Amgen, Inc. (NASDAQ:AMGN)
On October 28, 2015 Amgen had announced that it had received FDA approval for its skin cancer drug known as IMLYGIC. This drug is an injection type drug that helps boost the immune system to fight off and kill cancerous skin cells. This therapy only treats Melanoma — skin cancer– but does nothing for cancer found in the body. IMLYGIC is made up of the Herpes Simplex Virus type-1, which is a modified oncolytic viral therapy.
More specifically this type of therapy treats recurrent Melanoma. Recurrent meaning that the melanoma — skin cancer — continues to appear even after a patient receives initial surgery to remove it. As noted above the composition of this drug is an oncolytic viral therapy, and this is the first of its type to be approved by the FDA. Like many other cancer drugs the cost can eventually be quite high, but Amgen has stated that its therapy would cost about $65,000 for treatment.
This drug was approved because of positive efficacy observed in a phase 3 study, which was known as the OPTiM study. This study was measured using the primary endpoint in which patients were tested for durable response rates compared to a control. What is a Durable Response Rate — DRR? A durable response rate is the occurrence of when a patient either receives a partial response or a complete response from therapy. Receiving a complete response or a partial response involves the drug therapy either clearing the cancer, or partially clearing it.
In addition IMLYGIC received a positive response from European drug reviewers for a possible European approval. If all goes well and the EMA likes the efficacy/safety of the drug it could possibly be approved in Europe as well. We believe that Amgen still has some significant upside as its pipeline has been quickly growing with blockbuster type drugs.
Regulus Therapeutics (NASDAQ:RGLS)
On October 28, 2015 Regulus announced that it had received its final milestone payment from Biogen (NASDAQ:BIIB) for its Multiple Sclerosis partnership. Regulus was able to get this last installment milestone payment by leveraging its technology platform to create microRNA profiles targeting MS. The technology platform used to disdoveer these MS microRNA profiles is known as the “microMarkers SM Technology”.
The reason for the collaboration was that Biogen believed that by Regulus using its own technology it could more accurately predict MS biomarkers that would improve efficacy of current drug products. Regulus is leveraging its technology to be able to target many other indications other than MS as well, which means some nice potential future growth in other key areas. Believe it or not this collaboration started way back in 2012, but it wasn’t until 2014 when Biogen was really interested in buckling down with Regulus in creating microRNA target profiles for MS.
Still, Regulus has been doing quite well with its own pipeline in creating combo therapies for its own Hepatitis C drug. The total amount of milestone payments that Regulus had received for this collaboration was $3.7 million. In the future Biogen will now decide if it wants to continue its agreement with Regulus to further advance the initial research both companies have come up with. We are inclined to believe that Biogen will probably continue its research collaboration with Regulus for one main reason.
That reason being that Biogen would like to keep its market share of the MS market. That is because right now Biogen’s drug Tecfidera has a sizable market share as the leader in this category. In order to keep leading the MS space, Biogen will have to find ways to improve efficacy over its current drugs. This means that microRNA targets in MS might create a better drug product against MS. This would pave the way for Biogen to continue its leadership in this space.
Revance Therapeutics (NASDAQ:RVNC)
On October 29, 2015 Revance Therapeutics announced positive phase 2 data for their injectable drug, known as RT-002, that is being used to treat patients with glabellar lines. First, before we go any further we must know what glabellar lines are? Glabellar lines are wrinkles that form between the eyes, above the bridge of the nose and below the forehead. The company’s product, known as RT-002, is an injectable drug used to treat wrinkles.
RT-002 like BOTOX injection that comes from Allergan (NYSE:ACT), is a botulinum toxin Type A that reduces the expression of wrinkles on the skin. What makes RT-002 special over the current marketed leader BOTOX is that it is a treatment localized only to the injection site. This means that RT-002, unlike BOTOX, does not spread to the skin around the injection site. This provides greater efficacy at the point of injection improving patient outcomes.
The phase 2 trial known as the BELMONT study recruited up to 268 patients in total with glabellar lines. Each of these patients were randomized to either receive three doses of RT-002 or BOTOX — the placebo in the trial. The phase 2 results were nothing short of impressive because all three doses of RT-002 given to patients were shown to be superior in terms of efficacy to BOTOX.
None of the patients experienced any adverse effects so the drug was safe for them to take. The company’s technology platform is known as the TRANSIT peptide technology. What makes this technology unique is that not only can it deliver drugs as injections, but it can also deliver them in topical forms. This means that the company is working on other advanced drug products that could treat wrinkles with only a topical gel form.
This removes the need for injections in very sensitive areas for these patients. Drugs that treat wrinkles in gel form should be superior to injection drugs which can be quite annoying for the patient. Going forward we believe that this company has an excellent platform and will continue to advance its pipeline for FDA approval. We are not the management team of Allergan, but one must wonder that Allergan is probably watching this company like a hawk. There is no guarantee that Allergan wants to acquire this company, but if it wants to maintain its lead with drugs like BOTOX it just might have to.
[Image Courtesy of Idaho National Laboratory via Flickr]