Merck, Gilead teams up for HIV treatment; Bright Future for Sanofi/Regeneron’s Libtayo; Roche acquires GenMark; FDA okays Melinta’s Kimyrsa

Merck, Gilead  to co-develop combined HIV treatments

Merck and Gilead have announced a collaboration to investigate Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen. 

Both the drugs are first-in-class medicines in late-stage clinical trials, have long half-lives and have demonstrated clinical activity at low dosages in clinical trials. The molecules are under trials as a combination regimen being administered orally as well as intravenously with long-acting formulations. The trials to evaluate the combination therapy are expected to begin in the second half of 2021.

The boon companionship shall help Gilead to bolster its HIV portfolio with the added advantage of turning a potential contender into an ally. Both the companies are heralded as the two of the biggest players in the HIV market and now will be sharing operational responsibilities, operating and manufacturing costs, as well as future profits, if the combination gets successful. 

Sanofi, Regeneron’s Libtayo romps through in Cervical cancer

Overwhelmed with extremely favorable results, Sanofi and Regeneron Pharmaceuticals have halted the Phase III clinical trials evaluating their checkpoint inhibitor Libtayo (cemiplimab) in cervical cancer. The move came after the  Independent Data Monitoring Committee (IDMC) recommended the duo for the same, and now the companies are set to use the data for regulatory submissions.

Going by the word from the company, Libtayo monotherapy is the first therapy that managed to improve OSS in women with recurrent or metastatic cervical cancer following progression on platinum-based chemotherapy in a Phase III trial. 

Not long ago, the USFDA had approved the monotherapy for patients with advanced non-small-cell lung cancer (NSCLC) whose tumors have high PD-L1 expression. Besides, the therapy is approved in two skin cancers, basal cell carcinoma and cutaneous squamous cell carcinoma. However, the companies wanted to launch the drug in a domain that is a little less crowded and competitive. 

Roche set to acquire GenMark for USD 1.8 B

Roche has decided to take a bet worth USD 1.8 Billion on a US-based GenMark, a company that proffers molecular diagnostics solutions to detect multiple pathogens from a single sample. Roche has agreed to acquire all the outstanding shares of GenMark’s common stock at a price of $24.05 per share in an all-cash transaction. 

The deal will help Roche add GenMark’s syndromic panel testing portfolio to its diagnostic armamentarium. GenMark’s Respiratory Pathogen Panels that can detect the most common viral and bacterial organisms causing upper respiratory infections, including SARS-CoV-2, would also be added to Roche’s diagnostics kit.  

The merger has been unanimously approved by the boards of both companies and is expected to be completed during the second quarter of 2021.

Melinta Therapeutics nabs FDA nod for Kimyrsa for Skin infection 

Melinta Therapeutics has announced the USFDA approval of Kimyrsa (oritavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. The therapy is a lipoglycopeptide antibiotic that delivers a complete course of therapy for ABSSSI in a single, one hour 1,200 mg infusion.

The company used the data from Orbactiv’s clinical trials that evaluated the drug in nearly 2,000 patients demonstrating clinical safety and efficiency through a single infusion with headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea reported as the most common side effects. 

The approval can prove to be a turning point for the company providing it with a much-needed boost since, in 2019, it filed for bankruptcy.