San Diego, CA (Press Release) – Ligand Pharma­ceu­ticals Incorporated (NASDAQ: LGND) partner CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and accelerating the launch of inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts in China, the U.S., and through­out the world, announces the official prod­uct launch of mel­phalan hydro­chlo­ride for injection (EVOMELA) in China which is the first commercial prod­uct launch for CASI. EVOMELA uses Ligand’s Captisol tech­nology in its for­mu­la­tion.

Melphalan hydro­chlo­ride for injection (EVOMELA) received mar­ket approval by the China National Medical Products Admin­istra­tion (NMPA) for use as high-dose con­di­tioning …

Rockville, MD (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cial­iz­ing thera­peutics and pharma­ceu­tical prod­ucts in China, U.S., and through­out the world, announces the prod­uct launch of EVOMELA® (melphalan for injection) in China which is the first commercial prod­uct for the Company.

EVOMELA® received mar­ket approval by the China National Medical Products Admin­istra­tion (NMPA) for use as high-dose con­di­tioning treat­ment prior to hema­to­poietic progenitor (stem) cell trans­plant in patients with multiple myeloma, and as a palliative treat­ment of patients with multiple myeloma for whom oral …

• EVOMELA Received FDA Approval for Two Indications:
• High-Dose Conditioning Treatment for Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplantation (ASCT)
• Palliative Treatment of Patients with MM Who Cannot Take Oral Therapy
• EVOMELA Admixture Solution is Stable for 4 Hours at Room Temperature in Addition to the 1 Hour Following Reconstitution
• EVOMELA Does Not Contain Propylene Glycol
• Company Plans to Launch EVOMELA with Existing Sales Force in a Market

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• The FDA did not identify any clin­i­cal deficiency in the CRL
• Company plans to meet with FDA and seek clarification on the CRL

Henderson, NV (Press Release) – Spectrum Pharma­ceu­ticals (NasdaqGS: SPPI), a bio­technology com­pany with fully integrated commercial and drug devel­op­ment operations with a pri­mary focus in Hematology and Oncology, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Admin­istra­tion (FDA). A Complete Response Letter is a communication from the FDA that informs com­pa­nies that an appli­ca­tion …

• 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

 …

• 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.
• The Company expects FDA review to take approximately 10 months.
• The Company plans to launch this drug with its existing hematology/oncology sales force next year pending approval.
• Our formulation is free of propylene glycol and does not use a custom solvent

 …

• CE Melphalan is being developed as a novel version of the well-established conditioning treatment in autologous transplant for patients with multiple myeloma. CE Melphalan does not contain propylene glycol, an ingredient in currently available products which has been associated with renal and cardiac side effects.
• In its pivotal trial, CE Melphalan met its primary endpoint. The improved stability profile of CE Melphalan could lead to rapid adoption in the transplant conditioning market.
• The company expects to file an NDA in the 3rd quarter and plans to

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