Dec 3 Pharma News

Cumberland’s methotrexate product gets approval in the US; Baker Brothers purchases stake in Kodiak’s KSI-301; Sanofi offloads Seprafilm unit to Baxter

Cumberland Pharmaceuticals has recently received approval from the US FDA for its RediTrex injection for the treatment of rheumatoid arthritis.

Cumberland pharmaceuticals pharma company focusing on acquiring and commercializing prescription products has gained access to the injection from Nordic Group two years back. Nordic’s injectable methotrexate products manufactured to cure diseases, like active rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis, have already been approved in Europe in 2016.

With approval from the US FDA, Cumberland will gain the right to commercialize the product in the US. As per the agreement, Cumberland will proceed with the commercialization, marketing, branding, promoting, and distribution of the product line in the US. In return, Nordic will manufacture and receive payment upon achieving sales milestones.

Injectable methotrexate- RediTrex is available in both oral and injectable forms. The oral form formulation is already available; however, the injection has been proved to be more efficacious. Other marketed products of Cumberland pharmaceuticals include Acetadote injection, Caldolor injection, Kristalose oral solution, and others. Moreover, the company also has an innovative pipeline of products such as Hepatoren injection, Boxaban oral capsule, Vasculan and other in its armamentarium.

Kodiak Sciences faces a spur of its shares as much as 146.5% higher after Baker Brothers Advisors announced to enter into a financing partnership by investing a huge amount of USD 225 Million for the rights to KSI-301.

KSI-301 is an anti-VEGF antibody biopolymer conjugate therapy for the treatment of retinal vascular diseases, such as age-related macular degeneration (AMD) and diabetic eye diseases.

Baker Brothers will have the royalty rights capped at 4.5% of the global sales of Kodiak’s drug. Kodiak will receive an amount of USD 100 Million in the month of January 2020 upon the closure of the transaction. The remaining amount will be paid by Advisors after the achieving successful 50% enrolment of two planned the pivotal clinical studies of its drug in wet AMD patients, which were started in October.

Moreover, the agreement underlines that the cap of the royalty of the Advisors will never exceed the 4.5%, however, the investors might take a stake in other follow-on products of KSI-301, in case the company decides to develop.

During the whole period of the agreement, Kodiak retains the right to repurchase any portion of the whole of the stake in its drug from Baker Bros.

Sanofi has announced to trade off its unit Seprafilm Adhesion Barrier unit to Baxter International for USD 350 Million.

In a move to advance its surgery portfolio, Baxter has agreed to acquire Seprafilm, which will complement its leading hemostat and sealant portfolio for providing quality care to the patients in the operating unit.

Seprafilm has been approved to be used in abdominal or pelvic laparotomy (surgical incision into the abdominal or pelvic cavity). It is an adhesion barrier which acts as an adjunct to lower down the risk associated with postoperative adhesions between the abdominal wall and underlying viscera.

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