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Orchid expects to triple growth in cephalosporins
R BabyManoj - Bangalore
Orchid Chemicals & Pharmaceuticals Ltd, the Chennai-based pharma major
engaged in the manufacture and export of cephalosporin and non-cephalosporin
bulk actives, formulations and nutraceuticals is expecting a quantum jump in
the growth of business in both antibiotics and non-antibiotics segments taking
the business figure to US $30 million in the case of cephalosporins in a matter
of three years, said Dr Sumant Baukhandi, President, Regulatory and Quality
Affairs, to Express Pharma Pulse. The current market of the company is approximately
US $10 million in this segment. The company also expects a similar jump in the
export of non-antibiotics later.
Orchid had started integrating certain drug discovery IPR
and resources under the US discovery joint venture umbrella to fast-track the
combined programs, he added. With the completion of proof-of-concept clinical
trial on the anti-diabetic molecule, Orchid would increase its stake in the
drug discovery JV with contribution of its select IP, cash and services.
The company has seen further progress in the regulatory roadmap aimed at the
US generics market. The filings of Abbreviated New Drug Applications (ANDAs)
and Drug Master Files (DMFs) have worked well for the company, he said. The
company has a state-of-the-art formulations facility at Irungattukottai, near
Chennai. ‘‘Orchid expects the USFDA approval process to pave the way
for a strong regulated market business from the fiscal year 2005-06. Good progress
in terms of R&D and manufacturing infrastructure has also been achieved
in the non-penicillin, non-cephalosporin (NPNC) segment, the next growth horizon
identified by the company, he said. ‘‘Our dependence on the less-regulated
markets including African and Asian countries would taper down this fiscal year
onwards and we hope to post robust revenues with the flow of business in the
regulated market which would start increasingly from the next fiscal,’’
he added.
Orchid increased the pace of regulatory filings in the Cephalosporin space
with 5 DMF/ANDA filings during the quarter of 2004. Orchid has so far filed
15 US DMFs and 11 ANDAs to support its US generics thrust. Orchid’s flagship
product Cephalexin and sterile product Cefazolin have been approved by the USFDA.
Orchid has also been awarded Certificates of Suitability (CoS) from the European
Directorate for the Quality of Medicines (EDQM) for nine of its products, sources
added.
Orchid has identified several products in the non-penicillin, non-cephalosporin
segment to further enhance its growth from the year 2007 onwards. These products
broadly fall under the CNS, CVS and anti-diabetic therapeutic segments. The
company is establishing new bulk and formulation manufacturing infrastructure
in Aurangabad and Irungattukottai (Chennai) respectively to cater to these products.
Regulatory filings for these products is expected to start from the first quarter
of next fiscal, company sources said.
The company has a joint venture with Bexel of US for clinical trials, in which
it plans to hike the holding to 75 percent. The former has expertise in executing
regulatory studies, clinical trials and out-licensing options. Orchid feels
that certain promising molecules in Inflammation and Cancer which are in advanced
pre-clinical trials, could be fast-tracked if integrated under Bexel’s
umbrella. Bexel would then take such an integrated portfolio to proof-of-concept
efficacy studies and potential out-licensing deals. The company is consolidating
such select drug discoveries with that of Bexel.
Thus transfer of such select IPR, together with funding and services support
for clinical studies on the combined portolio would give Orchid a higher stake
of 75 per cent in the JV. The reconstitution of the JV would lead to faster
progress of drug leads to out-licensing stage and generation of greater value
to stakeholders. They successfully completed proof-of-concept Phase 2(a) trials
on its lead anti-diabetic molecule, BLX-1002, sources said.
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