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Business Presentation June 2009 PowerPoint Presentation
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Business Presentation June 2009

Business Presentation June 2009

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Business Presentation June 2009

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  1. Business Presentation June 2009

  2. prepared for

  3. APPENDIX I Abelcet Marketing Plan

  4. Analysis of theenvironment SGK (Sosyal Guvenlik Kurumu-Social Security Organisation) is a state controlled organisation which acts independently. Of course has close ties with the MOH and MOF(finance) and MOL (labour). MOH is responsible for registration of pharmaceuticals and SGK is the main body for reimbursement. Almost 2/3 of the population has State controlled social security coverage. Private insurance companies control 3-4% of the population. Pharmaceuticals pricing formula: The cheapest ex-factory price (hospital price if ex-factory is not available) in reference countries(France, Italy, Portugal, Spain, Greece) and country of origin will be accepted as Turkish ex-factory price.

  5. Analysis of theenvironment Reimbursement: For all reimbursed products 11% reimbursement discount is by law. Registered products may apply for reimbursement (fully or partly) which is a very difficult process. It takes time and huge effort is necessary. At the time being Abelcet is reimbursed in Turkiye but with an indication restriction. According to the restriction if the patient does not have renal or hepatic impairment conventional amphotericin B should be started instead of Ambisome or Abelcet. Because of this change Ambisome sales dramatically declined. Please find attached the copy of the related section of SUT (Regulation for Healthcare Implementation).

  6. Analysis of theenvironment Abelcet and Ambisome can only be prescribed with a health report prepared by a specialised doctor stating that the patient has either renal or hepatic impairment and systemic fungal infection. HIV prevalence is very low in Turkiye that is why most of the sales come from onco-hematology and some from infectious diseases. There are 998 infectious diseases specialists, 210 hematologists, 140 oncologists as the primary target group with a total number 1348.

  7. Analysis of theenvironment If the restrictive wording in SUT will be cancelled then the market will again be very attractive. As Gen Ilac we will try to do our best for this restriction to be cancelled. Conditions of the agreement will be open to renegotiation in this circum stances particularly from the pricing and margins point of view. You will see two forecasts; one for the current situation other for the hypothetical new SUT.

  8. Market Amphocil is not available in the market the only direct competitor is Ambisome which is marketed by a local company named Erkim.

  9. Market

  10. Businesscase • In general Gen Ilac will be waiting • Regulatory files need to be transferred, authorisation to be completed and import of the product should be done. These can not be completed before the end of the year 2009. That is why we do not expect any sales in 2009. • 2009 will be the year for the bottom line of the market. From 2010 on the market will slightly increase if the current SUT will be valid. Scenario 1 reflects sales and market for the 5 coming years with current SUT. • Scenario 2 reflects sales and market for the 5 coming years with hypothetical new SUT.

  11. Scenario 1 (current SUT) Total Market (for 5 coming years)

  12. Scenario 2 (hypotheticalnew SUT) Total Market Units (for 5 coming years)

  13. Productstrategy 2009-2010 Onco-hematology is one of the core specialties for Gen Ilac. We started to create awareness and build up a good image with our products Somatuline Autogel (for carcinoid tumors), Trisenox (for APL), Thioctacid (for cancer and chemotherapy induced neuropathy). Cephalon’s oncology portfolio is very important for Gen Ilac to increase the turnover in this area. With current SUT Abelcet does not seem to be a very profitable business for Gen Ilac but we will try to do our best for a new SUT. We do not expect any changes for regulatory, price and reimbursement status in 2009 and most probably in 2010 also.

  14. SWOT analysis Strengths: • Already used by some doctors in Turkiye. • Abelcet is a Amphotercin B in a lipid complex. • Rapidly being carried to target cells due to its unique structure. • 1:1 drug-to-lipid molar ratio. • Better uptake by the RES • Convenient pharmacological profile. • European registered. • Faster release • Bad image of the product due to previous distributor company’s activities. • Current SUT. Weaknesses :

  15. SWOT analysis Opportunities : • Serious side effects of conventional Amphotericine B. • Current SUT (competitors interest is low). • Continuation of current SUT. • Price cuts by MOH. • Reimbursement restrictions. • Generics . Threats:

  16. Myocet Marketing Plan

  17. Analysis of theenvironment SGK (Sosyal Guvenlik Kurumu-Social Security Organisation) is a state controlled organisation which acts independently. Of course has close ties with the MOH and MOF(finance) and MOL (labour). MOH is responsible for registration of pharmaceuticals and SGK is the main body for reimbursement. Almost 2/3 of the population has State controlled social security coverage. Private insurance companies control 3-4% of the population. Pharmaceuticals pricing formula: The cheapest ex-factory price (hospital price if ex-factory is not available) in reference countries (France, Italy, Portugal, Spain, Greece) and country of origin will be accepted as Turkish ex-factory price. Reimbursement: For all reimbursed products 11% reimbursement discount is by law. Registered products may apply for reimbursement (fully or partly) which is a very difficult process. It takes time and huge effort is necessary.

  18. Analysis of theenvironment Reimbursement: For all reimbursed products 11% reimbursement discount is by law. Registered products may apply for reimbursement (fully or partly) which is a very difficult process. It takes time and huge effort is necessary. Although both Myocet and Caelyx are liposomal doxorubicin formulations, from the registered indications point of view they can not even be accepted as competitors in Turkiye at the time being. The approved indications of Caelyx by the Turkish MOH are advanced ovarian cancer and AIDS related Kaposi’s Sarcoma. As you see metastatic breast cancer is not registered.

  19. Analysis of theenvironment • Meanwhile registration application of Myocet for MBC has been investigated by the Turkish MOH and eventhough Myocet has EMEA approval for this indication, the application was not accepted due to the following reasons declared by the MOH • Limited number of patients in the trials. • Severe side effects. • Lack of advantages over conventional Doxorubicin and Epirubicin. • As we do not know which data has been presented to the MOH we can not make any comments on the above mentioned reasons. Unfortunately we did not have the chance to investigate what really was the story behind this refusal as many committee members have been changed since the investigation of the Myocet dossier.

  20. Analysis of theenvironment We believe with a strongly supported medical approach it is possible to reapply Myocet dossier and get registration approval for this EMEA approved product. As the indications (at the time being), dose regimens and formulation (liposomal structure) are different it is not possible to apply Myocet as a generic product. So this prolongs the time needed for approval. Approximately expected time for approval will be 2nd half of 2011 earliest. After approval another problem will be the SUT. In SUT reimbursement conditions (fully or partly reimbursed, who can prescribe, which indication, first line or second line, therapeutic equivalent or not, generic or not) are clearly described. In Caelyx case in all descriptions “liposomal doxorubicin” wording is used.

  21. Analysis of theenvironment In order not to create confusion a new SUT is necessary. In this new SUT maybe the descriptions will be “liposomal doxorubicin” for Caelyx and “doxorubicin in lipid complex” for Myocet. New SUT can only be prepared after registration approval. Possibly it will take place in mid 2012. As Caelyx is not registered for MBC yet there is chance for Myocet to be prescribed in this indication under named patient sales. This will give us opportunity to convince the authorities and let them see the products popularity amongst the oncologists.

  22. Market Caelyx is marketed by Schering Plough Turkiye IMS Data

  23. Market IMS Data

  24. Businesscase 5 years forecast ( Myocet and Caelyx )

  25. Businesscase Total market forecast ( for 5 years)

  26. SWOT analysis Strengths: • Named patient sales; Gen is one of the leading companies in NPS. • Myocet is a Doxorubicin in a lipid complex. Different then Caelyx. • Well documented and experienced in combination. • Better safety profile then Caelyx (VS. Doxorubicin) • Previously rejected by the Turkish MOH. • Registration and reimbursement in 2012. Weaknesses :

  27. SWOT analysis Opportunities : • Named patient sales • Caelyx is not registered for MBC • Caelyx registration for MBC • Price cuts by MOH. • Reimbursement restrictions. • Generics Threats:

  28. Targretin Marketing Plan

  29. Analysis of theenvironment SGK (Sosyal Guvenlik Kurumu-Social Security Organisation) is a state controlled organisation which acts independently. Of course has close ties with the MOH and MOF(finance) and MOL (labour). MOH is responsible for registration of pharmaceuticals and SGK is the main body for reimbursement. Almost 2/3 of the population has State controlled social security coverage. Private insurance companies control 3-4% of the population. Pharmaceuticals pricing formula: The cheapest ex-factory price (hospital price if ex-factory is not available) in reference countries (France, Italy, Portugal, Spain, Greece) and country of origin will be accepted as Turkish ex-factory price.

  30. Analysis of theenvironment Reimbursement: For all reimbursed products 11% reimbursement discount is by law. Registered products may apply for reimbursement (fully or partly) which is a very difficult process. It takes time and huge effort is necessary. SUT is the regulations for reimbursement. In SUT reimbursement conditions (fully or partly reimbursed, who can prescribe, which indication, first line or second line, therapeutic equivalent or not, generic or not) are clearly described. Prevalence of CTCL in Turkiye is 60 per million which shows us 4000-5000 patients. Dermatologists are taking care of these patients. Only the patients with very advanced disease are referred to the oncologists. At the time being some targets doctors already know and use Targretin. There are 1500 dermatologists in Turkiye and almost 200 of them dealing frequently with CTCL treatment.

  31. Analysis of theenvironment In our discussions with target group they estimate 200-400 patients can be treated with Targretin. While waiting the registration approval we will start to promote the named patient sales. Expected time of registration is a question mark for us as we are not aware of the questions asked by the committees of the MOH.

  32. Market Units

  33. APPENDIX II COMPANY PRESENTATION

  34. REQUESTED INFORMATION/ANSWERS • Denomination: • Gen Ilac ve Saglik Urunleri LTD. STI. • Address: • Headquarter: • MUSTAFA KEMAL MAH. 50.SK NO: 15 D: 2-3 • BILKENT  CANKAYA / ANKARA /TURKIYE • Regional Offices: • ISTANBUL :  HALYOLU CAD. BAY PLAZA NO : 5 K:5 • 34752 ICERENKOY / ISTANBUL /TURKIYE • IZMIR :  52 / 72 SK. NESE AP.  NO : 7 D: 3 • HIFZISIHHA   ESENYALI / IZMIR /TURKIYE • TRABZON :  TOKLU MAH. İSTİKBAL SK. BULUT AP. K: 2 • TRABZON  / TURKIYE

  35. REQUESTED INFORMATION/ANSWERS • Web Site: www.genilac.com.tr • Telephone & Fax :+90 312 219 62 19 &+90 312 219 62 10 • Creation date and legal status:The date of establishment of Gen Ilac is 05 August 1997, The legal status is a Limited Liability Company with a paid capital 4 million TL. Trade registry number is 131040 and Company is a member of Ankara Chamber of Commerce. • Registred only in Turkiye • Owners and Their Shares:Abidin Gulmus 99,05%, Semra Gulmus 0,95% • Board members: Abidin Gulmus, Levent Zumreoglu, Ozgu Bozalp, Sukru Turkmen, Omer Dincer

  36. REQUESTED INFORMATION/ANSWERS • Headcounts:Countrywide: 128,Headquarter in Turkey: 47,Sales rep's in Turkiye : 65,Regional managers: 11

  37. BUSINESS & FINANCIAL INFORMATION

  38. REQUESTED INFORMATION/ANSWERS • Registred Products: Avonex (interferon Beta-1a), Apo-go (apomorphine), Allergodil eye drops and nasal spray (azelastine), Modiodal (modafinil), Somatuline Autogel (lanreotide), Dysport (botulinum toxin type A), Thioctacid (alpha lipoic acid), Shuyang IVIG (I.V. immunoglobulin), • Pipeline (named patient sales):Tysabri (natalizumab), Trisenox (ATO), Fosrenol ( lanthanum carbonate), Replagal (agalsidase alfa), Elaprase (idursulfase), Nutropin (somatotropin), Increlex (IGF 1), Xenazine (tetrabenazine), Trientine (trientine), Nuvigil (armodafinil).

  39. REQUESTED INFORMATION/ANSWERS • Partnerships: • Biogen Idec: Avonex, Tysabri, • Britannia-Stada: Apo-go, • Cambridge: Xenazine, • Cephalon: Modiodal, Trisenox, Nuvigil • Ipsen: Dysport, Somatuline Autogel, Nutropin, Increlex • Shire: Fosrenol, Replagal, Elaprase • Univar: Trientine

  40. REQUESTED INFORMATION/ANSWERS • Development plan for the 3 coming years: • Most of Gen’s three years pipeline is already mentioned above. Gen’s priority will always be specific and specialty products in rare diseases. Major fields will be neurology, endocrinology, oncology and genetical

  41. FINANCIAL OFFER

  42. REQUESTED INFORMATION/ANSWERS

  43. REQUESTED INFORMATION/ANSWERS

  44. REQUESTED INFORMATION/ANSWERS

  45. SUPPLY AND LOGISTICS 

  46. REQUESTED INFORMATION/ANSWERS • Delivery address: • Gen Ilac ve Saglik Urunleri LTD. STI. • MUSTAFA KEMAL MAH. 50.SK NO: 15 D: 2-3 BILKENT  CANKAYA / ANKARA /TURKIYE • In house capacity: • Number of pallets ambient: 60 pallets . • Number of pallets cold chain (+2 +8°C): • 80 cubic meter cold chain storage capacity. • Number of pallets opiates: we don’t have pallets for opiates at the time being. But we have available space to organize such conditions accordingly.

  47. REQUESTED INFORMATION/ANSWERS • Sub-contractor capacity,company name and address: • Expeditors International A.S. Esenboga yolu 28. Km Balikhisar Koyu mevkii Ankara/Turkiye phone: +90 312 841 63 70) • No. of pallets ambient: 200 pallets (at custom zone) • Number of pallets cold chain (+2 +8°C):120 cubic meter cold chain storage capacity dedicated to Gen Ilac usage at custom zone. • Number of pallets opiates: we don’t have pallets for opiates at the time being. But we have available space to organize such conditions accordingly at custom zone.

  48. REQUESTED INFORMATION/ANSWERS • Transportation: • Is transportation undertaken by the Company? No • Is transportation undertaken by Subcontractors ? Yes • Yurtici Kargo, Aras Kargo, MNG Kargo, Varan Kargo • Import licence owned by the Company • Cold chain management: Expeditors and Gen is responsible for the storage of the goods. Both parties controls the cold rooms by temperature loggers. From cold rooms to wholesalers goods are transported with cold chain packaging. Afterwards we have no control.

  49. QUALITY ASSURANCE 

  50. REQUESTED INFORMATION/ANSWERS