Alvogen to market Orchid Pharma’s CNS and osteoporosis formulations in US

Alvogen to market Orchid Pharma’s CNS and osteoporosis formulations in US

Indian generic firm Orchid Chemicals & Pharmaceuticals has entered into an out-licensing and distribution agreement with US-based pharma major Alvogen for marketing eight of its non-antibiotic generic formulations in the US market.

Under this agreement, Orchid will develop and manufacture eight oral non-antibiotic formulations for licensing to and marketing by Alvogen in the US.

These eight non-antibiotic oral formulations licensed to Alvogen under the agreement comprise products in the high-growth therapeutic segments of CNS and osteoporosis among others.

Alvogen will source these products from Orchid exclusively.

The products will be manufactured at Orchid’s state-of-the-art oral API and dosage form facilities, which are approved by the US FDA.

Alvogen would pay certain dossier license fees to Orchid based on development and regulatory milestones and share profits arising from marketing of these products in the US with Orchid. Both the companies would share the legal expenses and bio-study costs.

“Through the alliance that we have entered into with Alvogen, we are confident of achieving robust additions to our business from the US non-antibiotic generic formulations segment,” stated K Raghavendra Rao, managing director, Orchid in a press release

In December 2009, Hospira, Inc, the world leading generic injectable firm, acquired India’s Orchid Chemicals & Pharmaceuticals Ltd injectables business for nearly US $ 400 million.

Besides generic injectable finished-dosage form pharmaceuticals business, Hospira’s deal includes Orchid’s beta-lactam antibiotics manufacturing complex and pharmaceutical research and development (R&D) facility at Irungattukottai, Chennai, as well as its generic injectable product portfolio and pipeline.

Orchid’s beta-lactam antibiotics manufacturing complex comprise cephalosporin, penicillin and carbapenem facilities.

Hospira is currentlt the world leader in generics injactables business responsible for about 23 percent of the nearly $11 billion global generic injectables market. Hospira’s share is more than twice the share of its closest rivals.

Headquartered in Chennai, India, Orchid Chemicals & Pharmaceuticals Ltd. is involved in the development, manufacture and marketing of diverse bulk actives, formulations and nutraceuticals. Orchid is the largest manufacturer-exporter of cephalosporin bulk actives in India and is ranked amongst the top 5-cephalosporin producers in the world. Orchid’s world-class manufacturing infrastructure includes multiple USFDA compliant API and dosage form facilities at Chennai and Aurangabad in India. Orchid has dedicated state-of-the-art GLP compliant R&D centres for API research, drug discovery and pharmaceutical research at Chennai, India.

In September, Orchid Chemicals & Pharmaceuticals Ltd received approvals from the US Food and Drug Administration (US FDA) for its antibiotic combination piperacillin and tazobactam for injection, with 180-day exclusivity to market the products in US.

Orchid Pharma got approvals covering its generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g dosage forms and strengths, the company announced in a press release.

Piperacillin-tazobactam injections is commercially available as Tazocin (UK, marketed by Wyeth), Tazocin (Japan, marketed by Toyama), Tazocin (New Zealand, marketed by Wyeth), Zosyn (US, marketed by Wyeth) and Zobactin (India, marketed by GSK).

Orchid Pharma was also determined to be the first-to-file under para IV abbreviated new drug applications (ANDAs) for generic by the USFDA. No other company will be allowed to sell piperacillin and tazobactam injectable products in the strengths approved for Orchid within this exclusivity period.

Orchid’s first-to-file status entitles the company to have 180-day generic drug exclusivity, under applicable provisions, with considerable upsides for the company.

Orchid received approvals from several countries in EU for launch of Piperacillin-Tazobactam Injections in the financial year 2008-09.