Regulatory Index News: 11/05/2018

Welcome to your Regulatory Index News update today. Whilst one drug maker gains an approval, one gets a rejection, and another is bought-out. Read here to keep up to date.

Darzalex becomes first US approved monoclonal for newly diagnosed multiple myeloma

The FDA have approved Janssen and Genmab's Darzalex combination treatment in the US as the first ever monoclonal antibody to treat patients with newly diagnosed multiple myeloma which are ineligible for autologous stem cell transplant (ASCT). The drug is approved for use in combination of Velcade (proteasome inhibitor), melphalan (alkylating agent), and prednisone (collectively VMP). The FDA approval was based upon the recently published phase 3 data (ALCYONE) which showed the combining Darzalex with VMP reduced the risk of disease progression or death by 50% compared to VMP alone. The progression-free survival (PFS) of the combination had also not been reached, compared to 18.1 months for VMP alone. Please click here to read more from a PharmaTimes article.

FDA reject Lipocine's testosterone drug again

The US regulators have issued another Complete Response Letter (CRL) which has outlined the rejection of Lipocine’s testosterone drug, Tlando. The letter has reportedly requested for an ambulatory blood pressure monitoring study to provide definitive evidence that the testosterone replacement therapy can offer clinically meaningful increases in blood pressure for men with testosterone deficiencies. On top of this, the regulators have asked Lipocine to confirm the reliability of the testosterone, the maximum serum concentration (Cmax) data, and explain why the Cmax secondary endpoints were not applicable. This rejection has now caused a dive in Lipocine’s share price, with it dropping share value by more than a third on Wednesday morning. Please click here if you would like to read further from BioPharmaDIVE.  

Takeda and Shire settle the deal for £46 billion

Shire’s board have now approved an offer for acquisition by the Japanese drug maker, Takeda, for a whopping £46 billion ($62 billion). This amounts to a $30.33 in cash and either 0.839 New Takeda Shares or 1.678 Takeda ADSs for each Shire share, valuating totally at about £48.17 a share. This represents a 59.6% premium on Shire’s closing price the day before Takeda reported its intentions to buy the company, March 27th.  Providing the shareholders back the transaction, which requires 75% of Shire’s voting shareholders and 66% of Takeda’s, it is now expected to be complete in the first half of 2019. If you would like to read more of this report, please click here for an article from PharmaTimes.



Max Lymbery

Date Published

11th May 2018

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