On Thursday January 21, 2016 MannKind Corporation (NASDAQ:MNKD) had announced that it had entered into a license agreement, with a newly formed entity known as Receptor Life Sciences Inc. This collaboration was created to where both companies would come together to create inhaled type therapeutic products for commercial use. Such inhaled therapeutics both companies are thinking about creating are:
- Inflammatory disorders
- Chronic Pain
- Neurological diseases
The technology that will be used to create these inhaled therapeutic products will be Mannkind’s technology, known as the Technosphere Platform. This technology allows the use of dry powders to be able to fight off against a variety of diseases. It can do so both locally and systemically, without the use of any type of needles.
Because its Mannkind’s technology, the company itself will be responsible for creating and developing the initial studies. Once initial testing has been completed all development and commercialization rights will be transferred to Receptor Life Sciences. Mannkind even has the potential to earn up to $102.25 million in clinical milestone payments. If these products bypass the FDA and make it to market, then Mannkind can earn up to double digits in royalty sales.
This deal comes less than one month after Mannkind announced on Jan 5, 2016 that the partnership with Sanofi SA (NYSE:SNY) was terminated. It had been less than a year since Sanofi had been attempting to push sales for Afrezza — an inhaled insulin powder for patients with Diabetes. Sanofi was not happy with the sales to date so they chose to drop Mannkind. On the other side, Mannkind stated that Sanofi failed to commercialize the product properly by placing TV ads, and marketing it appropriately. There now will be a wait to see if Mannkind can somehow recover with this new deal in place.
Inovio Pharmaceuticals Inc
On Tuesday January 19, 2016 Inovio Pharmaceuticals Inc (NASDAQ:INO) announced that it had received a research grant from the U.S. Army. This small grant comes from a unit of the U.S. Army known as the Small Business Innovation Research — SBIR — program. The grant totals $500,000 and Inovio is to use this money to develop a device that delivers therapeutics to patients without the use of any needles. The company is basing this prototype vaccine delivery product on a current device it uses with needles known as CELLECTRA.
The new needle free device can be expected to treat a few different diseases such as:
The U.S. Army is interested because it would like to have a needle free device in order to vaccinate soldiers at a more rapid pace. Although, the U.S. Army would also want a needle free device to be able to handle pandemic events. This way it can deploy such devices quickly to places where pandemic events occur. Pandemic, means when a virus has spread quickly. In this case, having a needle free device that can vaccinate people quickly can quickly reverse the course of a pandemic.
With so many devices being created, why has the U.S. Army specifically chosen Inovio’s prototype? Honestly, because Inovio’s needle free prototype device has already shown positive results in early testing. It has shown positive immunogenicity results, and positive antigen expression. Immunogenicity tests the body’s ability to create an immune response against the disease. An antigen expression is how well the vaccine reacts against the disease.
Inovio currently uses needles to deliver its synthetic vaccines, along with the CELLECTRA electroporation device. The electroporation device opens up pores of the T-cells and allows the vaccine injected with needles to get in. A needle free device, where only electroporation would be needed would be a huge advantage over other products. One other such company that has licensed Inovio’s technology is OncoSec Medical (NASDAQ:ONCS) and to date they have shown positive phase 2 results in cancer trials as well.
On Wednesday January 20, 2016 Zafgen Inc (NASDAQ:ZFGN) closed the day up 78% after it had announced that its drug beloranib obtained positive phase 3 results in patients with obesity. These patients are obese because they have a disorder known as Prader-Willi Syndrome — PWS. In the PWS patients are unable to curb their appetite no matter how much food they consume everyday. Because their bodies don’t recognize when they are full, they end up gaining an excessive amount of weight.
The phase 3 trial is known as the PWS ZAF-311 study and recruited up to 81 patients to evaluate safety and efficacy of the drug. The trial proved to be efficacious as the drug, beloranib, was able to reduce patients’ weight, and reduce hyperphagia related behaviors. Hyperphagia is an injury to the hypthalmaus — brain portion that controls release of hormones. Both the 2.4 mg dose and 1.8 mg doses of beloranib were able to significantly reduce weight compared to placebo.
There is still one major problem, one that is holding the stock from going up. That is that on October of 2015 the FDA had placed a clinical hold on the beloranib drug due too safety concerns. Zafgen believes that the safety and efficacy data from this trial along with safety data from a previous trial should be enough to satisfy the FDA. If the FDA is satisfied that belornib is safe they will be able to remove the clinical hold. If the clinical hold is ultimately lifted by the FDA, then expect the share price of Zafgen to appreciate in the coming months.
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