India revokes patent on GSK's Tykerb

The country's Intellectual Property Appellate Board upheld a GSK patent granted on the active pharmaceutical ingredient in Tykerb, lapatinib, citing innovative merit. However Tykerb is the salt form of lapatinib and the board decided it represents an incremental innovation, so patent protection for the drug has been pulled.

Authorities in India have revoked a patent on GlaxoSmithKline's breast cancer drug Tykerb,in the latest blow to big pharma in terms of intellectual property.
The move follows the end of the long-running landmark case settled in April  when the Supreme Court of India rejected Novartis' application to patent an updated version of its cancer drug Glivec (imatinib). The Tykerb case was brought by Fresenius which had challenged patents granted to GSK for both the original molecule and Tykerb, saying both lacked innovation.

GSK issued a statement, reported by Reuters, said that "we are studying the IPAB's decision but maintain our belief in the inventiveness of the lapatinib ditosylate salt and will consider the possibility of taking further steps before the appropriate authorities to validate this". However the firm added that it is pleased the board upheld the basic patent for the lapatinib compound, which expires in January 2019.

GSK had already cut prices of Tykerb by a third in India as part of a flexible pricing programme for certain emerging markets. Reuters reported that a strip of 10 Tykerb tablets costs about 4,160 rupees (about £45) and a patient should take five tablets a day for 21 days if the cancer is in an advanced stage.

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Cipla announces Q2 FY 1213 Unaudited Financial Results

Mumbai, India: Cipla Limited (BSE: 500087, NSE : CIPLA) today announced its Unaudited Financial Results for the quarter ended September 30, 2012 (Q2).
Key Financial & Performance Highlights Q2 FY1213 vis-a-vis Q2 FY1112:

• Gross revenues grew by 23.6% to Rs. 2220 cr, up from Rs. 1796 cr in Q2 FY1112
• Operating margins grew by 57.7% to Rs. 677 cr, up from Rs. 429 cr in Q2 FY1112
• Profit after tax grew by 61.8% to Rs. 500 cr during Q2 FY1213, up from Rs. 309 cr (Q2 FY1112)

Profit & Loss Highlights:

• Material cost at 36.3% of Total Sales decreased by 4.2% during Q2 FY1213 as compared to Q2 FY1112.
• Operating margins increased by 57.7% and is at 30.5% of Income from Operations during Q2 FY1213 as
  compared to 23.9% during Q2 FY1112.
• Profit after tax increased by 61.8% to Rs. 500 cr during Q2 FY1213 as compared to Rs. 309 cr during Q2
  FY1112.

Performance Review:
Domestic business:

• Domestic revenues grew by 13.5% to Rs.962 cr during Q2 FY1213, up from Rs. 847 cr during Q2
  FY1112.
• The growth in domestic revenues was largely on account of growth in anti-asthma, anti-biotics and
  cardiovascular therapy segments.

International business:

• Exports of formulations grew by38.2% to Rs. 1039 cr during Q2 FY1213, up from Rs. 752 cr during Q2
  FY1112.
• Exports of APIs grew by 9.0% to Rs. 174 cr during Q2 FY1213, from Rs. 159 cr during Q2 FY1112.
• The growth in export revenues was primarily due to growth in anti-depressants, anti-ulcerant and anti-asthma segments.

About Cipla:
Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India
self‐reliant in healthcare. Over the years Cipla has emerged as one of the most respected names not just in
India but worldwide. Its state of the art R&D centre has given the country and the world many firsts. This
includes the revolutionary AIDS cocktail for less than a dollar a day. With over 34 manufacturing units
across the country, Cipla manufactures over 2000 products in 65 therapies.
With a turnover of over US $ 1.4 billion, Cipla serves doctors and patients in over 170 countries. It has
earned a name for maintaining one global standard across all its products and services. Cipla continues to
support,  improve  and  save  millions  of  lives  with  its  high‐quality  drugs  and  innovative  devices.
(www.cipla.com).