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How to view the strategic abandonment of multinational pharmaceutical enterprises in research projects
How to select excellent new drugs suitable for their own conditions has always been an issue of great concern to multinational pharmaceutical companies. As we all know, the development of new drugs has the characteristics of high investment, high income, high risk and long cycle. When the project is progressing to a certain extent, for some reasons, it is a pity to make a strategic abandonment of a certain variety, although it is a pity that the drifting drifting of the previous research and development is a pity, but sometimes this practice is more to save the manpower and material resources of the company in time. And the unique embodiment of enterprise's scientific research ability and market vision.
In recent years, projects that have been abandoned by multinational pharmaceutical companies:
1. Pfizer: Remoxy
Remoxy is a common analgesic oxycodone gel sustained-release capsule. It is a kind of anti abuse and sustained-release oxycodone preparation. Its dosage form is gel like high viscosity capsule. It is difficult to accumulate content by crushed or mixed with water and other solvents. It can effectively prevent the abuse of oxycodone. As a result, Remoxy was once considered to have broad market prospects, which was one of the reasons why Pfizer bought KingPharma in that year.
Remoxy hit FDA 3 times, but it was rejected. At the same time, the follow-up of competitors' products led to the bleak of the Remoxy market. Pfizer eventually had to give up the project, return all of Remoxy's rights back to partners PainTherapeutics and Durect, and at the same time no longer carry out any development work on Remoxy. .
2. Sanofi: SAR3419
SAR3419 is an antibody drug couplet obtained by coupling antibodies targeting CD19 protein to maytansinoid, an anti-tumor drug. Because CD19 is widely expressed on the surface of various tumor cells, SAR3419 will have better specificity than traditional drugs. In the two phase of the previous DLBCL clinical study, the patient's objective remission rate to SAR3419 was about 43.9%, and many analysts believe that the drug has the potential to go to market as a new type of tumor for two types of cancer.
SAR3419 was developed by Senofi and ImmunoGen. Out of strategic decision, Senofi chose to give up the development of SAR3419. This decision decided that the ImmunoGen company was affected, and the company's share price fell 11% after the news release. In addition to SAR3419, Senofi and ImmunoGen still have SAR650984, SAR566658 and SAR408701 in R & D cooperation.
3. AstraZeneca: brodalumab
Brodalumab is a novel monoclonal antibody that blocks the inflammatory signaling pathway by blocking the binding of IL-17 ligands to receptors. IL-17 plays a key role in inducing and promoting inflammatory diseases. Brodalumab has been developed for the treatment of moderate to severe plaque type psoriasis and psoriatic arthritis. Phase III clinical projects have been completed and a regulatory application for the treatment of moderate to severe psoriasis is planned to be submitted to the United States and the European Union at the end of the year.
Since clinical data have shown that brodalumab is likely to be associated with patient suicidal tendencies, Amgen has stopped working with AstraZeneca on brodalumab, and then AstraZeneca authorizes the exclusive right to develop and commercialize the brodalumab to Valeant. According to the agreement, Valeant will pay 445 million dollars for AstraZeneca.
4. Bayer: Riociguat
Riociguat is an innovative medicine developed by Bayer and plays a role in guanylate cyclase. Clinical mainly used for the treatment of pulmonary hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), the first sGC agonist, was approved by FDA in 2013 with commercial name Adempas for the treatment of two kinds of pulmonary hypertension, including postoperative (unoperated) thromboembolic pulmonary hypertension and unknown cause of pulmonary hypertension Type of pressure.
Since the market has not yet been targeted at the approved treatment of pulmonary arterial hypertension (PH-IIP) associated with idiopathic interstitial pneumonia, Bayer is hoping to use Riociguat to meet the current market demand for this indication.
Based on the company's previous clinical research data, Bayer commissioned an independent data analysis Committee (DMC) to analyze its research, and DMC finally suggested that the company suspend the development of Riociguat. Bayer has decided to suspend its clinical study on the Riociguat treatment of PH-IIP, and the company also says it will keep this clinical study for at least four months of follow-up.
5. staircase: MPC-150-IM
As a first-line candidate drug, MPC-150-IM is composed of nearly 1 million 500 thousand stromal cells and plays a role by direct injection into the cardiomyocytes of patients with chronic heart disease (heart failure). In damaged tissues, when some special receptor - ligands interact, MPC-150-IM releases a series of factors that can induce functional recovery of damaged cells in a variety of ways.
Initially, MPC-150-IM was developed by Mesoblast and was thought to be a heavy bomb with potential to be a peak of $4 billion 100 million a year, and Teva holds about 14% of Mesoblast's stake through the acquisition of Cephalon, and in the effort of Teva, MPC-150-IM has been progressing to the later stage of the day.
Perhaps out of the development strategy needs, Teva gave up the continued development of MPC-150-IM and returned all the rights to Mesoblast, and it continued to advance, initially estimating the cost of the subsequent research and development of the MPC-150-IM for about $100 million.
What are the characteristics of the strategic abandonment of the research project?
Through the above cases, it is not difficult to find that when the product is defective, the market prospects are not clear, and the number of declarations is too many, the multinational pharmaceutical companies usually consider the strategic abandonment of the project. In a mature market economy country, the R & D cost of the pharmaceutical industry accounts for far more than its global sales.