Russian biopharma Biocad was ahead of the curve when it concentrated its initial drug development efforts in then-nascent biosimilars. With a handful of biosimilars assets now launched in Russia and beyond and more in the pipeline, the St. Petersburg-based company increasingly is turning its attention to novel drugs, with an eye to expanding its market in a big way.
Gene therapy occupies a "really excellent place" after "extraordinary" scientific advances, several approvals, a plump development pipeline and a flurry of partnering deals, observed Geoff McDonough, president and CEO of Generation Bio. But despite their "unprecedented opportunities to provide durable benefit," version 1.0/2.0 gene therapies also bear significant mechanistic limitations that confine their usefulness to small populations and relatively rare indications.
Just last month, Australia's Viralytics Ltd. was marching to completion on its phase Ib immunotherapy programs of lead candidate Cavatak after landing a A$29.6 million (US$23.9 million) private placement with China's Lepu Medical Group. The funding boosted the company's coffers to A$57 million in cash, "which gets us well into 2020 with the full program we've got," Viralytics CEO Malcolm McColl told BioWorld Asia at the time. (See BioWorld, Jan. 26, 2018.)
Just last month, Australia's Viralytics Ltd. was marching to completion on its phase Ib immunotherapy programs of lead candidate Cavatak after landing a A$29.6 million (US$23.9 million) private placement with China's Lepu Medical Group.
Voyager Therapeutics Inc. struck another big pharma partnership for its gene therapy platform, attracting Abbvie Inc. to a strategic collaboration and option agreement to develop and commercialize vectorized antibodies against tau in Alzheimer's disease (AD) and other neurodegenerative diseases.
Shares of Apricus Biosciences Inc. plunged 70 percent Friday on word that the FDA issued another complete response letter (CRL) for the resubmitted new drug application (NDA) of Vitaros (alprostadil, DDAIP.HCl) to treat erectile dysfunction (ED). In late 2016, the San Diego-based company was hopeful that it had found a road forward in the U.S. for Vitaros – approved in Canada and in certain countries in Europe, Latin America and the Middle East – by resolving issues in the CRL dating back to 2008.
To some observers, Vertex Pharmaceuticals Inc. would seem to have the cystic fibrosis (CF) market wrapped up. With Kalydeco (ivacaftor) and Orkambi (lumacaftor/ivacaftor) already market-leading CF drugs, the Boston-based firm wowed investors and analysts this month with prospects for next-generation correctors, VX-659 and VX-445, which are moving into phase III development as part of separate triple-combination regimens.
Stressing the collaborative nature and "limited scope of exclusivity" of Nektar Therapeutics Inc.'s immuno-oncology (I-O) deal with Bristol-Myers Squibb Co. (BMS), Howard Robin, Nektar's president and CEO, touted the "transformative" nature of the potential $3.63 billion pact covering NKTR-214. The alliance provides Nektar with $1.85 billion up front – $1 billion in cash and the remainder through an $850 million purchase of approximately 8.28 million Nektar shares (NASDAQ:NKTR) at $102.60 apiece, a 35 percent premium to Tuesday's closing price of $75.66 per share.
Within hours of the earlier-than-expected approval of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg), Gilead Sciences Inc.'s once-daily single tablet regimen to treat HIV-1, Glaxosmithkline plc (GSK) and partners filed a patent infringement suit seeking to protect the interest of dolutegravir (Tivicay), the integrase inhibitor from Viiv Healthcare Ltd. Formed in 2009 as an HIV specialty company, Viiv is majority owned by London-based GSK, with Pfizer Inc. and Shionogi Ltd. as minority shareholders.
