MIRA
INFORM REPORT
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Report Date : |
07.05.2008 |
IDENTIFICATION
DETAILS
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Name : |
ORGANON INDIA LIMITED |
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Formerly Known As : |
INFAR INDIA LIMITED |
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Registered Office : |
7 Wood Street, Kolkata – 700 016, West Bengal |
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Country : |
India |
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Financials (as on) : |
31.12.2006 |
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Date of Incorporation : |
30.08.1967 |
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Com. Reg. No.: |
21-27128 |
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CIN No.: [Company
Identification No.] |
U24231WB1967PLC027128 |
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TAN No.: [Tax
Deduction & Collection Account No.] |
CALI00136D |
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PAN No.: [Permanent
Account No.] |
AAACI6949R |
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Legal Form : |
Public limited liability company. The company's shares are listed on the Kolkata Stock Exchanges Subject is a subsidiary of Akzo Nobel Pharma International BV - a constituent of the transnational conglomerate AKZO NOBEL. |
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Line of Business : |
Manufacturer and marketing of healthcare products. |
RATING &
COMMENTS
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MIRA’s Rating : |
Aa |
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RATING |
STATUS |
PROPOSED CREDIT LINE |
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71-85 |
Aa |
Possesses adequate working capital. No caution needed for credit
transaction. It has above average (strong) capability for payment of interest
and principal sums |
Large |
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Maximum Credit Limit : |
USD 5575600 |
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Status : |
Good |
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Payment Behaviour : |
Regular |
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Litigation : |
Clear |
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Comments : |
Subject is a well established and reputed company having fine track of performance and financial status. Available information indicates high financial responsibility of the company. Financial position of the company is good. Payments are always correct and as per commitments. The company can be considered good for any normal business dealings. It can be regarded as a promising business partner in a long term. |
LOCATIONS
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Registered Office/ Factory : |
Saturday Club Building, 7 Wood
Street, Kolkata 700 016, West Bengal, India |
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Tel. No.: |
91-33-22478301-05 / 22471211-15 / 22878301 / 8305
/ 22878301-05 / 22871211-15 |
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Fax No.: |
91-33-22473750 /22473254 / 22873254 / 22805069 / 22810046 / 22810046
/ 22873254 |
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E-Mail : |
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Website : |
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Corporate Office: |
‘Nishuvi’, 1st Floor, 75, Dr. Annie Besant Road, Worli,
Mumbai 40001, Maharashtra, India |
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Tel. No.: |
91-(0) 22 66661724-29 |
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Fax No.: |
91-(0) 22 66661988 / 66661740 |
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E-Mail : |
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Zonal Office : |
West :- Oberoi Garden Estate, Maharashtra, India Phone : 91-22-28478041 / 2 / 3 Fax: 91-22-56683157 / 56978327 North :- A - 22, 3rd Floor, Green Park Phone
: 91-11- 517 59325/27 Fax: 91-11-517 59328 East:- Saturday Club Building Phone : 91-33-22478301-05 / 22471211-15 Fax:91-33-22473750 / 22473254 South :- No. 713, 1st floor Phone: 91-44-28517883 / 7884 Fax: 91-44-28517488 |
DIRECTORS
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Name : |
Mr. P B J M Rohof |
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Designation : |
Chairman & Managing Director |
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Name : |
Mr. J C C B Evers |
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Designation : |
Director |
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Name : |
Mr. C P Thys |
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Designation : |
Director |
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Name : |
Mr. K Sinha |
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Designation : |
Director |
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Name : |
Mr. N K Sengupta |
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Designation : |
Director |
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Name : |
Mr. B N Chakraborty |
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Designation : |
Managing Director |
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Name : |
Mr. G C M Van Alphen |
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Designation : |
Director |
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Name : |
Mr. S Coomer |
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Designation : |
Director & Company Secretary |
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Name : |
Mr. E H A M Rohof |
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Designation : |
Director |
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Name : |
Mr. C H J Lujiben |
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Designation : |
Director |
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Name : |
Mr. N K Sengupta |
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Designation : |
Director |
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Name : |
Mr. K Sinha |
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Designation : |
Director |
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Name : |
Mr. P Lele |
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Designation : |
Director |
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Name : |
Mr. K G Ananthakrishnan |
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Designation : |
Director |
BUSINESS DETAILS
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Line of Business : |
Manufacture and marketing of healthcare products. |
PRODUCTION STATUS(as on 31.12.2004):-
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Particulars |
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Unit |
Actual Production |
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Bulk Drugs including Intermediates |
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Kgs. |
2603 |
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Formulations |
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A] Injectables |
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Amps. |
6742486 |
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B] Tablets |
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Nos. |
71348579 |
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C] Liquid |
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Ltrs. |
26672 |
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D] Ointments, Pessaries and Dexatopic Cream |
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Kgs. |
4052 |
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E] Capsules |
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Nos. |
3632840 |
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F] Isapgol Husk (Powder Palatable, Powder Effervescent and Granules) |
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Kgs. |
252481 |
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Powder Lactobacillus (1 gm pack size) |
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Nos. |
536510 |
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Lactobacil Capsules |
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Nos. |
3154780 |
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Contraceptive Device |
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Nos. |
364016 |
GENERAL
INFORMATION
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No. of Employees : |
892 |
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Bankers : |
Ø ABN Amro Bank N V Ø ANZ Grindlays Bank Ø United Bank of India Ø Citi Bank NA Ø HDFC Bank Limited |
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Facilities : |
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Banking Relations
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Good |
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Auditors : |
BSR and Company Chartered Accountants |
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Subsidiaries : |
Ø Intercare Limited 257, GIDC Industrial Estate, Modhera Road, Mehsana - 384 002, Gujarat Tel. No. 91-2762-51929 / 40012 Fax No. 91-2762-53448 E Mail : infar.mehsana@sme.sprintrpg.ems.vsnl.net.in The company has about 50 subsidiaries spread over all continents of the world |
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Associates : |
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Parent Company : |
Ø Akzo Nobel Pharma International BV It employs around 70000 people and operates in more than 60 countries |
CAPITAL STRUCTURE
Authorised Capital :
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No. of Shares |
Type |
Value |
Amount |
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10000000 |
Equity Shares |
Rs. 10/- each |
Rs.100.000 millions |
Issued, Subscribed & Paid-up Capital :
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No. of Shares |
Type |
Value |
Amount |
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6080000 |
Equity Shares |
Rs. 10/- each |
Rs.60.800
millions |
FINANCIAL DATA
[all figures are in Rupees Millions]
ABRIDGED BALANCE
SHEET
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SOURCES OF FUNDS |
31.12.2006 |
31.12.2005 |
31.12.2004 |
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SHAREHOLDERS FUNDS |
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1] Share Capital |
60.800 |
60.800 |
60.762 |
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2] Share Application Money |
0.000 |
0.000 |
0.000 |
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3] Reserves & Surplus |
1333.100 |
1189.300 |
1040.063 |
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4] (Accumulated Losses) |
0.000 |
0.000 |
0.000 |
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NETWORTH |
1393.900 |
1250.100 |
1100.825 |
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LOAN FUNDS |
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1] Secured Loans |
1.000 |
1.800 |
2.408 |
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2] Unsecured Loans |
0.700 |
1.800 |
5.982 |
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TOTAL BORROWING |
1.700 |
3.600 |
8.390 |
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DEFERRED TAX LIABILITIES |
0.000 |
0.000 |
1.171 |
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TOTAL |
1395.600 |
1253.700 |
1110.386 |
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APPLICATION OF FUNDS |
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FIXED ASSETS [Net Block] |
97.600 |
73.200 |
73.580 |
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Capital work-in-progress |
13.300 |
37.800 |
37.460 |
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INVESTMENT |
30.000 |
30.000 |
0.514 |
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DEFERREX TAX ASSETS |
0.000 |
0.000 |
0.000 |
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CURRENT ASSETS, LOANS & ADVANCES |
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Inventories |
207.100
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247.000
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187.969
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Sundry Debtors |
156.100
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241.100
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178.862
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Cash & Bank Balances |
799.300
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433.200
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658.543
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Other Current Assets |
0.000
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0.000
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5.389
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Loans & Advances |
366.600
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439.000
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135.093
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Total
Current Assets |
1529.100
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1360.300 |
1165.856 |
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Less : CURRENT
LIABILITIES & PROVISIONS |
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Current Liabilities |
204.900
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197.400 |
120.711
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Provisions |
69.500
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50.200 |
46.313
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Total
Current Liabilities |
274.400
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247.600 |
167.024 |
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Net Current Assets |
1254.700
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1112.700 |
998.832 |
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MISCELLANEOUS EXPENSES |
0.000 |
0.000 |
0.000 |
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TOTAL |
1395.600 |
1253.700 |
1110.386 |
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PROFIT & LOSS
ACCOUNT
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PARTICULARS |
31.12.2006 |
31.12.2005 |
31.12.2004 |
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Sales Turnover |
2036.600 |
2045.700 |
1230.844 |
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Other Income |
84.100 |
54.200 |
0.000 |
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Total Income |
2120.700 |
2099.900 |
1230.844 |
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Profit/(Loss) Before Tax |
295.200 |
292.400 |
220.526 |
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Provision for Taxation |
115.900 |
108.300 |
77.344 |
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Profit/(Loss) After Tax |
179.300 |
184.100 |
143.182 |
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Import Value
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462.000 |
520.000 |
310.524 |
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Export Value
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179.000 |
278.000 |
133.515 |
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Expenditures : |
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Manufacturing Expenses |
144.900 |
151.400 |
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Administrative Expenses |
777.700 |
723.700 |
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Raw Material Consumed |
545.300 |
677.300 |
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Increase/(Decrease) in Finished Goods |
35.300 |
[50.500] |
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Salaries, Wages, Bonus, etc. |
124.200 |
56.500 |
1010.318 |
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Interest |
2.800 |
2.900 |
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Excise Duty |
117.100 |
105.400 |
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Power & Fuel |
4.900 |
78.400 |
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Depreciation & Amortization |
10.900 |
11.900 |
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Other Expenditure |
62.400 |
50.500 |
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Total Expenditure |
1825.500 |
1807.500 |
1010.318 |
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KEY RATIOS
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PARTICULARS |
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31.12.2006 |
31.12.2005 |
31.12.2004 |
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PAT / Total Income |
(%) |
8.45
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8.76 |
11.63 |
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Net Profit Margin (PBT/Sales) |
(%) |
14.49
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14.29 |
17.91 |
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Return on Total Assets (PBT/Total Assets} |
(%) |
17.67
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19.47 |
17.26 |
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Return on Investment (ROI) (PBT/Networth) |
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0.21
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0.23 |
0.20 |
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Debt Equity Ratio (Total Liability/Networth) |
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0.20
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0.20 |
0.16 |
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Current Ratio (Current Asset/Current Liability) |
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5.57
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5.49 |
6.98 |
LOCAL AGENCY
FURTHER INFORMATION
HISTORY
The company was incorporated on 30th August, 1967 at Calcutta in West Bengal under the name and style of Subject having Company Registration Number 27128. The name of the company was subsequently changed to present with effect from 25th June, 1983.
Subject is a sole joint venture pharmaceutical company between Holland and India in the eastern sector of the country.
Subject commissioned its bulk drug manufacturing facilities at Ganganagar, 24 Parganas (North), West Bengal, India in 1970 and commenced commercial production in 1972. In 1973, the company took over a factory from Martin and Harris Private Limited located at 182, Acharya Jagdish Chandra Bose Road, Calcutta and commenced its formulation manufacturing activites.
In 1985, the company also took over Gujarat Drugs and Chemicals Limited at Mehsana. The name of this company was subsequently changed to Intercare Limited w.e.f. February, 1983. The company holds 100% of the shares of Inetrcare Limited.
The company also has a major investment of 26% in the shares of Intervet (India) Limited a company located at Hyderabad. The balance 74% of the shares of this company is held by Intervet International BV, The Netherlands - a constituent of Akzo Nobel.
Infar (India), a 50.43% subsidiary of AKZO Nobel Pharma, Netherlands, is a market leader in female healthcare and growth hormones. Nearly 80% of its sales come from pharmaceutical formulations (injectables and tablets). The remaining come from contraceptives and AIDS test units.
Infar has a subsidiary -- Intercare, which manufactures general purpose and
veterinary drugs which was amalgamated with the company from Oct.'00. Infar has
obtained the marketing licence from Solvay Duphar, Holland, to manufacture
Eldicet, the first selective calcium antagonist marketed in India. Nutricia, a
Dutch company, has also granted Infar the permission to import and market the
clinically nutritious products, Pepti 2000 and Bonvit. During 1996-97 it has
allotted bonus shares to the existing shareholders in the ratio of 3 shares for
every 5 shares held.
The company has taken up a project for construction of pharmaceutical factory
at Ganganagar, West Bengal for which land has already been acquired, the
state-of-the-art factory would be built to international standards and this
would lead to substantially expanding the capacity and quality of products of
the company.
During the year 1999, Recagon, a recombinant FSH was introduced for the first
time in India and considerable sum has been spent for its introduction and
reach in local clinical trials as it represents a complete new technology. The
company has acquired land in Village Unsani, Dist: Howrah on Kona Expressway
for setting up of a state-of-the art manufacturing facility.
The Company has divested from veterinary business and similar withdrawals from
areas where the company lacks necessary knowledge and strength or does not see
a long-term opportunity are under consideration. The upgradation and adaption
of new technology at Ganganagar factory under Diosynth Business was completed
during 2000-01.
The business units
are as under :
Business Unit Organon :
- For human pharma and ethical pharmaceutical products.
Business Unit Diosynth
- For production of bulk drugs, intermediates and chemical for pharmaceutical industry.
Business unit Organon Teknika
- For activities relating to diagnostics and anaesthetics.
Business unit Chefaro
- For OTC products
Several of the company's products including formulations, bulk drugs, animal vaccines, etc are manufactured through technical know-how and assistance obtained from Diosynth International BV, N.V. Organon, Organon Teknika NV and Intervet International BV.
The company has manufacturing facilities located at 15 countries.
The company's product
range include the following :
· NUVIR - Oral testosterone preparation
· SUSTANON - Injectable testosterone preparation
· Evalon
· Evalon Forte Tablets
· Evalon Cream
· LivialÒ - For post menopausal climateric symptoms
· Gonadomimetics with combines hormonal properties
· PROFERTILITY
Recombinant
RecagonÒ
Follitropin beta
HumegonÒ
PregnylÒ
· CONTRACEPTIVES
NovelonÒ
FemilonÒ
IUD comprises of Mutiload Cu 250 and Multiload Cu 375
· For Pregnancy Test
PregcolorÒ
Pregcolor CardÒ
International
Milestones :
· The first in Europe with commercial insulin
· The first in standardising sex hormones
· The first in standardising progestogen
· The first in isolating desoxy-croticosterone cortisone and corticosterone
· The first with the synthesis of ACTH
· The first with the synthesis of Vitamin A
· Commercial introduction of immunological pregnancy test
· Commercial introduction of Human Menopausal Gonadotrophin
· Commercial introduction of synthetic principle of ACTH, Introduction of a new nondepolarising muscle relaxant, pancuroniu bromide (PAVULON)
· Introduction of the diagnostic kit for the detection of hepatitis
· Introduction of MARVELON - an oral contraceptive
· Introduction of PREGCOLOR - a monoclonal pregnancy tube test
· Introduction of MERCILON - a combined oral contraceptive
· Introduction of LIVIAL - the first tissue specific treatment for menopausal care and prophylaxis of osteoporosis
· GRACIAL - the first combiphasic oral contraceptive
· REMERON - first new generation Noradrenergic and Specific Serotonergic Antidepressant (NASSA)
· PUREGON - recombinant Follicle Stimulating Hormone
Industry
Developments:
The Year 2006 has been an encouraging and an eventful period for the Indian pharmaceutical industry. After some five years, annual growth rate is back to double digits. The country's economy is doing exceedingly well and investment in healthcare and health infrastructure has moved up high on the Government's agenda. The Board now looks forward to a progressive regulatory fiscal and, Pricing Mechanism that will sustain this momentum and encourage innovation and research.
The Patent Act introduced in January 2005 was welcomed by the Industry but
there still remain concern areas related to patentability, compulsory licensing
and data exclusivity. The Pharmaceutical Policy 2006, after years of
discussions, is still in a draft stage. The present recommendations of adding
the entire WHO list of essential drugs to the drugs already under price control
is disconcerting and goes directly against all the previous policies of phased
de-control. The Board on the other hand, is happy to note that the Government
is in favour of forming a Central Drug Authority on the lines of U.S. FDA and
that reforms such as in the areas of Good Manufacturing Practices (GMP) and
Good Clinical Practices (GCP) have already begun, Guidelines are also expected
shortly on the serious issue of safety of bio-similars.
Operations and Future Outlook:
The Directors despite the drop in sales in the first quarter arising from VAT implementation in some states, the Company maintained the growth momentum carried from the previous year Domestic sales at Rs. 1338 million (reflected in the current year, net of a channel discount) reflects a 5% growth over 2005 contributed largely by the key products in its core therapeutic areas of fertility anaesthesia and contraception and well supported by the older established brands in anabolics and gastro-enterology. Available external data on both 'sales in the market' (ORG-IMS, MAT Dec'06) and on prescription audit (C Marc, July - Oct '06) suggest that in year 2006, the Company maintained market share and recorded growth in its operating segment well in excess of a number of major competitors. Export of APIs and Intermediates however, were down from Rs. 279 million in 2005 to Rs. I 80 million in the current year owing to lower requirements by the parent company. Formulation exports, mainly to Sri Lanka at Rs. 27 million, increased by over 70%.
The Company continued with its attention to systems, processes and efficiency
measures resulting in a further improvement in material consumption and
operating cost ratios. As a result, profit before taxes, al Rs. 295 million is
higher than corresponding 2005 figures, despite the lower gross revenue arising
from the reduced export sales.
In terms of fund movement, the Company generated dirge the year, a net cash
flow from operating activities totaling Rs. 236 million. The corresponding
figure previous year, was Rs. 83 million.
Arising from the above financial results and considering previous year P and L
balances, amount available to the Company for appropriation was Rs. 457.7
million. The Board decided, after accounting for Rs. 35.5 million for dividend
and related taxes, to transfer Rs. 17.9 million to the General Reserves and
carry forward the remainder Rs. 404.3 million in the P and L Account.
On Operations, the two key focus areas for the Company remains addressing work
processes and investing in its human resource. During the year, the web based
field force management system was linked to the sales and invoicing platform
with a view to evaluating field activities with results. A new ERR was
implemented across the Company that has enhanced data-sharing and real time
information generation. An E-learning module for the field is now in place. The
Company is also on target with the global programmes on XLence for customer
focus and functional integration and P and D Dialog, for performance
monitoring, people development and career planning.
The Board, considering the in-house initiatives, experiencing the commitment of
the employees and looking at the market developments, is of the view that the
Company has a good future for its products in the therapy areas that it is
operating in and this should lead to further improved financial and operating
results in the years ahead.
Open Offer By the
company Participations B V:
Organon Participations B V, the Parent Company received approvals from the Government of India and other concerned Authorities for increasing its shareholding in the Company upto 100% through purchase of shares of the Indian promoters and open offers to other shareholders at a price of Rs.285/- per share. As per the conditions prescribed by the stock exchanges for delisting of the Company's shares, an exit offer was given to all equity shareholders for selling the shares to The company Participations B V at the said price of Rs. 285/- per share, and such offer is still continuing. On the date of this Report, shares so transferred by shareholders in favour of The company Participations B V is around 98.3% of the equity shares of the Company.
Divestment By Parent Company:
The Directors have been informed that on 12th March 2007, Akzo Nobel NV of Holland, entered into a binding Agreement to sell its pharma business presently operating under the name of Organon Biosciences, to Schering; Plough, a U.S. based global pharmaceutical company. The Company's parent company, Organon Participations BV is a part of the said pharma business of Akzo Nobel. The transaction is now in the initial phase and is expected to be finalized before the end of 2007. Schering Plough as well as Organon Biosciences believe that owing to their complementary strengths, this arrangement would serve the best interests of both organizations and their employees and other stakeholders.
Foreign Exchange
Earnings And Outgo:
Earnings in foreign exchange through export was down to Rs. 179 million from Rs. 278 million in the previous year, resulting from the lower offtake of intermediates by the parent company. Outgo of foreign exchange on account of import of raw materials, packing materials, capital goods and finished goods, travelling and dividend was Rs. 462 million. (Previous year - Rs. 520 million).
AS PER WEBSITE
The company is part of the pharmaceutical MNC Organon - headquartered in Roseland, NJ, USA. The company creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, the company strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. The company products are sold in over 100 countries, of which more than 60 have an subject subsidiary: products that contribute to the health of people and their quality of life
Organon (India)
Limited
(Formerly Infar (India) Limited)
Nishuvi, 1st Floor,
75, Dr. Annie Besant Road,
Worli, Mumbai: 400 018
Tel: 022-56661724-29
Fax: 022-56661740 / 56661988
Email: biswasa@organonindia.com
Website: www.organon.com
PRESS RELEASES:-
Thursday, January 17, 2008 (Kenilworth, NJ, U.S.A.)
Schering-Plough Corporation (NYSE: SGP) announced that Nippon Organon K.K., now part of Schering-Plough, has filed a New Drug Application with the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking marketing approval for its novel selective relaxant binding agent (SRBA), sugammadex.
Sugammadex is specifically designed to rapidly reverse to rapidly reverse the effects of certain muscle relaxants, rocuronium bromide (marketed in the U.S. as ZEMURON(R) and in Japan as ESLAX(R)), as well as vecuronium bromide (marketed in Japan as MUSCULAX(R)). Muscle relaxants are used as part of general anesthesia during surgical procedures.
The company announced on January 2, 2008, that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the New Drug Application (NDA) filing for sugammadex. Additionally, the Marketing Authorization Application for sugammadex was accepted for review by the European Medicines Agency (EMEA) in July 2007.
Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.
About Sugammadex
Sugammadex is a novel selective relaxant binding agent (SRBA) under development by Organon, a part of Schering-Plough Corporation. Sugammadex was designed to reverse the effects of rocuronium bromide or vecuronium bromide, muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation, and to reduce the chance of complications.
In clinical trials to date, sugammadex has demonstrated the ability to rapidly reverse shallow and profound depths of rocuronium-induced neuromuscular blockade (NMB), thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs. Sugammadex also has demonstrated the ability to reverse the effects of NMB induced by vecuronium bromide. In a phase III clinical trial, the most frequently reported adverse events associated with sugammadex regardless of relationship to the study drug were procedural pain and nausea.
About ESLAX/ZEMURON.ESMERON
ESLAX (rocuronium bromide), marketed in the U.S. as ZEMURON, is a non- depolarizing muscle relaxant. It was introduced in the United States in 1994 and is one of the most widely used muscle relaxants in the United States, Canada and many European countries (where it is marketed under the brand name ESMERON(R)). It was approved for use in Japan on July 31, 2007, under the brand name ESLAX. To date, it has been used in over 140 million patients worldwide, including an estimated 20 million patients in 2006.
Important Safety Information
There have been rare reports of severe anaphylactic reactions to ZEMURON (rocuronium bromide) Injection, including some that have been life threatening. Clinicians should be prepared for the possibility of these reactions and take the necessary precautions, including the immediate availability of emergency treatment. ZEMURON Injection should be administered by experienced clinicians who are familiar with the drug's actions and the possible complications of its use.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for sugammadex. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A, "Risk Factors" in the company's third quarter 2007 10-Q.
Wednesday, January
02, 2008 (Kenilworth, USA)
Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the company’s New Drug Application (NDA) for sugammadex.
Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the United States as ZEMURON® (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. If approved, sugammadex will be the first in a new class of drugs known as selective relaxant binding agents that work in an entirely new and unique way to encapsulate the muscle relaxant molecule and render it inactive.
“Organon, now part of Schering-Plough Corporation, has had a strong presence in the anesthesia market for over 35 years,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “The development of sugammadex is an exciting advance for the practice of anesthesia. This novel drug has the potential to change the way doctors practice anesthesia as it will allow anesthesiologists to rapidly and safely reverse both shallow and profound levels of muscle relaxation, which is not possible with current reversal agents.”
Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.
About Sugammadex
Sugammadex is a novel selective relaxant binding agent (SRBA) under development by Organon, a part of Schering-Plough Corporation. Sugammadex was designed to reverse the effects of rocuronium bromide (ZEMURON/ESMERON®/ESLAX®) or vecuronium bromide, muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation, and to reduce the chance of complications.
In clinical trials to date, sugammadex has demonstrated the ability to rapidly
reverse shallow and profound depths of rocuronium-induced neuromuscular
blockade (NMB), thereby enabling control of the onset and offset of skeletal
muscle relaxation through the use of both drugs. Sugammadex also has
demonstrated the ability to reverse the effects of NMB induced by vecuronium
bromide. In a phase III clinical trial, the most frequently reported adverse
events associated with sugammadex regardless of relationship to the study drug
were procedural pain and nausea.
About ZEMURON
ZEMURON (rocuronium bromide) is a non-depolarizing muscle relaxant. It was introduced in the United States in 1994 and is one of the most widely used muscle relaxants in the United States, Canada and many European countries (where it is marketed under the brand name ESMERON). It was approved for use in Japan on July 31, 2007, under the brand name ESLAX. To date, it has been used in over 140 million patients worldwide, including an estimated 20 million patients in 2006.
Important Safety Information
There have been rare reports of severe anaphylactic reactions to ZEMURON (rocuronium bromide) Injection, including some that have been life threatening. Clinicians should be prepared for the possibility of these reactions and take the necessary precautions, including the immediate availability of emergency treatment. ZEMURON Injection should be administered by experienced clinicians who are familiar with the drug’s actions and the possible complications of its use.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company’s ongoing transformation. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J
SCHERING-PLOUGH
DISCLOSURE NOTICE: The information in this press release
includes certain “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements relating to the
development of, and potential market for, sugammadex. Forward-looking
statements relate to expectations or forecasts of future events.
Schering-Plough does not assume the obligation to update any forward-looking
statement. Many factors could cause actual results to differ materially
from Schering-Plough’s forward-looking statements, including market forces,
economic factors, product availability, patent and other intellectual property
protection, current and future branded, generic or over-the-counter
competition, the regulatory process, and any developments following regulatory
approval, among other uncertainties. For further details of these and
other risks and uncertainties that may impact forward-looking statements, see
Schering-Plough’s Securities and Exchange Commission filings, including Item
1A, “Risk Factors” in the company’s third quarter 2007 10-Q.
Organon
provides injectable contraceptives for essential USAID family health programs
Thursday, October 13,
2005 (Oss, The
Netherlands)
Under a new contract between Organon, the human healthcare
business unit of Akzo Nobel, and the U.S. Agency for International Development
(USAID), Organon will supply 3 million vials of Megestron® [1], its long-acting
injectable contraceptive, in the year 2006. The product will then be used for
vital USAID-sponsored family health programs in developing countries.
Wednesday, October 05, 2005 (Roseland, NJ, USA)
Wednesday, October 05, 2005 (Oss, The
Netherlands)
Thursday, September 29, 2005 (Oss, The
Netherlands)
Thursday, September 15, 2005 (Oss, The
Netherlands)
CMT REPORT
(Corruption, Money Laundering & Terrorism]
The Public Notice information has been collected from various sources
including but not limited to: The Courts, India Prisons Service,
Interpol, etc.
1] INFORMATION ON DESIGNATED
PARTY
No records exist designating subject or any of its beneficial owners,
controlling shareholders or senior officers as terrorist or terrorist
organization or whom notice had been received that all financial transactions
involving their assets have been blocked or convicted, found guilty or against
whom a judgement or order had been entered in a proceedings for violating
money-laundering, anti-corruption or bribery or international economic or
anti-terrorism sanction laws or whose assets were seized, blocked, frozen or
ordered forfeited for violation of money laundering or international
anti-terrorism laws.
2] Court Declaration :
No records exist to suggest that subject is
or was the subject of any formal or informal allegations, prosecutions or other
official proceeding for making any prohibited payments or other improper
payments to government officials for engaging in prohibited transactions or
with designated parties.
3] Asset Declaration :
No records exist to suggest that the property or assets of the subject
are derived from criminal conduct or a prohibited transaction.
4] Record on Financial
Crime :
Charges or conviction
registered against subject: None
5] Records on Violation of
Anti-Corruption Laws :
Charges or
investigation registered against subject: None
6] Records on Int’l
Anti-Money Laundering Laws/Standards :
Charges or
investigation registered against subject: None
7] Criminal Records
No available
information exist that suggest that subject or any of its principals have been
formally charged or convicted by a competent governmental authority for any
financial crime or under any formal investigation by a competent government
authority for any violation of anti-corruption laws or international anti-money
laundering laws or standard.
8] Affiliation with
Government :
No record
exists to suggest that any director or indirect owners, controlling
shareholders, director, officer or employee of the company is a government
official or a family member or close business associate of a Government
official.
9] Compensation Package :
Our market
survey revealed that the amount of compensation sought by the subject is fair
and reasonable and comparable to compensation paid to others for similar
services.
10] Press Report :
No press reports / filings exists on
the subject.
CORPORATE
GOVERNANCE
MIRA INFORM as part of its Due Diligence do provide comments on
Corporate Governance to identify management and governance. These factors often
have been predictive and in some cases have created vulnerabilities to credit
deterioration.
Our Governance Assessment focuses principally on the interactions
between a company’s management, its Board of Directors, Shareholders and other
financial stakeholders.
CONTRAVENTION
Subject is not known to have contravened any existing local laws,
regulations or policies that prohibit, restrict or otherwise affect the terms
and conditions that could be included in the agreement with the subject.
FOREIGN EXCHANGE
RATES
|
Currency |
Unit
|
Indian Rupees |
|
US Dollar |
1 |
Rs.40.69 |
|
UK Pound |
1 |
Rs.80.25 |
|
Euro |
1 |
Rs.63.08 |
SCORE & RATING
EXPLANATIONS
|
SCORE FACTORS |
RANGE |
POINTS |
|
HISTORY |
1~10 |
8 |
|
PAID-UP CAPITAL |
1~10 |
8 |
|
OPERATING SCALE |
1~10 |
8 |
|
FINANCIAL CONDITION |
|
|
|
--BUSINESS SCALE |
1~10 |
8 |
|
--PROFITABILIRY |
1~10 |
8 |
|
--LIQUIDITY |
1~10 |
8 |
|
--LEVERAGE |
1~10 |
8 |
|
--RESERVES |
1~10 |
8 |
|
--CREDIT LINES |
1~10 |
8 |
|
--MARGINS |
-5~5 |
-- |
|
DEMERIT POINTS |
|
|
|
--BANK CHARGES |
YES/NO |
YES |
|
--LITIGATION |
YES/NO |
NO |
|
--OTHER ADVERSE INFORMATION |
YES/NO |
NO |
|
MERIT POINTS |
|
|
|
--SOLE DISTRIBUTORSHIP |
YES/NO |
NO |
|
--EXPORT ACTIVITIES |
YES/NO |
YES |
|
--AFFILIATION |
YES/NO |
YES |
|
--LISTED |
YES/NO |
YES |
|
--OTHER MERIT FACTORS |
YES/NO |
YES |
|
TOTAL |
|
72 |
This score serves as a reference to assess SC’s credit risk and
to set the amount of credit to be extended. It is calculated from a composite
of weighted scores obtained from each of the major sections of this report. The
assessed factors and their relative weights (as indicated through %) are as
follows:
Financial
condition (40%) Ownership
background (20%) Payment
record (10%)
Credit history
(10%) Market trend
(10%) Operational
size (10%)
RATING
EXPLANATIONS
|
RATING |
STATUS |
PROPOSED CREDIT LINE |
|
|
>86 |
Aaa |
Possesses an extremely sound financial base with the strongest
capability for timely payment of interest and principal sums |
Unlimited |
|
71-85 |
Aa |
Possesses adequate working capital. No caution needed for credit transaction.
It has above average (strong) capability for payment of interest and
principal sums |
Large |
|
56-70 |
A |
Financial & operational base are regarded healthy. General
unfavourable factors will not cause fatal effect. Satisfactory capability for
payment of interest and principal sums |
Fairly Large |
|
41-55 |
Ba |
Overall operation is considered normal. Capable to meet normal
commitments. |
Satisfactory |
|
26-40 |
B |
Unfavourable & favourable factors carry similar weight in credit consideration.
Capability to overcome financial difficulties seems comparatively below
average. |
Small |
|
11-25 |
Ca |
Adverse factors are apparent. Repayment of interest and principal sums
in default or expected to be in default upon maturity |
Limited with
full security |
|
<10 |
C |
Absolute credit risk exists. Caution needed to be exercised |
Credit not
recommended |
|
NR |
In view of the lack of information, we have no basis upon which to
recommend credit dealings |
No Rating |
|