Tag Archives: nvs

AbbVie’s Newly Licensed Drug Scores Against Crohn’s Disease

Big Pharma AbbVie ( ABBV ) said Tuesday that a recently licensed drug candidate succeeded in a phase-two trial of Crohn’s disease, as the company seeks to refresh its blockbuster immunology franchise. In the late morning at the Digestive Disease Week conference in San Diego, AbbVie’s researchers presented results from an ongoing phase-two study of risankizumab, a drug AbbVie licensed from Boehringer Ingelheim during the first quarter, in Crohn’s disease. They said that after 12 weeks of treatment, 24% to 37% of patients were in remission — depending on the dose — compared with just 15% in the placebo group. The treated group also had fewer adverse events than the placebo group. Risankizumab is one of a newer group of drugs targeting interleukins, small proteins in cells associated with inflammation, among the proteins is TNF, or tumor necrosis factor. “These results are particularly encouraging because of the difficult-to-treat population within the study,” researcher Brian Feagan said in a statement. “Our patients had endoscopically confirmed moderate or more severe disease activity at study entry and the majority had previously failed treatment with one or more TNF antagonists.” The most popular TNF blocker happens to be Humira, AbbVie’s flagship drug treating Crohn’s disease as well as other immunological conditions like rheumatoid arthritis and psoriasis. Humira’s patents are under fire , however, and last week AbbVie’s stock tumbled when the patent board agreed to review a challenge to a methods patent brought by Coherus BioSciences ( CHRS ). Other drugs targeting interleukins include Novartis ‘ ( NVS ) Cosentyx, launched early last year for psoriasis, as well as Eli Lilly ‘s ( LLY ) Taltz, approved for psoriasis in March. Those drugs target interleukin (IL) 17, while risankizumab targets IL-23 through a novel mechanism of action. “The efficacy of this drug looks to be as good (as), or perhaps even better than IL-17,” Evercore ISI analyst John Scotti said in a video for clients recorded May 3. “And remember, Cosentyx peak sales in consensus right now are about $4 billion.” AbbVie stock was up 2.5% in afternoon trading on the stock market today , near 61, and shares in the past week have found support at the 50-day moving average line.

Pfizer Acquiring Anacor For Potential Blockbuster Eczema Drug

Big pharma Pfizer ( PFE ) said Monday that it’s acquiring small biopharma Anacor Pharmaceuticals ( ANAC ) for $4.5 billion in cash, sending the latter’s stock up more than 50% in early Monday trading. Pfizer agreed to pay $99.26 a share for Anacor, a 55% premium over Friday’s closing price. The total transaction value is $5.2 billion, assuming the conversion of Anacor’s outstanding convertible notes, Pfizer said. Anacor’s sole commercial product is a toenail-fungus ointment called Kerydin, distributed by Novartis ( NVS ), but Pfizer’s press release on the merger played up Anacor’s eczema treatment crisaborole, which is under FDA review due for completion by Jan. 7. “We believe the acquisition of Anacor represents an attractive opportunity to address a significant unmet medical need for a large patient population with mild-to-moderate atopic dermatitis, which currently has few safe topical treatments available,” said Albert Bourla, head of Pfizer’s innovative businesses, in the release. Pfizer estimates crisaborole could reach peak annual sales of $2 billion. The buyout adds another asset to Pfizer’s innovate drug business, which it is widely expected to separate from its established-products business sometime in the next few years. Pfizer has said that it will make a decision on whether to split by year’s end. Pfizer already has a significant presence in inflammation and immunology, including blockbuster rheumatoid arthritis treatments Enbrel (sold in partnership with Amgen ( AMGN )) and Xeljanz.  Regeneron Pharmaceuticals ( REGN ) recently reported strong late-stage data for its injectable drug dupilumab in atopic dermatitis, so while the market is currently underserved, it may soon become more competitive. Anacor stock was up 54.7% in opens trades  on the stock market today , near 99. Pfizer stock was down a fraction, near 33. Regeneron stock was up almost 3%.

Medivation Misses Q1 Estimates As Sanofi Turns Up The Buyout Heat

Drugmaker Medivation ( MDVN ) missed Wall Street’s Q1 estimates and affirmed guidance late Thursday, as it fended off the increasingly hostile attentions of big pharma Sanofi ( SNY ). Medivation’s revenue rose 41% over the year-earlier quarter to $182.5 million, missing analysts’ consensus by $14 million, according to Thomson Reuters. Net income climbed 35% to 11 cents a share, badly missing consensus of 23 cents. Medivation nonetheless affirmed its full-year guidance, calling for $900 million to $970 million in revenue and $1.30 to $1.40 in EPS. Last year, it made $1.01 a share on $943 million in revenue. The company’s revenue comes from royalties on its prostate-cancer drug Xtandi from Japan’s Astellas, which markets the treatment. Medivation said that Xtandi brought in a total of $547 million in the quarter and should sell $1.425 billion to $1.525 billion in the full year. “Consistent with the first quarter of 2015, our first-quarter 2016 non-GAAP net income was impacted by several seasonal items, including the lower royalty rate on ex-U.S. Xtandi sales, the higher gross-to-net (i.e. rebating) accrual by Astellas on U.S. net sales, inventory drawdowns and the previously mentioned SG&A (sales, general & administrative) expenses related to our Astellas collaboration,” Medivation said in its earnings release. Medivation stock was down a fraction in after-hours trading, following its earnings release. Shares had risen a fraction in Thursday’s regular session to 59.22. Earlier Thursday, Medivation rejected a renewed $9.3 billion buyout offer from Sanofi, which Sanofi first made last week, and which Medivation rejected as undervalued. Sanofi CEO Olivier Brandicourt said in a letter to Medivation’s directors that “there is overwhelming support by your shareholders for a transaction.” He said he preferred to engage with Medivation’s management rather than go hostile, but “if you are not prepared to engage with us, we have no choice but to go directly to your shareholders. As you know, your shareholders have the ability to act at any time by written consent to remove and replace the board.” Medivation responded with a press release saying that there was nothing new in the letter and that the offer was still inadequate. Meanwhile, rumors continued to fly about other interested parties. AstraZeneca ( AZN ), Novartis ( NVS ) and Pfizer ( PFE ) had already been named by anonymous sources in previous weeks, but on Thursday Bloomberg reported that big biotech Amgen ( AMGN ) was also pondering a bid as it seeks a major acquisition to fill out its aging drug portfolio. Weeks of buyout speculation have driven the stock up more than 120% since its 30-month low, hit on Feb. 9, helping it to a strong IBD Composite Rating of 97 and the No. 50 spot on the IBD 50 list of top-performing stocks over the past 12 months.