Morning Briefing
Summaries of health policy coverage from major news organizations
Countries Dredging Up Decades-Old Powers To Suspend Patent Rights In Anticipation Of Drug Shortages
Bloomberg: Inoculating The World May Mean Reviving Old Curbs On Patents
German Chancellor Angela Merkel described the coronavirus as the greatest challenge facing her country since the end of World War II. Germany’s parliament took that message to heart as part of a package to fight the virus, extending powers to suspend patent rights, a tool last used in the country in 1949. Governments around the world are reviving rarely used legislation or pledging new measures to ensure that they have the drugs they need to battle the pandemic. Israel last month invoked an emergency patent-suspension clause in its 1967 code for the first time, allowing it to import a generic version of AbbVie Inc.’s Kaletra, which has shown signs of combating coronavirus. (Miller, Matussek, Decker and Bodoni, 4/1)
Stat: Big Employers Could Have Saved Money If More Biosimilars Had Been Used
If some of the largest U.S. employers had used biosimilar versions of a pair of widely used brand-name biologic medicines two years ago, they could have saved an average of $1.5 million and their employees would also have spent hundreds of dollars less, according to a new study. Nearly all of the savings would have been realized if those 13 companies had relied on biosimilar versions of Remicade, a popular treatment for rheumatoid arthritis and Crohn’s disease, among other ailments. (Silverman, 4/2)
Stat: Alnylam And Dicerna, Onetime Rivals, Announce A Ceasefire
Rival biotechs Alnylam and Dicerna are announcing a ceasefire. The two companies, which are both developing drugs based on the Nobel Prize-winning technique known as RNA interference, announced an accord Monday intended to harmonize two of their drug programs. The biotechs are working on two sets of rival drug candidates: Each has a drug candidate that targets alpha-1 antitrypsin deficiency — a rare genetic disease that affects a person’s lungs and liver, and each also has a candidate that targets primary hyperoxaluria type 1, a rare genetic disorder. (Sheridan, 4/6)
Bloomberg: Zentalis Pharmaceuticals Climbs In Debut After Expanded IPO
Zentalis Pharmaceuticals Inc., a clinical-stage cancer treatment developer, rose 29% in its trading debut after raising about $165 million in an initial public offering. The company’s shares, which surged as much as 50% from the $18 offer price, closed Friday at $23.20, giving the firm a market value of $798 million. Zentalis sold 9.18 million shares on Thursday at the top of a marketed range, after expanding the IPO from 7.65 million shares. (Tse, 4/2)
FiercePharma: Bristol Myers, Acceleron's Reblozyl Moves Closer To Blockbusterland With New Blood Disorders Nod
As a potential blockbuster drug touted by Bristol Myers Squibb during its Celgene buyout, Reblozyl’s future success was in large part dependent on an approval for a group of bone marrow disorders called myelodysplastic syndromes (MDS). Now, it has that nod. On Friday, Bristol Myers and partner Acceleron Pharma said the FDA has greenlighted Reblozyl to treat anemia in MDS patients with ring sideroblasts, a low-risk subtype of the blood cancer in which red blood cells contain a ring of excess iron. (Liu, 4/6)
FiercePharma: Merck's Keytruda Inches Toward Another Biomarker-Based OK With Latest Priority Review
Merck & Co.’s immuno-oncology competitors have tried, so far fruitlessly, to use the investigational biomarker tumor mutational burden to help them win approvals. But regulators apparently like what they’re seeing from Merck where TMB is concerned. The FDA has awarded the pharma giant a priority review for the use of solo Keytruda in previously treated patients with high tumor mutational burdens, no matter where those tumors are in the body. The move will shorten the regulatory timeline, bringing the deadline for the agency’s verdict up to June 16. (Helfand, 4/7)
