Protocols

Helsinn buys global rights for skin cancer drug from Actelion; Akebia reels in more cash for vadadustat; EMA slams Bevyxxa

→ Swiss pharma group Helsinn is acquiring rights to skin cancer drug Valchlor (marketed as Ledaga in Europe) from Actelion Pharmaceuticals. The deal gets Helsinn worldwide rights to the rare disease drug, which is a topical drug for mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). Valchor is an FDA-approved formulation of mechlorethamine. It was launched in the US in 2013, and pulled in $35 million in annual global sales in 2017. Helsinn’s US-based subsidiary, Helsinn Therapeutics, says it will build up its sales force in the region to market the drug in the US. Financial details of the deal were not disclosed.

→ European regulators have slammed Portola Pharmaceuticals $PTLA with a negative opinion for betrixaban. The company plans to appeal, hoping that a re-examination will change the CHMP’s mind. Approved in the US as Bevyxxa, the drug barely missed the key endpoints in a pivotal trial but claimed success in preventing blood clots among acutely ill patients.

→ Akebia is shooting to raise $98 million in a new stock offering $AKBA, from which money will be socked away for the company’s closely-watched anemia drug. The med, called vadadustat, is in Phase III clinical trials, and Akebia said the new funds would go towards “optimization” of that program along with pre-commercialization activities, according to an SEC statement. The offering includes $85 million in common stock, and a 30-day option for the underwriter to purchase an additional $12.75 million.

Novo Nordisk is touting a Japanese approval for Ozempic today, with plans to launch the GLP-1 diabetes drug in the country in the coming months. The Danish company — which reaffirmed its blockbuster aspirations for Ozempic in obesity just days ago — made sure to highlight the Japanese-specific weight loss data on the label.

Humira is now approved for 10 indications in Japan, where regulators just gave it the green light in pustular psoriasis patients who have had an inadequate response to conventional therapy. AbbVie, which ran a small Phase III study with Japanese patients for this particular indication, continues to partner with Eisai for distribution and promotion of the drug.  

→ With an FDA review running in the background, Amicus $FOLD has scored an OK in Japan for its Fabry disease drug migalastat in patients with an amenable mutation. Once the company goes through the pricing and reimbursement process, that would make the 19th country that migalastat is reimbursed in. An estimated 850 people in Japan live with the lysosomal storage disorder, according to Cranbury, NJ-based Amicus.  


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Director/Sr Director, Oncology/Immuno-Oncology
Aro Biotherapeutics Company Denver, CO
Director/Sr. Director Oncology
Aro BioTx Philadelphia, PA
Manufacturing Associate – Upstream
Molecular Templates Austin, TX
Scientist, Process Development
Molecular Templates Austin, TX
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Molecular Templates Austin, TX
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Molecular Templates Austin, TX

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