Protocols

Merck KGaA sells off its biosimilars portfolio in €670M deal; uniQure boosted by PRIME; Struggling Ophthotech gets new CEO

→ With its new approval for the checkpoint drug avelumab in the bank, so to speak, Merck KGaA has completed a deal to sell off its portfolio of biosimilars. The German Merck says Fresenius is bagging the lot for €170 million upfront and €500 million more in milestones. Biosimilars are starting to stack up as the first wave of knockoffs arrive in the US. And that might explain a relatively modest upfront for these drugs. “We have increasing confidence in our Biopharma pipeline and this transaction will help prioritize innovative drug development of high quality and first-to-market best-in-disease assets,” commented Belén Garijo, member of the Executive Board of Merck KGaA and CEO of their Healthcare unit: “The partnership with Fresenius will allow us to exploit our Biosimilars portfolio to full potential while granting us a substantial return on prior investments.”

→ The Dutch biotech uniQure $QURE got a big boost from the news that its hemophilia B gene therapy AMT-060 has received a PRIME designation from the EMA. Its shares jumped 9% on the news, which closely followed a decision to scrap its $1.2 million treatment Glybera, which was largely unused. Stated Matthew Kapusta, chief executive officer of uniQure: “Similar to the Breakthrough Therapy designation that AMT-060 received from the U.S. Food and Drug Administration earlier this year, we look forward to this enhanced collaboration with the EMA to advance the clinical development of  this potentially transformative therapy for hemophilia B patients.”

→ Playa Vista, CA-based Science 37 has raised $29 million for its Series C, designed to further its work on using a telemedicine approach to creating site-less clinical trials. The biotech has now raised $67 million. Glynn Capital Management led the round with a contribution from GV, formerly Google Ventures. The round included a new investment from Amgen Ventures, as well as participation from all existing investors: Lux Capital, Redmile Group, dRx Capital (a Qualcomm and Novartis joint investment company), and Sanofi Ventures.

Arch Venture Partners and Venvest have led a $40 million round for Westlake Village, CA-based Sienna Biopharmaceuticals. The biotech is investing in a pipeline of topical therapies for conditions like psoriasis, atopic dermatitis and acne. “We are very pleased with the support of investors who share our commitment to developing innovative and disruptive new products in medical dermatology and aesthetics,” said Frederick C. Beddingfield III, Sienna’s President and Chief Executive Officer. “We have built out an accomplished team and a diversified multi-asset pipeline. We believe this financing will enable us to advance our development programs, which span pivotal clinical trials to preclinical programs.”

→ The share price of Ophthotech $OPHT fell off a cliff last fall after two Phase III studies of a wet-AMD drug — partnered with Novartis in a $1 billion deal — failed badly. And now, with its business development team on the hunt for new deals to reorganize the pipeline, the biotech is moving CEO David Guyer to the executive chairman’s role while promoting CFO Glenn P. Sblendorio to the CEO spot. “As the Company continues to review strategic alternatives and actively explores potentially obtaining rights to additional products, product candidates and technologies to treat ophthalmic diseases, particularly those of the back of the eye, David Guyer’s extensive expertise and experience brings a wealth of ophthalmology knowledge that is critical as we execute a strategy to maximize shareholder value,” stated Mr. Sblendorio.

→ Transgene has struck a deal with Bristol-Myers Squibb to put a combination of its cancer vaccine TG4010 into a Phase II trial for frontline non-squamous non-small cell lung cancer combined with Opdivo.


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RAPS Regulatory Convergence 2017