Sovaprevir

May 20, 2015 By Mark Terry , BioSpace.com Breaking News Staff Senior executives from the Johnson & Johnson company Janssen Pharmaceutical Companies announced at an analyst meeting today that it plans to new products for regulatory approval over the next four years. In addition to looking for approval for those 10 drugs, Janssen is looking to extend 40 existing product lines. Analysts believe the 10 new drugs have an annual sales potential of more than $1 billion—each. One of the drugs J&J plans to for in the U.S. and Europe is daratumumab for the treatment of double refractory multiple myeloma. The company paid more than $1.1 billion to Genmab A/S to license and develop the drug in 2012. Larry Biegelsen , an analyst at Wells Fargo & Co. indicates that the timeline for this drug is faster than expected. In addition, the company plans to defend its patent for Remicade, which expires in September 2018. Two companies, Celltrion and Hospira, Inc. , are working to develop biosimilars to Remicade, a treatment for arthritis. “Biosimilars are not generics and we expect the market to behave quite differently,” said Joaquin Duato , Worldwide Chairman, Pharmaceuticals for J&J in a statement. The company’s new products will be in Immunology, Neuroscience, Infectious Diseases & Virology, Cardiovascular/Metabolism and Oncology. In addition to the newly announced drug applications, the company notes that it may have other submissions on the near horizon. “Historically our growth has been driven by inorganic activity and you should expect that to continue in the future,” said Duato during today’s presentation. Analysts with Bloomberg Intelligence have projected that J&J ’s new drug sales, those approved in the last six years, will increase by eight percent each year through 2020. This is slower than the median rate of its competitors. Competition is fierce. J&J ’s hepatitis C treatment, Olysio, doesn’t compete with new and better products on the market such as AbbVie ’s Viekira Pak and Gilead Sciences, Inc. ’s Sovaldi and Harvoni. Merck & Co. announced in April 2015 the first data from its Phase II/III clinical trial for a drug, grazoprevir/elbasvir, to treat patients with advanced chronic kidney disease (CKD) that also have chronic hepatitis C (HCV) genotype 1 (GT1). J&J also plans to develop and sell Achillion Pharmaceuticals, Inc. ’s HCV drugs with an investment of $225 million in the company and a combined deal hitting $1.1 billion. Janssen Pharmaceuticals will be responsible for developing and selling the treatments. Achillion ’s lead HCV compounds include ACH-3102, ACH-3422 and sovaprevir. Despite this competition, according to IMS Health , Johnson & Johnson is among the fastest growing companies among the top 10 global pharmaceutical companies in the U.S., Europe and Japan in 2014. Each of the 10 new products J&J is submitting regulatory filings for has the potential to generate $1 billion in revenue each. “In the past two years,” said Duato in today’s webcast , our performance and growth rates have been industry-leading, and we look forward to continuing to drive above-industry growth with our current in-market portfolio and next wave of medicines. We are working with our partners to advance the innovative products in our pipeline and to delivery significant benefits to patients.” Will Mylan Buy Teva, As Predator Becomes Prey? The complicated three-way takeover waltz being conducted between Pittsburgh, Penn.-based Mylan Inc. , Israeli company Teva Pharmaceutical Industries Ltd. and Perrigo Company took another weird turn last week, after Mylan said that while it still views Teva’s unsolicited $40.1 billion bid as too low, it might want to acquire Teva itself eventually. Mylan Chairman Robert J. Coury made it clear that if Mylan is able to cement its deal with Perrigo, it might go shopping again—and this time to buy Teva, not be bought. With dealmaking heating up in 2015, we wanted to know your thoughts: Will perennial predator Teva wind up being prey? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-mylan-buy-teva-as-predator-becomes-prey", placeholder: "pd_1432056579" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));

May 20, 2015 By Riley McDermid , BioSpace.com Breaking News Sr. Editor Johnson & Johnson has signed a $1.1 billion pact with Achillion Pharmaceuticals, Inc. to develop and market its hepatitis C drugs, as the competition in the space becomes fierce and companies have been scrambling to combine forces to usher in a new era of treatment. Under the terms of the deal, Achillion will get up to $1.1 billion in milestone payments if the company hits its marks in development, regulatory approval and sales. Achillion will also get $225 million from JNJ in return for 18.4 million unregistered shares at $12.25 per share. The deal is a sign that Johnson and Johnson is looking to get ahead of the curve as “cure” treatments have begun appearing in the hepatitis C space, including the drugs Sovaldi and Harvoni from Gilead Sciences, Inc. , which have a 90 percent cure rate. Achillion has three hepatitis C drugs at various stage of readiness: ACH-3102 and sovaprevir in mid-stage trials and ACH-3422 in early-stage trials. The U.S. Food and Drug Administration (FDA) granted fast-track status to ACH-3102 in December and it quickly gained the attention of anyone trying to treat or cure the disease. Market leader Gilead Sciences, Inc. (GILD) has been feeling pressured by ACH-3102, which has shown promising Phase II results when combined with Gilead ’s own blockbuster near-cure Sovaldi. The shortened treatment duration could take a bite out of Gilead ’s sales, as the drug continues to meet important milestones. With a standard 12-week course of Sovaldi costing $84,000, a drug that can cut that timeline in half would be a significant threat to Gilead ’s bottom line. Achillion attracted a lot of notice last fall when it said a combo of ACH-3102 and Sovaldi had functionally cured 100 percent of the patients involved in a small, 8-week trial. Then in February, it released results that showed that the combo was able to replicate that 100 percent cure rate after only six weeks of treatment—a truncated timeline that could eventually cost Gilead millions of dollars in lost revenue. “The success of ACH-3102 suggests that it could be a better drug than ledipasvir, and that opens up the potential for ACH-3102 to be paired up with other Sovaldi alternatives,” wrote Todd Campbell , a columnist at the Motley Fool . “ Achillion Pharmaceuticals hopes that its own in-house option, ACH-3422, can prove to be just as potent as Sovaldi, and if it is, that it can achieve similar short-duration cure rates when paired up with ACH-3102.” Sovaldi sells for approximately $1,000 per pill, while its sister medication, also from Gilead , Harvoni, sold about $2.1 billion in 2014. Similar competitor AbbVie (ABBV) ’s HCV medication Humira recorded $12.5 billion in sales and is now gaining on the coattails of AbbVie ’s new hepatitis C treatment, Viekira Pak. AbbVie received fast-track designation for the Viekira Pak in December, but Wall Street analysts remained sanguine about the drug’s approval. So far they’ve expressed disappointment at the so far limited approved uses for it among a growing population of hepatitis C patients—particularly those in prison or covered under large benefits providers like Express Scripts Inc. or Medicaid and Medicare . “ AbbVie ‘s Viekira Pak was approved Friday afternoon as expected, with a label that failed to achieve the full advantage some had expected for the company’s powerful but cumbersome 3d regimen. Viekira Pak requires ribavirin for all G1a and cirrhotics,” wrote analyst Geoffrey Porges for Sanford Bernstein in a note to investors at the time. “Like Gilead (GILD) ‘s Harvoni, AbbVie ‘s duration of treatment was extended to 24 weeks for genotype 1a with cirrhosis (approximately 10 percent of patients) and only in genotype 1b without cirrhosis (20 percent of g1 patients) did Abbvie escape Ribavirin,” he said. Will Mylan Buy Teva, As Predator Becomes Prey? The complicated three-way takeover waltz being conducted between Pittsburgh, Penn.-based Mylan Inc. , Israeli company Teva Pharmaceutical Industries Ltd. and Perrigo Company took another weird turn last week, after Mylan said that while it still views Teva’s unsolicited $40.1 billion bid as too low, it might want to acquire Teva itself eventually. Mylan Chairman Robert J. Coury made it clear that if Mylan is able to cement its deal with Perrigo, it might go shopping again—and this time to buy Teva, not be bought. With dealmaking heating up in 2015, we wanted to know your thoughts: Will perennial predator Teva wind up being prey? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-mylan-buy-teva-as-predator-becomes-prey", placeholder: "pd_1432056579" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));