Prescribed Reading: Biosimilars or biologics? Why not both?
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
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Mergers & analysis
Samsung Inc.'s and Biogen Inc.'s biosimilar-developing joint venture Samsung Bioepis Co. Ltd. is expanding its repertoire beyond copycat biologics to start developing innovative large molecule drugs with new partner Takeda Pharmaceutical Company.
Samsung Bioepis has had a lot of success in the biosimilar category — the company is the first to garner approval for all three major TNF inhibitors, and it will be interesting to see how that expertise translates to innovative medicines.
Elsewhere, AstraZeneca tapped German biotech Ethris to use its RNA technology to develop respiratory therapies. The deal could help the British pharma rebuild its respiratory franchise, now that Symbicort (budesonide/formoterol) revenues are falling. Yet, looking to RNA technology for this is a big bet. The tech has been around for more than a decade, but has only recently been making real strides.
Allied Market Research estimates that RNA therapeutics could be worth as much as $1.2 billion by 2020.
Meanwhile, Stada is inching closer to being acquired by by Bain Capital Private Equity and Cinven Partners. The private equity firms have passed the first hurdle for taking over the generics drugmaker in a takeover saga that has been ongoing for the better part of the year.
Rare disease developer Ultragenyx Pharmaceutical Inc. was hit hard this week by the failure of its late-stage neuromuscular disorder drug, which didn't hit any of its primary or secondary endpoints in the Phase 3 trial. The failure has pushed the company to discontinue development of the drug and has prompted investors to question the promise of the ultra rare disease drug developer's pipeline.
AstraZeneca released further results this week from its development program for the anti-platelet drug Brilinta (ticagrelor), in an effort to bolster the drug's position. Brilinta significantly lowered patients' risk of cardiovascular death — an outcome that is positive given the drug's disappointing history of demonstrating heart health benefits. The data drop comes ahead of the European Society of Cardiology's 2017 Congress where the British pharma will present more in-depth results.
Novogen Ltd. has tapped Chiltern International to help the company conduct a Phase 2 study of its glioblastoma treatment. Drugs for the brain cancer have received more attention recently after Senator John McCain, R-AZ, revealed he had been diagnosed with the disease.
Novogen still needs to hammer out the details of its mid-stage study with regulators, but has high hopes for the compound, which it acquired from Roche's biotech unit Genentech.
Roche's potentially market disrupting hemophilia treatment emicizumab moved one step closer to approval this week, with the Food and Drug Administration setting a target action date of February 23. A green light for the drug could mean major competition to therapies from Novo Nordisk S/A and Shire plc.
The FDA also gave the go-ahead to Intra-Cellular Therapeutics, Inc., allowing the biotech to move forward with a long-term safety study after questions surfaced about animal toxicity issues for its lead drug. The company's stock price has been a roller coaster ride as Intra-Cellular has presented both good and bad study results for the drug. The latest twist: it will file a New Drug Application for lumateperone by mid-2018.
Cardiome Pharma Corp. got a slap in the face from the FDA as it once again tried to bring its cardiovascular drug Brinavess (dalbavancin) to market. The decade-long journey of the drug continues with the FDA saying this week that Cardiome's data package is just not strong enough for a resubmission of the NDA.
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