JPM 2016: Cipla Shapes Respiratory Build-Up
This article was originally published in PharmAsia News
Executive Summary
Around a quarter of Cipla's top 50 R&D projects currently underway are in the respiratory segment and the Indian firm says it aims to launch its own differentiated respiratory and oncology pipeline in the US in the "near future."
At the 34th Annual J.P. Morgan Healthcare Conference in San Francisco earlier this month, Cipla Ltd.'s global chief operating officer, Umang Vohra, said that the company had more than 200 development projects underway, with the top 50 in segments such as oncology, respiratory and antiretrovirals (ARVs).
Cipla, traditionally seen as a strong rival to GlaxoSmithKline PLC in the respiratory space in several emerging markets, indicated that 13 of the top 50 projects were in the respiratory space, with 10 in the ARVs segment and seven in the area of oncology.
26 of Cipla's top 50 R&D projects are targeted at the US market. Cipla's portfolio in the US is aimed at therapy areas where the market size, based on innovator sales, is around $30bn. It expects its US business to grow from the current 8% to 20-25% of overall sales by 2020.
Vohra said that Cipla has the "requisite levers" in place to progress its North America business and transition to a direct presence plus business-to-business (B2B) model. Last year, Cipla snapped up InvaGen Pharmaceuticals Inc. and Exelan Pharmaceuticals Inc. in the US, though it has traditionally been known for a risk-averse global partnerships-only approach and limited direct off-shore presence despite its products being available worldwide.
Asked whether the differentiated respiratory and oncology pipeline for the US, includes novel dosage forms, new drug delivery systems with an aim to improve compliance and convenience and largely 505(b)(2) kind of filings, Cipla told PharmAsia News’s sister publication Scrip Intelligence: "Our focus is to get generic versions on the market which are substitutable."
Respiratory Pipeline
Cipla, which boasts the world's largest inhalation portfolio available across over 100 nations, referred to its pipeline for the US with upcoming launches of short-acting beta agonists and inhaled corticosteroids, among others, in the respiratory space.
On whether plans were underway to develop generic versions of GSK's Breo (fluticasone furoate/vilanterol) and Anoro (umeclidinium/vilanterol), Cipla told Scrip that the "current focus is not on these products."
Cipla already has a partnership with Sandoz Inc. for a generic version Pulmicort Respules for the US and an alliance with Sweden's Meda AB for Dymista (azelastine HCl/fluticasone propionate) Nasal Spray.
Cipla manufactures generic Pulmicort Respules for Sandoz, which had earlier launched all three strengths of the product in the US. Sandoz had in July last year announced the introduction in the US of its budesonide inhalation suspension, a generic version of AstraZeneca PLC's Pulmicort Respules inhalation suspension 1mg.
In Europe, Cipla has seven metered dose inhalers (MDIs), nasal spray and respules products across 15 markets with further launches planned in the near term, though limited visibility on the launch timelines for its Advair (fluticasone/salmeterol) generic in markets like the UK has left some analysts concerned. Cipla had earlier launched its generic Advair MDI in certain European markets including Germany and Sweden.
In June last year, Mylan NV launched the first bioequivalent alternative to Seretide Evohaler (salmeterol xinafoate/fluticasone propionate) branded as Sirdupla in the UK. Sandoz's salmeterol/fluticasone product, AirFluSal Forspiro, has been approved in a number of European countries, among others.
Emerging Markets
Cipla previously said that it anticipates a tripling of its respiratory business over the next five years from around $350m in 2014-15, with about 50% of the growth coming from India, South Africa and emerging markets. Of the balance 50% growth, about two third is likely to be from North America, with Europe accounting for the remaining one-third, it then said.
The Indian firm is currently the leader in India, South Africa and Sri Lanka in the respiratory segment and among the top five players in Morocco, the Philippines and Vietnam.
In the biosimilars space, Vohra said that the Mumbai-headquartered firm has four “disruptive” biosimilars being developed in-house, in addition to one insulin product. Specifics could not be got immediately. Cipla had earlier launched biosimilar versions of darbepoetin alfa and etanercept on the Indian market.
(This story also appears in Scrip Intelligence
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