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Mar. 10, 2015, 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.
Mar. 6, 2015, 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)
Mar. 5, 2015, 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)
Mar. 5, 2015, 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.
Mar. 5, 2015, 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).
Mar. 4, 2015, 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)
Mar. 4, 2015, 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)
Mar. 4, 2015, 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.
Mar. 3, 2015, 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)
Mar. 2, 2015, 8:55 AM
- As rumored, Johnson & Johnson (NYSE:JNJ) sells its underperforming Cordis unit to Cardinal Health (NYSE:CAH), which picks up the interventional vascular technology business for $1.99B. The transaction is expected to close by end of the year.
- Both stocks are unchanged premarket.
- Previously: J & J rumored to have found a buyer for Cordis unit (Feb. 23)
Feb. 26, 2015, 6:15 PM
- UnitedHealth (NYSE:UNH) has tightened its controls on hysterectomy coverage -- requiring doctors to get pre-approval from the insurer before performing most types of the procedure.
- Only outpatient vaginal hysterectomies (a small minority) won't require approval -- but the overall insurance trend is for more pre-authorizations for care, and hysterectomies are one of the most common surgeries for American women.
- It's also another hit to the laparoscopic power morcellator -- which uses spinning blades to break up tissue through small incisions. The FDA started warning against using the devices last year, and many hospitals have banned them, as they can spread a dangerous uterine cancer.
- Johnson & Johnson (NYSE:JNJ) started removing its morcellators from the market last summer.
Feb. 25, 2015, 4:47 PM
- The FDA's Arthritis Advisory Committee postpones its March 17 meeting due to pending information requests with sponsor Celltrion. This is a setback for the South Korean biopharmaceutical firm since it was expecting a positive vote on its biosimilar to Janssen Biotech's (NYSE:JNJ) Remicade (infliximab). The pan-European launch is just getting underway.
- Previously: Remicade biosimilars launched in Europe (Feb. 25)
Feb. 25, 2015, 1:43 PM
Feb. 25, 2015, 7:36 AM
- The long-anticipated major debut of biosimilars is underway in Europe. South Korean biopharmaceutical firm Celltrion's biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab) will be launched in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden under the brand name Inflectra by commercial partner Hospira (NYSE:HSP) (NYSE:PFE) and in Germany, Italy, Britain, the Netherlands, Belgium and Luxembourg under the brand name Remsima by privately-held Indian drug firm Mundipharma.
- Biosimilars to Remicade have been available in certain smaller markets in Europe for several months, but this is the first move into major markets so the results will closely watched from the global biotech industry.
- Remicade generated almost $6.9B in sales for J&J the past four quarters, including ~$2.3B in Europe.
- Remsima was approved by the European Medicines Agency in 2013. The FDA's Arthritis Advisory Committee will meet on March 17 to discuss Celltrion's biologics license application (BLA) for clearance in the U.S.
Feb. 23, 2015, 4:18 PM
- It appears that Johnson & Johnson (NYSE:JNJ) may have found a buyer for its underperforming Cordis business, something it's been seeking since August. Cardinal Health (NYSE:CAH) is rumored to be the front-runner for the medical device company.
- Cordis is the second largest unit within J&J, but it was the worst performing last year with a 3.5% decline in sales despite being the pioneer of drug-coated stents and the former market leader. The company was unable to maintain its leadership due to formidable competition and downward price pressure from insurers and hospitals.
- The company expects Cordis to fetch $1.5B - 2.0B.
Feb. 23, 2015, 11:04 AM
- The FDA's Orthopedic and Rehabilitation Devices Advisory Panel votes 5 -1 (2 abstain) that VertiFlex's Superion Interspinous Spacer System is safe and 4 -2 (2 abstain) that the risk-benefit profile is adequate.
- The FDA does not have to abide by the vote in its final decision, but it usually follows the committee's recommendation.
- Related tickers: (ABT -0.2%)(MDT +0.3%)(JNJ +0.2%)
- Previously: Ad Comm review approaches for Vertiflex spinal implant (Feb. 18)
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale of products in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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