The British Pharmaceutical Company, Aztraneca shares drops after their potassium-lowering drug, ZS-9 got rejected by FDA. Their rival Relypsa soared in the stock market since they are the sole distributor of the drug that can treat hyperkalemia.
Aztraneca shares that FDA explain through the complete response letter or CRL, why they could not approve the release of the drug. ZS-9 is supposed to be a treatment for hyperkalemia or high levels of potassium in the blood. If left untreated, hyperkalemia can be deadly.
Potassium is an essential electrolyte in the body. It is very important for the nerves and muscles especially the heart. But too much potassium in the blood can be lethal. It may cause feeling of numbness or tingling, fatigue, weakness, nausea or vomiting and problems in breathing. Others experience chest pains and palpitation. In severe cases it can cause heart problem and paralysis.
The biopharmaceutical company noted that the problem is not on the drug itself but on the manufacturing process. So the company is still hopeful, that once they resolved the processing issue, they will apply again for FDA’s approval and then eventually launch their product.
Obviously, this news is favorable for Relypsa, the biotech company that offers Veltassa, since it is the only potassium lowering drug available in the market. The company got their approval just last October, so technically, they still owns the market.
However, Veltassa has been issued a black box warning because of its potential to interact with other drugs that may be detrimental to the health. Thus, it is advice to take other oral drugs six hours before or after taking Veltassa.
Aztraneca made a study of ZS-9 potential drug interactions but it has not been reviewed yet by FDA. The company pointed out that ZS-9 has a promising and competitive profile that may give them a positive advantage.
Relypsa understand the risks, and they are continuously working on Veltassa’s drug interaction. Last Wednesday, May 25, the company applied to change the label of the product. According to the result of the 12 series of Phase 1 Study, they found sufficient clinical evidence that a three-hour window period can be safe.
FDA’s rejection has caused the stock of AstraZeneca to go down to a fraction to 29.88. On the other hand, Relypsa stock soars high to 8.8%. Irina Kofler, Mizuho Securities shared that Relypsa’s shares has been unstable for the past few months, because of buy-out speculations.
Analysts view Valtessa’s launch as quite slow and there are a lot of apprehension in the market. It may also take time before Valtessa will have a concrete position in the market.
Seamus Fernandez, Leerink analyst is optimistic that ZS-9 will be able to get an approval in their second attempt. He believes that as soon as AstraZeneca is able to resolve their manufacturing issues, they have a very high probability to get an approval.
ZS-9 has an ongoing review in the Australia and European Medicines Agency. Fernandez reported that ZS-9 is pushing its launch within 1 year, and they are 80% positive that this will happen.
AstraZeneca: Is not Going to Give up!
The manufacturing issue has keep AstraZeneca’s approval in pending. But it will not be too long before they can resolve this issue. The competition of these two pharmaceutical companies will benefit the consumers in the longer run.
Both companies will continue to find ways to improve their drug portfolio. As expected, more innovative drugs may be out in the market to outsmart their competitors. The competition is tough, but the return of investment is high if they are able to come up with a reliable and competitive brand that will serve the welfare of the consumers.