Mon, Mar. 23, 7:30 AM
- With a shortened name and new logo, Biogen (NASDAQ:BIIB) is entering a high risk-high return phase of its corporate life. CEO George Scangos, on board since 2010, is leading the firm into several difficult-to-treat areas in neurodegenerative diseases like Alzheimer's (AD), ALS and spinal muscular dystrophy. It won't take but one or two successes for the payoff to be huge.
- Shares jumped on Friday after the company announced positive Phase 1b results for its Alzheimer's candidate, BIIB037 (aducanumab). If the Phase 3, due to start later this year, is successful it could be the largest selling drug in history. As many as 75M people could be living with AD by 2030.
- Mr. Scangos says, "The future looks pretty exciting for us. If the Alzheimer's thing works, then we're not just an MS (multiple sclerosis) company. We are broadly focused on neurodegenerative diseases. Five years down the road, with some luck, we'll have an Alzheimer's drug that's getting approved. I hope we can transform the treatment of MS. By that time, we will have made substantial progress on ALS and nerve degenerative diseases, spinal muscular dystrophy in kids. All that stuff is on our plate. I am sure of two things, not all it is going to work, but some of it will."
- The company is also working on biosimilars to Amgen's (NASDAQ:AMGN) Enbrel (etanercept) and J&J's (NYSE:JNJ) Remicade (infliximab).
Fri, Mar. 20, 3:56 PM
- Following up on its December announcement about its comparative clinical trial evaluating Cosentyx (secukinumab) versus Janssen's (JNJ +0.7%) Stelara (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis, Novartis (NVS +1.8%) presented more detailed data from the study during a research session at the American Academy of Dermatology meeting in San Francisco.
- Cosentyx showed superiority to Stelara as measured by the proportion of patients achieving a PASI 90 score (subjective improvement of 90%) at Week 16 (79.0% vs. 57.6%; p<0.0001). On the basis of PASI 100 score (completely clear skin), the results also favored Cosentyx (44.3% vs. 28.4%; p<0.0001). In addition, the proportion of patients achieving PASI 75 by Week 4 was 50.0% vs. 20.6%; p<0.0001) in favor of secukinumab.
- Secukinumab is a human monoclonal antibody that inhibits interleukin-17A, a protein found in high concentrations in psoriatic skin. Both the FDA and European Commission (EC) cleared it for the indication in January.
- Previously: Novartis' Cosentyx beats Stelara in Phase 3 trial (Dec. 12, 2014)
Thu, Mar. 19, 10:59 AM
- Janssen Pharmaceuticals (JNJ +0.2%) acquires the anti-thrombin antibody, ichorcumab, by buying XO1 Limited, a privately-held asset-centric virtual biopharmaceutical company founded by venture capital firm Index Ventures. Financial terms of the transaction are not disclosed.
- The antibody was initially developed by England's Cambridge University and Cambridge University Hospitals with the support of its commercialization arm, Cambridge Enterprise who, in turn, licensed it to X01 Limited.
- X01 Limited was established via a fund launched in 2012 by Index Ventures, in which Johnson & Johnson Innovation is an investor.
- Ichorcumab is a recombinant human antibody that mimics the activity of a human antibody that appears to produce an anticoagulated state without predisposition to bleeding.
Tue, Mar. 17, 7:58 AM
- Galapagos NV (OTC:GLPGF) (OTCPK:GLPYY) and Janssen Pharmaceutica NV (NYSE:JNJ) mutually agree to terminate their inflammation alliance and option agreements, a partnership that began in 2007. Galapagos regains the rights to GLPG1690, a selective autotaxin inhibitor currently in Phase 2 development for the treatment of ideopathic (cause unknown) pulmonary fibrosis.
- In December, the companies ended their collaboration in ulcerative colitis, with Galapagos regaining full rights to the GPR84 program, including GLPG1205 and GLPG2196. The original deal had a potential value of $1B+ for Galapagos.
Mon, Mar. 16, 8:50 PM
- A pre-planned interim analysis of the Phase 3 HELIOS study evaluating Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) showed the trial met is primary efficacy endpoint of a statistically significant improvement in progression-free survival (PFS). An Independent Data Monitoring Committee has recommended that the study be unblinded and patients receiving placebo plus BR be offered the option to receive Imbruvica.
- Bendamustine is a nitrogen mustard used to treat CLL. Rituximab (Biogen Idec's Rituxan) is a CD20-directed monoclonal antibody. CD20 is a protein found on the surface of B cells.
- HELIOS is the second randomized study to demonstrate that treatment with Imbruvica significantly improved PFS in CLL or SLL. The Phase 3 RESONATE trial showed similar results for Imbruvica as monotherapy compared to ofatumumab (Glaxo's Arzerra).
- Imbruvica is being co-developed and commercialized by Janssen Biotech (NYSE:JNJ) and Pharmacyclics (NASDAQ:PCYC).
- AbbVie (NYSE:ABBV) is undoubtedly appreciative of the encouraging results.
Wed, Mar. 11, 9:27 AM
- Johnson & Johnson's (NYSE:JNJ) McNeil consumer products business agrees to pay $25M to settle a U.S. government probe into a Pennsylvania-based facility that recalled Tylenol and other OTC medicines several years ago due to quality lapses. Under the terms of the settlement agreement, McNeil pleads guilty to a misdemeanor violation and accepts responsibility for the inadequate filing of required documents during the manufacturing process. It will pay a $20M criminal fine and forfeit $5M.
- The Fort Washington, PA plant was shut down in 2010 and has yet to reopen. Problems included excessive concentrations of active ingredients and musty-smelling products. The recalls included Zyrtec and Benadryl, in addition to Tylenol.
- McNeil's remaining U.S. facilities continue to operate, although under a 2011 permanent injunction.
Tue, Mar. 10, 3:51 PM
- Traders spread their love beyond the rumored acquisition target-stoked up move of Acadia Pharmaceuticals (ACAD +17.7%) to Geron (GERN +12.3%). Shares are up on a whopping 24M shares. Speculators are betting that Geron will be taken out, possibly by Johnson & Johnson (JNJ -0.8%), after the latter was outbid by AbbVie (ABBV +0.9%) for Pharmacyclics (PCYC).
- Previously: Geron gets boost from AbbVie-Pharmacyclics deal (March 5)
- Previously: Acadia Pharma now +17.7% as it cancels out of another conference (March 10)
Tue, Mar. 10, 1:23 PM
- Copenhagen, Denmark-based Genmab A/S plans to start a Phase 1 study of a subcutaneous formulation of its monoclonal antibody, daratumumab, that utilizes Halozyme Therapeutics' (HALO +0.9%) Enhanze technology.
- Daratumumab, being developed under a collaboration between Genmab and Janssen Biotech (JNJ -0.6%), binds to CD38 which is highly expressed on the surface of multiple myeloma cells.
- Cancer immunotherapeutics are typically slowly infused intravenously into patients in order to minimize their side effects while delivering therapeutic doses of medicine. Halozyme's Enhanze, based on its recombinant human hyaluronidase enzyme (rHuPH20), has demonstrated that it can remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). This has the potential to significantly simplify and shorten the process of drug administration.
Fri, Mar. 6, 8:04 AM
- In a trial over injuries blamed on the TVT Abbrevo transvaginal mesh, a California jury ordered Johnson & Johnson's (NYSE:JNJ) Ethicon unit to pay $5.7M to plaintiff Coleen Perry. After more than three days of deliberation in Kern County, jurors found Ethicon liable for problems with the design of TVT Abbrevo and failing to warn patients about its risks. Ms. Perry was awarded $700K in compensatory damages and $5M in punitive damages.
- The verdict is the fourth win for plaintiffs suing the company over the product. More than 36,000 lawsuits have been filed in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The FDA cleared it for sale in 2010.
- Ethicon won one trial in federal court in West Virginia, where another one started on Monday. Ethicon spokesman Matthew Johnson says the company believes it has strong grounds for an appeal of the California verdict. He says Ethicon stands behind the safety and effectiveness of Abbrevo, as well as its development and marketing.
- Ethicon, Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR) face more than 70,000 mesh injury lawsuits in federal court and thousands more in state courts. In December, a federal judge advised Bard to settle more than 12,000 lawsuits in light of the large verdicts awarded to date.
- Previously: Judge advises Bard to settle mesh lawsuits (Dec. 12, 2014)
- Previously: Boston Sci loses first federal case over vaginal mesh product (Nov. 14, 2014)
Thu, Mar. 5, 12:15 PM
- Small cap Geron (GERN +17.8%) jumps on a 3x surge in volume as traders take positions speculating on the potential for a move by imetelstat collaboration partner and exclusive licensee Johnson & Johnson (JNJ +0.8%) after it was apparently outbid by AbbVie (ABBV -3.5%) for Pharmacyclics (PCYC +10.5%).
- SA Contributor Stock Doctor recently published an article on why Geron may be worth a close look.
- Previously: Geron wins deal to develop blood disorder drug, could get $935M (Nov. 13, 2014)
Thu, Mar. 5, 10:07 AM
- On its conference call this morning to discuss the acquisition of Pharmacyclics (PCYC +10.6%), AbbVie (ABBV -2.4%) CEO Rick Gonzalez said that three companies were in the final bidding for the Imbruvica maker in an intensely competitive process. He said that a disclosure will be forthcoming that will provide additional details of the bids.
- The transaction will be accretive to earnings beginning in 2017, adding $0.60 to EPS in 2019 and more than $1.00 by 2021. The incremental sales in 2019 are projected to be >$4B.
- Imbruvica sales should be >$1B in the U.S. this year and peak at >$7B (ABBV's portion). Peak global sales may be ~$11.5B, but J&J's (JNJ +1.1%) contribution is its responsibility so no firm forecast is appropriate.
- Peak sales of the oncology portfolio of both companies could be >$20B by the mid-2020s.
- Mr. Gonzalez said that Humira's status had no bearing on the deal. He was confident with his top seller's long-term prospects, citing two new indications and the pending new formulation that will provide patent protection until the early 2030s. He also said AbbVie will vigorously defend Humira's IP against biosimilars.
- The transaction is 58% in cash and 42% in stock. The final number of ABBV shares will be determined at the time of closing in Q2. About 50% of the stock will be sourced from buybacks and half newly issued. The Board has authorized a $5B increase in its share repurchase program. There will be a 20% dilution to current shareholders. Updated 2015 Non-GAAP EPS is now $4.05 - 4.25 from $4.25 - 4.45.
Thu, Mar. 5, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Wed, Mar. 4, 11:39 PM
- Both boards have signed off on AbbVie's (NYSE:ABBV) $21B surprise acquisition of Pharmacyclics (NASDAQ:PCYC), announced a short while ago amid speculation that Johnson & Johnson (NYSE:JNJ) (or, earlier, Novartis (NYSE:NVS)) would be the one to acquire the cancer biotech.
- With the deal, AbbVie gets Pharmacyclics' blockbuster Imbruvica drug for hematologic malignancies -- which logged $548M in revenues in 2014 (Q4 earnings) and might go all the way to $5B/year. Imbruvica has received four indications in less than 15 months -- the latest being for Waldenström's Macroglobulinemia at the end of January.
- And with Imbruvica, AbbVie can lessen its reliance on its key drug Humira, an aging rheumatoid arthritis medication.
- The acquisition is expected to close in the middle of the year.
- Question: What happened to Pharmacyclics' Imbruvica partner JNJ on this deal?
- Previously: Pharmacyclics Q4 revenue up 135%, Imbruvica growing exponentially (Feb. 18 2015)
Wed, Mar. 4, 11:04 PM
- AbbVie (NYSE:ABBV) says it will be the one to acquire cancer biotech Pharmacyclics (NASDAQ:PCYC), with a surprise bid of about $21B: $261.25/share in cash and equity.
- Pharmacyclics closed up 6.3% today to $230.48 (and gained another 2.9% after hours) on rumors that Johnson & Johnson (NYSE:JNJ) was making a bid for the $17B company.
- Previously: Pharmacyclics up on rumored J&J interest (Mar. 04 2015)
- Previously: Pharmacyclics up on potential buyout (Feb. 25 2015)
- Press release
Wed, Mar. 4, 4:32 PM
- Pharmacyclics (NASDAQ:PCYC) jumps in apparent response to rumors that Johnson & Johnson (NYSE:JNJ) is close to making a premium bid for the $17B biotech. Shares were up 6% in today's session on double normal volume and are up another 2% after hours.
- The two companies have a history of working together. Pharmacyclics and J&J's Janssen Biotech inked a collaboration deal in late 2011 to develop PCI-32765 for a variety of blood cancers.
- The transaction would be the largest for J&J since its takeout of Synthes in 2011 for $21.3B.
Tue, Mar. 3, 7:25 AM
- Privately-held Boehringer Ingelheim files applications for marketing approval in the U.S., Europe and Canada for idarucizumab, a rapid reversal agent for its anticoagulant, dabigatran, the active ingredient in Pradaxa, a prescription blood thinner.
- The FDA designated idarucizumab a Breakthrough Therapy in June of last year. The company will pursue accelerated reviews with all three regulators.
- Blood thinner-related tickers: (NYSE:JNJ) (OTCPK:BAYRY) (NYSE:PFE) (NYSE:BMY)
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Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale ofproducts in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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