Mylan Resurrects Old Malaria Medication to Fight COVID-19

Mylan (MYL) reported that it has decided to restart the production of hydroxychloroquine sulfate tablets. The restart is to allow the use of these tablets as potential treatment of COVID-19. It is expected that the tablets will be available in the market by mid April. The tablet is currently approved to be used for treating malaria. Hydroxychloroquine is also approved to be used for treating some autoimmune diseases due to its anti-inflammatory properties and lower toxicity.

Mylan is currently looking to manufacture tablets in its West Virginia factory but may initiate such production outside of the United States as well. There had been a couple of studies which claimed that the tablet has the potential to treat COVID-19. The drug has been shortlisted by the World Health Organization as potential weapon to combat the coronavirus. However, Mylan is not the only firm to restart the production of hydroxychloroquine as Teva also announced its plan to donate over 6 million doses to US hospitals for meeting crucial demand.

As the world continues to be under threat from coronavirus, Mylan stands to gain substantial windfall should hydroxychloroquine proves its worth as a COVID-19 treatment. Currently, there is no approved treatment for this latest pandemic. However, given the severity of the situation, it is expected that the FDA will be taking swift measures for introducing treatments to the market.

Apart from focusing on fighting coronavirus, Mylan also recently reported its Biologics License Application for MYL 1402O which has been developed as a biosimilar to Avastin. The application has been reviewed under the 351(K) pathway and seeks approval for the drug candidate as first line and second treatment for patients suffering from metastatic colorectal cancer in combination with fluorouracil-based chemotherapy.

Mylan recently reported its fourth-quarter and full-year results. The company reported its total revenue for the year at $11.50 billion while its fourth-quarter revenue jumped 4 percent to touch $3.19 billion. Its adjusted EPS declined 3 percent to $4.42 and the companys adjusted free cash flow dipped 22 percent to $2.10 billion. The decline was mainly caused by investment in working capital on account new product launches. The company expects its FY 2020 revenue to be in the range of $11.5 billion to $12.5 billion while its adjusted EBITDA will likely be in the range of $3.2 billion to $3.9 billion.

Mylan is currently going through the process of merging with Upjohn, which is Pfizers (NYSE:PFE) off-patent branded and generic medicine business. The resulting entity will have 57 percent ownership of Pfizer shareholders whereas the remaining part will be held by Mylan shareholders. It was earlier reported that the new company will be called Viatris. The merger is expected to be completed by the mid of 2020. The portfolio of the Viatris will have a wide range of drugs and treatments including Celebrex, Viagra, Lipitor and EpiPen.

Mylan shows strong potential for its biosimilar business. The company has diverse biosimilar portfolio with robust development pipeline in place.

Lexicon Pharmaceuticals (LXRX) reported that it plans to shut down its two Zynquista studies due to paucity of funds. The drug candidate was being tested for its efficacy in treating heart failure, chronic kidney disease and type 2 diabetes. The two studies destined to be shut down are SOLOIST and SCORED. Lexicon stated that the decision has been taken after assessing the situation that a likely partnership intended to fund the studies is not likely to happen. The company also counted uncertainties caused by COVID-19 pandemic as one of the reasons.

Lexicon will provide further information about the trials during the announcement of its first-quarter results conference, scheduled to be held in May. The company stated that the decision was taken to preserve financial resources and to focus on other initiatives such as telotristat ethyl in biliary tract cancer and LX9211 in neuropathic pain. Lonnel Coats, president and chief executive officer of Lexicon, added, Pending review of the data, we expect that we will have accrued sufficient exposure data and cardiovascular events to satisfy all requirements for type 2 diabetes and, even with the early close-out, that these studies will contribute scientifically important data in the areas of cardiovascular and chronic kidney disease.

Zynquista has a long history behind it as Lexicon had earlier partnered with Sanofi (NASDAQ:SNY) for developing and commercializing the drug. However, following an FDA rejection earlier in 2019, Sanofi ended the alliance later the year. The companies were working to develop the drug as an add on therapy to insulin injection for improving blood sugar control. Sanofi paid $260 million to Lexicon for ending the collaboration. Zynquista is a dual inhibitor of SGLT1 and SGLT2 and believed to reduce glucose absorption in the gastrointestinal tract and glucose reabsorption by the kidneys. It also believed to stimulate the release of GLP-1.

Celsion (CLSN) provided positive update about Phase 1/2 clinical trial OVATION 2. The company stated that all 15 patients in the trail showed successful resection of their tumors. 78 percent of the patients included in GEN 1 cohort showed an R0 resection, in comparison to only 50 percent of the patients included in the NACT only cohort showing the similar results. R0 resection denotes margin negative resection implying that no cancer cells were found at the outer edge of surrounding tissue. However, the overall response rate of nearly 80 percent was similar for both the groups.

Celsion stated that it plans to begin enrollment for Phase 2 in the second half of this year. It is expected that final progression free data will be available 12 months after the completion of enrollment. Nicholas Borys, M.D., executive vice president and chief medical officer of Celsion, said, "The combined data from our previous Phase Ib dose-escalating trial (OVATION 1 Study) plus this latest data from the Phase I portion of the OVATION 2 Study further confirms the encouraging dose-dependent efficacy of GEN-1 plus NACT. At the highest dosage, the drug showed an 82 percent R0 resection rate.

OVATION 2 has been designed to study the impact of IL-12 gene-mediated immunotherapy GEN-1, combined with standard-of-care neoadjuvant chemo (NACT), in patients with advanced or metastatic ovarian cancer. The patients are required to undergo interval debulking surgery and then three additional cycles of chemo following the NACT. Out of 15 patients included in the study, 9 were given immunotherapy and neoadjuvant chemotherapy whereas remaining 6 were given neoadjuvant chemotherapy alone.

The initial safety data from the first 15 patients was studied by an independent Data Safety Monitoring Board, which concluded that no dose limiting toxicities were found in the 6 evaluable patients who received at least 4 weekly doses of GEN-1 at 100 mg/m2.

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Mylan's COVID-19 Medicine, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha