With investors growing cold towards the biotech industry following the “Invossa debacle” and “SillaJen shock,” there will be a series of big announcements from biotech companies after the Chuseok holidays that can change the market atmosphere.
Helixmith Co., formerly called Viromed, which ranks second in the KOSDAQ market in terms of market cap, will release the top-line results of the global phase 3 clinical trial for Engensis (VM202), a diabetic neuropathy treatment, at the end of this month.
Medytox Inc. and Daewoong Pharmaceutical Co. are expected to announce the results of DNA analysis on Daewoong’s botulinum toxin strain, which Medytox claims Daewoong has stolen from it.
In addition, Mezzion Pharma Co. will unveil the results of the phase 3 clinical trial of Udenafil, a treatment for single ventricle congenital heart disease, and the U.S. Food and Drug Administration (FDA) will decide whether to grant sales approval for Cenobamate, a novel drug to treat epilepsy developed by SK Biopharmaceuticals Co.
Helixmith is planning to release the results of the phase 3 clinical trial for Engensis between Sept. 23 and 27. It is a gene therapy that can create new blood vessels and regenerate damaged nerves by producing hepatocyte growth factor (HGF) protein in the body in large quantities. The company will be able to preempt the diabetic neuropathy treatment market worth 10 trillion won (US$8.39 billion) if it succeeds in developing Engensis. Helixmith had conducted the phase 3 clinical trial on 500 diabetic patients in the United States until July.
Mezzion, which was spun off from Dong-A Pharmaceutical Co., will announce the results of the phase 3 clinical trial for its Udenafil at the American Heart Association meeting on Nov. 16. Udenafil, a treatment for single ventricle congenital heart disease, helps stimulate the circulation of the blood of single ventricle patients who had the Fontan procedure which includes direct anastomosis of the right atrium to the main pulmonary artery. Udenafil, which is also the name of the ingredient of Zydena, the erectile dysfunction treatment developed by Dong-A Pharmaceutical, has recently completed the phase 3 clinical trial.
SK Biopharmaceuticals, which is pushing for an initial public offering (IPO), is expected to obtain approval for sales of Cenobamate, a novel drug to treat epilepsy, from the U.S. FDA in the second half of this year. The company filed a new drug application for Cenobamate in November last year based on the results of its clinical trials on 2,400 patients around the world. The FDA will decide on whether to grant approval on Nov. 21 but the market believes that it is certain that SK Biopharmaceuticals will receive the final approval. SK Biopharmaceuticals signed a US$530 million (600 billion won) licensing deal with Swiss drug company Arvelle Therapeutics in February. Under the agreement, it received a nonrefundable upfront payment of US$100 million (110 billion won), which was the largest figure in history. This is why market experts said the market cap of the SK Biopharmaceuticals will reach 5 trillion won (US$4.20 billion) if it is listed on the market by the end of this year as scheduled.
Furthermore, the four year-long dispute between Daewoong Pharmaceutical and Medytox will be ended by the end of this month. The U.S. International Trade Commission (ITC) will receive the analysis results of the botulinum toxin strain from Daewoong Pharmaceutical on Sept. 20. Medytox have claimed that Daewoong Pharmeceutical stole its strain and demanded that Daewoong Pharmeceutical open its whole base sequence for botulinum toxin Nabota. Daewoong Pharmeceutical have refused to disclose it by reason of trade secrets but it was forced to submit data by the ITC. The prevailing view is that Daewoong Pharmaceutical will win the case as the ITC’s earlier test confirmed that Daewoong’s botulinum toxin strain formed spores. However, Medytox says the dispute will be resolved only when the analysis results of botulinum toxin strain are unveiled.