Application Designed to Support Conversion of Accelerated to Full FDA Approval

Thousand Oaks, Calif., March 30, 2015 (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted the supple­mental New Drug Application (sNDA) of Kyprolis® (car­filz­o­mib) for Injection for the treat­ment of patients with re­lapsed multiple myeloma who have received at least one prior ther­apy. The sNDA is designed to sup­port the conversion of accelerated approval to full approval and expand the current Kyprolis indi­ca­tion. As part of the acceptance, the FDA granted Kyprolis priority review with a Prescription Drug User Fee Act …

MorphoSys Regains Rights to MOR202 Antibody Against CD38 and
Updates its Financial Guidance for 2015
Conference call on Friday, March 27, 2015, at 1:00pm CET (12:00pm GMT/8:00am EST)

Martinsried / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that it has regained rights to MOR202 from Celgene Corpo­ra­tion. The com­pa­nies have mutually agreed to terminate their co-development and co-promotion agree­ment for MOR202. Clinical devel­op­ment of MOR202, which cur­rently involves a MorphoSys-sponsored phase 1/2a trial in re­lapsed or refractory multiple myeloma patients, will con­tinue as planned. This trial in­cludes combi­na­tion cohorts with lena­lido­mide and poma­lido­mide which will be provided to MorphoSys by …

The ability of BI-505 to prevent or delay relapse of multiple myeloma (MM) to be in­ves­ti­gated in clin­i­cal study conducted by leading clinicians at University of Pennsylvania

Lund, Sweden (Press Release) – BioInvent Inter­na­tional AB (OMXS: BINV) com­pleted a strategic analysis of its ICAM-1 targeted phase II anti­body BI-505 with thought leaders to garner sup­port on the devel­op­ment of BI-505.

Based on the analysis of BI-505’s data, a clear direction emerged that BI-505 is uniquely positioned to in­crease the poten­tial depth and quality of response in patients receiving standard of care treat­ment …

• Recognition of the unmet medical need and high therapeutic potential of ImMucin in Multiple Myeloma
• A multi-center phase II clinical study under IND is planned to start in Multiple Myeloma patients during 2015.

Ness Ziona, Israel (Press Release) – Vaxil Bio (TASE: VAXL), a leading developer of immuno­therapeutic prod­ucts to treat cancer and infectious dis­eases, reports today that its lead drug can­di­date, ImMucin has received orphan drug desig­na­tion from the European Medicines Agency (EMA) of the European Com­mis­sion (EC) for the treat­ment of Multiple Myeloma (MM), a …

San Diego, CA (Press Release) – Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported today that Genmab A/S announced plans for a Phase 1 clin­i­cal trial of a sub­cu­tane­ous formulation of the anti-CD38 anti­body dara­tu­mu­mab using the ENHANZE™ tech­nol­o­gy. In December 2014, Janssen Biotech, Inc. (Janssen) entered into an agree­ment with Halozyme Therapeutics for the pur­pose of devel­op­ing and com­mer­cializing prod­ucts combining pro­pri­e­tary Janssen com­pounds with Halozyme's ENHANZE tech­nol­o­gy. This agree­ment has the poten­tial to lead to the devel­op­ment of a sub­cu­tane­ous formulation of dara­tu­mu­mab. Dara­tu­mu­mab is being developed under a col­lab­o­ration between Janssen …

• PDUFA decision expected October 23, 2015, 10 months from NDA filing.
• Approval is being sought for use as a high-dose con­di­tion­ing treatment prior to stem cell transplantation in multiple myeloma and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
• Spectrum’s formulation is propylene-glycol free and is more stable with a longer use time, which could simplify clinical administration logistics.
• The Company plans to launch this drug with its existing

 …

• Adds Imbruvica® a first in class BTK inhibitor approved in multiple indications for blood cancers.
• Extensive clinical program with over 50 studies ongoing evaluating Imbruvica® as a treatment for a wide range of additional indications, including early assessments for solid tumors and potential treatment of Graft v Host disease.
• Broadens and deepens AbbVie's already robust pipeline, and establishes the combined company as an emerging leader in the hematological oncology space.
• Accelerates the company's commercial presence in oncology.
• Transaction valued at $261.25 per Pharmacyclics' share, total transaction value of approximately $21 billion
• Highly accretive to both revenue and earnings by 2017.

North Chicago, IL and Sunnyvale, CA (Press Release) – AbbVie (NYSE:ABBV) and Pharmacyclics (NASDAQ:PCYC) today announced a definitive agree­ment under which AbbVie will acquire Pharmacyclics, and its flagship asset Imbruvica® (ibrutinib), a highly effective treat­ment for hema­to­logic malig­nan­cies. The acquisition accelerates AbbVie's clin­i­cal and commercial presence in on­col­ogy, strengthening its already robust pipe­line, and estab­lish­ing its strong leadership position in hema­to­logical on­col­ogy – …