Anacor Pharmaceuticals (NASDAQ:ANAC)
On Monday July 13, 2015 shares of Anacor went up 55%, closing around $131.93 per share after the company announced positive phase 3 results in patients who have atopic dermatitis. There were two phase 3 trials that were testing Anacor’s drug, Crisaborole, for these patients with atopic dermatitis — also known as Eczema. The company wanted to see if its Crisaborole treatment could reduce inflammation in patients with Eczema.
The Crisaborole drug is an anti-inflammatory drug that is in topical form. Crisaborole works by attempting to reduce inflammation of the skin in these patients. That is because Eczema patients have severe inflammation of the skin that causes itching continuously. Both phase 3 trials were powered greatly because they each recruited up to 750 patients with Eczema.
The primary endpoint of this study was to determine how well Crisaborole would be able to reduce inflammation of the skin for these patients. Crisaborole was able to meet the primary endpoint as the drug was able to significantly reduce inflammation of the skin in these patients. That is because Crisaborole was able to clear or almost completely clear more patients in the study than the placebo counterpart could.
There is an estimated 18 million to 25 million people in the United States that have Eczema. If not treated in time Eczema in these patients may potentially spread to other parts of the body causing more skin inflammation problems. With these results on hand Anacor states that it will file a New Drug Application to the FDA for Crisaborole approval in Eczema by the first half of 2016.
Celgene (NASDAQ:CELG) & Receptos (NASDAQ:RCPT)
On Tuesday July 14, 2015 Celgene announced that it would acquire Receptos for $7.2 billion in an all cash type deal. This $7.2 billion acquisition deal translates to about $232 per share in common stock of Receptos. The main reason Celgene chose to acquire Receptos is for the company’s main drug known as Ozanimod. Although this deal did allow Celgene to acquire the rest of the pipeline as well which is a huge added bonus.
This deal only went through because the board of directors from each company decided that it was a reasonable proposition. If all legal matters are settled accordingly both companies expect the acquisition to close sometime later this year.
Why would Celgene acquire Receptos? Well it’s no surprise that Celgene hasn’t ramped up their Research & Development department much if at all, therefore the company has been doing many types of deals. Right now Celgene either makes a long-term partnership deal or an acquisition of a pharmaceutical company for its future growth. In addition Celgene probably acquired Receptos because of pipeline synergy.
For instance Celgene has a drug compound known as Otezla, which treats both psoriasis and psoriatic arthritis. This addition of Ozanimod adds to Celgene’s inflammation and Immunology pipeline. We believe that this acquisition by Celgene was a smart one because Ozanimod targets two large market indications. Ozanimod targets Relapsing Multiple Sclerosis and Ulcerative Colitis. In addition Ozanimod has already proved to be superior to current standard of care in both of those indications as well. Both of these two indications listed above could be worth over $4 billion combined.
To show how much Celgene has been constantly making deals we will take a look at a recent transaction that had occurred prior to this acquisition of Receptos. On June 29, 2015 Celgene announced a $1 billion investment in Juno for its CAR-T therapies. In essence CAR-T stands for Chimeric antigen-receptor T-cells and they are used to boost the immune system to fight off cancerous cells in the body. We believe that Celgene will continue to make future investments/acquisitions to keep building shareholder value going forward.
On July 16, 2015 Amgen announced that it had received positive phase 2 results in a rare form of blood cancer. This rare form of blood cancer is known as Relapsed/Refractory Philadelphia chromosome-positive B-Cell precursor Acute Lymphoblastic Leukemia — PH+ ALL. This phase 2 trial used blinatumomab to treat these patients with a rare form of blood cancer. Blinatumomab is already marketed for other indications — known as Blincyto.
More specifically Blincyto has already been approved by the FDA for the PH- ALL indication. This trial was not powered to compare a drug treatment regimen to a placebo treatment. Instead this trial was run as a single-arm trial using only Amgen’s drug Blincyto. This single-arm trial focused on the survival for these patients that were on the Blincyto treatment. In addition as with all clinical trials the company was also looking for safety data for the dosage used.
The results were positive because statistically significant group of patients were able to achieve a complete remission or a complete remission with partial hematological recovery just only using the first two treatment cycles in the entire trial. The fact that these patients only completed two treatment cycles and saw remission from this rare form of blood cancer is remarkable in itself. There were some serious Adverse events reported but overall the drug was safe for patients to take.
These positive phase 2 results in PH+ ALL will be published in a prestigious medical journal possibly before the end of this year. In addition Amgen plans to show more detailed data from these results at an upcoming medical conference this year. Amgen as always continues to do well for itself in the Research & Development arm of its company, and will continue to build great shareholder value.
Original article –