• IKEMA trial results released early based on recom­men­da­tion of an Independent Data Monitoring Com­mit­tee
• Addition of Sarclisa sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to car­filz­o­mib and dexa­meth­a­sone alone
• Results will be sub­mitted to an upcoming medical meeting and form the basis for regu­la­tory sub­missions later this year

Paris, France (Press Release) – The Phase 3 IKEMA clin­i­cal trial eval­u­ating Sarclisa® (isatuximab) added to car­filz­o­mib and dexa­meth­a­sone met the pri­mary end­point at its first planned interim analysis, demonstrating sig­nif­i­cantly prolonged pro­gres­sion-free sur­vival com­pared to standard of care car­filz­o­mib and dexa­meth­a­sone alone in patients with re­lapsed multiple myeloma. There were no new safety signals identified in this study.

“When Sarclisa was added to standard-of-care treat­ment car­filz­o­mib and dexa­meth­a­sone in this phase 3 trial, results clearly dem­onstrated a sig­nif­i­cant re­duc­tion in …

• Bristol Myers Squibb to buy out its ex-U.S. mile­stone and royalty obli­ga­tions to bluebird bio for $200 million
• Bristol Myers Squibb assumes re­spon­si­bil­ity­ for vector manu­fac­tur­ing in ex-US territories
• bluebird to hold conference call and webcast to­day, May 11, 2020 at 8:00AM ET

Cambridge, MA (Press Release) – bluebird bio, Inc. (NASDAQ: BLUE) to­day an­nounced that it has amended its existing co-promotion / co-development agree­ment with Bristol Myers Squibb (BMS) to enable the com­pa­nies to focus their efforts on efficient com­mer­cial­iza­tion of idecabtagene vicleucel (ide-cel; bb2121) in the U.S., the com­pa­nies’ lead inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, cur­rent in review with the FDA.

“Under our amended col­lab­o­ration, we and BMS are redoubling our com­mitment to ide-cel …

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) to­day an­nounced that the U.S. District Court in Delaware issued a de­ci­sion upholding the validity of pat­ent claims from three pat­ents that pro­tect Amgen's multiple myeloma ther­apy KYPROLIS® (car­filz­o­mib). Today's de­ci­sion will prevent Cipla Limited, and Cipla USA, Inc. (collectively "Cipla") from making, using, selling, offering to sell, or importing its generic version of KYPROLIS until expiration of these three U.S. pat­ents. The latest pat­ent expiry is in De­cem­ber 2027.

Onyx Thera­peutics, Inc., an indirect, wholly-owned sub­sid­i­ary of Amgen Inc., brought a pat­ent in­fringe­ment suit …

Shanghai, China (Press Release) – Anten­gene Corpo­ra­tion (Antengene) to­day an­nounced a broadened part­ner­ship and territory ex­pan­sion agree­ment with Karyo­pharm Thera­peutics Inc. (NASDAQ: KPTI) (Karyopharm) for de­vel­op­ment and com­mer­cial­iza­tion of four oral novel drugs and drug can­di­dates to sup­port its mission of treating patients beyond borders. This agree­ment broadens Anten­gene's rights in the Asia Pacific region for XPOVIO® (seli­nexor, aka ATG-010), the first-in-class sel­ective in­hib­i­tor of nuclear export (SINE); eltanexor (ATG-016), a sec­ond-generation SINE com­pound; verdinexor (ATG-527), a lead com­pound in de­vel­op­ment for anti-viral and other non-oncology in­di­ca­tions; and KPT-9274 (ATG-019), a dual in­hib­i­tor …

• Acquisition of Stemline estab­lishes Menarini’s presence in the U.S. bio­pharma­ceu­tical on­col­ogy mar­ket
• Menarini will sup­port fur­ther de­vel­op­ment of Stemline’s ELZONRIS® and enable global ex­pan­sion by leveraging its com­mer­cial infrastructure in Europe and other ex-U.S. geographies
• Total poten­tial con­sid­er­a­tion of $12.50 per share comprising $11.50 cash and $1.00 Contingent Value Right (CVR)

Florence, Italy and New York, NY (Press Release) – Menarini Group, a privately held Italian pharma­ceu­tical and diagnostics com­pany, and Stemline Thera­peutics Inc., a com­mer­cial-stage bio­pharma­ceu­tical com­pany focused on the de­vel­op­ment and com­mer­cial­i­za­tion of novel on­col­ogy thera­peutics, (Nasdaq: STML) to­day an­nounced a definitive agree­ment under which Menarini Group will acquire Stemline in a trans­action valued up to $677 million.

Under the terms of the agree­ment, a wholly owned sub­sid­i­ary of the Menarini Group will com­mence a tender offer for all out­stand­ing shares …

• Subcutaneous for­mu­la­tion of dara­tu­mu­mab, DAR­ZA­LEX FASPRO™, approved by the U.S. FDA for the treat­ment of patients with mul­ti­ple myeloma
• Approval based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies
• In the stud­ies, the fixed-dose sub­cu­tane­ous for­mu­la­tion reduced treat­ment time from hours to min­utes and dem­onstrated similar ef­fi­cacy and safety with sig­nif­i­cantly fewer in­fusion-related reac­tions com­pared with the in­tra­venous for­mu­la­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab, DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj). The Biologics License Appli­ca­tion (BLA) for this for­mu­la­tion was sub­mitted by Genmab’s licensing part­ner, Janssen Biotech, Inc. (Janssen) in July 2019. DAR­ZA­LEX FASPRO is approved for the treat­ment of adult patients with mul­ti­ple myeloma: in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone in newly diag­nosed patients who are …

• New sub­cu­tane­ous for­mu­la­tion reduces the time taken for patients to re­ceive dara­tu­mu­mab treat­ment from hours to approx­i­mately three to five min­utes, with similar ef­fi­cacy and fewer in­fusion-related reac­tions com­pared to in­tra­venous admin­istra­tion^1,2
• If approved, dara­tu­mu­mab sub­cu­tane­ous for­mu­la­tion will be the first mono­clonal anti­body approved in Europe for sub­cu­tane­ous admin­istra­tion for patients with mul­ti­ple myeloma
• Positive Opinion is based on data from the Phase 3 COLUMBA (MMY3012) and Phase 2 PLEIADES (MMY2040) stud­ies

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) has issued a Positive Opinion rec­om­mending ap­­prov­al for DAR­ZA­LEX®▼ (dara­tu­mu­mab) sub­cu­tane­ous (SC) for­mu­la­tion for the treat­ment of adult patients with mul­ti­ple myeloma in front­line and re­lapsed / re­frac­tory settings. The novel SC for­mu­la­tion of dara­tu­mu­mab is co-formulated with recombinant human hyal­uron­i­dase PH20 (rHuPH20) [Halozyme's ENHANZE® drug de­livery tech­nology] and reduces …