rhematology Dr it comes in the first priority.
Has 4 ortho Drs
840, 767 $
-All the numbers mentioned reflects the real life practice of the Drs.
-It will take two months to fully penetrate all the departments.
-We can expand the osteoporosis market significantly.
-PHCs are a great generator for business,as it has a large pool of undiagnosed patients.
-Thinking inside the box first.
-Creating a Hot List to concentrate our effort and resources at the most important customers.
"Successful and unsuccessful people do not vary greatly in their abilities. They vary in their desires to reach their potential." --John Maxwell
Take Home messages: