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An agreement between a drug development company and a pharmaceutical corporation may not ordinarily be considered big news. However, in the case of Medivir AB and TetraLogic Pharmaceuticals, this is groundbreaking on many different fronts. The agreement, announced December 11, 2020, is a renegotiated agreement between the two entities that revolves around financial obligations related to the chemical compound known as birinapant. The new agreement is intended to create improved business development opportunities. In this article, we will look closer at the deal, as well as the original agreement, and dig a little deeper into what birinapant is and what it could become in the ongoing battle against cancer.
Birinapant is described as a SMAC (Second Mitochondria-derived Activator of Caspase) mimetic that attaches to and degrades IAPs (Inhibitors of Apoptosis Proteins). This leads to the death of cancer tumor cells. The body’s immune system is also stimulated which increases the attack on the cancer cells. Birinapant is in development to improve responses, and extend the lives of patients who have solid tumors located where current treatments cannot provide sufficient survival benefit, or for patients who have exhausted all other treatment options. Birinapant’s unique design and mechanism makes it a potential option that may enhance patient responses when used in combination with other treatments.
Birinapant was originally acquired by Medivir from TetraLogic in 2016. The agreement at the time between the two company’s included milestone payments of predetermined amounts along with royalty payments to TetraLogic. The royalties were only to take place once Medivir developed, marketed, or out-licensed birinapant further. That deal has been dissolved and replaced with the new arrangement. In the renegotiated agreement, Medivir is obligated to pay in a potential future transaction that is now based only on the distribution of actual future revenues to Medivir.
Medivir AB CEO Yilmaz Mashed states, “It is very satisfying that we have now dissolved the previous agreement and negotiated a new agreement which is entirely based on the distribution of potential future revenues.” He added, “This aligns and benefits both parties as the new agreement creates significantly improved conditions for a potential out-licensing or sale in our continued business development efforts with birinapant.”
The agreement from 2016 included a lot more than just birinapant and several payments. The deal saw TetraLogic sell the bulk of its assets to Medivir AB for the sum of USD 12 million with a potential to collect an additional USD 153 million in conditional payments. These conditional payments were what was referred to above as “milestone” payments. In the deal, Medivir acquired TetraLogic’s assets related to the research, development, manufacturing, and commercialization of birinapant and a second drug candidate known as SHP-141. Medivir also agreed to provide about $275,000 in funding to complete clinical trials on SHP-141. At the time of the original agreement, TetraLogic was in bad shape. Following disappointing clinical trial results on birinapant, the company laid-off 19 employees – or 66% of their workforce.
Founded in 2001 by John M. Gill, TetraLogic Pharmaceuticals is based in Malvern, Pennsylvania. The company “discovers and develops small molecule drugs that modulate programmed cell death pathways to treat debilitating diseases and conditions.” The company has two clinical-stage product candidates they are developing. One is birinapant and the other is identified as SHAPE. SHAPE, an HDAC (Histone Deacetylase) inhibitor, has been developed for topical application to treat early-stage CTCL (Cutaneous T-cell Lymphoma). TetraLogic is also exploring the potential of SHAPE being used to treat an autoimmune skin disease called alopecia aerata. The FDA has granted SHAPE a United States orphan drug designation for CTCL treatment.
Founded in 1988, Medivir AB is based in Stockholm, Sweden. The research-based pharmaceutical company says it has “a research focus on infectious diseases and oncology.” The company develops innovative drugs with an emphasis on cancer where unmet medical needs are prominent. Medivir’s business model features a component that relies on partnerships and collaborative arrangements. This means that the drug development process is either conducted solely by Medivir or in a partnership. Medivir appointed an Interim Chief Medical Officer in October 2020. Dr. Tom Morris brings over 20 years of experience to the position and most of that was with drug development, with a focus on oncology. The addition of Morris is sure to assist the company in forging ahead with their drug development programs.
That’s a good question. Although clinical trial results conducted by TetraLogic in 2016 were less than encouraging, how birinapant reacts in the body by seeking proteins to bind to and essentially destroy the cancer cells cannot be ignored. While it is miles away from being considered a super drug that can cure some forms of cancer, there is no doubt that – in the right setting and used with the right kinds of companion drugs – birinapant can leave a mark on cancer treatment. With so many different types of cancers, the possibility exists that birinapant will speed up the recovery rate for some patients with certain kinds of cancers. It has to be considered a possibility based solely on how the compound interacts with cancer cells.
An American drug development company and a Swedish pharmaceutical company formed an arrangement in 2016 that revolved around the development of two drug candidates. One, known as the compound birinapant, has an interesting trait. It will attach to proteins in cancer cells and effectively destroys them. This has given the partnership a tool to negotiate over as it has the potential of becoming a cancer drug. Earlier this month, the two company’s, TetraLogic and Medivir, renegotiated their original agreement. This time around, the deal includes financial commitments but opens the doors to further business development opportunities through the partnership. Could this mean the company’s sensing they are getting close to seeing birinapant being used in cancer treatments? It is a very good possibility.