Oncolytics Biotech (ONCY)
Shares of Oncolytics gained about 36% on 2/17/15 when it had announced that the company received FDA Orphan Drug Designation status for its pancreatic cancer drug Reolysin. Reolysin is a variant of the ReoVirus which occurs naturally in the environment. Oncolytics has engineered Reolysin to multiply at an alarming rate inside of cancer cells eventually eradicating them, but in normal cells Reolysin has effect. One thing to note is that Orphan drug status is only given to pharmaceutical companies that treat a rare disease with a huge unmet medical need. The company even receives many types of benefits such as longer market exclusivity with the drug and tax benefits.The orphan drug status was given for the pancreatic cancer indication which is still a huge unmet medical need for many cancer patients. Pancreatic cancer is one of the leading causes of cancer death because the cancer is not detected immediately. By the time it is detected the cancer has already spread to other parts of the body like the lungs, stomach, and other internal organs. There are 46,420 patients diagnosed with pancreatic cancer each year and among those about $39,590 die. So as you can see it has a high mortality rate and Oncolytic’s drug might be able to treat pancreatic cancer with Reolysin.
Roche(RHHBY) and Exelixis (EXEL)
On 2/19/15 Exelixis announced that the FDA has accepted the review for Genetech’s NDA — New Drug Application — for Cobimetinib in combination with Vemurafenib. One thing to note is that Genetech is a division of Roche (RHHBY). These combo drugs will be used to treat a rare type of melanoma — skin cancer — with a BRAF V600 type of mutation. Cobimetinib is a selective inhibitor that is responsible for blocking a protein known as MEK. The blocking of this MEK protein is important because MEK is part of a pathway for many types of cancers known as the RAS-RAF-MEK-ERK pathway. This pathway plays the key role in cell division and cell survival in cancerous cells. The combination of Cobimetinib and Vemurafenib produced better results then Vemurafenib alone in the melanoma patient population. For instance Cobimetinib together with Vemurafenib achieved a progression-free survival — PFS — rate of 9.9 months, while Vemurafenib alone only produced a PFS rate of 6.2 months. Progression-free survival indicates the amount of time that a patient is treated with a drug and that the cancer doesn’t progress to an even worse state. A 4-month improvement in PFS is huge and as such this combination drug has received FDA priority review. The FDA decision for approving this combo drug — Cobimetinib/Vemurafenib — is expected August 11, 2015.
Ariad Pharmaceuticals (ARIA)
On 2/20/15 Ariad’s largest shareholder with a 6.87% stake, started a proxy vote fight to get rid of the current CEO. The larges shareholder of Ariad is Sarissa Capital Management who claims that the current CEO is responsible for the poor sales for Iclusig. Iclusig is the company’s current lead drug that treats Chronic Myeloid Leukemia — CML — and Philadelphia Chromosome Positive acute lymphoblastic Leukemia — Ph+ ALL. Iclusig was FDA approved in the U.S. back in December of 2012 to treat these two rare types of Leukemia. Harvey Berger founded Ariad and is currently the CEO of Ariad Pharmaceuticals but Sarissa Capital management wants him out for good. Despite the CEO getting Iclusig back on the market after it was pulled off by the FDA for 2 months due to serious life-threatening risks it doesn’t seem like he is going to get a break when the proxy vote comes this June of 2015. The company expects Iclusig sales in 2015 to be between $130 million – $140 million dollars but that still won’t be enough to counter the company’s current expenses. Still the CEO hasn’t done all that bad for the company and the pipeline still remains intact with many phase 2 assets that may yet bring future value.