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NVS' Kymriah To Face FDA Again, AEZS Teams Up With SBBP, A Rival For EXAS?


Today's Daily Dose brings you news about Aeterna's alliance with Strongbridge; a new study about CellMax-CRC Colorectal Cancer Screening test and Novartis' Kymriah getting priority review from the FDA for a second indication.

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Aeterna Zentaris Inc. (AEZS) (AEZS.TO) has entered into a license and assignment agreement with Strongbridge Biopharma plc (SBBP) to carry out development, manufacturing, registration and commercialization of Macrilen in the United States and Canada.

Macrilen, an orally available ghrelin agonist, was approved by the FDA last month for use in the diagnosis of patients with adult growth hormone deficiency.

As per the deal terms, Aeterna Zentaris will receive an upfront cash payment of US$24 million and commercial milestone payments from Strongbridge. As long as Macrilen is patent-protected, Aeterna Zentaris will also be entitled to a 15% royalty on net sales up to US$75 million, and an 18% royalty on net sales above US$75 million.

Shares of Exact Sciences (EXAS), the maker of Cologuard, a noninvasive colon cancer screening test, were down more than 9% on Wednesday, on potential threat from liquid biopsy firm CellMax Life's CellMax CRC-Protect blood test.

Cologuard use stool samples and it has been able to detect 92% of colon cancers and 69% of the highest-risk precancers with 87% specificity. CellMax CRC-Protect, a multi-biomarker blood test clinically-proven for early detection of colorectal cancer, is available in Taiwan. It is not approved in the U.S.

A new study that involved 620 participants in Taiwan has found that CellMax-CRC Colorectal Cancer Screening test that identifies circulating tumor cells (CTCs) present in the bloodstream can detect colorectal cancer at an early stage, with accuracy ranging from 84 to 88%.

However, analysts are of the view that the study size is too small and that similar data may not be achieved in a larger study.

EXAS closed Wednesday's trading at $47.68, down 9.95%.

Novartis' (NVS) supplemental Biologics License Application seeking approval of Kymriah for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the FDA for Priority Review.

The supplemental Biologics License Application was submitted by the Company on October 31, 2017. Under Priority Review, the FDA will take action on an application within 6 months, and so the estimated timeline for the FDA decision is April 30, 2018.

Kymriah received FDA approval, last August, for the treatment of children and young adults up to 25 years of age suffering from a form of acute lymphoblastic leukemia that doesn't respond to standard treatment or has relapsed at least twice. It is the first ever CAR-T therapy to receive the FDA nod.

The European Medicines Agency has granted accelerated assessment to the Marketing Authorization Application for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r DLBCL who are ineligible for ASCT.

NVS closed Wednesday's trading at $86.88, up 0.17%.

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