Cipla Modifies International Strategy, Faces US Product Recalls with Sun Pharma

Cipla Details Future Strategy

Indian generic major Cipla, which has largely focused on partnerships to enter international markets, is looking at filing its own Abbreviated New Drug Applications (ANDAs) in the United States, reports Scrip. According to the sources interview with the firm's management, this will occur slowly over a two-to-three-year period, and only for select undisclosed products. It will, however, continue to nurture existing alliances and may even gain a greater off-shore presence in many countries such as Russia, South Africa, Latin America, Vietnam, Iran, Brazil, and Turkey, through investment in a partner.

For the first time, the firm is also looking outward with regards to financing its research and development (R&D) projects. The firm is not only looking at venture funding to partner with and fund some amount of R&D, but it is also open to partnering, inlicensing and acquiring "pioneering work", it revealed to the source.

In this regard, biosimilars continues to be a key area of interest for the generic firm, and may shortly see it licensing a biosimilar version of US pharma Amgen's arthritis drug Enbrel (etanercept) from its Chinese partner Biomab/Desano.

Product Recalls with Sun Pharma Also Faced

Both Cipla and its domestic peer Sun Pharma have announced product withdrawals in the US, reports Economic Times. Two of Cipla's marketing partners in the US—Teva (Israel) and Eagle Pharma (US)—have withdrawn 7,260 bottles of prostate cancer drug flutamide and an undisclosed quantity of argatroban injections, respectively. The flutamide bottles were found to contain some amount of another oncology agent, imatinib mesylate. Meanwhile, crystalline particles were found in the argatroban injections. In the case of Sun Pharma, the firm recalled 155,000 bottles of its eye solution prescribed for conjunctivitis, owing to the regulator's discovery of impurities. The eye solution and argatroban recalls fall under the US FDA's Class III category, where the use of the drug is not likely to have any adverse effects on the health of the patients. The flutamide recall is classified as Class II, which means the use of the drug may cause temporary or reversible adverse effects. All of the indicated drugs were manufactured in the firms' Indian manufacturing facilities, in Goa for Cipla and Gujarat for Sun Pharma.

Outlook and Implications

Cipla's new strategy to have a higher front-end presence in the US and other key markets is a modification of its current visibility in the global generic marketplace. Although the firm's generics are sold in over 180 markets, it has chosen to enter these markets through partnerships, with a strong front-end presence only in its domestic market. Its effort to look outward for funding and new products is also a marked sign of endeavouring to be less conservative; so far, most of its R&D development, and particularly funding, have been done internally. As indicated, this change in strategy will be slow, given the risk of an adverse outcome for the firm internationally. However, the firm has already been evolving, with the 2010 biosimilar collaboration agreement with Biomab/Desano.

Meanwhile, the product recalls do not show either firm in a favourable light, with such incidents casting a shadow on the quality of generic drugs originating from India.