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.
Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.
That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
View original post here:
Mylan's COVID-19 Medicine, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha
- Yes, But. The Annotated Atlantic. [Last Updated On: November 7th, 2009] [Originally Added On: November 7th, 2009]
- Health Insurance Benefit Costs by Region [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- For an Operator, Please Press... [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Pollyanna With a Pen: Maine Governor Signs 18 New Health Care Bills into Law [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- AMA Sounds the Alarm, Medicare Making Yet Another Attempt to Cut Reimbursement [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Mass Governor Asks Blue Cross to Keep Higher Employer Contribution [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Lifespan and Care New England Plan Monopoly (Again) [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Dirigo Health: Con Artists, Liars, and Thieves? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- New Orleans: Health Challenges [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- August a Flurry of Activity [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Maine's Dirigo Health Savings One-Third of Original Estimate [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- “Methodolatry”: My new favorite term for one of the shortcomings of evidence-based medicine [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Suzanne Somers’ Knockout: Dangerous misinformation about cancer (part 1) [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- A science-based blog about GMO [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- A Not-So-Split Decision [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Military Medicine in Iraq [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The effective wordsmithing of Amy Wallace [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- A Science Lesson from a Homeopath and Behavioral Optometrist [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Join CFI in opposing funding mandates for quackery in health care reform [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Mainstreaming Science-Based Medicine: A Novel Approach [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Those who live in glass houses… [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- J.B. Handley of the anti-vaccine group Generation Rescue: Misogynistic attacks on journalists who champion science [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- When homeopaths attack medicine and physics [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The cancer screening kerfuffle erupts again: “Rethinking” screening for breast and prostate cancer [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- All Medicines Are Poison! [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- When Loud Wins: Will Your Tax Dollars Pay For Prayer? [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- It’s All in Your Head [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The Skeptical O.B. joins the Science-Based Medicine crew [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- The Tragic Death Toll of Homebirth [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- What’s the right C-section rate? Higher than you think. [Last Updated On: November 8th, 2009] [Originally Added On: November 8th, 2009]
- Recombinant Human Antithrombin – Milking Nanny Goats for Big Bucks [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Does C-section increase the rate of neonatal death? [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Man in Coma 23 Years – Is He Really Conscious? [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Why Universal Hepatitis B Vaccination Isn’t Quite Universal [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Ontario naturopathic prescribing proposal is bad medicine [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- The Institute for Science in Medicine enters the health care reform fray [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Neti pots – Ancient Ayurvedic Treatment Validated by Scientific Evidence [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Early Intervention for Autism [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- A temporary reprieve from legislative madness [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- A critique of the leading study of American homebirth [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Lose those holiday pounds [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Endocrine disruptors—the one true cause? [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Evidence in Medicine: Experimental Studies [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Midwives and the assault on scientific evidence [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- The Mammogram Post-Mortem [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- An Influenza Recap: The End of the Second Wave [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- The End of Chiropractic [Last Updated On: December 13th, 2009] [Originally Added On: December 13th, 2009]
- Cell phones and cancer again, or: Oh, no! My cell phone’s going to give me cancer! (revisited) [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Another wrinkle to the USPSTF mammogram guidelines kerfuffle: What about African-American women? [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Acupuncture, the P-Value Fallacy, and Honesty [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- The One True Cause of All Disease [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Communicating with the Locked-In [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Are the benefits of breastfeeding oversold? [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Measles [Last Updated On: December 20th, 2009] [Originally Added On: December 20th, 2009]
- Radiation from medical imaging and cancer risk [Last Updated On: December 21st, 2009] [Originally Added On: December 21st, 2009]
- Multiple Sclerosis and Irrational Exuberance [Last Updated On: December 21st, 2009] [Originally Added On: December 21st, 2009]
- Medical Fun with Christmas Carols [Last Updated On: December 22nd, 2009] [Originally Added On: December 22nd, 2009]
- Lithium for ALS – Angioplasty for MS [Last Updated On: December 23rd, 2009] [Originally Added On: December 23rd, 2009]
- “Toxins”: the new evil humours [Last Updated On: December 24th, 2009] [Originally Added On: December 24th, 2009]
- 2009’s Top 5 Threats To Science In Medicine [Last Updated On: December 24th, 2009] [Originally Added On: December 24th, 2009]
- Buteyko Breathing Technique – Nothing to Hyperventilate About [Last Updated On: December 26th, 2009] [Originally Added On: December 26th, 2009]
- The Graston Technique – Inducing Microtrauma with Instruments [Last Updated On: December 29th, 2009] [Originally Added On: December 29th, 2009]
- The “pharma shill” gambit [Last Updated On: December 29th, 2009] [Originally Added On: December 29th, 2009]
- Ginkgo biloba – No Effect [Last Updated On: December 30th, 2009] [Originally Added On: December 30th, 2009]
- Oppose “Big Floss”; practice alternative dentistry [Last Updated On: January 1st, 2010] [Originally Added On: January 1st, 2010]
- Causation and Hill’s Criteria [Last Updated On: January 3rd, 2010] [Originally Added On: January 3rd, 2010]
- The life cycle of translational research [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- The anti-vaccine movement strikes back against Dr. Paul Offit [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- Osteoporosis Drugs: Good Medicine or Big Pharma Scam? [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- Acupuncture for Hot Flashes [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- The case for neonatal circumcision [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- A victory for science-based medicine [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- James Ray and testosterone replacement therapy (TRT) [Last Updated On: January 10th, 2010] [Originally Added On: January 10th, 2010]
- The Water Cure: Another Example of Self Deception and the “Lone Genius” [Last Updated On: January 12th, 2010] [Originally Added On: January 12th, 2010]
- Be careful what you wish for, Dr. Dossey, you just might get it [Last Updated On: January 13th, 2010] [Originally Added On: January 13th, 2010]
- You. You. Who are you calling a You You? [Last Updated On: January 15th, 2010] [Originally Added On: January 15th, 2010]
- The War on Salt [Last Updated On: January 16th, 2010] [Originally Added On: January 16th, 2010]
- Is breech vaginal delivery safe? [Last Updated On: January 16th, 2010] [Originally Added On: January 16th, 2010]