Recognizing potential in RSV

Johnson & Johnson deals out $1.75B for respiratory disease company Alios

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NEW BRUNSWICK, N.J.—Pharma giant Johnson & Johnson isn't interested in closing 2014 quietly, marking the last quarter of the year instead with the $1.75-billion acquisition of privately held Alios BioPharma Inc. The South San Francisco, Calif.-based clinical-stage biopharmaceutical firm is focused on the development of antiviral therapies for respiratory diseases, so the deal nabs Johnson & Johnson a portfolio of drug candidates in a variety of indications, including influenza, rhinovirus and respiratory syncytial virus (RSV). Both companies' boards of directors unanimously approved the transaction.
“We are so pleased to be joining the Janssen Pharmaceutical companies of Johnson & Johnson, who have an impressive track record of bringing breakthrough drugs for viral diseases to market,” Dr. Lawrence M. Blatt, president and CEO of Alios BioPharma, said in a news release. “Our portfolio of novel medications targets a diverse range of viral infections, including respiratory syncytial virus, which complements ongoing efforts by Janssen to develop innovative treatments for important and life-threatening infections.”
The transaction, which is subject to customary closing conditions including the Hart-Scott-Rodino Act, is expected to close in the fourth quarter of this year.
“We are excited that this acquisition will enable us to explore treatment options for a number of viral infections, including RSV, the last of the major pediatric diseases with no available preventive therapy,” commented Dr. William N. Hait, global head of research and development at Janssen. “AL-8176 complements our existing early-stage portfolio for RSV, which aims to prevent and treat this disease, the leading cause of acute lower respiratory infection in children under the age of five.”
AL-8176 is a nucleoside analog under development as an oral antiviral therapy against RSV. The compound inhibits RSV's replication by acting on the viral polymerase, and demonstrates a high barrier to the development of viral resistance. RSV is the most common cause of serious lower respiratory tract infections in infants, and though most healthy adults can recover from RSV infection fairly quickly, infection can also be severe for the elderly, immunocompromised or those with preexisting pulmonary issues. The U.S. Centers for Disease Control and Prevention note that “Almost all children will have had an RSV infection by their second birthday.” There is also a link between RSV infections and the later development of asthma in children. No effective treatments exist for RSV.
On Oct. 13, Alios announced results from a Phase 2 challenge study of AL-8176, a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers who had been infected with RSV intranasally. Sixty-two healthy volunteers received either placebo or one of three dosing regimens of AL-8176: 375 mg administered orally twice daily, or 750 mg given as a single loading dose followed by twice-daily maintenance doses of 150 mg or 500 mg. In the study, AL-8176 reached its primary and secondary endpoints of reduction in viral load and improvement in symptom scores compared to placebo. The drug candidate was found to be well tolerated, with no discontinuations and no clinically significant laboratory abnormalities.
All three dosage groups of AL-8176 demonstrated a rapid, significant reduction in RSV viral load following treatment, with a mean time to nondetectability of RSV load of 1.3 to 2.3 days for the AL-8176 treatment groups. At day 12, all subjects that received AL-8176 were RSV RNA undetectable, and remained so upon follow-up on days 16 and 28.
“Alios BioPharma’s pipeline is closely aligned with our vision to continue to address important unmet medical needs through scientific innovation,” Dr. Johan Van Hoof, global head of infectious diseases and vaccines at Janssen, noted in a statement. “This acquisition will allow us to combine their innovative compounds with our vast experience in viral diseases to deliver novel medicines and treatment options for patients worldwide.”
This could be a boost in Johnson & Johnson's ability to compete with rival Gilead Sciences in another arena, as Gilead is also advancing an RSV drug candidate: GS-5806, an investigational oral RSV fusion inhibitor that saw positive results in a Phase 2a study earlier in the year. Michael Yee, an RBC Capital Markets analyst, noted that an RSV drug could potentially see annual sales of at least $1 billion.
The companies raced each other to be the first to get a hepatitis C compound approved last year, and while both got a horse to the track, so to speak—Gilead's Sovaldi and Johnson & Johnson's Olysio—Sovaldi has outperformed its competition, seeing better Phase 3 clinical trial results and becoming “the drug to most rapidly ever reach billion-dollar blockbuster status, with sales totaling more than $5 billion in the first six months of this year,” according to a Motley Fool article. Alios also has three hepatitis C compounds in its pipeline, in preclinical, IND and Phase 2 development.

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