Senhwa gets FDA orphan drug designation

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Senhwa Biosciences Inc. of Taipei and San Diego received the orphan drug designation to CX-4945 for the treatment of cholangiocarcinoma.

CX-4945 is a novel small molecule drug that inhibits protein kinase CK2, the company said.

Orphan drug designation is granted by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. In the US, orphan drug status carries with it seven years of marketing exclusivity following FDA approval.

Under the agreement, Phylogica will receive a milestone payment of $2 million. Phylogica is eligible to receive research, development, and commercialization milestone payments totaling up to $142 million.

YOU MAY BE INTERESTED IN

For nearly 25 years, business executive Lou Weisbach and urologist Richard J. Boxer have argued that finding the money to finance the cures for devastating diseases is not as difficult as it appears. To start finding the cures, the U.S. Department of the Treasury needs to issue some bonds—$750 billion worth. Next, you hire CEOs—one...

There is general agreement that the United States spends too much on health care, especially on pharmaceuticals.  But what we spend on drugs is not simply a function of price. If eggs double in price, people can simply cut the number of eggs they eat in half.  Simply stated, cost is the product of (price per unit times the number of units purchased). 
What did President Richard M. Nixon and Senator Edward M. Kennedy have in common? They each played a pivotal role in the passage of the National Cancer Act signed by Nixon on Dec. 23, 1971. The NCA established the National Cancer Program authorizing the initial investment in the NCI-designated Cancer Centers Program. 
When I first proposed targeting PCNA (proliferating cell nuclear antigen) as a therapeutic approach, the response I got was: “No one will ever make a drug against PCNA. It’s undruggable.” The protein lacks enzymatic activity, has a disordered region, and binds to over 200 other proteins within the cell. From a traditional drug development perspective, these characteristics made PCNA an impossible target.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login