The Pharma sector is currently going through a highly charged period especially in the regulatory realm. However, despite the uncertainty, the sector is poised to perform well in the coming period. The pharma companies engaged in niche market are expected to push their R&D efforts further. Actinium Pharmaceuticals Inc. (NYSEMKT: ATNM) is one such firm, focusing on developing novel treatments for different types of cancers.
The latest feather in Actinium’s hat is receiving positive scientific advice from the European Medicines Agency for Iomab-B drug candidate. The guidance provides clear regulatory pathway for EU approval for Iomab-B. According to the communication from the EMA the company may use its US Pivotal Phase 3 SIERRA trial for the purpose of submitting a Marketing Authorization Application in Europe, underscoring Actinium’s potential for further development.
The company is currently focusing on boosting its portfolio of patents. It recently announced receiving a notice of allowance from the United States Patent and Trademark Office for a patent claiming the methods for generating a radioimmunoconjugate comprised of actinium-225. The claims are related to a method for producing actinium-225 radioconjugates, which is a key ingredient of the company’s main drug candidates Actimab-A and Actimab-M. The radioconjugates are also used by the company for its alpha particle immunotherapy technology platform.
With this new patent, the company’s patent portfolio now consists of over 60 patents. The company’s growing intellectual property pipeline is expected to offer a boost to its market valuation as well. The stock has reacted positively to the recent initiatives taken by the firm. This year so far, the stock price has skyrocketed by over 57 percent, wiping out a large portion of its previous year declines.
Among other developments which had positive impact on the company’s stock price is its positive growth trajectory for its drug candidates. The company is currently working on three main drug candidates which are Actimab-A, Actimab-M and Iomab-B. Out of these drugs, lomab-B is currently in pivotal Phase 3 trial which Actimab-A is in Phase 2 trial. The company is currently carrying out Phase 1 trial for Actimab-M for treating patients with multiple myeloma who are unresponsive to currently available therapies.
The company is able to generate synergies as Actimab-A, Actimab-M and Iomab-B are interrelated and are able to draw from common pool of research. Actimab-M comprises anti-CD33 monoclonal antibody HuM-195 coupled to actinium 225 and shares its construct with Actimab-A, which is designed for treating acute myeloid leukemia. The ailment is estimated to have 20,000 new diagnoses every year. Any positive development in this regard is likely to fuel increase in the company’s valuation on account of a variety of reasons. It will help diversifying the potential revenue streams for the company.
On the other hand, it may also make the company an attractive acquisition target as AML treatment offers a lucrative potential market. Recently Celator Pharmaceuticals Inc. was acquired by Jazz Pharmaceuticals for $1.5 billion. The main driver behind Celator’s valuation was its positive clinical trials showing improved survival rate for AML patients. Although Celator and Actinium Pharmaceuticals are following different trajectories, however, Celator valuations show the potential for Actinium Pharmaceuticals.
Actinium Pharmaceuticals also draws its strength from its focused approach. The company is currently involved in developing cancer treatments using its alpha particle immunotherapy platform and other technologies. The cancer treatment market was estimated to be over $83 billion in 2016 and Actinium Pharmaceuticals is looking to make its foothold in this lucrative segment through its focused approach. However, it also aims to develop novel approach for treating cancers which will be able to overcome some of the many drawbacks of traditional treatments for cancer. This poses both challenges and opportunities for the firm.
The company is not only focusing on expanding the scope of its current drug candidates but is also researching other types of cancers where appropriate opportunities may exist. It is specifically working on preclinical development for metastatic prostate cancer, antiangiogenesis and metastatic colorectal cancer.
Additionally, Actinium Pharmaceuticals is also focusing on its APIT platform which may be customized for developing treatments for various other types of cancer. Since this platform is used for implementing state of the art mAbs based cancer treatment, expansion in its utility may open up new markets for the company, leading to more diversified revenue streams.
Actinium Pharmaceuticals’ main drug candidate Iomab-B is currently in a pivotal Phase 3 multicenter clinical trial. The company is collaborating with the FDA for Phase 3 clinical trial design which has recommended a single pivotal study, contingent upon trial results. Actimab-A is in the Phase 2 portion of a multicenter Phase 1/2 clinical trial in AML, while Actimab-M is being studied in a Phase 2 clinical trial.
The latest developments provided positive fillip to the stock price, which despite its spectacular performance this year so far, is trading nearly 40 percent below its 52 weeks high price of $2.36. Keeping in mind the company’s current performance and its future plans, the current price point offers the right opportunity for investors to initiate a position in the sock. While Actinium Pharmaceuticals seems poised to provide good growth in medium to long term, the current momentum wave may prove to be suitable for short-term investors as well.
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