Biotech Stock News (MNKD) (SNY) (DVAX) (GSK) (AFFX) (TMO)


Mannkind Corporation (NASDAQ:MNKD)

On Tuesday January 5th, 2016 shares of Mannkind fell by more than 48% after it was announced that the collaboration agreement by Sanofi (NYSE:SNY) had been terminated. This agreement was formed way back in 2014 where Sanofi made an upfront payment of $150 million. Sanofi was to take global rights for Afrezza, an inhalation powder treatment for Diabetes. Mannkind was to also receive an additional $775 million in payments if certain sales milestones were reached.

The next course of action is for Sanofi to transfer all the commercialization rights back to Mannkind, which is expected to take about between 90 to 180 days. Things will have to be transferred quickly because once the 180 day mark hits, July 4, 2016, then Mannkind will have full control of Afrezza. Which means, at this point, Sanofi will have nothing to do with the compound and will move on to its own business segments.

The next course of action for Mannkind is to decide whether it should attempt to partner out Afrezza again, or if it should outright sell the company. The former will be tough because if Sanofi abandoned it as a partner, then it will be quite hard to find another interested big pharma partner. On the other hand if the company sells its assets it could be more beneficial for shareholders in the long-run anyways. It doesn’t seem like inhalable insulin has caught on yet, and if Management attempts to sell Afrezza on its own it may finally meet a certain doom of collapsing.

Dynavax Technologies (NASDAQ:DVAX)

On Thursday January 7, 2016 shares of Dynavax closed the day up 40% after the company  had announced positive phase 3 results for its Hepatitis B vaccine. The company’s Hepatitis B vaccine, known as Hepislav-B, was being tested in a phase 3 trial for safety and efficacy. The phase 3 trial was to compare Hepislav-B to an already approved vaccine from Glaxosmithkline (NYSE:GSK) known as Engerix-B.

The primary endpoint of this phase 3 study was to determine the non-inferiority of seroprotection in patients with diabetes mellitus. Hepislav-B obtained a seroprotection rate of 90% compared to Energix-B only obtaining 65.1%. With this data on hand, and previous data from another phase 3 trial the company expects to resubmit its Biologics License Application — BLA — by the end of the first quarter 2016.

The reason for Dynavax resubmitting the BLA again, was because it had obtained a Complete Response Letter — CRL — back in 2013. The CRL was obtained because Dynavax didn’t provide enough data on safety of the vaccine. The FDA believed that more safety data needed to be provided to disprove any chances for autoimmune body reactions. This new phase 3 trial along with the previous HBV-23 trial data should be enough to convince the FDA to approve the Hepatitis B vaccine this time around.

Affymetrix (NASDAQ:AFFX)

On Friday January 8, 2016 shares of Affymetrix surged as high as 50% in after-hours trading after the company announced that Thermo Fisher Scientific (NYSE:TMO) made an offer to buy the company for $1.3 billion in an all cash-type deal. Under the terms of Agreement, Thermo Fisher agreed to pay $14 per share which was about a 50% premium on the previous closing share price of $9.21 per share.

The board of directors of both companies agreed to the deal, but now all awaits is the approval of the Affymetrix shareholders. If the shareholders feel that this is a good deal then the transaction is expected to close by the end of the second quarter of 2016. Thermo Fisher made this acquisition because it gives its company access to additional genetic analysis. What this means is that the company will be able to better measure genomic items such as DNA, genes, and other potential molecules.

[Image Courtesy of Wikipedia]


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