Revenue Drop for Gilead's COVID-19 Antiviral Indicative of Waning Pandemic Returns

 Gilead Sciences has been a key player in the COVID-19 space, and in the first quarter of 2022, its antiviral, Veklury, was its largest driver for revenue. But in its Q2 report released Tuesday, Gilead reported Veklury sales had dropped by 46%.

Gilead said this drop was expected, citing the waning pandemic as the cause. In its press release, the company stated, “Veklury revenue generally reflects COVID-19 rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccinations and alternative treatments for COVID-19.” 

Despite this significant drop, Veklury revenue actually exceeded expectations for the quarter. Gilead now expects the drug to generate $2.5 billion in sales for the year, up half a billion from its previous prediction.  And in after-hours trading following the earnings report, the company's stock was up 1%, according to Investor’s Business Daily. 

Aside from Veklury, Gilead’s report was positive overall, with a mix of highs and lows. 

“Excluding Veklury, product sales grew 7% year-over-year. There was continued strong demand for our HIV portfolio with further share growth for Biktarvy, and oncology revenues reached an all-time high, driven by cell therapy and Trodelvy," Gilead Chairman and CEO Daniel O’Day said on a conference call Tuesday evening. 

HIV is a significant focus area for Gilead. Last month, the company resubmitted a New Drug Application to the U.S. Food and Drug Administration for lenacapavir, which is designed to be a long-acting inhibitor against HIV. And in late July, Gilead released positive data for a trial studying Biktarvy, another treatment for people with HIV, including patients with HBV coinfection. 

Biktarvy and Descovy were the leaders for Gilead in the HIV space, with respective increases of 28% and 6%. This could be partially due to Gilead’s efforts to decrease the sale of counterfeits. The company announced in January that about $250 million worth of counterfeit versions of both drugs had been sold to pharmacies for two years. By the time of the announcement, Gilead had already taken “direct and urgent legal action.” 

Gilead’s Diluted Earnings Per Share (EPS), Non-GAAP diluted EPS and total cash saw a marked decrease. The company largely attributed this decline to losses in equity investments, royalty expenses for Biktarvy and a $300 million upfront payment contained in its collaboration with Dragonfly Therapeutics. As BioSpace previously reported, Gilead's goal is to bring Dragonfly's DF7001 natural killer (NK) engager program designed for patients with cancer or inflammatory diseases to fruition. 

Gilead’s total revenue for Q2 increased 1% to $6.3 billion compared to Q2 2021. Overall, the company exceeded both its own expectations and the predictions of market analysts for the second quarter, surprising even itself and giving investors a much brighter outlook for the remainder of the year. 

https://www.biospace.com/article/despite-drop-in-covid-antiviral-gilead-exceeds-expectations-for-q2/

Ipsen's Onivyde Flops in Late-Stage Small Cell Lung Cancer

 Ipsen's Phase III RESILIENT study on Onivyde (irinotecan liposomal injection) for small cell lung cancer failed to achieve the primary overall survival (OS) target compared to topotecan.

In its announcement, the France-based company said Onivyde did not show greater benefit than the currently preferred topotecan when used in patients with SCLC who have progressed on or after platinum-based first-line therapy treatment.

The FDA granted Ipsen a Fast Track designation for Onivyde in December 2020. Onivyde is currently approved by the U.S. Food and Drug Administration to be used with leucovorin (LV) and fluorouracil (5-FU) for patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

In the randomized, open-label RESILIENT study, the drug was evaluated in two parts: first, in an open-label dose-finding trial involving 30 patients, and second, in a randomized efficacy trial versus intravenous topotecan, where 450 patients were enrolled.

The first part demonstrated Onivyde's safety, tolerability, and optimal monotherapy dose. However, in the second part, it was unable to show better OS outcomes, which was the primary endpoint.

Secondary endpoints were progression-free survival, objective response rate, quality of life assessments, serious adverse events, incidence of treatment-emergent adverse events and laboratory abnormalities.

Despite not meeting the primary endpoint, Ipsen scientists did see objective response rate (ORR) levels double for Onivyde takers in the second part. In addition, no new safety concerns had emerged. For this reason, the company is not entirely scrapping the project just yet and said it would explore the data further for any possible favorable indicators.

"We will now work with our teams to analyze the data further before decisions regarding next steps are made. These data confirm the complexities associated with treating small cell lung cancer. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial," Howard Mayer, M.D., executive vice president and head of research and development at Ipsen, commented.

The company expects to share the results of the RESILIENT study at an upcoming yet-to-be-named medical conference.

It has been a busy week for Ipsen, which announced Monday that it signed a multi-year partnership deal with Marengo Therapeutics to use its precision T cell immuno-oncology candidates for clinical testing. Ipsen will pay $45 million upfront for access to two of Marengo's solid tumor candidates created using its Selective T Cell Activation Repertoire (STAR) antibody fusion platform. Ipsen also will pay as much as $1.592 billion in the future if all milestones are achieved.

https://www.biospace.com/article/ipsen-s-onivyde-fails-to-meet-primary-endpoint-in-sclc-versus-topotecan/

Anticipating Fragmented Booster Market, Moderna Prioritizes New Product Launches

 Moderna reported a strong second-quarter Wednesday, citing revenues of $4.7 billion for a half-year total of $10.8 billion. The company’s strong position is bolstered by recently signed advanced purchase agreements with the U.S. government and others for its mRNA-based COVID-19 vaccine, equaling approximately $21 billion.

Moderna CEO Stéphane Bancel expressed unreserved confidence about his company’s prospects.

“Despite the slowing economy and challenges in the biotech industry, Moderna is in a unique position: a platform to drive scale and speed in research of new medicines, a strong balance sheet with $18 billion cash and an agile, mission-driven team of over 3,400 people and growing,” he said. “We will continue to invest and grow as we have never been as optimistic about Moderna’s future.”

The company currently has four Phase III trials underway for infectious diseases and is projecting proof-of-concept data later this year from its rare disease and immuno-oncology programs. While the company’s sole marketable product remains the COVID-19 vaccine, Bancel noted, “Our teams are actively working to prepare these new product launches to help patients and drive growth. This is an exciting time for Moderna as we continue to see significant scientific and business momentum.”

Moderna has 46 programs in development with 43 candidates, 31 of which are in active clinical trials. Although its original COVID-19 vaccine is still going strong and a two-dose series for children six months to 17 years of age recently received emergency use authorization from the U.S. Food and Drug Administration, it is also developing a bivalent vaccine that contains the original and a modified formulation to target the Omicron variants. Moderna expects this vaccine to be authorized in the fall.

The four Phase III trials are for two different flu shots, a COVID-19 and flu vaccine combination and an mRNA-based treatment for glycogen storage disease type 1 (GSDA1). Additional programs include vaccines for cytomegalovirus, Epstein-Barr virus, HIV, HSV, Zika virus and Nipah virus and therapeutics for methylmalonic acidemia (MMA) and cystic fibrosis. 

Anticipating a Fragmented Booster Market

On the investor call, Chief Medical Officer Dr. Paul Burton, M.D., Ph.D. focused on COVID-19. “The top of mind is who should get boosted and when to get boosted (for COVID-19). Boosting is highly effective, reducing the risk of infection,” he said, describing a Spanish study of more than 3 million people.

He also presented U.S. and U.K. studies supporting the effectiveness of the Moderna vaccine booster shots compared to the Pfizer-BioNTech vaccines. “Results show higher antibody levels with three Moderna shots compared to three Pfizer-BioNTech” shots, including against Omicron BA.1. “Taken together, these data demonstrate the strong performance of the Moderna vaccine in a real-world model, including against variants of concern.”

That said, the company believes the booster market will become increasingly fragmented and is planning accordingly to develop its bivalent vaccine and strike commercial agreements for it.

Shares Anyone?

Flush with cash, Moderna’s board of directors approved a new share buyback program for $3 billion. Prior to the fourth quarter of 2021, the company did not run share repurchases. It had put aside $1.9 billion in cash for stock buybacks for the months that ended June 30, 2022. From the end of the third quarter of 2021 to the close of Q2 2022, Moderna repurchased 16 million shares. The board authorized a repurchase program for $3 billion in August 2022 as a way to “return excess capital to shareholders.”

https://www.biospace.com/article/flush-with-cash-and-expectations-moderna-plans-3b-stock-buyback-/

Merck's Keytruda Takes Another Hit with Phase III Prostate Cancer Fail

 Merck's Keytruda (pembrolizumab) has taken another hit after the drug failed to meet dual primary endpoints in the Phase III KEYNOTE-921 trial for metastatic castration-resistant prostate cancer (mCRPC).

The randomized, double-blind study enrolled 1,030 patients who received either 200mg of Keytruda every three weeks for around two years plus prednisone and chemotherapy or a placebo with prednisone and chemotherapy. The participants were mCRPC patients who have not undergone chemotherapy but whose disease has progressed or are intolerant to a next-generation hormonal agent.

The two primary endpoints were overall survival (OS) and radiographic progression-free survival (rPFS). The secondary endpoints were prostate-specific antigen response rate, time to initiation of the first subsequent anti-cancer therapy, duration of response and objective response rate.

At the end of the study, although no new safety concerns were observed, Keytruda did not demonstrate significant improvements based on the pre-specified statistical plan. Full details will be shared at a future medical conference.

Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by boosting the immune system's ability to detect and kill tumor cells. Prostate cancer is the second most common cancer in men worldwide, and 10% to 20% of patients with the advanced version are likely to develop CRPC in five years. At least 85% of these will have metastases upon CRPC diagnosis.

"Results from this study serve as an important reminder that metastatic prostate cancer remains very difficult to treat, and more research is needed. We will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with this disease. We are grateful to the patients and investigators for their participation in this study," Dr. Eliav Barr, the senior vice president, head of global clinical development and chief medical officer of Merck Research Laboratories, said in a statement.

This disappointing news follows one month after the company announced that its Phase III trial of Keytruda for unresected, locally advanced head and neck squamous cell carcinoma (HNSCC) failed to achieve the primary endpoint of event-free survival. That same week, Merck also said it is no longer continuing its Phase III study on Lynparza for colorectal cancer.

Despite the results, Merck, known as MSD outside the United States and Canada, is not backing down on its oncology research and development activities, particularly for prostate cancer. It has several ongoing studies involving Keytruda to find a viable treatment for the said disease. These include Phase II trials KEYNOTE-199 and KEYNOTE-365 and Phase III trials KEYNOTE-641 and KEYNOTE-991.

Keytruda is approved in the U.S. for various indications, including unresectable or metastatic melanoma, relapsed or refractory classical Hodgkin lymphoma, locally advanced or metastatic urothelial carcinoma and non-muscle invasive bladder cancer, among others. There are currently over 1,600 trials studying Keytruda for various cancers and rare diseases worldwide.

https://www.biospace.com/article/merck-s-keytruda-takes-another-hit-fails-phase-iii-trial-for-prostate-cancer/

Horizon Therapeutics revises guidance

 Revises Full-Year 2022 Guidance:

-- Full-Year 2022 Net Sales Guidance of $3.53 Billion to $3.60 Billion, Reflecting Revised Net Sales Expectations for TEPEZZA and Inflammation Segment --
-- Full-Year 2022 Adjusted EBITDA Guidance of $1.30 Billion to $1.35 Billion --
-- Full-Year 2022 TEPEZZA Net Sales Percentage Growth in the High-Teens --

https://finance.yahoo.com/news/horizon-therapeutics-plc-reports-second-110000452.html

NeuroOne: $3.5 M Accelerated Milestone Payment from Zimmer

 NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company entered into an amendment to its Exclusive Development and Distribution Agreement with Zimmer Biomet, Inc. ("Zimmer") that will provide the Company with a $3.5 million accelerated payment within 10 business days which relates to certain milestone payments.  In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company's common stock, with an exercise price of $3.00 per share.

https://finance.yahoo.com/news/neuroone-announces-3-5-million-130000621.html

Poseida to Collaborate with Roche on Allogeneic CAR-T Cell Therapies

Leveraging Poseida's novel approach to cell therapy and Roche's expertise in developing and commercializing therapies to transform cancer care, the collaboration is focused on advancing multiple existing and additional next generation allogeneic CAR-T programs directed to hematologic malignancies

Poseida will receive $110 million upfront, could receive up to $110 million in near-term milestones and other payments, and is eligible for future development and commercial milestones and tiered royalty payments

Poseida to host a brief conference call today at 8:30 a.m. ET

Poseida Therapeutics Conference Call and Webcast Information
Wednesday, August 3, 2022 at 8:30 a.m. ET

Poseida's management team will host a conference call and webcast today at 8:30 a.m. ET to discuss the collaboration and Poseida's novel approach to allogeneic cell therapy. The dial-in numbers for domestic and international callers are 800-267-6316 and 203-518-9814, respectively. The conference ID number for the call is PSTX0803.

Participants may access the live webcast on the Investors & Media Section of the Poseida website, www.poseida.com. An archived replay of the webcast will be available for approximately 30 days following the event.

https://finance.yahoo.com/news/poseida-therapeutics-announces-strategic-global-113000681.html