Teva ($TEVA) and Korea’s Celltrion have come together to form a biosims commercial pact as the Israeli generics giant aims for deeper ties in the growing biologic copies space--and a new partner after Lonza backed away in 2013.
Teva will pay $160 million upfront to help sell two of Celltrion’s antibody biosimilars--namely its Rituxan (rituximab) copy CT-P10, sold by Roche ($RHHBY) and Biogen ($BIIB) for blood cancers and arthritis, and CT-P6, its experimental biosimilar to Roche’s ageing breast cancer treatment Herceptin (trastuzumab).
Neither drugs have yet been approved and are in Phase III studies--with both recently hitting their testing targets.
Celltrion submitted CT-P10 to the EMA last October, and said it is preparing CT-P6 for submission in Europe seeking approval from the EMA this quarter.
As part of the deal, Teva will be responsible for all commercial activities in North America, should they gain approval, while Celltrion will be responsible for finishing off all clinical development and regulatory activities.
Though paying $160 million, there is an unusual clause that could see $60 million “refundable or creditable under certain circumstances”, although further details were not given. Both companies are also set to share profits from the meds.
The North American sales of both Herceptin and Rituxan were around $6.5 billion last year, according to Teva’s figures, although they will likely sell their versions--should they get the green light--at around 10-25% cheaper than the original meds.
“This commercial partnership with Celltrion enables Teva to expand into the upcoming wave of biosimilars and build on its strong position in the biosimilar space,” said Siggi Olafsson, president and CEO of global generic medicines at Teva.
“The introduction of two additional mAb biosimilar candidates into our near-term pipeline bolsters our biosimilar portfolio and continues to leverage Teva’s unique cross-functional capabilities across both specialty and generic medicines. We look forward to our partnership with Celltrion with its expertise in mAb biosimilar development and manufacturing.”
Back in April, the FDA approved Celltrion's biosimilar version of Johnson & Johnson's Remicade (infliximab)--to be co-marketed by Pfizer ($PFE)--for a slew of indications, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, ulcerative colitis and psoriasis. Pfizer cut back on ties with Celltrion last year--for the Rituxan and Herceptin copies.
This also comes three years after Teva and former partner, the Swiss CDMO Lonza, broke up a joint venture on biosims that dated back to 2009. This came on reports that the two companies slammed the brakes on their own biosim version of Rituxan.
After the break-up, Teva said it aimed to pursue biosimilars development with a “highly selective approach” to picking programs.
HyoungKi Kim, CEO of Celltrion, said: “Following on the heels of our global success with Remsima (Inflectra), our infliximab biosimilar, which has brought affordable and effective biologic treatment to many patients around the world with proven record of quality, efficacy and safety to the reference product, we are confident that we will be able to repeat the same success in the U.S and Canada with CT-P10 and CT-P6 through our partnership with Teva.”